Scopolamine
Monograph
DRUG NAME: Scopolamine
Therapeutic Class: Anticholinergic (Antimuscarinic)
Subclass: Antiemetic / Antispasmodic
Speciality: Anaesthesiology
Schedule (India): H
Route(s): Parenteral (IM, SC, IV under monitoring)
Formulations Available in India:
| Formulation | Strengths Available |
|---|---|
| Scopolamine hydrobromide injection | 0.25 mg/mL, 0.4 mg/mL |
| Scopolamine tablets | NOT AVAILABLE in India |
| Scopolamine transdermal patch | NOT AVAILABLE in India |
Note: Only parenteral forms are marketed in India, primarily for hospital/anaesthesia use.
INDICATIONS + DOSING - FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Preoperative Medication (Sedation, Antisialogogue, Amnesia)
| Parameter | Recommendation |
|---|---|
| Starting dose | 0.3 mg IM or SC |
| Titration | Not applicable |
| Usual maintenance dose | 0.3–0.6 mg as single preoperative dose |
| Maximum dose | 0.6 mg/dose |
| Timing | 30–60 minutes before surgery |
| Route preference | IM or SC preferred; IV only under continuous monitoring |
Clinical Notes:
-
May be combined with opioid (e.g., pethidine) for balanced premedication
-
Provides antisialagogue effect, sedation, and partial amnesia
-
Avoid repeated dosing preoperatively
2. Gastrointestinal Spasms (Adjunctive Therapy)
| Parameter | Recommendation |
|---|---|
| Starting dose | 0.2 mg SC or IM |
| Titration | Increase to 0.4 mg per dose if required |
| Usual maintenance dose | 0.2–0.4 mg SC or IM, 3–4 times daily PRN |
| Maximum dose | 1.2 mg/day |
Clinical Notes:
-
Typically used as adjunct with other antispasmodics
-
Short-term use only; reassess if symptoms persist beyond 48-72 hours
3. Motion Sickness
NOT APPLICABLE in India - Transdermal patch (preferred route for motion sickness) is not marketed in India. Alternative agents such as promethazine or dimenhydrinate are used.
Secondary Indications - Adults (Off-label)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Sialorrhoea in Parkinsonism (OFF-LABEL) | 0.4 mg SC up to twice daily | Short-term; reassess regularly | Specialist only; high CNS side effect risk in elderly |
| Acute Vestibular Vertigo (OFF-LABEL) | 0.2–0.4 mg SC/IM every 6–8 hours | ≤48 hours | Specialist ENT/Neurology protocols; short-term only |
Evidence Basis: Indian specialist palliative/supportive care protocols; ENT/Neurology specialist practice
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
1. Preoperative Medication (Specialist Anaesthesia Use Only)
| Parameter | Recommendation |
|---|---|
| Age | >6 months |
| Starting dose | 6 μg/kg SC or IM |
| Titration | Not applicable |
| Usual maintenance dose | Single preoperative dose only |
| Maximum single dose | 0.3 mg |
Safety Monitoring:
-
Monitor for CNS excitability, paradoxical agitation
-
Monitor heart rate (risk of tachycardia)
-
Ensure adequate hydration
Secondary Indications - Paediatrics (Off-label)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Antisialagogue for severe drooling – Neurology/Palliative (OFF-LABEL) | 5–10 μg/kg SC every 6–8 hours | As clinically indicated | Specialist only; monitor for dry mouth, sedation, tachyarrhythmia |
| Neonatal palliative care – Respiratory secretions (OFF-LABEL) | 2–4 μg/kg SC every 8 hours | Inpatient monitoring essential | Specialist only; based on international palliative protocols + Indian case reports |
Age Restriction: NOT recommended below 6 months except under neonatal/palliative specialist supervision with documented indication
RENAL ADJUSTMENT
| Renal Function | Recommendation |
|---|---|
| Mild-to-moderate impairment | No dose adjustment required |
| Severe impairment (eGFR < 30 mL/min) | Use with caution; enhanced anticholinergic toxicity risk |
| Dialysis | No specific recommendations; use cautiously |
HEPATIC ADJUSTMENT
| Hepatic Function | Recommendation |
|---|---|
| Mild impairment | No dose adjustment typically required |
| Moderate impairment | Use with caution; start at lower dose range |
| Severe impairment | Avoid if possible; increased CNS sensitivity; specialist use only |
CONTRAINDICATIONS
-
Angle-closure glaucoma (or predisposition)
-
Prostatic hypertrophy with urinary retention
-
Myasthenia gravis
-
Hypersensitivity to scopolamine or belladonna alkaloids
-
Severe ulcerative colitis
-
Paralytic ileus or GI obstruction
-
Infants <6 months (except under specialist palliative care)
-
Tachyarrhythmias (uncontrolled)
CAUTIONS
-
Elderly: High risk of delirium, confusion, agitation
-
Cardiovascular disease: May increase heart rate; caution in coronary artery disease
-
GI obstruction: May mask symptoms; avoid unless clearly indicated
-
Febrile illness in children: Risk of hyperthermia due to impaired sweating
-
CNS penetration: Crosses blood-brain barrier readily; monitor for sedation, confusion
-
Down syndrome: Increased sensitivity to anticholinergic effects
-
Pyrexia/High ambient temperature: Risk of hyperthermia
PREGNANCY
| Aspect | Recommendation |
|---|---|
| Overall safety | Not well established in human pregnancy |
| Risk category | Avoid unless benefit clearly outweighs risk |
| First trimester | Avoid where possible |
| Acceptable use | Surgical premedication, palliative care (after risk-benefit discussion) |
