RAPIDUS 50/MG FC TAB 20/FC TAB

Indications

Approved Uses

Relief of pain and inflammation in musculoskeletal and joint disorders (e.g., osteoarthritis, rheumatoid arthritis), acute pain states (e.g., postoperative/dental/musculoskeletal), primary dysmenorrhea

Dosage & Administration

Dosing by Condition

Adults (immediate‑release diclofenac potassium): typical 50 mg 2-3 times daily; maximum 150 mg/day. Primary dysmenorrhea/acute pain: 50 mg up to 3 times daily (max 150 mg/day). Acute migraine: 50 mg at onset; may repeat once after 2 hours if needed; do not exceed 100 mg/day for a migraine attack and do not exceed 150 mg/day total from all indications.

Initial Dose

For mild to moderate pain or dysmenorrhea, 50mg three times daily, or a single 100mg dose followed by 50mg doses.

Maintenance Dose

For osteoarthritis: 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d.); for rheumatoid arthritis: 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d.).

Maximum Dose

For pain/dysmenorrhea: 150mg/day. For rheumatoid arthritis: 200mg/day. For osteoarthritis: 150mg/day.

Children's Dosage

Safety and efficacy not established in children under 18 years, except for Zipsor® (diclofenac potassium) capsules which are approved for ages 12 and older for acute pain.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. Use caution in the elderly and in renal, hepatic, or cardiac impairment; avoid in severe renal or severe hepatic impairment and monitor renal function, blood pressure, and for GI bleeding.

How to Take

Swallow the film‑coated tablet whole with water; do not crush or chew. Preferably take with or after food (or milk) to reduce gastrointestinal irritation.

Side Effects

Common Side Effects

Common: dyspepsia/heartburn, abdominal pain, nausea, vomiting, diarrhea (sometimes constipation), flatulence; headache, dizziness; rash/pruritus; and possible elevations in liver enzymes.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to diclofenac/other NSAIDs; history of asthma/urticaria/other allergic-type reactions after aspirin/NSAIDs (AERD); active GI bleeding or active peptic ulcer; peri‑operative pain in CABG surgery; third trimester of pregnancy.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; monitor/avoid in patients with cardiovascular disease risk, hypertension, or heart failure (fluid retention/edema). Serious GI bleeding can occur without warning-higher risk in elderly and prior ulcer/GI bleed. Monitor renal function in CKD, dehydration, diuretic/ACEi/ARB use, and the elderly. Monitor liver enzymes if symptoms or prolonged therapy; discontinue for significant LFT elevation. Discontinue at first sign of rash/SCAR; avoid in aspirin-sensitive asthma/AERD.

Age Restriction

Not recommended for children <14 years (oral diclofenac potassium 50 mg tablets); use in pediatrics only if specifically prescribed with an age/weight-appropriate product/labeling.

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR/avoid or closely monitor: anticoagulants/antiplatelets (e.g., warfarin), other NSAIDs/aspirin, methotrexate (especially high dose), lithium, cyclosporine/tacrolimus. MODERATE: ACE inhibitors/ARBs, diuretics (renal risk/attenuated effect), SSRIs/SNRIs (GI bleeding risk), digoxin. MINOR: antacids may slightly delay absorption.

Special Populations

Pregnancy

Avoid use starting at 30 weeks gestation (third trimester); earlier use may cause fetal risks.

Children

Safety and efficacy not established in children under 18 years, except for Zipsor® (diclofenac potassium) capsules which are approved for ages 12 and older for acute pain.

Elderly

Use lowest effective dose (25-50 mg 2-3 times daily), monitor renal function, blood pressure, and GI symptoms closely; increased risk of adverse events

Kidney Impairment

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

Liver Impairment

Hepatic metabolism accounts for almost 100% of diclofenac potassium tablets elimination, so patients with hepatic disease may require reduced doses compared to patients with normal hepatic function.

Storage & Patient Advice

Stopping the Medicine

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

Patient Counseling

Take with/after food (or milk) to reduce stomach upset; swallow whole. Use the lowest effective dose for the shortest time and do not exceed 150 mg/day unless specifically directed. Avoid combining with other NSAIDs/aspirin unless prescribed; limit alcohol. Seek urgent care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain/shortness of breath, sudden weakness/slurred speech, or swelling/rapid weight gain. Stop and seek advice for rash/blistering. Avoid in the 3rd trimester of pregnancy; tell your clinician about history of ulcer/bleeding, heart disease/stroke risk, kidney/liver disease, asthma, and all anticoagulants/antiplatelets/SSRIs/diuretics/ACEi/ARBs.

Monitoring Requirements

Consider monitoring blood pressure, renal function (BUN, creatinine), and liver function tests (transaminases) periodically for patients on long-term therapy. Monitor for signs of GI bleeding.

Pharmacology

Mechanism of Action

Reversibly inhibits cyclooxygenase (COX‑1 and COX‑2), decreasing prostaglandin synthesis and thereby reducing inflammation, pain, and fever.

Metabolism

Extensive hepatic metabolism primarily via CYP2C9 (major) with minor contribution from other CYPs (e.g., CYP3A4), producing hydroxylated metabolites followed by glucuronidation/sulfation

Product Information

Available Dosage Forms

For this SFDA-registered product: oral film‑coated tablet 50 mg (blister pack of 20).

Composition per Dose

Each film-coated tablet: 50 mg diclofenac potassium

Generic Availability

Yes

Pain Type

General/Muscular/Joint/Migraine

Nsaid

Yes

Opioid

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.