Monday, 24 September 2012

Aureomix





Dosage Form: FOR ANIMAL USE ONLY
Aureomix®

Granular 500

Chlortetracycline,

sulfamethazine, penicillin

Type A Medicated Article



Active drug ingredients








Chlortetracycline calcium complex equivalent to chlortetracycline HCl40 g/lb
Sulfamethazine8.8% (40 g/lb)
Penicillin (from procaine penicillin)20 g/lb

Ingredients


Calcium sulfate and dried Streptomyces aureofaciens fermentation product.



Indications


For reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; maintenance of weight gains in the presence of atrophic rhinitis; growth promotion and increased feed efficiency in swine weighing up to 75 pounds.



For use in the manufacture of swine feeds



Mixing directions


Use 2.5 lb Aureomix® 500 per 1 ton (907.2 kg) of final feed. Make a preblend of 2.5 lb of Aureomix® 500 with part (15-20 lb) of the feed ingredients. Mix thoroughly with the remainder of the ingredients to give a final concentration of 100 g chlortetracycline, 100 g sulfamethazine and 50 g penicillin per ton of feed.



Warning


Withdraw 15 days prior to slaughter



Restricted Drug (California) - use only as directed. Not for human use. NADA #35-688, Approved by FDA



Marketed by

ALPHARMA®

Alpharma, LLC

Bridgewater, New Jersey 08807


Net wt 50 LB (22.68 kg)



Made in USA


Trademarks

registered by

Alpharma, LLC


700356 1005



PRINCIPAL DISPLAY PANEL - 50 LB Label


Aureomix®

Granular 500


ALPHARMA


Chlortetracycline,

sulfamethazine, penicillin


Type A Medicated Article


See mixing directions, claims, cautions

and warnings on back


Net wt 50 LB (22.68 kg)


ALPHARMA®


Aureomix®

Granular 500










Aureomix 
chlortetracycline hydrochloride, sulfamethazine, and penicillin g procaine  granule










Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)46573-018
Route of AdministrationORALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlortetracycline Hydrochloride (Chlortetracycline)Chlortetracycline Hydrochloride40 g  in 0.45 kg
Sulfamethazine (Sulfamethazine)Sulfamethazine40 g  in 0.45 kg
Penicillin G Procaine (Penicillin G)Penicillin G Procaine20 g  in 0.45 kg






Inactive Ingredients
Ingredient NameStrength
Calcium Sulfate 


















Product Characteristics
ColorGRAY (Gray to Brown)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
146573-018-0022.68 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA03568801/01/2009


Labeler - Alpharma, LLC. (070954094)
Revised: 11/2010Alpharma, LLC.



Wednesday, 19 September 2012

Fucidin Ointment





Fucidin Ointment



sodium fusidate




Please read all of this leaflet carefully before you start taking this medicine.



  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
    even if their symptoms are the same as yours.

  • If any of the side effects become serious, or you notice any side effects not listed in this
    leaflet please tell your doctor or pharmacist.




In this leaflet:



  • 1. What Fucidin Ointment is and what it is used for

  • 2. Before you use Fucidin Ointment

  • 3. How to use Fucidin Ointment

  • 4. Possible side effects

  • 5. How to store Fucidin Ointment

  • 6. Further information





What Fucidin Ointment Is And What It Is Used For



Fucidin Ointment contains sodium fusidate. It is a type of antibiotic.



Fucidin Ointment works by killing germs (bacteria) that cause infections.




Fucidin Ointment is used to treat conditions where the skin is infected by germs (bacteria), such as:



  • Impetigo (a weeping, crusty and swollen patch of skin)

  • Infected dermatitis (inflammation of the skin) and spots

  • Infected cuts and grazes.





Before You Use Fucidin Ointment




Do not use Fucidin Ointment



  • If you are allergic (hypersensitive) to fusidic acid or sodium fusidate.

  • If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.




Take special care with Fucidin Ointment



  • Take special care if you are going to use this medicine near your eyes or the eyes of a child.

  • If you use the ointment over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.




Taking other medicines



Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.





Pregnancy and breast-feeding



Please ask your doctor or pharmacist for advice before using Fucidin Ointment:



  • If you are pregnant, or think you are pregnant. You must not use your medicine for a long time or in large amounts. You must ask your doctor for advice.

  • If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.





Driving and using machines



Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.





