Diclofenac

(dye kloe' fen ak)

PCI / LCaution when used during lactation : Contraindicated in pregnancy and 'Caution' during lactation (breast-feeding)

Molecule Info

| See TERMINOLOGY & ABBREVIATIONS |
WARNING

Cardiovascular Risk

  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

  • Diclofenac Sodium/Potassium tablets, USP are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. 

ATC Classification D11AX18 - diclofenac; class - other dermatologicals. 
M01AB05 - diclofenac; class - acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products. 
M02AA15 - diclofenac; class - non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains. 
S01BC03 - diclofenac; class - non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
Indication(s), Dosage & Administration

Adults and Elderly:

Relief of all grades of pain and inflammation in a wide range of conditions, including:

(i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout,
(ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis,
(iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Children (aged 1-12 years): Juvenile chronic arthritis (25mg tablet).

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Special warnings and precautions for use).

For oral administration

75-150mg daily in two or three divided doses.

The recommended maximum daily dose of Diclofenac Na is 150mg.

Special populations

Elderly

Although the pharmacokinetics of Diclofenac Na are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also precautions) and the patient should be monitored for GI bleeding during NSAID therapy.

Renal impairment

Diclofenac is contraindicated in patients with severe renal impairment. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment.

Hepatic impairment

Diclofenac is contraindicated in patients with severe hepatic impairment. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment.

Paediatric population

Children (aged 1-12 years): 1-3mg/kg per day in divided doses.

A dosage summary can be as follows:

Sprains
Adult: As sodium: 75-150 mg daily in divided doses orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Strains
Adult: As sodium: 75-150 mg daily in divided doses orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Tendinitis
Adult: As sodium: 75-150 mg daily in divided doses orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 

Pain and inflammation associated with musculoskeletal and joint disorders
Adult: As sodium: 75-150 mg daily in divided doses orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Bursitis
Adult: As sodium: 75-150 mg daily in divided doses orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Acute gout
Adult: As sodium: 75-150 mg daily in divided doses  orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Dysmenorrhoea
Adult: As sodium: 75-150 mg daily in divided doses  orally. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Migraine
Adult: As potassium: Initially, 50 mg taken orally at the 1st sign of an attack, an additional dose of 50 mg may be taken after 2 hr if symptoms persist. If needed, further doses of 50 mg may be taken every 4-6 hr. Max: 200 mg/day. 
Hepatic impairment: Dose adjustment may be needed. 

Intravenous
Postoperative pain
Adult: As sodium: 75 mg infusion in 5% glucose or 0.9% sodium chloride given over 30-120 minutes, may repeat after 4-6 hr if necessary.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Bursitis
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Sprains
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Strains
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Tendinitis
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Acute gout
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Dysmenorrhoea
Adult: As sodium: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions.
Hepatic impairment: Dose adjustment may be needed. 
Intramuscular
Renal colic
Adult: As sodium: 75 mg, may repeat once after 30 minutes if needed. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed. 
Intravenous
Prophylaxis of postoperative pain
Adult: As sodium: 25-50 mg infusion given after surgery over 15-60 minutes followed by 5 mg/hr. Max: 150 mg daily.
Hepatic impairment: Dose adjustment may be needed. 
Ophthalmic
Postoperative ocular inflammation
Adult: As sodium (0.1% solution): Instill into the appropriate eye 4 times daily starting 24 hr after surgery for up to 28 days.
Ophthalmic
Prophylaxis of intra-operative miosis
Adult: As sodium (0.1% solution): Instill into the appropriate eye 4 times within 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As sodium (0.1% solution): Instill into the eye twice in the hr before surgery, then 1 drop twice at 5-minute intervals immediately after surgery, then every 2-5 hr while awake for up to 24 hr.
Ophthalmic
Seasonal allergic conjunctivitis
Adult: As sodium (0.1% solution): Instill 1 drop into the affected eye(s) up to 4 times daily. 
Ophthalmic
Pain and discomfort after radial keratotomy
Adult: As sodium (0.1% solution): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days. 
Ophthalmic
Control of inflammation after argon laser trabeculoplasty
Adult: As sodium (0.1% solution): Instill 1 drop 4 times during the 2 hr before procedure followed by 1 drop 4 times daily, up to 7 days after procedure. 
Ophthalmic
Inflammation and discomfort after strabismus surgery
Adult: As sodium (0.1% solution): Instill 1 drop 4 times daily for the 1st wk; then tid in the 2nd wk, bid in the 3rd wk, and as required for the 4th wk. 
Ophthalmic
Pain after accidental trauma
Adult: As sodium (0.1% solution): Instill 1 drop 4 times daily for up to 2 days. 
Topical/Cutaneous
Local symptomatic relief of pain and inflammation
Adult: As sodium (1% gel): Apply onto affected area 3-4 times daily. 
Hepatic impairment: Dose adjustment may be needed. 
Topical/Cutaneous
Osteoarthritis
Adult: As sodium (1.6% solution): Apply in small amounts (20-40 drops) onto affected area 4 times daily. 
Hepatic impairment: Dose adjustment may be needed. 
Topical/Cutaneous
Actinic keratoses
Adult: As sodium (3% gel): Apply bid for 60-90 days. 
Hepatic impairment: Dose adjustment may be needed. 
Rectal
Postoperative pain
Adult: 75-150 mg daily, in divided doses (25 mg, 50 mg and 100 mg suppositories only). Max: 150 mg/day (inclusive of diclofenac administered through other routes). 
Child: 6-12 yr: 1-2 mg/kg/day in divided doses (12.5 mg and 25 mg suppositories only) for max of 4 days. 
Hepatic impairment: Dose adjustment may be needed.

