Schedule H

Oral

Formulation Strength

Tablets 5 mg, 10 mg

Orally Disintegrating Tablets (ODT) 5 mg, 10 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Acute Treatment of Migraine (with or without aura)

(Adults ≥18 years)

Parameter Recommendation

Starting dose 5 mg or 10 mg orally at onset of migraine headache

Titration If headache recurs after initial relief, may repeat dose after ≥2 hours

Usual maintenance dose 5–10 mg per attack

Maximum dose 30 mg/day (in divided doses)

Clinical Notes:

• Administer at first sign of migraine headache phase — effectiveness decreases with delayed administration

• Use lowest effective dose; prefer 5 mg initially in patients with cardiovascular risk factors

• If first dose provides no relief, second dose unlikely to be effective for same attack — do not repeat

• ODT formulation can be taken without water; dissolves on tongue

• Not for use in: Hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine

• Not indicated for migraine prophylaxis — acute treatment only

Secondary Indications — Adults Only (Off-label, if any)

Indication Dose Duration Notes Evidence

Menstrual-related migraine 5–10 mg at onset of attack Per attack OFF-LABEL; Use as per standard acute treatment protocol Indian specialist practice; no unique benefit over standard migraine dosing

Note: Use for cluster headache is not recommended in Indian practice due to insufficient evidence and absence from standard protocols.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable.

Rizatriptan is not formally approved for paediatric use in India.

Secondary Indications — Paediatric Doses (Off-label, if any)

Acute Migraine Treatment — Children ≥6 years

OFF-LABEL; Paediatric Neurologist Supervision Mandatory

Body Weight Dose Repeat Dose Maximum/Day

<40 kg 5 mg orally once May repeat after ≥2 hours if needed 10 mg/day

≥40 kg 10 mg orally once May repeat after ≥2 hours if needed 20 mg/day

Evidence: Supported by international RCTs and meta-analyses; not formally approved in India

Safety Statement:

• Not recommended below 6 years due to lack of safety and efficacy data

• Use only under paediatric neurologist supervision

• Avoid in children with underlying cardiac risk factors or congenital heart disease

Monitoring:

• Observe for somnolence, dizziness, chest discomfort after administration

• Screen for cardiovascular risk factors before first use

• Monitor response and document in headache diary

• Ischaemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischaemia)

• Coronary artery vasospasm (Prinzmetal's/variant angina)

• History of stroke or transient ischaemic attack (TIA)

• Peripheral vascular disease

• Uncontrolled hypertension

• Severe hepatic impairment (Child-Pugh C)

• Use within 24 hours of another triptan (sumatriptan, zolmitriptan, etc.)

• Use within 24 hours of ergotamine or ergot-type derivatives (ergotamine, dihydroergotamine, methysergide)

• Concurrent or recent use (within 2 weeks) of MAO-A inhibitors

• Known hypersensitivity to rizatriptan or any excipient

• Cardiovascular risk factors (diabetes mellitus, smoking, obesity, hyperlipidaemia, family history of CAD, postmenopausal women, men >40 years) — consider baseline ECG before first triptan use

• Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathways

• Controlled hypertension — monitor blood pressure

• Concurrent use with SSRIs/SNRIs — risk of serotonin syndrome

• Patients on propranolol — mandatory dose reduction (see Major Drug Interactions)

• Risk of medication-overuse headache with frequent use (>10 headache days/month)

• Sulfonamide allergy — theoretical cross-reactivity (clinical significance uncertain)

• Seizure disorders — use with caution

Parameter Recommendation

Risk category Limited human data; no established teratogenicity; use only if clearly needed

Preferred alternatives Paracetamol (first-line for mild-moderate migraine); Sumatriptan (more safety data in pregnancy if triptan required)

When to use Only if potential benefit justifies risk; specialist input recommended

Monitoring Fetal growth monitoring if used repeatedly; obstetric referral for recurrent migraine requiring treatment

Parameter Recommendation

Compatibility Likely compatible; short half-life (~2 hours) favours safety

Preferred alternatives Sumatriptan (better studied in lactation) if frequent triptan use required

Drug levels in milk Low (minimal infant exposure expected)

Infant monitoring Sedation, feeding difficulties, irritability

Practical advice: May pump and discard milk for 4 hours after dose if concerned, though generally not necessary.

