Scopolamine

DRUG NAME: Hyoscine Hydrobromide (Scopolamine)

---

Therapeutic Class:

Anticholinergic (Antimuscarinic)

---

Subclass:

Tertiary Amine Muscarinic Receptor Antagonist (Centrally-Acting)

---

Schedule (India):

---

Route(s):

• IV (intravenous — bolus)
• IM (intramuscular)
• SC (subcutaneous)
• Oral (tablets — swallowed whole)
• Transdermal (adhesive patch — applied to postauricular skin behind the ear)
• Ophthalmic (eye drops — specialist ophthalmology use for cycloplegia/mydriasis; limited availability in India)

---

Biosimilar Status:

---

Formulations Available in India:

---

PHARMACOKINETICS

• Transdermal delivery kinetics: The patch is designed for approximately zero-order release. After patch removal, a residual drug depot remains in the skin and continues to be absorbed for several hours. Patients should be warned that anticholinergic effects (dry mouth, blurred vision, drowsiness) may persist for up to 24 hours after patch removal.
• Placental transfer: Hyoscine hydrobromide crosses the placental barrier. Fetal effects (tachycardia, reduced beat-to-beat heart rate variability) have been documented when administered to the mother.
• Breast milk excretion: Small quantities are excreted into breast milk. The clinical significance for the nursing infant is uncertain but potential sedation and anticholinergic effects (reduced feeding, tachycardia, temperature dysregulation) should be monitored.
• Ophthalmic route — systemic absorption: After topical ocular instillation, systemic absorption occurs through nasolacrimal drainage and conjunctival vasculature. Systemic anticholinergic side effects (dry mouth, tachycardia, flushing, drowsiness, CNS effects) are possible, particularly in children, the elderly, and individuals with low body weight. Punctal occlusion after instillation reduces systemic absorption.
• Non-linear PK: No clinically significant non-linear pharmacokinetics, autoinduction, or saturation kinetics have been reported at therapeutic doses.

---

---

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

---

Primary Indications (Approved / Standard in India)

---

1. When to prefer this drug over alternatives: Prefer hyoscine hydrobromide over atropine when amnesia and sedation are specifically desired as part of premedication (e.g., for awake fibreoptic intubation, uncomfortable procedures, patients with high anxiety). Prefer over glycopyrrolate when central sedation/amnesia is desired, as glycopyrrolate does not cross the blood-brain barrier. Prefer over atropine when tachycardia must be minimised — hyoscine causes less tachycardia than atropine at equivalent antisecretory doses.
2. When NOT to use even though technically indicated:
   • ⚠️ Elderly patients at risk of postoperative delirium or cognitive dysfunction (POCD) — glycopyrrolate is strongly preferred in this population because it does not cross the BBB.
   • Patients with uncontrolled narrow-angle glaucoma.
   • Patients with bowel or urinary obstruction (anticholinergic effects worsen obstruction).
   • Patients with known paradoxical reactions to anticholinergics.
   • Patients with severe cardiac disease where any degree of tachycardia is dangerous (e.g., severe aortic stenosis, hypertrophic cardiomyopathy with outflow obstruction).
   • ⚠️ If only antisialagogue effect is required (without sedation/amnesia), glycopyrrolate is preferred — equally effective peripherally, no CNS effects, more predictable heart rate effect.
3. NLEM India status: Hyoscine hydrobromide is NOT listed in NLEM India 2022 for preanaesthetic medication. Atropine sulphate injection and glycopyrrolate injection are listed. However, hyoscine hydrobromide injection is stocked in most Indian tertiary hospital pharmacies and is part of anaesthesiology practice nationwide.
4. Typical time to expected clinical response:
   • IV: onset within 5–10 minutes; peak effect 20–60 minutes.
   • IM/SC: onset 15–30 minutes; peak effect 30–60 minutes.
   • Antisialagogue effect and sedation are the earliest observed effects.
5. Criteria for treatment failure and switching: If secretions remain excessive despite adequate dose, consider adding glycopyrrolate (0.2 mg IV) as a rescue antisialagogue rather than repeating hyoscine (to avoid cumulative CNS depression). If sedation is inadequate, consider a benzodiazepine (midazolam) rather than additional hyoscine.
6. Mandatory baseline investigations: No mandatory laboratory investigations before a single premedication dose. However:
   • RECOMMENDED: Check baseline heart rate (hyoscine can cause transient bradycardia followed by tachycardia). Document baseline mental status in elderly patients.
   • MANDATORY: Confirm no history of narrow-angle glaucoma (ask specifically).
   • MANDATORY in males >50 years: Enquire about prostatism/urinary retention symptoms.
7. Specialist initiation: Preanaesthetic use is inherently specialist — administered by the anaesthesiologist or under anaesthesia team supervision. Not applicable for primary care prescribing.
8. Indian guideline source: Standard anaesthesiology practice in India; referenced in most Indian anaesthesiology textbooks (Aitkenhead, Smith & Aitkenhead adapted editions). No specific ICMR guideline exists. Practice is consistent with AIIMS anaesthesiology department protocols.
9. Key disease-specific safety warning: ⚠️ In patients with pre-existing tachycardia (heart rate >100 bpm), hyoscine can paradoxically cause a transient initial bradycardia (via low-dose vagal stimulation before muscarinic blockade predominates), followed by tachycardia. Monitor heart rate continuously peri-administration.
10. Common dose adjustment scenarios:
    • Elderly (≥60 years): Use 0.1–0.2 mg maximum. Glycopyrrolate is strongly preferred.
    • Low body weight (<50 kg): Use lower end of dose range (0.2 mg).
    • Renal impairment: No formal adjustment required for a single dose, but monitor for prolonged effects.
    • Hepatic impairment: Use lower dose (0.2 mg); monitor for prolonged sedation.
    • Concomitant opioids/sedatives in premedication: Reduce hyoscine dose to 0.2 mg to avoid excessive sedation and respiratory depression.

