Clomifene citrate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing clomifene
Drugs List
Therapeutic Indications
Uses
Infertility - female - anovulatory
Dosage
Adults
The recommended dose for the first course of treatment is 50 mg once daily for 5 days, starting within 5 days of onset of spontaneous or induced menstrual bleeding. Treatment may begin at any time in women who have had no recent menstrual bleeding. If ovulation occurs at this dosage, there is no advantage to increasing the dose in future treatment cycles.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg as a single daily dose for 5 days should be given. This course may be started as early as 30 days after the previous one. An increase in the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.
If ovulation occurs but is not followed by pregnancy, subsequent courses at the same dosage may be given up to a maximum of 3 cycles. Long term therapy past 6 cycles is not recommended.
The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended for patients who do not show evidence of ovulation.
Contraindications
Children under 18 years
Galactosaemia
Hepatic disorder
History of hepatic impairment
Hormone dependent neoplasm
Non-polycystic ovarian cyst
Pregnancy
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Predisposition to thrombophlebitis
Breastfeeding
Depression
Glucose-galactose malabsorption syndrome
History of seizures
Hyperlipidaemia
Lactose intolerance
Polycystic ovarian syndrome
Thrombophlebitis
Uterine fibroids
Reduce subsequent dosage +/or duration if history of ovarian enlargement
Advise ability to drive/operate machinery may be affected by side effects
Consider monitoring at risk patients for hypertriglyceridaemia
Contains lactose
Examine patients complaining of abdominal/pelvic pain for ovarian cysts
If pregnancy occurs possibility of ectopic pregnancy should be considered
If visual disturbances occur, perform ophthalmic evaluation
Monitor closely patient with depression
Advise patient to report any abdominal or pelvic pain
May increase baseline risk of ovarian carcinoma
Ovarian hyperstimulation syndrome can occur
Pregnancy: Increased risk of multiple pregnancies
Uterine fibroids may increase in size
Discontinue if any kind of visual disturbance occurs
Withhold therapy in ovarian enlargement until return to pre-treatment size
Use beyond 6 cycles is not recommended
Ovarian hyperstimulation syndrome (OHSS) has been reported in patients receiving clomifene citrate treatment when used either cyclically or in combination with gonadotrophins. If pregnancy occurs, a progression towards the more severe form of ovarian hyperstimulation syndrome can occur.
In ovarian enlargement, withhold treatment until the ovaries return to pre-treatment size. Ovarian enlargement and cyst formation associated with clomifene therapy usually regress spontaneously within a few days or weeks after discontinuing treatment. Dosage and/or duration of the next course of treatment should be reduced.
Pregnancy and Lactation
Pregnancy
Clomifene is contraindicated in pregnancy.
Although there is no evidence of harmful effects on the human foetus, animal studies have shown a deleterious effect on the foetus when high doses have been given to the mother.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use clomifene with caution in breastfeeding.
It is not known if clomifene citrate is excreted in breast milk.
Clomifene can stop established milk production when used up to 4 days postpartum. Its effectiveness in stopping established lactation months after breastfeeding commences is believed to be minimal.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal discomfort
Abdominal distension
Acute abdomen
Acute respiratory distress
Allergic reaction
Anasarca
Angioneurotic oedema
Biliary stasis
Bloating
Blurred vision
Breast discomfort
Breast tenderness
Cataracts
Cerebral thrombosis
Cerebrovascular accident
Convulsions
Cyclic ovarian pain
Deep vein thrombosis (DVT)
Depression
Dermatitis
Disorientation
Dizziness
Ecchymosis
Endometriosis
Endometriosis (aggravation of)
Erythema multiforme
Fainting
Fatigue
Flushing
Hair loss
Hair thinning
Headache
Hydrothorax
Increase in bromsulphalein retention
Increased risk of ectopic pregnancy
Increased size of uterine fibroids
Insomnia
Intermenstrual spotting
Jaundice
Light-headedness
Menorrhagia
Multiple pregnancy
Nausea
Neoplasms
Nervous tension
Neurological effects
Optic neuritis
Ovarian cancer
Ovarian cysts
Ovarian enlargement
Ovarian haemorrhage
Ovarian hyperstimulation syndrome (OHSS)
Paranoia
Pericardial effusion
Phosphenes
Prolonged luteal phase of cycle
Psychotic reactions
Pulmonary oedema
Rash
Reduced visual acuity
Renal failure
Scintillating scotoma
Scotomata
Speech disturbances
Syncope
Torsion of the ovary
Urticaria
Vertigo
Visual disturbances
Vomiting
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet (https://www.toxbase.org/).
Further Information
Last Full Review Date: April 2014
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on March 31, 2014].
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Clomid 50mg tablets. Sanofi. Revised November 2013.
Summary of Product Characteristics: Clomifene 50mg Tablets. Wockhardt UK Ltd. Revised January 2012.
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