Diclofenac Sodium (Generic Voltaren ) - Product information and Uses

Diclofenac Sodium is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic reducing pain in certain conditions.
Diclofenac Sodium is available as a generic drug in a number of formulations. Cerytain Countries have approved it for Over-the-counter (OTC) use for minor aches and pains and fever associated with common infections.

Uses of Diclofenac Sodium (Generic Voltaren )

Diclofenac is used to treat pain, inflammatory disorders, and dysmenorrhea. Inflammatory disorder may include musculoskeletal complaints, especially arthritis, rheumatoid arthritis, polymyositis, dermatomyositis, osteoarthritis, dental pain, TMJ, spondylarthritis, ankylosing spondylitis, gout attacks, and pain management in cases of kidney stones and gallstones.
An additional indication is the treatment of acute migraines. Diclofenac is used commonly to treat mild to moderate post-operative or post-traumatic pain, in particular when inflammation is also present, and is effective against menstrual pain and endometriosis.
As long-term use of diclofenac and similar NSAIDs predisposes for peptic ulcer, many patients at risk for this complication are prescribed a combination (Arthrotec) of diclofenac and misoprostol, a synthetic prostaglandin analogue, to protect the gastric mucosa./p>

Diclofenac Sodium - Availability And Packaging

Diclofenac Sodium is available as Voltaren XR 100 Pills which is packaged in 50 mg tablets.

Diclofenac Sodium (Generic Voltaren ) - Contraindications

Listed below are the side effects of Generic Voltaren (Diclofenac Sodium)

  • Hypersensitivity against Diclofenac Sodium
  • History of allergic reactions (bronchospasm, shock, rhinitis, urticaria) following the use of aspirin or another NSAID
  • Third-trimester pregnancy
  • Active stomach and/or duodenal ulceration or gastrointestinal bleeding
  • Inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis
  • Severe insufficiency of the heart (NYHA III/IV)
  • A warning has been issued by the FDA not to use for the treatment of patients recovering from heart surgery
  • Severe liver insufficiency (Child-Pugh Class C)
  • Severe renal insufficiency (creatinine clearance <30 ml/min)
  • Caution in patients with preexisting hepatic porphyria, as diclofenac may trigger attacks
  • Caution in patients with severe, active bleeding such as cerebral hemorrhage
  • NSAIDs in general should be avoided during dengue fever.
  • On animals which after death may be eaten by vultures or other scavenging birds.

Side Effects of Diclofenac Sodium (Generic Voltaren )

Diclofenac Sodium is one of the better tolerated NSAIDs. Although 20% of patients on long-term treatment experience side-effects, only 2% have to discontinue the medication, mostly due to gastrointestinal complaints.
Cardiac Side effects
A relative increased rate of heart disease of 1.63 compared to non-users of Diclofenac Sodium. Diclofenac has similar COX-2 selectivity to celecoxib. A review by FDA concluded in September, 2006 that diclofenac does increase the risk of myocardial infarction.
Gastrointestinal
The development of ulceration and/or bleeding requires immediate termination of treatment with diclofenac. Most patients receive an ulcer-protective drug as prophylaxis during long-term treatment (misoprostol, ranitidine 150 mg at bedtime or omeprazole 20 mg at bedtime).
Hepatic
Liver damage occurs infrequently, and is usually reversible. Hepatitis may occur rarely without any warning symptoms and may be fatal. Patients with osteoarthritis more often develop symptomatic liver disease than patients with rheumatoid arthritis. Liver function should be monitored regularly during long-term treatment. If used for the short-term treatment of pain or fever, diclofenac has not been found to be more hepatotoxic than other NSAIDs.Cases of drug-induced hepatotoxicity have been reported in the first month, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Renal
Diclofenac caused acute kidney failure in vultures when they ate the carcasses of animals that had recently been treated with it. Species and individual humans that are drug sensitive are initially assumed to lack genes expressing specific drug detoxification enzymes. NSAIDs are associated with adverse renal [kidney] effects caused by the reduction in synthesis of renal prostaglandins in sensitive persons or animal species, and potentially during long-term use in non-sensitive persons if resistance to side-effects decreases with age.
Other Side Effects
Bone marrow depression is noted infrequently (leukopenia, agranulocytosis, thrombopenia with/without purpura, aplastic anemia). These conditions may be life-threatening and/or irreversible, if detected too late. All patients should be monitored closely. Diclofenac is a weak and reversible inhibitor of thrombocytic aggregation needed for normal coagulation. Induces warm antibody hemolytic anemia by inducing antibodies to Rh antigens, ibuprofen also does this. Diclofenac may disrupt the normal menstrual cycle.
Ecological Effects
Use of diclofenac in animals has been reported to have led to a sharp decline in the vulture population in the Indian subcontinent. In March 2005, the Government of India announced that it intended to phase out the veterinary use of diclofenac. The loss of tens of millions of vultures over the last decade has had major ecological consequences across the Indian subcontinent that pose a potential threat to human health.

Diclofenac Sodium (Generic Voltaren ) - Dosage

The individual patients dosage should be adjusted after observing the response to initial therapy with Generic Voltaren Tablets. For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg twice a day or thrice a day, or 75 mg twice a day).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg thrice a day or four times a day, or 75 mg twice a day). For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary.

Additional Information

Additional Info: Prescribing Information



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