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Diclofenac information from DrugsUpdate  

See Available Brands of Diclofenac in India

P - Contraindicated in pregnancy
L - Caution when used during lactation

Diclofenac (marketed as Voltaren and under a number of other trade names, see below) is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic reducing pain in conditions such as arthritis or acute injury. It can also be used to reduce menstrual pain, dysmenorrhea. The name is derived from its chemical name: 2-(2,6-dichloranilino)phenylacetic acid.
In the United Kingdom, India, and the United States, it may be supplied as either the sodium or potassium salt, in China most often as the sodium salt, while in some other countries only as the potassium salt. Diclofenac is available as a generic drug in a number of formulations. Over the counter (OTC) use is approved in some countries for minor aches and pains and fever associated with common infections.

Pharmacodynamics

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). In pharmacologic studies, Diclofenac has shown anti-inflammatory, analgesic, and antipyretic activity. As with other NSAIDs, its mode of action is not known; its ability to inhibit prostaglandin synthesis, however, may be involved in its anti-inflammatory activity.

Pharmacokinetics

Diclofenac has potent anti-inflammatory, analgesic and antipyretic actions. It inhibits the enzyme, cyclooxygenase, thus resulting in reduced synthesis of prostaglandin precursors.
Absorption: Rapidly absorbed (oral solution, rectal suppository, IM); more slowly (enteric-coated tab).
Distribution: Penetrates synovial fluid; enters breast milk (small amounts). Protein-binding: >99%.
Metabolism: Extensively hepatic; converted to metabolites.
Excretion: About 60% excreted in urine as glucuronide and sulfate conjugates; 35% in bile; 1-2 hr (elimination half-life).

Diclofenac Indications / Diclofenac Uses

Information Not Available

Diclofenac Adverse Reactions / Diclofenac Side Effects

GI disturbances; headache, dizziness, rash; GI bleeding, peptic ulceration; abnormalities of kidney function. Pain and tissue damage at Inj site (IM); local irritation (rectal); transient burning and stinging (ophthalmic).
Potentially Fatal: Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.

Precautions

Warnings
NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, inflammation, perforation of the stomach or intestines, and ulceration, which can be fatal. These events can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.
Monitor
Monitor for signs and symptoms of GI bleeding. Closely monitor BP during the initiation of treatment and throughout the course of therapy. Carefully monitor patients who may be adversely affected by alterations in platelet function (eg, patients with coagulation disorders, patients receiving anticoagulant therapy). Obtain baseline assessments of pain and ability to perform activities of daily living. Ensure CBC, serum electrolytes, and serum transaminases are evaluated periodically during prolonged therapy. Note dark, tarry stools; epigastric pain; indigestion; or unusual bleeding or bruising. If used in patients with advanced renal disease, monitor renal function. Monitor refractive stability for a year following corneal refractive procedures in patients treated with the ophthalmic solution.
Check hemoglobin or hematocrit in patients on long-term treatment if they exhibit signs or symptoms of anemia.
Overdosage:
Symptoms: Lethargy, drowsiness, nausea, vomiting, and epigastric pain, GI bleeding. Hypertension, acute renal failure, respiratory depression, anaphylactoid reactions and coma may occur rarely. Treatment in symptomatic and supportive. Emesis and/or activated charcoal and/or osmotic cathartic may reduce drug absorption if present within 4 hr of ingestion. Forced diuresis, alkalinisation of urine, haemodialysis, or haemoperfusion unlikely to be useful.

Special Precautions

History of GI ulceration; impaired cardiac, renal or hepatic function; hypertension; lactation. IV admin in patients with moderate or severe renal impairment; hypovolaemia or dehydration; asthma, porphyria. Monitor LFTs in patients on prolonged therapy. May prolong bleeding time; caution when used in patients with coagulation disorders or on anticoagulants. Prolonged therapy may increase risk of anaemia. 1st and 2nd trimester of pregnancy. Elderly, debilitated patients.

Other Drug Interactions

Not to be given IV to patients who are receiving other NSAIDs or anticoagulants including low dose heparin. Renal function may be worsened when used with ciclosporin or triamterene. Altered absorption when given with sucralfate, colestyramine or colestipol. Ophthalmic application of diclofenac may reduce the efficacy of ophthalmic acetylcholine and carbachol. Increased risk of GI ulceration and bleeding when used with corticosteroids, aspirin or anticoagulants.
Potentially Fatal: Increases blood levels of digoxin, lithium and methotrexate. Potentiate potassium-sparing diuretics.

Other Interactions

Food Interactions: Slow absorption of enteric-coated tab when given with food

Dosage

Oral
Bursitis
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Sprains
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Strains
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Tendinitis
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Acute gout
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Dysmenorrhoea
Adult: As sodium: 75-150 mg daily in divided doses. Max: 150 mg/day.
Hepatic impairment: Dose adjustment may be needed.
Oral
Migraine
Adult: As potassium: Initially, 50 mg taken 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.
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.
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.
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.
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
Prevention 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.

Food(before/after)

Should be taken with food. (Take immediately after meals.)

List of Contraindications

Diclofenac and Pregnancy

Contraindicated in pregnancy
D in 3rd trimester or near delivery.
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 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.

Diclofenac and Lactation

Caution when used during lactation

Diclofenac and Children

Information Not Available

Diclofenac and Geriatic

Information Not Available

Diclofenac and Other Contraindications

Active peptic ulcer; hypersensitivity to diclofenac or other NSAIDs. Treatment of perioperative pain in CABG surgery. 3rd trimester of pregnancy. Topical: Not to be applied onto damaged or nonintact skin.

Storage

Intramuscular: Store at 15-30°C.
Intravenous: Store at 15-30°C.
Ophthalmic: Store at 15-30°C. Oral: Store at 15-30°C.
Rectal: Store at 15-30°C.
Topical/Cutaneous: Store at 15-30°C.

Lab interference

Intramuscular: Store at 15-30°C.
Intravenous: Store at 15-30°C.
Ophthalmic: Store at 15-30°C. Oral: Store at 15-30°C.
Rectal: Store at 15-30°C.
Topical/Cutaneous: Store at 15-30°C.

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