Amena

As menopausal therapy in the treatment of menopausal vasomotor symptoms & prevention of postmenopausal osteoporosis.

2.5 mg daily. Commence treatment at least 12 mth after last menstrual bleed or may commence immediately in case of surgical menopause.

May be taken with or without food.

Hypersensitivity. Known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumors eg, endometrial cancer; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous idiopathic or recurrent VTE (DVT, pulmonary embolism); any history of arterial thromboembolic disease eg, angina, MI, stroke, or transient ischemic attack; acute or a history of liver disease; porphyria. Pregnancy & lactation.

Leiomyoma (uterine fibroids) or endometriosis; a history of, or risk factors for, thromboembolic disorders; risk factors for estrogen dependent tumors (eg, 1st degree heredity for breast cancer); HTN; liver disorders (eg, liver adenoma); DM w/ or w/o vascular involvement; cholelithiasis; migraine or (severe) headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Discontinue treatment in cases of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache; VTE develops after initiation of therapy. Increased risk of endometrial or breast cancer w/ increasing duration of use. Patients w/ history of VTE or known thrombophilic states; already on anticoagulant treatment. Temporarily stop HRT for 4-6 wk earlier in instances where prolonged immobilization is likely to follow elective surgery, particularly abdominal or orthopedic surgery to the lower limbs. CAD. Increased risk of ischemic stroke during the 1st yr of treatment & strongly age-dependent. Increased risk of ovarian cancer in hysterectomized women. Closely monitor women w/ pre-existing hypertriglyceridemia during estrogen therapy or HRT. Patients w/ cardiac or renal dysfunction. Probable dementia. Not recommended use in infants & childn.

Abdominal pain (upper & lower), GI upset, cholestatic jaundice, gall bladder disease; abnormal hair growth, acne, rash, pruritus, seborrheic dermatitis, itching, facial hypertrichosis, chloasma, erythema multiforme, erythema nodosum, vascular purpura; vag discharge, leucorrhea, vag hemorrhage/bleeding, candidiasis & mycosis, endometrial wall thickening/hyperplasia, postmenopausal hemorrhage, breast tenderness, genital pruritus, pelvic pain, cervical dysplasia, genital discharge, vulvovaginitis, breast discomfort, fungal infection, nipple pain; endometrial cancer, breast cancer; wt increase, abnormal cervical smear, changes in liver function parameters; dizziness, headache, migraine, depression, probable dementia; VTE (ie, deep leg or pelvic venous thrombosis & pulmonary embolism), MI, stroke/ischemic stroke; arthralgia, myalgia; visual disturbances, (including blurred vision), edema, thromboembolism.

May enhance the blood fibrinolytic activity of anticoagulants eg, warfarin. May affect to moderate extent the pharmacokinetics of midazolam (CYP450 3A4 substrate). Enhanced metabolism & reduced activity w/ compd that induce liver enzymes (eg, phenytoin, carbamazepine & rifampicin).

Oestrogens, Progesterones & Related Synthetic Drugs

G03CX01 - tibolone ; Belongs to the class of other estrogens. Used in the treatment of menopausal symptoms.

Rx