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Cyproterone Tablet

Latest prescription information about Cyproterone Tablet. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Cyproterone Tablet
Pronunciation : SYE-proe-teh-rone
Therapeutic Classification : Hormones
ICD Code : Y42.6
Trade Name(s): 
India- Diane-35, Dinac 35, Frauline, Ginette-35, Krimson.
International- Androcur, Cyprostat,Cyproteron, Procur, Cyprone, Cyprohexal, Ciproterona, Cyproteronum, Neoproxil, Siterone.
Why it is prescribed (Indications) : 
This medication is an antiandrogen, prescribed for prostate cancer, benign prostatic hyperplasia, priapism, hypersexuality, and hirsutism. It blocks the effect of the testosterone in the body.
When it is not to be taken (Contraindications): 
Contraindicated in patients with Dubin-Johnson or Rotor syndrome, severe depression, diabetes, sickle-cell anemia, blood clotting disorder, kidney impairment, liver impairment, and hypersensitivity.

Pregnancy Category :

A B C D X
Category X : Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Dosage & When it is to be taken : 
Adult: PO- Acne; Contraception; Hirsutism: The recommended dose is 2 mg/day (with ethinylestradiol) for 21 days of the menstrual cycle.
Palliative treatment for prostatic carcinoma: Initial- 300 mg/day in 2-3 divided doses. Maintenance: 200-300 mg/day.
Control of libido: 50 mg twice daily.
Hot flushes: 50mg/day, may increase to 150 mg/day in 3 divided doses if needed.
How it should be taken : 
It comes as a tablet to take by mouth, with food.
Warnings and Precautions : 
* Caution should be exercised in patients with history of prostate cancer, liver impairment, sugar, heart disease, during pregnancy and breastfeeding.
* Monitor liver function test, cholesterol level, and red blood cells count during treatment.
* In women: Interrupt treatment if persistent or recurrent bleeding occurs to exclude the possibility of organic diseases.
* Patient may develop with increased risk of blood clot disorder.
* Ineffective for male hypersexuality in chronic alcoholism.
* It may cause dizziness, do not drive a car or operate machinery while taking this medication.
Side Effects : 
Most Common - Dizziness, headache, intestinal problems, nausea, flushing, or leg pain might occur.
Genitourinary - Sexual deviance, mood changes and changes in breast.
Miscellaneous - Palpitations, chest pain, unusual weakness, vision changes, trouble breathing, stomach pain, weight gain, rash, increased urination and increased thirst.
Other Precautions : 
* Avoid excess dosage
Storage Conditions : 
Store it as directed by your physician.

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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