Monday, 27 February 2012

Urea 50 Gel





Dosage Form: gel, applicator
Urea 50 Applicator

DESCRIPTION:


Urea 50 Applicator contains a keratolytic solution, which is a gentle, yet potent, tissue softener for nails and dry rough skin. Urea 50 Applicator contains 50% urea along with acrylates copolymer, carbomer, cetyl alcohol, disodium EDTA, dl-alphatocopheryl acetate, glycerin, lactic acid, linoleic acid, mineral oil, PEG-6, polysorbate 60, purified water, sodium hydroxide solution, stearic acid, titanium dioxide, zinc undecylenate.


Urea is a diamide of carbonic acid with the following chemical structure:




CLINICAL PHARMACOLOGY:


Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin while shedding scaly skin at regular intervals, which then softens the hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS:


The mechanism of action of topically applied urea is not yet known.



INDICATIONS AND USES:


For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyper-keratotic conditions such as dry, rough skin, dermatitis, psoriasis, ichthyosis, keratoderma, eczema, keratosis pilaris, keratosis palmaris, xerosis, corns and calluses, as well as damaged, devitalized, and ingrown nails.



CONTRAINDICATIONS:


Known hypersensitivity to any of the listed ingredients.

WARNINGS:


For external use only. Avoid contact with eyes, lips or mucous membranes.



PRECAUTIONS:


This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.



PREGNANCY:


Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea 50 Applicator should be given to pregnant women only if clearly needed.



NURSING MOTHERS:


It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea 50 Applicator is administered to nursing women.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS:


Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.


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



DOSAGE AND ADMINISTRATION:


Apply Urea 50 Applicator to diseased or damaged nail and/or skin tissue twice per day, or as directed by a physician.

HOW SUPPLIED:


Urea 50 Applicator, NDC #49769-404-12, is supplied in a carton containing three 4 mL pre-filled applicators. Net wt. 12 mL.

STORAGE:


Store at controlled room temperature 15°C–30°C (59°F–86° F).


Protect from freezing.


Manufactured for:

Kylemore Pharmaceuticals

Suwanee, GA 30024

Rev. 12/09 404-10

PACKAGING:


Urea 50 Applicator labeling:



Urea 50 Applicator carton:










UREA 50 
urea  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49769-404
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UREA)UREA500 mg  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
149769-404-1212 mL In 1 APPLICATORNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/06/2010


Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010Kylemore Pharmaceuticals, LLC




More Urea 50 Gel resources


  • Urea 50 Gel Use in Pregnancy & Breastfeeding
  • Urea 50 Gel Support Group
  • 9 Reviews for Urea 50 - Add your own review/rating


Compare Urea 50 Gel with other medications


  • Dermatological Disorders
  • Dry Skin
  • Pityriasis rubra pilaris

Tuesday, 27 December 2011

Kemicetine




Kemicetine may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

UK matches:

  • Kemicetine Succinate Injection (SPC)

Ingredient matches for Kemicetine



Chloramphenicol

Chloramphenicol is reported as an ingredient of Kemicetine in the following countries:


  • India

  • Indonesia

  • Philippines

  • Turkey

Chloramphenicol succinate sodium (a derivative of Chloramphenicol) is reported as an ingredient of Kemicetine in the following countries:


  • Hong Kong

  • Indonesia

  • United Kingdom

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Discotrine




Discotrine may be available in the countries listed below.


Ingredient matches for Discotrine



Nitroglycerin

Nitroglycerin is reported as an ingredient of Discotrine in the following countries:


  • Denmark

  • France

  • Iceland

International Drug Name Search

Monday, 26 December 2011

Periodent




Periodent may be available in the countries listed below.


Ingredient matches for Periodent



Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Periodent in the following countries:


  • Argentina

International Drug Name Search

Saturday, 24 December 2011

Remeron-S




Remeron-S may be available in the countries listed below.


Ingredient matches for Remeron-S



Mirtazapine

Mirtazapine is reported as an ingredient of Remeron-S in the following countries:


  • Sweden

International Drug Name Search

Friday, 23 December 2011

Noodipina




Noodipina may be available in the countries listed below.


Ingredient matches for Noodipina



Nimodipine

Nimodipine is reported as an ingredient of Noodipina in the following countries:


  • Brazil

International Drug Name Search

Wednesday, 21 December 2011

ReVia


Generic Name: naltrexone (oral) (nal TREX own)

Brand Names: ReVia


What is ReVia (naltrexone (oral))?

Naltrexone oral is an special narcotic drug that blocks the effects of other narcotic medicines and alcohol.


