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Micotil 300

Dosage Form: FOR ANIMAL USE ONLY
Micotil ® 300 Injection

Tilmicosin Injection, USP

NADA 140-929, Approved by FDA

AH0230

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Micotil® is a solution of the antibiotic tilmicosin. Each mL contains 300 mg of tilmicosin, USP as tilmicosin phosphate in 25% propylene glycol, phosphoric acid as needed to adjust pH and water for injection, Q.S. Tilmicosin, USP is produced semi-synthetically and is in the macrolide class of antibiotics.

Indications:

Micotil is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and for the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica. Micotil is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica.

Dosage and Administration:

Inject Subcutaneously in Cattle and Sheep Only. In cattle, administer a single subcutaneous dose of 10 to 20 mg/kg of body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs). In sheep greater than 15 kg, administer a single subcutaneous dose of 10 mg/kg of body weight (1 mL/30 kg or 1.5 mL per 100 lbs).

Do not inject more than 10 mL per injection site.

If no improvement is noted within 48-hours, the diagnosis should be reevaluated.

For cattle and sheep, injection under the skin in the neck is suggested. If not accessible, inject under the skin behind the shoulders and over the ribs.

Note: Swelling at the subcutaneous site of injection may be observed.

Contraindications:

Do not use in automatically powered syringes. Do not administer intravenously to cattle or sheep. Do not use in lambs less than 15 kg body weight. Intravenous injection in cattle or sheep will be fatal. Do not administer to animals other than cattle or sheep. Injection of this antibiotic has been shown to be fatal in swine and non-human primates, and it may be fatal in horses and goats.

Warnings:

Human Warnings: Not for human use. Injection of this drug in humans has been associated with fatalities. Keep out of reach of children. Do not use in automatically powered syringes. Exercise extreme caution to avoid accidental self-injection. In case of human injection, consult a physician immediately and apply ice or cold pack to injection site while avoiding direct contact with the skin. Emergency medical telephone numbers are 1-800-722-0987 or 1-800-428-4441. Avoid contact with eyes.

Note To the Physician: The cardiovascular system is the target of toxicity and should be monitored closely. Cardiovascular toxicity may be due to calcium channel blockade. In dogs, administration of intravenous calcium offset Micotil-induced tachycardia and negative inotropy (decreased contractility). Dobutamine partially offset the negative inotropic effects induced by Micotil in dogs. β-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of Micotil in dogs.

Epinephrine potentiated lethality of Micotil in pigs. This antibiotic persists in tissues for several days.

Residue Warnings: Animals intended for human consumption must not be slaughtered within 42 days of the last treatment. Not for use in lactating dairy cattle 20 months of age or older. Use of tilmicosin in this class of cattle may cause milk residues. Not for use in lactating ewes producing milk for human consumption.

For Subcutaneous Use in Cattle and Sheep Only. Do Not Use in Automatically Powered Syringes.

Precautions:

Read accompanying literature fully before use. Intramuscular injection will cause a local reaction which may result in trim loss of edible tissue at slaughter. The effects of tilmicosin on bovine and ovine reproductive performance, pregnancy and lactation have not been determined.

Adverse Reactions:

The following adverse reactions have been reported post-approval: In cattle: injection site swelling and inflammation, lameness, collapse, anaphylaxis/anaphylactoid reactions, decreased food and water consumption, and death.

In sheep: dyspnea and death.

For a complete listing of adverse reactions for tilmicosin phosphate reported to the CVM see http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm

Clinical Pharmacology:

A single subcutaneous injection of Micotil at 10 mg/kg of body weight dose in cattle resulted in peak tilmicosin levels within one hour and detectable levels (0.07 μg/mL) in serum beyond 3 days. However, lung concentrations of tilmicosin remained above the tilmicosin MIC 95% of 3.12 μg/mL for Mannheimia haemolytica for at least 3 days following the single injection. Serum tilmicosin levels are a poor indicator of total body tilmicosin. The lung/serum tilmicosin ratio in favor of lung tissue appeared to equilibrate by 3 days post-injection at approximately 60. In a study with radioactive tilmicosin, 24% and 68% of the dose was recovered from urine and feces respectively over 21 days. After a single subcutaneous injection of Micotil at 10 mg/kg of body weight, tilmicosin concentrations in excess of 4 μg/mL were maintained in the alveolar macrophages and neutrophils of most cattle for at least 10 days. The clinical relevance of these findings has not been determined.

Microbiology: Tilmicosin has an in vitro antibacterial spectrum that is predominantly Gram-positive with activity against certain Gram-negative microorganisms. In vitro activity against several Mycoplasma species has also been observed.

Effectiveness: In a multi-location field study, 1508 calves with naturally occurring BRD were treated with Micotil. Responses to treatment were compared to saline-treated controls. A cure was defined as a calf with normal attitude and activity, normal respiration, and a rectal temperature of <104°F on Day 13. The cure rate was significantly higher (P=0.004) in Micotil-treated calves (63.1%) compared to saline-treated calves (29.2%). During the treatment phase of the study, there were 10 BRD-related deaths in the Micotil-treated calves compared to 47 in the saline-treated calves.

Animal Safety: A safety study was conducted in feeder calves receiving subcutaneous doses of 20, 30, 40, or 60 mg/kg of body weight, injected 3 times at 72-hour intervals. Death was not seen in any of the treatment groups. Injection site swelling and mild hemorrhage at the injection site were seen in animals in all dosage groups. Lesions were described as being generally more severe and occurred at higher frequency rates in the animals treated with higher doses of tilmicosin. Lameness associated with the injection site was noted in two of twenty-four animals (one animal in the 30 mg/kg body weight treatment group and one animal in the 60 mg/kg treatment group). No other drug related lesions were observed macroscopically or microscopically. Decreases in food and water consumption were noted in all treatment groups compared to the control group.

A separate safety study conducted in feeder calves, subcutaneous doses of 10, 30, or 50 mg/kg of body weight, injected 3 times at 72-hour intervals did not cause any deaths. Edema at the site of injection was noted. The only lesion observed at necropsy was minimal myocardial necrosis in some animals dosed at 50 mg/kg.

In an additional safety study, subcutaneous doses of 150 mg/kg body weight injected at 72-hour intervals resulted in death of two of the four treated animals. Edema was marked at the site of injection. Minimal myocardial necrosis was the only lesion observed at necropsy. Deaths of cattle have been observed with a single intravenous dose of 5 mg/kg of body weight.

