Medroxyprogesterone acetate subcutaneous
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Suspension for injection containing medroxyprogesterone acetate.
Drugs List
Therapeutic Indications
Uses
Contraception - injectable
Dosage
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.
Adults
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.
Children
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).
Administration
For subcutaneous injection only.
Contraindications
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
Pregnancy
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
Obesity
Prolonged immobilisation
Recent major surgery
Risk factors for cardiovascular disorder
Tobacco smoking
Atrial fibrillation
Breastfeeding
Cardiac valvulopathy
Cardiovascular disorder
Cervical cancer
Diabetes mellitus
Dyslipoproteinaemia
Epileptic disorder
History of chloasma
History of haemolytic uraemic syndrome
History of hepatic impairment
History of migraine
History of severe depression
Hyperlipidaemia
Hyperprolactinaemia
Hypertension
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
Pregnancy
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.
Lactation
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
Acne
Alopecia
Alterations in hepatic enzymes
Amenorrhoea
Anaphylactoid reaction
Anaphylaxis
Angioedema
Anorgasmia
Anxiety
Arthralgia
Asthenia
Backache
Breast pain
Breast tenderness
Changes in breast size
Chloasma
Decrease in bone mineral density
Decreased glucose tolerance
Depression
Dermatitis
Disturbances of appetite
Dizziness
Dysmenorrhoea
Dyspareunia
Ecchymosis
Embolism
Emotional disorder
Emotional lability
Fatigue
Fluid retention
Fractures
Galactorrhoea
Gastro-intestinal discomfort
Headache
Hirsutism
Hot flushes
Hypersensitivity reactions
Hypertension
Impaired fertility
Increased risk of breast cancer
Injection site reactions
Insomnia
Irritability
Jaundice
Limb pain
Lipoatrophy at injection site
Lipodystrophy
Local pain (injection site)
Menstrual disturbances
Migraine
Mood changes
Muscle cramps
Nausea
Nervousness
Oedema
Osteoporosis
Ovarian cysts
Premenstrual-like syndrome
Prolonged bleeding
Pruritus
Pulmonary embolism
Pyrexia
Rash
Reduced libido
Seizures
Somnolence
Striae
Tachycardia
Thrombophlebitis
Thrombosis
Urticaria
Uterine haemorrhage
Vaginal discharge
Vaginal dryness
Vaginitis
Varicose veins
Vertigo
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).
Overdosage
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 ).
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: www.nice.org.uk Last accessed: 11 August 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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