Finasteride description, usages, side effects, indications, overdosage, supplying and lots more!

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Finasteride

Bryant Ranch Prepack
Bryant Ranch Prepack

Finasteride Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

FINASTERIDE DESCRIPTION




N233622
Finasteride


CLINICAL PHARMACOLOGY




½in vivoin vitro







Pharmacokinetics

Drug Interactions


PRECAUTIONS, Drug Interactions


*Range
Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)

 
Mean (± SD)
   Bioavailability
   63% (34-108%)*   
   Clearance (mL/min)
165 (55)
   Volume of Distribution (L)   
76 (14)
   Half-Life (hours)
6.2 (2.1)

*First-dose values; all other parameters are last-dose values
Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 5 mg/day in Older Men

 
Mean (± SD)
  45 to 60 years old  (n=12)

  ≥70 years old   (n=12)

   AUC (ng•hr/mL)
389 (98)
463 (186)
   Peak Concentration (ng/mL)   
46.2 (8.7)
48.4 (14.7)
   Time to Peak (hours)
1.8 (0.7)
1.8 (0.6)
   Half-Life (hours)*
6 (1.5)
8.2 (2.5)

Clinical Studies




FINASTERIDE INDICATIONS AND USAGE





FINASTERIDE CONTRAINDICATIONS





Pregnancy.
WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS   PRECAUTIONS, Information for Patients Pregnancy

WARNINGS


PRECAUTIONS, Pediatric Use WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS;   PRECAUTIONS , Information for Patients Pregnancy HOW SUPPLIED

PRECAUTIONS

General






Information for Patients


CONTRAINDICATIONS ; , WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS; PRECAUTIONS Pregnancy HOW SUPPLIED

ADVERSE REACTIONS

ADVERSE REACTIONS

Drug/Laboratory Test Interactions




Drug Interactions


Carcinogenesis, Mutagenesis, Impairment of Fertility


(0-24 hr)(0-24 hr)



in vitroin vitroin vitroin vivo

Pregnancy




. CONTRAINDICATIONS



in utero

11in utero

in utero

Nursing Mothers




Pediatric Use




Geriatric Use


  CLINICAL PHARMACOLOGY, Pharmacokinetics Clinical Studies

FINASTERIDE ADVERSE REACTIONS


OVERDOSAGE




222

FINASTERIDE DOSAGE AND ADMINISTRATION






CLINICAL PHARMACOLOGY, Pharmacokinetics

Finasteride Tablets, USP


Patient Information about Finasteride Tablets

Finasteride tablets are for use by men only.

What are finasteride tablets?





Who should NOT take finasteride tablets?





Do Not Take finasteride tablets if you are:

  • a woman who is pregnant or may potentially be pregnant. Finasteride tablets may harm your unborn baby. Do not touch or handle crushed or broken finasteride tablets (see ). “A warning about finasteride tablets and pregnancy”
  • allergic to finasteride or any of the ingredients in finasteride tablets. See the end of this leaflet for a complete list of ingredients in finasteride tablets.

A warning aboutfinasteride tablets and pregnancy.  



How should I take

finasteride tablets?



  • Take one tablet by mouth each day. To avoid forgetting to take finasteride tablets, you can take them at the same time every day.
  • If you forget to take finasteride tablets, do not take an extra tablet. Just take the next tablet as usual.
  • You may take finasteride tablets with or without food.
  • Do not share finasteride tablets with anyone else; they were prescribed only for you.

What are the possible side effects offinasteride tablets?



  • trouble getting or keeping an erection (impotence)
  • decrease in sex drive
  • decreased volume of ejaculate
  • ejaculation disorders
  • enlarged or painful breast. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge.

Allergic reactions:
Testicular pain
:





What you need to know while taking finasteride tablets?

  • Follow your doctor's advice about when to have these checkups. You should see your doctor regularly while taking finasteride tablets.
  • Your doctor has prescribed finasteride tablets for BPH and not for treatment of prostate cancer — but a man can have BPH and prostate cancer at the same time. Checking for prostate cancer should continue while you take finasteride tablets. Checking for prostate cancer.
  • Your doctor may have done a blood test called PSA for the screening of prostate cancer. Because finasteride tablets decreases PSA levels, you should tell your doctor(s) that you are taking finasteride tablets. Changes in PSA levels will need to be carefully evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point should be carefully evaluated, even if the test results are still within the normal range. You should also tell your doctor if you have not been taking finasteride tablets as prescribed because this may affect the PSA test results. For more information, talk to your doctor. About Prostate-Specific Antigen (PSA).

How should I store finasteride tablets?
  • Store finasteride tablets in a dry place at room temperature.
  • Keep finasteride tablets in the original container and keep the container closed.

Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.  



What are the ingredients in

finasteride tablets?Active ingredient:

Inactive ingredients:

What is BPH?





  • a weak or interrupted urinary stream
  • a feeling that you cannot empty your bladder completely
  • a feeling of delay or hesitation when you start to urinate
  • a need to urinate often, especially at night
  • a feeling that you must urinate right away.

What

finasteride tablets do?



  • Even though the prostate shrinks, you may NOT notice an improvement in urine flow or symptoms.
  • You may need to take finasteride tablets for six (6) months or more to see whether it improves your symptoms.
  • Therapy with finasteride tablets may reduce your risk for a sudden inability to pass urine and the need for surgery for an enlarged prostate.


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


Finasteride 5mg Tablet

Finasteride

Finasteride

Finasteride TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:63629-1585(NDC:65862-149)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FINASTERIDE FINASTERIDE 5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
DOCUSATE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
hydroxypropyl cellulose
titanium dioxide
talc
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
BLUE 8 mm E;61 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63629-1585-1 100 in 1 BOTTLE
2 NDC:63629-1585-2 30 in 1 BOTTLE
3 NDC:63629-1585-3 60 in 1 BOTTLE
4 NDC:63629-1585-4 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078341 2007-10-30


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