In sheep, single subcutaneous injections of 10 mg/kg body weight dose did not cause any deaths and no adverse effects of tilmicosin were observed on blood pressure, heart rate, or respiratory rate.

Toxicology: The heart is the target of toxicity in laboratory and domestic animals given Micotil by oral or parenteral routes. The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotropy). Cardiovascular toxicity may be due to calcium channel blockade.

Upon subcutaneous injection, the acute median lethal dose of tilmicosin in mice is 97 mg/kg, and in rats is 185 mg/kg of body weight. Given orally, the median lethal dose is 800 mg/kg and 2250 mg/kg body weight in fasted and nonfasted rats, respectively. No compound-related lesions were found at necropsy.

In dogs, intravenous calcium offset Micotil-induced tachycardia and negative inotropy, restoring arterial pulse pressure. Dobutamine partially offset the negative inotropic effects induced by Micotil in dogs. Β-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of Micotil in dogs.

In monkeys, a single intramuscular dose of 10 mg/kg body weight caused no signs of toxicity. A single dose of 20 mg/kg body weight caused vomiting and 30 mg/kg body weight caused the death of the only monkey tested.

In swine, intramuscular injection of 10 mg/kg body weight caused increased respiration, emesis, and a convulsion, 20 mg/kg body weight resulted in mortality in 3 of 4 pigs, and 30 mg/kg body weight caused the death of all 4 pigs tested. Injection of 4.5 and 5.6 mg/kg body weight intravenously followed by epinephrine, 1mL (1:1000) intravenously 2 to 6 times, resulted in death of all pigs injected. Pigs given 4.5 mg/kg and 5.6 mg/kg body weight intravenously with no epinephrine all survived. These results suggest intravenous epinephrine may be contraindicated.

Results of genetic toxicology studies were all negative. Results of teratology and reproduction studies in rats were negative. The no effect level in dogs after daily oral doses for up to one year is 4 mg/kg of body weight.

Storage Conditions: Store at or below 86°F (30°C). Protect from direct sunlight.

How Supplied:

Micotil is supplied in 100 mL and 250 mL multi-dose amber glass bottles.

Elanco®, Micotil® and the diagonal bar are trademarks of Eli Lilly and Company.

Manufactured for:

Elanco Animal Health

A Division of Eli Lilly and Company

Indianapolis, IN 46285, USA

Revised JANUARY 2010

Micotil® 300

AH0230

PA9980DEAMX

SAFE HANDLING PRACTICES WHEN USING

MICOTIL® 300 TILMICOSIN INJECTION, USP

Please read this information before you start using Micotil. This information is a summary and is not intended to take the place of discussions with your veterinarian. Micotil can only be prescribed by a licensed veterinarian who has information specific to your operation. You should discuss with your veterinarian how to use Micotil, human warnings associated with the product and recommended safe handling and use practices. For emergency medical information call 1-800-722-0987 or 1-800-428-4441. If you have any questions about Micotil, talk with your veterinarian or call Elanco at 1-800-428-4441. To report an adverse drug event contact Elanco at 1-800-428-4441.

WHAT ARE THE POSSIBLE EFFECTS OF ACCIDENTAL HUMAN INJECTION?

Human injections of Micotil have been associated with fatalities. Clinical signs from human exposure include off taste in the mouth, nausea, headache, dizziness, rapid heart rate, chest pain, anxiety or lightheadedness. Local reactions such as injection site pain, bleeding, swelling or inflammation have been reported.

WHAT SHOULD I DO IN THE CASE OF ACCIDENTAL HUMAN INJECTION?
- Immediately seek medical attention.
- Apply ice or cold pack to injection site, while avoiding direct contact with the skin, and transport immediately to a hospital.
- Call 1-800-722-0987 or 1-800-428-4441 for further emergency information.

WHAT SHOULD MY PHYSICIAN KNOW IN THE CASE OF ACCIDENTAL HUMAN INJECTION?
- The cardiovascular system is the target of toxicity and should be monitored closely.
- Cardiovascular toxicity may be due to calcium channel blockade.
- Intravenous calcium administration reversed the cardiovascular effects of Micotil in dogs and may provide benefit in patients exhibiting low blood pressure (hypotension) or rapid heart rate (tachycardia).
- Dobutamine improved some of the cardiac function in dogs given Micotil.
- Epinephrine increased the toxicity of Micotil in pigs, resulting in death.
- Propranolol (a beta-adrenergicantagonist), further decreased cardiac function in dogs given Micotil.
- The active ingredient in Micotil is tilmicosin phosphate and persists in tissue for several days.
- Call 1-800-722-0987 or 1-800-428-4441 for further emergency information.

WHAT ARE THE PROPER WAYS TO HANDLE AND STORE MICOTIL?
- Store at or below 86°F (30°C), out of direct sunlight, in a safe location, not easily accessible to the general public.
- Read, understand and follow all label use directions.
- Keep the needle capped until ready to use.
- Never carry a loaded syringe with an attached needle in pocket or clothing.
- Wash hands thoroughly with soap and water after handling.

WHAT ARE THE PROPER METHODS FOR ADMINISTERING MICOTIL?
- Properly restrain animals prior to administration.
- Work in a team, or if alone, advise someone of your location and how long you plan to be there.
- For subcutaneous use. Do not use in automatically powered syringes.
- Use a 1/2-inch to 5/8-inch, 18- to 16-gauge needle.
- With a single hand on the syringe, insert the needle subcutaneously, at a top-down angle, while avoiding penetration of underlying muscle.
- For cattle and sheep, injection under the skin in the neck is suggested. If not accessible, inject under the skin behind the shoulders and over the ribs.
- Administer a single subcutaneous dose of 1.5 mL to 3.0 mL of Micotil per 100 lbs of body weight, in either of the two areas noted in the adjacent drawing.
- For beef cattle, Beef Quality Assurance recommends injection site 1, unless this site is inaccessible or places the operator in a potentially dangerous situation.
- Ensure proper disposal of sharp needles and syringes.
- Wash hands thoroughly with soap and water after administration.
- Do not administer intravenously (IV) as IV administration will be fatal.
- Intramuscular injection will cause a local reaction, which may result in trim loss.
- Do not inject more than 10 mL per injection site.
- Do not use in lambs less than 15 kg body weight.

