Medroxyprogesterone acetate subcutaneous
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Suspension for injection containing medroxyprogesterone acetate.
Contraception - injectable
Women must be made fully aware of the potential for menstrual disturbances and other side effects and the potential delay to full fertility for up to one year after treatment. Patients should be warned that the contraceptive effect of the injection cannot be immediately reversed.
104mg to be injected over 5-7 seconds during the first five days of a normal menstrual cycle. No additional contraception is necessary.
If not breastfeeding, the first injection should be given within 5 days to increase assurance that the patient is not pregnant.
If breastfeeding, delay the first injection until six weeks post partum.
Further treatments should be administered at 13 week intervals. If given no later than seven days after this time, no additional contraceptives (e.g. barrier) are required. If the interval between treatments is greater than 14 weeks, then pregnancy must be excluded before the next injection is given.
Aged 12 to 18 years
(See Dosage; Adult)
May be used, but only after other methods of contraception are discussed and deemed unsuitable.
Note that the loss of bone mineral density is of particular concern in this age group.
Additional Dosage Information
When switching from other contraception methods, medroxyprogesterone injection should be given based upon the mechanism of action of both methods in a manner that ensures continuous contraceptive coverage (e.g. patient switching from oral contraceptives should have their first injection of medroxyprogesterone within 7 days after their last active pill).
For subcutaneous injection only.
Multiple risk factors for thromboembolic disease
Predisposition to thromboembolic disease
Abnormal liver function test
Diabetes mellitus with vascular involvement
Female genital cancer
History of acute pancreatitis with hyperlipidaemia
History of breast cancer
History of cerebrovascular disorder
History of hormone dependent neoplasm
History of thromboembolic disorder
Hormone dependent neoplasm
Ischaemic heart disease
Metabolic bone disease
Severe hepatic impairment
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Children under 18 years
Disorders aggravated by fluid retention
Family history of thromboembolic disorder
Females over 35 years
Major risk factors for decreased bone mineral content
Recent major surgery
Risk factors for cardiovascular disorder
History of chloasma
History of haemolytic uraemic syndrome
History of hepatic impairment
History of migraine
History of severe depression
Inflammatory bowel disease
Non focal aura migraine
Recent trophoblastic disorder
Sickle cell disease
Systemic lupus erythematosus
May decrease glucose tolerance in patients with diabetes mellitus
Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Pre-treatment medical history and clinical examination
Administer injection slowly
Resume use only after 2wks full ambulation from surgery/immobilisation
Exclude pregnancy prior to initiation of treatment
Abnormal and/or irregular bleeding should be investigated
Evaluate treatment at least annually
Full clinical assessment should be made at 2 years in all patients
If upper abdominal complaints/liver enlargement consider liver tumour
If visual disturbances occur, perform ophthalmic evaluation
Investigate development of severe headaches or migraine
May cause prolonged and heavy bleeding during the puerperium
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with a history of depression and/or suicide attempts
May cause loss of bone mineral density
Inform pathology lab of this medicine if endometrial/cervical tissue sent
May affect results of some laboratory tests
Discontinue 4 - 6 weeks before major surgery
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of jaundice, hepatitis or whole body itching
Discontinue if depression worsens or recurs
Discontinue if epilepsy is exacerbated
Discontinue if hypertension develops
Discontinue if liver function tests become abnormal
Discontinue if persistent hypertension unresponsive to therapy occurs
Discontinue if retinal thrombosis occurs
Discontinue if sudden, severe pain in stomach occurs
Discontinue if symptoms of cerebrovascular accident occur
Discontinue if symptoms of deep vein thrombosis occur
Discontinue if symptoms of pulmonary embolism occur
Discontinue of symptoms of myocardial infarction occur
Delay in return to fertility can occur following treatment discontinuation
Advise patient concurrent St John's wort may reduce contraceptive effect
Advise patient of slight increased risk of breast cancer
Changes in menstrual bleeding patterns should be expected
Ensure patient is informed of risks of treatment
Treatment does not protect against risk of sexually transmitted disease
Women with a history of chloasma should avoid exposure to sun/UV light
The most important risk factor for breast cancer is the age women discontinue treatment; the older the age at stopping the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the 10 years after stopping injectable progestogen use such that after 10 years there appears to be no excess.
Pregnancy and Lactation
Medroxyprogesterone acetate is contraindicated in pregnancy.
The use of medroxyprogesterone acetate during pregnancy is contraindicated by the manufacturer. Available reports indicate exposure in the first trimester can result in genital abnormalities in the foetus. Another study found unintentional conception during treatment lead to low birth weights and an increase in neonatal mortality.
Use medroxyprogesterone acetate with caution during breastfeeding.
The manufacturer advises caution if medroxyprogesterone is used when breastfeeding. Small quantities of medroxyprogesterone are present in breast milk, but studies show no adverse effects to breastfed infants. Milk production and quality are not affected. Treatment is not recommended until at least 6 weeks postpartum, when the infant's enzyme system is more developed.
Abnormal cervical smear
Alterations in hepatic enzymes
Changes in breast size
Decrease in bone mineral density
Decreased glucose tolerance
Disturbances of appetite
Increased risk of breast cancer
Injection site reactions
Lipoatrophy at injection site
Local pain (injection site)
Effects on Laboratory Tests
Some endocrine, liver function tests and blood components may be affected by treatment with medroxyprogesterone acetate. The pathologist should be advised of progesterone therapy when relevant specimens are submitted.
Plasma/urinary steroids (decreased).
Plasma and urinary gonadotropin levels (decreased).
Sex-hormone-binding-globulin (SHBG) concentrations (decreased).
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2022
Summary of Product Characteristics: Sayana Press 104 mg/0.65ml suspension for injection. Pfizer Ltd. Revised March 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 August 2022
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