Sustanon precautions

SUSTANON 250 from description to precautions

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Sustanon is used for HRT ( TRT ) hormone replacement or testosterone replacement treatment in males with insufficient testosterone production weather due to old age, disease or trauma. Sustanon cost is low therefore it makes a very effective and convinient testosterone replacement medication.
Other trt medications are testosterone enanthate, testosterone cypionate, propionate or even testosterone suspension.
Sustanon is a mixture of testosterone with different timre release formulas.
Testosterone cypionate injection, USP, for intramuscular injection, contains Testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone Testosterone. 

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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 C27H40O3, and the molecular weight 412.61.

The structural formula is represented below:

Testosterone cypionate injection, USP 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
Testosterone – Clinical 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.

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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.
Pharmacokinetics

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 conjugated 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.

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Testosterone cypionate injection, USP 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) idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

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 or who may become pregnant
5. Patients with serious cardiac, hepatic or renal disease

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.

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.

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Precautions
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 is not 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 thyroxine­binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. 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.

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Human Data

There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

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.
Pregnancy
Teratogenic Effects

Pregnancy Category X. (See CONTRAINDICATIONS.)
Nursing Mothers

Testosterone cypionate injection, USP 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.
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.
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.
Miscellaneous

Inflammation and pain at the site of intramuscular injection.

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Overdosage

There have been no reports of acute overdosage with the androgens.
Testosterone Dosage and Administration

Testosterone cypionate injection, USP 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, USP 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.
How is Testosterone Supplied

Testosterone cypionate injection, USP is available as follows:

100 mg/mL:

NDC 0781-3073-70 – 10 mL multidose vial

200 mg/mL:

NDC 0781-3074-71 – 1 mL vial

NDC 0781-3074-70 – 10 mL multidose vial

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.

03-2009M

U1006824

Manufactured in Canada by

Sandoz Canada Inc. for

Sandoz Inc., Princeton, NJ 08540

mg/mL 10 mL Label

NDC 0781-3073-70

Testosterone CIII

Cypionate

Injection, USP

1,000 mg/10 mL

(100 mg/mL)

FOR INTRAMUSCULAR USE ONLY

Sterile. Protect from light.

Rx only 10 mL Multidose Vial

SANDOZ

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Today we talk about sustanon 250, how to buy sustanon, side effects, price, cost, benefits.

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Mixture of testosterone called sustanon 250 or 100 is the trademark Organon brand or as other products using the same name is one of the most popular testosterone ester products. Not like most other steroid injectables, Sustanon comprises a mix of esters. To be precise, each ampule or mL contains testosterone propionate 30 mg, testosterone phenylpropionate 60 mg, testosterone isocaproate 60 mg, and testosterone decanoate 100 mg. This mixture includes short, medium, and long-acting esters.

There are two advantages to combining multiple esters in the same formulation as Sustanon does. Here, using multiple esters allows the fairly high total concentration of 250 mg/mL without requiring a large percentage of solubility enhancers in the vehicle. More generally, solubilities of different esters of a steroid are nearly independent of each other, so for example if a vehicle (oil plus solubility enhancers) could dissolve 100 mg/mL of one steroid ester alone or 100 mg/mL of another, it could probably dissolve 200 mg/mL total as a combination of both. This can add convenience.

A second effect of the blending is that extended duration of action can be achieved from having a long-acting ester included in the mix without having the slow onset of action that such esters have when provided alone. From the medical standpoint, it’s desirable that a patient experience benefit shortly after treatment. Sustanon, since it also contains short-acting esters, can accomplish this while also providing a fairly long duration of action.
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From the bodybuilding perspective, this is helpful where the bodybuilder does not know how to frontload a steroid. But if he does, frontloading will accomplish very nearly the same thing, so a different testosterone ester product such as testosterone enanthate can very readily be used in place of Sustanon.

