Triclofem

Medroxyprogesterone acetate.

Each dose (1 millilitre) contains 150 mg of medroxyprogesterone acetate.
Excipients/Inactive Ingredients: The other ingredients of Triclofem are methyl paraben, propyl paraben, polysorbate 80, polyethylene glycol 3350, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

Triclofem (DMPA) is used for long-term contraception in women aged over 18 years. It can also be used for short-term contraception to cover specific periods when: the patient's partner is awaiting vasectomy to become effective; the patient is awaiting sterilization; the patient is awaiting immunization against rubella to become effective.
Triclofem (DMPA) may be used in adolescents aged over 12 years if there is compelling reason for contraception and other methods are unsuitable or unacceptable.
Women who are living with HIV or are on antiretroviral (ARV) therapy can safely use DMPA.

Dosage: Each mL of suspension contains 150 mg medroxyprogesterone acetate. The sterile aqueous suspension of Triclofem should be vigorously shaken just before use to ensure that the dose being given represents a uniform suspension of Triclofem. Doses should be given by deep intramuscular injection into the buttock or arm.
Care should be taken to ensure that the depot injection is given into the muscle tissue, preferably the gluteus maximus, but other muscle tissue such as the deltoid may be used and the site of injection should be cleansed using standard methods prior to administration of the injection.
Assembly of syringe for single use: 1. Remove tip cap.
2. Position needle using aseptic technique.
3. Remove needle shield. The syringe is now ready for use.
Further doses: These should be given at 12 week intervals, however, as long as the injection is given no later than five days after this time, no additional contraceptive measures (e.g. barrier) are required.
(NB For partners of men undergoing vasectomy a second injection of 150 mg i.m. 12 weeks after the first may be necessary in a small proportion of patients where the partner's sperm count has not fallen to zero.) If the interval from the preceding injection is greater than 12 weeks for any reason, then pregnancy should be excluded before the next injection is given and the patient should use additional contraceptive measures (e.g. barrier) for fourteen days after this subsequent injection.
Administration: Adults: First injection: To provide contraceptive cover in the first cycle of use, an injection of 150 mg i.m. should be given during the first five days of a normal menstrual cycle. If the injection is carried out according to these instructions, no additional contraceptive cover is required.
Postpartum: To increase assurance that the patient is not pregnant at the time of first administration, this injection should be given within 5 days postpartum if not breast-feeding.
There is evidence that women prescribed Triclofem in the immediate puerperium can experience prolonged and heavy bleeding. Because of this, the drug should be used with caution in the puerperium. Women who are considering use of the product immediately following delivery or termination should be advised that the risk of heavy or prolonged bleeding may be increased.
Health care providers are reminded that in the non breast-feeding postpartum patient, ovulation may occur as early as week 4. If the puerperal woman will be breast-feeding, the initial injection should be given no sooner than six weeks postpartum, when the infant's enzyme system is more fully developed. Further injections should be given at 12 week intervals.
Paediatric population (12-18 years): Triclofem is not indicated before menarche. Data in adolescent females (12-18 years) is available. Other than concerns about loss of BMD, the safety and effectiveness of Triclofem is expected to be the same for adolescents after menarche and adult females.
Switching from other Methods of Contraception: Triclofem should be given in a manner that ensures continuous contraceptive coverage. This should be based upon the mechanism of action of other methods (e.g. patients switching from oral contraceptives should have their first injection of Triclofem within 7 days of taking their last active pill).
Hepatic Insufficiency: The effect of hepatic disease on the pharmacokinetics of Triclofem is unknown. As Triclofem largely undergoes hepatic elimination it may be poorly metabolised in patients with severe liver insufficiency (see Contraindications).
Renal Insufficiency: The effect of renal disease on the pharmacokinetics of Triclofem is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Triclofem is almost exclusively eliminated by hepatic metabolism.

Triclofem should not be used: If the patient is allergic (hypersensitive) to medroxyprogesterone acetate or to any of the other ingredients (listed in Description); If the patient thinks she may be pregnant; If the patient has had, or thinks she may have, hormone-dependent cancer of the breast or genital organs; If the patient has abnormal uterine bleeding; If the patient has liver disease; If the patient is hypertensive; If the patient has had diabetes for longer than 20 years; If the patient has a history of ischemic heart disease (e.g. myocardial infarction) or stroke; If the patient has or has had arterial thrombosis; If the patient has acute deep venous thrombosis or pulmonary embolism; If the patient has systemic lupus erythematosus.

