Diclogesic (diclofenac sodium) is a non-steroidal anti- inflammatory agent with marked anti-rheumatic, analgesic antipyretic properties.

PHARMACOLOGY

Diclofenac is rapidly absorbed when given orally or as rectal suppository. It is absorbed more slowly when given as enteric coated tablet, especially when this dosage form is given with food.

Although orally administered diclofenac is almost completely absorbed; it is subject to first-pass metabolism so that about 50% of the drug reaches the systemic circulation in the unchanged form.

At therapeutic concentrations, more than 99% of diclofenac is bound to plasma proteins. Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of glucuronide and sulfate conjugates of the metabolites. The terminal plasma half-life is about 1 to 2 hours.

INDICATIONS

Diclogesic is used in the treatment of the following: –

Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. -Inflammation and swelling following dental and orthopaedic surgery.
Acute attacks of gout.
Post-traumatic and post-operative pain,
Painful inflammatory conditions in gynecology and primary dysmenorrhea.

CONTRAINDICATIONS

Diclofenac sodium is contraindicated in:

Patients with known hypersensitivity to the drug.
Patients with peptic ulcer.
Patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin, or other NSAIDs.

SIDE EFFECTS

Gastrointestinal tract: occasional epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia and very rare gastrointestinal bleeding or gastric or intestinal ulcer.

Central nervous system: occasional headache, dizziness, vertigo and rare drowsiness.

Skin: occasional rashes and rare urticaria.

Kidney: rare oedema, isolated cases of acute renal failure and urinary abnormality.

Blood: isolated cases of thrombocytopenia, leucopenia, hemolytic anaemia, aplastic anaemia and agranulocytosis.

Liver: occasional elevation of serum aminotransferase enzymes and rare hepatitis.

Hypersensitivity: hypersensitivity reaction such as asthma, systemic anaphylactic/anaphylactoid reactions including hypotension.

Special senses: disturbances of vision, impaired hearing, tinnitus and taste disturbances.

PRECAUTIONS

Gastrointestinal bleeding or ulceration can occur at any time during treatment with or without warning symptoms or a previous history, they generally have more serious consequences in the elderly, however, in these rare cases where gastrointestinal bleeding or ulceration occur in patients receiving Diclogesic the drug should be discontinued.

As with other NSAIDs, allergic reactions including anaphylactic/ anaphylactoid reactions could also occur in rare cases without earlier exposure to the drug.

As with other NSAIDs, values of one or more liver enzymes may increase during prolonged treatment with Diclogesic monitoring of hepatic function is indicated as precautionary measure. If abnormal liver function tests persist or worsen, Diclogesic should be withdrawn.

Caution is indicated in the elderly on basic medical grounds, in particular, it is recommended that the lowest effective dosage be used in frail elderly patients or those with low body weight.

Only Diclogesic 50mg tablets contain sunset yellow, which may cause hypersensitivity reactions.

Pregnancy: Diclogesic should be employed only for compelling reasons and only in the lowest effective doses (closure of ductus arteriosus).

Nursing mothers: The active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

DRUG INTERACTIONS

Aspirin: Concomitant administration of diclofenac and aspirin is not recommended because diclofenac is displaced from its binding sites during the concomitant administration with aspirin resulting in lower plasma concentrations, peak plasma levels, and AUC values.

Digoxin, methotrexate and cyclosporin: Diclofenac, like other NSAIDs, may increase the toxicity of these drugs. Patients should be observed closely, particularly if renal function is impaired.

Lithium: Diclofenac decreases lithium renal clearance and increases its plasma levels. In patients taking diclofenac and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics: Diclofenac does not alter glucose metabolism in normal subjects nor does it alter the effects oral hypoglycemic agents. However, there are rare reports of changes in effects of insulin or oral hypoglycemic agents in the presence of diclofenac that necessitated changes in doses of such agents.

Diuretics: Diclofenac and other NSAIDs may inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with an increase in serum potassium levels.

DOSAGE AND ADMINISTRATION

The recommended initial daily dosage is 100-150mg. In milder cases, as well as for long term therapy 75-100mg daily is usually sufficient. The total daily dosage should be divided into 2-3 doses. The dosage of Diclogesic should be individualized to the lowest effective dose to minimize adverse effects.

Rheumatoid arthritis: The recommended dosage is 100-200mg/ day. In rare cases where 100mg diclofenac is unsatisfactory, the dose may be increased to 100mg twice daily. Dosage above 200mg is not recommended.

