Finasteride 5 mg/1
Finasteride · TABLET · Dr. Reddy's Laboratories Limited
Finasteride is a prescription tablet taken by mouth that works by blocking an enzyme involved in male hormone conversion. It is used to treat benign prostate enlargement and male pattern hair loss.
Key Facts
- Brand Name
- Finasteride
- Generic Name
- Finasteride
- NDC Code (Product)
55111-172- Manufacturer
- Dr. Reddy's Laboratories Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076437
- Drug Class
- 5-alpha Reductase Inhibitor [EPC]
- Marketing Start
- 02/28/2007
Recall History
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Aidapak Services, LLC
Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD62829_8, EXP: 5/23/2014; PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003061, EXP: 5/31/2014.
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
MPRX, Inc. dba Medical Park Pharmacy
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MasterPharm LLC
Lack of Processing Controls (lack of assurance of conformity to specifications).
Direct Rx
cGMP deviations
MasterPharm LLC
Lack of Processing Controls (lack of assurance of conformity to specifications).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets USP are not indicated for use in women. • Finasteride tablets USP are 5α-reductase inhibitors indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY ( 1 ). • Finasteride tablets USP are not indicated for use in women ( 1 , 4 , 5.1 ).
Dosage & Administration
2 DOSAGE & ADMINISTRATION Finasteride tablets USP may be administered with or without meals. The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months. • Finasteride tablets USP may be administered with or without meals ( 2 ). • One tablet (1 mg) taken once daily ( 2 ). • In general, daily use for three months or more is necessary before benefit is observed ( 2 ).
Contraindications
4 CONTRAINDICATIONS Finasteride tablets USP are contraindicated in the following: • Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [ See Warnings and Precautions (5.1) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.1) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. • Hypersensitivity to any component of this medication. • Pregnancy ( 4 , 5.1 , 8.1 , 16 ). • Hypersensitivity to any components of this product ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS 7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. 7.2 Other Concomitant Therapy Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H 2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions, reported in ≥1% of patients treated with finasteride tablets USP and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Studies for Finasteride Tablets USP 1 mg in the Treatment of Male Pattern Hair Loss In three controlled clinical trials for finasteride tablets USP of 12-month duration, 1.4% of patients taking finasteride tablets USP (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934). Clinical adverse experiences that were reported as possib…
Frequently Asked Questions
What is Finasteride used for?
Finasteride is a prescription tablet taken by mouth that works by blocking an enzyme involved in male hormone conversion. It is used to treat benign prostate enlargement and male pattern hair loss.
Is Finasteride a controlled substance?
Finasteride is not classified as a controlled substance by the DEA.
What is the generic name for Finasteride?
The generic name for Finasteride is Finasteride. There are no other listed brand versions of Finasteride.
What is the NDC code for Finasteride 5 mg/1?
The NDC (National Drug Code) for Finasteride 5 mg/1 is 55111-172, listed by Dr. Reddy's Laboratories Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)