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Testone CIK
Overview
What is Testone CIK?
Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.
The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is CHO, and the molecular weight 412.61.
The structural formula is represented below:
Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.
What does Testone CIK look like?
What are the available doses of Testone CIK?
Sorry No records found.
What should I talk to my health care provider before I take Testone CIK?
Sorry No records found
How should I use Testone CIK?
Stop use and ask a doctor if:
Wipe injection site vigorously and discard
What interacts with Testone CIK?
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What are the warnings of Testone CIK?
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.
Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.
Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.
This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.
This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
What are the precautions of Testone CIK?
General:
Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.
Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.
Testosterone cypionate for intravenous use.
Information for patients:
Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.
Laboratory tests:
Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.
Serum cholesterol may increase during androgen therapy.
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.
Drug/Laboratory test interferences:
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T serum levels and increased resin uptake of T and T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Carcinogenesis:
Animal data.
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.
Human data.
Pregnancy:
Pregnancy Category X. (See .)
Nursing mothers:
Testosterone cypionate is not recommended for use in nursing mothers.
Pediatric use:
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
What are the side effects of Testone CIK?
The following adverse reactions in the male have occurred with some androgens:
Endocrine and urogenital:
Skin and appendages:
Fluid and electrolyte disturbances:
Gastrointestinal:
Hematologic:
Nervous system:
Allergic:
Vascular
Disorders
Miscellaneous:
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Testone CIK?
What might happen if I take too much Testone CIK?
There have been no reports of acute overdosage with the androgens.
How should I store and handle Testone CIK?
Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:1 mL vials NDC 0574-0820-0110 mL vials NDC 0574-0827-10Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.Made in PortugalManufactured ByHikma Farmacéutica SATerrugem Sintra, PortugalDistributed ByPerrigo®Minneapolis, MN 554278Z100 RC J3Rev 06-14 BPIN323-PER/3
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorous, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.
Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).
There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.
Non-Clinical Toxicology
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.
Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.
Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.
Testosterone cypionate for intravenous use.
The following adverse reactions in the male have occurred with some androgens:
Endocrine and urogenital:
Skin and appendages:
Fluid and electrolyte disturbances:
Gastrointestinal:
Hematologic:
Nervous system:
Allergic:
Vascular
Disorders
Miscellaneous:
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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