VOTREX 50/MG TAB 20/TAB

Indications

Approved Uses

Relief of pain and inflammation in rheumatic conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; and short-term treatment of acute pain conditions (e.g., dysmenorrhea and other acute musculoskeletal/post‑operative/dental pain) depending on local labeling.

Off-Label Uses

Off-label uses may include acute migraine treatment and renal colic analgesia (practice varies); gout and postoperative pain are commonly on-label in many jurisdictions rather than off-label.

Dosage & Administration

Dosing by Condition

Adults (immediate‑release diclofenac sodium): Osteoarthritis/Rheumatoid arthritis: 50 mg 2-3 times daily (usual max 150 mg/day). Ankylosing spondylitis: 25 mg 4 times daily; may add 25 mg at bedtime if needed (max typically 150 mg/day). Acute pain/dysmenorrhea: 50 mg up to 3 times daily; some labels allow an initial 100 mg dose then 50 mg every 8 hours (max 150 mg/day).

Initial Dose

For osteoarthritis: 50 mg 2 or 3 times daily. For rheumatoid arthritis: 50 mg 3 or 4 times daily. For ankylosing spondylitis: 25 mg 4 times daily, with an extra 25 mg at bedtime if necessary.

Maintenance Dose

For osteoarthritis: 100-150 mg/day (50 mg 2-3 times daily); rheumatoid arthritis: 150-200 mg/day (50 mg 3-4 times daily); ankylosing spondylitis: 100-125 mg/day (25 mg 4 times daily, plus 25 mg at bedtime if needed).

Maximum Dose

150 to 200 mg/day for rheumatoid arthritis; 100 to 125 mg/day for ankylosing spondylitis; 100 to 150 mg/day for osteoarthritis.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in older adults and in mild-moderate renal/hepatic impairment; avoid in severe renal or hepatic impairment and monitor renal function/BP and for GI/CV risk.

How to Take

Swallow the tablet with water; take with or after food to reduce gastrointestinal upset. Do not crush or chew if the product is enteric‑coated/modified‑release (confirm the specific VOTREX tablet type on the pack).

Side Effects

Common Side Effects

Common adverse effects: dyspepsia/indigestion, abdominal pain, nausea (± vomiting), diarrhea or constipation, flatulence, headache, dizziness; possible elevations in liver enzymes.

Side Effect Frequency

Common (≥1% to <10%): GI symptoms (dyspepsia, abdominal pain, nausea, diarrhea/constipation, flatulence), headache, dizziness, rash/pruritus, edema/fluid retention, and transaminase elevations. Uncommon (≥0.1% to <1%): GI ulceration/bleeding, hepatitis/jaundice, tinnitus, anemia, renal impairment. Rare/very rare: serious skin reactions (SJS/TEN), anaphylaxis/angioedema, severe hepatic failure, and thrombotic cardiovascular events (MI/stroke).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or excipients; history of asthma/urticaria/allergic-type reactions after aspirin or other NSAIDs; active GI bleeding or active peptic ulcer; use for peri-operative pain in the setting of CABG surgery; third trimester of pregnancy.

Warnings & Precautions

Warnings/precautions: increased CV thrombotic risk (avoid in established high-risk situations; use lowest effective dose/shortest duration); serious GI bleeding/ulcer/perforation (higher risk in elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs); renal toxicity and hyperkalemia risk (monitor in CKD, HF, dehydration, diuretics/ACEi/ARB use); hepatotoxicity (check LFTs with prolonged therapy or if symptoms); fluid retention/HTN; avoid in aspirin-exacerbated respiratory disease; serious skin reactions.

Age Restriction

Not recommended for routine use in children; oral diclofenac 50 mg tablets are generally used in adults and adolescents ≥14 years only if specifically prescribed (pediatric dosing is typically weight-based using other formulations).