Important information about some of the ingredients of Fucidin Ointment



Fucidin Ointment contains:



  • Lanolin (wool fat). This may give you an itchy rash and inflammation on your skin where your medicine is used.

  • Cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.



Please ask your doctor if you are worried about any of the ingredients in this medicine.





How To Use Fucidin Ointment



Always use Fucidin Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.




How to put on Fucidin Ointment



This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.



Remove the cap. Check the seal is not broken before you first use the ointment. Then push the spike in the cap through the seal on the tube.



Always wash your hands before using Fucidin Ointment. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes.



Unless you are using the ointment to treat your hands, always wash your hands after using Fucidin Ointment.



If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.





How much Fucidin Ointment to use



Your doctor will tell you how much Fucidin Ointment to use.



Usually, you should use this medicine three or four times each day.



If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.





If you forget to use Fucidin Ointment



If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time.




If you have any further questions about using this medicine, please ask your doctor or pharmacist.





Fucidin Ointment Side Effects



Like all medicines, Fucidin Ointment can cause side effects, although not everybody gets them.




Important side effects to look out for:



You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:



  • You have difficulty breathing

  • Your face or throat swell

  • Your skin develops a severe rash.




Other possible side effects:



Skin problems



  • Rash

  • Stinging and irritation

  • Itchy rash and skin inflammation in the area where the medicine is used.



If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.





How To Store Fucidin Ointment



  • Keep out of the reach and the sight of children.

  • Do not use Fucidin Ointment after the expiry date on the carton. The expiry date is the last day of that month.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help protect the environment.





Further Information




What Fucidin Ointment contains



  • The active ingredient is sodium fusidate 2%.

  • The other ingredients are cetyl alcohol, lanolin (wool fat), liquid paraffin and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.





What Fucidin Ointment looks like and contents of the pack



Fucidin Ointment is an off white ointment.



Fucidin Ointment comes in tubes of 15 g and 30 g.





Marketing Authorisation Holder and Manufacturer



Marketing Authorisation Holder:




LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK



Manufacturer:




LEO Laboratories Limited

Dublin 12

Ireland




This leaflet was last revised in March 2008.



Registered Trade Mark






LEO



014156-03






Ampicillin



Pronunciation: AM-pi-SIL-in
Generic Name: Ampicillin
Brand Name: Principen


Ampicillin is used for:

Treating infections caused by certain types of bacteria.


Ampicillin is a penicillin antibiotic. It works by killing sensitive bacteria by interfering with formation of the bacteria's cell wall while it is growing. This weakens the cell wall and it ruptures, resulting in the death of the bacteria.


Do NOT use Ampicillin if:


  • you are allergic to any ingredient in Ampicillin or to any other penicillin antibiotic (eg, amoxicillin)

  • you are taking a tetracycline antibiotic (eg, doxycycline)

  • you have mononucleosis ("mono")

  • you have recently received or will be receiving live oral typhoid vaccine

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



Before using Ampicillin:


Some medical conditions may interact with Ampicillin. 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 stomach infection or diarrhea

  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a cephalosporin antibiotic (eg, cephalexin) or other beta-lactam antibiotic (eg, imipenem)

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


  • Tetracyclines (eg, doxycycline) because they may decrease Ampicillin's effectiveness

  • Probenecid because it may increase the risk of Ampicillin's side effects

  • Allopurinol because the risk of skin rash may be increased

  • Anticoagulants (heparin, warfarin) or methotrexate because the risk of their side effects may be increased by Ampicillin

  • Aminoglycosides (eg, gentamicin), birth control pills, or live oral typhoid vaccine because their effectiveness may be decreased by Ampicillin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ampicillin 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 Ampicillin:


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


  • Take Ampicillin by mouth at least one-half hour before or 2 hours after eating.

  • Take Ampicillin with a full glass of water (8 oz/240 mL).

  • Take Ampicillin on a regular schedule to get the most benefit from it. Taking Ampicillin at the same time each day will help you remember to take it.

  • To clear up your infection completely, use Ampicillin for the full course of treatment. Keep using it even if you feel better in a few days.

  • If you miss a dose of Ampicillin, 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 Ampicillin.



Important safety information:


  • Ampicillin only works against bacteria; it does not treat viral infections (eg, the common cold).

  • Be sure to use Ampicillin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Long-term or repeated use of Ampicillin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Ampicillin. To prevent pregnancy, use an extra form of birth control (eg, condoms).

  • Diabetes patients - Ampicillin may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.

