Striant SR (testosterone)

How does it work?

Striant SR tablets contain the active ingredient testosterone, which is the same as the naturally occurring male hormone testosterone.

Testosterone is known as an androgen. It is produced by the testicles and is the main hormone essential for normal growth and development of the male sex organs and male sexual characteristics.

The natural production of testosterone is controlled by another set of hormones called gonadotrophins, which are released from the pituitary gland in the brain.

During adult life, testosterone is essential for the production of sperm, the maintenance of sex drive, erectile potency, and the functioning of the prostate gland and other reproductive structures. It also has functions in the skin, muscles, skeleton, kidney, liver, bone marrow and central nervous system.

Low levels of testosterone can cause decreased sex drive, impotence, infertility due to decreased sperm production, decreased mental and physical activity, fatigue and weakening of bones.

Testosterone is given as replacement therapy when natural testosterone levels fall too low, causing symptoms such as those above. Natural testosterone levels fall with age and following surgical removal of the testicles (castration). They may also fall due to decreased functioning of the testicles (hypogonadism or eunuchoidism) caused by testicular disease, or by decreased gonadotrophin production by the pituitary gland, as a result of pituitary disease.

Testosterone replacement allows natural testosterone levels to return to normal, thus relieving the symptoms of the deficiency.

Striant SR tablets are designed to be stuck to the gums in the mouth. The testosterone is slowly released from the tablet and is absorbed into the bloodstream through the areas of gum and cheek that are in contact with the tablet.

The rounded side of the tablet should be placed in a comfortable position against the gum, just above either of the incisor teeth. (Use alternate sides of the mouth with each application.) Hold the tablet firmly in place with a finger over the lip and against the tablet for 30 seconds to ensure that it has stuck to the gum. The tablet is designed to stay in place until it is removed after 12 hours. To remove the tablet, gently slide it downwards from the gum towards the tooth to avoid scratching the gum.

It is recommended that the tablet is applied in the morning and evening after brushing the teeth.

What is it used for?

Replacement therapy of low testosterone levels in men.

Warning!

Striant SR tablets should not be chewed or swallowed, as they will not be effective if taken this way. They should be stuck to the gum as described above.

If the tablet fails to stick properly to the gum or falls off during the 12 hour dosing interval, the old tablet should be removed and a new one applied. If this happens four or less hours before your next dose, the replacement tablet can be regarded as your second dose for the 24 hour period.

You will need to have blood tests to measure your blood level of testosterone before starting and regularly throughout treatment with this medicine.

Tell your doctor if you experience symptoms such as frequent or persistent erections, irritability, nervousness or weight gain after starting treatment with this medicine, as these suggest your testosterone levels are too high and your dose may need adjusting.

You will also need to have regular blood tests to monitor your red blood cells, liver function and prostate specific antigen (PSA) levels.

Testosterone can increase the growth of prostate cancers and benign enlargement of the prostate. Your doctor will perform various examinations to make sure you don't have prostate cancer before you start treatment with this medicine. Your doctor will need to perform a digital rectal exam to check your prostate gland at least once a year while you are receiving testosterone replacement (more frequently than this if you are elderly or have risk factors for prostate cancer).

Use with caution in

Men over 65 years of age.

Decreased kidney function.

Decreased liver function.

Heart failure.

Heart disease caused by inadequate blood flow to the heart.

High blood pressure .

Epilepsy.

History of migraines.

Diabetes.

Cancer that has spread from its original site to the bones (skeletal metastases).

Sleep apnoea (temporarily stopping breathing during sleep).

Dry mouth due to disorders of the salivary glands.

Not to be used in

Women.

Children and adolescents under 18 years of age.

Men with breast cancer.

Prostate cancer.

History of or current liver cancer.

A syndrome caused by kidney inflammation, characterised by a large amount of protein in the urine, swelling, weight gain and high blood pressure (nephrotic syndrome).

High level of calcium in the blood (hypercalcaemia).

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Striant SR tablets contain lactose).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Irritation, swelling or pain at application site.

inflammation of the gums (gingivitis).

Taste disturbance.

Bitter taste.

Headache.

Fatigue.

Breast pain, enlargement of the breasts.

Salt and water retention.

Swelling caused by fluid retention (oedema).

Weight gain.

Hair loss.

Acne.

Depression.

Hostility.

Nervousness.

Prostate problems.

Persistent painful erection of the penis (priapism).

Decreased sperm count.

Increased levels of red blood cells and haemoglobin in the blood.

Jaundice.

Liver tumours.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Testosterone may increase the anti-blood-clotting effects of anticoagulants such as warfarin, nicoumalone and phenindione. If you are taking any of these your blood clotting time (INR) may need to be monitored more frequently; in particular it should be measured after you start or stop testosterone treatment.

If testosterone is used in combination with corticosteroids such as dexamethasone, there may be a greater chance of fluid retention and oedema since both medicines can cause fluid retention. This combination of medicines should be used with caution in people with heart, liver or kidney disease.

If you have diabetes, your dose of insulin or antidiabetic tablets may need to be reduced after you start treatment with this medicine.

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