The multiple esters in Sustanon result in slightly complex pharmacokinetics or change in drug level with time. With a single ester, the half-life behavior of a drug is such that after so many hours or so many days blood level falls to one-half of what it had been; then by double that time that falls in half again resulting in one-quarter of the previous level; then by triple that time the level falls to one-eighth of what it had been, etc.

For Sustanon there is no such fixed time period. Estimated approximate values are that after the last injection levels drop to one-half by the 4 day point; to one-quarter by the 10 day point; to one-eighth by the 16 day point; and to one-sixteenth by the 23 day point. Or if preferring to work with round numbers in terms of percent, as approximate values levels drop to 40% by day 6; to 30% by day 8; to 20% by day 11; and to 10% by day 18.

As to how this information is useful: While there is no exact black-and-white value, a good figure to work with is that when clomiphene or tamoxifen is correctly used, recovery of LH production may reasonably begin when levels from injected androgen have fallen to a level commensurate with ongoing 200 mg/week usage.

So let’s say Sustanon was used at 500 mg/week. In this case the user would need levels to fall by 40% before recovery might plausibly begin. We see above that this would be at approximately 6 days after the last injection.

If we had another who used the rather high, but hardly unknown, dosage of 2000 mg per week, he would need for levels to drop to 10% of what they had been. This would be at about 18 days past the last injection.

So much for the matter of the time required between the last injection and the point where recovery could begin. The remaining question regarding Sustanon’s unusual pharmacokinetics is, How to frontload it?

Ordinarily, determining a frontloading value is simple enough, being calculated from the half-life and the dosing schedule. However, Sustanon does not have any one half-life figure, so there is no mathematically perfect answer.

In practice, the amount used for frontloading — the first day’s injection amount — should be that which will on average be taken in 5 days, plus the usual dosage. This total value may be rounded for convenience as exactness isn’t required.

So for example if taking 750 mg/week as three injections of 250 mg each, the average daily rate is 107 mg/day (750 mg divided by 7 days.) So the average taken in 5 days is 535 mg (107 mg/day times 5 days.) Add what will be the usual injection amount which is 250 mg, and our total is 785 mg, which I’d recommend rounding to 750 mg.

After this, subsequent injections are all 250 mg.

This procedure will give proper blood levels much more rapidly than is the case when failing to frontload.

As to dosage, there are many ways to look at it, but a fairly simple and useful one is to categorize usage at increments of 250 mg/week.

Usage of 250 mg/week usually amounts to nothing other than high-end testosterone replacement therapy. There is no guarantee that this usage will even cause testosterone levels to exceed the normal range. The dosing is high enough to suppress LH production, but in most cases is not high enough for any striking anabolic or fat-loss effects. Depending on individual sensitivity, this amount may be high enough to cause gynecomastia if an aromatase inhibitor is not used, or may be enough to cause oily skin or acne. In a few instances, anabolic or fat loss benefits may be impressive, as there are individuals who are high responders. But this isn’t the usual outcome for this dosage level.

500 mg/week. In my opinion, this is a reasonable minimum for an actual steroid cycle. I see little point in suppressing the HPTA but probably failing to get much gains out of it, as is the usual outcome for any dosage much less than this. Again, because testosterone aromatizes to estradiol, an aromatase inhibitor may be required to avoid estrogen-related problems. No one, I think, will fail to see substantially improved gains at this dosage level compared to natural training, but the rate of improvement may be slow. Eight weeks, however, is sufficient even at this amount for a quite significant improvement, unless of course one has trained for enough time at this usage level to have gotten most of what the individual can obtain from it.

750 mg/week. I would rather see this amount used if choosing to do a cycle. If an aromatase inhibitor is used it is unlikely that increased side effects would be a real reason to prefer 500 mg/weeek over this dosage, and results are very substantially superior.

1000 mg/week. I have no problem with this being the dosage for a first cycle but that is in the context of a serious lifter who understands what he is doing. If the steroid use is in fact cycled — that is to say, there are both on and off periods and the on periods are not overly long, and normalization of function is accomplished in the off periods — this is not an overly aggressive dosage by any means. At this dosage, the superiority over natural training is dramatic.

