Finasteride (Page 5 of 6)

14.2 Studies in Women

In a study involving 137 postmenopausal women with androgenetic alopecia who were treated with finasteride tablets USP (n=67) or placebo (n=70) for 12 months, effectiveness could not be demonstrated. There was no improvement in hair counts, patient self-assessment, investigator assessment, or ratings of standardized photographs in the women treated with finasteride tablets USP when compared with the placebo group [see Indications and Usage (1)].

16 HOW SUPPLIED/STORAGE AND HANDLING

Finasteride tab le t s USP, 1 mg, is brown color, round film coated tablets, debossed with ‘H’ on one side and ‘36’ on other side.

They are supp lied as f o llo w s:

NDC 31722-526-30 bottles of 30

NDC 31722-526-90 bottles of 90

NDC 31722-526-10 bottles of 1000
Storage and Handling
Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep container closed and protect from moisture.
Women should not handle crushed or broken finasteride tablets USP tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)and Patient Counseling Information (17.1)].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

17.1 Exposure of Women-Risk to Male Fetus


Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets USP because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken finasteride tablets USP, the contact area should be washed immediately with soap and water [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

17.2 Increased Risk of High-Grade Prostate Cancer


Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

17.3 Additional Instructions

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 (6.1)].
Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride tablets USP and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding finasteride tablets USP.
Manufactured for:

structure9

Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

Manufactured by:
HETEROTM
Hetero Labs Limited
Jeedimetla, Hyderabad-500 055, India.
or

Manufactured by:
HETEROTM
Hetero Labs Limited
Unit V, Polepally, Jadcherla,
Mahaboob Nagar-509 301, India.

Patient Information

Patient Information
Finasteride Tablets USP, 1 mg
(fin-As-tur-eyed)
Rx Only
Finasteride tablets USP are for use by MEN ONLY and should NOT be used by women or children.
Read this Patient Information before you start taking finasteride tablets USP and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What are finasteride tablets USP?
Finasteride tablets USP is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).
It is not known if finasteride tablets USP works for a receding hairline on either side of and above your forehead (temporal area).
Finasteride tablets USP are not for use by women and children.
Who should not take finasteride tablets USP?
Do not take finasteride tablets USP if you:
• are pregnant or may become pregnant. Finasteride tablets USP may harm your unborn baby.
o Finasteride tablets USP are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed finasteride tablets USP. If a pregnant woman comes in contact with crushed or broken finasteride tablets USP, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in finasteride tablets USP, a healthcare provider should be consulted.
o If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in finasteride tablets USP, the male baby may be born with sex organs that are not normal.
• are allergic to any of the ingredients in finasteride tablets USP. See the end of this leaflet for a complete list of ingredients in finasteride tablets USP.
What should I tell my healthcare provider before taking finasteride tablets USP?
Before taking finasteride tablets USP, tells your healthcare provider if you:
• have any other medical conditions, including problems with your prostate or liver
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take finasteride tablets USP?
• Take finasteride tablets USP exactly as your healthcare provider tells you to take it.
• You may take finasteride tablets USP with or without food.
• If you forget to take finasteride tablets USP do not take an extra tablet. Just take the next tablet as usual.
Finasteride tablets will not work faster or better if you take it more than once a day.
What are the possible side effects of finasteride tablets USP?
• decrease in your blood Prostate Specific Antigen (PSA) levels.
Finasteride tablets USP can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking finasteride tablets USP because finasteride tablets USP decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking finasteride tablets USP. You should also tell your healthcare provider if you have not been taking finasteride tablets USP as prescribed because this may affect the PSA test results. For more information, talk to your healthcare provider.
• There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of finasteride tablets USP.
The most common side effects of finasteride tablets USP include:
• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen
The following have been reported in general use with finasteride tablets USP:
• breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• depression;
• decrease in sex drive that continued after stopping the medication;
• allergic reactions including rash, itching, hives and swelling of the lips and face;
• problems with ejaculation that continued after stopping medication;
• testicular pain;
• difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen.
• in rare cases, male breast cancer.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of finasteride tablets USP. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store finasteride tablets USP?
• Store finasteride tablets USP at 20° to 25° C (68° to 77° F) [see USP Controlled room temperature].
• Keep finasteride tablets USP in a closed container and keep finasteride tablets USP dry (protect from moisture).
Keep finasteride tablets USP and all medicines out of the reach of children.
General information about the safe and effective use of finasteride tablets USP.
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. Do not use finasteride tablets USP for a condition for which it was not prescribed. Do not give finasteride tablets USP to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about finasteride tablets USP. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about finasteride tablets USP that is written for health professionals.
What are the ingredients in finasteride tablets USP?
Active ingredient: finasteride USP.
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, and Opadry brown (hypromellose, iron oxide red, talc, titanium dioxide, yellow iron oxide).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured For:
structure10
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Manufactured By:
structure11
HETEROTM
Hetero Labs Limited
22-11, I.D.A.,Jeedimetla,
Hyderabad-500 055, India.
or

Manufactured by:
HETEROTM
HETERO LABS LIMITED
Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India.

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