NAME (and dosage form):
Testosterone Cypionate Injection, USP

COMPOSITION:
Each 1ml contains:
Testosterone Cypionate 100mg
Benzyl Alcohol 0.9% m/v as preservative

INDICATIONS:
Treating symptoms of low testosterone when the body does not make any testosterone or insufficient testosterone (hypogonadism).

It may also be used for other conditions as determined by your doctor. Testosterone Cypionate is a male sex hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.Testosterone Cypionate may also be used for certain conditions in females as determined by your doctor.

CONTRA-INDICATIONS:
If you are allergic to any ingredient in Testosterone Cypionate Injection USP; if you are pregnant, planning to become pregnant, or are breast-feeding ; you have breast cancer and are male; known or suspected prostate cancer; or serious heart, liver, or kidney problems ;Inform or contact your doctor or health care provider if any of these apply to you.

DIRECTIONS FOR USE:
Use Testosterone Cypionate Injection USP as directed by your doctor. Check the label on the medicine for exact dosing instructions. Testosterone Cypionate Injection, USP is for intramuscular use only.Testosterone Cypionate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Testosterone Cypionate at home, a health care provider will teach you how to use it. Be sure you understand how to use Testosterone Cypionate Injection USP. Follow the procedures you are taught when you use a dose.

Contact your health care provider if you have any questions. Do not use Testosterone Cypionate Injection USP if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Testosterone Cypionate Injection USP, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use the product.

IDENTIFICATION AND PRESENTATION:
A transluscent yellowish/slightly straw-coloured oily solution. Presented in 5ml amber glass vials.

STORAGE INSTRUCTIONS:
Store below 300C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

PRECAUTIONS:
Tell your doctor or dentist that you take Testosterone Cypionate Injection USP before you receive any medical or dental care, emergency care, or surgery. Diabetes patients - Testosterone Cypionate Injection USP may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Testosterone Cypionate Injection USP may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Testosterone Cypionate Injection USP. Lab tests, including liver function, blood cell counts, blood cholesterol, prostate specific antigen, bone growth, and blood testosterone, may be performed while you use Testosterone Cypionate Injection USP. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Testosterone Cypionate Injection USP with caution in the ELDERLY; they may be more sensitive to its effects, especially in cases of an enlarged prostate or prostate cancer. Testosterone Cypionate Injection USP should be used with extreme caution in CHILDREN younger than 18 years old.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.Patients should report any of the following effects to their practitioner immediately: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis. Please report any other effects that you may experience to your practitioner immediately.

Do not share medicines prescribed for you with other persons. In the event of an overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre without delay.Not all side effects and/or adverse effects reported for this medicine are included in this information leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice without delay.

Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: if you are pregnant, planning to become pregnant, or are breast-feeding ;if you are taking any prescription or non-prescription medicine, herbal preparation, or dietary supplement ; if you have allergies to medicines, foods, or other substances ;if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep); if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity.

The efficacy of Testosterone Cypionate Injection USP may be affected by some medical conditions or it may be contra-indicated in other medical conditions.Some medicines MAY INTERACT with Testosterone Cypionate Injection USP. Tell your health care provider if you are taking ANY other medicines (both prescription and over-the-counter medicines), especially any of the following: Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because their actions and the risk of their side effects may be increased by Testosterone Cypionate ;Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because their side effects, including risk of bleeding, may be increased by Testosterone Cypionate; Propranolol because its effectiveness may be decreased by Testosterone Cypionate. This may not be a complete list of all interactions that may occur. Ask your health care provider if Testosterone Cypionate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.