Lastly, there are of course uses such as 2000 mg/week. I don’t see a reason to go to this until one has achieved such a level of development — relative to the individual — that for example 1000 mg/week has done about all that it can do. In that case, if personal goals call for it, a dose such as this can be completely appropriate.

Regardless of dosing level, frequency of injection should be up to twice a week to ensure maximal success.

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Sustanon is a 4 testosterone blend blended to make an even gradual release of testosterone, buy sustanon

Sustanon is a 4 testosterone blend blended to make an even gradual release of testosterone

Sustanon is a blend of four testosterone esters:

* Testosterone propionate 30 mg
* Testosterone phenylpropionate 60 mg
* Testosterone isocaproate 60 mg
* Testosterone decanoate 100 mg

250 mgs. / 1 cc. vials or preloads.

Sustanon is one of the most popular steroids and for good reason. It is precisely set up to give you results for up to a month after injection because each of the testosterones that make up Sustanon stay active in the body for differing time periods. It gives you almost instant results that you can feel since it will hit you about 3 hours after your first injection. The reason for this is the fast acting properties of the testosterone propionate that is in it. The testosterone phenylpropionate and testosterone isocaproate will typically stay active for about 2-3 weeks each and the testosterone decanoate stays active in the body for up to a month. This combination is what gives Sustanon its quick onset which continues to hit you for about 4 weeks after the last injection. This drug also degrades and tapers nicely for the same reasons. Some people will argue that Sustanon is good because since it is made up of multiple types of testosterone, that it “will hit multiple androgen receptors.” This could not be further from the truth. You only have one type of androgen receptor. All steroids hit the same androgen receptor regardless of what you are taking.

Sustanon is highly anabolic as well as highly androgenic. This makes it a favorite of those trying to bulk up. It is a steroid that gives you what you are looking for; that 20-25 lbs during a 6 week cycle for most steroid novices. You gain mass rapidly and get a nice kick in strength as well while taking this drug. There is almost a synergistic action to Sustanon, meaning that the combination of the various testosterones in it work better together than the sum of their parts.

Side effects:
Sustanon can cause acne problems, and will aromatize and retent water in your body. It Decreases HTPA function severely, and converts DHT.
Sustanon is considered mildly toxic for liver.

Effective dosage for sustanon is from 250 mg monthly to 250 mg weekly for TRT treatment.

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Sustanon 250 description or profile

Sustanon 250 contains 4 testosterones that due to different time release provide steady and even testosterone displacement over a period of 4 -6 weeks.

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Testosterone
Generic Name: Testosterone cypionate
Dosage Form: injection, solution

Sustanon 250 , USP
100 mg/mL and 250 mg/mL
Testosterone Description

Sustanon 250 contains 4 different testorones one of them is:
Testosterone cypionate injection, USP, 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 C27H40O3, and the molecular weight 412.61.

The structural formula is represented below:

Sustanon injection, USP is available in two strengths, 100 mg/mL and 250 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
Testosterone – Clinical 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.
Pharmacokinetics

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 conjugated 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.
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Indications and Usage for Sustanon

Sustanon injection, USP 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) idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

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 or who may become pregnant
5. Patients with serious cardiac, hepatic or renal disease

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.

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.
Precautions
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 is not 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 thyroxine­binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. 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

There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

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.
Pregnancy
Teratogenic Effects

Pregnancy Category X. (See CONTRAINDICATIONS.)
Nursing Mothers

Sustanon injection, USP 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.
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.
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.
Miscellaneous

Inflammation and pain at the site of intramuscular injection.

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Overdosage

There have been no reports of acute overdosage with the androgens.
Testosterone Dosage and Administration

Sustanon injection, USP 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 Sustanon injection, USP 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.
How is Testosterone Supplied

Sustanon injection, USP is available as follows:

100 mg/mL:

NDC 0781-3073-70 – 10 mL multidose vial

200 mg/mL:

NDC 0781-3074-71 – 1 mL vial

NDC 0781-3074-70 – 10 mL multidose vial

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.

