Hydroxyprogesterone caproate

Known, suspected, or history of breast cancer or other hormone-sensitive cancer; undiagnosed abnormal vaginal bleeding not related to pregnancy; current or history of thrombosis or thromboembolic disorders; uncontrolled hypertension. Hepatic impairment, including liver tumours (benign or malignant), active liver disease, or cholestatic jaundice of pregnancy.

Women with pre-diabetes or diabetes, history of clinical depression; risk factors for VTE (e.g. personal or family history, obesity, prolonged immobilisation, major trauma or surgery); existing or history of arterial and CV disease (e.g. MI, CVA, ischaemic heart disease); conditions that may be exacerbated by fluid retention (e.g. asthma, migraine, epilepsy, preeclampsia). Women who develop hypertension or jaundice during treatment. Treatment recommendations may vary among individual products or between countries (refer to detailed product guideline). Renal impairment. Pregnancy. For use in reduction of preterm birth risk: Not intended for use in women with multiple gestations or other risk factors for premature birth, or to stop active premature labour. Discontinue use at 37 weeks of gestation or upon delivery. Monitoring Parameters Perform physical and gynaecological exam and take complete medical history before treatment initiation. Monitor blood pressure; blood glucose (in patients with pre-diabetes or diabetes). When used for primary or secondary amenorrhoea: Verify pregnancy status and screen patient for the presence of prolactin-producing pituitary tumour prior to starting therapy; perform breast and pelvic examination, and Papanicolau smear before treatment. Assess for signs or symptoms of fluid retention, jaundice, thromboembolic disorders, or depression.

Significant: Arterial thrombosis, DVT, thromboembolic events, retinal vascular thrombosis; hypersensitivity reactions (e.g. urticaria, pruritus, angioedema); certain degree of fluid retention, reduced glucose tolerance; recurrence of depression (in patients with history of clinical depression); chloasma (particularly in patients with history of chloasma gravidarum). Rarely, benign or malignant liver tumours. Gastrointestinal disorders: Nausea, diarrhoea. General disorders and administration site conditions: Inj site reactions (e.g. pain, swelling, redness, pruritus, nodules). Pregnancy, puerperium and perinatal conditions: Admission for preterm labour (other than delivery admission), preeclampsia or gestational hypertension, gestational diabetes, oligohydramnios. Skin and subcutaneous tissue disorders: Pruritus, urticaria.

May enhance clearance and lead to decreased therapeutic efficacy when given with enzyme inducers (e.g. carbamazepine, rifampicin, barbiturates, phenytoin). May interfere with the metabolism of ciclosporin, particularly tissue and plasma concentrations.

Oestrogens & Progesterones & Related Synthetic Drugs