DICLORAN*25/50 (Diclofenac)

DICLORAN*25/50 (Diclofenac)

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DICLORAN*25/50 (Diclofenac)

Diclofenac sodium is a benzene-acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzene acetic acid, monosodium salt.

Diclofenac is a non steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities.

Pharmacokinetics

Absorption: Diclofenac is 100% absorbed after oral administration. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available. Food has no significant effect on the extent of Diclofenac absorption.

Excretion: Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged Diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged Diclofenac plus metabolites.

Indications

  • Relief of signs and symptoms of osteoarthritis.
  • Relief of signs and symptoms of rheumatoid arthritis
  • Acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.

Contraindications

Dicloran is contraindicated in patients with known hypersensitivity to Diclofenac Dicloran should not be given to patients who have experienced asthma., urticaria, or other allergic type reactions after taking aspirin or other NSAIDs.

Warnings

Serious gastrointestinal toxicity such as inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, can occur at any time with or without warning symptoms, in patients treated with non steroidal anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur.

To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Because of the known effects of non steroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy should be avoided.

Labor and delivery: The effects of Diclofenac on labor and delivery in pregnant women are unknown

Nursing mothers: It is not known whether Diclofenac is excreted in human milk. Because of the potential for serious adverse reactions, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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Pediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: As with any NSAIDs, caution should be exercised in treating the elderly.

Precautions

Diclofenac sodium cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency

Hepatic effects: rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.

Renal effects: Caution is recommended in patients with preexisting kidney disease. As with other NSAIDs, metabolites of which are excreted by the kidney, patients with significantly impaired renal function should be more closely monitored.

Hematological effects: Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, GI loss or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

Fluid retention and edema have been observed in some patients taking NSAIDs. Therefore as with other NSAIDs, Dicloran should be used with caution in patients with fluid retention, hypertension or heart failure.

Drug interactions

Aspirin: As with other NSAIDs, concomitant administration of Diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

Methotrexate: Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Cyclosporine: Dicloran like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Dicloran may increase cyclosporine’s nephrotoxicity. Caution should be used when Dicloran is administered concomitantly with cyclosporine.

Warfarin: Use of Diclofenac with warfarin have a risk of serious GI bleeding higher than the use of either drug alone.

Adverse reactions

Body as whole: fever, infection, sepsis

Cardiovascular system: congestive heart failure, hypertension, tachycardia, syncope

Digestive system: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice.

Nervous system: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo

Respiratory system: asthma, dyspnea

Skin and appendages: alopecia, photosensitivity, sweating increased

Special senses: blurred vision

Urogenital system: cystitis, dysuria, hematuria, intestinal nephritis, oliguria/polyuria, proteinuria, renal failure.

Overdosage

Overdosage are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Patients should be managed by symptomatic and supportive care following a NSAID overdosage. There are no specific antidotes.

Dosage and administration

As with other NSAIDs, the lowest dose should be sought for each patient. The dose and frequency should be adjusted to suit an individual patient’s needs.

Initially daily dose is 100-150mg. The total daily dose should be divided into 2-3 doses. For milder cases or long term therapy, 75-100mg daily. Tablets should be swallowed whole.

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