---

1. When to prefer this drug over alternatives: Hyoscine hydrobromide is the most effective single agent for motion sickness prophylaxis (superior to antihistamines like cinnarizine, dimenhydrinate, meclizine in comparative trials). Preferred for sea sickness and space-motion sickness where vestibular stimulation is severe. The transdermal patch is ideal for prolonged exposure (sea voyages, multi-day travel).
2. When NOT to use even though technically indicated:
   • Elderly patients or those with prostatic hypertrophy, narrow-angle glaucoma, or cognitive impairment — prefer meclizine or cinnarizine.
   • Patients who need to remain fully alert (drivers, pilots, operators of heavy machinery) — hyoscine causes significant drowsiness and impaired cognitive function. Meclizine or low-dose cinnarizine are less sedating alternatives.
   • Children <10 years (high risk of paradoxical excitation; use age-appropriate alternatives — promethazine, dimenhydrinate in appropriate doses).
3. NLEM India status:Not listed in NLEM India 2022 for motion sickness.
4. Typical time to expected clinical response:
   • Oral: 30–60 minutes.
   • Transdermal: 4–8 hours (partial onset); full effect at approximately 24 hours. This is why the patch must be applied the evening before travel for optimal prophylaxis.
5. Criteria for treatment failure and switching: If motion sickness occurs despite properly timed hyoscine, consider adding a non-sedating antihistamine (e.g., meclizine 25 mg). Do not combine hyoscine with other anticholinergics (additive anticholinergic toxicity). For refractory cases requiring travel, consider onboard parenteral ondansetron.
6. Mandatory baseline investigations: None required for short-term prophylactic use. Clinical assessment for contraindications (glaucoma, prostatism, cardiac history) is sufficient.
7. Specialist initiation:Not required. May be prescribed by any registered medical practitioner. However, availability of the oral and transdermal formulations in India is limited; prescribers should confirm local availability.
8. Indian guideline source: No specific Indian guideline addresses motion sickness pharmacotherapy in detail. Practice is consistent with international consensus. API Textbook of Medicine (current edition) mentions hyoscine as the drug of choice for motion sickness prophylaxis. Goodman & Gilman (14th Edition, Chapter on Histamine, Serotonin, and the Ergot Alkaloids / Muscarinic Receptor Antagonists) provides the pharmacological basis.
9. Key disease-specific safety warning: ⚠️ Transdermal patch — withdrawal effect: Abrupt removal of the patch after prolonged use (>72 hours) can cause rebound nausea, vomiting, headache, and dizziness (cholinergic rebound). Advise gradual withdrawal (e.g., cut patch in half for the final day if available as non-reservoir type, or simply warn the patient about potential rebound symptoms and manage symptomatically).
10. Common dose adjustment scenarios:
    • Elderly: Oral dose 0.15 mg (half tablet) every 8 hours. Transdermal patch: use half a patch if available (cut only non-reservoir matrix-type patches; do NOT cut reservoir-type patches). Alternatively, avoid hyoscine entirely and use meclizine 12.5–25 mg.
    • Hepatic impairment: Reduce oral dose. Monitor for excessive sedation.
    • Renal impairment: No specific adjustment for short-term use; monitor for excessive anticholinergic effects.

