Schedule H

Oral, Parenteral (IM, IV), Topical (gel, patch, solution), Rectal, Ophthalmic

Form Strengths Available

Tablet (immediate-release) 25 mg, 50 mg

Tablet (sustained-release) 75 mg, 100 mg

Injection (IM) 75 mg/3 mL

Injection (IV) 75 mg/1 mL

Topical gel 1%, 2%

Transdermal patch 100 mg

Eye drops 0.1%

Suppository 50 mg, 100 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Osteoarthritis, Musculoskeletal Pain, Low Back Pain

Parameter Oral (Immediate-Release) Oral (Sustained-Release)

Starting dose 50 mg twice daily 75 mg once daily

Titration Increase by 25–50 mg/day based on response and tolerability May increase to twice daily if inadequate response

Usual maintenance dose 100–150 mg/day in 2–3 divided doses 75–100 mg once or twice daily

Maximum dose 150 mg/day (200 mg/day short-term only, ≤14 days) 200 mg/day (short-term only)

Clinical Notes: Use lowest effective dose for shortest duration. Co-prescribe PPI if risk factors for GI bleeding present.

1. Rheumatoid Arthritis, Ankylosing Spondylitis

Parameter Dosing

Starting dose 50 mg twice or thrice daily OR 75 mg SR twice daily

Titration Adjust based on disease activity and tolerance

Usual maintenance dose 100–150 mg/day in divided doses

Maximum dose 200 mg/day (short periods during flares only, ≤7 days)

Clinical Notes: Often used as adjunct to DMARDs. Regular monitoring of LFTs and renal function essential with long-term use.

1. Acute Migraine

Parameter Dosing

Starting dose 50–75 mg orally at onset

Titration Not applicable

Usual maintenance dose Single dose at onset; may repeat once after 8 hours

Maximum dose 150 mg/day

Alternative routes Rectal: 50–100 mg suppository; IM: 75 mg once (if vomiting present)

Clinical Notes: Most effective when administered early in attack. Specialist supervision recommended for frequent use.

1. Acute Post-operative Pain, Renal Colic

Route Dosing Details

IM Injection Starting dose: 75 mg stat

Titration: May repeat after 6–8 hours if required

Maximum dose: 150 mg/day

Maximum duration: 2 days

IV Infusion Dilute 75 mg in 100–500 mL NS or 5% dextrose

Infuse over 30–120 minutes

Maximum duration: 2 days, then switch to oral

Clinical Notes: Avoid IM route in anticoagulated patients. IV route preferred in hospital settings with monitoring.

1. Localized Soft Tissue Inflammation (Sprain, Tendinitis, Sports Injuries)

Parameter Topical Gel/Solution

Starting dose Apply 2–4 g to affected area

Frequency 3–4 times daily

Maximum dose 8 g per joint per day; 32 g total body per day

Duration Up to 14 days for acute conditions

Clinical Notes: Systemic absorption is minimal. Preferred route for localized knee/hand osteoarthritis in elderly.

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Supervision Evidence

Renal colic (adjunct to hydration/antispasmodics) 75 mg IM once; repeat after 6 hours if needed ≤3 days ER physician Supported by RCTs; AIIMS ER protocols

Dysmenorrhoea (primary) 50 mg thrice daily or 75 mg SR twice daily During menstruation only General practice Indian specialist practice; standard obstetric texts

Acute gout flare (if colchicine contraindicated) 50 mg thrice daily 5–7 days Specialist only OFF-LABEL; API Textbook supportive

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Juvenile Idiopathic Arthritis (JIA) — Paediatric Rheumatologist Only

Parameter Dosing

Age limit ≥14 years only

Starting dose 1 mg/kg/day in 2–3 divided doses

Titration Increase based on response; maximum 2 mg/kg/day

Usual maintenance dose 1–2 mg/kg/day in divided doses

Maximum dose 150 mg/day (regardless of weight)

Safety Monitoring:

• Baseline and periodic LFTs (every 4–6 weeks initially)

• Monitor for GI symptoms (epigastric pain, black stools)

• Avoid sustained-release preparations

• Ensure adequate hydration

Secondary Indications — Paediatric Doses (Off-label)

Indication Dose Age Supervision Evidence

Post-operative analgesia (short-term) 0.5–1 mg/kg/dose twice daily ≥14 years Specialist only OFF-LABEL; limited paediatric surgery data

Not recommended for:

• Migraine prophylaxis in children

• General pain relief in children <14 years

• Fever management

⚠️ CLEAR STATEMENT: Diclofenac is NOT recommended in children <14 years except under paediatric rheumatology or specialist supervision. First-line alternatives: Paracetamol, Ibuprofen (for children ≥3 months).

