Erdon TR 100mg Capsule

Erdon contains diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, inflammation and swelling. Depending on the formulation, it may be prescribed for:

• Rheumatic conditions: Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and other inflammatory or degenerative joint disorders.
• Musculoskeletal injuries: Sprains, bruises, strains and other soft-tissue injuries.
• Pain and inflammation: Post-operative and post-traumatic pain, including dental pain and swelling.
• Gynecological conditions: Primary dysmenorrhea (painful menstruation) and selected inflammatory conditions when prescribed by a physician.
• Acute pain: Acute gout attacks and renal or biliary colic, under medical supervision.
• Topical treatment: Localized pain and inflammation affecting muscles and joints, when using the gel formulation.

The appropriate indication depends on the specific dosage form and the patient's condition.

Pharmacology

Diclofenac sodium is an NSAID with analgesic, anti-inflammatory and antipyretic properties. It works primarily by inhibiting cyclooxygenase (COX) enzymes, thereby reducing prostaglandin production. Prostaglandins contribute to pain, inflammation and fever.

Oral diclofenac is absorbed through the gastrointestinal tract, metabolized mainly in the liver and eliminated through urine and bile. Topical formulations act primarily at the application site, although some medicine may be absorbed into the bloodstream.

Dosage and Administration

The dose depends on the formulation, strength, indication, age and response to treatment. Use the lowest effective dose for the shortest necessary duration.

Oral immediate-release tablets

• Adults: A commonly used total daily dose is 75–150 mg in divided doses, depending on the condition and prescribed product.
• Take with or after food if needed to reduce stomach discomfort.

Sustained-release or extended-release tablets/capsules

• The usual schedule may be once daily, depending on the product strength.
• Swallow whole with water; do not crush or chew modified-release formulations.
• Do not combine different diclofenac formulations unless specifically instructed by a physician.

Dispersible tablets

• Prepare and take according to the product instructions. The required amount of water and timing in relation to meals depend on the formulation.

Suppositories and injections

• These formulations require product-specific dosing and administration instructions. Injections should be administered by a qualified healthcare professional.

Topical gel

• Apply the prescribed amount to the affected area according to the product label.
• For many diclofenac gels, the application frequency depends on the concentration and treated body area.
• Do not apply to broken skin or cover with an airtight dressing unless specifically instructed.

Children and older adults: Pediatric dosing must be determined by a clinician according to age, weight and indication. Older adults should generally receive the lowest effective dose because of increased gastrointestinal, kidney and cardiovascular risks.

Do not exceed the prescribed dose or combine diclofenac with other NSAIDs without medical advice.

Side Effects

Possible side effects include:

• Stomach pain, indigestion, nausea, vomiting, diarrhea and abdominal discomfort.
• Headache, dizziness or drowsiness.
• Skin rash, itching or other allergic skin reactions.
• Fluid retention and swelling.
• Local redness, irritation or itching with topical gel.

Serious adverse effects can include stomach ulcers or gastrointestinal bleeding, kidney or liver injury, severe allergic reactions, increased blood pressure, heart attack or stroke. Seek urgent medical attention for black stools, vomiting blood, chest pain, difficulty breathing, facial swelling or markedly reduced urine output.

Drug Interactions

Erdon may interact with the following medicines:

• Anticoagulants and antiplatelet medicines: Such as warfarin, apixaban, rivaroxaban, aspirin and clopidogrel; may increase bleeding risk.
• Other NSAIDs and corticosteroids: May increase the risk of stomach ulcers and gastrointestinal bleeding.
• Lithium and digoxin: Diclofenac may increase their blood concentrations.
• Methotrexate: May increase the risk of serious toxicity.
• Cyclosporine or tacrolimus: May increase the risk of kidney injury.
• Diuretics, ACE inhibitors and ARBs: May reduce blood-pressure control and increase the risk of kidney problems.
• Quinolone antibiotics: May increase the risk of seizures in susceptible patients.
• Diabetes medicines: Blood glucose monitoring may be appropriate when treatment is started or changed.

Tell the physician about all medicines and supplements being taken, including non-prescription painkillers.

Contraindications

Diclofenac should not be used in patients with:

• Known hypersensitivity to diclofenac or any ingredient of the formulation.
• A history of asthma, hives or allergic reactions triggered by aspirin or other NSAIDs.
• Active peptic ulcer, gastrointestinal bleeding or a history of recurrent ulceration or bleeding associated with NSAIDs.
• Severe kidney or liver impairment, or certain serious cardiovascular conditions, unless specifically assessed and directed by a specialist.
• Established ischemic heart disease, peripheral arterial disease, cerebrovascular disease or significant heart failure where diclofenac is contraindicated under the applicable product labeling.

Diclofenac gel should not be applied to damaged skin, eyes or mucous membranes.

Pregnancy and Breastfeeding

Diclofenac should generally be avoided during pregnancy unless a healthcare professional determines that it is necessary. NSAIDs can cause fetal harm, particularly from around 20 weeks of pregnancy onward, and should be avoided from 30 weeks onward because of additional fetal cardiovascular risks. Topical diclofenac also requires medical advice during pregnancy.

Small amounts may pass into breast milk. Consult a healthcare professional before using diclofenac while breastfeeding, especially for repeated or prolonged treatment.

Precautions and Warnings

• Gastrointestinal risks: Use cautiously in people with a history of ulcers, gastrointestinal bleeding or inflammatory bowel disease.
• Cardiovascular risks: Diclofenac may increase the risk of heart attack, stroke, fluid retention and worsening hypertension, particularly with higher doses or prolonged use.
• Kidney function: Use cautiously in people with kidney disease, dehydration or those taking medicines that affect kidney function.
• Liver function: Seek medical advice if yellowing of the skin or eyes, dark urine or persistent nausea develops.
• Older adults: They may be more susceptible to serious adverse effects.
• Topical gel: Wash hands after application, unless treating the hands themselves. Avoid contact with the eyes and mucous membranes, and do not take the product by mouth.

Overdose

An overdose may cause nausea, vomiting, abdominal pain, gastrointestinal bleeding, dizziness, drowsiness, kidney injury or other serious complications. Seek urgent medical attention if an overdose is suspected. Do not induce vomiting unless instructed by a healthcare professional.

Therapeutic Class

Non-steroidal anti-inflammatory drugs (NSAIDs); medicines used for pain, inflammation and arthritis.

Storage Conditions

Store below 30°C in a cool, dry place, protected from light. Keep out of the reach of children.