Norfen-SR 100 mg (Capsule (Sustained Release))
Medicine Details
Category | Details |
---|---|
Generic | Diclofenac sodium |
Company | Kumudini pharma ltd |
Also available as |
Indications
- Rheumatology
- Inflammatory and degenerative forms of rheumatism
- Chronic involutive
- Polyarthritis
- Ankylosing spondylarthritis
- Osteoarthritis
- Spondylarthroses
- Acute gout
- Peri-articular rheumatic disorders
- Sprain
- Bruises
- Dislocations
- Fractures
- Soft tissue injuries
- Surgical interventions
- Primary dysmenorrhoea
- Episiotomy
- Adnexitis
- Endometritis
- Parametritis
- Salpingitis
- Mastitis
- Pre-operative medication for the prevention of pain, inflammation, and swelling
- Post-operative and post-traumatic pain, inflammation, and swelling
- For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract
- Renal and biliary colic
Pharmacology
Dilofenac 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 effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis to reduce inflammation, pain, and fever. It is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after food. 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 & Administration
- Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use
- Diclofenac SR Tablet: Adult: 1 tablet daily, taken whole with liquid, preferably at meal times
- Diclofenac Dispersible Tablet: Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg
- Diclofenac TR Capsule: One capsule daily
- Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg
- Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily
- Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily.
Interaction
- Lithium and digoxin: Norfen-SR may increase plasma concentrations of lithium and digoxin
- Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of diclofenac and anticoagulant therapy
- Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect
- Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving cyclosporin and diclofenac concomitantly
- Methotrexate: Cases of serious toxicity have been reported when methotrexate and NSAIDs are given within 24 hours of each other
- Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs
- Other NSAIDs and steroids: Co-administration of diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects.
Contraindications
Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents. Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.
Side Effects
- Adverse effects are mild, rare and transient
- Epigastric pain
- Eructation
- Nausea
- Diarrhea
- Dizziness
- Headache
- Peripheral edema
- Skin reactions like rash and eczema
- Local irritation and reddening of the skin and skin rash
Pregnancy & Lactation
During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.
Precautions & Warnings
- In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Norfen-SR
- In patients with advanced age should be kept under close observation
- Norfen-SR Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth
Therapeutic Class
- Drugs for Osteoarthritis
- Drugs used for Rheumatoid Arthritis
- Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Storage Conditions
Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.
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