Medroxyprogesterone acetate intramuscular
- 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
Parenteral progestogen-only contraceptive.
Medroxyprogesterone acetate injection is long term contraceptive suitable for use in women who have been made fully aware of the potential for menstrual disturbance and the potential delay to full fertility after treatment.
It may be used for short term contraception for:
Partners of men undergoing vasectomy until the vasectomy becomes effective
After vaccination against rubella (to prevent pregnancy during the period that the virus is active)
Women awaiting sterilisation
Dosage
Adults
First injection
Intramuscular injection
150mg to be injected during the first five days of a normal menstrual cycle. No additional contraception is necessary.
Post partum
If not breast feeding, the first injection should be given within 5 days to increase assurance that the patient is not pregnant. However, women given medroxyprogesterone acetate immediately after delivery or termination may experience prolonged or heavy bleeding.
If breast feeding, delay the first injection until six weeks post partum when the infant's enzyme system is better developed. If intercourse has already occurred, exclude pregnancy before treatment.
Further doses
Intramuscular injection
These should be given at 12 week intervals as required for long term contraception.
Subsequent doses should be no later than 12 weeks and 5 days (89 days) after the last injection. If the interval is greater, pregnancy should be excluded before the next injection and additional contraceptive measures (e.g. barrier methods) used for 14 days after this subsequent injection.
Partners of men undergoing vasectomy may require a second injection of 150mg intramuscularly after 12 weeks if the partner's sperm count has not fallen to zero.
Adolescents
Aged 12 to 18 years
May be used, but only after other methods of contraception are discussed and deemed unsuitable.
Additional Dosage Information
Switching from other methods of contraception
When switching from other contraception methods, medroxyprogesterone injection should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g. patient switching from oral contraceptives should have their first injection of medroxyprogesterone within 7 days after their last active pill).
Administration
The 150mg/ml injection is to be given by deep intramuscular injection.
Care should be taken to ensure that the injection is administered into muscle tissue. The gluteus maximus is the preferred administration site, although other muscle tissue such as the deltoid may also be injected.
The sterile aqueous suspension should be vigorously shaken just before use to ensure uniform dispersion.
Contraindications
Breast cancer
Female genital cancer
History of severe hepatic disorder
Hormone dependent neoplasm
Porphyria
Pregnancy
Severe hepatic disorder
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Children under 18 years
Major risk factors for decreased bone mineral content
Severe headache
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Disorder of lipid metabolism
Hepatic disorder
History of acute visual disturbances
History of endogenous depression
History of migraine
Recent trophoblastic disorder
Thromboembolic disorder
May decrease glucose tolerance in patients with diabetes mellitus
Assess family medical history prior to commencing treatment
Ensure adequate vitamin D and calcium supplementation
Exclude breast cancer before treatment
Pre-treatment medical history and clinical examination
Exclude pregnancy prior to initiation of treatment
Abnormal and/or irregular bleeding should be investigated
Full clinical assessment should be made at 2 years in all patients
If visual disturbances occur, perform ophthalmic evaluation
Investigate development of severe headaches or migraine
May cause prolonged and heavy bleeding during the puerperium
Monitor patients with a history of depression and/or suicide attempts
Advise patient to report any new or worsening depression/suicidal ideation
May cause loss of bone mineral density
May cause weight gain
May affect results of some laboratory tests
Discontinue if cerebrovascular disorders occur
Discontinue if pulmonary embolism occurs
Discontinue if retinal thrombosis occurs
Advise patient of slight increased risk of breast cancer
Changes in menstrual bleeding patterns should be expected
Treatment does not protect against risk of sexually transmitted disease
If abnormal bleeding persists or is severe, rule out the possibility of organic pathology. Excessive bleeding can be controlled by the co-administration of oestrogen either in the form of a low dose (30 micrograms oestrogen) combined contraceptive pill or oestrogen replacement therapy such as conjugated equine oestrogen (0.625 to 1.25mg daily). Oestrogen therapy may need to be repeated for 1 to 2 cycles. Long term oestrogen therapy is not recommended.
The most important risk factor for breast cancer is the age women discontinue the injectable progestogen; 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.
The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits of injectable progestogen.
Perform a general medical and gynaecological examination before therapy and at appropriate intervals thereafter.
Women must be made fully aware of the potential for menstrual disturbances and other side effects and the potential delay to full fertility after treatment. Patients should be warned that the contraceptive effect of the injection cannot be immediately reversed.
The CSM has advised that:
in adolescents, medroxyprogesterone acetate be used only when other methods of contraception are inappropriate,
in all women, the benefits of using medroxyprogesterone acetate beyond 2 years should be evaluated against the risks,
in women with risk factors for osteoporosis an alternative method of contraception instead of medroxyprogesterone acetate should be considered.