60 No adjustment; use standard dosing

30–60 Use with caution; start at lower dose; monitor creatinine weekly

<30 AVOID — increased risk of acute kidney injury and fluid retention

Haemodialysis Not dialysed significantly; AVOID due to residual renal function risk

Peritoneal dialysis AVOID

Monitoring: Serum creatinine, urea, and electrolytes at baseline and periodically (every 2–4 weeks if used in mild-moderate impairment).

• Known hypersensitivity to diclofenac or any excipient

• History of asthma, urticaria, angioedema, or allergic reactions precipitated by aspirin or other NSAIDs

• Active peptic ulcer disease or gastrointestinal bleeding

• History of GI bleeding or perforation related to prior NSAID therapy

• Severe hepatic impairment (Child-Pugh C)

• Severe renal impairment (eGFR <30 mL/min/1.73 m²)

• Severe heart failure (NYHA Class III–IV)

• Established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease

• Perioperative pain management in coronary artery bypass graft (CABG) surgery

• Third trimester of pregnancy

• Active inflammatory bowel disease (ulcerative colitis, Crohn's disease)

• Elderly patients (increased GI, renal, and cardiovascular risk)

• Mild-to-moderate hypertension (may worsen blood pressure control)

• Compensated heart failure (NYHA Class I–II)

• History of peptic ulcer disease (healed)

• Concurrent anticoagulant or antiplatelet therapy

• NSAID-exacerbated respiratory disease (aspirin-sensitive asthma)

• Volume depletion or dehydration

• Concurrent use of nephrotoxic drugs

• Systemic lupus erythematosus (SLE) or mixed connective tissue disease

• Long-term use: requires regular monitoring of renal, hepatic function, and CBC

• Smokers and alcohol users (increased GI bleeding risk)

Aspect Details

Risk Category First/Second Trimester: Category C equivalent; Third Trimester: CONTRAINDICATED

First Trimester Avoid if possible; potential association with miscarriage (conflicting data)

Second Trimester Use only if clearly necessary; short-term use; lowest effective dose

Third Trimester CONTRAINDICATED — risk of premature closure of ductus arteriosus, oligohydramnios, delayed labour

Preferred Alternatives Paracetamol (first-line for pain/fever throughout pregnancy)

Monitoring If use unavoidable in second trimester: monitor amniotic fluid volume via ultrasound; fetal echocardiography if prolonged use

Aspect Details

Compatibility Compatible with breastfeeding for short-term use

Levels in breast milk Low (milk:plasma ratio ~0.01–0.1)

Duration limit Avoid oral use beyond 3 days; topical preferred for local pain

Infant monitoring Observe for GI upset (vomiting, diarrhoea), reduced feeding, irritability

Preferred alternatives Paracetamol, Ibuprofen (both well-established in lactation)

Aspect Recommendation

Starting dose 25–50 mg/day (lowest effective dose)

Titration Slow titration over 1–2 weeks based on response

Maximum dose Aim for ≤100 mg/day

Duration Shortest duration possible

Special risks Increased GI bleeding (4-fold higher), renal impairment, cardiovascular events, confusion, fluid retention

Co-prescription PPI (e.g., Pantoprazole 40 mg daily) strongly recommended for gastroprotection

Preferred alternatives Topical diclofenac for localized OA; Paracetamol for mild pain

Interacting Drug Effect Management

Warfarin, Acenocoumarol Increased bleeding risk; enhanced anticoagulant effect Avoid combination OR monitor INR closely; consider PPI co-prescription

Apixaban, Rivaroxaban, Dabigatran Increased bleeding risk Avoid combination if possible

Aspirin (antiplatelet doses) Additive GI toxicity; may reduce cardioprotective effect of aspirin Avoid combination; if essential, use lowest NSAID dose + PPI

Methotrexate (high-dose) Decreased methotrexate clearance → toxicity Avoid within 24 hours of high-dose MTX

Lithium Increased serum lithium levels (20–40%) → toxicity Monitor lithium levels; reduce lithium dose if needed

Other NSAIDs Additive GI and renal toxicity; no additional efficacy Avoid combination

Pemetrexed Decreased renal clearance → increased toxicity Avoid for 2 days before to 2 days after pemetrexed

Interacting Drug Effect Management

ACE inhibitors (Enalapril, Ramipril) Reduced antihypertensive effect; increased nephrotoxicity risk Monitor BP and renal function; ensure hydration

ARBs (Losartan, Telmisartan) Same as ACE inhibitors Monitor BP and renal function

Loop diuretics (Furosemide) Reduced diuretic efficacy; increased nephrotoxicity Monitor fluid status, urine output, renal function

Thiazides (Hydrochlorothiazide) Reduced antihypertensive and diuretic effect Monitor BP