---

1. When to prefer over alternatives: Consider hyoscine as the third or fourth agent in multimodal PONV prophylaxis, especially in patients undergoing procedures with high PONV risk (laparoscopic surgery, gynaecological surgery, strabismus surgery, middle ear surgery). The transdermal patch is particularly useful for patients who will have continued nausea risk postoperatively (e.g., opioid PCA use, day-case surgery where oral antiemetics may not be tolerated). Preferred when ondansetron and dexamethasone have already been administered and additional prophylaxis is desired.
2. When NOT to use:
   • Elderly patients at high risk of POCD or delirium — ondansetron, dexamethasone, and droperidol (low-dose) are preferred.
   • Patients with pre-existing tachycardia, urinary retention risk (BPH), or narrow-angle glaucoma.
   • ⚠️ If the patient already received atropine or glycopyrrolate as premedication — adding hyoscine increases total anticholinergic burden significantly. Reduce the hyoscine dose or omit.
3. NLEM India status: Not listed in NLEM India 2022 specifically for PONV. Ondansetron and dexamethasone are the NLEM-listed antiemetics used in PONV prophylaxis.
4. Typical time to expected clinical response: IV: antiemetic effect within 15–30 minutes. Transdermal: requires at least 4 hours for initial therapeutic levels.
5. Criteria for treatment failure: If PONV occurs despite hyoscine, add/switch to a different mechanistic class — ondansetron (5-HT₃ antagonist), dexamethasone, or low-dose droperidol. Do not repeat hyoscine if the first dose was ineffective.
6. Mandatory baseline investigations: No specific investigations required beyond standard preoperative assessment. Verify absence of contraindications (glaucoma, prostatism).
7. Specialist initiation: Administered by the anaesthesiology team. Not applicable for primary care.
8. Indian guideline source: Indian Society of Anaesthesiologists (ISA) practice is consistent with Society for Ambulatory Anesthesia (SAMBA) consensus guidelines, adapted for Indian drug availability. API Textbook does not specifically address PONV pharmacotherapy in detail; this is within anaesthesiology specialist domain.
9. Key safety warning: ⚠️ Postoperative visual disturbance: Transdermal patch can cause unilateral mydriasis (anisocoria) if the patient touches the patch and then rubs the eye. This can mimic a neurological emergency (third cranial nerve palsy, raised intracranial pressure) and may trigger unnecessary CT/MRI imaging. Educate nursing staff and patients to avoid touching the patch and to wash hands if they do. Document patch application in anaesthesia notes.
10. Common dose adjustment scenarios:
    • Elderly: Reduce dose to 0.2 mg IV/IM. Avoid transdermal patch in patients >75 years or those with cognitive impairment. Glycopyrrolate + ondansetron is the preferred combination.
    • Renal/hepatic impairment: No formal adjustment for single PONV prophylaxis dose; use lower end of range.

