Schedule H

Oral, Topical

• Tablets: 100 mg, 200 mg (modified-release)

• Suspension: NOT AVAILABLE in India

• Topical gel: 1.5% w/w

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Indication Starting Dose Titration Usual Maintenance Dose Maximum Dose Clinical Notes

Osteoarthritis 100 mg once daily Increase to 100 mg BD after 1 week if needed 100 mg twice daily 200 mg/day Administer after food; assess GI and CV risk before initiation

Rheumatoid arthritis 100 mg once daily Increase to 100 mg BD after 1 week if tolerated 100 mg twice daily 200 mg/day Clinical response may take 2–4 weeks; combine with DMARDs as appropriate

Ankylosing spondylitis 100 mg once daily Increase to 100 mg BD based on response 100 mg twice daily 200 mg/day Efficacy comparable to other NSAIDs in this indication

Topical Formulation (Gel 1.5% w/w):

Parameter Recommendation

Application Thin layer over affected area

Frequency 3–4 times daily

Duration Short-term use preferred (1–2 weeks)

Precautions Avoid broken skin, infected areas, occlusive dressings; wash hands after application

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

Indication Dose Duration Notes Evidence Basis

Acute musculoskeletal pain — OFF-LABEL 100 mg twice daily 3–5 days Step-down to paracetamol when symptoms resolve; specialist supervision in patients with comorbidities Common Indian outpatient practice; supported by clinical experience

Post-operative pain — OFF-LABEL 100 mg twice daily 3–5 days Use with PPI cover; short course only Indian orthopaedic practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not approved for paediatric use in India.

• Safety and efficacy data in children are insufficient

• No CDSCO-approved paediatric indications

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

Indication Age Dose Maximum Dose Duration Notes

Juvenile idiopathic arthritis — OFF-LABEL ≥6 years 1–3 mg/kg/day in 2 divided doses 200 mg/day As directed by specialist Paediatric rheumatologist supervision mandatory

Monitoring Requirements (Paediatric):

• Baseline: CBC, LFT, serum creatinine

• Periodic: LFT and renal function every 4–6 weeks

• Monitor for GI symptoms, rash, and growth parameters

Clear Statement:

Aceclofenac should NOT be used in children below 6 years of age. Use in patients 6–18 years is strictly off-label and requires paediatric rheumatologist supervision.

60 (Normal to mild impairment) No dose adjustment; standard dosing

30–60 (Moderate impairment) Start with 100 mg once daily; use with caution; monitor renal function

<30 (Severe impairment) Avoid use

Haemodialysis Avoid — limited clearance, risk of drug accumulation

Peritoneal dialysis No data available; avoid use

• Known hypersensitivity to aceclofenac, aspirin, or other NSAIDs

• History of NSAID-induced asthma, urticaria, or angioedema

• Active peptic ulcer disease or gastrointestinal bleeding

• History of recurrent GI ulceration (≥2 distinct episodes)

• Severe hepatic impairment (Child-Pugh C)

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

• Congestive heart failure (NYHA Class II–IV)

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

• Severe uncontrolled hypertension

• Third trimester of pregnancy

• Concurrent use with other NSAIDs (including COX-2 inhibitors)

• Controlled hypertension — may worsen blood pressure control

• Elderly patients (≥65 years) — increased risk of all NSAID-related adverse effects

• Volume depletion or concurrent diuretic use — risk of acute kidney injury

• Cardiovascular risk factors (diabetes, hyperlipidaemia, smoking)

• History of healed peptic ulcer or GI bleeding

• Asthma (particularly NSAID-exacerbated respiratory disease)

• Concurrent anticoagulant, antiplatelet, or corticosteroid therapy

• First and second trimester of pregnancy — use only if essential

• Prolonged treatment duration — reassess need periodically

Parameter Details

Overall Safety Not recommended; avoid throughout pregnancy if possible

First Trimester Possible increased risk of miscarriage; avoid unless essential

Second Trimester Avoid if alternatives available

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

Preferred Alternatives Paracetamol for mild-moderate pain

If Use Essential Lowest effective dose for shortest duration; first/second trimester only with specialist input

Monitoring Fetal growth, amniotic fluid volume, ductus arteriosus patency if late exposure

Parameter Details

Compatibility Likely compatible — minimal excretion expected

Drug Levels in Milk Low (based on class pharmacokinetics)

Preferred Alternatives Paracetamol, ibuprofen (short-term)

Infant Monitoring GI disturbance (vomiting, diarrhoea), rash, irritability

Recommendation Use lowest effective dose for shortest duration; monitor infant

Parameter Recommendation

Starting Dose 100 mg once daily

Titration Slow; increase to 100 mg BD only if clearly needed and tolerated

Maximum Dose Use lowest effective dose; avoid 200 mg/day if possible

Special Risks GI bleeding, renal impairment, cardiovascular events, fluid retention, drug interactions due to polypharmacy

Monitoring Renal function, blood pressure, haemoglobin (for occult GI blood loss) at baseline and periodically