Oral formulation should be taken immediately after meals.

Overdosage

Symptoms

There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to high protein binding and extensive metabolism.

Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life threatening overdose.

Contraindications

- Hypersensitivity to the active substance or any of the excipients.

- Active, gastric or intestinal ulcer, bleeding or perforation.

- History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy

- Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

- Last trimester of pregnancy (see Pregnancy and lactation).

- Severe hepatic, renal or cardiac failure (see Special warnings and precautions for use).

- Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

Special Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

The concomitant use of Diclofenac Na with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects (see Interactions with other medicaments and other forms of interaction).

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

As with other nonsteroidal anti-inflammatory drugs including diclofenac , allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.

Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties.

Diclofenac Na 25 mg and 50 mg gastro-resistant tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Gastrointestinal effects:

Gastrointestinal bleeding (haematemesis, melaena) ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn.

As with all NSAIDs, including diclofenac close medical surveillance is imperative and particular caution should be excised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal disorders, or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses including diclofenac, and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.

The elderly have increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA/aspirin or medicinal products likely to increase gastrointestinal risk. (See Interactions with other medicaments and other forms of interaction).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).

Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as acetylsalicylic acid (see Interaction with other medicaments and other forms of interaction).

Close medical surveillance and caution should be exercised in patients with ulcerative colitis, or with Crohn's disease as these conditions may be exacerbated.

Hepatic effects:

Close medical surveillance is required when prescribing Diclofenac Na to patients with impairment of hepatic function as their condition may be exacerbated.

As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure.

If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac Na should be discontinued.

Hepatitis may occur with diclofenac without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects:

As fluid retention and oedema have been reported in association with NSAIDs therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.

Skin effects:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Diclofenac Na. Patients appear to be at the highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac Na should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy including diclofenac.

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with diclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking).

Haematological effects:

During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of the blood count is recommended.

Diclofenac Na may reversibly inhibit platelet aggregation (see anticoagulants in Interaction with other medicaments and other forms of interactions). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.

Pre-existing asthma:

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so called intolerance to analgesics / analgesics asthma), Quincke's oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.

Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of bronchial asthma.

Female fertility:

The use of Diclofenac Na may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Diclofenac should be considered.

Adverse Drug Reaction(s)

Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (> 1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000); not known: cannot be estimated from available data.

The following undesirable effects include those reported with other short-term or long-term use.

Table 1
Blood and lymphatic system disorders
Very rare Thrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders
Rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare Angioneurotic oedema (including face oedema).
Psychiatric disorders
Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders
Common Headache, dizziness.
Rare Somnolence,tiredness.
Very rare Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.
Unknown Confusion, hallucinations, disturbances of sensation, malaise
Eye disorders
Very rare Visual disturbance, vision blurred, diplopia.
Unknown Optic neuritis.
Ear and labyrinth disorders
Common Vertigo.
Very rare Tinnitus, hearing impaired.
Cardiac disorders
Very rare Palpitations, chest pain, cardiac failure, myocardial infarction.
Vascular disorders
Very rare Hypertension, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders
Rare Asthma (including dyspnoea).
Very rare Pneumonitis.
Gastrointestinal disorders
Common Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Rare Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly).
Very rare Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Hepatobiliary disorders
Common Transaminases increased.
Rare Hepatitis, jaundice, liver disorder.
Very rare Fulminant hepatitis, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders
Common Rash.
Rare Urticaria.
Very rare Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.
Renal and urinary disorders
Very rare Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions
Rare Oedema
Reproductive system and breast disorders
Very rare Impotence

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Drug Interactions
Aspirin

When Diclofenac Sodium is administered with aspirin, its proteinbinding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Cyclosporine

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

ACE Inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.

