SUSTAVIRON 250 Injection 1ml

Introduction About SUSTAVIRON 250 INJECTION

SUSTAVIRON 250 INJECTION contains Testosterone which belongs to the group of
medicines called Androgens. It is used in adult men to replace testosterone in
male hypogonadism (various health problems caused by a deficiency of
testosterone). Male hypogonadism is characterized by symptoms like impotence,
infertility, decreased sex drive, tiredness, depressive moods and bone loss due
to low hormone levels.

SUSTAVIRON 250 INJECTION is not recommended for use in patients with known or
suspected prostate or breast cancer, high blood calcium levels or who have or
had liver tumors, kidney disease. Consult your doctor before receiving it.

SUSTAVIRON 250 INJECTION should be used with caution in patients with severe
liver, kidney or heart disease, high blood pressure, fits, migraine, diabetes.
Consult your doctor before receiving it.

SUSTAVIRON 250 INJECTION is intended for use by men only. It is not indicated
for use in pregnant and breastfeeding women. Consult your doctor before
receiving it.

SUSTAVIRON 250 INJECTION is not recommended for use in children and adolescents
(under 18 years of age) and it should be used with caution in elderly patients
(aged above 65 years). Consult your doctor before receiving it.

The most common side effects of receiving SUSTAVIRON 250 INJECTION are acne,
weight gain, hot flushes, enlarged prostate and related problems, pain,
bruising, irritation at the site of injection. Contact your physician if any of
the symptoms worsen.

Uses Of SUSTAVIRON 250 INJECTION

• To replace testosterone in male hypogonadism in adult men

How SUSTAVIRON 250 INJECTION Works

SUSTAVIRON 250 INJECTION works by replacing testosterone in adult male patients
with hypogonadism (various health problems caused by a lack of testosterone, a
natural male hormone). Thus, helps to improve clinical symptoms such as
impotence, infertility, low sex drive, tiredness, depressive moods, bone loss
caused by low hormone levels.

How to use SUSTAVIRON 250 INJECTION

SUSTAVIRON 250 INJECTION will be given to you only by a doctor or a nurse into a
muscle as an intramuscular injection. Your doctor will decide the correct dose
and duration for you depending upon your age, body weight and disease condition.
Do not stop receiving SUSTAVIRON 250 INJECTION unless your doctor advises you to
stop. Otherwise, your symptoms of testosterone deficiency may reoccur.

Side Effects Of SUSTAVIRON 250 INJECTION

Common

• increased appetite
• depression, emotional disorder
• lack of sleep, restlessness, aggression, irritation
• headache, migraine, shaking
• cardiovascular disorder, high blood pressure, dizziness
• bronchitis, sinusitis, cough, breathlessness, snoring, voice problems
• diarrhoea, nausea
• hair loss or various skin reactions (itching, reddening, dry skin)
• joint pain, pain in limbs, muscle problems (spasm, pain, stiffness)
• urinary tract disorders (reduced flow of urine, urinary retention, urge to pass urine at night)
• prostatic disorders like prostatic intraepithelial neoplasia, hardening or inflammation of the prostate), changes in sexual desire, painful testicles, painful, hardened or enlarged breasts, increased levels of male and female hormones
• tiredness, generalized weakness, too much sweating or night sweats

Rare

• pulmonary micro embolism (cough, breathlessness, feeling generally unwell, excessive sweating, chest pain, dizziness, pins and needles sensation or fainting)

Stop receiving SUSTAVIRON 250 INJECTION and contact your doctor immediately if
you experience any of the following side effects:

• allergic reaction (severe rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, weakness, feeling dizzy or faint and nausea)

How To Manage Side Effects

Nausea:

Receive the medicine, with or just after a meal. Stick to simple meals. Avoid
eating oily or spicy food. Contact your doctor if the nausea did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating
Solution) and apply a pain-relieving balm on the head if necessary. Contact your
doctor if the headache did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines
while you are feeling dizzy. Contact your doctor if your dizziness did not
improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated.
Do not take any medicine on your own for managing diarrhoea. Contact your doctor
if your diarrhoea did not improve.

Warning & Precautions

!### Pregnancy

SUSTAVIRON 250 INJECTION is intended for use by men only. It is not indicated
for use in pregnant women due to the possibility of virilisation (development of
male sex characteristics) of the female foetus. Consult your doctor before
receiving it.

!### Breastfeeding

SUSTAVIRON 250 INJECTION is not indicated for use in breastfeeding women.
Consult your doctor before receiving it.

!### Driving and Using Machines

SUSTAVIRON 250 INJECTION does not affect your ability to drive or use machinery.

!### Kidney

SUSTAVIRON 250 INJECTION is not recommended for use in patients with kidney
disease (nephrosis). Inform your doctor if you have severe kidney disease as
this medicine may cause water retention in the body.

!### Liver

SUSTAVIRON 250 INJECTION is not recommended for use in patients who have or had
liver tumors.

SUSTAVIRON 250 INJECTION should be used with caution in patients with liver
problems like severe upper abdominal complaints. Consult your doctor before
receiving it.

!### Allergy

Do not receive SUSTAVIRON 250 INJECTION if you are allergic to Testosterone or
any of the other ingredients of this medicine.

