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Dihydrocodeine Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Opioid Analgesic

Subclass

Semi-synthetic Opioid (Codeine Derivative)

Speciality

Pain Medicine

Schedule (India)

Schedule H (Controlled substance under NDPS Act — special prescription requirements and record-keeping may apply as per state regulations)

Routes

Oral

Formulations

Tablets (Immediate-release): 30 mg
Tablets (Sustained-release/Modified-release): 60 mg, 90 mg, 120 mg (limited availability; may vary by region)
Oral solution: NOT AVAILABLE in India
Injectable formulations: NOT AVAILABLE in India

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Moderate to Moderately Severe Pain (Chronic Pain Management)

Immediate-Release Formulation (30 mg tablet):

Parameter	Dose
Starting dose	30 mg orally every 4–6 hours as needed
Titration	Increase by 30 mg per dose based on analgesic response and tolerability; allow 48–72 hours between dose increments
Usual maintenance dose	30–60 mg orally every 4–6 hours
Maximum dose	240 mg/day

Modified-Release Formulation (60 mg, 90 mg, 120 mg tablets):

Parameter	Dose
Starting dose	60 mg orally every 12 hours
Titration	Increase by 30–60 mg/day every 3–5 days based on response
Usual maintenance dose	60–120 mg orally every 12 hours
Maximum dose	240 mg/day

Clinical Notes:

Use lowest effective dose for shortest possible duration
Modified-release formulations are preferred for chronic pain requiring around-the-clock analgesia
Immediate-release may be added for breakthrough pain (use sparingly)
Always co-prescribe laxatives (lactulose, bisacodyl) for chronic use to prevent opioid-induced constipation
Reassess need for continued opioid therapy every 1–3 months
Document pain scores, functional improvement, and adverse effects at each visit
NDPS Act compliance: Maintain prescription records as per state regulations

2. Severe Cough (Refractory to Non-opioid Antitussives)

Parameter	Dose
Starting dose	10–15 mg orally every 6–8 hours
Titration	Not applicable for short-term use
Usual maintenance dose	10–30 mg orally every 6–8 hours
Maximum dose	120 mg/day for antitussive use

Clinical Notes:

Reserve for intractable cough unresponsive to non-opioid antitussives
Short-term use only (typically ≤7 days)
Risk of respiratory depression — avoid in patients with compromised respiratory function
Not for routine cough — use only when cough is significantly distressing

Secondary Indications – Adults (Off-label)

Indication	Dose	Duration	Supervision	Evidence Basis
Dyspnoea in Palliative Care / End-of-Life (OFF-LABEL)	Starting: 10–15 mg orally every 4–6 hours; Titration: increase by 5–10 mg per dose based on symptom relief; Maximum: 60–90 mg/day for this indication	As needed for symptom palliation	Specialist only (Palliative Care)	AIIMS Palliative Care protocols; ICMR Palliative Care Guidelines; global palliative care consensus
Restless Legs Syndrome — Severe/Refractory (OFF-LABEL)	30–60 mg at bedtime	Long-term if effective	Specialist only (Neurology/Sleep Medicine)	Limited evidence; international case series; consider only when dopamine agonists and gabapentinoids have failed
Opioid Substitution for Codeine Intolerance (OFF-LABEL)	Equivalent dose conversion: Codeine 60 mg ≈ Dihydrocodeine 30 mg	As per pain management needs	Specialist recommended	Pharmacological equivalence; Indian pain medicine practice

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

⚠️ Not recommended in children below 12 years of age due to significant risk of respiratory depression, particularly in CYP2D6 ultra-rapid metabolisers.

⚠️ Avoid in adolescents (12–18 years) except under specialist palliative care or paediatric pain management supervision.

Primary Indications

Not applicable — no approved paediatric indications in India.

