Use only if there is a clear diagnosis of migraine; exclude other potentially serious neurological conditions. Monitor BP closely. May impair ability to drive or operate machinery. Pregnancy and lactation. Child. Moderate to severe hepatic impairment. Prior CV evaluation for patients with risk factors of coronary heart disease; admin of first dose under close supervision and ECG if satisfactory CV assessment in these patients. Periodic CV evaluation for patients with risk factors of coronary arteries on zolmitriptan. Avoid oral disintegrating formulation for patients with phenylketouria. Long term use may cause accumulation of zolmitriptan in melanin rich tissue (e.g. eye).
Lactation: unknown, use caution
Indication
Acute migraine attacks
Contra Indication
Patients at risk of coronary artery disease (post-menopausal women, men >40 yr, hypertension, hypercholesterolemia, smoking, obesity, DM, family history of coronary artery disease) unless evaluated. Wolff-Parkinson-White syndrome; arrhythmias associated with accessory cardiac conduction pathways; previous cerebrovascular accident; uncontrolled or severe hypertension; ischaemic heart disease, history of MI, coronary vasospasm, transient ischaemic attack. Basilar or hemiplegic migraine.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Zolmitriptan is a selective agonist for serotonin (5HT1 receptors). It relieves migraine by selective constriction of intracranial blood vessels, neuropeptide release inhibition and decreased transmission in the trigeminal pain pathway.
Interaction
Increased risk of serotonin syndrome with SSRI, selective serotonin- and norepinephrine-reuptake inhibitors (SNRI). Increased zolmitriptan concentrations with cimetidine, quinolone antibacterials and drugs that inhibit the cytochrome P450 isoenzyme CYP1A2.
Potentially Fatal: Increased risk of fatal serotonin syndrome with sibutramine. Increased risk of serotonin syndrome with MAOI and reversible inhibitors of monoamine oxidase type-A (RIMA); do not use zolmitriptan during and for 2 wk after the use of MAOI and RIMAs Do not use within 24 hr of treatment with another 5-HT1 agonist. Increased risk of additive vasoconstriction with ergot alkaloids; zolmitriptan should not be taken within 24 hr of any ergotamine or ergot-type medication.
Pregnancy Category Note
Pregnancy
There are no adequate data on the developmental risk associated with the use in pregnant women; in reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures
Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy
Lactation
There are no data on presence of drug or metabolites in human milk, effects on the breastfed infant, or on milk production; in rats, oral dosing with zolmitriptan resulted in levels in milk up to 4 times that in maternal plasma
Developmental and health benefits of breastfeeding should be considered along with mother?s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Adult Dose
Oral
Acute migraine attacks
Adult: Initially, 2.5 mg. A 2nd dose may be taken at least 2 hr after the 1st dose if symptoms recur within 24 hr. Max dose: 10 mg in 24 hr. Safety of treating > three headaches in a 30-day period has not been established.
Hepatic impairment: Dose reduction may be needed with BP monitoring. Moderate to severe: Max dose: 5 mg/24 hr
Child Dose
N/A
Renal Dose
After orally dosing zolmitriptan, renal clearance was Reduced by 25% in patients with severe renal impairment (Clcr ?5 ?25mL/min) compared to the normal group (Clcr ?70 mL/min);
No significant change in renal clearance was observed in the moderately renally impaired group (Clcr ?26 ?50 mL/min).
Administration
May be taken with or without food.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.