PROVERA 5MG TABLET

Indications

• Endometrial hyperplasia
• Menstrual irregularities
• Secondary amenorrhea
• Endometriosis
• Hormonal contraception
• Palliative treatment of endometrial carcinoma

Dosage

Children: Refer to the BNF for Children for appropriate dosing information in the paediatric population.

Adults: Refer to the BNF for specific dosing guidelines based on the indication and route of administration.

Mechanism of action

Medroxyprogesterone exerts its effects primarily through binding to progesterone receptors, leading to the modulation of gene expression and subsequent physiological outcomes. This action results in the inhibition of ovulation, alteration of the menstrual cycle, and changes in the endometrial lining, making it suitable for various therapeutic applications.

Pharmacodynamics

The pharmacodynamic properties of medroxyprogesterone include its ability to promote secretory changes in the endometrium, thus preparing it for potential implantation of an embryo. Additionally, it influences the cervical mucus, making it thicker and less permeable to sperm. The drug also has anti-estrogenic effects, which can be beneficial in treating estrogen-dependent conditions.

Pharmacokinetics

Medroxyprogesterone is well-absorbed following oral administration. It has a half-life of approximately 24 hours, although its effects can last longer due to its action on the endometrium. The drug is extensively metabolized in the liver, primarily by the cytochrome P450 system, and is excreted mainly in urine. The pharmacokinetics can vary based on the route of administration, with intramuscular injections providing a longer duration of action compared to oral formulations.

Contra-indications

• Known hypersensitivity to medroxyprogesterone or any component of the formulation
• Undiagnosed vaginal bleeding
• Current or past history of thromboembolic disorders
• Severe liver disease
• Known or suspected breast cancer
• Pregnancy

Adverse effects

• Weight gain
• Headaches
• Depression
• Breast tenderness
• Menstrual irregularities
• Nausea
• Fatigue
• Acne
• Decreased libido
• Thromboembolic events

Interactions

• Antiepileptic drugs (e.g., phenytoin, carbamazepine) which may reduce the effectiveness of medroxyprogesterone
• Rifampicin and other rifamycins which can affect metabolism
• St. John's Wort may reduce plasma concentrations of medroxyprogesterone

Precautions

• Monitor for signs of thromboembolic events, especially in patients with risk factors
• Assess blood pressure regularly during treatment
• Consider the risk of osteoporosis with long-term use
• Use with caution in patients with history of depression or mental illness
• Regular gynecological examinations are recommended

Pregnancy

Medroxyprogesterone is contraindicated in pregnancy and should not be used during this time due to potential harm to the fetus.

Breast-feeding

Medroxyprogesterone is excreted in breast milk, and although it is generally considered safe, caution is advised and monitoring of the infant is recommended.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

• Oral tablets
• Injectable formulations
• Intravaginal preparations