  • Lab tests, including white blood cell counts and kidney function tests, may be performed while you use Ampicillin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Ampicillin with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ampicillin while you are pregnant. Ampicillin is found in breast milk. If you are or will be breast-feeding while you use Ampicillin, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Ampicillin:


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:



Inflammation and redness of the tongue; irritation of mouth or throat; mild diarrhea; nausea; second infection; 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); bloody stools; severe diarrhea; stomach pain/cramps; vaginal irritation or discharge .



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: Ampicillin 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 diarrhea; nausea; seizures; vomiting.


Proper storage of Ampicillin:

Store Ampicillin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Ampicillin out of the reach of children and away from pets.


General information:


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

  • Ampicillin 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 Ampicillin. 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 Ampicillin resources


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


  • Ampicillin Prescribing Information (FDA)

  • Ampicillin Monograph (AHFS DI)

  • Ampicillin Professional Patient Advice (Wolters Kluwer)

  • ampicillin Concise Consumer Information (Cerner Multum)

  • Ampicillin Sodium and Sulbactam Sodium Monograph (AHFS DI)

  • Principen Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Ampicillin with other medications


  • Bacterial Endocarditis Prevention
  • Bronchitis
  • Endocarditis
  • Gastroenteritis
  • Intraabdominal Infection
  • Kidney Infections
  • Leptospirosis
  • Meningitis
  • Otitis Media
  • Peritonitis
  • Pharyngitis
  • Pneumonia
  • Prevention of Perinatal Group B Streptococcal Disease
  • Septicemia
  • Shigellosis
  • Sinusitis
  • Skin Infection
  • Surgical Prophylaxis
  • Typhoid Fever
  • Upper Respiratory Tract Infection
  • Urinary Tract Infection

Tuesday, 18 September 2012

Faslodex


Pronunciation: fool-VES-trant
Generic Name: Fulvestrant
Brand Name: Faslodex


Faslodex is used for:

Treating certain types of advanced breast cancer in women after menopause who have not responded well to other medicines (eg, antiestrogen drugs) or therapy. It may also be used for other conditions as determined by your doctor.


Faslodex is an estrogen receptor antagonist. It works by blocking estrogen from tumors that need estrogen to grow.


Do NOT use Faslodex if:


  • you are allergic to any ingredient in Faslodex

  • you are pregnant

  • you are taking an anticoagulant (eg, warfarin, heparin)

  • you have low blood platelet levels or a history of bleeding or blood clotting problems

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



Before using Faslodex:


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


  • if you plan 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 liver problems

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


  • Anticoagulants (eg, heparin, warfarin) because risk of bleeding may be increased by Faslodex

This may not be a complete list of all interactions that may occur. Ask your health care provider if Faslodex 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 Faslodex:


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


  • Faslodex is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Faslodex at home, carefully follow the injection procedures taught to you by your health care provider.

  • If Faslodex contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

  • If you miss a dose of Faslodex, contact your doctor immediately.

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



Important safety information:


  • Faslodex may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Faslodex. Using Faslodex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks

  • Avoid becoming pregnant while you are using Faslodex. Your doctor should make sure that you are not pregnant before you begin using Faslodex.

  • Use Faslodex with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not use Faslodex if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Faslodex is excreted in breast milk. Do not breast-feed while taking Faslodex.


Possible side effects of Faslodex:


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:



Abnormal skin sensations; anxiety; back, bone, joint, or pelvic pain; constipation; diarrhea; dizziness; headache; hot flushes; increased cough; loss of appetite; nausea; pain, swelling, or redness at the injection site; sleeplessness; sore throat; stomach pain; sweating; vomiting; weakness.



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); chest pain; depression; fever or chills; frequent or painful urination; mental or mood changes; pain, redness, or tenderness in the legs; persistent sore throat; persistent vaginal bleeding; severe tiredness or weakness; shortness of breath; swelling of the hands or feet.



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: Faslodex 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 Faslodex:

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


General information:


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

  • Faslodex 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 Faslodex. 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 Faslodex resources


  • Faslodex Side Effects (in more detail)
  • Faslodex Use in Pregnancy & Breastfeeding
  • Faslodex Support Group
  • 2 Reviews for Faslodex - Add your own review/rating


  • Faslodex Prescribing Information (FDA)

  • Faslodex Consumer Overview

  • Faslodex Monograph (AHFS DI)

  • Faslodex Advanced Consumer (Micromedex) - Includes Dosage Information

  • Fulvestrant Professional Patient Advice (Wolters Kluwer)



Compare Faslodex with other medications


  • Breast Cancer
  • Breast Cancer, Metastatic

Thursday, 13 September 2012

Ketoconazole Shampoo



Pronunciation: kee-toe-KOE-na-zole
Generic Name: Ketoconazole
Brand Name: Nizoral A-D


Ketoconazole Shampoo is used for:

Treating scaling associated with dandruff. It may also be used for other conditions as determined by your doctor.


