Testosterone Gel, 1% 10 mg/g
Testosterone Gel, 1% · GEL · Bryant Ranch Prepack
Testosterone Gel, 1% is a gel containing testosterone gel, 1% at 10 mg/g, taken transdermal. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Testosterone Gel, 1%
- Generic Name
- Testosterone Gel, 1%
- NDC Code (Product)
72162-1274- Manufacturer
- Bryant Ranch Prepack
- Strength
- 10 mg/g
- Dosage Form
- GEL
- Route
- TRANSDERMAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA212984
- Drug Class
- Androgen [EPC]
- Marketing Start
- 01/10/2021
Recall History
Teva Pharmaceuticals USA Inc
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Teva Pharmaceuticals USA, Inc
Defective Container - A defect in the side-seal which allows leakage of product.
Teva Pharmaceuticals USA
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Strides Pharma, Inc.
Presence of foreign substance: Presence of Benzene.
Strides Pharma, Inc.
Presence of foreign substance: Presence of Benzene.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Testosterone gel, 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of testosterone gel, 1% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of testosterone gel, 1% in males less than 18 years old have not been established [ see Use in…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage and Administration for testosterone gel, 1% differs from testosterone gel, 1.62%. For dosage and administration of testosterone gel, 1.62% refer to its full prescribing information. (2) Prior to initiating testosterone gel, 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Dosage and Administration for testosterone gel, 1% differs from testosterone gel, 1.62%. For dosage and administration of testosterone gel, 1.62% refer to its full prescribing information. (2) Prior to initiating testosterone gel, 1%., confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). Starting dose of testosterone gel, 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied once daily in the morning. ( 2.1 ) Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply Testosterone …
Contraindications
4 CONTRAINDICATIONS Testosterone gel, 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ), and Nonclinical Toxicology ( 13.1 )] . Testosterone gel, 1% is contraindicated in women who are pregnant. Testosterone gel, 1% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel, 1%. If a pregnant woman is exposed to testosterone gel, 1%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 )] . Men with carcinoma of the breast or known or suspected prostate cancer. ( 4 , 5.1 ) Women who are pregnant. Testosterone may cause fetal harm. ( 4 , 8.1 )
Drug Interactions
7 DRUG INTERACTIONS Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. ( 7.1 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended. ( 7.2 ) Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. ( 7.3 ) 7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires car…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence greater than or equal to 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Hypogonadal Men Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel, 1% and reported by greater than 1% of patients in a 180 Day, Phase 3 study. Table 2: Adverse Events Possibly, Probably or Definitely Related to Use of Testosterone Gel, 1% in the 180-Day Controlled Clinical Trial Adv erse Event Dose of Testosterone Gel, 1% 50 mg 75 mg 100 mg N = 77 N = 40 N = 78 Acne 1% 3% 8% Alopecia 1% 0% 1% Application Site Reaction 5% 3% 4% Asthenia 0% 3% 1% Depression 1% 0%…
Frequently Asked Questions
What is Testosterone Gel, 1% used for?
Testosterone Gel, 1% contains Testosterone Gel, 1%. It is a gel taken transdermal. Consult your doctor for specific uses.
Is Testosterone Gel, 1% a controlled substance?
Yes, Testosterone Gel, 1% is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Testosterone Gel, 1%?
The generic name for Testosterone Gel, 1% is Testosterone Gel, 1%. There are no other listed brand versions of Testosterone Gel, 1%.
What is the NDC code for Testosterone Gel, 1% 10 mg/g?
The NDC (National Drug Code) for Testosterone Gel, 1% 10 mg/g is 72162-1274, listed by Bryant Ranch Prepack.
Other Testosterone Gel, 1% Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)