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Medroxyprogesterone acetate subcutaneous


Suspension for injection containing medroxyprogesterone acetate.

Drugs List

  • medroxyprogesterone 104mg/0.65ml injection
  • SAYANA PRESS 104mg/0.65ml injection
  • Therapeutic Indications


    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.


    First injection
    104mg to be injected over 5-7 seconds during the first five days of a normal menstrual cycle. No additional contraception is necessary.

    Post partum
    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 doses
    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
    Acute pancreatitis
    Acute porphyria
    Breast cancer
    Cerebral ischaemia
    Cerebrovascular disorder
    Diabetes mellitus with vascular involvement
    Endometrial hyperplasia
    Female genital cancer
    Focal migraine
    Hepatic neoplasm
    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 dyslipoproteinaemia
    Severe hepatic impairment
    Severe hypertension
    Thromboembolic disorder
    Undiagnosed gynaecological haemorrhage
    Venous thromboembolism

    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
    Prolonged immobilisation
    Recent major surgery
    Risk factors for cardiovascular disorder
    Tobacco smoking
    Atrial fibrillation
    Cardiac valvulopathy
    Cardiovascular disorder
    Cervical cancer
    Diabetes mellitus
    Epileptic disorder
    History of chloasma
    History of haemolytic uraemic syndrome
    History of hepatic impairment
    History of migraine
    History of severe depression
    Inflammatory bowel disease
    Malignant neoplasm
    Non focal aura migraine
    Recent trophoblastic disorder
    Rheumatoid arthritis
    Severe depression
    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
    Contains hydroxybenzoate
    Contains polysorbate
    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.

    Side Effects

    "Spotting" bleeding
    Abdominal distension
    Abdominal pain
    Abnormal cervical smear
    Alterations in hepatic enzymes
    Anaphylactoid reaction
    Breast pain
    Breast tenderness
    Changes in breast size
    Decrease in bone mineral density
    Decreased glucose tolerance
    Disturbances of appetite
    Emotional disorder
    Emotional lability
    Fluid retention
    Gastro-intestinal discomfort
    Hot flushes
    Hypersensitivity reactions
    Impaired fertility
    Increased risk of breast cancer
    Injection site reactions
    Limb pain
    Lipoatrophy at injection site
    Local pain (injection site)
    Menstrual disturbances
    Mood changes
    Muscle cramps
    Ovarian cysts
    Premenstrual-like syndrome
    Prolonged bleeding
    Pulmonary embolism
    Reduced libido
    Uterine haemorrhage
    Vaginal discharge
    Vaginal dryness
    Varicose veins
    Weight changes

    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2022

    Reference Sources

    Summary of Product Characteristics: Sayana Press 104 mg/0.65ml suspension for injection. Pfizer Ltd. Revised March 2020.

    NICE Evidence Services Available at: Last accessed: 11 August 2022

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