Ketoconazole Shampoo is an imidazole antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it. The weakened cell membrane allows the cell contents to leak out and results in the death of the fungus.


Do NOT use Ketoconazole Shampoo if:


  • you are allergic to any ingredient in Ketoconazole Shampoo

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



Before using Ketoconazole Shampoo:


Some medical conditions may interact with Ketoconazole Shampoo. 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 low blood sugar levels, liver disease, or porphyria (a blood disease), sulfite sensitivity, or you drink more than 3 alcohol-containing drinks a day

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


Ask your health care provider if Ketoconazole Shampoo 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 Ketoconazole Shampoo:


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


  • Moisten hair and scalp with water. Apply enough shampoo to wash your scalp and hair. Gently massage the entire scalp, leaving the shampoo on for about 5 minutes. Rinse thoroughly, then dry your hair as you normally do.

  • Keep Ketoconazole Shampoo out of your eyes, nose, and mouth. If this occurs, wash with water and contact your doctor, nurse, or pharmacist.

  • If you miss a dose of Ketoconazole Shampoo, 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 Ketoconazole Shampoo.



Important safety information:


  • Be sure to use Ketoconazole Shampoo for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • If you use topical products too often, your condition may become worse.

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

  • Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

  • Talk to your doctor before you take Ketoconazole Shampoo if you drink more than 3 drinks with alcohol per day.

  • Using Ketoconazole Shampoo on hair that has been permanently waved may cause a loss of the curl.

  • Ketoconazole Shampoo should be used with extreme caution 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 Ketoconazole Shampoo while you are pregnant. If you are or will be breast-feeding while you use Ketoconazole Shampoo, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Ketoconazole Shampoo:


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:



Itching; mild irritation or stinging; oiliness and dryness of hair and scalp.



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); increased or abnormal hair loss; reddening, blistering, peeling, itching, or burning of your 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.



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 Ketoconazole Shampoo:

Store Ketoconazole Shampoo between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketoconazole Shampoo out of the reach of children and away from pets.


General information:


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

  • Ketoconazole Shampoo 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 Ketoconazole Shampoo. 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 Ketoconazole resources


  • Ketoconazole Use in Pregnancy & Breastfeeding
  • Ketoconazole Support Group
  • 10 Reviews for Ketoconazole - Add your own review/rating


Compare Ketoconazole with other medications


  • Cutaneous Candidiasis
  • Dandruff
  • Seborrheic Dermatitis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor

Thursday, 6 September 2012

indomethacin Rectal



in-doe-METH-a-sin


Rectal route(Suppository)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .



Commonly used brand name(s)

In the U.S.


  • Indocin

In Canada


  • Indocid

  • Novo-Methacin Suppositories

  • Ratio-Indomethacin

  • Rhodacine

Available Dosage Forms:


  • Suppository

Therapeutic Class: Analgesic


Pharmacologic Class: NSAID


Chemical Class: Acetic Acid (class)


Uses For indomethacin


Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain. However, indomethacin does not cure arthritis and will help you only as long as you continue to take it.


Indomethacin is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. indomethacin may also be used to treat painful shoulder caused by bursitis or tendinitis.


indomethacin is available only with your doctor's prescription.


Before Using indomethacin


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 indomethacin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to indomethacin 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 indomethacin in children below 14 years of age. 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 indomethacin in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted effects (e.g., stomach ulcers, confusion, psychosis) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving indomethacin.


Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during 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 indomethacin, 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 indomethacin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Ketorolac

  • Pentoxifylline

Using indomethacin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abciximab

  • Ardeparin

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Certoparin

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Digoxin

  • Dipyridamole

  • Enoxaparin

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Lepirudin

  • Methotrexate

  • Nadroparin

  • Nefazodone

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Potassium

  • Protein C

  • Reviparin

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Tacrolimus

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Vilazodone

  • Zimeldine

Using indomethacin 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.


