Taro-Testosterone

Uses

Testosterone Capsule: The active substance of Testosterone is turned into Testosterone by your body. Testosterone is the natural male hormone, necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. Preparations containing Testosterone are usually prescribed to replace the hormone if the body is unable to produce enough on its own.Do not take Testosterone

• if you have a tumour of the prostate or the breast
• if you are hypersensitive (allergic) to Taro-Testosterone or any of the other ingredients of Testosterone

Testosterone Gel: This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.This drug should not be used by women.

Testosterone is a steroid sex hormone found in both men and women. In men, testosterone is produced primarily by the Leydig (interstitial) cells of the testes when stimulated by luteinizing hormone (LH). It functions to stimulate spermatogenesis, promote physical and functional maturation of spermatozoa, maintain accessory organs of the male reproductive tract, support development of secondary sexual characteristics, stimulate growth and metabolism throughout the body and influence brain development by stimulating sexual behaviors and sexual drive. In women, testosterone is produced by the ovaries (25%), adrenals (25%) and via peripheral conversion from androstenedione (50%). Testerone in women functions to maintain libido and general wellbeing. Testosterone exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Testosterone may be further converted to dihydrotestosterone or estradiol depending on the tissue.

Taro-Testosterone is also used to associated treatment for these conditions: Hypergonadotropic Hypogonadism, Hypogonadotrophic Hypogonadism

How Taro-Testosterone works

Testosterone is produced by Leydig cells and exerts it's effects by binding to androgen receptors throughout the body. Testosterone affects the voice, genitalia, mood, and influences muscle growth and protein expression. Accordingly, males with low levels of testosterone often experience decreased libido, fatigue, mood changes and dysphoria. Exogenous sources of testosterone are designed to mimic the effects of endogenous testosterone.

Dosage

Taro-Testosterone dosage

Testosterone Capsule: Usually, the dosage is 3-4 capsules daily during the first 2-3 weeks, followed by a gradual decrease to 1-3 capsules daily. You must take Testosterone with a meal. Swallow the capsules whole without chewing, using some water or other fluid.

Take half of the daily dose in the morning and the other half in the evening.

If the daily dose is an uneven number of capsules, take the larger number in the morning.

If you have the impression that the effect of Testosterone is too strong or too weak, inform your doctor immediately.

Do not take a double dose to make up for forgotten individual dose.

When treatment with Testosterone is stopped, complaints as those before treatment may re-occur within a few weeks.

Testosterone Gel: Apply the medication as directed to clean, dry skin of the shoulders/upper arms once daily in the morning or as directed by your doctor. Apply only to areas that would be covered if you were to wear a short sleeve t-shirt. Certain brands of this medication may also be applied to the stomach area (abdomen). Check your product's instructions or ask your pharmacist if your brand may be applied to the abdomen. Avoid applying this medication to broken, irritated skin. Do not apply to the genitals (penis or scrotum). Do not let others apply this medication to your body.

Dosage is based on your medical condition, laboratory tests, and response to treatment.

After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Before dressing, wait a few minutes for the application site to dry completely. Be sure to always wear clothing (such as a t-shirt) to cover the application site until you wash the areas well with soap and water.

To get the best effect, wait several hours (2 to 5 hours depending on brand) before showering/swimming to allow the drug to be absorbed through the skin. Check the manufacturer's information or ask your pharmacist for details. See also Warning and Precautions sections.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Food allows Taro-Testosterone to be taken up by your body. Therefore, Testosterone must be taken with a meal.

Side Effects

Like all medicines, Testosterone can have side effects.

In general: increased sexual desire, fluid retention in the tissues, usually marked by swelling of ankles or feet

In men: prolonged abnormal, painful erection of the penis, disturbed formation of sperm, decreased amount of sperm with seminal discharge

In elderly men: problems with passing urine

In young boys: early sexual development, erections occurring more often than normal, enlarged penis, disturbed growth

Tell your doctor as soon as possible if any side-effect becomes troublesome or continues.

Toxicity

There is evidence that in adolescent users, testosterone at supra-therapeutic levels may contribute to aggressive behaviour and increased rates of suicide. However, testosterone does not appear to negatively affect cognition in adult men receiving testosterone replacement therapy and may in fact benefit cognitive function. Administration of exogenous testosterone affects normal physiological hormonal regulation, and ultimately depresses the release of follicle-stimulating hormone and luteinizing hormone resulting in reduced sperm production. This should be considered before initiating testosterone in males who wish to start or grow a family. Increased levels of testosterone can also cause increased sebum production, therefore acne may be observed in patients taking exogenous testosterone. Since testosterone is converted to estrogen in the body by aromatization, males taking testosterone replacement may experience gynecomastia and/or breast pain.

Precaution

Extra supervision by a doctor is necessary in the treatment of young boys, since Testosterone suppletion may cause early sexual development and disturb growth. Extra supervision by a doctor is also necessary in the treatment of elderly men, since male hormones may increase the size of the prostate gland.

Medical checks may also be necessary in some other conditions. Therefore, tell your doctor if you have or have ever had heart disease, kidney disease, high blood pressure, epilepsy, migraine headaches, prostatic complaints, such as problems with passing urine

Driving and using machines: As far as is known Testosterone have no adverse effect on alertness and concentration.

Interaction

Other medicines may influence the effects of Testosterone or Testosterone may affect other medicines. You must tell your doctor or pharmacist if you are using (or intend to use) rifampicin (an antibiotic) or medicines for epilepsy or sleeplessness.

Food Interaction

• Take with food. Take Jatenzo (testosterone undecanoate) oral capsule with food.

Elimination Route

The absorption of testosterone undecanoate varies based on the formulation. The intramuscular formulation of testosterone esters is suspended in oil and is absorbed from the lipid phase. Testosterone is released when tissue esterases cleave the undecanoic acid side chain.
The oral formulation of testosterone undecanoate is also formulated as a prodrug, is best absorbed with food and ideal absorption occurs when taken with a meal containing at least 30 g of fat.

Half Life

Based on one source, Testosterone undecanoate in castor oil (for intramuscular injection) has a half life of 33.9 days, allowing it to maintain serum levels in the normal range for over 6 weeks. It should be noted that the half life of testosterone reported in the literature is inconsistent.

Elimination Route

The majority (~90%) of an intramuscularly administered dose of testosterone is conjugated and eliminated in the urine. Approximately 6% of the dose is eliminated primarily unconjugated in the feces.

Pregnancy & Breastfeeding use

Pregnancy Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Contraindication

Hypercalcaemia or hypercalciuria, males with breast or prostate carcinoma. Pregnancy and lactation.

Acute Overdose

If you have taken several capsules at once, there is no need for great concern. However, you should consult your doctor. The oily substance in the capsule may cause diarrhoea.

Storage Condition

Keep Testosterone out of reach and sight of children. Store at 8°C-30°C. Store in the original package in order to protect from light. Do not use Testosterone after the expiry date stated on the package, sachet and blister.

Innovators Monograph

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