VOLTIC.D 50/MG DISP TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic conditions (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and short-term treatment of acute pain conditions such as primary dysmenorrhea and acute musculoskeletal/post‑operative/dental pain; acute migraine treatment may be included depending on local label, but is not universal for all diclofenac oral products.

Off-Label Uses

Off-label examples: renal colic and biliary colic (analgesia), and adjunct analgesia in some cancer pain regimens; acute gout is generally an accepted NSAID use but may be labeled in some regions and not in others.

Dosage & Administration

Dosing by Condition

Adults (immediate‑release/dispersible diclofenac): Osteoarthritis/Rheumatoid arthritis: 50 mg 2-3 times daily (typical max 150 mg/day). Ankylosing spondylitis: 25 mg 4 times daily, with an additional 25 mg at bedtime if needed (max 150 mg/day). Acute pain/primary dysmenorrhea: 50 mg up to 3 times daily (max 150 mg/day); some references allow an initial 100 mg loading dose in selected acute pain/dysmenorrhea if tolerated and appropriate.

Initial Dose

50 mg two to three times daily (100-150 mg/day).

Maintenance Dose

For osteoarthritis: 100-150 mg/day b.i.d. or t.i.d.; rheumatoid arthritis: 150 mg/day b.i.d. or t.i.d., may increase to 200 mg/day; ankylosing spondylitis: 100-125 mg/day q.i.d. with extra 25 mg at bedtime if needed.

Maximum Dose

150mg per day for most conditions; up to 200mg per day for rheumatoid arthritis.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; no routine dose adjustment is required in mild-moderate renal impairment but avoid/use extreme caution in severe renal impairment; in hepatic impairment use caution and consider lower doses with close monitoring, and avoid in severe hepatic disease; in older adults use caution and consider lower effective doses.

How to Take

Disperse (allow to disintegrate) one 50 mg dispersible tablet in a glass of water, stir, and drink immediately; take with or after food to reduce GI irritation. Do not chew; if swallowed whole, take with a full glass of water (acceptable if dispersion is not possible).

How to Prepare

Place the tablet in a glass of water, allow it to disperse completely, stir, and drink the entire mixture immediately; rinse the glass with a little water and drink to ensure the full dose is taken.

Side Effects

Common Side Effects

Common: dyspepsia/heartburn, abdominal pain, nausea, vomiting, diarrhea (sometimes constipation/flatulence), headache, dizziness; less common but clinically important: edema and elevated liver enzymes; rash can occur.

Side Effect Frequency

Common (≥1% to <10%): gastrointestinal symptoms (nausea, dyspepsia/heartburn, abdominal pain), diarrhea; nervous system symptoms (headache, dizziness). Uncommon (≥0.1% to <1%): vomiting, gastritis, constipation/flatulence; rash/pruritus; edema/fluid retention; elevated liver enzymes. Rare (≥0.01% to <0.1%) to very rare (<0.01%): peptic ulcer, gastrointestinal bleeding/perforation; severe hypersensitivity (anaphylaxis/angioedema, bronchospasm); severe cutaneous adverse reactions (SJS/TEN); hepatitis/liver failure; acute kidney injury/renal failure.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs; history of asthma/urticaria/allergic-type reactions after aspirin/NSAIDs (AERD); active peptic ulcer or GI bleeding; severe hepatic impairment; severe renal impairment/advanced renal disease; severe heart failure; third trimester of pregnancy; peri‑operative pain in CABG surgery.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; monitor/avoid in patients with cardiovascular disease or risk factors (MI/stroke risk) and in heart failure/fluid retention; GI bleeding can occur without warning (higher risk in elderly, prior ulcer, anticoagulants/SSRIs/steroids); monitor renal function in CKD/elderly/volume depletion and with ACEi/ARB+diuretic; monitor liver enzymes and stop if significant elevation/symptoms; may cause serious skin reactions and hypersensitivity; may mask fever/infection.

Age Restriction

Use and dose must be determined by doctor in children; not specifically recommended <14 years without clinical judgment.