  • Acebutolol

  • Acetohexamide

  • Alacepril

  • Alprenolol

  • Amiloride

  • Arotinolol

  • Atenolol

  • Azilsartan Medoxomil

  • Azosemide

  • Befunolol

  • Bemetizide

  • Benazepril

  • Bendroflumethiazide

  • Benzthiazide

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bopindolol

  • Bucindolol

  • Bumetanide

  • Bupranolol

  • Buthiazide

  • Candesartan Cilexetil

  • Canrenoate

  • Captopril

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chlorothiazide

  • Chlorpropamide

  • Chlorthalidone

  • Cilazapril

  • Clopamide

  • Cyclopenthiazide

  • Cyclosporine

  • Delapril

  • Desvenlafaxine

  • Dilevalol

  • Dipyridamole

  • Duloxetine

  • Enalaprilat

  • Enalapril Maleate

  • Eprosartan

  • Esmolol

  • Ethacrynic Acid

  • Fosinopril

  • Furosemide

  • Gentamicin

  • Gliclazide

  • Glimepiride

  • Glipizide

  • Gliquidone

  • Glyburide

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Imidapril

  • Indapamide

  • Irbesartan

  • Labetalol

  • Landiolol

  • Levobetaxolol

  • Levobunolol

  • Lisinopril

  • Lithium

  • Losartan

  • Mepindolol

  • Methyclothiazide

  • Metipranolol

  • Metolazone

  • Metoprolol

  • Milnacipran

  • Moexipril

  • Nadolol

  • Nebivolol

  • Nipradilol

  • Olmesartan Medoxomil

  • Oxprenolol

  • Penbutolol

  • Pentopril

  • Perindopril

  • Pindolol

  • Piretanide

  • Polythiazide

  • Propranolol

  • Quinapril

  • Ramipril

  • Sotalol

  • Spirapril

  • Spironolactone

  • Talinolol

  • Tasosartan

  • Telmisartan

  • Temocapril

  • Tertatolol

  • Timolol

  • Tolazamide

  • Tolbutamide

  • Torsemide

  • Trandolapril

  • Triamterene

  • Trichlormethiazide

  • Valsartan

  • Venlafaxine

  • Warfarin

  • Xipamide

  • Zofenopril

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 indomethacin. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Bleeding problems or

  • Blood clots or

  • Depression or other mental changes or

  • Edema (fluid retention or body swelling) or

  • Heart attack, history of or

  • Heart disease (e.g., congestive heart failure) or

  • Hepatitis or jaundice, history of or

  • Hypertension (high blood pressure) or

  • Kidney disease or

  • Parkinsonism or

  • Seizures or epilepsy, history of or

  • Stomach ulcers or bleeding, history of or

  • Stroke, history of—Use with caution. May make these conditions worse.

  • Aspirin-sensitive asthma, history of or

  • Aspirin sensitivity, history of or

  • Proctitis (inflammation of the rectum), history of or

  • Rectal bleeding, recent—Should not be used in patients with these conditions.

  • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

  • Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of indomethacin


For safe and effective use of indomethacin, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of indomethacin may increase the chance of unwanted effects.


indomethacin should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


When used for severe or continuing arthritis, indomethacin must be taken regularly as ordered by your doctor in order for it to help you. indomethacin usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of indomethacin.


Do not take rectal suppositories by mouth.


To use the suppository:


  • If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

  • Remove the foil wrapper and moisten the suppository with cold water.

  • Lie down on your side and use your finger to push the suppository well up into the rectum

  • Remain lying down for about 15 minutes to keep the suppository from coming out before it melts.

  • Make sure to wash your hands with soap and water before and after inserting indomethacin.

Dosing


The dose of indomethacin 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 indomethacin. 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 rectal dosage form (suppositories):
    • For ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, bursitis, tendinitis, or gout:
      • Adults and teenagers older than 14 years of age—One 50-milligram (mg) suppository, inserted into the rectum up to four times a day.

      • Teenagers and children 14 years of age or younger—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of indomethacin, 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


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


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.


Precautions While Using indomethacin


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.


indomethacin may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use indomethacin for a long time might also have a higher risk.


indomethacin may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).


Serious skin reactions can occur during treatment with indomethacin. Check with your doctor right away if you have any of the following symptoms while using indomethacin: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.


Some possible warning signs of serious side effects that can occur during treatment with indomethacin may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop using indomethacin and check with your doctor right away if you notice any of these warning signs.


indomethacin may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.