Furosemide

Clinical studies, as well as postmarketing observations, have shown that Diclofenac Sodium can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

CYP2C9 Inhibitors or Inducers

Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac. Use caution when dosing diclofenac with CYP2C9 inhibitors or inducers; a dosage adjustment may be warranted.

Food Interaction
Slow absorption of enteric-coated tab when given with food.
Pregnancy Category (FDA)

ROUTE(S): PO / PARENT

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Category D in 3rd trimester or near delivery.

ROUTE(S): OPHTH / TOPICAL

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Storage
Oral, parenteral or other formulations: Store at 15-30°C.
Pharmacology

Pharmacodynamics

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, andantipyretic activities in animal models. The mechanism of action of Diclofenac Sodium, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Pharmacokinetics

Absorption

Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). Food has no significant effect on the extent of diclofenac absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of < 20%.

Table 1: Pharmacokinetic Parameters for Diclofenac

  MEAN COEFFICIENT OF MEAN VARIATION (%)
Absolute Bioavailability (%) [N = 7] 55 40
Tmax (hr) [N = 56] 2.3 69
Oral Clearance (CL/F; mL/min) [N = 56] 582 23
Renal Clearance (% unchanged drug in urine) [N = 7] < 1 --
Apparent Volume of Distribution (V/F; L/kg) [N = 56] 1.4 58
Terminal Half-life (hr) [N = 56] 2.3 48

 Distribution

The apparent volume of distribution (V/F) of diclofenac sodium is 1.4 L/kg.

Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15-105 micro gm/mL) achieved with recommended doses.

Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.

Metabolism

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'hydroxy-4'-methoxy-diclofenac. The major diclofenac metabolite, 4'-hydroxy-diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy- diclofenac is primarily mediated by CPY2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3'-hydroxy-diclofenac. In patients with renal dysfunction, peak concentrations of metabolites 4'-hydroxy- and 5-hydroxy-diclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects.

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. Because renal elimination is not a significant pathway of elimination for unchanged diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary. The terminal half-life of unchanged diclofenac is approximately 2 hours

Drug Interactions

When co-administered with voriconazole (inhibitor of CYP2C9, 2C19 and 3A4 enzyme), the Cmax and AUC of diclofenac increased by 114% and 78%, respectively.

Special Populations

Pediatric: The pharmacokinetics of Diclofenac Sodium has not been investigated in pediatric patients.

Race: Pharmacokinetic differences due to race have not been identified.

Hepatic Insufficiency: Hepatic metabolism accounts for almost 100% of Diclofenac Sodium elimination, so patients with hepatic disease may require reduced doses of Diclofenac Sodium compared to patients with normal hepatic function.

Renal Insufficiency: Diclofenac pharmacokinetics has been investigated in subjects with renal insufficiency. No differences in the pharmacokinetics of diclofenac have been detected in studies of patients with renal impairment. In patients with renal impairment (inulin clearance 60-90, 30-60, and < 30 mL/min; N=6 in each group), AUC values and elimination rate were comparable to those in healthy subjects.

 

