DOLVIC-K 50/MG FC TAB 20/FC TAB

Indications

Approved Uses

Mild to moderate pain, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhea, dental pain, postoperative pain

Dosage & Administration

Initial Dose

50 mg

Maintenance Dose

For osteoarthritis: 50 mg 2-3 times daily (100-150 mg/day). For rheumatoid arthritis: 50 mg 3-4 times daily (150-200 mg/day). For acute pain/dysmenorrhea: 50 mg 3 times daily

Maximum Dose

200 mg per day

Dose Adjustment Notes

Use lowest effective dose for shortest duration. Reduce dose in elderly. Avoid in severe renal or hepatic impairment. No specific titration required for standard indications

How to Take

Swallow tablet whole with a full glass of water. Take with food or milk to reduce gastric irritation. Do not crush or chew film-coated tablets

Side Effects

Common Side Effects

Nausea, vomiting, dyspepsia, abdominal pain, diarrhea, headache, dizziness, elevated liver enzymes, flatulence

Safety & Warnings

Contraindications

Active peptic ulcer or GI bleeding, hypersensitivity to diclofenac or any NSAID, aspirin-sensitive asthma, severe heart failure, severe renal impairment (CrCl <30 mL/min), severe hepatic impairment, third trimester of pregnancy, coronary artery bypass graft (CABG) surgery perioperative use

Warnings & Precautions

Increased risk of serious cardiovascular thrombotic events; use with caution in patients with cardiovascular disease or risk factors. GI bleeding, ulceration, and perforation can occur without warning symptoms. Monitor liver function; discontinue if hepatic dysfunction develops. Use with caution in patients with renal impairment, hypertension, or fluid retention. Avoid in patients with aspirin-exacerbated respiratory disease. Increased risk of GI adverse events in elderly patients

Drug Interactions

Drug Interactions

Anticoagulants (warfarin - increased bleeding risk), antiplatelet agents (aspirin - increased GI bleeding), lithium (increased lithium levels), methotrexate (increased methotrexate toxicity), ACE inhibitors/ARBs (reduced antihypertensive effect, increased nephrotoxicity), diuretics (reduced diuretic effect), cyclosporine (increased nephrotoxicity), SSRIs (increased GI bleeding risk), other NSAIDs (additive toxicity), corticosteroids (increased GI bleeding risk), quinolone antibiotics (increased seizure risk)

Interaction Severity

MAJOR: Warfarin (increased bleeding risk), methotrexate (increased toxicity), lithium (increased lithium levels), other NSAIDs (additive toxicity and GI risk). MODERATE: ACE inhibitors/ARBs (reduced efficacy, nephrotoxicity), diuretics (reduced diuretic effect), cyclosporine (nephrotoxicity), SSRIs (increased GI bleeding), corticosteroids (increased GI bleeding). MINOR: Antacids (may slightly reduce absorption rate)

Food Interaction

Take with food

Special Populations

Elderly

Use lowest effective dose (25-50 mg), shortest duration possible; monitor renal function, blood pressure, and GI symptoms closely

Kidney Impairment

Mild-moderate impairment (CrCl 30-60 mL/min): use with caution, monitor renal function. Severe impairment (CrCl <30 mL/min): contraindicated

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use

Overdose

Symptoms: nausea, vomiting, epigastric pain, drowsiness, headache, GI bleeding, renal failure, convulsions, hypertension. Management: gastric lavage if within 1 hour of ingestion, activated charcoal, supportive care, monitor renal and hepatic function. No specific antidote. Seek immediate medical attention

Monitoring Requirements

Periodic liver function tests with long-term use, renal function monitoring, blood pressure monitoring, CBC with prolonged use

Pharmacology

Mechanism of Action

Inhibits cyclooxygenase-1 (COX-1) and COX-2) enzymes, reducing prostaglandin synthesis, thereby decreasing inflammation, pain, and fever

Onset of Action

Approximately 1 hour (range 0.33 to 2 hours) for peak plasma levels; measurable plasma levels observed within 10 minutes in some fasting volunteers

Duration of Effect

4-6 hours

Half-Life

Approximately 2 hours (terminal half-life)

Bioavailability

50-60% (due to first-pass metabolism)

Metabolism

Extensive first-pass hepatic metabolism; primarily excreted as metabolites in urine (about 65%) and bile (about 35%); metabolites are hydroxylated and conjugated with glucuronide and sulfate

Protein Binding

>99% (primarily albumin)

Product Information

Composition per Dose

Each film-coated tablet: 50 mg diclofenac potassium

Generic Availability

Yes

OTC Alternatives

Ibuprofen 200-400 mg (OTC), paracetamol 500-1000 mg (OTC) for mild to moderate pain

Pain Type

General

Nsaid

Yes

Opioid

No

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