Stercia Special Precautions

General: Caution should be used in the administration of finasteride tablets in patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.
Information for Patients: Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. (See also Contraindications and Use in Pregnancy under Precautions.)
Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge, Breast changes including breast enlargement, tenderness and neoplasm have been reported (see Adverse Reactions).
Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride tablets and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding finasteride tablets.
Drug/Laboratory Test Interactions: Finasteride had no effect on circulating levels of cortisol, thyroid-stimulating hormone, or thyroxin, nor did it affect the plasma lipid profile (e.g., total cholesterol, low-density lipoproteins, high-density lipoproteins and triglycerides) or bone mineral density. In studies with finasteride, no clinically meaningful changes in luteinizing hormone (LH), follicle-stimulating hormone (FSH) or prolactin were detected. In healthy volunteers, treatment with finasteride did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.
In clinical studies with finasteride tablets 1 mg in men 18 to 41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at month 12. Further, in clinical studies with finasteride tablets 5 mg when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride.
Drug Interactions: 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 have include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.
Other Concomitant Therapy: Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with Zacetaminophen, acetylsalicylic acid, a-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H₂ antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory (NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of a tumorigenic effect was observed in a 24-month study in Sprague-Dawley rats receiving doses of finasteride up to 160 mg/kg/day in males and 320 mg/kg/day in females. These doses produced respective systemic exposure in rats of 888 and 2,192 times those observed in man receiving the recommended human dose of 1 mg/day. All exposure calculations were based on calculated AUC_{(0 to 24 hr)} for animals and mean AUC_{(0 to 24 hr)} for man (0.05 mcg·hr/mL).
No evidence of mutagenicity was observed in an in vitro bacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro chromosome aberration assay, using Chinese hamster ovary cells, there was a slight increase in chromosome aberrations. In an in vivo chromosome aberration assay in mice, no treatment-related increase in chromosome aberration was observed with finasteride at the maximum tolerated dose of 250 mg/kg/day (1,824 times the human exposure) as determined in the carcinogenicity studies.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Finasteride tablets are not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
Use in the Elderly: Clinical efficacy studies with finasteride tablets did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for finasteride tablets (see Pharmacology: Pharmacokinetics under Actions). However, the efficacy of finasteride tablets in the elderly has not been established.