Issued January, 2010

Elanco Animal Health

A Division of Eli Lilly and Company, Indianapolis, IN 46285, USA

Elanco® and Micotil® are trademarks of Eli Lilly and Company.

Copyright © 2003, Elanco Animal Health.

PA9980DEAMX (V06-01-2010)

Principal Display Panel - 100 mL Bottle Label

Elanco® AH230-82X

For use in Cattle and Sheep Only

Micotil® 300

Tilmicosin Injection, USP

300 mg tilmicosin, USP as tilmicosin phosphate per mL

™

Do Not Use in Automatically Powered Syringes

NADA 140-929, Approved by FDA

UPC 7 2780420213

Principal Display Panel - 100 mL Carton Label

Elanco® AH0230-82X

For use in Cattle and Sheep Only

Micotil® 300

Tilmicosin Injection, USP

300 mg tilmicosin, USP as tilmicosin phosphate per mL

™

Do Not Use in Automatically Powered Syringes

Caution: Federal (USA) law restricts the drug to use by or on the order of a licensed veterinarian.

Description: Micotil® is a solution of the antibiotic Tilmicosin. Each mL contains 300 mg of tilmicosin, USP as tilmicosin phosphate in 25% propylene glycol, phosphoric acid as needed to adjust pH and water for injection, Q.S. Tilmicosin, USP is produced semi-synthetically and is in the macrolide class of antibiotics.

NADA 1 40-929

Approved by FDA

UPC 7 27804 202132 100 mL

Principal Display Panel - 250 mL Bottle Label

Elanco® AH0230-38W

For use in Cattle and Sheep Only

Micotil® 300

Tilmicosin Injection, USP

300 mg tilmicosin, USP as tilmicosin phosphate per mL

™

Do Not Use in Automatically Powered Syringes

Caution: Federal (USA) law restricts the drug to use by or on the order of a licensed veterinarian.

Indications: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica. For the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica.

NADA 1 40-929, Approved by FDA

UPC 7 27804 202132 250 mL

Elanco®, Micotil® and the diagonal bar are trademarks of Eli Lilly and Company

Micotil 300
tilmicosin phosphate injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	0986-0230
Route of Administration	SUBCUTANEOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TILMICOSIN PHOSPHATE (TILMICOSIN)	TILMICOSIN PHOSPHATE	300 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0986-0230-02	1 BOTTLE In 1 CARTON	contains a BOTTLE, GLASS
1		100 mL In 1 BOTTLE, GLASS	This package is contained within the CARTON (0986-0230-02)
2	0986-0230-03	250 mL In 1 BOTTLE, GLASS	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140929	02/19/2010

Labeler - Elanco Animal Health Co (807447169)

Establishment
Name	Address	ID/FEI	Operations
Norbrook Laboratories Limited		232880554	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Dottikon Exclusive Synthesis AG		480000413	API MANUFACTURE

Revised: 02/2010Elanco Animal Health Co

MicRhoGAM

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)

Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:

heart disease or a history of coronary artery disease (hardened arteries);

high triglycerides (a type of fat in the blood);

a bleeding disorder (such as hemophilia); or

immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, shaking, back pain, dark colored urine;

rapid breathing, feeling short of breath.

urinating less than usual or not at all, swelling, rapid weight gain; or

pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

joint or muscle pain;

headache, dizziness;

feeling weak or tired;

mild itching or skin rash;

nausea, diarrhea, vomiting, stomach pain; or

pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More MicRhoGAM resources

MicRhoGAM Side Effects (in more detail)
MicRhoGAM Use in Pregnancy & Breastfeeding
MicRhoGAM Drug Interactions
MicRhoGAM Support Group
0 Reviews for MicRhoGAM - Add your own review/rating

BayRho-D Advanced Consumer (Micromedex) - Includes Dosage Information

Bayrho-D full dose

HyperRHO S/D Full Dose Prescribing Information (FDA)

MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)

RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)

Rhophylac Prescribing Information (FDA)

Rhophylac Consumer Overview

Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)

WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)

Compare MicRhoGAM with other medications

Idiopathic Thrombocytopenic Purpura
Rh-Isoimmunization

Where can I get more information?

Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

See also: MicRhoGAM side effects (in more detail)

Miconazole Powder

Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Examples include Lotrimin AF and Zeasorb-AF

Miconazole Powder is used for:

Treating athlete's foot, jock itch, or ringworm and relieving the itching, scaling, burning, and discomfort due to those conditions. It may also be used for other conditions as determined by your doctor.

Miconazole Powder is an antifungal. It works by weakening the fungal cell membrane, which kills the fungus.

Do NOT use Miconazole Powder if:

you are allergic to any ingredient in Miconazole Powder

Contact your doctor or health care provider right away if any of these apply to you.

Before using Miconazole Powder:

Some medical conditions may interact with Miconazole Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Miconazole Powder. Because little, if any, of Miconazole Powder is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Miconazole Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Miconazole Powder:

Use Miconazole Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clean the affected area and dry it thoroughly.

Sprinkle a thin layer of medicine over the entire affected area in the morning and evening unless otherwise directed by your doctor.

Wash hands immediately after using Miconazole Powder unless your hands are part of the treated area.

For athlete's foot, pay special attention to the area between the toes. Wear well-fitting, ventilated shoes, and change your shoes and socks at least once daily.

To clear up your infection completely, continue using Miconazole Powder for the full course of treatment even if you feel better in a few days.

Supervise children in the use of this product.

If you miss a dose of Miconazole Powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Miconazole Powder.

Important safety information:

Miconazole Powder is for external use only. Avoid contact with the eyes. If you get Miconazole Powder in your eyes, rinse them immediately with a generous amount of cool water.

If Miconazole Powder is swallowed, contact a doctor or poison control center immediately.

Do not cover the treated area with a bandage or dressing unless directed otherwise by your doctor.

If there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks, or if your condition persists, contact your health care provider.

Miconazole Powder is not effective on the scalp or nails.

Do not use on CHILDREN younger than 2 years of age unless directed by a doctor.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Miconazole Powder, discuss with your doctor the benefits and risks of using Miconazole Powder during pregnancy. It is unknown if Miconazole Powder is excreted in breast milk. If you are or will be breast-feeding while you are using Miconazole Powder, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Miconazole Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Miconazole Powder:

Store Miconazole Powder at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Miconazole Powder out of the reach of children and away from pets.

