Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Acute and chronic pain (including rheumatic diseases), fever, pain, swelling and inflammation after injury or surgery
Oral 6 months up to 14 years 19.5 mg/kg/day in 3 doses. Max: 1.000 mg/day. Rectal 6 months up to 8 years 12 mg/kg/dose, as required, max. 3 times daily. 8 years up to 14 years No appropriate formulation strengh available for this age group 14 years up to 18 years 500 mg/dose, as required, max. 3 times daily. 14 years up to 18 years 500 mg/dose, as required, max. 3 times daily.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Consider whether the use of NSAIDs is justified. If mefenamic acid is still prescribed and the patient belongs to a risk group: Check kidney function before and within 1 week after starting treatment with mefenamic acid.

GFR 30-50 ml/min/1.73 m2

Consider whether the use of NSAIDs is justified. If mefenamic acid is still prescribed and the patient belongs to a risk group: Check kidney function before and within 1 week after starting treatment with mefenamic acid.

GFR 10-30 ml/min/1.73 m2

Consider whether the use of NSAIDs is justified. If mefenamic acid is still prescribed and the patient belongs to a risk group: Check kidney function before and within 1 week after starting treatment with mefenamic acid.

GFR < 10 ml/min/1.73 m2

General information cannot be given.

Clinical consequences

Risk factors include heart failure, cirrhosis of the liver, nephrotic syndrome, chronic kidney disease, factors that promote dehydration (e.g. heat), taking kidney-damaging medications such as diuretics or RAAS inhibitors.
NSAIDs (including COX-2 inhibitors) can cause acute renal failure due to decreased kidney perfusion (due to hypovolaemia). Usually, excessive decrease in kidney perfusion is prevented by increased prostaglandin synthesis in the kidneys. NSAIDs interfere with this compensation mechanism. Reduced kidney perfusion also leads to water and salt retention, which leads to the development or worsening of high blood pressure and heart failure.

Patients on dialysis

Hemodialysis / continuous veno-venous hemodialysis / hemofiltration:
• Kidney function (urine production) present: Do not use to maintain residual kidney function.
• Renal function (urine production) NOT present: Avoidance of use is not necessary.

Patients on dialysis are at higher risk of bleeding, which is likely due to abnormal platelet function. The risk of bleeding can be increased by using a low molecular weight heparin to avoid coagulation in the extracorporeal circulation at the beginning of hemodialysis.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Hypothermia has occurred in children and adolescents with an unknown frequency.

Kidney failure, posterior reversible leukoencephalopathy and pancreatitis have occurred in children. [(Wurm, Schreiber et al. 2015), (Yokobori, Yokota et al. 2006), (Itami, Akutsu et al. 1990), (Onay, Ercoban et al. 2009)].

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

An overdose of mefenamic acid in children can lead to seizures. (Robson, Balali et al. 1979) (Kamour, Crichton et al. 2017)

In children, mefenamic acid should not be given for longer than 7 days unless it is used to treat Still's disease. (Pfizer 03/2019)

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• MUSCULO-SKELETAL SYSTEM
• ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Acetic acid derivatives and related substances
	Diclofenac Related Medicines Menu">	M01AB05
	Indomethacin Related Medicines Menu">	M01AB01

Oxicams
	Piroxicam Related Medicines Menu">	M01AC01

Propionic acid derivatives
	Dexibuprofen Related Medicines Menu">	M01AE14
	Ibuprofen Related Medicines Menu">	M01AE01
	Naproxen Related Medicines Menu">	M01AE02

Coxibs
	Celecoxib Related Medicines Menu">	M01AH01

References

1. Onay, OS,, Acute, reversible nonoliguric renal failure in two children associated with analgesic-antipyretic drugs, Pediatr Emerg Care, 2009, 25(4), 263-266
2. Pfizer, SmPC Parkemed 250 mg Kps. (12949), 03/2019
3. Robson, RH,, Mefenamic acid poisoning and epilepsy, Br Med J, 1979, 2(6202), 1438
4. Pfizer, SmPC Parkemed orale Suspension (13621), 03/2019
5. Itami, N,, Progressive renal failure despite discontinuation of mefenamic acid, Nephron, 1990, 54(3), 281-282
6. Kamour, A,, Central nervous system toxicity of mefenamic acid overdose compared with other NSAIDs: an analysis of cases reported to the United Kingdom National Poisons Information Service, Br J Clin Pharmacol, 2017, 83(4), 855-862
7. Yokobori, S,, Pediatric posterior reversible leukoencephalopathy syndrome and NSAID-induced acute tubular interstitial nephritis, Pediatr Nephrol, 2006, 34(3), 245-247
8. Pfizer, SmPC Parkemed 125 mg Supp. (14290), 03/2019
9. Pfizer, SmPC Parkemed 500 mg Supp. (14291), 03/2019
10. Wurm, S,, Mefenamic acid: A possible cause of drug-induced acute pancreatitis, Pancreatol, 2015, 15(5), 570-572

Changes

Therapeutic Drug Monitoring

Overdose