Using indomethacin in the last few months of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.


Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


indomethacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if used at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to indomethacin before you drive, use machines, or do anything else that could be dangerous if you are not alert.


Before having any kind of surgery or medical tests, tell your doctor that you are using indomethacin. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.


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. .


indomethacin 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:


Less common
  • Acid or sour stomach

  • belching

  • diarrhea

  • heartburn

  • indigestion

  • nausea

  • stomach discomfort, upset, or pain

  • vomiting

Rare
  • Abdominal or stomach cramping, burning, or tenderness

  • back or leg pains

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • bloody or black, tarry stools

  • blue lips and fingernails

  • blurred vision

  • breast enlargement and tenderness

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • burning upper abdominal pain

  • canker sores

  • change in consciousness

  • change in hearing

  • chest pain, discomfort, or burning

  • clay colored stools

  • cloudy or bloody urine

  • confusion

  • continuing diarrhea

  • cough or hoarseness

  • coughing that sometimes produces a pink frothy sputum

  • cracks in the skin

  • dark urine

  • decreased appetite

  • decreased vision or any change in vision

  • depression

  • difficult or labored breathing

  • difficulty with swallowing

  • dilated neck veins

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

  • double vision

  • dry mouth

  • extreme fatigue

  • false sense of well-being

  • feeling of unreality

  • feeling of warmth

  • fever with or without chills

  • flushed, dry skin

  • fruit-like breath odor

  • general body swelling

  • greatly decreased frequency of urination or amount of urine

  • hair loss

  • headache

  • heavier menstrual periods

  • hives or welts

  • increased hunger

  • increased sweating

  • increased thirst

  • increased urination

  • irregular breathing

  • irritation and swelling of the eye

  • itching skin

  • jerky movements of the head, face, mouth, and neck

  • joint pain

  • large, flat, blue or purplish patches in the skin

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • loss of balance control

  • loss of bladder control

  • loss of consciousness

  • loss of hearing

  • loss of heat from the body

  • lower back or side pain

  • mask-like face

  • mental confusion

  • mood swings

  • muscle aches, pains, or weakness

  • muscle spasm or jerking of all extremities

  • nervousness

  • noisy, rattling breathing

  • nosebleeds

  • numbness or tingling in the hands, feet, or lips

  • pain in ankles or knees

  • pain or discomfort in upper stomach or throat

  • pain with swallowing

  • painful or difficult urination

  • painful, red lumps under the skin, mostly on the legs

  • pale skin

  • persistent bleeding or oozing from puncture sites, mouth, or nose

  • personality changes

  • pinpoint red or purple spots on the skin

  • pounding in the ears

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • red, swollen skin

  • redness of the face, neck, arms and occasionally, upper chest

  • scaly skin

  • seeing double

  • seeing, hearing, or feeling things that are not there

  • seizures

  • sense of detachment from self or body

  • severe constipation

  • severe mental changes

  • severe or continuing stomach pain

  • shortness of breath

  • shuffling walk

  • skin rash

  • slow, fast, irregular, pounding, or racing heartbeat or pulse

  • slowed movements

  • slurred speech

  • small red or purple spots on the skin

  • sore throat

  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

  • stiffness of the arms and legs

  • sudden loss of consciousness

  • sugar in the urine

  • swelling in the legs and ankles

  • swelling of the face, fingers, feet, or lower legs

  • swelling of the breasts or breast soreness in both females and males

  • swollen or painful glands

  • tightness in the chest

  • trembling and shaking of the fingers and hands

  • troubled breathing at rest

  • troubled breathing with exertion

  • unexplained weight loss

  • unpleasant breath odor

  • unsteadiness or awkwardness

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vaginal bleeding

  • vomiting of blood or material that looks like coffee grounds

  • weakness in the arms, hands, legs, or feet

  • weight gain

  • wheezing

  • yellow eyes or skin

Incidence not known
  • Frequent urge to defecate

  • rectal bleeding, burning, dryness, itching, or pain

  • straining while passing stool

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Confusion about identity, place, and time

  • severe headache

  • unusual drowsiness, dullness, or feeling of sluggishness

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
  • Mild headache

Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears

  • difficulty having a bowel movement (stool)