General information:

If you have any questions about Miconazole Powder, please talk with your doctor, pharmacist, or other health care provider.

Miconazole Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Miconazole Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Miconazole resources

Miconazole Use in Pregnancy & Breastfeeding
Miconazole Drug Interactions
Miconazole Support Group
8 Reviews for Miconazole - Add your own review/rating

Compare Miconazole with other medications

Cutaneous Candidiasis
Oral Thrush
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor
Vaginal Yeast Infection

Microzide

Pronunciation: HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Hydrochlorothiazide
Brand Name: Microzide

Microzide is used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Microzide is a thiazide diuretic. It works by helping the kidneys to remove fluid from the body.

Do NOT use Microzide if:

you are allergic to any ingredient in Microzide or to another sulfonamide medicine (eg, sulfamethoxazole)

you are unable to urinate

you are taking dofetilide or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Microzide:

Some medical conditions may interact with Microzide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of gout, liver problems, (eg, cirrhosis), lupus, kidney problems, diabetes or high blood sugar, asthma, parathyroid gland problems, or high blood cholesterol or lipid levels

if you have high or low blood electrolyte levels (eg, sodium, potassium, magnesium, calcium)

if you are taking another medicine for high blood pressure

Some MEDICINES MAY INTERACT with Microzide. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin, dofetilide, or ketanserin because the risk of irregular heartbeat may be increased

Barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), corticotropin, other diuretics (eg, furosemide), or narcotic pain medicines (eg, codeine) because they may increase the risk of Microzide's side effects

Cholestyramine, colestipol, or nonsteroidal anti-inflammatory medicines (NSAIDs) (eg, ibuprofen) because they may decrease Microzide's effectiveness

Diazoxide or lithium because the risk of their side effects may be increased by Microzide

Diabetes medicines (eg, glipizide, metformin) or insulin because their effectiveness may be decreased by Microzide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Microzide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Microzide:

Use Microzide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Microzide by mouth with or without food.

If you take colestipol or cholestyramine for high cholesterol, ask your doctor or pharmacist how to take it with Microzide.

Microzide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.

If you miss a dose of Microzide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Microzide.

Important safety information:

Microzide may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Microzide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Microzide may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Report any light-headedness or fainting to your doctor immediately. Your risk of light-headedness or fainting may be increased if you experience diarrhea, vomiting, or excessive sweating; if you do not drink enough fluids; or if you are on a low-salt (sodium) diet. Contact your health care provider at once if any of these events occur.

Microzide is a sulfonamide. It can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Microzide. Contact your doctor right away if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.

Your doctor may also prescribe a potassium supplement for you. If so, take the potassium supplement exactly as prescribed. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.

Tell your doctor or dentist that you take Microzide before you receive any medical or dental care, emergency care, or surgery.

Tell your doctor if you will be exposed to high temperatures. The risk of certain side effects (eg, low blood sodium levels) may be increased in hot weather.

Microzide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Microzide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

Microzide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Microzide may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking Microzide.

Lab tests, including kidney function, blood pressure, and electrolyte levels, may be performed while you take Microzide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Microzide with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness.

Microzide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Microzide may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Microzide while you are pregnant. Microzide is found in breast milk. If you are or will be breast-feeding while you take Microzide, check with your doctor. Discuss any possible risks to your baby. Do not breast-feed while taking Microzide.

Possible side effects of Microzide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; light-headedness; loss of appetite; nausea; temporary blurred vision.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased urination; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased thirst; joint pain, swelling, warmth, or redness (especially of the big toe joint); muscle pain, weakness, or cramps; numbness or tingling; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; severe or persistent nausea or stomach pain; shortness of breath; symptoms of low blood sodium levels (eg, confusion, mental or mood changes, seizures, sluggishness); unusual bruising or bleeding; unusual drowsiness, restlessness, tiredness, or weakness; unusually dry mouth; vision changes (eg, decreased vision clearness); vomiting; yellowing of the eyes or skin.

See also: Microzide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, dry mouth or eyes; decreased urination; fast heartbeat; unusual thirst, tiredness, or weakness).

Proper storage of Microzide:

Store Microzide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Microzide out of the reach of children and away from pets.

General information:

If you have any questions about Microzide, please talk with your doctor, pharmacist, or other health care provider.

Microzide is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Microzide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Microzide resources

Microzide Side Effects (in more detail)
Microzide Use in Pregnancy & Breastfeeding
Drug Images
Microzide Drug Interactions
Microzide Support Group
0 Reviews for Microzide - Add your own review/rating

Microzide Advanced Consumer (Micromedex) - Includes Dosage Information

Microzide Concise Consumer Information (Cerner Multum)

Microzide Prescribing Information (FDA)

Hydrochlorothiazide Prescribing Information (FDA)

Hydrochlorothiazide Professional Patient Advice (Wolters Kluwer)

Hydrochlorothiazide Monograph (AHFS DI)

Esidrix Prescribing Information (FDA)

Compare Microzide with other medications

Diabetes Insipidus
Edema
High Blood Pressure
Nephrocalcinosis
Osteoporosis

Miacalcin Nasal

Generic Name: calcitonin (Nasal route)

kal-si-TOE-nin (SA-man)

Commonly used brand name(s)

In the U.S.

Fortical

Miacalcin

In Canada

Miacalcin Ns

Available Dosage Forms:

Spray

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Calcitonin

Uses For Miacalcin

Calcitonin nasal is used together with calcium and vitamin D to treat bone loss in women with postmenopausal osteoporosis who have been postmenopause for at least 5 years.

This medicine is available only with your doctor's prescription.

Before Using Miacalcin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of calcitonin nasal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcitonin nasal in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., irritation or redness of the nose, stuffy or runny nose), which may require caution in patients receiving calcitonin nasal.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Lithium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of calcitonin (salmon)

This section provides information on the proper use of a number of products that contain calcitonin (salmon). It may not be specific to Miacalcin. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.

Each spray bottle contains 30 doses of the medicine. Keep track of the doses you use and throw away any unused medicine after 30 doses, even if the bottle is not completely empty.