General Advice Consider topical formulation for localised musculoskeletal pain; co-prescribe PPI if oral NSAID essential

Interacting Drug Effect / Mechanism Management

ACE inhibitors / ARBs Reduced antihypertensive efficacy; increased risk of renal impairment Monitor BP and renal function closely; ensure adequate hydration

Warfarin / Acenocoumarol Increased bleeding risk; may elevate INR Monitor INR closely; consider alternative analgesic

Methotrexate Increased methotrexate levels and toxicity (reduced renal clearance) Avoid concurrent use with high-dose methotrexate; monitor closely with low-dose

Lithium Increased lithium plasma concentration Monitor lithium levels; may require dose reduction

Other NSAIDs / COX-2 inhibitors Additive GI and CV toxicity; no additional efficacy Avoid combination

Diuretics + ACE inhibitors/ARBs ("Triple Whammy") Significantly increased risk of acute kidney injury Avoid triple combination; ensure hydration

Interacting Drug Effect / Mechanism Management

Diuretics (furosemide, thiazides) Reduced diuretic and antihypertensive efficacy Monitor BP and fluid status

Antiplatelets (aspirin, clopidogrel) Increased GI bleeding risk Consider PPI gastroprotection

Corticosteroids Additive GI ulceration and bleeding risk Consider PPI cover; monitor for GI symptoms

Sulfonylureas (glibenclamide, glimepiride) Enhanced hypoglycaemic effect Monitor blood glucose more frequently

Ciclosporin Additive nephrotoxicity Monitor renal function closely

SSRIs (fluoxetine, sertraline) Increased GI bleeding risk Consider PPI cover

Quinolones (ciprofloxacin) Possible increased CNS stimulation and seizure risk Use with caution

• Dyspepsia, epigastric pain

• Nausea, vomiting

• Diarrhoea or constipation

• Headache

• Dizziness

• Elevated hepatic transaminases (usually transient)

• Peripheral oedema

• Abdominal bloating

Adverse Effect Notes

GI bleeding / Peptic ulcer perforation May occur without warning symptoms; requires immediate discontinuation and urgent management

Hepatotoxicity Hepatitis, cholestatic jaundice; discontinue if ALT >3× ULN or clinical hepatitis develops

Acute kidney injury Especially in volume-depleted or elderly; monitor creatinine

Stevens-Johnson syndrome / Toxic epidermal necrolysis Rare but life-threatening; immediate discontinuation and hospitalisation required

Severe bronchospasm In NSAID-sensitive asthmatic patients

Cardiovascular events Myocardial infarction, stroke — risk increases with dose and duration

Anaphylaxis / Angioedema Immediate discontinuation; emergency management

After initiation (2–4 weeks) Serum creatinine, LFTs; earlier if symptoms arise

Long-term (if >4 weeks) LFT and renal function monthly; haemoglobin every 2–3 months; BP at each visit

Additional GI symptoms monitoring especially if on anticoagulants, antiplatelets, or corticosteroids

Single-ingredient formulations:

• Hifenac (Ipca)

• Zerodol (Ipca)

• Acemiz (Lupin)

• Movon (Macleods)

• Acenac (Alkem)

Common Fixed-Dose Combinations (FDCs):

Note: Use FDCs judiciously — increased polypharmacy risk and adverse effects.

• NLEM Status: Aceclofenac + Paracetamol combination is under NPPA price control

• Single-ingredient aceclofenac: Not under price control

1. GI risk assessment essential: Always evaluate GI bleeding history and consider prophylactic PPI in high-risk patients (elderly, prior ulcer, concurrent anticoagulants/steroids).

1. Avoid prolonged use: For chronic pain conditions, reassess need every 4–6 weeks and consider non-pharmacological alternatives.

1. Renal vigilance in vulnerable patients: Monitor creatinine closely in elderly, diabetics, and those on ACE inhibitors/ARBs or diuretics — especially during dehydration states.

1. Topical route underutilised: For localised musculoskeletal pain, topical aceclofenac offers adequate local effect with minimal systemic exposure — consider before oral route in elderly.

1. FDC caution: Aceclofenac + Paracetamol FDCs are widely prescribed but may lead to inadvertent paracetamol overdose if additional paracetamol is taken — counsel patients.

1. Not a first-line analgesic: Reserve for inflammatory pain conditions where paracetamol is inadequate; paracetamol remains safer for baseline analgesia.

aceclofenac; NSAID; analgesic; arthritis; osteoarthritis; rheumatoid arthritis; GI-risk; renal-caution; hepatotoxicity; cardiovascular-risk; Schedule-H; NLEM-FDC

RxIndia v1.0 — 10 Jan 2025

• CDSCO approved product information

• Indian Pharmacopoeia 2018

• NLEM India 2022

• API Textbook of Medicine (NSAID chapter)

• AIIMS Drug Formulary and Clinical Pharmacology protocols

• National Centre for Disease Control (NCDC) — Pain management modules

• Indian Rheumatology Association clinical practice