Drug Interactions

Drug Interactions

Clinically significant interactions include: anticoagulants (e.g., warfarin) and antiplatelets (including aspirin) ↑ bleeding; SSRIs/SNRIs ↑ GI bleeding; other NSAIDs ↑ toxicity; ACE inhibitors/ARBs and diuretics ↑ renal risk/↓ antihypertensive or diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; digoxin ↑ levels.

Interaction Severity

MAJOR/clinically significant: anticoagulants (e.g., warfarin), antiplatelets (including aspirin), other NSAIDs, SSRIs/SNRIs (↑ bleeding), methotrexate (↑ toxicity), lithium (↑ levels), cyclosporine/tacrolimus (↑ nephrotoxicity). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect; ↑ AKI risk-“triple whammy”), digoxin (↑ levels).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

FDA Pregnancy Category C (first and second trimesters); contraindicated in third trimester.

Elderly

Use lowest effective dose (start with 25-50mg twice daily), monitor renal function, blood pressure, and GI tolerance closely; increased risk of adverse effects

Kidney Impairment

No formal dose adjustment; use the lowest effective dose with close monitoring in renal impairment and avoid in advanced/severe renal disease (e.g., eGFR/CrCl <30 mL/min) or if renal function is deteriorating.

Liver Impairment

No specific dose adjustment is defined; use with caution in hepatic impairment, monitor liver function, and avoid/use is generally not recommended in severe hepatic impairment/active liver disease.

Storage & Patient Advice

Overdose

Symptoms: nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe cases may include hypotension, metabolic acidosis, acute kidney injury, respiratory depression, and rarely seizures/coma. Management: supportive care, consider activated charcoal if recent ingestion, monitor renal/hepatic function and GI bleeding; seek urgent medical attention/poison center.

Patient Counseling

Take with food or milk and a full glass of water; use the lowest effective dose for the shortest duration. Do not exceed 150 mg/day (e.g., 50 mg up to three times daily) unless specifically directed. Avoid combining with other NSAIDs (e.g., ibuprofen, naproxen) and avoid alcohol due to increased GI bleeding risk; low‑dose aspirin only if prescribed. Seek urgent care for GI bleeding symptoms (black/tarry stools, vomiting blood), severe abdominal pain, or allergic reactions. Stop and seek urgent care for chest pain, shortness of breath, weakness/slurred speech (possible thrombotic event). Inform your prescriber if you have a history of ulcer/bleeding, cardiovascular disease, hypertension, kidney or liver disease, asthma/NSAID allergy, or if taking anticoagulants/antiplatelets/SSRIs/steroids. Avoid in 3rd trimester of pregnancy; use in earlier pregnancy or when trying to conceive only if advised by a clinician.

Monitoring Requirements

Periodic liver function tests during long-term use, renal function monitoring, blood pressure monitoring, CBC for long-term use

Pharmacology

Mechanism of Action

Reversibly inhibits COX-1 and COX-2, decreasing prostaglandin synthesis to reduce inflammation, pain, and fever.

Onset of Action

About 30-60 minutes for immediate‑release oral diclofenac.

Half-Life

1.2-2 hours.

Bioavailability

Approximately 50-60% (about 55%) oral bioavailability due to first-pass metabolism.

Metabolism

Extensive hepatic metabolism primarily via CYP2C9; minor contributions from other CYPs (e.g., CYP3A4/2C8) with subsequent glucuronidation/sulfation to hydroxylated and conjugated metabolites.

Excretion

Approximately 65% excreted in urine (mainly as metabolites) and ~35% via bile/feces.

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

Common diclofenac sodium dosage forms include oral immediate‑release tablets, enteric‑coated (delayed‑release) tablets, prolonged/modified‑release tablets, suppositories, injectable forms, and topical preparations (e.g., gel); ophthalmic drops are typically diclofenac (often as diclofenac sodium) but are product-specific.

Composition per Dose

Each tablet: 50mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen are common OTC alternatives for mild-moderate pain/fever; naproxen may be OTC in some countries but is prescription-only in others.

Pain Type

General, Muscular, Joint, Migraine

Nsaid

Yes

Opioid

No

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