Rizatriptan Schedule (India)

Schedule H

Rizatriptan Routes

Oral

Rizatriptan Formulations

Formulation Strength

Tablets 5 mg, 10 mg

Orally Disintegrating Tablets (ODT) 5 mg, 10 mg

Rizatriptan Adult indications

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.

Rizatriptan Paediatric indications

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

Rizatriptan Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
Haemodialysis	Not studied; use not recommended

Rizatriptan Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A)	No dose adjustment required
Moderate impairment (Child-Pugh B)	Starting dose: 5 mg; Maximum dose: 15 mg/day; use with caution
Severe impairment (Child-Pugh C)	Avoid use — significantly increased drug exposure expected

Rizatriptan Contraindications

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

Rizatriptan Cautions

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

Rizatriptan Pregnancy

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

Rizatriptan Lactation

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.

Rizatriptan Elderly

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

Rizatriptan Major drug interactions

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)

Rizatriptan Moderate drug interactions

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

Rizatriptan Common Adverse effects

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.

Rizatriptan Serious Adverse effects

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

Rizatriptan Monitoring requirements

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

Rizatriptan Brands in India

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

Rizatriptan Price range (INR)

Formulation	Approximate Price (per tablet)
Tablets 5 mg	₹30–60 per tablet
Tablets 10 mg	₹45–80 per tablet
ODT 5 mg	₹35–70 per tablet
ODT 10 mg	₹50–90 per tablet

Notes:

Not included in NLEM 2022

Not under NPPA price control

Primarily available in private sector; limited government supply

Rizatriptan Clinical pearls

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

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

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

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

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

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

Rizatriptan Tags

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

Rizatriptan Version

RxIndia v1.0 — 10 Jun 2025

Rizatriptan Reference

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)

RxIndia

The Drug Registry

Rizatriptan