Testosterone Cypionate (Testosterone Cypionate)

Trade Name : Testosterone Cypionate

West-Ward Pharmaceuticals Corp

INJECTION

Strength 200 mg/mL

TESTOSTERONE CYPIONATE Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Testosterone Cypionate (Testosterone Cypionate) which is also known as Testosterone Cypionate and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 200 mg/mL per ml. Read more

Testosterone Cypionate (Testosterone Cypionate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Testosterone Cypionateu00a0Injection, USPu00a0for intramuscular injection, contains Testosterone Cypionate, USPu00a0which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone.
Testosterone Cypionate, USPu00a0is 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, USPu00a0is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17u03b2)-. Its molecular formula is CHO, and the molecular weight 412.61.
The structural formula is represented below:
Testosterone Cypionateu00a0Injection, USPu00a0is available in one strength,u00a0200 mg/mL Testosterone Cypionate, USP.
Each mL of the 200 mg/mL solution contains:u00a0u00a0u00a0u00a0Testosterone Cypionate, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 200 mgu00a0u00a0u00a0u00a0Benzyl Benzoate, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 0.2 mLu00a0u00a0u00a0u00a0Cottonseed Oil, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 560 mgu00a0u00a0u00a0u00a0Benzyl Alcohol, USPu00a0(as preservative)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 9.45 mg

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 phosphorus, 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.
Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate can be given at intervals of two to four weeks.
Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life.
About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6 percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways.
The half-life of testosterone cypionate when injected intramuscularly is approximately eight days.
In many tissues the activity of testosterone appears to depend on reduction to dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.

Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Safety and efficacy of testosterone cypionate in men with u201cage-related hypogonadismu201d (also referred to as u201clate-onset hypogonadismu201d) have not been established.

No data

Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued.
Prolonged use of high doses of androgens (principally the 17-u03b1 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.u00a0 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.u00a0 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 date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone cypionate.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see ).
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
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.
The preservative benzyl alcohol has been associated with serious adverse events, including the u201cgasping syndromeu201d, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the u201cgasping syndromeu201d, the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.
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.

No data

The following adverse reactions in the male have occurred with some androgens:
Endocrine and urogenital:
Skin and appendages:
Cardiovascular Disordersn- :
Fluid and electrolyte disturbances:
Gastrointestinal:n- Array
Hematologic:
Nervous system:
Allergic:
Vascular Disorders:
Special senses:
Miscellaneous:
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001 oru00a0FDA at 1-800-FDA-1088 or .

Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
Abusen
Abuse-Related Adverse Reactions
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dependencen n
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

There have been no reports of acute overdosage with the androgens.

Prior to initiating 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.
Testosterone cypionateu00a0injection 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 dose and in adjusting the dose.
For replacement in the hypogonadal male, 50 to 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.

Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as:
1 mLu00a0Vial, Cartons of 1u00a0vial NDC 0143-9659-0110 mL Multiple Dose Vials, Cartons of 1 vial NDC 0143-9726-01
Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature].Protect from light.
Manufactured by:
Distributed by:n
Revised: October 2018n
PIN300-WES/11

NDC 0143-9726-01Rx ONLYTestosteroneCypionateInjection,u00a0USPCIII2,000 mg/10 mL(200 mg/mL)Contains Benzyl Alcoholas a PreservativeFor Intramuscular Use Onlyn n- Each mL containsn- USUAL DOSAGE:n- Store product in the carton to protectcontents from light.
NDC 0143-9726-01One 10 mL Multiple Dose VialTestosteroneCypionateInjection,u00a0USPCIII2,000 mg/10 mL(200 mg/mL)Contains Benzyl Alcholas a PreservativeFor Intramuscular Use OnlyRx ONLYn
Arrayn- Array

NDC 0143-9659-01n n Contains Benzyl Alcoholas a PreservativeFor Intramuscular Use OnlyRx ONLY1 mL Single Dose Vialn u00a0See package insert.n n
Arrayn- Array
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OR
NDC 0143-9659-01u00a0u00a0 Rx onlyn n Contains Benzyl Alcoholas a PreservativeFor Intramuscular Use Only1 mL Single Dose Vialn u00a0See package insert.n n
Arrayn- Array
u00a0
NDC 0143-9659-01One 1 mL Single Dose Vialn n Contains Benzyl Alcohol as aPreservativeFor Intramuscular Use OnlyRx ONLYn n n
OR
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Testosterone Cypionate (Testosterone Cypionate)

Trade Name : Testosterone Cypionate

INJECTION

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Testosterone Cypionate (Testosterone Cypionate)

Trade Name : Testosterone Cypionate

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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