Parameter Recommendation

General recommendation Not routinely recommended in patients >65 years due to increased cardiovascular risk

Starting dose (if used) 5 mg

Titration Conservative; avoid repeat dosing unless clearly needed

Special risks Increased risk of coronary events, hypertensive crisis; reduced renal/hepatic reserve affecting drug clearance

Monitoring Blood pressure, ECG if any cardiac symptoms; careful cardiovascular risk assessment mandatory

Interacting Drug/Class Effect Mechanism Management

Propranolol Increases rizatriptan AUC by ~70% Inhibition of MAO-A metabolism Limit rizatriptan to 5 mg/dose; maximum 15 mg/day; separate doses by at least 2 hours

MAO-A inhibitors (moclobemide) Markedly increased rizatriptan exposure; risk of serotonin syndrome MAO-A metabolises rizatriptan Contraindicated — do not use within 2 weeks of MAO-A inhibitor

Other triptans (sumatriptan, zolmitriptan, etc.) Additive vasoconstriction; increased risk of coronary vasospasm Pharmacodynamic Avoid within 24 hours of each other

Ergotamine derivatives (ergotamine, dihydroergotamine) Additive/prolonged vasospastic effects Pharmacodynamic Avoid within 24 hours of each other

SSRIs/SNRIs (fluoxetine, sertraline, venlafaxine, duloxetine) Risk of serotonin syndrome Additive serotonergic activity Monitor closely; educate patient on symptoms (agitation, hyperthermia, hyperreflexia)

Interacting Drug/Class Effect Management

Other beta-blockers (metoprolol, atenolol) Minor increase in rizatriptan levels (less than propranolol) Monitor; no mandatory dose reduction but consider starting at 5 mg

Tramadol Increased serotonin syndrome risk Monitor for serotonergic symptoms

Linezolid Weak MAO inhibition; serotonin syndrome risk Avoid if possible; if essential, monitor closely

CYP enzyme inducers (rifampicin, carbamazepine, phenytoin) May reduce rizatriptan efficacy Monitor clinical response; may need higher dose in same attack

Lithium Additive serotonergic effects Monitor for serotonin syndrome symptoms

St. John's Wort Serotonergic interaction Avoid concurrent use

• Dizziness (10–15%)

• Somnolence/fatigue

• Asthenia (weakness)

• Nausea

• Dry mouth

• Chest discomfort/tightness (usually non-cardiac — "triptan sensations")

• Paraesthesias (tingling, numbness)

• Warm/hot sensations

• Neck/throat tightness

Chest symptoms are common with triptans and usually benign; however, first occurrence should prompt cardiac evaluation in at-risk patients.

Adverse Effect Action Required

Myocardial infarction / acute coronary syndrome Discontinue immediately; emergency cardiac care

Coronary artery vasospasm Discontinue permanently; cardiology evaluation

Stroke / TIA Discontinue permanently; urgent neurological evaluation

Serotonin syndrome (agitation, hyperthermia, hyperreflexia, clonus, autonomic instability) Discontinue rizatriptan and all serotonergic agents; supportive care; hospitalisation

Hypertensive crisis Discontinue; antihypertensive management

Anaphylaxis / severe hypersensitivity Discontinue permanently; emergency management

Peripheral vascular ischaemia Discontinue; vascular evaluation

Phase Parameters

Baseline Cardiovascular risk assessment; blood pressure; consider ECG in patients >40 years or with cardiac risk factors; document migraine frequency and pattern

After first dose / initial use Monitor response within 2–4 hours; assess for chest symptoms, neurological symptoms; document efficacy

Long-term Headache diary to monitor frequency (assess for medication-overuse headache if >10 days/month); periodic cardiovascular review if repeated use; renal/hepatic function annually in frequent users

Brand Name Manufacturer Formulations

Rizact Cipla Tablets 5 mg, 10 mg

Rizora Intas Tablets 5 mg, 10 mg

Rizora-MT Intas ODT 5 mg, 10 mg

Rizamelt Sun Pharma ODT 5 mg, 10 mg

Maxalt MSD (imported) Tablets 5 mg, 10 mg (limited availability)

Rizatan Torrent Tablets 5 mg, 10 mg

Notes:

• Not included in NLEM 2022

• Not under NPPA price control

• Primarily available in private sector; limited government supply

1. Early treatment maximises efficacy: Administer rizatriptan at first sign of headache phase — delay significantly reduces response rate

1. Non-response rule: If first dose provides no relief within 2 hours, do not repeat for the same attack — try rescue therapy (NSAIDs, antiemetics)

1. Propranolol interaction is clinically significant: Must reduce rizatriptan to 5 mg/dose (max 15 mg/day) in patients on propranolol for migraine prophylaxis

1. Cardiovascular screening essential: First triptan use warrants cardiovascular risk assessment; consider supervised first dose in-clinic for high-risk patients

1. Medication-overuse headache prevention: Limit triptan use to <10 days/month; counsel patients on this risk explicitly

1. ODT advantage: Orally disintegrating tablets useful when nausea/vomiting accompanies migraine; no water needed; similar bioavailability to regular tablets

rizatriptan; migraine; triptan; acute headache; 5-HT1B/1D agonist; propranolol interaction; cardiovascular risk; serotonin syndrome; ODT; Schedule H; neurology

RxIndia v1.0 — 10 Jun 2025

• CDSCO (Central Drugs Standard Control Organisation)

• Indian Pharmacopoeia / National Formulary of India (IP/NFI)

• NLEM 2022 (for exclusion note)

• API Textbook of Medicine

• AIIMS Neurology Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian specialist neurology practice protocols

• RCT/meta-analyses (for paediatric off-label dosing only)

• Product Inserts: Rizact (Cipla), Rizora (Intas)