Medroxyprogesterone Acetate

Registered South African indications

• Endometriosis
• Contraception
• Endometrial cancer

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Porphyria
• Hormone-dependent malignancy of breast or genital organs
• Severe hepatic disease in patients whose hepatic function tests have not returned to normal
• Abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital tract malignancy eliminated

Cautions

• Mild to moderate hepatic impairment
• Loss of bone mineral density
• Osteoporosis and risk factors thereof
• Menstrual irregularity
• Delay in return to full fertility 
• Risk factors for breast cancer
• Anaphylaxis
• Thrombo-embolic disorders
• Depression 
• Migraine or unusually severe headaches
• Visual disturbances
• Coronary vascular disease
• Diabetes mellitus
• Trophoblastic disease
• Women older than 65 years

Forms avail. in SA and covered in this monograph: inj

Endometriosis

• IM: 100mg, every 2 weeks; Treatment duration: 3-6 months

Contraception

• IM: 150mg, every 12 weeks

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Initiate within the first 5 days of the menstrual cycle (1st day of menstruation = 1st day of cycle)

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See additional prescribing points

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Endometrial cancer - adjunctive and/or palliative therapy in inoperable, recurrent or metastatic endometrial carcinoma

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Consult specialist for dosages and regimens

Not indicated for use in premenarchal children

Pregnancy

• Contraindicated
• Patients should be checked if they are not pregnant before initial injection with medroxyprogesterone acetate, and also if administration of any subsequent injection is delayed beyond 89 days (12 weeks and five days)
• Infants from accidental pregnancies that occur 1-2 months after injection of medroxyprogesterone acetate may be at an increased risk of low birth weight, which in turn is associated with an increased risk of neonatal death. The attributable risk is low because such pregnancies are uncommon.  Children exposed to medroxyprogesterone acetate in utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development

Breastfeeding

• Caution
• Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk, but there is no evidence to suggest that this presents any hazard to the child. Infants exposed to medroxyprogesterone acetate via breast milk have been studied for developmental and behavioural effects to puberty. No adverse effects have been noted

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Mild to moderate: Caution; no information available
• Severe: Contraindicated 

Elderly

• Not indicated for use in geriatric patients

Porphyria Information

• Probably porphyrinogenic (PRP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Nervousness
• Depression
• Libido decreased
• Insomnia
• Anorgasmia
• Emotional disturbance
• Affective disorder
• Irritability
• Anxiety
• Headache
• Dizziness
• Seizure
• Somnolence
• Paraesthesia
• Migraine
• Paralysis
• Syncope
• VIIth nerve paralysis
• Fatigue

Cardiovascular Disorders

• Tachycardia
• Hot flush
• Embolism
• Thrombosis
• Thrombophlebitis
• Hypertension
• Varicose veins
• Odema
• Chest pain

Respiratory Disorders

• Dyspnoea
• Pulmonary embolism

Gastrointestinal Disorders

• Abdominal pain
• Nausea
• Abdominal distension
• Rectal haemorrhage

Hepatobiliary Disorders

• Hepatic impairment
• Jaundice

Genitourinary Disorders

• Vaginal discharge
• Breast tenderness
• Dysmenorrhea
• Genitourinary tract infection
• Dysfunctional uterine bleeding
• Galactorrhoea 
• Pelvic pain
• Dyspareunia
• Suppressed lactation
• Vaginitis
• Amenorrhoea
• Breast pain
• Metrorrhagia
• Menometrorrhagia
• Menorrhagia
• Vulvovaginal dryness
• Breast atrophy
• Ovarian cyst
• Premenstrual syndrome
• Endometrial hyperplasia
• Breast mass
• Nipple exudate bloody
• Vaginal cyst
• Breast enlargement
• Lack of return to fertility
• Sensation of pregnancy
• Breast cancer
• Fluid retention

Endocrine and Metabolic Disorders

• Increased appetite 
• Decreased appetite
• Decreased glucose tolerance
• Abnormal cervical smear

Musculoskeletal Disorders

• Back pain
• Pain in extremity
• Arthralgia 
• Muscle spasms
• Osteoporosis
• Osteoporotic fractures
• Decreased bone density

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Acne
• Rash
• Hirsutism
• Urticaria
• Pruritus
• Chloasma
• Lipodystrophy 
• Dermatitis
• Ecchymosis
• Scleroderma
• Skin striae
• Injection site reaction
• Injection site persistent atrophy/indentation/dimpling
• Injection site nodule/lump
• Injection site pain/tenderness

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Blood disorder
• Drug hypersensitivity
• Anaphylactic reaction
• Angioedema
• Pyrexia

Sensory Disorder

• Vertigo
• Dysphonia

Others

• Axillary swelling
• Thirst

• Aminoglutethimide 
• Oral anticoagulants
• CYP3A4 inhibitors
• CYP3A4 inducers  

None routine. Specific cases may require

• Hepatic function
• Mental status
• Ophthalmic examination
• Blood glucose levels
• Lipid profile

Initiating in special circumstances

• Postpartum (not breastfeeding): Initiate within 5 days of delivery if not breastfeeding
• Postpartum (breastfeeding): Initiate at or after the 6th week postpartum

Missed dose

• If repeat injection is delayed by more than 5 days beyond the date that it was due, additional barrier contraceptive methods will be required for 14 days and pregnancy must be excluded before injection given

Medroxyprogesterone acetate inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and causes thickening of cervical mucus which inhibits sperm entry into the uterus.

Injection (per ml) 150mg

• Depo-Provera (Pfizer) originator
• Petogen Fresenius (Bodene)