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Brand/Product Info


Total Products : 181                                                                                                                                                                                     
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
A-FENAC The Acme Laboratories Ltd. Diclofenac sodium 25mg & 50mg Tablet 100's each: 55.00 & 84.00 MRP
A-FENAC Injection The Acme Laboratories Ltd. Diclofenac sodium 25mg/ml, 3ml amp. Injection 10's: 140.60 MRP
A-FENAC SR The Acme Laboratories Ltd. Diclofenac sodium 100mg Tablet (sustained release) 100's: 300.00 MRP
A-FENAC Suppository The Acme Laboratories Ltd. Diclofenac sodium 12.5mg & 50mg Suppository 10's each: 80.40 & 140.60 MRP
ALCOFEN Aexim Pharmaceutical Ltd. Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
ALCOFEN SR Aexim Pharmaceutical Ltd. Diclofenac sodium 100mg Capsule (sustained release) 100's: 150.00 MRP
ALTERIN Euro Pharma Ltd. Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
ALTERIN TR Euro Pharma Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
ANFENAC Nipa Pharmaceuticals Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 80.00 MRP
ANODYNE IBN SINA Pharmaceutical Industry Ltd. Diclofenac sodium 50mg Tablet 100's: 100.00 IP
ANODYNE Drop IBN SINA Pharmaceutical Industry Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 80.00 MRP
ANODYNE Gel IBN SINA Pharmaceutical Industry Ltd. Diclofenac sodium 10mg/gm Gel 10gm: 13.00 MRP
ANODYNE SR IBN SINA Pharmaceutical Industry Ltd. Diclofenac sodium 100mg Capsule (sustained release) 50's: 152.50 MRP
APAIN Kemiko Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 75.00 MRP
APAIN Injection Kemiko Pharmaceuticals Ltd Diclofenac sodium 25mg/ml Injection 10 amps: 100.00 MRP
APAIN-TR Kemiko Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule (timed release) 50's: 125.00 MRP
APNAC Supreme Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
APNAC SR Supreme Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (sustained release) 50's: 150.00 MRP
BEONAC-SO Benham Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 80.00 IP
C-FENAC Chemist Laboratories Ltd. Diclofenac sodium 50mg Tablet 100's: 30.00 MRP
C-FENAC Drop Chemist Laboratories Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 65.00 MRP
C-FENAC Injection Chemist Laboratories Ltd. Diclofenac sodium 75mg/3ml Injection 10 amps: 111.30 MRP
C-FENAC TR Chemist Laboratories Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
CLOFEN Cosmic Chemical Industries Limited Diclofenac sodium 50mg Tablet 100's: 76.00 MRP
CLOFEN-TR Cosmic Chemical Industries Limited Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
CLOFENAC 100 SUPP Square Pharmaceuticals Ltd. Diclofenac Sodium 100mg Suppository 2x5's: 200.60 MRP
CLOFENAC 100 TR Square Pharmaceuticals Ltd. Diclofenac Sodium 100mg Capsule 5x10's: 201.00 MRP
CLOFENAC 12.5 Square Pharmaceuticals Ltd. Diclofenac Sodium 12.5mg Suppository 2x5's: 90.60 MRP
CLOFENAC 25 Square Pharmaceuticals Ltd. Diclofenac Sodium 25mg Tablet 10x10's: 100.00 MRP
CLOFENAC 25 SUPP Square Pharmaceuticals Ltd. Diclofenac Sodium 25mg Suppository 3x5's: 181.35 MRP
CLOFENAC 50 Square Pharmaceuticals Ltd. Diclofenac Sodium 50mg Tablet 20x10's: 302.00 MRP
CLOFENAC 50 SUPP Square Pharmaceuticals Ltd. Diclofenac Sodium 50mg Suppository 4x5's: 302.00 MRP
CLOFENAC EMULGEL Square Pharmaceuticals Ltd. Diclofenac Diethylamine 11.6mg/gm Emulgel 20 gm: 40.27 MRP
CLOFENAC GEL Square Pharmaceuticals Ltd. Diclofenac Diethyl-ammonium Salt 10mg/gm Gel 10 gm: 12.99 MRP
CLOFENAC INJ Square Pharmaceuticals Ltd. Diclofenac Sodium 75mg/3 ml IM Injection 5x2's: 151.00 MRP
CLOFENAC SR-TAB Square Pharmaceuticals Ltd. Diclofenac 100mg Tablet 10x10's: 402.00 MRP
CLONAC Somatec Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 83.00 MRP
CLONAC TR Somatec Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.50 MRP
COSFENAC SR Cosmo Pharma Laboratories Ltd. Diclofenac sodium 100mg Capsule (sustained release) 50's: 150.00 MRP
DCF Decent Pharma Laboratories Ltd. Diclofenac sodium 50mg Tablet 100's: 60.00 MRP
DECAFEN Renata Limited Diclofenac sodium 50mg Tablet 100's: 84.00 MRP
DECAFEN SR Renata Limited Diclofenac sodium 100mg Tablet 100's: 289.00 MRP