The health care provider will ask about the patient and her family's medical problems, check her blood pressure and exclude the likelihood of her being pregnant. The patient may also need a breast examination or other checks if she has any special concerns.
The patient should tell the health care provider if she is using medicines such as steroids, antiepileptics and thyroid hormones. It is important that the patient tells the health care provider if she has or has had in the past any of the following conditions. The health care provider will then discuss with the patient whether Triclofem is suitable for her or recommend a more suitable method of contraception: Migraine headaches; Diabetes or a family history of diabetes; Severe pain or swelling in the calf; Blood clotting disorders such as blood clot in the legs, lung or a stroke; Problems with eyesight for example a sudden partial or complete loss of vision or double vision; Depression; Problems with the liver or liver disease; Problems with the kidneys or kidney disease; Heart disease or cholesterol problems including any family history; Abnormal pregnancy; Asthma; Epilepsy.
Undesirable Events: Intramuscular Injection: Potential injection site reactions (injection site necrosis and atrophy).
Psychiatric disorders: Some women using hormonal contraceptives including Triclofem have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If the patient experiences mood changes and depressive symptoms, she should contact the health care provider for further medical advice as soon as possible.
Cervical smear testing: The results of a cervical smear and some laboratory tests could be affected if the patient is using Triclofem so it is important that she tells the health care provider.
Protection against sexually transmitted infections: Triclofem does not protect against HIV infection, e.g. AIDS and other sexually transmitted infections. Safer sex practices, including correct and consistent use of condoms, reduce the transmission of sexually transmitted infections through sexual contact, including HIV. The patient should seek advice from the health care provider on how to decrease the risk of catching sexually transmitted infections including HIV.
Triclofem contains methyl paraben, propyl paraben and sodium: Each vial contains methyl paraben and propyl paraben which may cause allergic reactions (possibly delayed), and exceptionally bronchospasm (difficulty breathing caused by narrowing of the airways).
This medicinal product also contains less than 1 mmol sodium, i.e., is essentially 'sodium-free'.
Driving and using machines: Triclofem may cause headaches and dizziness. The patient should not operate machines or drive if she feels dizzy after taking Triclofem.

Pregnancy: The health care provider will check that the patient is not pregnant before giving her the first injection and also if any following injection is delayed beyond 12 weeks. The patient should not take Triclofem if she is pregnant as hormonal medicines can affect the developing baby.
Breast-feeding: Triclofem does not prevent the breast from producing milk so nursing mothers can use it, however, it is better for the baby that for the first few weeks after birth its mother's milk contains no traces of any medicines, including Triclofem. The health care provider may advise to wait until at least 6 weeks after the baby has been born before the patient starts using Triclofem for contraception.
Fertility: The usual level of fertility should return when the effect of the injection has worn off. This takes different amounts of time in different women, and does not depend on how long the patient has been using Triclofem. Some women have become pregnant as early as 14 weeks after their last injection.

