- Approval Id
- 947510dbb79de465
- Drug Name
- Finasteride Mevon 5mg tablet
- Product Name
- Finasteride Mevon 5mg tablet
- Approval Number
- SIN13681P
- Approval Date
- 2009-08-03
- Registrant
- NOVEM PHARMA PRIVATE LIMITED
- Licence Holder
- NOVEM PHARMA PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Dosage and mode of administration**
The recommended dose is 5mg per day, with or without food.
Dosage in renal insufficiency
No dosage readjustment is required in patients with any degree of renal insufficiency (creatinine clearance as low as 9ml/min), and also no change was presented in the disposition of finasteride from pharmacokinetics studies.
Dosage in elderly patients
No dosage readjustment is required, although studies of pharmacokinetics show that the excretion of finasteride is slightly more reduced in patients aged above 70 years old.
Dosage in liver failure
There are no data for the administration of finasteride in patients with liver failure.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic Indications**
It is indicated for the treatment of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate, since it reduces the prostate size, leading to improvement of the urinary flow rate and in BPH’s symptoms, it reduces the frequency of acute retention of urine and the need for surgical procedure for prostate transurethral resection and prostatectomy.
- Contraindications
- **4.3 Contraindications**
FINASTERIDE MEVON 5MG TABLET is contraindicated in women or children.
FINASTERIDE MEVON 5MG TABLET is contraindicated in the following cases:
- Hypersensitivity in any component of the drug.
- Pregnancy. Finasteride is contraindicated in women who are or may be pregnant (see 4.4. Special Warnings and Precautions during use. PRECAUTIONS, Pregnancy and Exposure to finasteride – danger to male fetus – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- G04CB01
- Atc Item Name
- finasteride
- Pharma Manufacturer Name
- NOVEM PHARMA PRIVATE LIMITED
- Company Detail Path
- /organization/novem-pharma-private-limited
