Indications:

Indication

Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Pain, Migraine, Dysmenorrhea, Muscle aches, Acute gout, Inflammation, Renal colic,Tendinitis, Backaches, Dental pain, Menstrual cramps, Bursitis

Pharmacology:

Diclofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effects. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after a meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first-pass metabolism.

Dosage (breakdown or, not) :

Adult: 

Enteric-coated tablet: A total of 75-150 mg daily given in two or three divided doses. 

Sustained-release tablets: One tablet daily, taken whole with liquid, preferably during a meal.

Suppositories: 75-150 mg daily in divided doses.

Gel: Depending on the painful site to be treated, 2-4 g gel may be applied 3-4 times daily.

Child: 

Enteric-coated tablet : 1-3 mg/kg per day in divided doses.

Sustained-release tablets: Not recommended.

Suppositories: 1-3 mg/kg body weight in divided doses.

Interaction:

May increase serum levels of methotrexate. Concomitant use w/ other NSAIDs or anticoagulants (e.g. warfarin) is associated w/ higher risk of GI bleeding. Increased risk of nephrotoxicity w/ ciclosporin or triamterene. May increase the risk of developing corneal complications in patients w/ significant pre-existing corneal inflammation when use concomitantly w/ ophth preparation containing corticosteroids. Colestyramine and colestipol reduce the bioavailability of diclofenac. Decreased plasma concentration when administered after sucralfate. Ophth application of diclofenac may reduce the efficacy of ophth acetylcholine and carbachol. May increase serum levels of lithium and digoxin.

Contraindication:

Ultrafen should not be given in patients with previous hypersensitivity to Diclofenac, asthmatic patients and in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs.

Side Effects: 

Epigastric pain, nausea and diarrhoea, headache and slight dizziness may be complained by some patients. These are often transient, disappearing with continuation of medication. Occasionally skin rash, peripheral oedema and abnormalities of serum transaminase have been reported. Very rarely reported side effects include activation of peptic ulcer, haematemesis or melaena, blood dyscrasia (in course of extensive usage). There have been isolated reports of anaphylactoid reactions.

Pregnancy: 

Diclofenac should not be prescribed during pregnancy unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drug is not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected. Since no experience has been acquired with diclofenac gel in pregnancy or lactation,  it is not recommended for use in these circumstances. 

Precautions & Warnings: 

Store in a cool and dry place, away from light. Keep out of reach of children.  Commercial Pack  Ultrafen IM Injection: Box containing 2 x 5 ampoules of 3 ml in a blister pack. Each 3  ml ampoule contains Diclofenac Sodium BP 75 mg. 

Storage Conditions:

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.