Secondary Indications – Paediatrics (Off-label)

Indication	Age	Dose	Duration	Supervision	Evidence Basis
Moderate to Severe Pain in Palliative Care / Oncology (OFF-LABEL)	≥12 years only	Starting: 0.5 mg/kg/dose orally every 6 hours; Titration: increase by 0.25 mg/kg/dose based on response; Maximum: 1 mg/kg/dose OR 60 mg per dose (whichever is lower); Maximum daily: 240 mg/day	As needed for pain control	Specialist only (Paediatric Oncology/Palliative Care)	Extrapolated from adult data; AIIMS Paediatric Palliative Care protocols

Safety Monitoring:

Respiratory rate and depth (target: age-appropriate normal range)
Sedation level (use validated paediatric sedation scale)
Oxygen saturation (if available)
Constipation — always co-prescribe laxatives
Signs of opioid toxicity (pinpoint pupils, excessive drowsiness, respiratory depression)

Age Restrictions:

Absolutely not recommended below 12 years of age
Use in 12–18 years only under exceptional circumstances with specialist supervision
Avoid in patients with sleep apnoea, neuromuscular disorders, or respiratory compromise

Renal Adjustments

eGFR (mL/min/1.73 m²)	Recommendation
≥60	No dose adjustment required
30–59	Start at lower dose (50% of normal); extend dosing interval to every 8 hours; monitor for accumulation
15–29	Use with caution; reduce dose by 50–75%; extend interval to every 12 hours; active metabolites accumulate
<15	Avoid if possible; if essential, use very low doses under close supervision
Haemodialysis	Not recommended; if essential, give post-dialysis; specialist input required

Additional Notes:

Dihydrocodeine and its active metabolite (dihydromorphine) are renally excreted
Risk of accumulation and prolonged sedation/respiratory depression in renal impairment
Consider alternative analgesics (fentanyl, buprenorphine) in severe renal impairment

Hepatic adjustment

Contraindications

Known hypersensitivity to dihydrocodeine, codeine, or other opioids
Severe respiratory depression
Acute or severe bronchial asthma (unmonitored setting)
Acute COPD exacerbation with respiratory failure
Paralytic ileus or suspected gastrointestinal obstruction
Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation
Severe hepatic impairment
Children below 12 years of age
Post-tonsillectomy/adenoidectomy pain in patients below 18 years

Cautions

History of substance use disorder or opioid dependence (high risk of misuse, diversion, addiction)
Elderly or debilitated patients (increased sensitivity to CNS and respiratory depression)
Head injury or raised intracranial pressure (may mask neurological signs; risk of respiratory depression worsening ICP)
Hypotension or hypovolaemia
Mild to moderate hepatic or renal impairment
Concurrent use with other CNS depressants (benzodiazepines, alcohol, sedative antihistamines)
Sleep apnoea syndrome
Adrenal insufficiency
Hypothyroidism
Prostatic hypertrophy or urethral stricture
Biliary tract disorders (may cause sphincter of Oddi spasm)
Inflammatory bowel disease
Patients who are CYP2D6 ultra-rapid metabolisers (increased toxicity risk)
Patients who are CYP2D6 poor metabolisers (reduced efficacy)

Pregnancy

Parameter	Information
Overall Safety	Use only if clearly necessary and no safer alternatives; limited human data
Risk	Neonatal opioid withdrawal syndrome if used chronically or near term; neonatal respiratory depression; potential for preterm birth
Preferred Alternatives	Paracetamol (first-line for mild-moderate pain); if opioid required, consider tramadol (short-term) with obstetric supervision
When Use May Be Justified	Severe pain uncontrolled by non-opioid analgesics; short-term use preferred; avoid in third trimester if possible
Monitoring	Fetal growth and well-being; neonatal monitoring for withdrawal symptoms (irritability, feeding difficulties, tremor, seizures) and respiratory depression after delivery if used near term

Lactation

Parameter	Information
Compatibility	Not recommended; avoid if possible
Expected Drug Level in Milk	Low to moderate; however, active metabolite (dihydromorphine) may accumulate in infant
Risk to Infant	Sedation, respiratory depression (particularly if mother is CYP2D6 ultra-rapid metaboliser), feeding difficulties, poor weight gain
Preferred Alternatives	Paracetamol; ibuprofen (if NSAID appropriate); if opioid essential, codeine single dose with monitoring may be considered
Infant Monitoring	Sedation, breathing pattern, feeding behaviour, weight gain
Recommendation	If used, limit to lowest effective dose for shortest duration; monitor infant closely; consider temporary cessation of breastfeeding during treatment

