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The information provided in this report is intended solely for educational and professional reference purposes and is not a substitute for medical advice, diagnosis, or treatment. Clinical decisions must always be based on the official prescribing information approved by regulatory authorities and the judgment of qualified healthcare professionals.
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2. Summary
BRISTAFLAM® is a non-steroidal anti-inflammatory drug (NSAID) containing aceclofenac, formulated as oral film-coated tablets and a topical cream. It is used for the symptomatic relief of pain, inflammation, and stiffness associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and various acute musculoskeletal conditions. Aceclofenac exhibits preferential COX-2 inhibition, contributing to effective anti-inflammatory activity with relatively improved gastrointestinal tolerability compared to some traditional NSAIDs, though class-related risks remain.
3. Brand Name
BRISTAFLAM®
4. Category
- Therapeutic Class: Non-Steroidal Anti-Inflammatory Drug (NSAID)
- Chemical Class: Acetic acid derivative (phenylacetic acid group)
5. Active Ingredient
Aceclofenac
6. Pharmaceutical Form & Strength
- Film-Coated Tablets: 100 mg aceclofenac (immediate release)
- Topical Cream: 1.5% w/w aceclofenac
Reported Pack Sizes:
- Tablets: 20 tablets
- Cream: 30 g tube
7. Manufacturer & Marketing Authorization Holder
Original Developer / Legacy Manufacturer: SmithKline Beecham
Corporate Status: SmithKline Beecham merged with Glaxo Wellcome in 2000 to form GlaxoSmithKline (GSK)
Current Status:
BRISTAFLAM® appears discontinued or license-transferred in many markets. Aceclofenac is currently marketed mainly as generic products by various regional manufacturers.
⚠️ The current marketing authorization holder may vary by country and should be confirmed through local regulatory authorities.
8. Mechanism of Action
Aceclofenac exerts analgesic, anti-inflammatory, and antipyretic effects through:
- Preferential inhibition of cyclooxygenase-2 (COX-2), reducing prostaglandin synthesis at sites of inflammation
- Partial hepatic metabolism to 4′-hydroxyaceclofenac and diclofenac, contributing to pharmacological activity
- Suppression of pro-inflammatory cytokines (e.g., IL-1β, TNF-α)
- Modulation of cartilage metabolism, with evidence of reduced matrix degradation in osteoarthritis models
9. Spectrum of Activity
Not applicable. Aceclofenac is not an antimicrobial agent and has no antibacterial, antiviral, or antifungal activity.
10. Pharmacokinetics
Oral Administration:
- Absorption: Rapid and nearly complete
- Peak Plasma Concentration (Tmax): ~1.25–3 hours
- Bioavailability: Approximately 100%
- Protein Binding: >99% (mainly albumin)
- Metabolism: Hepatic (primarily CYP2C9)
- Elimination Half-Life: ~4 hours
- Excretion: Mainly via urine as metabolites (~70%)
Topical Administration:
- Systemic absorption: Minimal (<5% compared to oral dose)
- Action: Predominantly local at the site of application
11. Indications
Oral Tablets:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Acute musculoskeletal pain
- Dental and postoperative pain (where appropriate)
Topical Cream:
- Localized muscle and joint pain
- Sprains, strains, tendonitis
- Soft tissue inflammation
12. Administration
Tablets:
- Usual adult dose: 100 mg twice daily
- Administer orally with or after meals to reduce gastrointestinal irritation
Cream:
- Apply a thin layer to the affected area 2–3 times daily
- Gently massage until absorbed
13. Method of Preparation
Not applicable. BRISTAFLAM® is supplied as a ready-to-use oral tablet and topical cream.
14. Contraindications
- Hypersensitivity to aceclofenac, diclofenac, aspirin, or other NSAIDs
- History of NSAID-induced bronchospasm or allergic reactions
- Active or recurrent peptic ulcer disease
- Gastrointestinal bleeding or perforation
- Severe hepatic impairment
- Severe renal impairment (eGFR <30 mL/min)
- Severe heart failure (NYHA III–IV)
- Ischemic heart disease or cerebrovascular disease
- Third trimester of pregnancy
15. Warnings & Precautions
- Increased risk of gastrointestinal bleeding, ulceration, and perforation
- Potential cardiovascular thrombotic risk with long-term use
- Use with caution in patients with hypertension, renal, hepatic, or cardiac impairment
- Monitor renal, hepatic, and hematological parameters during prolonged therapy
- Use the lowest effective dose for the shortest possible duration
16. Drug Interactions
- Other NSAIDs or corticosteroids → increased GI toxicity
- Anticoagulants and antiplatelets → increased bleeding risk
- Antihypertensives and diuretics → reduced efficacy, increased renal risk
- Lithium and methotrexate → increased plasma levels and toxicity
- CYP2C9 inhibitors (e.g., fluconazole) → increased aceclofenac exposure
17. Side Effects
Common:
- Dyspepsia, abdominal pain, nausea, diarrhea
- Dizziness, headache
Uncommon to Rare:
- Gastrointestinal ulceration or bleeding
- Elevated liver enzymes
- Renal impairment
- Skin reactions (rash, pruritus)
Topical Form:
- Local irritation, erythema, itching
18. Use in Special Populations
- Pregnancy: Contraindicated in the third trimester; avoid if possible in earlier stages
- Lactation: Use with caution; not recommended unless clearly necessary
- Elderly: Increased risk of adverse effects; careful monitoring advised
- Pediatrics: Safety and efficacy not established
19. Storage Conditions
- Store below 25–30°C (according to local labeling)
- Protect from heat, light, and moisture
- Keep out of reach of children
20. Additional Sections
Overdose:
Management is supportive. Activated charcoal may be considered if ingestion is recent. Hemodialysis is ineffective due to high protein binding.
21. Frequently Asked Questions (FAQ)
Q1: Is aceclofenac safer than other NSAIDs?
A: It may offer better gastrointestinal tolerability, but class-related risks remain.
Q2: Can oral and topical forms be used together?
A: Yes, under medical supervision, to enhance pain relief while limiting systemic exposure.
Q3: Does BRISTAFLAM® cure arthritis?
A: No. It provides symptomatic relief only and does not alter disease progression.
22. References
- British National Formulary (BNF) – Aceclofenac
- European Medicines Agency (EMA) – Aceclofenac Product Information
- Martindale: The Complete Drug Reference
- Clinical pharmacology literature on aceclofenac
- Regional Summary of Product Characteristics (SmPCs), 2023–2024