DENAC-50 Desh Pharmaceuticals (Pvt) Ltd Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
DICLO-50 Apollo Pharmaceutical Laboratories Ltd. Diclofenac sodium 50mg Tablet 100's: 40.00 MRP
DICLO-TR Apollo Pharmaceutical Laboratories Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 IP
DICLOFEN Opsonin Pharma Limited Diclofenac sodium 25mg & 50mg Tablet 100's each: 52.00 & 88.00 MRP
DICLOFEN Drop Opso Saline Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 75.28 MRP
DICLOFEN Gel Opsonin Pharma Limited Diclofenac sodium 10mg/gm Gel 10gm: 12.90 MRP
DICLOFEN Injection Opsonin Pharma Limited Diclofenac sodium 75mg/3ml Injection 10's: 150.00 MRP
DICLOFEN Suppository Opsonin Pharma Limited Diclofenac sodium 12.5mg, 25mg & 50mg Suppository 12.5mg x25's, 25mg x10's, 50mg x25's: 225.00 & 120.00 & 375.00 MRP
DICLOFEN-SR Opsonin Pharma Limited Diclofenac sodium 100mg Tablet (sustained release) 100's: 300.00 MRP
DICLON Central Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 85.00 MRP
DICLON Drop Reman Drug Laboratories Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 78.50 MRP
DICLON SR Central Pharmaceuticals Ltd Diclofenac sodium 100mg Tablet (sustained release) 100's: 300.00 MRP
DICLONAC Ziska Pharmaceuticals Ltd. Diclofenac sodium 75mg/3ml Injection 10 amps: 75.00 MRP
DICLONAC 100 Ziska Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule 50's: 100.00 MRP
DICLONAC 50 Ziska Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 83.00 MRP
DICLONIL Zenith Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
DICLONIL SR Zenith Pharmaceuticals Ltd. Diclofenac sodium 100mg Tablet (sustained release) 100's: 300.00 MRP
DICLOPAIN R A K Pharmaceuticals Pvt. Ltd. Diclofenac sodium 50mg Tablet 100's: 85.00 MRP
DICLORA 50 Marksman Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
DICLORA TR Marksman Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
DICLOREX Medimet Pharmaceuticals Ltd Diclofenac sodium 25mg & 50mg Tablet 100's each: 54.00 & 70.00 MRP
DICLOREX Injection Medimet Pharmaceuticals Ltd Diclofenac sodium 75mg/3ml Injection 10 amps: 95.00 MRP
DICLOREX Rtd Medimet Pharmaceuticals Ltd Diclofenac sodium 100mg Tablet 50's: 150.00 MRP
DIDOL Concord Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
DIFEN-50 Peoples Pharma Ltd. Diclofenac sodium 50mg Tablet 100's: 38.00 MRP
DIFENAC Rephco Laboratories Ltd. Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
DIFENAC Injection Rephco Laboratories Ltd. Diclofenac sodium 75mg/3ml Injection 10 amps: 100.00 MRP
DIFENAC-CR Rephco Laboratories Ltd. Diclofenac sodium 100mg Capsule 100's: 250.00 MRP
DILOCK 50 Bristol Pharma Limited Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
DILOCK-TR Bristol Pharma Limited Diclofenac sodium 100mg Capsule (timed release) 50's: 100.00 MRP
DINAC-TR Navana Pharmaceuticals Limited Diclofenac sodium 100mg Capsule (timed release) 100's: 200.00 IP
DK-TR Apex Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 150.00 MRP
DSR SR NIPRO JMI Pharma Ltd. Diclofenac sodium 100mg Capsule 50's: 150.00 MRP
E-FENAC-50 Reliance Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
EDIFENAC Edruc Limited Diclofenac sodium 50mg Tablet 100's: 70.00 IP
EDIFENAC Injection Edruc Limited Diclofenac sodium 75mg/3ml Injection 8 amps: 76.00 IP
EDIFENAC TR Edruc Limited Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 IP
ERDON Aristopharma Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 80.00 MRP
ERDON 100 TR Aristopharma Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
ERDON Gel Aristopharma Ltd. Diclofenac sodium 10mg/gm Gel Cream 10gm: 12.90 MRP
FENGEL Pharmadesh Laboratories Limited Diclofenac sodium 10mg/gm Gel 15gm: 19.68 MRP
FENTAB Pharmadesh Laboratories Limited Diclofenac sodium 50mg Tablet 100's: 75.00 MRP
FENTAB SR Pharmadesh Laboratories Limited Diclofenac sodium 100mg Tablet (sustained release) 50's: 150.00 MRP
FENUM-TR Belsen Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
FICLON Injection Sanofi Diclofenac sodium 75mg/3ml Injection 10 amps: 152.29 MRP
FICLON Suppository Sanofi Diclofenac sodium 50mg Suppository 10's: 120.46 MRP
G-DICLOFENAC Gonoshasthaya Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 61.00 MRP
G-DICLOFENAC Inj Gonoshasthaya Pharmaceuticals Ltd Diclofenac sodium 75mg/3ml Injection 5 amps: 47.50 MRP