This medicine usually comes with patient instructions. Read the instructions carefully before using this medicine. If you have any questions about using the pump spray, ask your doctor.

To assemble the pump:

If your medicine and its pump were not already assembled by the pharmacist, carefully follow the instructions provided with the container.

Remove the bottle of solution from the refrigerator and let it slowly warm up to room temperature (less than 77 degrees F).

Lift the plastic tab and pull the metal safety seal off the bottle.

Hold the bottle upright and carefully pull the rubber stopper out of the bottle.

Hold the spray pump unit and remove the plastic cap from the bottom of the unit.

Hold the bottle upright and place the spray pump unit into the bottle.

Turn the spray pump unit clockwise and tighten it until it is securely fastened.

To prepare this medicine:

Before you use a new bottle of calcitonin spray, the spray pump will need to be primed (started). If your pharmacist assembled the unit for you, check to see if it has already been primed by pumping the unit once. If a full spray comes out, the unit has already been primed; if not, you must prime the pump.

To prime a new bottle, hold the bottle upright and away from you, then pump it several times until you see a faint spray.

Do not prime the pump again before each daily use.

To use the nose spray:

Before using the spray, blow your nose gently to clear the nostrils.

Keeping your head in an upright position, carefully place the nozzle into one nostril.

Press the pump toward the bottle one time. Do not spray more than once.

Do not inhale while spraying.

To keep the nosepiece clean, wipe it with a clean tissue and replace the dust cap after use.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nasal dosage form (nose spray):
- For postmenopausal osteoporosis:
  - Adults—One spray into one nostril per day. It is best to change which nostril you use each day. As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unopened bottle in the refrigerator. Do not freeze. You may store the opened bottle in an upright position at room temperature, away from heat and direct light. An opened bottle of Miacalcin® can be stored for up to 35 days, and an opened bottle of Fortical® can be stored for up to 30 days. Throw away any unused medicine after 30 or 35 days based on the brand you are using.

Precautions While Using Miacalcin

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Your doctor may also want to check your nose before and during treatment with this medicine.

Your doctor might give you an allergy skin test to see if you are allergic to calcitonin before using this medicine.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause irritation in the nose that can be painful and serious. Stop using this medicine and check with your doctor right away if you have more than one of the following symptoms: sneezing; runny or stuffy nose; shortness of breath; troubled breathing; or heavy nosebleeds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Miacalcin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Crusting, patches, or sores inside the nose

dryness, itching, redness, swelling, tenderness, or other signs of nasal irritation not present before use of this medicine

headaches (severe or continuing)

nosebleeds

runny nose

stuffy nose

sneezing

Less common

Bloody or cloudy urine

difficult, burning, or painful urination

difficulty with breathing or wheezing (severe)

dizziness

frequent urge to urinate

loss of sense of smell

swollen glands

upper respiratory infection, with chest pain, chills, cough, ear congestion or pain, fever, head congestion, hoarseness or other voice changes, nasal congestion, runny nose, sneezing, or sore throat

Rare

Hair loss

hives, itching, or skin rash

increased thirst

taste disturbances

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

joint pain

Less common or rare

Abdominal or stomach pain

burning, dry, or itching eyes

constipation

diarrhea

flu-like symptoms (fever with or without chills, headache, body ache)

flushing

mental depression

muscle pain

nausea

unusual tearing of the eyes

unusual tiredness or weakness

upset stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Miacalcin Nasal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Miacalcin Nasal resources

Miacalcin Nasal Side Effects (in more detail)
Miacalcin Nasal Use in Pregnancy & Breastfeeding
Miacalcin Nasal Drug Interactions
Miacalcin Nasal Support Group
0 Reviews for Miacalcin Nasal - Add your own review/rating

Calcitonin Monograph (AHFS DI)

Fortical Consumer Overview

Fortical Spray MedFacts Consumer Leaflet (Wolters Kluwer)

Fortical Prescribing Information (FDA)

Miacalcin Prescribing Information (FDA)

Miacalcin MedFacts Consumer Leaflet (Wolters Kluwer)

Miacalcin Consumer Overview

Compare Miacalcin Nasal with other medications

Hypercalcemia
Osteogenesis Imperfecta
Osteoporosis
Paget's Disease

Miacalcin

Pronunciation: kal-si-TOE-nin
Generic Name: Calcitonin-Salmon
Brand Name: Miacalcin

Miacalcin is used for:

Treating Paget disease, postmenopausal osteoporosis (fragile or brittle bones), and high blood calcium levels. It may also be used for other conditions as determined by your doctor.

Miacalcin is a hormone. It works by regulating calcium in the blood and bone.

Do NOT use Miacalcin if:

you are allergic to any ingredient in Miacalcin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Miacalcin:

Some medical conditions may interact with Miacalcin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Miacalcin. However, no specific interactions with Miacalcin are known at this time.

Ask your health care provider if Miacalcin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Miacalcin:

Use Miacalcin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Miacalcin is sometimes given as an injection at your doctor's office, hospital, or clinic. If you will be using Miacalcin at home, a health care provider will teach you how to use it. Be sure you understand how to use Miacalcin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do not use Miacalcin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Miacalcin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Miacalcin.

Important safety information:

Follow the diet program given to you by your health care provider.

Miacalcin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Miacalcin while you are pregnant. It is not known if Miacalcin is found in breast milk. If you are or will be breast-feeding while you use Miacalcin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Miacalcin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; flushing of the face or hands; increased frequency of urination; loss of appetite; metallic taste in mouth; nausea; reaction, redness, or pain at injection site; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

See also: Miacalcin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Miacalcin:

Store Miacalcin in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Miacalcin out of the reach of children and away from pets.

General information:

If you have any questions about Miacalcin, please talk with your doctor, pharmacist, or other health care provider.

Miacalcin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Miacalcin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Miacalcin resources

Miacalcin Side Effects (in more detail)
Miacalcin Use in Pregnancy & Breastfeeding
Miacalcin Drug Interactions
Miacalcin Support Group
0 Reviews for Miacalcin - Add your own review/rating

Miacalcin Prescribing Information (FDA)

Miacalcin Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Miacalcin Consumer Overview

Calcitonin Monograph (AHFS DI)

Fortical Consumer Overview

Fortical Prescribing Information (FDA)

Fortical Nasal Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Miacalcin with other medications

Hypercalcemia
Osteogenesis Imperfecta
Osteoporosis
Paget's Disease

Micon 7

Generic Name: miconazole vaginal (my CAW nah zole)

Brand Names: M-Zole Dual Pack, Micon 7, Monistat 3, Monistat 5, Monistat 7

What is Micon 7 (miconazole vaginal)?

