Cyproheptadine oral formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation containing cyproheptadine hydrochloride
Drugs List
Therapeutic Indications
Uses
Allergic reaction
Pruritus
Relief of migraine and other vascular headaches
Dosage
Adults
Treatment of allergy and pruritus:
Initially 4 mg three times a day. Then adjusted according to patient's weight and response. The effect of a single dose usually lasts for four to six hours.
Therapeutic range 4 mg to 20 mg daily, most patients requiring 12 mg to 16 mg a day. Dosage must be determined on an individual basis.
Maximum dose 32 mg a day.
For treatment of vascular headache and migraine:
For prophylactic and therapeutic use
An initial dose of 4 mg, repeated if necessary after half an hour. Patients who respond usually obtain relief with 8 mg, and this dose should not be exceeded within a 4 to 6 hour period.
Maintenance
4 mg every four to six hours.
Elderly
Not recommended for elderly, debilitated patients.
Elderly patients are more likely to experience dizziness, sedation and hypotension.
Children
Treatment of allergy and pruritus:
Children aged 7 to 14 years
Usually 4 mg two or three times a day, according to the patient's weight and response. If an additional dose is required, it should be given at bedtime. Maximum 16mg a day.
Children aged 2 to 7 years
Initially 2 mg two or three times a day, adjusted according to the patient's weight and response. If an additional dose is required, it should be given at bedtime. Maximum 12mg a day.
Adolescents
Adolescents aged 14 to 18 years
(see dosage; Adults)
Contraindications
Children under 2 years
Debilitation
Elderly
Within 2 weeks of discontinuing MAOIs
Acute asthma
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Galactosaemia
Glaucoma
Porphyria
Pyloroduodenal obstruction
Stenosing peptic ulcer
Urinary retention
Precautions and Warnings
Predisposition to narrow angle glaucoma
Cardiovascular disorder
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
Hypertension
Hyperthyroidism
Lactose intolerance
Pregnancy
Advise impaired alertness may affect ability to drive or operate machinery
Contains lactose
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Patient should avoid alcohol as effect may be potentiated
Pregnancy and Lactation
Pregnancy
Use cyproheptadine with caution in pregnancy
The animal reproduction data and limited human pregnancy experience suggest that cyproheptadine is low risk for structural anomalies. Although reporting bias is evident, preterm birth occurred in three women exposed to the drug during pregnancy. Because preterm birth has been associated with other serotonin antagonists (e.g.,selective serotonin reuptake inhibitors), there might be a causal association with cyproheptadine.
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
Cyproheptadine is contraindicated in breastfeeding.
Unless it is intentionally being used to lower maternal serum prolactin levels, cyproheptadine may interfere with lactation and should be avoided during that period, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. The nonsedating antihistamines are preferred alternatives. Because of the increased sensitivity of newborns to antihistamines and the potential for adverse reactions, the manufacturer considers cyproheptadine to be contraindicated in nursing mothers.
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
Acute labyrinthitis
Agranulocytosis
Anaphylaxis
Anorexia
Behavioural disturbances
Blood dyscrasias
Blurred vision
Cholestasis
Confusion
Constipation
Convulsions
Diarrhoea
Difficulty in micturition
Diplopia
Dizziness
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Epigastric distress
Epistaxis
Euphoria
Excitation
Extrasystoles
Faintness
Fatigue
Feeling of tightness in chest
Haemolytic anaemia
Hallucinations
Headache
Hepatic failure
Hepatic impairment
Hepatitis
Hypotension
Hysteria
Impaired co-ordination
Increased appetite
Insomnia
Irritability
Jaundice
Leucopenia
Menstrual disturbances
Nasal stuffiness
Nausea
Nervousness
Neuritis
Oedema
Palpitations
Paraesthesia
Photosensitivity
Rash
Restlessness
Rigors
Sedation
Sleepiness
Sweating
Tachycardia
Thickening of bronchial secretions
Thrombocytopenia
Tinnitus
Tremor
Urinary retention
Urticaria
Vertigo
Vomiting
Weight gain
Wheezing
Effects on Laboratory Tests
Cyproheptadine may cause a false positive test result for tricyclic antidepressant drugs (TCA) when evaluating a drug screen (e.g. urine serum).
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2015
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 11 February 2015.
Summary of Product Characteristics: Periactin, Merck Sharp & Dohme Ltd, Revised 02/02/2011.
The Drug Database for Acute Porphyria available at https://www.drugs-porphyria.com/languages/UnitedKingdom/index.php?l=gbr
Last accessed: 11 February 2015.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Cyproheptadine. Last revised: 16 January 2014
Last accessed:11 February 2015.
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