Ponstel Generic Name & Formulations
Legal Class
Rx
General Description
Mefenamic acid 250mg; caps.
Pharmacological Class
NSAID (fenamate).
How Supplied
Caps—30, 100
Manufacturer
Generic Availability
YES
Ponstel Indications
Indications
Dysmenorrhea.
Ponstel Dosage and Administration
Adult
Use lowest effective dose for shortest duration. ≥14yrs: 500mg once, then 250mg every 6hrs; usually for up to 2–3 days.
Children
<14yrs: not established.
Ponstel Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Ponstel Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Ponstel Warnings/Precautions
Warnings/Precautions
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers: not recommended.
Ponstel Pharmacokinetics
See Literature
Ponstel Interactions
Interactions
Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by concomitant magnesium-containing antacids.
Ponstel Adverse Reactions
Adverse Reactions
GI disturbances, anemia, dizziness, edema, headache, pruritus, rash, tinnitus; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs).
Ponstel Clinical Trials
See Literature
Ponstel Note
Not Applicable
Ponstel Patient Counseling
See Literature
Ponstel Generic Name & Formulations
Legal Class
Rx
General Description
Mefenamic acid 250mg; caps.
Pharmacological Class
NSAID (fenamate).
How Supplied
Caps—30, 100
Manufacturer
Generic Availability
YES
Ponstel Indications
Indications
Mild to moderate pain.
Ponstel Dosage and Administration
Adult
Use lowest effective dose for shortest duration. ≥14yrs: 500mg once, then 250mg every 6hrs as needed; usually for up to 7 days.
Children
<14yrs: not established.
Ponstel Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Ponstel Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Ponstel Warnings/Precautions
Warnings/Precautions
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers: not recommended.
Ponstel Pharmacokinetics
See Literature
Ponstel Interactions
Interactions
Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by concomitant magnesium-containing antacids.
Ponstel Adverse Reactions
Adverse Reactions
GI disturbances, anemia, dizziness, edema, headache, pruritus, rash, tinnitus; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs).
Ponstel Clinical Trials
See Literature
Ponstel Note
Not Applicable
Ponstel Patient Counseling
See Literature