Schedule H

Oral, Intramuscular, Intravenous

• Tablets: 40 mg, 80 mg

• Injection (IM/IV): 2 mL ampoule (20 mg/mL = 40 mg per ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Smooth Muscle Spasm of Gastrointestinal Origin

(Including irritable bowel syndrome with spasm, functional bowel disorders)

Parameter Oral IM IV

Starting dose 40 mg TID 40 mg 40 mg (dilute in 5–10 mL NS)

Titration Increase to 80 mg TID if needed May repeat after 4–6 hours May repeat after 4–6 hours

Usual maintenance dose 120–240 mg/day 40–80 mg/dose PRN 40 mg/dose PRN

Maximum dose 240 mg/day 240 mg/day 240 mg/day

Clinical Notes:

• Administer oral doses 30 minutes before meals for GI-related symptoms

• IV route: Administer slowly over 1–2 minutes; rapid bolus may cause hypotension

1. Biliary Colic

Parameter Oral IM/IV

Starting dose 80 mg STAT 40–80 mg

Titration May repeat 40–80 mg after 4–6 hours May repeat after 4–6 hours

Usual maintenance dose 80 mg TID 40–80 mg PRN

Maximum dose 240 mg/day 240 mg/day

Clinical Notes:

• Often combined with NSAIDs (e.g., diclofenac) for synergistic pain relief

• Parenteral route preferred in acute presentations

1. Renal Colic

Parameter Oral IM/IV

Starting dose 80 mg STAT 40–80 mg

Titration May repeat after 4–6 hours May repeat after 4–6 hours

Usual maintenance dose 80 mg TID 40–80 mg PRN

Maximum dose 240 mg/day 240 mg/day

Clinical Notes:

• Use in combination with NSAIDs or opioid analgesics for optimal pain control

• IM/IV preferred for acute severe colic; transition to oral after relief

1. Primary Dysmenorrhea

Parameter Oral

Starting dose 40–80 mg at onset of pain

Titration May repeat every 8 hours

Usual maintenance dose 40–80 mg TID during menses

Maximum dose 240 mg/day

Clinical Notes:

• Start at onset of menstrual pain for best effect

• May be combined with mefenamic acid or ibuprofen

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

Indication Dose Duration Notes

Labour-related cervical dystocia / spastic dysmenorrhea Oral: 40–80 mg TID OR IM: 40–80 mg single dose Based on labour progress and pain control OFF-LABEL — Specialist only (Obstetrics/Gynaecology). Limited RCT support; used in Indian obstetric practice to facilitate cervical dilatation. Monitor uterine contractions and fetal status.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Functional Abdominal Pain / Irritable Bowel-Associated Colic

1–6 years 10 mg TID May increase to 20 mg TID if needed 10–20 mg TID 60 mg/day

6–12 years 20 mg TID May increase to 40 mg TID if needed 20–40 mg TID 120 mg/day

Parenteral Dosing (IM only — under supervision):

• Dose: 0.8–1.6 mg/kg/dose

• Frequency: 2–3 times/day

• Maximum: 40 mg/dose

Safety Monitoring:

• Blood pressure before and after parenteral administration

• Sedation level

• GI symptoms (nausea, vomiting)

Minimum Age: 1 year

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

Indication Dose Duration Notes

Infantile colic / spasmodic pain in infants <1 year NOT RECOMMENDED — OFF-LABEL — NOT RECOMMENDED below 1 year of age due to lack of safety data. Use only under specialist supervision in exceptional circumstances.

