Contraindications
Primary ovarian failure, tumours of the pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin, malformation of sexual organs or fibroid uterine tumours incompatible with pregnancy; ovarian cysts or enlargement not due to polycystic ovarian syndrome; ovarian, uterine, or mammary carcinoma. Pregnancy and lactation.
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Special Precautions
Women with recognised risk factors for thromboembolic events (e.g. personal or family history of thrombosis, severe obesity with BMI >30 kg/m2, thrombophilia). Renal and hepatic impairment. Monitoring Parameters Evaluate patient for infertility, hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, and pituitary or hypothalamic tumours before treatment initiation. Monitor sufficient follicular growth and maturation estimated directly by transvaginal sonography of the ovaries and endometrial lining and measurement of estradiol levels. Monitor for signs and symptoms of OHSS (for at least 2 weeks after hCG administration) and thromboembolism.
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Adverse Reactions
Significant: Ovarian enlargement, ovarian hyperstimulation syndrome (OHSS), ovarian and other reproductive system neoplasms (benign and malignant), ovarian torsion; multiple pregnancy, spontaneous miscarriage, ectopic pregnancy, congenital malformations; serious pulmonary effects (e.g. atelectasis, acute respiratory distress syndrome, asthma exacerbation), thromboembolic events, hypersensitivity and anaphylactic reactions.
Endocrine disorders: Hyperthyroidism.
Gastrointestinal disorders: Abdominal pain or distension, nausea, dyspepsia, constipation.
General disorders and administration site conditions: Pain, fatigue. Rarely, inj site reactions (e.g. pain, redness, haematoma).
Investigations: Prolonged bleeding time.
Nervous system disorders: Headache, lethargy, dizziness.
Psychiatric disorders: Mood swings.
Renal and urinary disorders: Cystitis.
Reproductive system and breast disorders: Breast enlargement or pain.
Respiratory, thoracic and mediastinal disorders: Epistaxis, dyspnoea.
Skin and subcutaneous tissue disorders: Erythema, pruritus.
Vascular disorders: Hot flushes.
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Drug Interactions
May enhance the follicular response when given concomitantly with clomifene citrate.
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CIMS Class
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ATC Classification
G03GA04 - urofollitropin ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
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