SALOFALK 500MG TAB

Indications

Approved Uses

Treatment of acute episodes of mild to moderate ulcerative colitis, Maintenance of remission of ulcerative colitis, Treatment of acute attacks of Crohn's disease.

Dosage & Administration

Dosing by Condition

Ulcerative colitis (active): 1.5-3 g/day in divided doses (some guidelines allow up to 4-4.8 g/day depending on formulation/severity). Ulcerative colitis (maintenance): typically 1.5 g/day in divided doses (range commonly 1-2 g/day; some patients may require up to 3 g/day). Crohn’s disease: mesalazine has limited benefit; if used, doses around 2-4 g/day have been studied, but it is not routinely recommended for induction/maintenance in most guidelines.

Initial Dose

For acute ulcerative colitis: 1.5g to 3g daily, for example one 500mg tablet three times daily, which can be increased.

Maintenance Dose

500mg two to three times daily (1-1.5g/day)

Maximum Dose

3g/day for active disease

Children's Dosage

Children 5 years and older: weight-based dosing

Dose Adjustment Notes

No routine dose adjustment is recommended, but use with caution and monitor closely in renal impairment; contraindicated/avoid in severe renal impairment. Use with caution in hepatic impairment (avoid in severe hepatic impairment).

How to Take

Swallow the gastro-resistant tablets whole with plenty of water; do not crush, chew, or break. Take in divided doses as prescribed; may be taken with or without food (follow product-specific directions if provided).

Side Effects

Common Side Effects

Headache, nausea, abdominal pain, diarrhea, flatulence, vomiting, dyspepsia, rash

Safety & Warnings

Contraindications

Hypersensitivity to mesalazine/salicylates or excipients; severe renal impairment; severe hepatic impairment.

Warnings & Precautions

Baseline and periodic renal function monitoring is essential; monitor liver function and consider CBC (especially if on thiopurines or if symptoms suggest blood dyscrasia); stop and assess if acute intolerance syndrome occurs (cramps, acute abdominal pain, bloody diarrhea, fever); use caution in asthma/pulmonary disease and in patients with prior peptic ulcer disease; counsel to report rash, chest pain, dyspnea, or reduced urine output promptly.

Age Restriction

Not recommended in children <6 years (limited experience); use in pediatrics only under specialist supervision with weight-based dosing.

Drug Interactions

Interaction Severity

MAJOR: Azathioprine/6-mercaptopurine/thioguanine (additive myelosuppression-monitor CBC closely). MODERATE: NSAIDs (increased risk of renal adverse effects), methotrexate (possible increased toxicity-monitor), warfarin (variable effect on anticoagulation-monitor INR). MINOR/FORMULATION-RELATED: agents that markedly lower intestinal pH (may affect pH-dependent release for some products).

Special Populations

Pregnancy

Caution

Children

Children 5 years and older: weight-based dosing

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; stopping can precipitate relapse-maintenance therapy is often long-term, and any change should be clinician-directed (no routine taper required).

Patient Counseling

Swallow tablets whole with water; do not crush/chew (gastro-resistant). Take regularly as prescribed and continue even when symptoms improve. Attend scheduled renal (and other) blood/urine monitoring. Seek care urgently for signs of hypersensitivity/intolerance (worsening bloody diarrhea/cramps, fever), unexplained bruising/bleeding or sore throat (possible blood dyscrasia), or reduced urine output/flank pain (kidney injury).

Monitoring Requirements

Baseline and periodic renal function (serum creatinine/eGFR and urinalysis); consider baseline and periodic CBC and liver enzymes, especially early in therapy and in at-risk patients; increase monitoring frequency if renal/hepatic impairment or concomitant nephrotoxic/myelosuppressive drugs.

Pharmacology

Mechanism of Action

Mechanism is not fully defined; mesalazine acts topically on intestinal mucosa to reduce inflammation, in part via inhibition of cyclooxygenase and lipoxygenase pathways and downstream prostaglandin/leukotriene production (and other local anti-inflammatory effects).

Onset of Action

Symptom improvement is often seen within 2-4 weeks; full benefit for induction may take up to 6-8 weeks.

Duration of Effect

Effect is maintained only with continued therapy; remission maintenance requires ongoing dosing, and relapse risk increases after discontinuation.

Half-Life

Mesalazine: ~0.5-2 hours; N-acetyl-mesalazine: ~5-10 hours (values vary by formulation and sampling).

Bioavailability

Approximately 20-30% systemic absorption (varies by formulation), with the remainder acting locally in the gut.

Metabolism

Primarily acetylated in the intestinal mucosa and liver to N-acetyl-5-aminosalicylic acid; not meaningfully CYP450-mediated.

Excretion

Unabsorbed drug is excreted in feces; absorbed mesalazine is largely converted to N-acetyl-mesalazine and eliminated mainly via the kidneys (urine).

Product Information

Available Dosage Forms

Gastro-resistant tablets, prolonged-release tablets, granules, rectal suspension (enema), suppositories, rectal foam

Composition per Dose

Each gastro-resistant tablet: 500mg mesalazine (5-aminosalicylic acid).

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Gi Condition

Inflammatory Bowel Disease

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