---

1. When to prefer over alternatives: Hyoscine hydrobromide has very limited clinical niche in Indian ophthalmology. Tropicamide (0.5–1%) is preferred for routine fundoscopy (shortest duration). Cyclopentolate (1%) is preferred for cycloplegic refraction in adults and older children (intermediate duration, adequate cycloplegia). Atropine (1%) is preferred for paediatric cycloplegic refraction (strongest cycloplegia, especially in heavily pigmented irides). Hyoscine may be considered when cyclopentolate is contraindicated (e.g., allergy) and atropine’s prolonged effect (7–14 days) is undesirable.
2. When NOT to use: ⛔ Narrow-angle glaucoma or anatomically narrow anterior chamber angle — risk of precipitating acute angle-closure crisis. ⛔ Known hypersensitivity to belladonna alkaloids.
3. NLEM India status: Not listed. Atropine eye drops and tropicamide eye drops are NLEM-listed.
4. Typical time to response: Mydriasis 15–30 minutes; cycloplegia 30–60 minutes.
5. Treatment failure criteria: If adequate mydriasis/cycloplegia is not achieved, switch to atropine 1% drops (with appropriate warnings about prolonged effect).
6. Baseline investigations: Slit-lamp assessment of anterior chamber depth to rule out narrow angle before instillation. Baseline IOP measurement if glaucoma is suspected. MANDATORY in patients >40 years or those with hypermetropia, family history of glaucoma.
7. Specialist initiation: Ophthalmologist or optometrist use only. Not for primary care prescribing.
8. Indian guideline source: Standard ophthalmology practice. Kanski’s Clinical Ophthalmology (used widely in Indian ophthalmology training); Parsons’ Diseases of the Eye (Indian edition).
9. Key safety warning: ⚠️ Systemic absorption via nasolacrimal duct: Especially dangerous in children and elderly. Instruct punctal occlusion (press on inner corner of eye for 2–3 minutes after instillation) to minimise systemic absorption. Monitor for systemic anticholinergic effects (flushing, tachycardia, dry mouth, confusion, urinary retention).
10. Dose adjustment: No dose adjustment needed for the topical route, but extra caution regarding systemic absorption in elderly (use punctal occlusion rigorously, observe for 30–60 minutes post-instillation).

---

Secondary Indications — Adults Only (Off-label)

• Hyoscine hydrobromide: Provides concurrent sedation (which may be desirable in the terminal phase for an agitated patient). More likely to cause confusion/delirium (problematic if patient is still conscious).
• Glycopyrrolate: Does NOT cross BBB — no sedation, no delirium. Preferred if the patient is still alert and wishes to communicate, or if delirium is already present.
• Hyoscine butylbromide: Peripheral only. Less effective for secretions originating from the respiratory tract (compared to upper airway/oropharyngeal pooling). Does not cause sedation.

---

---

---

---

---

PAEDIATRIC DOSING (Specialist Only)

• ⚠️ Paradoxical excitation: Children, especially those under 6 years, are at significant risk of paradoxical CNS excitation (agitation, hyperactivity, restlessness, hallucinations, seizures) rather than the expected sedation seen in adults. This risk is highest in febrile children and those receiving concurrent CNS-active drugs.
• ⚠️ Anticholinergic toxicity: Neonates and infants have immature hepatic conjugation pathways, incomplete blood-brain barrier maturation, and higher sensitivity to anticholinergic effects. Temperature dysregulation (hyperthermia due to suppressed sweating) is a particular concern in the hot Indian climate.
• Safety monitoring requirements:
  • Continuous heart rate and SpO₂ monitoring during and for at least 30–60 minutes after parenteral administration.
  • Monitor temperature (risk of hyperthermia from suppressed sweating — especially relevant in Indian climate).
  • Monitor for urinary retention (especially postoperatively).
  • Monitor mental status and level of consciousness.
  • Monitor bowel sounds (risk of ileus, especially when combined with opioids).
• Minimum age: Generally avoided in children <3 months (some references state <6 months). Use in neonates (<28 days) is exceptional and restricted to NICU settings.
• Minimum weight: No strict minimum weight threshold defined; however, extreme caution is warranted in infants <5 kg due to enhanced susceptibility to toxicity and difficulty in accurate dose measurement.
• Formulation suitability for children:
  • Injectable (0.4 mg/mL or 0.6 mg/mL): Suitable — allows accurate weight-based dose calculation. Requires dilution for very small doses in neonates/infants to ensure accurate measurement.
  • Oral tablet (0.3 mg): NOT practically suitable for young children — tablets cannot be easily split into the small doses required. No paediatric oral liquid formulation is commercially available in India. Extemporaneous preparation may be considered at specialist centres but stability data is limited.
  • Transdermal patch (1.5 mg): ⛔ NOT recommended in children <12 years. The patch delivers a fixed dose that cannot be adjusted for body weight. Cutting the patch is unreliable for dose accuracy (and dangerous for reservoir-type patches). Risk of accidental transfer to child’s eyes (causing mydriasis) or mouth (causing systemic toxicity) is high.
  • Eye drops (0.25%): May be used in children under ophthalmologist supervision, but cyclopentolate (1%) and atropine (1%) are preferred in Indian paediatric ophthalmology practice.
• Palatability: Not applicable (no oral liquid formulation available; injectable is the primary paediatric route).