Miconazole is an antifungal medication. It prevents fungus from growing.

Miconazole vaginal is used to treat vaginal candida (yeast) infections.

Miconazole vaginal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Micon 7 (miconazole vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Micon 7 (miconazole vaginal)?

If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.

Do not use miconazole vaginal if you have ever had an allergic reaction to it.

Before using miconazole vaginal, talk to your doctor if you have

a fever,

abdominal pain,

foul-smelling discharge,

diabetes, or

HIV or AIDS.

You may not be able to use miconazole vaginal, or you may require special monitoring during treatment if you have any of the conditions listed above.

Do not use miconazole vaginal without first talking to your doctor if you are pregnant. Do not use miconazole vaginal without first talking to your doctor if you are breast-feeding a baby.

How should I use Micon 7 (miconazole vaginal)?

Use miconazole vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the medication.

Insert the tablet, suppository, or cream into the vagina using the applicator as directed.

Use this medication continuously, even during your menstrual period.

You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth. Store miconazole vaginal at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of miconazole vaginal is unlikely. If you do suspect that a much larger than normal dose has been used or that miconazole vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Micon 7 (miconazole vaginal)?

Miconazole may damage a condom or diaphragm. Use another form of birth control while using miconazole vaginal.

Micon 7 (miconazole vaginal) side effects

Stop using miconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Micon 7 (miconazole vaginal)?

Do not use miconazole vaginal without first talking to your doctor if you are taking warfarin (Coumadin). Special monitoring or a dosage adjustment may be necessary.

Avoid using other vaginal creams or douches at the same time as miconazole vaginal unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with miconazole vaginal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Micon 7 resources

Micon 7 Side Effects (in more detail)
Micon 7 Use in Pregnancy & Breastfeeding
Micon 7 Drug Interactions
Micon 7 Support Group
0 Reviews for Micon 7 - Add your own review/rating

Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Monistat 3 Prescribing Information (FDA)

Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Micon 7 with other medications

Vaginal Yeast Infection

Where can I get more information?

Your pharmacist has additional information about miconazole vaginal written for health professionals that you may read.

See also: Micon 7 side effects (in more detail)

Miacalcin

calcitonin salmon

Dosage Form: injection, solution
Miacalcin®

(calcitonin-salmon)

Injection, Synthetic

Rx only

DESCRIPTION

Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.

Miacalcin® (calcitonin-salmon) Injection, Synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:

It is provided in sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin-salmon 200 I.U., acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP, qs to 1.0 mL.

The activity of Miacalcin Injection is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London.

CLINICAL PHARMACOLOGY

Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still incompletely understood.

Bone: Single injections of calcitonin cause a marked transient inhibition of the ongoing bone resorptive process. With prolonged use, there is a persistent, smaller decrease in the rate of bone resorption. Histologically, this is associated with a decreased number of osteoclasts and an apparent decrease in their resorptive activity. Decreased osteocytic resorption may also be involved. There is some evidence that initially bone formation may be augmented by calcitonin through increased osteoblastic activity. However, calcitonin will probably not induce a long-term increase in bone formation.

Animal studies indicate that endogenous calcitonin, primarily through its action on bone, participates with parathyroid hormone in the homeostatic regulation of blood calcium. Thus, high blood calcium levels cause increased secretion of calcitonin which, in turn, inhibits bone resorption. This reduces the transfer of calcium from bone to blood and tends to return blood calcium to the normal level. The importance of this process in humans has not been determined. In normal adults, who have a relatively low rate of bone resorption, the administration of exogenous calcitonin results in only a slight decrease in serum calcium. In normal children and in patients with generalized Paget’s disease, bone resorption is more rapid and decreases in serum calcium are more pronounced in response to calcitonin.

Paget’s Disease of Bone (osteitis deformans): Paget's disease is a disorder of uncertain etiology characterized by abnormal and accelerated bone formation and resorption in one or more bones. In most patients, only small areas of bone are involved and the disease is not symptomatic. In a small fraction of patients, however, the abnormal bone may lead to bone pain and bone deformity, cranial and spinal nerve entrapment, or spinal cord compression. The increased vascularity of the abnormal bone may lead to high output congestive heart failure.

Active Paget’s disease involving a large mass of bone may increase the urinary hydroxyproline excretion (reflecting breakdown of collagen-containing bone matrix) and serum alkaline phosphatase (reflecting increased bone formation).

Calcitonin-salmon, presumably by an initial blocking effect on bone resorption, causes a decreased rate of bone turnover with a resultant fall in the serum alkaline phosphatase and urinary hydroxyproline excretion in approximately 2/3 of patients treated. These biochemical changes appear to correspond to changes toward more normal bone, as evidenced by a small number of documented examples of: 1) radiologic regression of Pagetic lesions, 2) improvement of impaired auditory nerve and other neurologic function, 3) decreases (measured) in abnormally elevated cardiac output. These improvements occur extremely rarely, if ever, spontaneously (elevated cardiac output may disappear over a period of years when the disease slowly enters a sclerotic phase; in the cases treated with calcitonin, however, the decreases were seen in less than one year.)

Some patients with Paget’s disease, who have good biochemical and/or symptomatic responses initially, later relapse. Suggested explanations have included the formation of neutralizing antibodies and the development of secondary hyperparathyroidism, but neither suggestion appears to explain adequately the majority of relapses.

Although the parathyroid hormone levels do appear to rise transiently during each hypocalcemic response to calcitonin, most investigators have been unable to demonstrate persistent hypersecretion of parathyroid hormone in patients treated chronically with calcitonin-salmon.

Circulating antibodies to calcitonin after 2-18 months’ treatment have been reported in about half of the patients with Paget’s disease in whom antibody studies were done, but calcitonin treatment remained effective in many of these cases. Occasionally, patients with high antibody titers are found. These patients usually will have suffered a biochemical relapse of Paget’s disease and are unresponsive to the acute hypocalcemic effects of calcitonin.

