DIVIDO 75/MG DR CAP 20/CAP

Indications

Approved Uses

Relief of pain and inflammation in rheumatic conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; and for acute pain conditions where diclofenac is indicated (e.g., acute musculoskeletal/post‑operative pain and primary dysmenorrhea).

Off-Label Uses

Off‑label uses may include acute migraine (some diclofenac formulations), renal colic, and various acute musculoskeletal pains (e.g., low back pain) depending on local practice; however, off‑label status is formulation- and jurisdiction-dependent.

Dosage & Administration

Dosing by Condition

For this 75 mg modified‑release capsule: typical adult dosing is 75 mg once daily; may increase to 75 mg twice daily if needed; usual maximum 150 mg/day. (Higher RA doses such as 150-200 mg/day apply to some immediate‑release regimens and are not typical for MR products without label support.)

Initial Dose

For osteoarthritis or rheumatoid arthritis, 75 mg twice daily or 50 mg three times daily.

Maintenance Dose

75-150 mg/day, adjusted to the lowest effective dose for the individual patient.

Maximum Dose

150 mg/day.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. No routine dose adjustment is defined for mild-moderate renal impairment but use caution/monitor; avoid in severe renal impairment. In hepatic impairment, use caution and consider lower starting dose/close monitoring; avoid in severe hepatic impairment. Elderly: start low and monitor closely.

How to Take

Swallow the modified‑release (dual‑release) capsule whole with water; do not crush, chew, or open. Preferably take with/after food (or milk) to reduce gastrointestinal irritation.

Side Effects

Common Side Effects

Common: dyspepsia/heartburn, abdominal pain, nausea, diarrhea or constipation, flatulence, headache, dizziness; less commonly: elevated liver enzymes and edema/hypertension.

Side Effect Frequency

Common (≥1% to <10%): dyspepsia/abdominal pain, nausea, diarrhea, flatulence, headache, dizziness, rash/pruritus, and edema. Uncommon/rare (<1%): peptic ulcer, GI bleeding/perforation, hepatitis/jaundice, severe skin reactions (e.g., SJS/TEN), renal impairment, and thrombotic cardiovascular events; liver enzyme elevations are common (not typically classified as 'very common' across all sources).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs; history of asthma/urticaria/allergic-type reactions after aspirin/NSAIDs (AERD); active GI ulcer/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

CV risk (MI/stroke) - use lowest effective dose/shortest duration, caution in CVD/risk factors; GI risk (bleeding/ulcer/perforation) - higher risk in elderly/prior ulcer/GI bleed and with anticoagulants/SSRIs/steroids; renal toxicity and hyperkalemia - monitor in CKD, dehydration, ACEi/ARB/diuretic use; hepatotoxicity - monitor LFTs and stop if injury suspected; fluid retention/HTN/HF exacerbation; bronchospasm in aspirin-sensitive asthma; serious skin reactions; may mask fever/inflammation.

Age Restriction

Not recommended in children <14 years (use in pediatrics only if specifically prescribed by a specialist).

Driving Warning

Safe

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR: Other NSAIDs (increased risk of GI bleeding and kidney damage), Anticoagulants like warfarin (increased bleeding risk), Methotrexate (increased methotrexate toxicity). MODERATE: ACE inhibitors and ARBs (reduced antihypertensive effect, increased risk of renal impairment), Diuretics (reduced effect, increased risk of renal impairment), Lithium (increased lithium levels), SSRIs (increased bleeding risk).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

FDA Pregnancy Category D (contraindicated in third trimester)

Breastfeeding

Caution

Elderly

Use lowest effective dose with shortest duration; monitor renal function, blood pressure, and GI tolerance closely; increased risk of adverse events

Kidney Impairment

Mild-moderate renal impairment: no formal dose adjustment but use with caution and monitor renal function; severe renal impairment/advanced renal disease (e.g., CrCl <30 mL/min): avoid/contraindicated.

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

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next dose; if close, skip the missed dose and resume the regular schedule. Do not double doses.

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use. For long-term use, gradual dose reduction is advisable to avoid rebound pain.

Overdose

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

Patient Counseling

Swallow the modified‑release capsule whole with water (preferably with/after food); do not crush, chew, or open. Use the lowest effective dose for the shortest duration; do not exceed the prescribed dose (typical max for diclofenac is 150 mg/day from all diclofenac products). Avoid taking with other NSAIDs (e.g., ibuprofen/naproxen) and avoid alcohol to reduce GI ulcer/bleeding risk; low‑dose aspirin only if specifically directed by the prescriber. Seek urgent care for signs of GI bleeding (black/tarry stools, blood in vomit), severe abdominal pain, chest pain/shortness of breath/weakness (CV events), or severe rash/swelling. Tell your prescriber before use if you have a history of peptic ulcer/GI bleed, cardiovascular disease or risk factors (e.g., hypertension), kidney disease, liver disease, asthma/NSAID allergy, or if pregnant (especially ≥20 weeks/3rd trimester).

Monitoring Requirements

Monitor blood pressure and signs of fluid retention; renal function (especially in elderly, dehydration, HF, CKD, or with ACEI/ARB/diuretics); liver function tests (baseline and within ~4-8 weeks after initiation, then periodically if continued); and CBC if long‑term or if bleeding is suspected; monitor for GI bleeding/ulcer symptoms.

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

Analgesic onset typically within ~30-60 minutes for diclofenac; modified/dual‑release products may have a rapid component with sustained effect thereafter (full effect may take longer in chronic inflammatory conditions).

Duration of Effect

Approximately up to 12 hours of analgesic/anti‑inflammatory effect for dual/modified‑release diclofenac, supporting once‑ or twice‑daily dosing.

Half-Life

Terminal plasma half‑life of diclofenac is about 1-2 hours (often cited ~1.1-2 h).

Bioavailability

Approximately 50% due to first-pass metabolism.

Metabolism

Hepatic metabolism primarily via CYP2C9 (major), with minor contribution from other CYPs (e.g., CYP3A4) plus glucuronidation/sulfation; metabolites are largely inactive.

Excretion

Excretion is mainly as metabolites: ~65% in urine and ~35% via bile/feces.

Protein Binding

>99%, primarily to albumin.

Product Information

Available Dosage Forms

For this PRODUCT: modified‑release (dual‑release) oral capsule. (Diclofenac in general is also available in other forms-IR/EC/ER oral tablets, topical gel/patch, suppositories, and injectable forms-depending on country/brand.)

Composition per Dose

Each modified-release capsule: 75mg diclofenac sodium (dual release: immediate-release pellets + sustained-release pellets)

Generic Availability

Yes

OTC Alternatives

OTC alternatives for mild pain/fever where appropriate include ibuprofen and (where OTC) naproxen; choice depends on local OTC status, patient risk factors, and contraindications.

Pain Type

General, Muscular, Joint

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.