Elderly

Parameter	Recommendation
Starting dose	15–30 mg orally every 6–8 hours (50% of usual adult starting dose)
Titration	Very slow titration; increase by 15 mg per dose no more frequently than every 5–7 days
Maximum recommended	120–180 mg/day (lower than general adult maximum)
Increased Risks	Respiratory depression, excessive sedation, confusion/delirium, falls, constipation (severe), urinary retention, hypotension
Additional Precautions	Assess renal and hepatic function before dosing; use immediate-release formulations initially to allow dose adjustment; ensure laxative co-prescription; monitor cognitive function; regular reassessment for continued need

Major drug interactions

Interacting Drug	Mechanism	Effect	Management
MAOIs (phenelzine, tranylcypromine, moclobemide, linezolid)	MAO inhibition + opioid effect	Severe CNS excitation or depression, serotonin syndrome, hypertensive crisis, respiratory depression	Contraindicated — avoid combination; wait 14 days after stopping MAOI
Benzodiazepines (diazepam, lorazepam, alprazolam)	Additive CNS and respiratory depression	Profound sedation, respiratory depression, coma, death	Avoid if possible; if essential, reduce doses of both by 50% and monitor closely
Alcohol	Additive CNS depression	Severe sedation, respiratory depression, increased overdose risk	Avoid concurrent use; patient counselling mandatory
Other Opioids (morphine, tramadol, fentanyl)	Additive opioid effects	Respiratory depression, excessive sedation, overdose	Avoid concurrent prescribing unless specialist pain management; if transitioning, use appropriate equianalgesic conversion
CYP2D6 Inhibitors (fluoxetine, paroxetine, bupropion, quinidine)	Inhibit conversion to active metabolite (dihydromorphine)	Reduced analgesic efficacy	Consider alternative analgesic or alternative antidepressant
Serotonergic Drugs (SSRIs, SNRIs, triptans, tramadol)	Additive serotonergic effect (dihydrocodeine has weak serotonergic activity)	Potential serotonin syndrome (rare but possible)	Use with caution; monitor for serotonin toxicity symptoms

Moderate drug interactions

Interacting Drug	Effect	Management
CYP3A4 Inducers (rifampicin, carbamazepine, phenytoin, phenobarbital)	Increased metabolism; reduced dihydrocodeine efficacy	Monitor analgesic response; may need dose adjustment
CYP3A4 Inhibitors (ketoconazole, clarithromycin, erythromycin, ritonavir)	Decreased metabolism; increased dihydrocodeine levels	Monitor for toxicity; may need dose reduction
Anticholinergics (oxybutynin, tolterodine, tricyclic antidepressants)	Additive anticholinergic effects	Increased risk of severe constipation, urinary retention, confusion; monitor closely
Gabapentinoids (gabapentin, pregabalin)	Additive CNS depression	Monitor for sedation; may be used together for multimodal analgesia with caution
Antiemetics (metoclopramide, domperidone)	May alter GI motility and opioid absorption; metoclopramide may have additive extrapyramidal effects	Generally can be used; monitor response
Antihypertensives	Additive hypotensive effects	Monitor blood pressure; counsel on postural hypotension
Muscle relaxants (baclofen, tizanidine)	Additive sedation	Use with caution; monitor for excessive sedation

Common Adverse effects

Constipation (very common; dose-related)
Nausea, vomiting (especially with initiation; usually improves)
Drowsiness, sedation
Dizziness, lightheadedness
Dry mouth
Sweating
Headache
Pruritus
Euphoria/dysphoria

Serious Adverse effects

Adverse Effect	Clinical Action
Respiratory depression (particularly in elderly, opioid-naive, those with sleep apnoea, or concurrent CNS depressants)	Discontinue immediately; supportive ventilation; naloxone 0.4–2 mg IV (repeat every 2–3 minutes as needed); hospitalisation
Opioid dependence and withdrawal syndrome (with chronic use: anxiety, insomnia, sweating, diarrhoea, piloerection, muscle cramps)	Do not discontinue abruptly; taper gradually over 2–4 weeks minimum
Severe hypotension	Supportive care; IV fluids; reduce or discontinue opioid
CNS depression, confusion, delirium (especially in elderly)	Reduce dose or discontinue; assess for other contributing factors
Paralytic ileus	Discontinue opioid; supportive management; may require nasogastric decompression
Biliary spasm	May mimic biliary colic; reduce dose or switch analgesic
Seizures (rare; usually in overdose or with concurrent proconvulsant drugs)	Discontinue; benzodiazepines for seizure control; supportive care
Anaphylaxis / Severe hypersensitivity (rare)	Discontinue permanently; emergency management
Serotonin syndrome (with concurrent serotonergic drugs: hyperthermia, rigidity, myoclonus, autonomic instability)	Discontinue all serotonergic drugs; supportive care; cyproheptadine may be used