Pregnancy and Lactation
Pregnancy
Medroxyprogesterone acetate is contraindicated during pregnancy.
The manufacturer recommends that pregnancy should be excluded before the initial injection and if the administration of any subsequent injection is delayed beyond the manufacturers recommended period.
Accidental pregnancy occurring 1 to 2 months after medroxyprogesterone injection are associated with an increased risk of low birth weight and a subsequent increased risk of neonatal death.
Children exposed in utero showed no adverse effects on their health, including physical, intellectual, sexual or social development.
Use with caution immediately after childbirth or termination. Following administration of medroxyprogesterone in the immediate puerperium, prolonged and heavy bleeding may occur.
Lactation
Use Medroxyprogesterone acetate with caution during breastfeeding.
The manufacturer states that medroxyprogesterone acetates and/or its metabolites are secreted in breast milk but there is no evidence to suggest that this presents any hazard to the infant. Infants exposed to medroxyprogesterone via breast milk have shown no adverse effects on their development or behaviour.
If given to breast feeding women, it is recommended that the first injection is not administered until the infant is 6 weeks old.
Counselling
Advise patient to report signs of mood changes and depressive symptoms.
Advise patient treatment may cause weight gain.
Advise patient that treatment does not protect against sexually transmitted disease.
Women must be made fully aware of the potential for menstrual disturbances and other side effects and the potential delay to full fertility after treatment. Patients should be warned that the contraceptive effect of the injection cannot be immediately reversed.
Full counselling necessary (supported by the manufacturer's approved literature) to warn patients of likelihood of menstrual disturbance and the potential delay in return to full fertility (normally within 12-18 months).
The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits of injectable progestogen.
Side Effects
"Spotting" bleeding
Abdominal distension
Abdominal pain
Abscess formation (injection site)
Acne
Alopecia
Alterations in hepatic enzymes
Amenorrhoea
Anaemia
Anaphylactoid reaction
Anaphylaxis
Angioedema
Anorgasmia
Anxiety
Arthralgia
Asthenia
Axillary swelling
Backache
Bloating
Blood dyscrasias
Breast nodules (benign)
Breast pain
Changes in breast size
Chest pain
Chloasma
Convulsions
Decrease in bone mineral density
Decreased glucose tolerance
Deep vein thrombosis (DVT)
Depression
Dermatitis
Disturbances of appetite
Dizziness
Dysmenorrhoea
Dyspareunia
Dyspnoea
Ecchymosis
Emotional lability
Endometrial hyperplasia
Facial palsy
Fatigue
Fluid retention
Fractures
Galactorrhoea
Gastro-intestinal disturbances
Genitourinary infections
Headache
Hirsutism
Hoarseness
Hot flushes
Hypersensitivity reactions
Hypertension
Impaired fertility
Increased risk of breast cancer
Insomnia
Irritability
Jaundice
Leg cramps
Leucorrhoea
Limb pain
Local pain (injection site)
Melasma
Menstrual disturbances
Migraine
Mood changes
Muscle cramps
Nausea
Nervousness
Nipple discomfort
Oedema
Osteoporosis
Ovarian cysts
Paraesthesia
Paralysis
Pelvic pain
Premenstrual-like syndrome
Prolonged bleeding
Pruritus
Pulmonary embolism
Pyrexia
Rash
Rectal bleeding
Reduced libido
Scleroderma
Sensation of pregnancy
Somnolence
Striae
Suppression of lactation post-partum
Syncope
Tachycardia
Thirst
Thrombophlebitis
Urticaria
Vaginal cysts
Vaginal discharge
Vaginal dryness
Vaginitis
Varicose veins
Vertigo
Weight changes
Effects on Laboratory Tests
The following laboratory tests may be affected by the use of medroxyprogesterone acetate:
Gonadotrophin levels (decreased)
Plasma progesterone levels (decreased)
Urinary pregnanediol levels (decreased)
Plasma oestrogen levels (decreased)
Plasma cortisol levels (decreased)
Glucose tolerance test
Metyrapone test
Liver function tests (may increase)
Thyroid function tests (protein bound iodine levels may increase and T3 uptake levels may decrease)
Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX and X may increase.
Physicians should be aware that pathologists should be informed of the patient's use of medroxyprogesterone if endometrial or endocervical tissue is submitted for examination.
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: November 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Depo-Provera 150mg/ml Injection sterile suspension for injection. Pfizer Ltd. Revised March 2020.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Medroxyprogesterone Acetate Last revised: 31 October 2018
Last accessed: 09 November 2020
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last accessed: 09 November 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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