Registrants (1)
650082092
Manufacturing Establishments (1)
Rising Pharma Holdings, Inc.
Aurobindo Pharma Limited
918917642
Products (1)
Finasteride
57237-062
ANDA078341
ANDA (C73584)
ORAL
February 28, 2024
Drug Labeling Information
Dosage Forms & Strengths Section
Highlight:
5 mg film-coated tablets (3).
3 DOSAGE FORMS AND STRENGTHS
5 mg: Blue colored, circular, biconvex, beveled edged film-coated tablets debossed with ‘E’ on one side and ‘61’ on the other side.
Contraindications Section
Highlight:
Hypersensitivity to any components of this product (4).
Females who are or may potentially be pregnant (4, 5.3, 8.1, 16).
4 CONTRAINDICATIONS
Finasteride tablets are contraindicated in the following:
- Hypersensitivity to any component of this medication. *Pregnancy. Finasteride use is contraindicated in females when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3), Use in Specific Populations (8.1), and How Supplied/Storage and Handling (16).] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.
Overdosage Section
10 OVERDOSAGE
Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.
Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m2 (400 mg/kg) and 5900 mg/m2 (1000 mg/kg), respectively.
Nonclinical Toxicology Section
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
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 111 and 274 times those observed in man receiving the recommended human dose of 5 mg/day. All exposure calculations were based on calculated AUC(0-24 hr) for animals and mean AUC(0-24 hr) for man (0.4 mcg•hr/mL).
In a 19-month carcinogenicity study in CD-1 mice, a statistically significant (p≤0.05) increase in the incidence of testicular Leydig cell adenomas was observed at 228 times the human exposure (250 mg/kg/day). In mice at 23 times the human exposure, estimated (25 mg/kg/day) and in rats at 39 times the human exposure (40 mg/kg/day) an increase in the incidence of Leydig cell hyperplasia was observed. A positive correlation between the proliferative changes in the Leydig cells and an increase in serum LH levels (2- to 3-fold above control) has been demonstrated in both rodent species treated with high doses of finasteride. No drug-related Leydig cell changes were seen in either rats or dogs treated with finasteride for 1 year at 30 and 350 times (20 mg/kg/day and 45 mg/kg/day, respectively) or in mice treated for 19 months at 2.3 times the human exposure, estimated (2.5 mg/kg/day).
Mutagenesis
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. These concentrations correspond to 4000 to 5000 times the peak plasma levels in man given a total dose of 5 mg. 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 (228 times the human exposure) as determined in the carcinogenicity studies.
Impairment of Fertility
In sexually mature male rabbits treated with finasteride at 543 times the human exposure (80 mg/kg/day) for up to 12 weeks, no effect on fertility, sperm count, or ejaculate volume was seen. In sexually mature male rats treated with 61 times the human exposure (80 mg/kg/day), there were no significant effects on fertility after 6 or 12 weeks of treatment; however, when treatment was continued for up to 24 or 30 weeks, there was an apparent decrease in fertility, fecundity and an associated significant decrease in the weights of the seminal vesicles and prostate. All these effects were reversible within 6 weeks of discontinuation of treatment. No drug-related effect on testes or on mating performance has been seen in rats or rabbits. This decrease in fertility in finasteride-treated rats is secondary to its effect on accessory sex organs (prostate and seminal vesicles) resulting in failure to form a seminal plug. The seminal plug is essential for normal fertility in rats and is not relevant in man.
SPL Patient Package Insert Section
Finasteride Tablets, USP
Patient Information about Finasteride Tablets, USP
****(fin-AS-tur-eyed)
** Finasteride tablets are for use by men only.**
Please read this leaflet before you start taking finasteride tablets. Also, read it each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss finasteride tablets when you start taking your medication and at regular checkups.
** What are finasteride tablets?**
Finasteride tablets are a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Finasteride tablets may also be used to reduce the risk of a sudden inability to pass urine and the need for surgery related to BPH in men with an enlarged prostate.
Finasteride tablets may be prescribed along with another medicine, an alpha- blocker called doxazosin, to help you better manage your BPH symptoms.
** Who should NOT take finasteride tablets?**
Finasteride tablets are for use by MEN only.
** 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 about****finasteride tablets and pregnancy:
Women who are or may potentially be pregnant must not use finasteride tablets. They should also not handle crushed or broken tablets of finasteride. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
If a woman who is pregnant with a male baby absorbs the active ingredient in finasteride tablets after oral use or through the skin, it may cause the male baby to be born with abnormalities of the sex organs. If a woman who is pregnant comes into contact with the active ingredient in finasteride tablets, a doctor should be consulted.****
** How should I take****finasteride tablets?**
Follow your doctor’s instruction.
- 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 of finasteride tablets?
****Finasteride tablets may increase the chance of a more serious form of prostate cancer.
The most common side effects of finasteride tablets include:
- 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.
The following have been reported in general use with finasteride tablets and/or finasteride at lower doses:
- allergic reactions, including rash, itching, hives, and swelling of the lips, tongue, throat, and face
- rarely, some men may have testicular pain
- blood in semen
- trouble getting or keeping an erection that continued after stopping the medication
- problems with ejaculation that continued after stopping the medication
- male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.
- depression
- decrease in sex drive that continued after stopping the medication
- in rare cases, male breast cancer has been reported.
You should discuss side effects with your doctor before taking finasteride tablets and anytime you think you are having a side effect. These are not all the possible side effects with finasteride tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at: 1-800-FDA-1088.
What you need to know while taking finasteride tablets:
*You should see your doctor regularly while taking**finasteride tablets.**Follow your doctor’s advice about when to have these checkups. *Checking for prostate cancer. 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. Your doctor may continue checking for prostate cancer while you take finasteride tablets. *About Prostate-Specific Antigen (PSA). 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 evaluated by your doctor(s). 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. 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.
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.
Keep finasteride tablets and all medications out of the reach of children.
Do not give your finasteride tablets to anyone else. It has been prescribed only for you.
For more information call Rising Health, LLC at 1-833-395-6928.
What are the ingredients in finasteride tablets?
Active ingredient: finasteride
**Inactive ingredients:**lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pregelatinised starch (maize), docusate sodium, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, talc, iron oxide yellow, and FD&C Blue #2 aluminum lake.
What is BPH?
BPH is an enlargement of the prostate gland. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:
- 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.
In some men, BPH can lead to serious problems, including urinary tract infections, a sudden inability to pass urine (acute urinary retention), as well as the need for surgery.
What finasteride tablets do:
Finasteride tablets lower levels of a hormone called DHT (dihydrotestosterone), which is a cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. Finasteride tablets will help reduce the risk of developing a sudden inability to pass urine and the need for surgery related to an enlarged prostate. However, since each case of BPH is different, you should know that:
- 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.
Distributed by:
****Rising Health, LLC
Saddle Brook, NJ 07663
Made in India
Code: TS/DRUGS/19/1993
Revised: 11/2021
How Supplied Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Finasteride Tablets USP, 5 mgare blue colored, circular, biconvex, beveled edged film-coated tablets debossed with ‘E’ on one side and ‘61’ on the other side.
Bottles of 30 NDC 57237-062-30
Bottles of 90 NDC 57237-062-90
Bottles of 500 NDC 57237-062-05
** Store at**20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed.
Females 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 a male fetus [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].