---

• Immature hepatic conjugation → prolonged drug effect
• Immature thermoregulatory mechanisms → high risk of hyperthermia
• Immature blood-brain barrier → exaggerated CNS effects
• Neonatal tachycardia response may mask cardiovascular compromise

---

---

• 6–10 mcg/kg (0.006–0.01 mg/kg) as a single IV dose, administered slowly over 2–3 minutes.
• Max 0.3 mg per dose (IV) in children <30 kg.
• Max 0.4 mg per dose (IV) in children ≥30 kg or ≥12 years.

1. When to prefer over alternatives: Only when sedation and amnesia are specifically desired as part of premedication (e.g., difficult paediatric airway management with awake technique, extremely anxious child where midazolam alone is insufficient). For routine antisialagogue premedication in children, glycopyrrolate (5–10 mcg/kg IV/IM) is preferred (no CNS effects, no paradoxical excitation risk).
2. When NOT to use:
   • ⚠️ Children with Down syndrome — increased sensitivity to anticholinergic effects, increased risk of paradoxical excitation, and increased risk of hyperthermia.
   • Children with febrile illness — anticholinergic suppression of sweating combined with fever increases hyperthermia risk, especially in Indian summer conditions.
   • Children with gastro-oesophageal reflux — reduces lower oesophageal sphincter tone, worsening reflux.
   • Children with uncontrolled seizure disorders — may lower seizure threshold.
3. NLEM India status: Not listed. Atropine injection is the NLEM-listed anticholinergic premedication for children.
4. Time to response: IV: 5–10 minutes; IM/SC: 15–30 minutes.
5. Treatment failure: If secretions remain problematic, add glycopyrrolate rather than repeating hyoscine.
6. Mandatory baseline: Heart rate, temperature, document absence of glaucoma/prostatism (in adolescent males).
7. Specialist initiation: Mandatory — paediatric anaesthesiologist only.
8. Indian guideline source: IAP Textbook of Pediatrics (current edition) references hyoscine hydrobromide under anticholinergic premedication; standard Indian paediatric anaesthesiology teaching.
9. Key safety warning: ⚠️ Temperature monitoring is MANDATORY in all children receiving hyoscine hydrobromide, especially in non-air-conditioned OTs and recovery areas (common in district hospitals in India). Hyperthermia from impaired sweating can develop rapidly.
10. Dose adjustment: Reduce dose by 25–50% in children with hepatic impairment, concurrent CNS depressant use, or dehydration.

---

• Oral: 0.15 mg (half tablet) 30 minutes before travel. May repeat every 6–8 hours. Max 0.15 mg per dose; Max 0.45 mg per day. Accurate half-tablet dosing is difficult with 0.3 mg tablets; consider alternative agents.
• Transdermal: ⛔ NOT recommended in children <12 years.
• ℹ️ Preferred alternatives for children 6–10 years in Indian practice: Promethazine (0.25–0.5 mg/kg oral, available as syrup); dimenhydrinate (1–1.5 mg/kg oral, available as tablets and syrup); cinnarizine (available as tablets — not widely used in young children); meclizine (available as tablets — limited paediatric data).

• ⛔ Hyoscine hydrobromide is NOT recommended for motion sickness prophylaxis in children under 6 years due to high risk of paradoxical excitation, no appropriate formulation, and availability of safer alternatives.
• Preferred alternatives: Promethazine syrup (>2 years), dimenhydrinate (>2 years), or non-pharmacological measures (positioning, visual fixation, ginger, acupressure wristbands).