03-2009M

U1006824

Manufactured in Canada by

Sandoz Canada Inc. for

Sandoz Inc., Princeton, NJ 08540

mg/mL 10 mL Label

NDC 0781-3073-70

Testosterone CIII

Cypionate

Injection, USP

1,000 mg/10 mL

(100 mg/mL)

FOR INTRAMUSCULAR USE ONLY

Sterile. Protect from light.

Rx only 10 mL Multidose Vial

SANDOZ

mg/mL 10 mL Carton

NDC 0781-3073-70

CIII

Testosterone

Cypionate

Injection, USP

1,000 mg/10 mL

(100 mg/mL)

FOR INTRAMUSCULAR

USE ONLY

Sterile

Rx only

10 mL

Multidose Vial

SANDOZ

mg/mL 1 mL Label

NDC 0781-3074-71

Testosterone CIII

Cypionate

Injection, USP

200 mg/mL

FOR IM USE ONLY. Sterile.

Rx only

1 mL Vial

Manufactured in Canada by

Sandoz Canada Inc. for

Sandoz Inc.,

Princeton, NJ 08540

mg/mL 1 mL Carton

NDC 0781-3074-71

CIII

Testosterone

Cypionate

Injection, USP

200 mg/mL

FOR INTRAMUSCULAR

USE ONLY

Sterile

Rx only

1 mL Vial

SANDOZ

mg/mL 10 mL Label

NDC 0781-3074-70

Testosterone CIII

Cypionate

Injection, USP

2,000 mg/10 mL

(200 mg/mL)

FOR INTRAMUSCULAR USE ONLY

Sterile. Protect from light.

Rx only 10 mL Multidose Vial

SANDOZ

mg/mL 10 mL Carton

NDC 0781-3074-70

CIII

Testosterone

Cypionate

Injection, USP

2,000 mg/10 mL

(200 mg/mL)

FOR INTRAMUSCULAR

USE ONLY

Sterile

Rx only

10 mL

Multidose Vial

SANDOZ

Testosterone CYPIONATE
Testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0781-3073
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone CYPIONATE (Testosterone) Testosterone CYPIONATE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9.45 mg in 1 mL
BENZYL BENZOATE 0.1 mL in 1 mL
COTTON SEED 736 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0781-3073-70 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE
1 10 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0781-3073-70)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040615 08/10/2006

Testosterone CYPIONATE
Testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0781-3074
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone CYPIONATE (Testosterone) Testosterone CYPIONATE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9.45 mg in 1 mL
BENZYL BENZOATE 0.2 mL in 1 mL
COTTON SEED 560 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0781-3074-70 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE
1 10 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0781-3074-70)
2 0781-3074-71 1 VIAL In 1 CARTON contains a VIAL
2 1 mL In 1 VIAL This package is contained within the CARTON (0781-3074-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040615 08/10/2006

Labeler – Sandoz Inc (110342024)

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Sustanon 250 availability.

Sustanon 250

Sustanon 250 is NOT known to be marketed in the USA. Sustanon 250 may be available in the countries listed below.
Possible matches for Sustanon 250:

testosterone
Testosterone is reported as an ingredient of Sustanon 250 in the following countries:

* Australia
* Bahrain
* Bangladesh
* Belgium
* Cyprus
* Czech Republic
* Egypt
* Ethiopia
* Finland
* Ghana
* Indonesia
* Iran
* Iraq
* Ireland
* Israel
* Italy
* Jordan
* Kenya
* Kuwait
* Lebanon
* Libya
* Netherlands
* Oman
* Qatar
* Saudi Arabia
* Sudan
* Syria
* Tanzania
* Turkey
* United Arab Emirates
* United Kingdom
* Yemen
* Zambia
* Zimbabwe

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