Flowel Plus Capsules

Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2) Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. …

• The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa
• Dutasteride may be administered with or without food
• Monotherapy: 0.5 mg once daily
• Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily
• Dosing considerations: Swallow whole
• May take with or without food
• Monotherapy The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily
• Combination with Alpha-adrenergic Antagonist The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily

0.5 mg, yellow, oblong capsules containing clear liquid printed with ‘AT131’ with black ink. 0.5-mg capsules ( 3 )

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• PSA Monitoring Inform patients that dutasteride reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual
• For patients undergoing PSA screening, increases in PSA levels while on treatment with dutasteride may signal the presence of prostate cancer and should be evaluated by a healthcare provider [see Warnings and Precautions ] . …

• Dutasteride is contraindicated for use in: Pregnancy
• Dutasteride use is contraindicated in women who are pregnant
• In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia
• Therefore, dutasteride may cause fetal harm when administered to a pregnant woman [see Warnings and Precautions , Use in Specific Populations ] . …

Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir). (7) 7.1 Cytochrome P450 3A Inhibitors Dutasteride is extensively metabolized in humans by the cytochrome P450 (CYP)3A4 and CYP3A5 isoenzymes. The effect of potent CYP3A4 inhibitors on dutasteride has not been studied. Because of the potential for drug-drug interactions, use caution when prescribing dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir) [see Clinical Pharmacology (12.3)] . …

Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.1) Dutasteride may increase the risk of high-grade prostate cancer. (5.2, 6.1) Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. (5.3) Women who are pregnant or may be pregnant should not handle dutasteride capsules due to potential risk to a male fetus. …

The most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 with rates in the clinical trial of another drug and may not reflect the rates observed in practice. …

IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus [see Contraindications (4)] . Dutasteride is not indicated for use in women. Dutasteride is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. …

In volunteer trials, single doses of dutasteride up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical trial, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for dutasteride. Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.