GENAC Globe Pharmaceuticals Ltd Diclofenac sodium 75mg/3ml Injection 10 amps: 95.00 MRP
GENAC-50 Globe Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
HI-FENAC Hudson Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 50mg x1000's: 50.00 MRP
HI-FENAC-TR Hudson Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
HITFLAM Ambee Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 84.00 MRP
HITFLAM Gel Ambee Pharmaceuticals Ltd. Diclofenac sodium 10mg/gm Gel 10gm: 12.95 MRP
HITFLAM Injection Ambee Pharmaceuticals Ltd. Diclofenac sodium 75mg/3ml Injection 10 amps: 76.20 MRP
HITFLAM-SR Ambee Pharmaceuticals Ltd. Diclofenac sodium 100mg Tablet (sustained release) 50's: 152.50 MRP
INDOFENAC Indo-Bangla Pharmaceuticals Works Ltd. Diclofenac sodium 50mg Tablet 100's: 50.00 MRP
INDOFENAC SR Indo-Bangla Pharmaceuticals Works Ltd. Diclofenac sodium 100mg Tablet (sustained release) 100's: 300.00 MRP
Intafenac 50 Incepta Pharmaceuticals Limited Diclofenac sodium BP 50 mg Tablet (Enteric Coated) 10x10's:MRP 75 Tk
Intafenac Drop Incepta Pharmaceuticals Limited Diclofenac Sodium 0.1% Eye Drop Eye drop 5ml:MRP 80 Tk
Intafenac Injection Incepta Pharmaceuticals Limited Diclofenac Sodium BP 75mg/3ml Injection 10x1's:MRP 95 Tk
JEFENAC-TR Ad-din pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
LARDON-TR Desh Pharmaceuticals (Pvt) Ltd Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
LOCOPAIN Asiatic Laboratories Ltd. Diclofenac sodium 50mg Tablet 100's: 40.00 MRP
LOCOPAIN Drop Asiatic Laboratories Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 80.00 MRP
LOCOPAIN-TR Asiatic Laboratories Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
MEDIFEN Medicon Laboratories Ltd Diclofenac sodium 50mg Tablet 100's: 100.00 MRP
MEDIFEN-TR Medicon Laboratories Ltd Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
MEGAFEN Jayson Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 81.00 IP
MEGAFEN Injection Jayson Pharmaceuticals Ltd. Diclofenac sodium 75mg/3ml Injection 20 amps: 203.00 IP
MEGAFEN-SR Jayson Pharmaceuticals Ltd. Diclofenac sodium 100mg Tablet (sustained release) 50's: 151.00 IP
MICLOFEN-100 Millat Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule 50's: 150.00 MRP
MICLOFEN-50 Millat Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 83.00 MRP
MOBIFEN ACI Ltd. Diclofenac sodium 50mg Tablet 100's: 88.00 MRP
MOBIFEN Drop ACI Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 75.28 MRP
MOVONAC Sharif Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
MOVONAC TR Sharif Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
NASIDA SR Delta Pharma Limited Diclofenac sodium 100mg Capsule 100's: 150.00 MRP
NEOFENAC Modern Pharmaceuticals Ltd Diclofenac sodium 50mg Tablet 100's: 84.00 MRP
NEOFENAC 50 Ad-din pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 40.00 MRP
NEOFENAC SR Modern Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule (sustained release) 40's: 120.00 MRP
NIRO SR Everest Pharmaceuticals Ltd. Diclofenac sodium 100mg Tablet (sustained release) 50's: 150.00 MRP
NIRO TR Everest Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 125.00 MRP
NODINAC SR Novus Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (sustained release) 100's: 300.00 MRP
NOPAIN Drop Drug International Ltd Diclofenac sodium 0.1% Eye Drop 5ml: 70.00 MRP
NORFEN Kumudini Pharma Ltd Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
NORFEN SR Kumudini Pharma Ltd Diclofenac sodium 100mg Capsule (sustained release) 50's: 155.00 MRP
NOVARIN Amico Laboratories Ltd. Diclofenac sodium 10mg/gm Gel 10gm: 12.90 MRP
NOVARIN SR Amico Laboratories Ltd. Diclofenac sodium 100mg Capsule (sustained release) 100's: 250.00 MRP
ORAFEN SR Orion Pharma Ltd. Diclofenac sodium 50mg Tablet (sustained release) 100's: 80.00 MRP
ORFENAC TR Orion Pharma Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.50 MRP
PAIN ZERO TR Reliance Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
PANFRE SR Pacific Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (sustained release) 50's: 150.00 MRP
PENAC-50 APC Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 100's: 75.00 MRP
PENAC-TR APC Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
PROFENAC Drop Popular Pharmaceuticals Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 75.28 MRP