!### Heart Disease

SUSTAVIRON 250 INJECTION should be used with caution in patients with high blood
pressure. Inform your doctor if you have severe heart disease as this medicine
may cause water retention in the body accomp

Others

SUSTAVIRON 250 INJECTION is not recommended for use if you:

• have known or suspected prostate or breast cancer
• have high blood calcium levels

Before receiving SUSTAVIRON 250 INJECTION, inform your doctor if you:

• tend to retain fluid causing problems like swelling of the ankles
• suffer from sleep apnea (interrupted breathing during sleep)
• have or had blood clotting problems like bleeding disorders (haemophilia) or abnormal blood coagulation that increases the risk of blood clots in blood vessels
• have risk of developing blood clots (smoking, obesity, cancer, immobility, family history of blood clot in the leg, lung or other organ at a young or older age)
• have fits
• have migraine
• have diabetes (high blood sugar)
• have cancerous bone diseases
• are going to have lab tests (thyroid function tests)

Use in pediatrics:

SUSTAVIRON 250 INJECTION is not recommended for use in children and adolescents
(under 18 years of age) as safety and efficacy have not been established.
Consult your doctor before receiving it.

Use in geriatrics:

SUSTAVIRON 250 INJECTION should be used with caution in elderly patients (aged
above 65 years) due to increased risk of prostate cancer or enlargement of
prostate gland. Consult your doctor before receiving it.

Interactions

A. Drug - Drug interactions:

Before receiving SUSTAVIRON 250 INJECTION, inform your doctor if you are taking
any of the following medicine:

• medicines used to manage nervousness and sleep problems (Ex. pentobarbital, clonazepam)
• oxyphenbutazone (used to manage pain or inflammation)
• medicines used to thin the blood (Ex. warfarin, acenocoumarol)
• medicines used to manage diabetes (Ex. metformin, glimepiride)
• corticosteroids (medicines used to manage rheumatism, arthritis, allergic conditions and asthma) Ex. hydrocortisone, dexamethasone
• adrenocorticotropic hormone (used in the diagnosis of adrenocortical insufficiency)

Overdosage:

SUSTAVIRON 250 INJECTION will be administered to you only by a doctor or a nurse
in a hospital and so it is unlikely to receive an overdose. However, consult
your doctor or nurse if you experience irritability, nervousness, weight gain,
long-lasting or frequent erections.

Synopsis

Drug	:	Testosterone
Pharmacological Category	:	Androgens
Therapeutic Indication	:	Male hypogonadism
Dosage Forms	:	Tablet, Capsule, Injection, Gel, Spray

More Information

• Keep SUSTAVIRON 250 INJECTION out of reach of children
• Store at 25°C

FAQs About SUSTAVIRON 250 INJECTION

Can I receive SUSTAVIRON 250 INJECTION while I am being managed for high blood
pressure?

No. Before receiving SUSTAVIRON 250 INJECTION, inform your doctor if you have
high blood pressure or if you are being managed for it as SUSTAVIRON 250
INJECTION may increase your blood pressure.

Can SUSTAVIRON 250 INJECTION be used in women?

No. SUSTAVIRON 250 INJECTION should not be used in women because they may
develop male physical characteristics like acne, increased facial or body hair
growth and voice changes. Consult your doctor before receiving it.

Can SUSTAVIRON 250 INJECTION cause prostate cancer?

Although there is no clear evidence that SUSTAVIRON 250 INJECTION causes
prostate cancer, it can enhance the growth of any existing cancer of the
prostate. To avoid this, regular prostate examinations in men are recommended,
especially if you are elderly. Inform your doctor if you have prostate cancer
before receiving SUSTAVIRON 250 INJECTION.

Can SUSTAVIRON 250 INJECTION be used in children?

SUSTAVIRON 250 INJECTION is not indicated for use in children and adolescents,
under 18years of age as earlier development of male secondary sex
characteristics may occur. SUSTAVIRON 250 INJECTION can also affect bone growth
and sometimes reduce final height. It’s safety and efficacy have also not been
adequately determined in children and adolescents. So, consult your doctor
before receiving it.

Can SUSTAVIRON 250 INJECTION affect fertility?

Yes, management with high doses of SUSTAVIRON 250 INJECTION may affect fertility
by reversibly lowering the sperm production. Consult your doctor for advice
before receiving this medicine.

Do I need to take any tests during management with SUSTAVIRON 250 INJECTION?

SUSTAVIRON 250 INJECTION may increase the growth of prostate cancer and enlarged
prostate glands (benign prostatic hypertrophy). Before and during management
with this medicine, your doctor might carry out a blood test to check the
haemoglobin, testosterone blood level and will examine your breast and prostate
gland at regular intervals by digital rectal examination (DRE) and by conducting
blood tests for prostate-specific antigen (PSA).

What if I forget to receive a dose of SUSTAVIRON 250 INJECTION?

Please stick to the prescribed schedule agreed upon with your doctor for o
efficacy of SUSTAVIRON 250 INJECTION management. Notify your doctor whenever you
miss receiving any dose.

Can I stop receiving SUSTAVIRON 250 INJECTION?

Do not stop receiving SUSTAVIRON 250 INJECTION without asking your doctor as it
may cause symptoms of your condition to recur. If you have any more doubts
regarding the use of this medicine, ask your doctor.

Can I use SUSTAVIRON 250 INJECTION for muscle building?

SUSTAVIRON 250 INJECTION is not suitable for increasing muscular development in
healthy people or for increasing physical strength. Consult your doctor for
advice before receiving this medicine.

Useful Diagnostic Tests

• Blood testosterone level
• Digital rectal examination (DRE)
• Prostate-specific antigen (PSA)
• Complete blood count
• Liver function tests