Ponstel

— THERAPEUTIC CATEGORIES —
  • Dysmenorrhea
  • Nonnarcotic analgesics

Ponstel Generic Name & Formulations

General Description

Mefenamic acid 250mg; caps.

Pharmacological Class

NSAID (fenamate).

How Supplied

Caps—30, 100

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

General Description

Mefenamic acid 250mg; caps.

Pharmacological Class

NSAID (fenamate).

How Supplied

Caps—30, 100

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