Monitoring requirements

Timing	Parameters
Baseline	Pain assessment (severity, character, location); hepatic function (LFTs); renal function (serum creatinine, eGFR); respiratory status; mental status/cognition; history of substance use; concurrent medications
After initiation / dose change (1–7 days)	Pain control efficacy; sedation level; respiratory rate (target ≥12/min); nausea/vomiting; bowel function (constipation assessment)
Short-term (2–4 weeks)	Continued efficacy; adverse effects; early signs of tolerance or dependence; functional improvement assessment
Long-term (every 1–3 months)	Reassess need for continued opioid therapy; pain scores and functional status; signs of tolerance, dependence, or misuse; constipation management adequacy; cognitive effects (especially elderly); endocrine effects with chronic use (testosterone levels if hypogonadism suspected)
On discontinuation	Taper gradually (reduce by 10–25% every 2–4 days); monitor for withdrawal symptoms

Brands in India

Immediate-Release (30 mg):

DF-118™ (Genus/Mundipharma) — 30 mg tablets
Dihydrocodeine™ (Generic — limited manufacturers)

Modified-Release:

DHC Continus™ — 60 mg, 90 mg, 120 mg (availability may vary by region)

Fixed-Dose Combinations:

Co-dydramol™ (Dihydrocodeine 10 mg + Paracetamol 500 mg) — limited availability
Paramol™ (similar FDC) — limited availability

Note: Availability of dihydrocodeine formulations in India is limited and may vary by region. Verify local availability before prescribing. NDPS Act documentation requirements apply.

Price range (INR)

Formulation	Price Range	Notes
30 mg IR tablet	₹5–₹12 per tablet	Limited availability
60 mg MR tablet	₹12–₹20 per tablet	Regional variation
90 mg MR tablet	₹18–₹28 per tablet	Limited availability
FDCs (Dihydrocodeine + Paracetamol)	₹4–₹8 per tablet	Variable availability

Regulatory: Not listed under NLEM 2022; not under NPPA price control; controlled substance under NDPS Act — special prescription and record-keeping requirements apply as per state regulations

Clinical pearls

Modified-release for baseline, immediate-release for breakthrough — Use MR formulations for stable chronic pain requiring round-the-clock analgesia; reserve IR formulations for breakthrough pain episodes (limit to 2–3 breakthrough doses per day)
Always co-prescribe laxatives — Opioid-induced constipation is near-universal with chronic use and does not develop tolerance; start stimulant laxative (bisacodyl) plus stool softener (lactulose) prophylactically
CYP2D6 variability matters — Dihydrocodeine is partially converted to dihydromorphine (active metabolite) via CYP2D6; ultra-rapid metabolisers may experience toxicity at standard doses; poor metabolisers may have inadequate analgesia; consider genetic testing or therapeutic monitoring if response is unexpected
NDPS Act compliance — Maintain proper prescription records and documentation as required by state NDPS regulations; prescription format requirements may vary by state
Avoid abrupt discontinuation — Physical dependence develops with regular use beyond 1–2 weeks; taper gradually (10–25% dose reduction every 2–4 days) to prevent withdrawal syndrome
Elderly require special attention — Start at 50% of usual adult dose; titrate slowly; increased risk of falls, confusion, and respiratory depression; prefer immediate-release initially to allow careful titration

Version

RxIndia v1.0 — 04 Apr 2025

Reference

CDSCO Product Information
Indian Pharmacopoeia (IP)
NLEM 2022 (exclusion noted)
NDPS Act and Rules (prescription requirements)
API Textbook of Medicine
AIIMS Pain Management and Palliative Care Protocols
ICMR Palliative Care Guidelines
Goodman & Gilman's The Pharmacological Basis of Therapeutics
Harrison's Principles of Internal Medicine
Indian Association for Palliative Care — Opioid Prescribing Guidelines

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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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