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.

1. 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.


2. 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.
   
   


3. 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.
   
   


4. 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.
   
   


5. 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.

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: 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?

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).

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.

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.

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

Copyright © 2012 Wolters Kluwer Health, Inc.

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.

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.

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

Copyright © 2012 Wolters Kluwer Health, Inc.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Paget's disease—Use with caution. Some medicines used for this condition (e.g., alendronate, etidronate, or risedronate) may keep calcitonin nasal from working properly.

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).

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.

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

Copyright © 2012 Wolters Kluwer Health, Inc.

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 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.

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)?

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.

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.

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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)