Progesterone

Should be taken on an empty stomach (i.e. At least one hour before food or two hours after food).

Hypersensitivity to progesterone, soybean lecithin, peanut, palm oil, or sesame seed/oil. Undiagnosed vaginal bleeding, known or suspected malignancy of the breast or genital organs, missed abortion or ectopic pregnancy, active or history of thrombophlebitis or thromboembolic disorders, porphyria. Severe hepatic impairment. Pregnancy (oral cap).

Patient with diseases that may be exacerbated by fluid retention (e.g. cardiac impairment, asthma, migraine, epilepsy), diabetes, hypercholesterolaemia, hypertension, SLE, personal or family history of venous thromboembolism, history of depression. Patients undergoing surgery; obese, smokers, >35 years. Abrupt withdrawal. Renal and mild to moderate hepatic impairment. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness and/or dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure; serum triglycerides (2 weeks after starting therapy in patients with baseline level >200 mg/dL) and TSH (6-12 months after starting oral therapy in patients taking thyroid replacement) during therapy. Perform age-appropriate breast and pelvic exams during therapy. Assess baseline risk for breast cancer and CV disease prior to combination hormonal therapy for menopause women. Monitor unscheduled bleeding lasting >6 months for endometrial pathology (sooner in patients with a history of endometrial cancer; obese or diabetic). Assess efficacy beginning 1-3 months after starting therapy, then every 6-12 months as needed. Evaluate the duration of treatment at least annually.

Significant: Increased risk of invasive breast cancer, endometriosis, transient dizziness and drowsiness, eosinophilic pneumonia (particularly in inj preparations containing sesame oil), fluid retention, retinal vascular thrombosis, increase risk of probable dementia (in women ≥65 years), toxic shock syndrome (vaginal preparations); increase risk of DVT, pulmonary embolism, stroke, MI; decrease glucose tolerance. Rarely, increase the risk of ovarian cancer. Cardiac disorders: Chest pain (oral). Gastrointestinal disorders: Abdominal pain, bloating, nausea, vomiting, diarrhoea, constipation, cramps, abdominal distention. General disorders and administration site conditions: Irritability, fatigue, pyrexia; injection site pain, irritation, swelling, redness, haematoma, or induration. Hepatobiliary disorders: Cholestatic jaundice (oral/inj). Infections and infestations: Viral infection; UTI (vaginal insert). Metabolism and nutrition disorders: Weight changes, peripheral oedema. Musculoskeletal and connective tissue disorders: Musculoskeletal pain. Nervous system disorders: Headache, nervousness. Psychiatric disorders: Depression, anxiety, insomnia. Renal and urinary disorders: Urinary problems. Reproductive system and breast disorders: Breast tenderness, breast hypertrophy, mastalgia, vaginal discharge, decreased libido, irregular menstruation, amenorrhea; perineal pain, dyspareunia, genital candidiasis (vaginal gel); uterine spasm (vaginal insert/tab); vaginal haemorrhage, vulvovaginal dryness, vaginal burning sensation, vulvovaginal discomfort (vaginal insert/cap); breakthrough bleeding, spotting, change in menstrual flow, galactorrhoea not associated with childbirth (inj). Respiratory, thoracic and mediastinal disorders: Cough (oral). Skin and subcutaneous tissue disorders: Rash, urticaria, melasma, alopecia; genital pruritus (vaginal gel/vaginal tab/inj); acne vulgaris, hirsutism (inj). Vascular disorders: Hot flush.

Decreased bioavailability with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, griseofulvin, spironolactone). Increased bioavailability with CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). May inhibit ciclosporin metabolism leading to increase plasma ciclosporin concentrations and risk of toxicity. May diminish the therapeutic effect of antidiabetic agents. May diminish the therapeutic effect with other vaginal products (e.g. antifungal agents).

Oestrogens & Progesterones & Related Synthetic Drugs

G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.