Sulfasalazine
Contraindicated
Textbook
Exacerbation of inflammatory bowel disease (IBD).
Avoid combining sulfasalazine with traditional NSAIDs.
Source: G&G 14e · p1112
Drug reference
Aceclofenac + Paracetamol
NSAID · Analgesic, Anti-inflammatory, Antipyretic
Also known as Zerodol-P, Hifenac-P, Acelo-P, Acecloflam-P, Dolokind Plus
NSAIDAnalgesic, Anti-inflammatory, Antipyretic
CDSCO approved
EXCRETION
—
not curated
INTERACTIONS
12 major
incl. contraindicated
PREGNANCY
—
not curated
Top interactionssee all 12 →
- SulfasalazineContraindicatedTextbookG&G 14e · p1112
- AminoglycosideSevereTextbookKDT 7e · p746
- AminoglycosidesSevereTextbookKDT 7e
- AnticoagulantsSevereTextbookKDT 7e
Mechanism
Aceclofenac, an NSAID, primarily exerts its anti-inflammatory and analgesic effects by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis at the site of inflammation. Paracetamol (Acetaminophen) acts predominantly in the central nervous system, where it inhibits prostaglandin synthesis and may also involve other mechanisms like the serotonergic descending inhibitory pathway. The combination provides complementary actions, with aceclofenac targeting peripheral inflammation and pain, and paracetamol offering additional central analgesic and antipyretic effects. Combination rationale: This Fixed Dose Combination is rational as aceclofenac provides potent anti-inflammatory and analgesic effects, while paracetamol contributes additional analgesic and antipyretic actions. The combination allows for a potentially lower dose of aceclofenac to achieve comparable efficacy, which may reduce the risk of NSAID-related gastrointestinal side effects. It offers broader pain relief, particularly beneficial for inflammatory pain conditions often accompanied by fever.
Indications
Pain and inflammation associated with musculoskeletal disorders (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis)Post-operative painDental painMild to moderate pain with feverDysmenorrhea
Dosing
- Adult
- One tablet of Aceclofenac 100mg + Paracetamol 325mg or 500mg, orally, twice daily after meals. Common strengths available in India are Aceclofenac 100mg + Paracetamol 325mg and Aceclofenac 100mg + Paracetamol 500mg.
- Pediatric
- Generally not recommended for children under 12 years due to the aceclofenac component. Use individual components if needed, following age and weight-appropriate dosing.
- Renal adjustment
- Use with caution and dose reduction in mild-moderate renal impairment. Contraindicated in severe renal impairment (CrCl <30 mL/min). Renal function monitoring is advised.
Pharmacokinetics
Onset
Aceclofenac: 30-60 minutes; Paracetamol: 30-60 minutes
Peak effect
Aceclofenac: 1.25-3 hours; Paracetamol: 0.5-2 hours
Protein binding
Aceclofenac: >99%; Paracetamol: 10-25%
Contraindications
- Hypersensitivity to aceclofenac, paracetamol, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulceration
- Severe renal impairment (CrCl < 30 mL/min)
- Severe hepatic impairment
- Severe heart failure
- Third trimester of pregnancy
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Coronary artery bypass graft (CABG) surgery (peri-operative pain)
Side effects
Common
NauseaVomitingDiarrheaDyspepsiaAbdominal painDizzinessHeadacheSkin rashElevated liver enzymes
Serious
- Gastrointestinal ulceration or bleeding
- Renal impairment/failure
- Hepatotoxicity (especially with paracetamol overdose)
- Cardiovascular thrombotic events (MI, stroke) with NSAIDs
- Severe skin reactions (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis)
- Anaphylactoid reactions
- Asthma exacerbation
Drug interactions
Aminoglycoside
Severe
Textbook
Increased risk of nephrotoxicity.
Avoid concurrent use.
Source: KDT 7e · p746
Aminoglycosides
Severe
Textbook
Increased aminoglycoside levels and potential toxicity.
Monitor aminoglycoside levels and renal function; adjust dosage as needed.
Source: KDT 7e
Anticoagulants
Severe
Textbook
Increased risk of gastrointestinal bleed.
Monitor for bleeding; consider alternative analgesics or gastroprotective agents.
Source: KDT 7e
Ciprofloxacin
Severe
Textbook
Enhanced CNS toxicity, seizures reported.
Source: KDT 7e
Citalopram
Severe
Textbook
Increased risk of gastrointestinal bleed.
Monitor for bleeding; consider gastroprotective agents or alternative analgesics.
Source: KDT 7e
Clopidogrel
Severe
Textbook
Increased bleeding risk.
Exercise extra caution and monitor for signs of bleeding.
Source: G&G 14e
Corticosteroids
Severe
Textbook
Increased risk of gastrointestinal bleed.
Monitor for bleeding; consider gastroprotective agents.
Source: KDT 7e
Cyclosporine
Severe
Textbook
Increased nephrotoxicity.
Avoid concomitant use or monitor renal function closely.
Source: KDT 7e
Dapoxetine
Severe
Textbook
Increased risk of gastrointestinal bleed.
Monitor for bleeding; consider gastroprotective agents or alternative analgesics.
Source: KDT 7e
Enalaprilat
Severe
Textbook
Reduced effectiveness of ACE inhibitors. Marked hyperkalemia, potentially leading to cardiac arrhythmia.
Use with caution, especially in the elderly and in patients with hypertension, diabetes mellitus, or ischemic heart disease.
Source: G&G 14e · p836
Escitalopram
Severe
Textbook
Increased risk of gastrointestinal bleed.
Monitor for bleeding; consider gastroprotective agents or alternative analgesics.
Source: KDT 7e
Related guidelines
Other NSAID drugs
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