PROFENAC Gel Popular Pharmaceuticals Ltd. Diclofenac sodium 10mg/gm Gel 10gm: 12.95 MRP
PROFLAM Novo Healthcare and Pharma Ltd. Diclofenac sodium 50mg Tablet 100's: 30.00 MRP
PROFLAM SR Novo Healthcare and Pharma Ltd. Diclofenac sodium 100mg Tablet (sustained release) 100's: 123.00 MRP
PROLADIN Alco Pharma Ltd Diclofenac sodium 50mg Tablet 100's: 75.00 MRP
PROLADIN-TR Alco Pharma Ltd Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
PRONAC-SR Hallmark Pharmaceuticals Ltd Diclofenac sodium 100mg Tablet (sustained release) 50's: 125.50 MRP
REFAIN Monico Pharma Limited Diclofenac sodium 50mg Tablet 100's: 83.00 MRP
REFAIN Injection Monico Pharma Limited Diclofenac sodium 75mg/3ml Injection 10's: 95.00 MRP
REFAIN TR Monico Pharma Limited Diclofenac sodium 100mg Capsule (timed release) 48's: 144.00 MRP
RENAC-TR Reman Drug Laboratories Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
REUTREN Gaco Pharmaceutical Ltd. Diclofenac sodium 0.1% Eye Drop 5ml: 70.00 MRP
REUTREN Injection Gaco Pharmaceutical Ltd. Diclofenac sodium 75mg/3ml Injection 1 amp: 7.74 MRP
REUTREN-100-SR Gaco Pharmaceutical Ltd. Diclofenac sodium 100mg Tablet (sustained release) 50's: 150.00 MRP
RONAC TR General Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule (timed release) 50's: 150.50 MRP
ROTAFEN Salton Pharmaceuticals Ltd. Diclofenac sodium 50mg Tablet 200's: 166.00 MRP
ROTAFEN-TR Salton Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 301.00 MRP
S-FENAC-TR Seema Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 50's: 150.00 MRP
SAFENAC-TR Shamsul Alamin Pharmaceuticals Ltd Diclofenac sodium 100mg Capsule (timed release) 50's: 90.00 MRP
SIFEN TR Silva Pharmaceuticals Limited Diclofenac sodium 100mg Capsule (timed release) 100's: 250.94 MRP
SUNAC Syntho Laboratories Ltd. Diclofenac sodium 50mg Tablet 150's: 120.00 MRP
ULTRAFEN 25 Beximco Pharmaceuticals Ltd Diclofenac Sodium BP 25mg enteric coated tablet Tablet 200's: 108.00 MRP
ULTRAFEN 50 Beximco Pharmaceuticals Ltd Diclofenac Sodium BP 50mg enteric coated tablet Capsule 200's: 166.00 MRP
ULTRAFEN Injection Beximco Pharmaceuticals Ltd Diclofenac Na BP 75mg/3ml Injection 3ml x10's: 150.00 MRP
ULTRAFEN SR Beximco Pharmaceuticals Ltd Diclofenac Sodium BP 100mg sustained release tablet Tablet 100's: 300.00 MRP
ULTRAFEN Suppository Beximco Pharmaceuticals Ltd Diclofenac Sodium BP 12.5mg & 50mg Suppository 10's each: 90.00 & 150.00 MRP
VOLCAN Biopharma Laboratories Ltd Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
VOLCAN SR Biopharma Laboratories Ltd Diclofenac sodium 100mg Tablet (sustained release) 50's: 150.50 MRP
VOLCAN TR Biopharma Laboratories Ltd Diclofenac sodium 100mg Capsule (timed release) 100's: 301.00 MRP
VOLFAST TR S.N. Pharmaceuticals Ltd. Diclofenac sodium 100mg Capsule (timed release) 100's: 300.00 MRP
VOLIGEL Beximco Pharmaceuticals Ltd Diclofenac Sodium 30 & 50gm tube Gel 30 & 50gm: 80.00 & 97.00 MRP
VOLMAX SR Eskayef Bangladesh Ltd Diclofenac Sodium BP 100mg Tablet (sustained release) 60's MRP: 180.00
VOLPRO 50 Mystic Pharmaceuticals Limited Diclofenac sodium 50mg Tablet 100's: 80.00 MRP
VOLTALIN Novartis (Bangladesh) Ltd. Diclofenac Sodium BP 25mg Tablet 100's: MRP 305.00
VOLTALIN D Novartis (Bangladesh) Ltd. Diclofenac free acid 46.5mg (corresponding to 50mg of diclofenac sodium) Tablet (dispersible) 100's: MRP 560.00
VOLTALIN FORTE Novartis (Bangladesh) Ltd. Diclofenac Sodium BP 50mg Tablet 100's: MRP 603.00
VOLTALIN Injection Novartis (Bangladesh) Ltd. Diclofenac Sodium BP 75mg/3ml Injection 5 amps: 471.80 MRP
VOLTALIN SR 100 Novartis (Bangladesh) Ltd. Diclofenac sodium BP 100mg Tablet (sustained release) 50's: MRP 610.00
VOLTALIN SR 75 Novartis (Bangladesh) Ltd. Diclofenac sodium BP 75mg Tablet (sustained release) 50's: MRP 452.50
VOLTALIN SUPPOSITORY Novartis (Bangladesh) Ltd. Diclofenac Sodium BP 12.5mg & 50mg Suppository 12.5mg x 10's: MRP 290.00; 50mg x 10's: MRP 500.00
VOLTAROL Techno Drugs Diclofenac sodium 75mg/3ml Injection 5 amps: 45.00 MRP
VOLTID-50 Pharmasia Limited Diclofenac sodium 50mg Tablet 100's: 60.00 MRP
VOLTID-SR Pharmasia Limited Diclofenac sodium 100mg Capsule (sustained release) 50's: 151.00 MRP
VOLTON 50 The White Horse Pharma Diclofenac sodium 50mg Tablet 100's: 84.00 MRP