1. Prefer alternatives: In Indian practice, promethazine syrup is more readily available and easier to dose accurately in children than hyoscine hydrobromide tablets.
2. Warn caregivers: Drowsiness is expected. Do not allow the child to engage in activities requiring alertness (cycling, swimming) while medicated.
3. NLEM status: Not listed.
4. Specialist initiation: Not mandatory for children ≥10 years; however, for children 6–10 years, prescribing by a paediatrician is recommended.
5. Indian source: IAP guidelines on supportive care reference motion sickness briefly; no specific Indian paediatric motion sickness guideline exists.

---

---

---

• Glycopyrrolate oral solution (1 mg/5 mL — limited availability in India; tablets may be crushed and given via NG tube in some centres): Better evidence in paediatric sialorrhoea, no CNS effects. Dose: 40–100 mcg/kg/dose, three times daily. Max 3 mg/day.
• Botulinum toxin injection into salivary glands: Available at tertiary centres; provides 3–6 months of effect; requires specialist (paediatric neurologist or ENT).
• Trihexyphenidyl (benzhexol): Sometimes used in children with dystonic CP but has significant CNS side effects.

---

---

MISSED DOSE / DELAYED DOSE GUIDANCE

---

---

• Take the missed dose as soon as remembered, unless the next scheduled dose is within 3 hours.
• If within 3 hours of the next dose, skip the missed dose and take the next dose at the scheduled time.
• ⛔ Never take a double dose to compensate for a missed dose.

---

---

---

• No risk of immunogenicity (not a biologic).
• No withdrawal syndrome from the drug itself upon stopping (the cholinergic rebound described above after prolonged transdermal use is a rebound of the blocked system, not a drug withdrawal syndrome per se).
• No need for re-titration when resuming after interruption.

---

RECONSTITUTION / ADMINISTRATION QUICK REFERENCE (For Nurses & Clinical Staff)

---

---

---

Example: A 15 kg child requires hyoscine hydrobromide 10 mcg/kg IM for premedication.

• • Required dose = 15 × 10 = 150 mcg = 0.15 mg
  • Using the standard 0.4 mg/mL ampoule:
    • Volume to draw = 0.15 / 0.4 = 0.375 mL
  • Alternatively, using the diluted 0.04 mg/mL solution (for smaller children):
    • Volume to draw = 0.15 / 0.04 = 3.75 mL — easier to measure accurately.
  • Administer as a deep IM injection into the vastus lateralis.

---

---

---

---

---

---

---

---

RENAL ADJUSTMENT

---

HEPATIC ADJUSTMENT

---

CONTRAINDICATIONS

---

CAUTIONS

---

---

---

PREGNANCY

---

---

---

LACTATION

---

---

---

---

ELDERLY

---

---

---

---

• Increased risk of cognitive decline with chronic use
• Increased risk of all-cause dementia with cumulative exposure
• Increased mortality in some observational studies of elderly patients

---

---

---

---

MAJOR DRUG INTERACTIONS

---

---

MODERATE DRUG INTERACTIONS

---

---

COMMON ADVERSE EFFECTS

---

---

---

---

SERIOUS ADVERSE EFFECTS

---

---

---

---

MONITORING REQUIREMENTS

---

---

---

---

---

• Single-dose use (premedication, PONV): Monitoring can be discontinued once the patient is fully alert, haemodynamically stable, has voided, and has no signs of anticholinergic toxicity — typically 4–6 hours after parenteral dose (longer in elderly: 8–12 hours).
• Transdermal patch (single application for motion sickness): Monitoring can be relaxed 24 hours after patch removal (residual skin depot effect).
• Chronic use (sialorrhoea, palliative care): Continue monitoring throughout the duration of therapy.

