zolmitriptan (Rx)

Brand and Other Names:Zomig, Zomig Rapimelt, more...Zomig-ZMT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2.5mg (scored)
  • 5mg

oral disintegrating tablet

  • 2.5mg
  • 5mg

intranasal spray

  • 2.5mg/single-use device
  • 5mg/single-use device

Migraine

Indicated for acute treatment of migraine with or without aura

2.5 mg PO/intranasally, initially, at onset of migraine

Dosing considerations

  • May increase dose to 5 mg; not to exceed 5 mg per single dose; individual response varies
  • May repeat dose if migraine has not resolved after 2 hr; not to exceed 10 mg/24 hr
  • Safety not established for tablets in the treatment of >3 migraines/30 days or >4 migraines/30 days for the intranasal formulation

Dosage Modifications

Coadministration with cimetidine: Limit zolmitriptan to 2.5 mg/dose and 5 mg/day

Renal impairment

  • No dosage adjustment provided by manufacturer labeling; clearance is reduced in patients with severe renal impairment (CrCl 5-25 mL/min)

Hepatic impairment

  • Tablet
    • Mild: No dosage adjustment provided by manufacturer labeling
    • Moderate to severe: 1.25 mg; not to exceed 5 mg/day in severe impairment
  • Disintegrating tablet, oral
    • Mild: No dosage adjustment provided by manufacturer labeling
    • Moderate to severe: Not recommended
  • Nasal inhalation
    • Mild: No dosage adjustment provided by manufacturer labeling
    • Moderate to severe: Not recommended

Dosage Forms & Strengths

Intranasal spray

  • 2.5mg/single-use device
  • 5mg/single-use device

Migraine

Nasal spray dosage form indicated for acute treatment of migraine with or without aura in pediatric patients aged ≥12 yr

<12 years

  • Safety and efficacy not established

≥12 years

  • 2.5 mg PO/intranasally, initially, at onset of migraine

Dosing considerations

  • May increase dose to 5 mg; not to exceed 5 mg per single dose; individual response varies
  • May repeat dose if migraine has not resolved after 2 hr; not to exceed 10 mg/24 hr
  • Safety not established for tablets in the treatment of >3 migraines/30 days or >4 migraines/30 days for the intranasal formulation

Dosage Modifications

Coadministration with cimetidine: Limit zolmitriptan to 2.5 mg/dose and 5 mg/day

Renal impairment

  • No dosage adjustment provided by manufacturer labeling; clearance is reduced in patients with severe renal impairment (CrCl 5-25 mL/min)

Hepatic impairment

  • Tablet
    • Mild: No dosage adjustment provided by manufacturer labeling
    • Moderate to severe: 1.25 mg; not to exceed 5 mg/day in severe impairment
  • Disintegrating tablet, oral
    • Mild: No dosage adjustment provided by manufacturer labeling
    • Moderate to severe: Not recommended
  • Nasal inhalation
    • Mild: No dosage adjustment provided by manufacturer labeling
    • Moderate to severe: Not recommended
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Interactions

Interaction Checker

and zolmitriptan

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Dizziness (6-10%)

            Neck/throat/jaw pain (4-10%)

            Parasthesia (5-9%)

            Nausea (4-9%)

            Weakness (3-9%)

            Somnolence (5-8%)

            Warm/cold sensation (5-7%)

            Xerostomia (3-5%)

            Chest pain (2-4%)

            Diaphoresis (3%)

            Pain (2-3%)

            Dyspepsia (1-3%)

            Dysphagia (2%)

            Myasthenia (2%)

            Palpation (2%)

            Vertigo (2%)

            Hypoesthesia (1-2%)

            Myalgia (1-2%)

            <1%

            QT prolongation

            Bradycardia

            Tachycardia

            Thrombophlebitis

            Postural hypotension

            Hyperglycemia

            Alk phos increased

            Arthritis

            Twitching

            Myocardial infarction and artery vasospasm in patients with CAD risk factors

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            Warnings

            Contraindications

            Hypersensitivity

            History of myocardial infarction

            Ischemic or vasospastic artery disease, including Prinzmetal variant angina or other significant underlying cardiovascular disease

            Uncontrolled HTN

            Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders

            Peripheral vascular disease

            Ischemic bowel disease

            Not indicated for basilar or hemiplegic migraine

            Do not use concurrently with or within 2 wk of using MAO Inhibitors

            Within 24 hr of other 5-HT agonist or ergotamine-containing or ergot-type medication

            History of stroke

            Transient ischemic attack, or history of hemiplegic or basilar migraine

            Cautions

            Little added benefit with 5 mg PO dose compared with 2.5 mg

            Coronary artery vasospasm, myocardial infarction, transient ischemia, ventricular tachycardia/fibrillation, cardiac arrest, and death reported with use

            Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)

            As with other 5-HT1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur that are not cardiac in origin

            Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred with 5-HT1 agonists, including some fatalities

            May cause noncoronary vasospastic reactions (eg, peripheral vascular ischemia, GI vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome

            Significant elevation in blood pressure, including hypertensive crisis reported in patients with and without history of hypertension

            Serotonin syndrome: Potentially life-threatening serotonin syndrome may occur, particularly during combined use with SSRIs (eg, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRIs (eg, venlafaxine, duloxetine)

            Partial vision loss and blindness (transient and permanent) reported with 5-HT1 agonists

            Use caution in elderly patients, who are more likely to have underlying cardiovascular disease and hepatic or renal impairment; cardiovascular evaluation recommended in patients with other cardiovascular risk factors prior to initiation of therapy

            Therapy is indicated for acute treatment of migraine headache; not for migraine prophylaxis

            Use for 10 or more days per month may lead to worsening of headaches; withdrawal treatment may be necessary in the setting of overuse

            Coronary artery disease

            • Not for administration to patients with risk factors for coronary artery disease (CAD), including hypercholesterolemia, obesity, smoker, diabetes, menopause, male >40 years, or strong family history of CAD
            • Patients at risk should have CAD ruled out before initiating therapy
            • First dose should be given in healthcare providers office if cardiovascular evaluation is satisfactory
            • Cardiovascular status should be evaluated periodically in all patients receiving therapy
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            Pregnancy & Lactation

            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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Selective 5-HT1 receptor agonist in cranial arteries. Causes vasoconstriction and reduces inflammation associated with antidronic neuronal transmission associated with relief of migraine

            Pharmacokinetics

            Half-Life elimination: 2.8-3.7 hr

            Peak Plasma Time: 1.5 hr; 3 hr (ZMT)

            Bioavailability: 40%

            Onset of action: 0.5-1 hr

            Protein Bound: 25%

            Vd: 7.0 L/kg

            Metabolism: liver

            Metabolites: N-desmethyl zolmitriptan

            Excretion: Urine (65%); Feces (30%)

            Clearance

            • Total Body: 31.5 mL/min/kg
            • Renal: 5.25 mL/min/kg
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            Administration

            Instructions

            For 1.25 mg dose, manually break the scored 2.5 mg regular oral tablet in half

            Do not break orally disintegrating tablets

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.