General Medical Info

IMPORTANT WARNING:

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as diclofenac may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take diclofenac right before or right after the surgery.

NSAIDs such as diclofenac may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking diclofenac. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin; aspirin; other NSAIDs such as ibuprofen and naproxen; or oral steroids such as dexamethasone, methylprednisolone, and prednisone. Also inform your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking diclofenac and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to diclofenac. Be sure to inform your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.  

 

Why is this medication prescribed?

Diclofenac is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Diclofenac immediate-release (short-acting) tablets are also used to treat painful menstrual periods and pain from other causes. Diclofenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

How should this medicine be used?

Diclofenac comes as an immediate-release tablet and liquid-filled capsule and an extended-release (long-acting) tablet to take by mouth. Diclofenac immediate-release tablets and capsules are usually taken two to four times a day. Diclofenac extended-release tablets are usually taken once a day, and in rare cases are taken twice a day. Take diclofenac at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take diclofenac exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Other uses for this medicine

Diclofenac is also used sometimes to treat pain caused by gout, painful shoulder and cancer. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking diclofenac,
  • inform your doctor if you are allergic to diclofenac, aspirin or other NSAIDs such as ibuprofen and naproxen, any other medications, or any of the inactive ingredients in diclofenac tablets or extended release tablets. Carefully read manufacturer's packaging insert to understand more about the product and consult your doctor.
  • inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, and trandolapril; cyclosporine (Neoral, Sandimmune); digoxin; diuretics; insulin and oral medication for diabetes; lithium; and methotrexate. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); porphyria (an abnormal increase in the amount of certain natural substances made by the liver); liver or kidney disease; or swelling of the hands, feet, ankles, or lower legs .
  • inform your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking diclofenac, call your doctor.
  • if you are having surgery, including dental surgery, inform the doctor or dentist that you are taking diclofenac.

What special dietary instructions should I follow?

Unless your doctor informs you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   

Diclofenac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • diarrhea
  • constipation
  • gas or bloating
  • headache
  • dizziness
  • ringing in the ears
  • unexplained weight gain
  • excessive tiredness
  • lack of energy
  • nausea
  • loss of appetite
  • itching
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • flu-like symptoms
  • fever
  • blisters
  • rash
  • hives
  • swelling of the eyes, face, tongue, lips, throat, arms, hands, feet, ankles, or lower legs
  • difficulty breathing or swallowing
  • hoarseness
  • pale skin
  • fast heartbeat
  • cloudy, discolored, or bloody urine
  • back pain
  • difficult or painful urination

Diclofenac may cause other side effects. Consult your doctor if you have any unusual problems while taking this medication.

In case of emergency/overdose

In case of overdose, contact Hospital Emergency.

Symptoms of overdose may include:
  • nausea
  • vomiting
  • stomach pain
  • bloody, black, or tarry stools
  • vomiting a substance that is bloody or looks like coffee grounds
  • drowsiness
  • slow, shallow, or irregular breathing
  • loss of consciousness

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed.

What other information should I know?

Do not let anyone else take your medication. Ask your healthcare provider any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

 | See Brand Manufacturer's Prescribing Information for Diclofenac Sodium extended release tablet |

See Brand Manufacturer's Prescribing Information for Diclofenac Potassium film coated tablet |

 | See Brand Manufacturer's Prescribing Information for Diclofenac Sodium ophthalmic solution |

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