---

PATIENT COUNSELLING

---

---

• Tablet: ”Swallow the tablet whole with a glass of water. You can take it with or without food. For travel sickness, take it 30 minutes before your journey begins.“
• Patch: ”Stick the patch on the clean, dry skin behind your ear (the hairless area). Press firmly for 10–15 seconds. Wash your hands thoroughly with soap and water after touching the patch. Replace the patch every 3 days. When you remove the old patch, fold it in half with the sticky side inward and throw it away safely where children or pets cannot reach it. Put the new patch behind the other ear.“
• Injection: ”This will be given to you by a doctor or nurse. You do not need to do anything.“
• Eye drops: ”The doctor or nurse will put the drops in your eye. After the drops are put in, press gently on the inner corner of your eye (near your nose) for 2–3 minutes. This stops the medicine from going into your body through your tear duct.“

---

• Tablet (for travel sickness): ”If you forget to take it before travel, take it as soon as you remember. But if your next dose is due within 3 hours, skip the missed dose and take the next one on time. Never take two doses together.“
• Patch: ”If your patch falls off or you forget to replace it, put on a new patch as soon as you remember. Do not put on two patches at the same time.“

---

---

• Severe confusion, seeing things that are not there (hallucinations), or unusual behaviour
• Very fast heartbeat or feeling your heart racing
• High fever with dry, hot skin and no sweating (especially in summer)
• Inability to pass urine for more than 8 hours
• Severe stomach pain with bloating and no gas passage
• Severe eye pain, headache with blurred vision and coloured halos around lights (this could be a serious eye problem — it is an emergency)
• Skin rash, swelling of face/lips/tongue, or difficulty breathing (this could be an allergic reaction)"

---

• ”⛔ Do not drink alcohol while using this medicine — it will make drowsiness much worse and can be dangerous.“
• ”⛔ Do not drive, ride a motorcycle, operate machinery, or do any work that needs full alertness while using this medicine. Wait at least 6 hours after an injection, or until 24 hours after removing the patch.“
• ”⚠️ Avoid very hot environments (direct sunlight, working outdoors in summer, hot kitchens, saunas) — this medicine reduces your ability to sweat, and you may overheat. Drink plenty of water. Stay in a cool place.“
• ”⚠️ Do not touch your eyes after handling the patch — the medicine can get into your eye and cause your pupil to widen (one eye may look bigger than the other). This is not dangerous but can be frightening. Wash your hands thoroughly after handling the patch.“

---

• ”Store tablets and patches at room temperature, in a dry place, away from direct sunlight.“
• ”In very hot weather (above 30°C), keep medicines in the coolest part of the house — not in the bathroom, not in a car, and not near a window.“
• ”Keep all medicines away from children.“

---

• ”For travel sickness: this medicine is used only when needed — before and during travel. It is not for daily long-term use.“
• ”For operations: this is given as a single dose. You do not need to continue it at home.“
• ”If your doctor has prescribed the patch for drooling (excess saliva): use it as directed. Do not stop suddenly without talking to your doctor — you may feel nauseous or dizzy for a few days after stopping.“

---

• ”For single-dose use (before an operation or for travel): no routine follow-up blood tests are needed.“
• ”If you are using the patch regularly for drooling: see your doctor every 4–6 weeks initially, then every 3 months, to check whether the medicine is still needed and to watch for side effects.“

---

---

• Watch for confusion, restlessness, hallucinations (seeing things that are not there), or unusual agitation — report to the doctor immediately.
• Make sure the patient is in a cool environment — this medicine stops sweating and the patient can overheat, especially in Indian summer weather.
• Check that the patient has passed urine within 6–8 hours of receiving the injection — tell the nurse or doctor if not.
• Keep the patch, tablets, and used patches away from children and pets — even a used patch contains enough medicine to be dangerous to a small child if sucked or swallowed.
• If the patient is wearing a patch, do not touch it with bare hands and then touch your own or anyone else’s eyes."

