PONSTAN FORTE 500/MG FC TAB 20/FC TAB

Indications

Approved Uses

Short‑term treatment of mild to moderate pain (including primary dysmenorrhea and dental/musculoskeletal/post‑operative pain where clinically appropriate) and menorrhagia associated with menstruation; not indicated for rheumatoid arthritis or osteoarthritis for this product’s typical labeled use.

Dosage & Administration

Dosing by Condition

Mild-moderate pain: 500 mg once initially, then 250 mg every 6 hours as needed (generally ≤7 days). Primary dysmenorrhea: 500 mg initially, then 250 mg every 6 hours as needed, started at onset of symptoms/bleeding (typically 2-3 days). Menorrhagia: 500 mg three times daily during menstruation (short-term, during bleeding days only).

Initial Dose

500mg.

Maintenance Dose

500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week.

Maximum Dose

1500mg per day; treatment duration generally not to exceed 7 days except for dysmenorrhea

Children's Dosage

Children 14 years and older: same as adult dosing (500mg initial, then 250mg every 6 hours). Not approved for children under 14 years.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; avoid in severe renal impairment and use caution/consider dose reduction in hepatic impairment; monitor for renal/GI toxicity especially in elderly/dehydrated patients; no routine adjustment solely for CYP2C9 status but increased exposure is possible with CYP2C9 inhibitors/poor metabolizers.

How to Take

Swallow the film‑coated tablet whole with a full glass of water; take with food or milk to reduce gastrointestinal irritation; do not crush or chew.

Side Effects

Common Side Effects

Abdominal pain, Diarrhea, Nausea, Vomiting, Heartburn, Constipation, Dizziness, Tinnitus, Rash.

Side Effect Frequency

Common: GI upset (abdominal pain, nausea, vomiting, diarrhea, dyspepsia), headache, dizziness, rash. Uncommon/serious: GI ulceration/bleeding, fluid retention/edema, renal impairment, elevated liver enzymes, hypersensitivity reactions (including bronchospasm/anaphylaxis), and severe cutaneous adverse reactions (e.g., SJS/TEN).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to mefenamic acid or other NSAIDs; history of asthma/urticaria/other allergic-type reactions after aspirin/NSAIDs; active peptic ulcer disease or gastrointestinal bleeding; severe renal impairment; severe hepatic impairment; severe heart failure; treatment of peri-operative pain in CABG surgery; and use in the third trimester of pregnancy.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; monitor/avoid in patients with cardiovascular disease or risk factors; high risk of serious GI events (higher in elderly, prior ulcer/bleed, concomitant anticoagulants/SSRIs/corticosteroids); monitor renal function in CKD, heart failure, dehydration, or with ACEi/ARB+diuretic; may cause fluid retention/edema and worsen hypertension/heart failure; avoid in aspirin-sensitive asthma; discontinue at first sign of rash or hypersensitivity; may mask fever/infection; monitor liver enzymes if symptoms/signs of hepatotoxicity occur.

Age Restriction

Not approved under 14 years.

Drug Interactions

Drug Interactions

Clinically important interactions include: anticoagulants/antiplatelets (e.g., warfarin) and SSRIs/SNRIs (↑ bleeding); other NSAIDs/aspirin (↑ GI/renal toxicity); corticosteroids (↑ GI bleeding); ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect and ↑ AKI risk-"triple whammy"); lithium (↑ lithium levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity).

Interaction Severity

MAJOR: Anticoagulants/antiplatelets (e.g., warfarin), other NSAIDs/aspirin, methotrexate (especially high-dose), lithium. MODERATE: ACE inhibitors/ARBs/diuretics (renal risk/attenuated effect), SSRIs/SNRIs and corticosteroids (increased GI bleeding risk), cyclosporine/tacrolimus (nephrotoxicity). MINOR: Antacids may reduce/slow absorption rate.

Special Populations

Children

Children 14 years and older: same as adult dosing (500mg initial, then 250mg every 6 hours). Not approved for children under 14 years.

Elderly

Use with caution; start at lowest effective dose, monitor renal function, cardiovascular status, and GI tolerance. Increased risk of adverse effects.

Kidney Impairment

Avoid/contraindicated in significant or severe renal impairment (e.g., advanced CKD/CrCl <30 mL/min); in mild-moderate impairment use with caution and monitor renal function and volume status.

Liver Impairment

Mild-moderate hepatic impairment: use with caution and monitor; severe hepatic impairment/failure: avoid/contraindicated.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next dose. Do not double the dose.

Stopping the Medicine

No taper is required; it can be stopped at any time, but if used regularly/longer-term, advise clinician review before stopping and reassess pain/bleeding/renal/GI risk.

Overdose

Overdose may cause nausea/vomiting/abdominal pain, drowsiness/dizziness, GI bleeding, metabolic acidosis, seizures/coma, hypotension, and acute kidney injury; management is urgent medical evaluation with supportive care, activated charcoal if early, and benzodiazepines for seizures (no specific antidote).

Patient Counseling

Take with food or milk and a full glass of water; use the lowest effective dose for the shortest time (often ≤7 days for pain and ≤2-3 days for dysmenorrhea unless prescribed otherwise); avoid alcohol and other NSAIDs/aspirin unless directed; seek urgent care for black/bloody stools, severe abdominal pain, chest pain/shortness of breath, facial swelling/wheezing, or severe rash; use caution driving if dizzy; inform clinician about kidney/liver disease, ulcers/bleeding history, hypertension/heart disease, and all anticoagulants/SSRIs/diuretics.

Monitoring Requirements

If used beyond a short course or in high‑risk patients: monitor renal function (SCr/eGFR), liver enzymes, and CBC; monitor blood pressure and assess for GI bleeding/ulcer symptoms.

Pharmacology

Mechanism of Action

Nonselective inhibition of COX‑1 and COX‑2 leading to reduced prostaglandin synthesis, producing analgesic, anti‑inflammatory, and antipyretic effects.

Duration of Effect

4-6 hours

Half-Life

Approximately 2-4 hours.

Metabolism

Hepatic metabolism predominantly via CYP2C9 to hydroxymethyl and carboxy metabolites (e.g., 3‑hydroxymethyl mefenamic acid and 3‑carboxymefenamic acid), followed by conjugation.

Protein Binding

>90%.

Product Information

Available Dosage Forms

Capsule 250 mg (Ponstel); 500 mg film-coated tablet (Ponstan Forte, this product).

Composition per Dose

Each film-coated tablet: 500mg mefenamic acid

Generic Availability

Yes

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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