Miotrol

Approved Indications:

• Acute treatment of migraine with or without aura in adults (oral tablets, orally disintegrating tablets, nasal spray).
• Acute treatment of migraine in adolescents aged 12 years and older (nasal spray only).

Off-Label but Clinically Accepted Uses:

• Acute treatment of cluster headaches.
• Menstrual migraine (especially short-term prophylaxis or treatment during perimenstrual period).

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults:

• Initial dose: 1.25 mg or 2.5 mg orally or nasally.
• If needed, a second dose may be taken after at least 2 hours.
• Maximum single dose: 5 mg.
• Maximum total daily dose: 10 mg (regardless of formulation).
• Use should be limited to no more than 4 doses in a 30-day period (nasal) or 3 doses per month (oral).

Pediatric (12–17 years):

• Initial dose: 2.5 mg (nasal spray); repeat dose after 2 hours if needed.
• Maximum daily dose: 5 mg.
• Safety and efficacy not established in children under 12 years.

Elderly:

• Use with caution due to increased risk of cardiovascular disease. Start with the lowest effective dose.

Renal Impairment:

• No dosage adjustment is recommended for mild to moderate impairment.
• In severe renal impairment, reduced clearance may occur; use lowest effective dose with caution.

Hepatic Impairment:

• Mild impairment: No dose adjustment required.
• Moderate to severe impairment: Maximum single dose should be reduced to 2.5 mg; total daily dose not to exceed 5 mg.
• Nasal spray is not recommended in moderate to severe hepatic impairment.

Administration Notes:

• Orally disintegrating tablets should be placed on the tongue to dissolve and should not be split.
• Nasal spray is single-use only and should be discarded after use.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Zolmitriptan is a selective agonist of serotonin 5‑HT₁B/₁D receptors. It induces cranial vasoconstriction, inhibits neurogenic inflammation by reducing vasoactive peptide release (e.g., CGRP), and suppresses trigeminal pain pathways centrally—effectively aborting migraine attacks.

• Absorption: Rapidly absorbed after oral administration with peak plasma levels in 1.5 to 2 hours. Nasal spray achieves faster systemic absorption, detectable in plasma within minutes.
• Bioavailability: Approximately 40% after oral administration.
• Distribution: Volume of distribution is around 8.3 L/kg; protein binding is low (~25%).
• Metabolism: Primarily metabolized by CYP1A2 to an active N-desmethyl metabolite with similar potency.
• Elimination: Half-life is about 3 hours. Both parent drug and metabolite are eliminated mainly via renal excretion (65%) and to a lesser extent in feces (30%).
• Special Populations: Hepatic and renal impairment can alter pharmacokinetics; dose adjustment may be necessary.

• Pregnancy: There are no adequate, well-controlled studies in pregnant women. Animal studies suggest possible fetal harm. Use only if potential benefits justify the potential risk.
• Lactation: Zolmitriptan is excreted in breast milk. The effects on the nursing infant are unknown. Use caution and monitor infants for signs of adverse effects.

• Primary Class: Serotonin (5‑HT₁B/₁D) receptor agonist.
• Subclass: Triptan class antimigraine agent; second-generation triptan due to improved CNS penetration and metabolic profile.

• Known hypersensitivity to zolmitriptan or any formulation components.
• History of ischemic heart disease, angina, myocardial infarction.
• Uncontrolled hypertension.
• History of stroke or transient ischemic attack (TIA).
• Peripheral vascular disease.
• Hemiplegic or basilar migraine.
• Severe hepatic impairment.
• Concurrent use of ergotamine or other triptans within 24 hours.
• Use of monoamine oxidase A (MAO-A) inhibitors within the past 14 days.

• Cardiovascular Risk: Serious cardiovascular events, including myocardial infarction, have occurred even in patients without known heart disease. Evaluate patients with risk factors prior to initiation.
• Cerebrovascular Events: Stroke and TIA reported. Avoid in patients with cerebrovascular risk.
• Vasospasm: Risk of vasospastic events including coronary, peripheral, or gastrointestinal ischemia.
• Serotonin Syndrome: Risk when combined with SSRIs, SNRIs, or other serotonergic agents. Monitor for confusion, agitation, hyperreflexia, or muscle rigidity.
• Medication Overuse Headache: Frequent use can lead to chronic headaches. Limit to recommended frequency.
• Hypersensitivity Reactions: Including angioedema and anaphylaxis. Discontinue if any severe reaction occurs.
• Blood Pressure Elevation: Monitor especially in patients with known hypertension or hepatic impairment.

Common Side Effects (by body system):

• Neurological: Dizziness, paresthesia, somnolence, headache.
• Gastrointestinal: Nausea, dry mouth.
• Respiratory: Nasal discomfort or taste perversion (nasal spray).
• Musculoskeletal: Jaw, neck, or chest tightness.

Serious or Rare Adverse Effects:

• Myocardial infarction, arrhythmia.
• Cerebral infarction or hemorrhage.
• Angioedema, anaphylaxis.
• Ischemic colitis or bowel infarction.
• Serotonin syndrome (especially with other serotonergic agents).

Onset & Dose-Dependence:

• Adverse effects may occur within hours of dosing. Risk increases with higher or repeated doses.

• Other Triptans/Ergotamines: Avoid co-administration within 24 hours due to risk of additive vasoconstriction.
• MAO-A Inhibitors: Contraindicated; markedly increases zolmitriptan levels.
• Cimetidine: Doubles zolmitriptan half-life and exposure; reduce maximum dose to 5 mg/day.
• SSRIs/SNRIs/TCAs: Risk of serotonin syndrome; monitor closely.
• Oral Contraceptives: May increase zolmitriptan plasma levels by 30–50%.
• Propranolol: Can increase plasma levels of zolmitriptan and active metabolite.
• Alcohol: No known direct interaction, but CNS depression may be additive.

• Updated product labeling includes enhanced warnings about serotonin syndrome and cardiovascular events.
• Neurological societies now include nasal spray zolmitriptan among recommended options for adolescent migraine.
• Recognized off-label use for cluster headaches in updated clinical guidelines.

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C–30°C (59°F–86°F).
• Keep tablets in blister packs until use.
• Protect from moisture and light.
• Do not refrigerate or freeze.
• Orally disintegrating tablets should not be broken or split.
• Nasal spray is single-use and should be discarded after one application.