Testosterone 30 mg/1.5mL
Testosterone · SOLUTION · Cipla USA Inc.
Testosterone is a solution containing testosterone at 30 mg/1.5mL, taken topical. Manufactured by Cipla USA Inc..
Key Facts
- Brand Name
- Testosterone
- Generic Name
- Testosterone
- NDC Code (Product)
69097-363- Manufacturer
- Cipla USA Inc.
- Strength
- 30 mg/1.5mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA209533
- Drug Class
- Androgen [EPC]
- Marketing Start
- 03/30/2018
Recall History
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Lupin Pharmaceuticals Inc.
Defective Container: Repetitive complaints received indicating pump not working.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
The Medicine Shoppe Pharmacy
Lack of Processing Control
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Right Value Drug Stores, Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Testosterone cypionate 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 testosterone cypionate injection 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 testosterone cypionate injection, 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. Testosterone cypionate 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 testosterone cypionate 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 1. Known hypersensitivity to the drug 2. Males with carcinoma of the breast 3. Males with known or suspected carcinoma of the prostate gland 4. Women who are pregnant (see PRECAUTIONS , Pregnancy ) 5. 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. To report SUSPECTED ADVERSE R…
Frequently Asked Questions
What is Testosterone used for?
Testosterone contains Testosterone. It is a solution taken topical. Consult your doctor for specific uses.
Is Testosterone a controlled substance?
Yes, Testosterone is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Testosterone?
The generic name for Testosterone is Testosterone. There are 9 other brand versions of Testosterone.
What is the NDC code for Testosterone 30 mg/1.5mL?
The NDC (National Drug Code) for Testosterone 30 mg/1.5mL is 69097-363, listed by Cipla USA Inc..
Other Testosterone Dosages
Other Testosterone Brands
See all →- testosterone cypionate200 mg/mL76420-747
- testosterone20.25 mg/1.25g16714-968
- AndroGel10 mg/g17139-501
- Depo-Testosterone200 mg/mL0009-0417
- Testosterone Cypionate200 mg/mL50090-4920
- testosterone cypionate200 mg/mL70700-289
- testosterone cypionate200 mg/mL76420-752
- TESTOSTERONE ENANTHATE200 mg/mL0143-9750
- testosterone40.5 mg/2.5g45802-366
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)