Sumatriptan

Registered South African indications:

• Migraine  
• Cluster headache (inj)

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients
• Severe hepatic impairment
• Ischaemic heart disease
• Uncontrolled hypertension
• Coronary vasospasm/Prinzmetal's angina
• Peripheral vascular disease 
• History of cerebrovascular accident or transient ischaemic attack
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use
• Coadministration of ergotamine or derivatives of ergotamine
• Coadministration of serotonin (5-HT1) agonists

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Hypersensitivity to sulphonamides
• Cardiovascular risk factors
• Hypertension
• History of seizures
• Excessive use
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab, nas, inj

Migraine

• Oral (tab): 50mg; Repeat dose after 2hrs if needed; Max single dose: 100mg/single dose; Max: 300mg/24hrs
• SC: 4-6mg; Repeat dose after 1hr if needed; Max: 12mg/24hrs
• Nasal (nas): 20mg; Repeat dose after 2hrs if needed; Max: 40mg/24hrs

Cluster headache

• SC: 6mg; Repeat dose after 1hr if needed; Max: 12mg/24hrs

Not to be used prophylactically

Tablet: Do not cut/crush/chew/dissolve

Injection: DO NOT admin via IV route

Not established for use in children below 18 years

Pregnancy 

• Caution
• Post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, they do not point to an increased risk of congenital defects. Experience with the use of sumatriptan in the second and third trimester is limited
• Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development. However, embryo-foetal viability might be affected in the rabbit. Administration of sumatriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus

Breastfeeding 

• Caution; not recommended
• It has been demonstrated that following subcutaneous administration sumatriptan is excreted into breast milk. Infant exposure can be minimised by avoiding breastfeeding for 12 hours after the treatment during which time any breast milk expressed should be discarded

Renal Impairment 

• Caution; no dose adjustment recommended

Hepatic Impairment 

• Mild to moderate: Caution; dose adjustment recommended
  Dosage should not exceed 50mg daily
• Severe: Contraindicated

Elderly 

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Drowsiness
• Sensory disturbances
• Seizures
• Tremor
• Dystonia
• Nystagmus
• Weakness
• Anxiety

Cardiovascular Disorders

• Transient increases in blood pressure
• Flushing
• Bradycardia
• Tachycardia
• Palpitations
• Cardiac arrhythmias
• Transient ischaemic ECG changes
• Coronary artery vasospasm
• Angina
• Myocardial infarction
• Hypertension
• Raynaud's phenomenon

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Ischaemic colitis
• Diarrhoea

Hepatobiliary Disorders

• Minor disturbances in hepatic function tests

Musculoskeletal Disorders

• Neck stiffness
• Arthralgia
• Sensations of heaviness
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis

Immune System Disorders

• Hypersensitivity reactions 

Sensory Disorders

• Flickering
• Diplopia
• Reduced vision
• Scotoma

Others

• Sensations of heat or cold
• Pressure or tightness in the chest

• Serotonin agonists
• Ergotamine or ergotamine derivatives
• Selective serotonin reuptake inhibitors
• Serotonin noradrenaline reuptake inhibitors
• Monoamine oxidase inhibitors
• St. John's wort

None routine. Specific cases may require

• Vital signs
• ECG

Pharmacokinetics

• Elimination half-life: approximately 2 hours.

Crushing/Open

• Tablet: Do not cut/crush/chew/dissolve.

Risk of Serotonin syndrome

• Post-marketing reports describe patients with serotonin syndrome following the use of sumatriptan and selective serotonin reuptake inhibitors
• Serotonin syndrome has also been reported following concomitant treatment with sumatriptan and serotonin-norepinephrine reuptake inhibitors

Sumatriptan acts on serotonin receptors of intracranial blood vessels and sensory nerves of the trigeminal system resulting in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Tablet 50mg

• Accord Sumatriptan (Accord)
• Imigran 50 (GSK) originator
• Migrex OTC (Sandoz SA)
• Migrex 50 (Sandoz SA)
• Triptam (Pharmacare)

Tablet 100mg 

• Accord Sumatriptan (Accord)
• Imigen (Mylan)
• Imigran 100 (GSK) originator
• Migrex 100 (Sandoz SA)
• Triptam (Pharmacare)

Injection (per 0.5ml) 6mg

• Imigran injection (GSK) originator

Nasal spray (per spray) 20mg

• Imigran 20mg nasal spray (GSK) originator