Depo-Provera (1x1ml)

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Each pre-filled syringe contains 1 ml of suspension containing 150 mg medroxyprogesterone acetate.

Excipients with known effect:

• Methyl parahydroxybenzoate (E218) – 1.35 mg
• Propyl parahydroxybenzoate (E216) – 0.15 mg
• Sodium chloride – 3.38 mg/ml

As a progestogen, for parenteral administration: Contraception
Depo-Provera is indicated for contraception.

Depo-Provera may also be used for short-term contraception in the following circumstances:

1. For partners of men undergoing vasectomy, for protection until the vasectomy becomes effective.
2. In women who are being immunised against rubella, to prevent pregnancy during the period of activity of the virus.
3. In women awaiting sterilisation.

Since loss of bone mineral density (BMD) may occur in females of all ages who use DMPA injection long-term (see section 4.4), a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered.

It is of the greatest importance that adequate explanations of the long-term nature of the product, of its possible side-effects and of the impossibility of immediately reversing the effects of each injection are given to potential users and that every effort is made to ensure that each patient receives such counselling as to enable her to fully understand these explanations. Patient information leaflets are supplied by the manufacturer. It is recommended that the doctor uses these leaflets to aid counselling of the patient.
Consistent with good clinical contraceptive practice a general medical as well as gynaecological examination should be undertaken before administration of Depo-Provera and at yearly intervals thereafter.

All potential users of Depo-Provera should have a negative pregnancy test before first administration.
Because of the risk of heavy or prolonged bleeding in some women, the drug should be used with caution in the puerperium.
The recommended dose is 150 mg of DMPA injectable suspension every 3 months (12-13 weeks) administered by intramuscular injection in the gluteal or deltoid muscle. The gluteal muscle is the optimal site, however the deltoid muscle may be used if sufficiently well developed. The initial injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days postpartum if not breast-feeding; or, if exclusively breast-feeding, at or after 6 weeks postpartum.
For second and subsequent injections, if the time interval between IM injections is greater than 13 weeks, pregnancy should be ruled out before administering the next IM injection.
As with other hormonal contraceptives, regular consideration should be given to whether the previous treatment has resulted in: first-time migraine or unusually severe headaches, visual disturbances, reappearance of depression, pathological changes in liver function tests.

Paediatric population
DMPA IM is not indicated before menarche.
Data regarding the effects of DMPA on BMD in adolescent females (12-18 years) is available. Other than concerns about loss of BMD, the safety and effectiveness of DMPA IM are expected to be the same for post-menarcheal adolescent and adult females.

Switching from other Methods of Contraception
When switching from other contraceptive methods, (DMPA IM or SC) should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g. patients switching from oral contraceptives should have their first injection of DMPA within 7 days after taking their last active pill).

Hepatic Insufficiency
No clinical studies have evaluated the effect of hepatic disease on the pharmacokinetics of DMPA. However, MPA is almost exclusively eliminated by hepatic metabolism and steroid hormones may be poorly metabolized in patients with severe liver insufficiency.

Renal Insufficiency
No clinical studies have evaluated the effect of renal disease on the pharmacokinetics of DMPA. However, since MPA is almost exclusively eliminated by hepatic metabolism, no dosage adjustment should be necessary in women with renal insufficiency.

Method of administration
The sterile aqueous suspension of Depo-Provera should be vigorously shaken just before use to ensure that the dose being given represents a uniform suspension of Depo-Provera.
Doses should be given by deep intramuscular injection into the gluteal or deltoid muscle. The gluteal muscle is the optimal site if sufficiently well developed.