CLOFEN CREAMGEL 50G

Indications

Approved Uses

Relief of pain and inflammation in rheumatic and musculoskeletal conditions (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) and short-term treatment of acute pain conditions such as primary dysmenorrhea; other pain indications depend on local label.

Dosage & Administration

Dosing by Condition

Adults (delayed-release diclofenac sodium 50 mg): Osteoarthritis: 50 mg 2-3 times daily (100-150 mg/day). Rheumatoid arthritis: 50 mg 3-4 times daily (150-200 mg/day). Ankylosing spondylitis: 25 mg 4 times daily (100 mg/day), with an extra 25 mg at bedtime if necessary (125 mg/day).

Initial Dose

For osteoarthritis: 50 mg two or three times daily (100-150 mg/day); for rheumatoid arthritis: 50 mg three times daily (150 mg/day).

Maintenance Dose

For osteoarthritis: 100-150 mg/day in divided doses; for rheumatoid arthritis: 150-200 mg/day in divided doses; for ankylosing spondylitis: 100-125 mg/day.

Maximum Dose

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

Children's Dosage

Not recommended in children under 18 years.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. Use caution and consider lower starting doses in older adults. Avoid/use with extreme caution in severe renal impairment, severe hepatic impairment, or advanced heart failure; monitor renal/hepatic function if prolonged therapy.

How to Take

Swallow the 50 mg coated tablet whole with water; do not crush, chew, or break. Preferably take with food or milk to reduce gastrointestinal irritation.

Side Effects

Common Side Effects

Common: dyspepsia/indigestion, abdominal pain, nausea, diarrhea (sometimes constipation/flatulence), headache, dizziness; may cause elevations in liver enzymes.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or excipients; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs (AERD); use in the setting of CABG surgery (perioperative pain); pregnancy (contraindicated, especially in the third trimester due to risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction/oligohydramnios).

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events (higher in patients with CV disease/risk factors) and serious GI bleeding/ulcer/perforation; avoid around CABG; monitor/avoid in renal impairment, dehydration, heart failure, and with ACEi/ARB+diuretic; hepatotoxicity-check LFTs if prolonged therapy and stop if liver injury suspected; fluid retention/HTN; bronchospasm in aspirin-sensitive asthma; serious skin reactions and anaphylaxis; increased bleeding risk with anticoagulants/antiplatelets/SSRIs and with corticosteroids.

Drug Interactions

Drug Interactions

Clinically significant interactions include: anticoagulants (e.g., warfarin) and antiplatelets (↑ bleeding), SSRIs/SNRIs (↑ GI bleeding), other NSAIDs/aspirin (↑ GI/renal risk; aspirin may reduce diclofenac levels and diclofenac may blunt aspirin antiplatelet effect if co-administered), ACE inhibitors/ARBs and diuretics (↑ renal risk/↓ antihypertensive/diuretic effect; “triple whammy”), lithium (↑ levels), methotrexate (↑ toxicity), cyclosporine/tacrolimus (↑ nephrotoxicity), corticosteroids (↑ GI ulcer/bleed), digoxin (↑ levels).

Interaction Severity

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

Food Interaction

Take with food

Special Populations

Pregnancy

Pregnancy Category C (first and second trimesters); Category D (third trimester)

Breastfeeding

Caution

Children

Not recommended in children under 18 years.

Elderly

Use the lowest effective dose; start at 50mg twice daily. Monitor renal function, blood pressure, and GI tolerance closely. Increased risk of adverse events in patients over 65 years

Kidney Impairment

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

Liver Impairment

No specific dose adjustment is defined for mild-moderate hepatic impairment, but use with caution and monitor; avoid use in severe hepatic impairment/active significant liver disease and discontinue if abnormal LFTs or clinical liver injury develops.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and continue as usual-do not double doses.

Stopping the Medicine

Can be stopped without tapering; for long-term use, stop and reassess with a clinician rather than tapering (no physiologic withdrawal), using the lowest effective dose for the shortest duration.

Overdose

Symptoms: nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache, tinnitus; severe cases may include hypotension, metabolic acidosis, acute kidney injury, hepatic injury, respiratory depression, and rarely seizures/coma. Management: urgent medical evaluation; supportive care, monitor renal/hepatic function and bleeding; consider activated charcoal if recent ingestion (generally within 1-2 hours) and airway protected; no specific antidote.

Patient Counseling

Diclofenac 50 mg coated tablet (oral): Take with food or milk and swallow whole with water. Use the lowest effective dose for the shortest duration; do not exceed the prescribed dose. Avoid combining with other NSAIDs (e.g., ibuprofen/naproxen); low‑dose aspirin only if specifically prescribed. Limit/avoid alcohol due to increased GI bleeding risk. Seek urgent care for GI bleeding (black/tarry stools, vomiting blood), severe abdominal pain, chest pain, shortness of breath, sudden weakness/slurred speech (MI/stroke), or severe rash/swelling. Tell your prescriber if you have a history of ulcer/bleeding, cardiovascular disease, kidney or liver disease, uncontrolled hypertension, asthma/NSAID allergy, or are taking anticoagulants/antiplatelets/SSRIs/steroids. Avoid in the 3rd trimester of pregnancy.

Monitoring Requirements

If prolonged therapy: monitor blood pressure, renal function (SCr/BUN), liver enzymes, and CBC; monitor for GI bleeding/ulcer symptoms and cardiovascular risk.

Pharmacology

Mechanism of Action

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

Onset of Action

Peak plasma levels achieved in 2 hours (range 1-4 hours) in fasting state; delay in onset of absorption of 1-4.5 hours with food.

Duration of Effect

Approximately 6-8 hours for immediate-release diclofenac sodium tablets (clinical analgesic effect).

Half-Life

Terminal half-life: 2.3 hours.

Bioavailability

Approximately 50% due to first-pass metabolism.

Protein Binding

Protein binding: >99% (primarily to albumin).

Product Information

Available Dosage Forms

For this SFDA-registered product: coated tablet, oral use, 50 mg (blister pack).

Composition per Dose

Each coated tablet: 50mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and OTC NSAIDs such as ibuprofen or naproxen (where available/appropriate).

Pain Type

Muscular/Joint/General

Nsaid

Yes

Opioid

No

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