TESTOSTERONE ENANTHATE 200 mg/mL
TESTOSTERONE ENANTHATE · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
TESTOSTERONE ENANTHATE is a injection, solution containing testosterone enanthate at 200 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- TESTOSTERONE ENANTHATE
- Generic Name
- TESTOSTERONE ENANTHATE
- NDC Code (Product)
0143-9750- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 200 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA091120
- Marketing Start
- 09/18/2012
Recall History
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
Auro Pharmacies, Inc.
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Pallimed Solutions
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Wells Pharmacy Network LLC
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Males Testosterone enanthate injection is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) – Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) – Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. Safety and efficacy of testosterone enanthate injection in men with age-related hypogonadism have not been established. Delayed puberty – Testosterone enanthate injection may be used to st…
Dosage & Administration
DOSAGE AND ADMINISTRATION Prior to initiating testosterone enanthate injection, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Dosage and duration of therapy with testosterone enanthate injection will depend on age, sex, diagnosis, patient’s response to treatment, and appearance of adverse effects. When properly given, injections of testosterone enanthate are well tolerated. Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection (see PRECAUTIONS ). In general, total doses above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every two weeks are rarely indicated. NOTE: Use of a wet needle or wet syringe may cause the solution to become cloudy; however this does not affect the potency of the material. Parenteral drug products should be inspected visually for particul…
Warnings
WARNINGS In patients with breast cancer and in immobilized patients, androgen therapy may cause hypercalcemia by stimulating osteolysis. In patients with cancer, hypercalcemia may indicate progression of bony metastasis. If hypercalcemia occurs, the drug should be discontinued and appropriate measures instituted. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS, Carcinogenesis ). Peliosis hepatis can be a life-threatening or fatal complication. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone enanthate. Evaluate patients who report sympto…
Contraindications
CONTRAINDICATIONS Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus. This preparation is also contraindicated in patients with a history of hypersensitivity to any of its components.
Drug Interactions
Drug Interactions When administered concurrently, the following drugs may interact with androgens: Anticoagulants, oral – C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirement. Patients receiving oral anticoagulant therapy require close monitoring especially when androgens are started or stopped. Antidiabetic drugs and insulin – In diabetic patients, the metabolic effects of androgens may decrease blood glucose and insulin requirements. ACTH and corticosteroids – Enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease. Oxyphenbutazone – Elevated serum levels of oxyphenbutazone may result.
Adverse Reactions
ADVERSE REACTIONS Endocrine and Urogenital, Female – The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of the external genitalia of the female fetus. Male – Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY ). Skin and Appendages – Hirsutism, male pattern baldness, and acne. Cardiovascular Disorders – myocardial infarction, stroke Fluid and Electrolyte Disturbances – Retention of sodium, chloride, water, potassium, calcium (see WARNINGS ), and inorganic phosphates. Gastrointestinal – Nausea, cholestatic jaundice, alterations in liver function tests; rarely, hepatocellular neoplasms, peliosis hepatis (see WARNINGS ). Hematologic – Suppression of clotting factors II, V, VII, and X; bleeding in patients on concomitant anticoagulant therapy; polycythemia. Nervous System – Increased or decreased libido…
Frequently Asked Questions
What is TESTOSTERONE ENANTHATE used for?
TESTOSTERONE ENANTHATE contains TESTOSTERONE ENANTHATE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is TESTOSTERONE ENANTHATE a controlled substance?
Yes, TESTOSTERONE ENANTHATE is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for TESTOSTERONE ENANTHATE?
The generic name for TESTOSTERONE ENANTHATE is TESTOSTERONE ENANTHATE. There are 3 other brand versions of TESTOSTERONE ENANTHATE.
What is the NDC code for TESTOSTERONE ENANTHATE 200 mg/mL?
The NDC (National Drug Code) for TESTOSTERONE ENANTHATE 200 mg/mL is 0143-9750, listed by Hikma Pharmaceuticals USA Inc..