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Medroxyprogesterone acetate high strength oral

Presentation

Tablets containing high strength medroxyprogesterone acetate

Drugs List

  • medroxyprogesterone 100mg tablets
  • medroxyprogesterone 200mg tablets
  • medroxyprogesterone 400mg tablets
  • PROVERA 100mg tablets
  • PROVERA 200mg tablets
  • PROVERA 400mg tablets
  • Therapeutic Indications

    Uses

    Carcinoma - endometrium
    Control of breast carcinoma in post-menopausal women
    Renal cell carcinoma

    Dosage

    Whilst the doses stated below are those recommended by the manufacturers, local cancer network protocols for the relevant indication should be consulted.

    Adults

    Breast carcinoma:
    400 to 1500 mg daily is recommended.

    Response to hormonal therapy may not be evident until at least 8 to 10 weeks of therapy.

    Endometrial and Renal cell carcinoma:
    200 to 600 mg daily

    Response to hormonal therapy may not be evident until at least 8 to 10 weeks of therapy.

    Elderly

    Breast carcinoma:
    400 to 1500 mg daily is recommended.

    Response to hormonal therapy may not be evident until at least 8 to 10 weeks of therapy.

    Endometrial and Renal cell carcinoma:
    200 to 600 mg daily

    Response to hormonal therapy may not be evident until at least 8 to 10 weeks of therapy.

    Contraindications

    Children under 18 years
    Hepatic impairment
    History of thromboembolic disorder
    Hypercalcaemia
    Metrorrhagia
    Missed abortion
    Pregnancy
    Severe arterial disorder
    Thromboembolic disorder
    Thrombophlebitis
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Disorders aggravated by fluid retention
    Family history of venous thromboembolism
    Major surgery
    Predisposition to venous thromboembolism
    Severe obesity
    Asthma
    Breastfeeding
    Cardiac impairment
    Diabetes mellitus
    Epileptic disorder
    History of depression
    Hyperlipidaemia
    Hypertension
    Migraine
    Porphyria
    Renal impairment
    Systemic lupus erythematosus

    May decrease glucose tolerance in patients with diabetes mellitus
    Treatment to be prescribed under the supervision of a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Investigate if abnormal vaginal bleeding, pain or discharge occurs
    May cause adrenal suppression
    Monitor patients with a history of treatment of mental depression
    Advise patient to contact a doctor if symptoms of thromboembolism develop
    Investigate occurrence of visual disturbance or severe headache
    Discontinue at first signs of jaundice
    Discontinue if first occurrence or worsening of migraine/severe headache
    Discontinue if first occurrence or worsening of visual disturbances
    Discontinue if hepatic function deteriorates
    Discontinue if significant rise in blood pressure occurs
    Discontinue if thromboembolism occurs
    Not licensed for use in children under 18 years
    Female: Ensure adequate contraception during treatment

    Since medroxyprogesterone acetate appears to enhance blood clotting potential, treatment should be discontinued upon the appearance of thromboembolic episodes. Patients who are at risk of developing venous thromboembolism (e.g. patients with a family history of venous thromboembolism, severe obesity or patients with systemic lupus erythematosus) should be treated with caution. Patients should be told to contact their doctor immediately if they become aware of symptoms suggestive of thromboembolism.

    Any patient who develops an acute impairment of vision such as sudden or partial or total loss of vision, diplopia, vascular lesions of the retina or migraine headache should be carefully evaluated ophthalmologically to exclude the presence of papilloedema or retinal vascular lesions before continuing.

    Medroxyprogesterone acetate, as one of the progestogens, is known to be porphyrinogenic. The use of medroxyprogesterone acetate should be carefully assessed for benefit and risk in patients with porphyria.

    Pregnancy and Lactation

    Pregnancy

    Medroxyprogesterone acetate is contraindicated during pregnancy.

    There is insufficient experience in human pregnancies exposed to high dose medroxyprogesterone acetate to be sure of the risk to the foetus. However, pregnancies exposed to contraceptive doses have shown some structural defects in genitalia and cardiovascular systems, and foetal growth retardation has also been reported.

    Nevertheless, accidental administration of medroxyprogesterone acetate during pregnancy is not a reason for termination of the pregnancy (Schaefer). Ultrasound examination may be performed to monitor the normal development of the foetus.

    Animal studies carried out on mice, rats and rabbits have shown dose-related teratogenicity and toxicity.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use medroxyprogesterone acetate with caution in breastfeeding.

    Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk.

    Based on information available from the administration of intramuscular Medroxyprogesterone acetate for contraception in breastfeeding mothers, it is not known to present any hazard to the child (Briggs).

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Acne
    Alopecia
    Amenorrhoea
    Anaphylactoid reaction
    Anaphylaxis
    Angioedema
    Angioneurotic oedema
    Breast tenderness
    Cerebral infarct
    Cervical erosion
    Changes in cervical secretion
    Changes in libido
    Confusion
    Congestive cardiac failure
    Constipation
    Cushingoid changes
    Decreased glucose tolerance
    Depression
    Diabetic cataract
    Diarrhoea
    Disturbances of appetite
    Dizziness
    Dry mouth
    Euphoria
    Exacerbation of diabetes
    Fatigue
    Fine tremor (usually hands)
    Galactorrhoea
    Glycosuria
    Headache
    Hirsutism
    Hypercalcaemia
    Hyperpyrexia
    Hypersensitivity reactions
    Hypertension
    Impaired concentration
    Increased platelet count
    Indigestion
    Insomnia
    Jaundice
    Leg cramps
    Liver function disturbances
    Malaise
    Mastodynia
    Moon face
    Myocardial infarction
    Nausea
    Nervousness
    Oedema
    Palpitations
    Prolonged anovulation
    Pruritus
    Pulmonary embolism
    Rash
    Retinal vascular thrombosis
    Somnolence
    Sweating
    Tachycardia
    Thromboembolic disorders
    Thrombophlebitis
    Tremor
    Urticaria
    Vaginal bleeding
    Visual disturbances
    Vomiting
    Weight gain
    White blood cell count raised

    Effects on Laboratory Tests

    Medroxyprogesterone acetate can decrease the levels of the following endocrine biomarkers:

    - Plasma/urinary steroids (e.g. cortisol, oestrogen, pregnanediol, progesterone, testosterone)
    - Plasma/urinary gonadotrophins (e.g. LH, FSH)
    - Sex hormone binding globulin

    If a histological examination of endometrial or endocervical tissue is indicated, the laboratory should be informed that the patient has been receiving a progestogen.

    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: September 2014

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on 22 September, 2014].

    Summary of Product Characteristics: Provera tablets 100mg. Pfizer Limited. Revised September 2012.
    Summary of Product Characteristics: Provera tablets 200mg. Pfizer Limited. Revised September 2012.
    Summary of Product Characteristics: Provera tablets 400mg. Pfizer Limited. Revised September 2012.

    UK Drugs in Lactation Advisory Service.
    Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
    Last accessed: 15 May, 2014

    The Norwegian Porphyria Centre (NAPOS).
    Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
    Last revised: 30 July, 2010
    Last accessed: 22 September, 2014

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