  • discouragement

  • feeling sad or empty

  • general feeling of discomfort or illness

  • hearing loss

  • irritability

  • loss of interest or pleasure

  • sleepiness

  • trouble with concentrating

Rare
  • Anxiety

  • bloated full feeling

  • changes in patterns and rhythms of speech

  • excess air or gas in the stomach or intestines

  • feeling of constant movement of self or surroundings

  • involuntary muscle movements

  • lightheadedness

  • passing gas

  • sensation of spinning

  • sleeplessness

  • tiredness

  • trouble with speaking

  • trouble sleeping

  • unable to sleep

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: indomethacin Rectal 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 indomethacin Rectal resources


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


Compare indomethacin Rectal with other medications


  • Ankylosing Spondylitis
  • Back Pain
  • Bartter Syndrome
  • Bursitis
  • Cluster Headaches
  • Frozen Shoulder
  • Gitelman Syndrome
  • Gout, Acute
  • Langerhans' Cell Histiocytosis
  • Osteoarthritis
  • Pain
  • Patent Ductus Arteriosus
  • Rheumatoid Arthritis
  • Sciatica
  • Tendonitis

Wednesday, 5 September 2012

Aldara 5% Cream






Aldara 5% cream



Imiquimod



Read all of this leaflet carefully before you start using this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, please ask your doctor or your pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:


1. What Aldara cream is and what it is used for

2. Before you use Aldara cream

3. How to use Aldara cream

4. Possible side effects

5. How to store Aldara cream

6. Further information





What Is Aldara Cream And What It Is Used For


Aldara cream may be used for three different conditions. Your doctor may prescribe Aldara cream for the treatment of:


  • Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage)

  • Superficial basal cell carcinoma.

    This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body. It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure. If left untreated, basal cell carcinoma can disfigure, especially on the face – therefore early recognition and treatment are important.

  • Actinic keratosis

    Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. Some are skin coloured, others are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty. Aldara should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Aldara is the most appropriate treatment for you.

Aldara cream helps your body´s own immune system to produce natural substances which help fight your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.




Before You Use Aldara Cream



Do not use Aldara cream :


  • If you are allergic to imiquimod (the active ingredient) or any of the ingredients of the cream.



Children and adolescents:


  • Use in children and adolescents is not recommended.



Take special care with Aldara cream:


  • If you have previously used Aldara cream or other similar preparations tell your doctor before starting this treatment.

  • Tell your doctor if you have problems with your immune system.

  • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.

  • Avoid contact with the eyes, lips and nostrils. In the event of accidental contact, remove cream by rinsing with water.

  • Do not apply the cream internally.

  • Do not use more cream than your doctor has advised.

  • Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.

  • If the treated site becomes too uncomfortable, wash the cream off with mild soap and water.

    As soon as the problem has stopped you may restart to apply the cream.

  • Tell your doctor if you have an abnormal blood count.

Because of the way Aldara works, there is a possibility that the cream may worsen existing inflammation in the treatment area.


  • If you are being treated for genital warts follow these additional precautions:


    Men with warts under the foreskin should pull the foreskin back each day and wash underneath it. If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back. If these symptoms occur, stop the treatment immediately and call your doctor.


    If you have open sores: do not start using Aldara cream until after the sores have healed.


    If you have internal warts: do not use Aldara cream in the urethra (the hole from which urine is passed), the vagina (birth canal), the cervix (internal female organ), or anywhere inside your anus (rectum).


    Do not use this medication for more than one course if you have problems with your immune system, either due to illness or because of the medicines you are already taking. If you think this applies to you talk to your doctor.


    If you are HIV positive you should inform your doctor as Aldara cream has not been shown to be as effective in HIV positive patients. If you decide to have sexual relations while you still have warts, apply Aldara cream after - not before - sexual activity. Aldara cream may weaken condoms and diaphragms, therefore the cream should not be left on during sexual activity. Remember, Aldara cream does not protect against giving HIV or other sexually transmitted diseases to someone else.

  • If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:


    Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Aldara cream. Wear protective clothing and wide brimmed hats when outdoors.

Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.




Using other medicines:


Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.


There are no medicines known to be incompatible with Aldara cream.




Pregnancy and breast-feeding:


Ask your doctor or pharmacist for advice before taking any medicine.


You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of using Aldara cream during pregnancy. Studies in animals do not indicate direct or indirect harmful effects in pregnancy.


Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.




Important information about some of the ingredients of Aldara cream:


Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions (possibly delayed). Cetyl and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).





How To Use Aldara Cream



Children and adolescents:


Use in children and adolescents is not recommended.



Adults:


Always use Aldara cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


Wash hands carefully before and after applying the cream. Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.