Osteoarthritis: The recommended dosage is 100-150mg/day in 2 or 3 divided doses. More than 200mg are not recommended for patients with osteoarthritis.

Ankylosing spondylitis: The recommended dosage is 100-125mg /day, Diclogesic 25mg 4 times daily with an extra 25mg at bedtime if necessary.

In primary dysmenorrhea: The recommended dosage is 50mg 3 times daily. In some patients, an initial dose of 100mg followed by 50mg dose will provide better relief.

Other indications such as post-traumatic pain, post-operative pain, dental surgery, inflammation and swelling or orthopedic surgery. The recommended dose should not exceed 150mg in 3 divided doses daily.

OVERDOSAGE

In the event of acute overdosage, it is recommended that the stomach be emptied by vomiting or gastric lavage. Forced Diuresis may be beneficial because the drug is excreted in the urine.

The effect of dialysis or hemoperfusion in the elimination of diclofenac remains unproven. In addition to supportive measures. the use of oral activated charcoal may help to reduce the absorption of diclofenac

PRESENTATION

Diclogesic® 25 Enteric Coated Tablets: Packs of 20, 30 and 500 tablets. Each tablet contains 25mg diclofenac sodium.
Diclogesic 50 Enteric Coated Tablets: Packs of 20, 30 and 500 tablets. Each tablet contains 50mg diclofenac sodium.
Diclogesic Retard 100 Film Coated Tablets: Packs of 10 and 500 tablets. Each tablet contains 100mg diclofenac sodium.
Diclogesic Retard 100 Capsules: Packs of 12 and 500 capsules. Each capsule contains 100mg diclofenac sodium.
Diclogesic 50 Suppositories: Pack of 10 suppositories. Each suppository contains 50mg diclofenac sodium.
Diclogesic 100 Suppositories: Pack of 5 suppositories. Each suppository contains 100mg diclofenac sodium.
Diclogesic is also available as gel, 75mg ampoules, 12.5mg suppositories for children and eye drops.

STORAGE CONDITIONS

Tablets & Capsules: Protect from light. Store in a dry place below 25°C.
Suppositories: Store up to 25°C. Do not freeze.

Diclogesic – PIL (arabic leaflet)

Diclogesic – PIL (english leaflet)

The Anatomical Therapeutic Chemical (ATC) classification system is a widely used international system for classifying drugs based on their therapeutic and pharmacological properties. The ATC code for a drug consists of seven alphanumeric characters that provide information about the drug’s anatomical, therapeutic, and chemical characteristics.

Let’s break down the ATC code for diclofenac sodium:

Anatomical main group (1st level): The first character represents the anatomical main group, which classifies drugs based on the organ or system on which they act. For diclofenac sodium, the first character is “M,” which indicates that the drug primarily affects the Musculoskeletal system.
Therapeutic subgroup (2nd level): The second character further classifies the drug into a therapeutic subgroup within the main anatomical group. For diclofenac sodium, the second character is “01,” which places it in the subgroup of Anti-inflammatory and antirheumatic products.
Pharmacological subgroup (3rd level): The third character narrows down the classification by specifying the drug’s pharmacological action or mechanism of action. For diclofenac sodium, the third character is “A,” which means it is an Anti-inflammatory and antirheumatic product (non-steroidal anti-inflammatory drug – NSAID).
Chemical subgroup (4th level): The fourth character identifies the chemical subgroup to which the drug belongs. In the case of diclofenac sodium, the fourth character is “02,” indicating it is a derivative of Acetic acid.
Chemical substance (5th level): The fifth character is left blank for future use or to specify a particular salt or ester form of the drug. In the case of diclofenac sodium, the fifth character would be “A” to specify the sodium salt form.
ATC code extension (6th and 7th level): The sixth and seventh characters, if present, are used for additional classification or alternative presentations of the drug. They may indicate different formulations, dosages, or routes of administration. These characters are not always used and are often left blank.

So, the complete ATC code for diclofenac sodium is M01AB05. Here’s what each part of the code means:

M: Musculoskeletal system
01: Anti-inflammatory and antirheumatic products
A: Anti-inflammatory and antirheumatic products, non-steroids (NSAIDs)
B: Acetic acid derivatives
05: Diclofenac (specifically the sodium salt form)

The ATC code helps healthcare professionals, researchers, and regulatory agencies to easily identify and classify drugs for various purposes, including drug utilization studies, pharmacovigilance, and comparing drug usage patterns across different regions.