• Hypersensitivity to drotaverine or any excipient

• Severe hepatic dysfunction

• Severe renal failure

• Severe cardiac failure or cardiogenic shock

• Atrioventricular block (2nd or 3rd degree)

• Porphyria

• Children below 1 year of age

• Hypotension — monitor closely, especially with IV use

• Elderly patients — increased risk of hypotension and sedation

• Tachyarrhythmias — use with caution

• Cardiac conduction disorders — PDE inhibition may affect cardiac conduction

• Avoid rapid IV administration — risk of transient hypotension

• Lactation — manufacturer advises caution

Parameter Details

Risk category Generally considered safe; non-teratogenic in available studies

When may be used Under obstetrician supervision for spasmodic pain, dysmenorrhea, or as adjunct in labour

Precautions Avoid high or repeated IV doses

Monitoring Fetal heart rate, uterine contraction pattern, maternal blood pressure

Preferred alternatives If antispasmodic required, drotaverine is acceptable; hyoscine may be alternative

Parameter Details

Compatibility Manufacturer advises caution — inadequate human data

Recommendation Breastfeeding not recommended during treatment

Expected levels in milk Not adequately studied

Preferred alternatives Hyoscine butylbromide (poorly absorbed), mefenamic acid (case-dependent)

Infant monitoring Poor feeding, drowsiness, irritability

Parameter Recommendation

Starting dose Lower end of dose range (40 mg BID)

Titration Slow titration; increase only if tolerated

Special risks Hypotension, dizziness, falls, syncope

Monitoring Blood pressure monitoring essential, especially with parenteral use

IV use Avoid unless necessary; if used, administer very slowly with BP monitoring

Drug Interaction Recommendation

Levodopa Antagonistic effect — drotaverine may reduce efficacy of levodopa and worsen Parkinsonian symptoms Avoid co-administration

Drug Interaction Recommendation

Antihypertensives Additive hypotensive effect, particularly with IV drotaverine Monitor BP; avoid concurrent IV use if possible

CNS depressants (benzodiazepines, opioids) May potentiate sedation Monitor for excessive sedation

Other smooth muscle relaxants (papaverine) Additive effect on smooth muscle relaxation Monitor clinical response; avoid combination unless necessary

Note: No major CYP450 interactions documented.

• Nausea

• Dizziness

• Headache

• Dry mouth

• Hypotension (especially with IV route)

• Facial flushing

• Palpitations

Adverse Effect Notes

Severe hypotension Rare; mainly with rapid IV administration — discontinue and provide supportive care

Allergic reactions Rash, pruritus, angioedema — rare; discontinue immediately

Cardiac conduction disturbances Rare; associated with high IV doses — ECG monitoring if suspected

Timing Parameter

Baseline Not routinely required for short-term use

After IV administration Blood pressure monitoring essential

Long-term use Periodic liver and renal function if hepatic/renal impairment exists

Elderly/High-risk BP and heart rate with each dose

• Drotin® (Wockhardt)

• Doverin® (various manufacturers)

• Drotaver® (various manufacturers)

• Drotikind® (Mankind Pharma)

• Spasmonil® (various manufacturers)

Common FDCs:

Note: Drotaverine (single ingredient) is NOT listed in NLEM. Some FDCs may be under NPPA price regulation.

• Drotaverine is preferred over papaverine for GI/biliary spasm due to better tolerability and longer duration of action

• Does NOT cause anticholinergic side effects — safe in patients with benign prostatic hyperplasia and narrow-angle glaucoma

• Provides rapid relief in colicky abdominal pain; use IM/IV route for acute presentations

• Combine with NSAIDs (diclofenac, ketorolac) for synergistic effect in renal/biliary colic

• Avoid repeated IV boluses without BP monitoring — hypotension is the main concern

• Not a disease-modifying agent — should not be used for chronic unexplained abdominal pain without definitive diagnosis

drotaverine; antispasmodic; smooth muscle relaxant; biliary colic; renal colic; dysmenorrhea; non-anticholinergic; safe in glaucoma; PDE4 inhibitor; Schedule H

RxIndia v1.0 — 20 Apr 2025

• CDSCO approved product labels

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

• NLEM 2022 (Drotaverine not listed as single agent)

• API Textbook of Medicine

• AIIMS treatment protocols

• Indian paediatric handbooks (supportive data for colic management)

• International RCTs reviewed for off-label obstetric use (documented)