Fincar is made in India. Even though it contains the exact same chemical as Proscar (5mg of finasteride), its cost is significantly less than that of Proscar.
Cipla is allowed by Indian patent law to make drugs that are patented by other companies internationally as the law protects only the processes by which drugs are made, and not the drugs themselves.
Under current Indian law, which recognizes patents on ways to make drugs but not the drugs themselves. This means Indian companies can make drugs under patent in the West, provided they use a process that is different from the original. Manufacturers are able to produce and sell medicines here at a tiny fraction of the prices charged in the United States. In some cases, though, the generic makers have been blocked from selling their wares in other developing countries that have Western-style patent laws.
Each film-coated tablet contains Finasteride 5 mg.
Description
Fincar (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of 5 alpha-reductase, an intracellular enzyme that converts testosterone into the potent 5 alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulation of prostatic growth.
Indications
Fincar is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Dosage and Administration
Fincar is recommended for use in adult males. The recommended dose is 5mg once a day with or without meals. Although early improvement is seen, at least 6-12 months of therapy with Fincar, it may be necessary in some patients to assess whether a beneficial response has been achieved. Periodic follow up evaluations should be performed to determine whether a clinical response has occurred. Dose adjustment is not required in geriatric individuals with impaired renal function. No dose adjustment is required in impaired hepatic function. Since finasteride is metabolised extensively in the liver, the drug should be used with caution in patients with hepatic impairment.
Contra-Indications
Fincar is contraindicated to anyone with hypersensitivity to any component of this medication and, women and children.
Warnings and Precautions
GENERAL
Digital rectal examinations, as well as other evaluations for prostate cancer should be performed on patients with BPH prior to initiating therapy with finasteride and periodically thereafter. Since not all patients demonstrate a response to Fincar, patients with a large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for this therapy. Caution should be used in the administration of Fincar in those patients with liver abnormalities, as finasteride is metabolised extensively in the liver.
INFORMATION FOR PATIENTS
Women of child bearing potential should not handle crushed or broken Fincar tablets and avoid exposure to the semen of men on Fincar because of the potential risk to the male foetus.
LABORATORY TEST INTERACTIONS
When PSA laboratory determinations are evaluated, consideration should be given to take into account that PSA levels are decreased in patients with Fincar.
CARINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No evidence of a tumorigenic effect was observed in a 24-month study in Sprangue female rats receiving doses of finasteride up to 160 mg/kg/day in males and 320mg in females.
Drug Interactions
Antipyrine
Antipyrine is used as a model for drugs that are metabolised by the same iso-enzymatic cytochrome P450 system. In 12 subjects receiving finasteride 10 mg/day for 28 days, finasteride had no effect on the pharmacokinetic parameters of antipyrine or its metabolites.
No drug interaction of clinical importance with concomitant use of propranolol, digoxin, theophylline and warfarin has been identified.
Other concomitant therapy
Although specific interaction studies were not performed, finasteride was concomitantly used in clinical studies with alpha-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, H2 antagonists and quinolone antiinfectives without evidence of clinically significant adverse interactions.
Adverse Reactions
Finasteride is generally well tolerated and has been used for up to 5 years; adverse reactions usually have been mild and transient. These include impotence, decreased libido, decreased volume of ejaculate, breast tenderness and enlargement, hypersensitivity reactions including lip swelling and skin rash.
Overdosage
Patients have received single doses of finasteride up to 400mg and multiple doses of finasteride up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.
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