Drug Interactions

Drug Interactions

Major interactions include anticoagulants (e.g., warfarin) and antiplatelets/aspirin (↑ bleeding), SSRIs/SNRIs (↑ GI bleeding), corticosteroids (↑ GI bleeding), other NSAIDs (additive toxicity), ACEi/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-“triple whammy”), lithium (↑ levels), methotrexate (↑ toxicity), cyclosporine/tacrolimus (↑ nephrotoxicity), and digoxin (↑ levels).

Interaction Severity

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

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Avoid in third trimester; earlier trimesters use only if benefit outweighs risk (FDA Pregnancy Category D in third trimester, C earlier)

Elderly

Use the lowest effective dose; increased risk of GI bleeding, renal impairment, and cardiovascular events; monitor closely

Kidney Impairment

No formal dose adjustment for mild-moderate impairment, but use with caution and monitor renal function; avoid/contraindicated in severe renal impairment or advanced renal disease (e.g., CrCl <30 mL/min) unless benefits clearly outweigh risks.

Liver Impairment

Mild-moderate hepatic impairment: use with caution at the lowest effective dose and monitor LFTs; severe hepatic impairment: avoid/contraindicated.

Storage & Patient Advice

Preparation Instructions

Place the tablet in a glass of water, allow it to disperse completely, stir, and drink the entire mixture immediately; rinse the glass with a little water and drink to ensure the full dose is taken.

Missed Dose

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

Stopping the Medicine

No taper is required; can be stopped at any time, but if used chronically or for inflammatory disease, reassess with a clinician to avoid symptom rebound and to ensure an alternative plan.

Overdose

Symptoms: nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe toxicity may include hypotension, acute kidney injury, metabolic acidosis, seizures, respiratory depression/coma. Management: urgent medical evaluation, supportive care, consider activated charcoal if early after ingestion, and monitor renal/hepatic function and bleeding.

Patient Counseling

Disperse the tablet in water and drink immediately; take with/after food. Do not use with other NSAIDs. Use the lowest effective dose for the shortest time and do not exceed 150 mg/day unless specifically directed. Seek urgent care for GI bleeding (black stools/vomiting blood), severe abdominal pain, chest pain/shortness of breath, or signs of allergy; avoid in late pregnancy and inform the prescriber about ulcer history, kidney/liver disease, hypertension/heart disease, and all anticoagulant/antiplatelet medicines.

Monitoring Requirements

If used beyond short-term: monitor blood pressure, renal function (SCr/eGFR), liver function tests, and CBC periodically; counsel/monitor for GI bleeding and cardiovascular thrombotic symptoms.

Pharmacology

Mechanism of Action

Inhibits cyclooxygenase (COX-1 and COX-2), enzymes responsible for prostaglandin synthesis, which leads to reduced inflammation, pain, and fever.

Onset of Action

30-60 minutes

Duration of Effect

6-8 hours

Half-Life

1-2 hours

Bioavailability

Approximately 50% due to first-pass metabolism

Metabolism

Extensive hepatic metabolism; primarily via multiple CYP enzymes including CYP2C9 (major), CYP3A4, and others; subsequent glucuronidation and sulfation.

Excretion

Excretion is mainly as metabolites: ~60-70% via urine and ~30-40% via bile/feces.

Protein Binding

>99%

Product Information

Available Dosage Forms

For diclofenac (active ingredient): oral immediate‑release tablets (including dispersible), enteric‑coated/delayed‑release tablets, extended/modified‑release tablets/capsules, suppositories, injectable forms, and topical formulations (gel/solution/patch); ophthalmic drops also exist in some markets.

Composition per Dose

Each dispersible tablet: 50mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

OTC alternatives for mild-moderate pain (where locally available): ibuprofen and naproxen; topical diclofenac gel may be OTC in some countries but is not universally OTC.

Pain Type

General/Muscular/Joint/Migraine

Nsaid

Yes

Opioid

No

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