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Testocyp 200

Testocyp 200

·  Chemical Name: (Cyclopentyl-1-oxopropyl)androst-4-én-3-one

·  Molecular Weight:412.6047 g/mol

·  Formula: C27H40O3

Cypionate testosterone  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-cyclopentyl1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.

 

The structural formula is represented below:

 

Cypionate testosterone Structural Formula Illustration

cypionate testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.

Each mL of the 100 mg/mL solution contains:

 

Testosterone cypionate: 100 mg

Benzyl benzoate: 0.1 mL

Cottonseed oil: 736 mg

Benzyl alcohol (as preservative): 9.45 mg

 

Each mL of the 200 mg/mL solution contains:

 

Testosterone cypionate: 200 mg

Benzyl benzoate: 0.2 mL

Cottonseed oil: 560 mg

Benzyl alcohol (as preservative): 9.45 mg

Indications & Dosage

INDICATIONS

 

testosterone cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of 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 LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

 

Safety and efficacy of cypionate Testosterone in men with “agerelated hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

DOSAGE AND ADMINISTRATION

 

Prior to initiating cypionate Testosterone 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.

 

cypionate 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 cypionateTestosterone 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 dose and in adjusting the dose.

 

For replacement in the hypogonadal male, 50-400 mg should be administered every two to four weeks.

 

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

HOW SUPPLIED

 

cypionate testosterone Injection is available as follows:

 

200 mg/mL

 

1 mL vials

 

 

Vials should be stored at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from light.

 

Distributed by: Pfizer, Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised: April 2015

Side Effects & Drug Interactions

SIDE EFFECTS

 

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 thromboembolis

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