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Chemical
nameBenzeneacetic acid, 2 -
[(2, 6 -dichlorophenyl) amino] - , diethylammonium salt.
CategoryAntirheumatic; Analgesic.
Mechanism of
action
Diclofenac inhibits the activity of the enzyme cyclo -
oxygenase, resulting in decreased formation of precursors of
prostaglandins and thromboxanes from arachidonic acid. Diclofenac may
block pain impulse generation via a peripheral action that may involve
reduction of the activity of prostaglandins, and possibly inhibition of
the synthesis or actions of other substances that sensitize pain receptors
to mechanical or chemical stimulation.
Indications
Tendinitis; Edema post-operation or post trauma; Local
symptomatic relief of pain and inflammation.
Precautions to
consider
This medication should not be used when the following
medical problems exist: Allergic reaction, severe, such as anaphylaxis
or angioedema, induced by aspirin or other NSAIDs, history of; Nasal
polyps associated with bronchospasm, aspirin - induced (high risk of
severe allergic reactions because of cross - sensitivity); Blood
dyscrasis, active or history of; Bone marrow depression (diclofenac may
induce or exacerbate these conditions). Risk benefit should be
considered when the following medical problems exist: Allergic
reaction, mild, such as allergic rhinitis, urticaria, or skin rash,
induced by aspirin or other NSAIDs, history of (possibility of cross -
sensitivity); Anemia; Asthma; Hypertension: Edema; Inflammatory or
ulcerative disease of the upper or lower gastrointestinal tract; Diabetes
mellitus; Hemophilia or other bleeding problems; hepatic or renal function
impairment; Stomatitis; Systemic lupus erythematosus; Porphyria, (
diclofenac may precipitate an acute attack); Eczema; Infected lesions or
wounds.
Pregnancy
Embryotoxicity and other adverse effects, but not
teratogenicity, demonstrated in animal studies. FDA Pregnancy Category
B.
Breast -
feeding
Diclofenac is distributed into breast milk.
Drug
interactions
In addition to the interactions listed below, the
possibility should be considered that additive or multiple effects leading
to impaired blood clotting and / or increased risk of bleeding may occur
if any NSAID is used concurrently with any medication having a siginficant
potential for causing hypoprothrombinemia, thrombocytopenia, or
gastrointestinal ulceration or hemorrhage. Acetaminophen, Alcohol,
Potassium supplements, Anticoagulants, Heparin, Thrombolytic agents,
Potassium-sparing diuretics, Lithium, Probenecid, Salicylates, Digoxin,
Antidiabetic agents or insulin, Corticosteroids, Cyclosporine, Valproic
acid.
Side / Adverse
effects
Hypersensitivity reactions such as: Rhinosinusitis /
asthma or angioedema / urticaria; Anaphylaxis. Gastrointestinal
problems; Dermatologic effects; Headache; Renal and hepatic function
impairment; Hearing problems, CNS effects; Hyperkalemia; Edema.
Administration and
dosage
Usual adult, adolescent, children (15 years of age and
over): It is applied to the affected site 3 to 4 times daily; Treatment
should be reviewed after 14 days or after 28 days if used for
osteoarthritis.
How
suppliedTopical gel, 60
grams. Each 100 g contains diclofenac diethylammonium salt equivalent
to diclofenac sodium 1 g.
StorageStore below 30° C, protect from freezing.
References1 - USP DI Vol: 1 (1997) - Pages:
379-395. 2 - Drug facts and comparisons (1994). 3 - Vidal (1995) -
Page: 1637. 4 - Martindale, the extra pharmacopoeia, 31 edition -
(1996).
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