Open a new sachet each time you use the cream. Dispose of any cream left in the sachet after use. Do not save the opened sachet for use at a later date.


The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).





  • If you are being treated for genital warts:


Application Instructions – (Mon, Wed and Fri)



1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto your fingertip.
3. Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
4. After application of the cream, throw away the opened sachet and wash hands with soap and water.
5. Leave Aldara cream on the warts for 6 to 10 hours. Do not shower or bathe during this time.
6. After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.


Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover a wart area of 20 cm2 (approx. 3 square inches).


Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 “Take special care with Aldara cream:”)


Continue to use Aldara cream as instructed until your warts have completely gone (half the females who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients warts may clear as early as 4 weeks).


Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.


If you have the impression that the effect of Aldara cream is too strong or too weak, talk to your doctor or pharmacist.




  • If you are being treated for basal cell carcinoma:


Application Instructions – (Mon, Tues, Wed, Thurs and Fri)


1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.

2. Open a new sachet and squeeze some cream onto your fingertip.

3. Apply Aldara cream to the affected area and 1cm (approx. 0.5 inch) around the affected area. Rub gently into the skin until the cream vanishes.

4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.

5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.

6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.


Apply sufficient Aldara cream to cover the treatment area and 1 cm (about ½ an inch) around the treatment area each day for 5 consecutive days each week for 6 weeks. For example, apply the cream from Monday to Friday. Do not apply the cream on Saturday and Sunday.




  • If you are being treated for actinic keratosis


Application Instructions – (Mon, Wed and Fri)


1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.

2. Open a new sachet and squeeze some cream onto your fingertip.

3. Apply the cream to the affected area. Rub gently into the area until the cream vanishes.

4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.

5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.

6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.


Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover an area of 25 cm2 (approx. 4 square inches). Continue treatment for four weeks. Four weeks after finishing this first treatment, your doctor will assess your skin. If the lesions have not all disappeared, a further four weeks of treatment may be necessary.



If you use more Aldara cream than you should:


Wash the extra away with mild soap and water. When any skin reaction has gone you may then continue with your treatment.


If you accidentally swallow Aldara cream please contact your doctor.




If you forget to use Aldara cream:


If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule. Do not apply the cream more than once per day.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible Side Effects


The frequency of side effects is classified as follows:


Very common side effects (likely to occur in more than 1 in 10 patients)


Common side effects (likely to occur in fewer than 1 in 10 patients)


Uncommon side effects (likely to occur in fewer than 1 in 100 patients)


Rare side effects (likely to occur in fewer than 1 in 1,000 patients)


Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).


Like all medicines, Aldara cream can cause side effects, although not everybody gets them.


Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.


Some patients have experienced changes in skin colour in the area where Aldara cream was applied. While these changes have tended to improve with time, in some patients they may be permanent.


If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.


In some individuals a lowering of blood counts was noted. A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue. If you notice any of these symptoms, tell your doctor.


Serious skin reactions have been reported rarely. If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor immediately.


A small number of patients have experienced hair loss at the treatment site or surrounding area.


If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.



  • If you are being treated for genital warts:

Many of the undesirable effects of Aldara cream are due to its local action on your skin.



Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling. Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur. You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients). Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.



Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.



Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine. If this occurs you should seek medical help immediately.



  • If you are being treated for basal cell carcinoma:

Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.



Very Commonly the treated skin may be slightly itchy.



Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.


If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).


If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include swollen glands and back pain.



Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.



  • If you are being treated for actinic keratosis

Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.



Very commonly the treated skin may be slightly itchy.



Common effects include pain, burning, irritation or redness.


If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).


If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.



Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.




How To Store Aldara Cream


Keep out of the reach and sight of children.


Do not store above 25°C.


Do not use after the expiry date stated on the label.


Sachets should not be re-used once opened.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Aldara cream contains:


  • The active substance is imiquimod. Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).

  • The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.



What Aldara cream looks like and contents of the pack:


  • Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.

  • Each box contains 12 or 24 single-use polyester/aluminium foil sachets. Not all pack sizes may be marketed.



Marketing Authorisation Holder:



Meda AB

Box 906

170 09 Solna

Sweden




Manufacturer :



3M Health Care Limited

Derby Road

Loughborough

Leicestershire

LE11 5SF

United Kingdom


For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
































United Kingdom

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop´s Stortford

CM22 6PU

Tel.:+ 44 845 460 0000





This leaflet was last approved in (04/2010)