Mefenamic Acid for Menstrual Pain in a 12-Year-Old
Mefenamic acid (Meftal Spas) should NOT be given to a 12-year-old child for menstrual pain, as it is only FDA-approved for patients ≥14 years of age. 1
Age-Specific FDA Restrictions
- The FDA label explicitly states mefenamic acid is indicated "for relief of mild to moderate pain in patients ≥14 years of age" and "for treatment of primary dysmenorrhea" 1
- Safety and effectiveness in pediatric patients below the age of 14 have not been established 1
- A study in preterm infants showed the half-life was approximately five times longer than in adults, consistent with low metabolic enzyme activity in younger patients 1
Alternative Treatment Options for This Age Group
For a 12-year-old with menstrual pain, ibuprofen is the recommended first-line NSAID:
- Multiple NSAIDs are approved for adolescents aged 12-17 years for pain management 2
- Ibuprofen is specifically recommended as first-line medication for children and adolescents, at doses appropriate for body weight 2
- NSAIDs can be used judiciously in children with pain, though antiplatelet activity and gastrointestinal/renal toxicity are rare but recognized adverse effects 2
Dosing Considerations if Age-Appropriate NSAIDs Are Used
- Ibuprofen: 200-600 mg tablets, maximum 4×600 mg daily (2400 mg/day total) 2
- Medication should be dosed based on age, weight, and comorbidities 3
- Use the lowest effective dose for the shortest duration 1
When to Escalate Care
- If acute medication provides insufficient pain relief, referral to specialist care is indicated 2
- Consider referral to a pediatric specialist when pain significantly impacts daily functioning or quality of life 3
Critical Pitfall to Avoid
Do not underdose or undertreat pain in adolescents — proactive use of appropriate analgesic therapy is recommended, but this must be with age-appropriate medications 3. Using mefenamic acid in a patient under 14 years old would be off-label use without established safety data in this population 1.