Clomifene


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Anovulatory infertility
Adult: 50 mg once daily for 5 days, starting on or around the 5th day of menstrual cycle if progestin-induced bleeding is planned or spontaneous uterine bleeding occurs before therapy, or at any time if there is no uterine bleeding. If ovulation does not occur after the 1st course, may give 100 mg once daily for 5 days, starting as early as 30 days after the previous course. Further treatment is not recommended if ovulation does not occur after 3 therapy courses or if pregnancy has not occurred within 3 ovulatory cycles. Long-term cyclic therapy (>6 cycles) is not recommended.
Suy gan
Contraindicated.
Cách dùng
May be taken with or without food.
Chống chỉ định
Abnormal uterine bleeding of unknown origin, uncontrolled thyroid or adrenal impairment, presence of an organic intracranial lesion (e.g. pituitary tumour), hormone-dependent tumours, ovarian cysts or enlargement not due to PCOS. Active liver disease or history of hepatic impairment. Pregnancy.
Thận trọng
Patient with uterine fibroids, PCOS, pre-existing or family history of hyperlipidaemia. Lactation.
Tác dụng không mong muốn
Significant: Ovarian hyperstimulation syndrome (OHSS), ovarian enlargement and cyst formation (high doses or prolonged treatment), visual disturbances (e.g. blurred vision, scintillating scotomata, phosphenes), multiple or ectopic pregnancy, new-onset or exacerbation of endometriosis; hypertriglyceridaemia, hypersensitivity reactions (including anaphylaxis and angioedema). Rarely, ovarian cancer.
Cardiac disorders: Tachycardia, palpitations.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, abdominal symptoms or pelvic discomfort (e.g. distention, bloating, pain), pancreatitis.
General disorders and administration site conditions: Fatigue.
Investigations: Increased transaminases.
Nervous system disorders: Headache, dizziness, lightheadedness, paraesthesia, convulsions.
Psychiatric disorders: Nervousness, insomnia, depression, anxiety, mood disturbances.
Renal and urinary disorders: Increased urinary frequency or volume.
Reproductive system and breast disorders: Menorrhagia, breast discomfort, abnormal uterine haemorrhage.
Skin and subcutaneous tissue disorders: Rash, urticaria, dermatitis. Very rarely, alopecia.
Vascular disorders: Vasomotor flushes.
Thông tin tư vấn bệnh nhân
This drug may cause dizziness, lightheadedness or visual disturbances, if affected, do not drive or operate machinery.
Chỉ số theo dõi
Prior to therapy, obtain serum estrogen and triglycerides level; rule out primary pituitary or ovarian failure, endometriosis or endometrial carcinoma, adrenal and thyroid disorders, hyperprolactinaemia, and male factor infertility. Monitor ovulation by obtaining urinary LH, serum estradiol, and progesterone, and/or performing ultrasound. Perform pelvic exam and pregnancy test prior to each cycle of therapy. Assess for signs and symptoms of OHSS (e.g. severe abdominal pain or bloating, vomiting, diarrhoea, excessive weight gain, dyspnoea, or changes in urination).
Quá liều
Symptoms: Nausea, vomiting, vasomotor flushes, blurred vision, scotomata, ovarian enlargement with pelvic or abdominal pain. Management: Symptomatic and supportive treatment. Perform gastrointestinal decontamination.
Tác dụng
Description:
Mechanism of Action: Clomifene is a nonsteroidal compound with both estrogenic and anti-estrogenic effects. Its exact mechanism of action in inducing ovulation has not been determined; however, it appears to stimulate the release of pituitary gonadotropic hormones probably by inhibiting the negative feedback effect of estrogens at the receptor sites in the hypothalamus and pituitary.
Synonym: clomiphene.
Onset: 5-10 days after a course of treatment.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 6 hours.
Metabolism: Metabolised in the liver; undergoes enterohepatic recirculation.
Excretion: Mainly via faeces (42%); urine (8%). Elimination half-life: Approx 5 days.
Đặc tính

Chemical Structure Image
Clomifene

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 1548955, Zuclomiphene. https://pubchem.ncbi.nlm.nih.gov/compound/Zuclomiphene. Accessed Apr. 28, 2023.

Bảo quản
Store between 15-30°C. Protect from heat, light, and moisture.
Phân loại MIMS
Hormon dinh dưỡng & các thuốc tổng hợp có liên quan
Phân loại ATC
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
Tài liệu tham khảo
Anon. Clomifene [Clomiphene]. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/03/2023.

Anon. Clomiphene. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 24/03/2023.

Buckingham R (ed). Clomifene Citrate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/03/2023.

Clomid 50 mg Tablets (Aventis Pharma Limited Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 26/04/2023.

Clomid Tablet (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 24/03/2023.

Clomifene 50 mg Tablets (Wockhardt UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 24/03/2023.

Joint Formulary Committee. Clomifene Citrate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/03/2023.

Ova-mit Tablet 50 mg (Eucogen Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 26/04/2023.

YSP Clomiphene Tablet 50 mg (Y.S.P. Industries [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/03/2023.

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