FDA records indicate that there are no current recalls for this drug.
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Vaprisol Dextrose In Plastic Container Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Finasteride tablets, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
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- Improve symptoms
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- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed greater than or equal to 4 point increase in American Urological Association (AUA) symptom score).
Finasteride is not approved for the prevention of prostate cancer.
History
There is currently no drug history available for this drug.
Other Information
Finasteride, USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:
Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, lauryl macrogolglycerides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium starch glycolate and titanium dioxide.
Sources
Vaprisol Dextrose In Plastic Container Manufacturers
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Cumberland Pharmaceuticals Inc.
Vaprisol Dextrose In Plastic Container | American Health Packaging
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
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