---

---

BRANDS AVAILABLE IN INDIA

---

---

---

---

---

---

---

PRICE RANGE (INR)

---

---

---

---

CLINICAL PEARLS

---

VERSION

---

REFERENCES

---

1. CDSCO Product Insert — Hyoscine Hydrobromide Injection IP (generic manufacturers; multiple product inserts reviewed). Approved indications, contraindications, dosing, and adverse effects for the Indian market. Specific manufacturer revision dates vary; most recent reviewed inserts from 2022–2024.
2. Indian Pharmacopoeia 2022 (IP 2022), Indian Pharmacopoeia Commission, Ghaziabad. Monograph on Hyoscine Hydrobromide — specifications, identification, and official standards. 8th Edition.
3. National List of Essential Medicines (NLEM) India 2022, Ministry of Health & Family Welfare, Government of India. Hyoscine hydrobromide is NOT listed; atropine sulphate and glycopyrrolate are listed as anticholinergic premedications. Ondansetron and dexamethasone are listed antiemetics.
4. Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 14th Edition (2023). Chapter 9: Muscarinic Receptor Agonists and Antagonists. Pharmacology of scopolamine (hyoscine) — mechanism of action, pharmacokinetics, clinical pharmacology, adverse effects, and drug interactions. Used for pharmacological depth; deferred to CDSCO product inserts for Indian-specific labelling and approved indications.
5. Harrison’s Principles of Internal Medicine, 21st Edition (2022). Relevant sections on motion sickness, nausea and vomiting, and anticholinergic poisoning.
6. API Textbook of Medicine, 11th Edition (2019), Association of Physicians of India. Sections on motion sickness, palliative care, and anticholinergic pharmacology. References hyoscine hydrobromide as the drug of choice for motion sickness prophylaxis.
7. Indian Association of Palliative Care (IAPC) Treatment Guidelines — Symptom management in terminal illness: management of death rattle, malignant bowel obstruction, nausea and vomiting in palliative care. Hyoscine hydrobromide listed as a first-line option for terminal respiratory secretions.
8. IAP Textbook of Pediatrics, 6th Edition (2021), Indian Academy of Pediatrics. Sections on preanaesthetic medication in children and paediatric palliative care. Dosing references for paediatric anticholinergic use.
9. Pallium India Training Modules — Essentials of Palliative Care. Drug formulary section: hyoscine hydrobromide for terminal secretions and malignant bowel obstruction.
10. Kerala State Palliative Care Policy and Treatment Protocols — References hyoscine hydrobromide for symptom management in terminal illness.
11. American Geriatrics Society 2023 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Lists scopolamine (all formulations) as a drug to avoid in older adults. Used as additional international reference for elderly section.
12. STOPP/START Criteria version 2 (O’Mahony D, et al. Age and Ageing, 2015; 44: 213–218). Used as additional international reference for elderly section — anticholinergic drug cautions.
13. Anticholinergic Cognitive Burden (ACB) Scale (Boustani M, Campbell N, Munger S, et al. Aging Health, 2008; 4: 311–320). ACB score assignment and cumulative burden methodology.
14. Parsons’ Diseases of the Eye, 23rd Edition (2019, Indian edition). Elsevier India. Section on cycloplegic and mydriatic agents. Used for ophthalmic indication context.
15. Cochrane Database of Systematic Reviews — Relevance to the myth vs fact pearl on hyoscine in labour: Samuels LA, Christie L, Roberts-Gittens B, Fletcher H, Frederick J. ”The effect of hyoscine butylbromide on the first stage of labour in term pregnancies.“ Cochrane Database Syst Rev, 2007. (Note: Most Cochrane reviews address hyoscine butylbromide in labour, not hydrobromide; the distinction is noted. Indian studies on hyoscine hydrobromide in labour have shown conflicting results — referenced as general evidence for the clinical pearl.)
16. NPPA (National Pharmaceutical Pricing Authority) — Drug Prices Control Order (DPCO) schedule and ceiling price notifications. Hyoscine hydrobromide is NOT currently price-controlled.
17. PMBJP (Pradhan Mantri Bhartiya Janaushadhi Pariyojana) — Product catalogue reviewed. No hyoscine hydrobromide product currently listed.
18. CDSCO website (https://cdsco.gov.in) — Reviewed for banned FDC notifications, NSQ alerts, and product recall notices relevant to hyoscine-containing formulations. No specific alerts identified for hyoscine hydrobromide.
19. PvPI (Pharmacovigilance Programme of India) — ADR reporting methodology referenced. IPC National Coordinating Centre, Indian Pharmacopoeia Commission.

---