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MEDROXYPROGESTERONE ACETATE is a brand name for Medroxyprogesterone (also known as Medroxyprogesterone Acetate). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Progestogen indicated for the treatment of certain hormone dependant neoplasms, such as: 1. Endometrial carcinoma. 2. Renal cell carcinoma. 3. Carcinoma of breast in post menopausal women.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Endometrial and renal cell carcinoma 200 - 600 mg daily Breast carcinoma 400 - 1500 mg daily The incidence of minor side-effects, such as indigestion and weight gain, increases with the increase in dose. Response to hormonal therapy may not be evident until after at least 8-10 weeks of therapy.
Elderly patients:
This product has been used primarily in the older age group for the treatment of malignancies. There is no evidence to suggest that the older age group is any less prepared to handle the drug metabolically than is the younger patient.
Therefore, the same dosage, contra-indications, and precautions would apply to either age group.
Paediatric population:
The product is not anticipated for paediatric use in the indications recommended. Method of administration For Oral use.
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from 1337 patients who received MPA in 4 pivotal studies that evaluated efficacy and safety of MPA for oncology indications. The following lists of adverse reactions are listed within the organ system classes, under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
System Organ Class Very Common ≥1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Rare ≥ 1/10,000 to < 1/1000 Very Rare < 1/10,000 Frequency Not Known (cannot be estimated from available data) Neoplasms benign, malignant and unspecified Meningioma Immune system disorders Angioedema Drug hypersensitivity Anaphylactic reaction, Anaphylactoid reaction Endocrine disorders Corticoid-like effects Prolonged anovulation Metabolism and nutritional disorders Weight fluctuation, Increased appetite Diabetes mellitus exacerbated, Hypercalcaemia Psychiatric disorders Insomnia Depression, Euphoria, Changes in libido Nervousness Confusion Nervous system disorders Headache, Dizziness, Tremors Cerebral infarction, Somnolence Loss of concentration, Adrenergic-like effects Eye disorders Retinal embolism and thrombosis, Cataract diabetic, Visual impairment Cardiac disorders Cardiac failure congestive Myocardial infarction Tachycardia, Palpitations Vascular disorders Thrombophlebitis Embolism and thrombosis Respiratory, thoracic and mediastinal disorders Pulmonary embolism Gastrointestinal disorders Vomiting, Constipation, Nausea, Diarrhoea, Dry mouth Hepatobiliary disorders Jaundice Skin and subcutaneous tissue disorders Hyperhidrosis Acne, Hirsutism Alopecia, Rash Urticaria, Pruritus Musculoskeletal and connective tissue disorders Muscle spasms Renal and urinary system disorders Glycosuria Reproductive system and breast disorders Erectile dysfunction Dysfunctional uterine bleeding (irregular, increase, decrease, spotting), Breast pain Amenorrhoea, Uterine cervical erosions, Cervical discharge, Galactorrhoea General disorders and administration site conditions Oedema /fluid retention, Fatigue Malaise, Pyrexia Investigations Glucose tolerance decreased, Blood pressure increased Liver function test abnormal, White blood cell count increased, Platelet count increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Warnings:
In the treatment of carcinoma of breast occasional cases of hypercalcaemia have been reported. Unexpected vaginal bleeding during therapy with medroxyprogesterone acetate should be investigated. Medication should not be readministered pending examination if there is sudden, partial or complete loss of vision or if there is a sudden, onset of proptosis, diplopia or migraine.
If examination reveals papilloedema or retinal vascular lesions, medication should not be readministered. Medroxyprogesterone acetate may produce Cushingoid symptoms. Some patients receiving medroxyprogesterone acetate may exhibit suppressed adrenal function.
Medroxyprogesterone acetate may decrease ACTH and hydrocortisone blood levels. Treatment with medroxyprogesterone acetate should be discontinued in the event of: • jaundice or deterioration in liver function • significant increase in blood pressure • new onset of migraine-type headache Meningioma Cases of meningioma (single and multiple) have been reported in patients treated with medroxyprogesterone acetate for a prolonged time (several years).
If a patient is diagnosed with meningioma, the need for further treatment with medroxyprogesterone acetate should be carefully considered on a case-by-case basis taking into account individual benefits and risks. In some cases, shrinkage of meningioma was observed after treatment discontinuation of depot medroxyprogesterone acetate.
Caution is advised when recommending medroxyprogesterone acetate to patients with a history of meningioma.
Precautions:
Animal studies show that medroxyprogesterone acetate possesses adrenocorticoid activity. This has also been reported in man, therefore, patients receiving large doses continuously and for long periods should be observed closely for signs normally associated with adrenocorticoid therapy, such as hypertension, sodium retention, oedema, etc.
g. angina, myocardial infarction) • suspected or early breast carcinoma Progestogens are known to be porphyrogenic. Patients with a history of attacks or aged under 30 are at greatest risk of an acute attack while on progesterone treatment.
A careful assessment of potential benefit should be made where this risk is present.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Medroxyprogesterone in United Kingdom.
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It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Care is needed in treating patients with diabetes and/or arterial hypertension. Before using medroxyprogesterone acetate, the general medical condition of the patient should be carefully evaluated. This product should be used under the supervision of a specialist and the patient kept under regular surveillance.
Patients with the following conditions should be carefully monitored while taking progestogens: • Conditions which may be influenced by potential fluid retention o Epilepsy o Migraine o Asthma o Cardiac dysfunction o Renal dysfunction • History of mental depression • Diabetes (a decrease in glucose tolerance has been observed in some patients).
• Hyperlipidaemia The pathologist (laboratory) should be informed of the patient’s use of medroxyprogesterone acetate if endometrial or endocervical tissue is submitted for examination. g. g. LH and FSH) • Sex-hormone-binding-globulin The use of medroxyprogesterone acetate in oncology indications may also cause partial adrenal insufficiency (decrease in pituitary-adrenal axis response) during Metyrapone testing.
Thus, the ability of adrenal cortex to respond to ACTH should be demonstrated before metyrapone is administered. Although medroxyprogesterone acetate has not been causally associated with the induction of thromboembolic disorders, any patient with a history or who develops this kind of event while undergoing therapy with medroxyprogesterone acetate should have her status and need for treatment carefully assessed before continuing therapy.
Risk of venous thromboembolism (VTE) The risk of VTE has not been assessed for progesterone alone. However, VTE is a known risk factor of oestrogen-only and combined hormone replacement therapy. When prescribing medroxyprogesterone acetate for oncology indications the following precautions and risk factors should be considered in the light of the patient’s condition, the dose of medroxyprogesterone acetate and the duration of therapy: • Generally recognised risk factors for VTE include a personal or family history of VTE or known thromboembolic states, severe obesity (BMI > 30 kg/m2) and systemic lupus erythematosus • The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.
• If VTE develops after initiating therapy, medroxyprogesterone acetate should be discontinued. g. painful swelling of a leg, sudden pain in the chest, dyspnoea). 278 mg sodium benzoate (see section 2). Benzoates may increase unconjugated bilirubin levels by displacing bilirubin from albumin, which may increase neonatal jaundice.
Neonatal hyperbilirubinaemia may lead to kernicterus (non-conjugated bilirubin deposits in the brain tissue) and encephalopathy. However, this medicinal product is not indicated for use in children and this warning is only included for completeness.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.