Zolmitriptan

Registered South African indications:

• Migraine

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients 
• Uncontrolled hypertension
• Ischaemic heart disease
• Coronary vasospasm/Prinzmetal's angina
• History of cerebrovascular accident or transient ischaemic attack
• Coadministration with ergotamine or ergotamine derivatives
• Coadministration with other serotonin receptor agonists

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Moderate to severe hepatic impairment
• Elderly
• Symptomatic Wolff-Parkinson-White syndrome
• Arrhythmias associated with cardiac accessory conduction pathways
• Cardiovascular risk factors
• Hypertension
• Excessive use
• Phenylketonuria (dispersible tab)
• Galactose intolerance (tab)
• Lapp lactase deficiency (tab)
• Glucose-galactose (tab)

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

Migraine

• Oral (tab, dsp): 2.5mg; Repeat after 2hrs if needed; Max single dose: 5mg; Max: 10mg/24hrs

Not recommended for use > 7 days

Not to be used prophylactically

See additional prescribing points for administration directions

Not established for use in children below 18 years

Pregnancy

• Caution
• Zolmitriptan should be used in pregnancy only if the benefits to the mother justify the potential risk to the foetus. There are no studies in pregnant women, but there is no evidence of teratogenicity in animal studies

Breastfeeding

• Caution; not recommended
• Studies have shown that zolmitriptan passes into the milk of lactating animals. No data exist for passage of zolmitriptan into human breast milk. Therefore, caution should be exercised when administering zolmitriptan to women who are breastfeeding

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended

Hepatic Impairment

• Mild: No dose adjustment recommended
• Moderate to severe: Caution; dose adjustment recommended
  Initial: 1.25mg; Max: 5mg/24hrs

Elderly

• Caution; no dose adjustment recommended
  Initiate at the lower end of the dosage range

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Disturbances of sensation
• Dizziness
• Headache
• Hyperaesthesia
• Paraesthesia
• Somnolence
• Warm sensation
• Fatigue

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Angina pectoris
• Coronary vasospasm
• Myocardial infarction
• Transient increases in systemic blood pressure

Gastrointestinal Disorders

• Abdominal pain
• Dry mouth
• Nausea and vomiting
• Vomiting
• Dysphagia
• Bloody diarrhoea
• Gastrointestinal infarction or necrosis
• Ischaemic colitis
• Splenic infarction

Genitourinary Disorders

• Polyuria
• Increased urinary frequency
• Urinary urgency

Musculoskeletal Disorders

• Muscle weakness
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Urticaria

Immune System Disorders

• Anaphylaxis
• Anaphylactoid reactions
• Hypersensitivity reactions

Others

• Heaviness or tightness in the chest
• Pain or pressure in throat, neck, limbs or chest

• Ergotamine or ergotamine derivatives
• CYP1A2 inhibitors
• Serotonin receptor agonists
• Selective serotonin reuptake inhibitors
• Serotonin noradrenaline reuptake inhibitors
• Monoamine oxidase inhibitors
• St. John's wort

None routine. Specific cases may require

• Vital signs
• ECG

Administration directions

• Tablet: Do not cut/crush/chew/dissolve
• Orodispersable tablets:Place tablet on the tongue. Blister pack should be peeled open (tablets should not be pushed through the foil)

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

Tablet 2.5mg

• Zomig (AstraZeneca) originator
• Zolmifor ODT (LeBasi Pharmaceutical)

Tablet dispersible 2.5mg

• Zomig rapimelt (AstraZeneca) originator