Triclofem Dosage/Direction for Use

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.