Depo-Testosterone 200 mg/mL
testosterone cypionate · INJECTION, SOLUTION · Pharmacia & Upjohn Company LLC
Depo-Testosterone is a prescription injection, solution containing testosterone cypionate at 200 mg/mL, taken intramuscular. Manufactured by Pharmacia & Upjohn Company LLC.
Key Facts
- Brand Name
- Depo-Testosterone
- Generic Name
- testosterone cypionate
- NDC Code (Product)
0009-0417- Manufacturer
- Pharmacia & Upjohn Company LLC
- Strength
- 200 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA085635
- Drug Class
- Androgen Receptor Agonists [MoA]; Androgen [EPC]
- Marketing Start
- 07/25/1979
Recall History
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Dosage & Administration
DOSAGE AND ADMINISTRATION Prior to initiating DEPO-Testosterone (testosterone cypionate), 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. DEPO-Testosterone Injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage for DEPO-Testosterone Injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial d…
Warnings
WARNINGS Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis —all potentially life-threatening complications. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. 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 cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management. Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To d…
Contraindications
CONTRAINDICATIONS Known hypersensitivity to the drug Males with carcinoma of the breast Males with known or suspected carcinoma of the prostate gland Women who are pregnant (see PRECAUTIONS, Pregnancy ) Patients with serious cardiac, hepatic or renal disease (see WARNINGS )
Drug Interactions
Drug interactions Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions in the male have occurred with some androgens: Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne. Cardiovascular Disorders: myocardial infarction, stroke. Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions. Vascular disorders: Venous thromboembolism. Special senses: Rare cases of central serous chorioretinopathy (CSCR). Miscellaneous: Inflammation and pain at the site of intramuscular injection.
Frequently Asked Questions
What is Depo-Testosterone used for?
Depo-Testosterone contains testosterone cypionate. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Depo-Testosterone a controlled substance?
Yes, Depo-Testosterone is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Depo-Testosterone?
The generic name for Depo-Testosterone is testosterone cypionate. There are 11 other brand versions of testosterone cypionate.
What is the NDC code for Depo-Testosterone 200 mg/mL?
The NDC (National Drug Code) for Depo-Testosterone 200 mg/mL is 0009-0417, listed by Pharmacia & Upjohn Company LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)