Testosterone cypionate (intramuscular route)


    Brand Name

    US Brand Name

    Depo-Testosterone

    Testone CIK


    Description

    Testosterone cypionate injection is use to treat males whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics. This medicine is not for use in female patients.

    This medicine is to be given only by or under the direct supervision of your doctor.

    This product is available in the following dosage forms:

    • Oil

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of testosterone cypionate injection in children younger than 12 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies on the relationship of age to the effects of testosterone cypionate injection have not been performed in the geriatric population. However, elderly patients are more likely to have heart or prostate problems (including enlarged prostate), which may require caution in patients receiving this medicine.

    Breastfeeding

    Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Anisindione
    • Apixaban
    • Bupropion
    • Dabigatran Etexilate
    • Dicumarol
    • Edoxaban
    • Insulin
    • Insulin Aspart, Recombinant
    • Insulin Bovine
    • Insulin Degludec
    • Insulin Detemir
    • Insulin Glulisine
    • Insulin Lispro, Recombinant
    • Levoketoconazole
    • Methotrexate
    • Paclitaxel
    • Paclitaxel Protein-Bound
    • Phenprocoumon
    • Rivaroxaban
    • Warfarin

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Licorice

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
    • Enlarged prostate or
    • Heart attack, or history of or
    • Heart or blood vessel disease or
    • Hypercalcemia (high calcium in the blood) or
    • Hyperlipidemia (high cholesterol or fats in the blood) or
    • Liver disease or
    • Sleep apnea or
    • Stroke, history of—Use with caution. May make these conditions worse.
    • Breast cancer or
    • Prostate cancer, known or suspected—Should not be used in patients with these conditions.
    • Heart disease (eg, congestive heart failure) or
    • Kidney disease or
    • Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.
    • Lung disease, chronic or
    • Obesity—Use with caution. May increase risk for more side effects.

    Proper Use

    A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a muscle (usually in the buttock).

    This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    This medicine should not be used by female patients, especially if pregnant or breastfeeding. Testosterone may cause birth defects if a pregnant person comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

    This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

    This medicine may increase the risk of prostate cancer, especially in older males. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.

    This medicine may cause blood clotting problems (eg, deep vein thrombosis, pulmonary embolism). Tell your doctor right away if you have anxiety, chest pain, coughing, dizziness or lightheadedness, fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, or trouble breathing.

    This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

    In some cases, this medicine may decrease the amount of sperm males make and affect the ability to have children. Talk with your doctor before you use this medicine if you plan to have children.

    Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    This medicine may cause edema (fluid and sodium retention). Check with your doctor right away if you have a decrease in amount of urine, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain.

    This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

    This medicine may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.

    Hypercalcemia (high calcium in the blood) may occur in patients taking this medicine. Check with your doctor right away if you have stomach pain, confusion, constipation, depression, dry mouth, increased urination, loss of appetite, metallic taste, or muscle weakness.

    Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.

    This medicine may increased risk of bone growth problems in children. Your doctor will check your child's bone growth every 6 months.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Acne
    • anxiety
    • bleeding gums or nose
    • bluish lips or skin
    • chest pain, discomfort, or tightness
    • chills
    • clay-colored stools
    • confusion
    • constipation
    • cough
    • dark urine
    • decrease in amount of urine
    • diarrhea
    • difficulty in speaking
    • difficulty swallowing
    • discouragement
    • dizziness or lightheadedness
    • double vision
    • dry mouth
    • enlargement of penis or testes
    • eye pain
    • fast heartbeat
    • feeling sad or empty
    • fever
    • growth of pubic hair
    • headache
    • hives, itching, skin rash
    • inability to move the arms, legs, or facial muscles
    • inability to speak
    • increased urination
    • irritability
    • lack or slowing of normal growth in children
    • loss of appetite
    • loss of interest or pleasure
    • metallic taste
    • muscle weakness
    • nausea
    • pain, redness, or swelling in the arm or leg
    • pain or discomfort in the arms, jaw, back or neck
    • painful or prolonged erection of the penis
    • penile pain during erection
    • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
    • rapid increase in height
    • ringing in the ears
    • slow speech
    • stomach pain
    • sweating
    • swelling
    • swelling of the breasts or breast soreness
    • swelling of the fingers, hands, feet, or lower legs
    • thirst
    • tiredness
    • trouble breathing
    • trouble concentrating
    • trouble sleeping
    • unpleasant breath odor
    • unusual tiredness or weakness
    • vomiting
    • vomiting of blood
    • weight gain or loss
    • yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Blurred vision
    • inability to speak
    • seizures
    • severe or sudden headache
    • slurred speech
    • temporary blindness
    • weakness in the arm or leg on one side of the body, sudden and severe

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Decreased or increased interest in sexual intercourse
    • inability to have or keep an erection
    • increased or loss in sexual ability, desire, drive, or performance
    • pain and swelling at the injection site

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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