Naltrexone oral is used to treat narcotic drug or alcohol addiction..


Naltrexone oral may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about ReVia (naltrexone (oral))?


Your doctor may recommend that naltrexone oral be given to you by a family member or other caregiver. This is to make sure you are using the medicine as it was prescribed as part of your treatment.


Do not use narcotic drugs or alcohol while taking naltrexone oral. Never try to overcome the effects of the medication by taking large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain while taking naltrexone oral. These medicines may contain narcotics or alcohol. Naltrexone oral can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Carry an ID card or wear a medical alert bracelet stating that you are using naltrexone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using this medication.

Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone oral.


What should I discuss with my health care provider before using ReVia (naltrexone (oral))?


Do not take this medicine if you are allergic to naltrexone, or if you have:

  • an addiction to narcotics;




  • a history of alcohol or narcotic drug use within the past 7-10 days; or




  • drug or alcohol withdrawal symptoms.



Before taking naltrexone, tell your doctor if you are allergic to any drugs, or if you have:


  • kidney disease;

  • liver disease; or

  • a bleeding disorder such as hemophilia (if you are using naltrexone oral injection).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether naltrexone oral passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use ReVia (naltrexone (oral))?


Use naltrexone oral exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.


Take the naltrexone oral tablet with a full glass of water. You may take the naltrexone oral tablet with food to decrease stomach upset.

It is important to take naltrexone oral regularly to get the most benefit.


Your doctor may recommend that naltrexone oral be given to you by a family member or other caregiver. This is to make sure you are using the medicine as it was prescribed as part of your treatment.


Carry an ID card or wear a medical alert bracelet stating that you are using naltrexone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using this medication.

Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone oral.


Store naltrexone oral tablets at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.


Overdose symptoms may include nausea, stomach pain, dizziness, or seizure (convulsions).


What should I avoid while using ReVia (naltrexone (oral))?


Naltrexone oral can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use narcotic drugs or alcohol while taking naltrexone oral. Never try to overcome the effects of the medication by taking large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain while taking naltrexone oral. These medicines may contain narcotics or alcohol.

ReVia (naltrexone (oral)) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using naltrexone oral and call your doctor at once if you have any of these serious side effects:

  • blurred vision or eye problems;




  • fast heartbeat;




  • mood changes, hallucinations (seeing or hearing things), confusion, thoughts of hurting yourself;




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • ear pain, ringing in your ears;




  • skin rash or itching; or




  • wheezing, difficulty breathing.



Less serious side effects may include:



  • feeling anxious, nervous, restless, or irritable;




  • feeling light-headed, fainting;




  • increased thirst;




  • muscle or joint aches;




  • weakness or tiredness;




  • sleep problems (insomnia); or




  • decreased sex drive, impotence, or difficulty having an orgasm.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect ReVia (naltrexone (oral))?


The pain-relieving effects of any narcotic pain medications you use will be blocked if you use them during your treatment with naltrexone oral. Harmful side effects could also occur.


Before using naltrexone, tell your doctor if you use any of the following drugs:



  • buprenorphine (Buprenex, Subutex);




  • butorphanol (Stadol);




  • codeine (Tylenol with codeine);




  • hydrocodone (Lortab, Vicodin);




  • dezocine (Dalgan);




  • hydromorphone (Dilaudid);




  • levorphanol (Levo-Dromoran);




  • meperidine (Demerol);




  • methadone (Dolophine, Methadose);




  • morphine (Kadian, MS Contin, Roxanol);




  • nalbuphine (Nubain);




  • nalmefene (Revex);




  • naloxone (Narcan);




  • oxycodone (OxyContin, Roxicodone, Percocet);




  • oxymorphone (Numorphan); or




  • propoxyphene (Darvon, Darvocet).



This list it not complete and there may be other drugs that can interact with naltrexone oral. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More ReVia resources


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


  • Naltrexone Prescribing Information (FDA)

  • Naltrexone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Naltrexone Monograph (AHFS DI)

  • Revia Advanced Consumer (Micromedex) - Includes Dosage Information

  • Revia MedFacts Consumer Leaflet (Wolters Kluwer)

  • Revia Prescribing Information (FDA)

  • Vivitrol Prescribing Information (FDA)

  • Vivitrol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Vivitrol Consumer Overview



Compare ReVia with other medications


  • Alcohol Dependence
  • Fibromyalgia
  • Opiate Dependence
  • Trichotillomania


Where can I get more information?


  • Your pharmacist can provide more information about naltrexone.

See also: ReVia side effects (in more detail)