Description

How Supplied

Diclofenac sodium Capsules are presented as froms that containing 100 mg (pellet Extended release) diclofenac sodium. 10 Capsules per blister pack, 10 blisters with a leaflet in a box.

Category

Antirheumatic(nonsteroidal anti-inflammatory);Analgesic;Antigout agent;Anti dysmenorrheal; vascular headache suppressant

Mechanism of action

Nonsteroidal anti – inflammatory drags (NSAIDs) inhibit the activity of the enzyme cyclo – oxygenase , resulting in decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Although the resultant decrease in prostaglandin synthesis and activity in various tissues may be responsible for many of the therapeutic (and adverse) effects of NSAIDs , other actions may also contribute significantly to the therapeutic effects of these medications.

Pharmacokinetics

• Absorption:Rapid(food)

• Distribution: up to 8 hr

• Half – life: -Elimination:1.2-2 hr
• Elimination:renal-40-65%;biliary-fecal:35%.

Pregnancy and Breast- Feeding

FDA pregnancy category B. it is also distributed into breast milk.

Precautions

• Regular visits to physician during prolonged therapy.
• Possibility that use of alcohol may increase the risk of ulceration and , with phenylbutazone , depressant effects,so checking with physician if you consume 3 or more alcohol – containing beverages per day ; alcohol consumption may increase the risk of NSAID  induced gastrointestinal toxicity.
• Not taking 2 or more NSAIDs , including ketodolac , concurrently , and not taking acetaminophen or aspirin or other salieylates for more than a few days while receiving NSAID therapy , unless concurrent use is prescribed by , and patient remains under the care of , a physician or dentist.
• Importance of immediately reporting to physician symptoms of edema , gastrointestinal bleeding or ulceration , cardiovascular events , un usual weight gain , or skin rash.
• Caution if any surgery is required because of possible enhanced
• Caution if confusion , dizziness or lightheadness , drowsiness , or vision problems occur.
•  Possibility of photosensitivity
• Possibility of gastrointestinal ulceration and bleeding.
• Notifying physicion immediately if influenza – like symptoms (chills , fever , or mascle aches and pains) occur shortly prior to or together with a skin rash ; rarely , these symptoms may indicate a serious reaction to the medication.

Drug interaction

 Inform your doctor if you have any of the following medicine:ACE inhibitors ; acetaminophen ; alcohol ; corticosteroids , oral glucocorticid ;corticotropin ; potassium supplements ; anticoagulants , coumarin – or indanedione – derivative ; heparin ;Thrombolytic agents like : Alteplase , Anistreplase , streptovinase , urokinase , warfarin ; antidiabetic agents , oral or insulin ; antihypertensives or diuretics , especially triamterene ; aspirin or NSAIDs , two or more concurrently , especially diflunisal and indomethacin concurrently or salicylates other than aspirin and diflunisal ; cefamandole ; cefoperazone ; cefotetan ; plicamycin ; valproic acid ; colchicines ; cyclosporine or gold compounds or nephrotoxic medications ; digitalis glycosides ; lithium ; methotrexate ; photosensitizing medications ;platelet aggregation inhibitors; probenecid.

Dosage and administration

Usual adult dose

• Antirheumatic (nonsteroidal anti – inflammatory) : 75 or 100 mg once a day , in the morning or evening , or 75 mg two times a day , in the morning and evening.

Usual pediatric dose

Safety and efficacy have not been established.

Side Effects

Those indicating need for medical attention:Gastrointestinal effects,Abdominal cramps, pain, discomfort;Diarrhea;Indigestion;Nausea;constipation;headache mild to moderate ; renal effect;Angina Pectoris or exacerbation of chest pain;cardiac arrhythmias; Itching; Skin rash; abdominal distention; ringing or buzzing in ears;dizziness;bloated feeling or gas; carcinoma ; hemoptysis;congestive heart failure;increased blood pressure;aseptic meningitis;mental depression;Hives;erythema multiform;stevens-johnson syndrome;colitis or exacerbation; gastrointestinal bleeding or hemorrhage; cystitis;proteinuria;Hematologic effects;Anemia ;nephritic syndrome ;oliguria;Hemolytic anemia;Leukopenia;thrombocytopenia with or without purpura; renal impairment;shortness of breath;drowsiness;trouble in sleeping;  unusual weakness;bitter taste ;vomiting;general feeling of discomfort; muscle weakness.Anaphylaxis or anaphylactoid reaction;Hepatitis or jaundice; angioedema; Bronchospastic allergic reaction;laryngeal edema;blurred or double vision; Scotomata; swelling of lip or tong;decreased  hearing or any change to hearing;interstitial nerphritis; pancreatitis.

Storage:

Store below 30 ^˚ C, protect from light and moisture. Keep out of reach of children.