Like all medicines, this medicine can cause side effects although not everybody gets them.
Seek medical help immediately if any of the following side effects are noticed: Hypersensitivity (allergic) reaction (It is not known how frequently this occurs). Symptoms include sudden skin rash, swelling of the face, lips, tongue or throat, wheezing or difficulty in breathing.
A blood clot in the lungs (this occurs rarely - may affect up to 1 in 1000 people). Symptoms include: Shortness of breath; Breath-related chest pains; Coughing up blood.
A blood clot in the leg (this occurs rarely - may affect up to 1 in 1000 people). Deep vein thrombosis (DVT) is a condition in which blood clot forms in one of the deep veins, usually in the leg. These are symptoms of a deep-vein thrombosis (DVT): The patient has pain, tenderness or swelling in the calf, ankle or foot; The patient has painful or inflamed veins in the leg; The patient finds it difficult to put full weight on the affected leg; The patient has purple discolouration of the skin of the leg or the skin becomes red and warm to touch.
Jaundice (yellowing of the skin or the whites of the eyes).
Other side-effects include: Very common: may affect more than 1 in 10 people: nervousness; headache; stomach pain or discomfort; weight increase or decrease.
Common: may affect up to 1 in 10 people: depression; libido decreased (reduced sex drive); dizziness; feeling sick; feeling bloated; hair loss; acne; back pain; vaginal discharge; breast tenderness; difficult or painful period; urinary tract infection; oedema/fluid retention; weakness.
Uncommon: may affect up to 1 in 100 people: appetite increased or decreased; difficulty sleeping; convulsions (fits); drowsiness; tingling; hot flush; liver disorder; facial hair growth; nettle rash or hives; itchy skin; temporary brown patches; difficult or painful period; unexpected or unusual vaginal bleeding or spotting; milky discharge from the breast when not pregnant or breast-feeding; pelvic pain; painful intercourse; prevention of lactation.
Rare: may affect up to 1 in 1,000 people: breast cancer; reduction in red blood cell; blood disorder; difficulty reaching orgasm; behavior change; mood change; irritability; anxiety; migraine; paralysis; fainting; feeling of dizziness or spinning; heart beats more rapidly; high blood pressure; varicose veins; rectal bleeding; digestive disorder; liver enzyme disorder; accumulation of fat (at injection site); inflammation of the skin; scar tissue formation; stretch marks; pain in a joint; muscular cramps; bone density decreased (osteoporosis); vaginal pain or inflammation; stopping or extended break of periods; inflammation of the vagina; breast pain; uterine bleeding or excessive bleeding; periods with abnormally heavy or prolonged bleeding; vaginal dryness; change in breast size; ovarian or vaginal cyst; premenstrual syndrome; excessive thickening of the lining of the womb; breast lump; nipple bleeding; delayed egg release with longer menstrual cycles (periods); feel pregnant; fever; tiredness; injection site pain or tenderness; injection site lump or dimple; feeling thirsty; hoarseness; facial nerve paralysis; decreased sugar tolerance; abnormal smear.
Possible effect on periods: After the first injection of Triclofem it is likely that the patient will have irregular, possibly lengthy bleeding or spotting. This is quite normal and nothing to worry about.
One third of women will not have any bleeding at all after the first injection. After 4 injections, most women find that their periods have stopped completely. Not having periods is nothing to worry about.
If the patient experiences very heavy or prolonged bleeding, she should talk to the health care provider. This happens rarely but can be treated.
When the patient stops taking Triclofem, periods will return to normal in a few months.
Possible effects on the bones: Triclofem works by lowering levels of oestrogen and other hormones. However, lower oestrogen levels can cause bones to become thinner (by reducing bone mineral density). Women who use Triclofem tend to have lower bone mineral density than women of the same age who have never used it.
The effects of Triclofem are greatest in the first 2-3 years of use. Following this, bone mineral density tends to stabilise and there appears to be some recovery of bone density when Triclofem is stopped. It is not yet possible to say whether Triclofem increases the risk of osteoporosis (weak bones) and fractures in later life (after the menopause).
The following are risk factors in the development of osteoporosis in later life. The patient should discuss with the health care provider before starting treatment if she has any of the following as an alternative contraceptive may be more suitable to her needs: Chronic alcohol or tobacco use; Chronic use of drugs that can reduce bone mass, e.g. epilepsy medication or steroids; Low body mass index or eating disorder, e.g. anorexia nervosa or bulimia; Previous low trauma fracture that was not caused by a fall; Strong family history of osteoporosis.
Teenagers (up to 18 years): Normally, the bones of teenagers are rapidly growing and increasing in strength. The stronger the bones are when adulthood is reached, the greater the protection against osteoporosis in later life. Since Triclofem may cause teenage bones to become thinner at a time when they should be growing, its effect may be particularly important in this age group. Bones start to recover when Triclofem is stopped, but it is not yet known whether the bone mineral density reaches the same levels as it would have if Triclofem had never been used.
The patient should therefore discuss whether another form of contraception might be more suitable for her with the person who provides the contraception before starting Triclofem.
If the patient uses Triclofem, it may help her bones if she takes regular weight-bearing exercise and has a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D (e.g. in oily fish).
Possible risk of cancer: Studies of women who have used different forms of contraception found that women who used Triclofem, for contraception had no increase in overall risk of developing cancer of the ovary, womb, cervix or liver.
Possible risk of breast cancer: Breast cancer is rare among women under 40 years of age whether or not they use hormonal contraceptives. Older women have a higher baseline risk of breast cancer and therefore the increase in the number of cases due to Triclofem is greater in older women than in younger women.
Possible risk of forming an abscess at the injection site: As with any intramuscular injection, there is a risk of an abscess forming at the site of injection. This may require medical or surgical attention.
Possible risk of weight gain: Some women gained weight while using Triclofem. Studies show that over the first 1-2 years of use, the average weight gain was 5-8 lbs. Women completing 4-6 years of therapy gained an average of 14-16.5 lbs.
Reporting of side effects: If the patient gets any side effects, the patient should talk to the health care provider. This includes unwanted effects not listed. If available, the patient can also report side effects directly through the national reporting system. By reporting side effects the patient can help provide more information on the safety of this medicine.

The patient should tell the health care provider: If she is taking, have recently taken or might take any other medicines; If she is taking a medicine called aminoglutethiamide or other medicines that thin the blood (anticoagulants).
The patient should always tell the health care provider who treats her that she is using Triclofem as a contraceptive because medicines can sometimes interact with each other.

This medicine must not be used if description of the visible signs of deterioration is noticed.
Do not throw away any medicines in wastewater or household waste. Ask the health care provider how to throw away medicines no longer used. These measures will help protect the environment.

Do not store above 30°C. Keep the glass vial in the provided carton to protect the product from light. Do not freeze. Vials must be stored upright. Avoid excursions above 30°C.

Depot Contraceptives

G03AC06 - medroxyprogesterone ; Belongs to the class of progestogens. Used as systemic contraceptives.

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