| Monitoring | Monitor fetal movements; ensure maternal hydration |
| Preferred alternatives | Consult anaesthesia/obstetric specialist for alternatives |
LACTATION
| Aspect | Recommendation |
|---|---|
| Compatibility | Use with caution; not well studied |
| Expected levels in milk | Presumed low amounts, but data limited |
| Effect on milk production | May reduce milk production (anticholinergic effect) |
| Infant monitoring | Monitor for dry mouth, sedation, poor feeding, reduced urine output |
| Preferred alternatives | Consider alternative antiemetics if needed for longer duration |
ELDERLY
| Aspect | Recommendation |
|---|---|
| Starting dose | Half adult dose (0.15–0.3 mg IM) |
| Titration | Avoid repeated dosing unless essential |
| Key risks | Sedation, delirium, hallucinations, urinary retention, constipation |
| Monitoring | Close observation of mental status; use lowest effective dose |
MAJOR DRUG INTERACTIONS
| Interacting Drug/Class | Effect | Management |
|---|---|---|
| CNS depressants (opioids, benzodiazepines, barbiturates) | Additive sedation; respiratory depression risk | Reduce doses of both; close monitoring |
| Monoamine oxidase inhibitors (MAOIs) | Risk of enhanced anticholinergic effects; potential hypertensive crisis | Avoid combination or use with extreme caution |
| Other anticholinergics (antihistamines, TCAs, antipsychotics) | Additive anticholinergic burden; increased toxicity risk | Avoid combination; monitor for toxicity |
| Drugs prolonging QT interval | Potential additive effect on cardiac conduction | ECG monitoring; avoid if possible |
MODERATE DRUG INTERACTIONS
| Interacting Drug/Class | Effect | Management |
|---|---|---|
| Metoclopramide | Antagonistic effect on GI motility | Avoid concurrent use if possible |
| Potassium supplements (oral) | Increased GI irritation due to slowed transit | Use liquid/effervescent forms; monitor |
| Ritonavir and other CYP3A4 inhibitors | Potential increase in CNS drug effects | Monitor for enhanced sedation |
| Donepezil/Rivastigmine (cholinesterase inhibitors) | Pharmacological antagonism | Avoid combination |
COMMON ADVERSE EFFECTS
-
Dry mouth (xerostomia)
-
Blurred vision
-
Drowsiness, sedation
-
Tachycardia
-
Constipation
-
Urinary hesitation or retention
-
Mydriasis (dilated pupils)
-
Mild confusion
SERIOUS ADVERSE EFFECTS
| Adverse Effect | Clinical Notes |
|---|---|
| Acute psychosis, hallucinations | More common in elderly; requires immediate discontinuation |
| Angle-closure glaucoma precipitation | Emergency; requires urgent ophthalmology referral |
| Hyperthermia | Especially in children; discontinue and cool patient |
| Paralytic ileus | Discontinue; supportive management |
| Seizures | Rare; supportive care |
| Anaphylaxis | Rare; emergency management |
MONITORING REQUIREMENTS
| Phase | Parameters |
|---|---|
| Baseline | Mental status (especially elderly), heart rate, intraocular pressure risk assessment, urinary symptoms |
| After initiation | Sedation level, CNS effects (confusion, agitation), heart rate |
| Long-term (if applicable) | Bowel function, bladder function, vision changes, cognitive status |
BRANDS AVAILABLE IN INDIA
| Brand Name | Manufacturer | Form |
|---|---|---|
| Merisop® | AMI Lifesciences | Injection |
Important Clarification:
-
Buscopan® contains hyoscine butylbromide (peripheral-acting quaternary compound) — this is NOT the same as scopolamine hydrobromide (central-acting tertiary amine)
-
Transdermal patches are NOT marketed in India
PRICE RANGE (INR)
| Formulation | Approximate Price |
|---|---|
| Scopolamine injection (0.4 mg/mL ampoule) | ₹12–₹25 per ampoule |
-
NLEM Status: Not included in NLEM 2022
-
Availability: Mostly limited to hospital/anaesthesia settings; government supply restricted
CLINICAL PEARLS
-
Scopolamine hydrobromide (tertiary amine) crosses the blood-brain barrier and causes central effects; hyoscine butylbromide (Buscopan®) is a quaternary compound with peripheral-only action — do not confuse the two.
-
Very limited clinical use in India — primarily restricted to anaesthesia premedication and palliative care settings.
-
Avoid in elderly patients prone to delirium — anticholinergic burden can precipitate or worsen cognitive dysfunction.
-
Transdermal scopolamine patch is not available in India — for motion sickness, use promethazine, dimenhydrinate, or cinarazine instead.
-
In paediatrics, only specialists should prescribe; children below 6 months require neonatal/palliative specialist oversight.
-
Paradoxical excitation (especially in children and elderly) may occur instead of expected sedation — monitor closely.
TAGS
scopolamine; hyoscine hydrobromide; anticholinergic; antimuscarinic; anaesthesia premedication; antisialagogue; GI spasm; drooling; Parkinson sialorrhoea; CNS side effects; specialist-only; hospital-use; India
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Clinical Disclaimer
The information provided here is for healthcare professionals only. It is not intended for patient use or as a substitute for professional medical advice, diagnosis, or treatment. Always verify dosages and clinical protocols with latest hospital guidelines.