Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK
Progestogen: for contraception.
Depo-Provera is indicated for long-term female contraception. Each injection prevents ovulation and provides contraception for at least 12 weeks (+/- 5 days). However, it should be taken into consideration that the return to fertility (ovulation) may be delayed for up to one year (see section 4.4).
Depo-Provera is suitable for use in women who have been appropriately counselled concerning the likelihood of menstrual disturbance and the potential for a delay in return to full fertility.
Depo-Provera may also be used for short-term contraception in the following circumstances:
Since loss of bone mineral density (BMD) may occur in females of all ages who use Depo-Provera 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 before giving the injection of Depo-Provera.
In adolescents, Depo-Provera may be used, but only after other methods of contraception have been discussed with the patient and considered unsuitable or unacceptable.
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 before giving the injection of Depo-Provera.
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.
Post Partum: To increase assurance that the patient is not pregnant at the time of first administration, this injection should be given within 5 days post partum if not breast-feeding.
There is evidence that women prescribed Depo-Provera 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. Doctors are reminded that in the non breast-feeding, post partum 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 post partum, when the infant’s enzyme system is more fully developed. Further injections should be given at 12 week intervals.
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. (N.B. 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 89 days (12 weeks and five days) 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.
Not appropriate.
Depo-Provera is not indicated before menarche (see section 4.1 Therapeutic Indications)
Data in adolescent females (12-18 years) is available for IM administration of medroxyprogesterone acetate (MPA) (see Section 4.4 Special Warnings and Precautions for Use and section 5.1 Pharmacodynamic properties). Other than concerns about loss of BMD, the safety and effectiveness of Depo-Provera is expected to be the same for adolescents after menarche and adult females.
Depo-Provera 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 Depo-provera within 7 days of taking their last active pill)
The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown. As Depo-Provera largely undergoes hepatic elimination it may be poorly metabolised in patients with severe liver insufficiency (see section 4.3).
The effect of renal disease on the pharmacokinetics of Depo-Provera is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera is almost exclusively eliminated by hepatic metabolism.
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. 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.
The site of injection should be cleansed using standard methods prior to administration of the injection.
No positive action is required other than cessation of therapy.
Syringe: 3 years.
Vial: 5 years.
Do not store above 25°C.
Do not refrigerate or freeze.
1 ml suspension for injection in a pre-filled glass syringe with halobutyl rubber plunger stopper and halobutyl rubber tip cap, packed singly.
1 ml suspension for injection in glass vials with halobutyl rubber stopper and aluminum cap with a plastic flip off in pack sizes of 1 or 25 vials.
Not all pack sizes may be marketed.
No special requirements for disposal.
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