Hypercalcemia: In clinical trials, calcitonin-salmon has been shown to lower the elevated serum calcium of patients with carcinoma (with or without demonstrated metastases), multiple myeloma, or primary hyperparathyroidism (lesser response). Patients with higher values for serum calcium tend to show greater reduction during calcitonin therapy. The decrease in calcium occurs about 2 hours after the first injection and lasts for about 6-8 hours. Calcitonin-salmon given every 12 hours maintained a calcium lowering effect for about 5-8 days, the time period evaluated for most patients during the clinical studies. The average reduction of 8-hour post-injection serum calcium during this period was about 9%.

Kidney: Calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. In some patients, the inhibition of bone resorption by calcitonin is of such magnitude that the consequent reduction of filtered calcium load more than compensates for the decrease in tubular reabsorption of calcium. The result in these patients is a decrease rather than an increase in urinary calcium.

Transient increases in sodium and water excretion may occur after the initial injection of calcitonin. In most patients, these changes return to pretreatment levels with continued therapy.

Gastrointestinal Tract: Increasing evidence indicates that calcitonin has significant actions on the gastrointestinal tract. Short-term administration results in marked transient decreases in the volume and acidity of gastric juice and in the volume and the trypsin and amylase content of pancreatic juice. Whether these effects continue to be elicited after each injection of calcitonin during chronic therapy has not been investigated.

Metabolism: Information from animal studies with calcitonin-salmon and from clinical studies with calcitonins of porcine and human origin suggest that calcitonin-salmon is rapidly metabolized by conversion to smaller inactive fragments, primarily in the kidneys, but also in the blood and peripheral tissues. A small amount of unchanged hormone and its inactive metabolites are excreted in the urine.

The absolute bioavailability of salmon calcitonin is approximately 66% and 71% after intramuscular (i.m.) or subcutaneous (s.c.) injection, respectively. After subcutaneous administration, peak plasma levels are reached in approximately 23 minutes. The terminal half-life is approximately 58 minutes for i.m. administration and 59 to 64 minutes for s.c. administration. The apparent volume of distribution is 0.15-0.3 L/kg.

It appears that calcitonin-salmon cannot cross the placental barrier and its passage to the cerebrospinal fluid or to breast milk has not been determined.

INDICATIONS AND USAGE

Miacalcin® (calcitonin-salmon) Injection, Synthetic is indicated for the treatment of symptomatic Paget’s disease of bone, for the treatment of hypercalcemia, and for the treatment of postmenopausal osteoporosis.

Paget’s Disease: At the present time, effectiveness has been demonstrated principally in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion.

In these patients, the biochemical abnormalities were substantially improved (more than 30% reduction) in about 2/3 of patients studied, and bone pain was improved in a similar fraction. A small number of documented instances of reversal of neurologic deficits have occurred, including improvement in the basilar compression syndrome, and improvement of spinal cord and spinal nerve lesions. At present, there is too little experience to predict the likelihood of improvement of any given neurologic lesion. Hearing loss, the most common neurologic lesion of Paget’s disease, is improved infrequently (4 of 29 patients studied audiometrically).

Patients with increased cardiac output due to extensive Paget’s disease have had measured decreases in cardiac output while receiving calcitonin. The number of treated patients in this category is still too small to predict how likely such a result will be.

The large majority of patients with localized, especially monostotic disease do not develop symptoms and most patients with mild symptoms can be managed with analgesics. There is no evidence that the prophylactic use of calcitonin is beneficial in asymptomatic patients, although treatment may be considered in exceptional circumstances in which there is extensive involvement of the skull or spinal cord with the possibility of irreversible neurologic damage. In these instances, treatment would be based on the demonstrated effect of calcitonin on Pagetic bone, rather than on clinical studies in the patient population in question.

Hypercalcemia: Miacalcin Injection is indicated for early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.

Postmenopausal Osteoporosis: Miacalcin Injection is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Miacalcin Injection is recommended in conjunction with adequate calcium and vitamin D intake to prevent the progressive loss of bone mass. No evidence currently exists to indicate whether or not Miacalcin Injection decreases the risk of vertebral crush fractures or spinal deformity. A recent controlled study, which was discontinued prior to completion because of questions regarding its design and implementation, failed to demonstrate any benefit of salmon calcitonin on fracture rate. No adequate controlled trials have examined the effect of salmon calcitonin injection on vertebral bone mineral density beyond 1 year of treatment. Two placebo-controlled studies with salmon calcitonin have shown an increase in total body calcium at 1 year, followed by a trend to decreasing total body calcium (still above baseline) at 2 years. The minimum effective dose of Miacalcin Injection for prevention of vertebral bone mineral density loss has not been established. It has been suggested that those postmenopausal patients having increased rates of bone turnover may be more likely to respond to anti-resorptive agents such as Miacalcin Injection.

CONTRAINDICATIONS

Clinical allergy to synthetic calcitonin-salmon.

WARNINGS

Allergic Reactions

Because calcitonin is a polypeptide, the possibility of a systemic allergic reaction exists. Administration of calcitonin-salmon has been reported in a few cases to cause serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis. The usual provisions should be made for the emergency treatment of such a reaction should it occur. Allergic reactions should be differentiated from generalized flushing and hypotension.

For patients with suspected sensitivity to calcitonin, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin® (calcitonin-salmon) Injection, Synthetic. Physicians may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from the Medical Services Department of Novartis Pharmaceuticals Corporation.

The incidence of osteogenic sarcoma is known to be increased in Paget’s disease. Pagetic lesions, with or without therapy, may appear by X-ray to progress markedly, possibly with some loss of definition of periosteal margins. Such lesions should be evaluated carefully to differentiate these from osteogenic sarcoma.

PRECAUTIONS

Drug Interactions

Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may need to be adjusted.

General

The administration of calcitonin possibly could lead to hypocalcemic tetany under special circumstances although no cases have yet been reported. Provisions for parenteral calcium administration should be available during the first several administrations of calcitonin.

Laboratory Tests

Periodic examinations of urine sediment of patients on chronic therapy are recommended.

Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment became normal after calcitonin was stopped. Urine sediment abnormalities have not been reported by other investigators.