SSRIs (Fluoxetine, Sertraline) Increased GI bleeding risk Co-prescribe PPI

Corticosteroids Increased GI ulceration and bleeding risk Co-prescribe PPI; limit duration

Cyclosporine Additive nephrotoxicity Monitor renal function closely

Tacrolimus Additive nephrotoxicity Monitor renal function closely

Methotrexate (low-dose) Mild increase in MTX levels Monitor for MTX toxicity; check CBC

Quinolones (Ciprofloxacin, Levofloxacin) Rare increased seizure risk Use with caution in epilepsy

Digoxin Increased digoxin levels Monitor digoxin levels if initiating/stopping diclofenac

• Dyspepsia, epigastric discomfort (10–30%)

• Nausea, vomiting (3–10%)

• Diarrhoea or constipation (1–10%)

• Headache (3–9%)

• Dizziness (1–3%)

• Peripheral oedema, fluid retention (1–3%)

• Elevated transaminases (up to 15%, usually transient)

• Application site reactions with topical use (pruritus, erythema, dermatitis)

Adverse Effect Clinical Notes

Peptic ulcer, GI bleeding, perforation May occur without warning; higher risk in elderly, prior ulcer history

Acute kidney injury Especially with dehydration, concurrent nephrotoxins, or pre-existing renal impairment

Hepatotoxicity Monitor LFTs; discontinue if ALT >3× ULN with symptoms

Cardiovascular thrombotic events MI, stroke — risk increases with dose and duration

Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN) Rare; discontinue immediately if mucocutaneous lesions appear

Anaphylaxis, angioedema Immediate discontinuation; emergency management

NSAID-exacerbated respiratory disease Bronchospasm in aspirin-sensitive asthmatics

Agranulocytosis, aplastic anaemia Rare; discontinue and refer to haematology

Aseptic meningitis Rare; reported in SLE patients

Phase Parameters

Baseline CBC, LFTs (ALT, AST), renal function (creatinine, urea, eGFR), blood pressure

After 1–2 weeks Renal function, LFTs (especially if prolonged use anticipated)

Monthly (if long-term) Renal function, LFTs

Every 2–3 months (chronic use) CBC, LFTs, renal function

Ongoing GI symptoms (dyspepsia, melaena, haematemesis); blood pressure if hypertensive; signs of fluid retention

Brand Name Manufacturer Notes

Voveran Novartis Tablets, SR, injection, gel

Voveran SR Novartis Sustained-release formulation

Diclogem Gemini Tablets, gel

Dicloran Ipca Tablets, injection

Dynapar Troikaa Tablets, gel, injection

Reactin Alkem Tablets, SR

Voltaren GSK (Originator) Limited availability

Jonac Cadila Tablets, gel

Note: Multiple fixed-dose combinations (FDCs) with paracetamol, serratiopeptidase exist — evaluate rationality and necessity before prescribing. Many FDCs banned by CDSCO.

Note: Prices regulated by NPPA under Drug Price Control Order for NLEM formulations. Government supply available at subsidised rates.

1. Gastroprotection is essential: Co-prescribe PPI (Pantoprazole/Omeprazole) for patients aged >65 years, those with ulcer history, or on concurrent anticoagulants/corticosteroids/SSRIs.

1. Topical route reduces systemic risk: For localized knee or hand osteoarthritis, topical diclofenac achieves adequate local effect with minimal systemic exposure — preferred in elderly or those with cardiovascular/renal concerns.

1. Renal colic efficacy: IM diclofenac 75 mg provides rapid, effective analgesia for renal colic and is equivalent to opioids in many RCTs — first-line in AIIMS ER protocols.

1. Avoid IM in anticoagulated patients: Risk of intramuscular haematoma; use IV infusion or oral/rectal alternatives.

1. Shortest duration principle: Cardiovascular risk increases with dose and duration — use lowest effective dose for shortest period necessary.

1. Third trimester is absolute contraindication: Risk of premature ductus arteriosus closure — no exceptions; switch to paracetamol.

1. Transaminase elevations common but often transient: Monitor LFTs; discontinue only if ALT >3× ULN with symptoms or ALT >5× ULN without symptoms.

NSAID; musculoskeletal pain; osteoarthritis; rheumatoid arthritis; renal colic; NLEM India; renal-caution; GI-risk; cardiovascular-risk; elderly-caution; topical-NSAID; Schedule-H

RxIndia v1.1 — 28 Mar 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• AIIMS Drug Formulary

• AIIMS Emergency Department protocols (renal colic management)

• ICMR Guidelines on rational use of analgesics

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive)

• Harrison's Principles of Internal Medicine (supportive)

• International RCTs for renal colic efficacy (off-label evidence)