Chemical Additives

Mefenamic Acid is an anti-inflammatory and analgesic drug with antipyretic, analgesic and anti-inflammatory effects. The analgesic effect is strong and the antipyretic effect is long-lasting, but the anti-inflammatory effect is not as good as that of Baotaisong and flufenamic acid.

1. Introduction

Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the fenamate class. It is primarily used for its analgesic, anti-inflammatory, and antipyretic properties.

2. Mechanism of Action

– Inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis.

– Modulates pain and inflammation by blocking prostaglandin-mediated effects.

3. Therapeutic Uses

– Pain Relief: Effective for mild to moderate pain (e.g., headaches, dental pain, dysmenorrhea).

– Inflammatory Conditions: Used in rheumatoid arthritis and osteoarthritis (though less common than other NSAIDs).

– Menstrual Pain (Primary Dysmenorrhea):** One of its key indications due to strong prostaglandin inhibition.

4. Pharmacokinetics

– Absorption: Rapidly absorbed after oral administration (~50% bioavailability).

– Metabolism: Hepatic metabolism via CYP2C9.

– Excretion:Primarily renal (urine), with a half-life of **2–4 hours**.

5. Adverse Effects

– Common: GI disturbances (nausea, diarrhea, dyspepsia), dizziness, headache.

– Serious:

– GI ulcers/bleeding (higher risk than some NSAIDs).

– Renal impairment (especially in dehydrated or elderly patients).

– Hypersensitivity reactions (rash, Stevens-Johnson syndrome).

– Hepatotoxicity (rare but reported).

6. Drug Interactions

– Anticoagulants (e.g., warfarin): ↑ Bleeding risk.

– Diuretics/ACE inhibitors:Reduced efficacy due to fluid retention.

– Other NSAIDs/aspirin: ↑ GI toxicity.

7. Contraindications & Precautions

– Contraindicated in:

– Peptic ulcer disease.

– Severe renal/hepatic impairment.

– Asthma/NSAID-induced hypersensitivity.

– Use with caution in:

– Elderly patients.

– Cardiovascular disease (may ↑ BP).

8. Special Considerations

– Short-term use preferred (due to higher GI toxicity risk).

– Avoid in pregnancy (3rd trimester)—risk of premature ductus arteriosus closure.

9. Conclusion

Mefenamic acid is effective for acute pain and dysmenorrhea but carries significant GI and renal risks. Should be used at the **lowest effective dose for the shortest duration.

Basic Physicochemical Properties

Property	Specification	Test Method
Chemical Name	2-[(2.3-Dimethylphenyl)amino]benzoic acid	IUPAC nomenclature
Molecular Formula	C₁₅H₁₅NO₂	Elemental analysis
Molecular Weight	241.29 g/mol	Mass spectrometry
Appearance	White to pale yellow crystalline powder	Visual inspection
Solubility (25°C)	Practically insoluble in water, soluble in ethanol, acetone	USP <911>
Melting Point	230–235°C	DSC analysis

Pharmacological Profile

Parameter	Value/Description	Reference Standard
Mechanism of Action	Non-selective COX inhibitor	FDA label
Bioavailability	~90% (oral)	Clinical studies
Half-life (t₁/₂)	2–4 hours	Pharmacokinetic data
Protein Binding	>90%	In vitro studies
Metabolism	Hepatic (CYP2C9-mediated)	EMA assessment report

Therapeutic Applications & Dosage

Medical Condition	Recommended Dosage	Maximum Daily Dose
Mild to moderate pain	500 mg initial dose, then 250 mg every 6h	1.500 mg
Primary dysmenorrhea	500 mg loading dose, then 250 mg every 6h	1.500 mg
Rheumatoid arthritis	250–500 mg three times daily	1.500 mg

Pharmacopoeial Compliance

Standard	Requirement	Compliance Status
USP-NF	Meets monograph standards	Compliant
Ph. Eur.	Conforms to EP 10.0	Compliant
BP 2023	Meets British Pharmacopoeia	Compliant
ICH Q3D (Impurities)	Heavy metals <20 ppm	Compliant
Residual Solvents	Class 2/3 limits per ICH Q3C	Compliant

Stability & Storage Conditions

Parameter	Specification
Storage temperature	15–30°C (controlled room temp)
Shelf life	36 months (unopened)
Light sensitivity	Protect from light
Packaging	HDPE bottles with desiccant
Regulatory status	FDA/EMA-approved prescription drug

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