Instructions for the Patient

Careful instruction in sterile injection technique should be given to the patient, and to other persons who may administer Miacalcin® (calcitonin-salmon) Injection, Synthetic.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

An increased incidence of pituitary adenomas has been observed in one-year toxicity studies in Sprague-Dawley rats administered calcitonin-salmon at dosages of 20 and 80 I.U./kg/day and in Fisher 344 rats given 80 I.U./kg/day. The relevance of these findings to humans is unknown. Calcitonin-salmon was not mutagenic in tests using Salmonella typhimurium, Escherichia coli, and Chinese Hamster V79 cells.

Pregnancy: Teratogenic Effects

Category C

Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given in doses 14-56 times the dose recommended for human use. Since calcitonin does not cross the placental barrier, this finding may be due to metabolic effects on the pregnant animal. There are no adequate and well-controlled studies in pregnant women. Miacalcin Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on this drug since many drugs are excreted in human milk. Calcitonin has been shown to inhibit lactation in animals.

Pediatric Use

Disorders of bone in children referred to as juvenile Paget’s disease have been reported rarely. The relationship of these disorders to adult Paget’s disease has not been established and experience with the use of calcitonin in these disorders is very limited. There is no adequate data to support the use of Miacalcin Injection in children.

ADVERSE REACTIONS

Gastrointestinal System

Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration.

Dermatologic/Hypersensitivity

Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients. Flushing of face or hands occurred in about 2-5% of patients. Skin rashes, nocturia, pruritus of the ear lobes, feverish sensation, pain in the eyes, poor appetite, abdominal pain, edema of feet, and salty taste have been reported in patients treated with calcitonin-salmon. Administration of calcitonin-salmon has been reported in a few cases to cause serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis. (see WARNINGS).

In addition, the following adverse events were reported with Miacalcin Injection.

Body as a Whole – General Disorders: influenza-like symptoms, fatigue, edema (facial, peripheral, and generalized),

Musculoskeletal/Collagen: arthralgia, musculoskeletal pain

Cardiovascular: hypertension

Gastrointestinal: abdominal pain, diarrhea,

Immune System Disorders: hypersensitivity, anaphylactic and anaphylactoid reactions, anaphylactic shock

Urinary System: polyuria

Central and Peripheral Nervous System: dizziness, headache

Vision: visual disturbance

OVERDOSAGE

A dose of l000 I.U. subcutaneously may produce nausea and vomiting as the only adverse effects. Doses of 32 units per kg per day for 1-2 days demonstrate no other adverse effects.

Data on chronic high-dose administration are insufficient to judge toxicity.

DOSAGE AND ADMINISTRATION

Paget’s Disease: The recommended starting dose of Miacalcin® (calcitonin-salmon) Injection, Synthetic in Paget's disease is 100 I.U. (0.5 mL) per day administered subcutaneously (preferred for outpatient self-administration) or intramuscularly. Drug effect should be monitored by periodic measurement of serum alkaline phosphatase and 24-hour urinary hydroxyproline (if available) and evaluations of symptoms. A decrease toward normal of the biochemical abnormalities is usually seen, if it is going to occur, within the first few months. Bone pain may also decrease during that time. Improvement of neurologic lesions, when it occurs, requires a longer period of treatment, often more than one year.

In many patients, doses of 50 I.U. (0.25 mL) per day or every other day are sufficient to maintain biochemical and clinical improvement. At the present time, however, there are insufficient data to determine whether this reduced dose will have the same effect as the higher dose on forming more normal bone structure. It appears preferable, therefore, to maintain the higher dose in any patient with serious deformity or neurological involvement.

In any patient with a good response initially who later relapses, either clinically or biochemically, the possibility of antibody formation should be explored. The patient may be tested for antibodies by an appropriate specialized test or evaluated for the possibility of antibody formation by critical clinical evaluation.

Patient compliance should also be assessed in the event of relapse.

In patients who relapse, whether because of antibodies or for unexplained reasons, a dosage increase beyond 100 I.U. per day does not usually appear to elicit an improved response.

Hypercalcemia: The recommended starting dose of Miacalcin Injection in hypercalcemia is 4 I.U./kg body weight every 12 hours by subcutaneous or intramuscular injection. If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 I.U./kg every 12 hours. If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 I.U./kg every 6 hours.

Postmenopausal Osteoporosis: The minimum effective dose of Miacalcin Injection for the prevention of vertebral bone mineral density loss has not been established. Data from a single one-year placebo-controlled study with salmon calcitonin injection suggested that 100 I.U. (subcutaneously or intramuscularly) every other day might be effective in preserving vertebral bone mineral density. Baseline and interval monitoring of biochemical markers of bone resorption/turnover (e.g., fasting AM, second-voided urine hydroxyproline to creatinine ratio) and of bone mineral density may be useful in achieving the minimum effective dose. Patients should also receive supplemental calcium such as calcium carbonate 1.5 g daily and an adequate vitamin D intake (400 units daily). An adequate diet is also essential.

If the volume of Miacalcin Injection to be injected exceeds 2 mL, intramuscular injection is preferable and multiple sites of injection should be used.

Miacalcin vials should be inspected visually. If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.

HOW SUPPLIED

Miacalcin® (calcitonin-salmon) Injection, Synthetic is available as a sterile solution in individual 2 mL vials containing 200 I.U. per mL NDC 0078-0149-23

Store in refrigerator between 2°C-8°C (36°F-46°F).

Manufactured by:

Novartis Pharma Stein AG

Stein, Switzerland

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

REV: FEBRUARY 2009 T2009-113

PRINCIPAL DISPLAY PANEL

Package Label – 2 mL

Rx Only NDC 0078-0149-23

Miacalcin® (calcitonin-salmon) Injection, Synthetic

200 I.U. per mL.

2 mL Multi-dose vial

Miacalcin
calcitonin salmon injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0078-0149
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCITONIN SALMON (CALCITONIN SALMON)	CALCITONIN SALMON	200.0 [iU] in 1.0 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID	2.25 mg in 1.0 mL
PHENOL	5.0 mg in 1.0 mL
SODIUM ACETATE	2.0 mg in 1.0 mL
SODIUM CHLORIDE	7.5 mg in 1.0 mL
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0078-0149-23	2.0 mL In 1 VIAL	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017808	07/03/1986

Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 11/2009Novartis Pharmaceuticals Corporation

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Hypercalcemia
Osteogenesis Imperfecta
Osteoporosis
Paget's Disease

Thursday, September 29, 2016

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