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Luxafen Gel (Diclofenac Diethylammonium 1.16g)Miodarone Tablets (Amiodarone HCL 200mg)

Luxafen K Tablets (Diclofenac Potassium 50mg Tablets)

Luxafen K Tablets (Diclofenac Potassium 50mg Tablets)

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LUXAFEN-K Immediate Release Tablet is a non-steroidal anti-inflammatory drug (NSAID), with pronounced analgesic, antipyretic and anti-inflammatory properties. It is an inhibitor of cyclo-oxygenase.

LUXAFEN-K Immediate Release Tablet is readily absorbed after administration and acts by inhibiting prostaglandin biosynthesis, which plays a major rule in causing inflammation, pain and fever. LUXAFEN-K Immediate Release Tablet has been formulated to make available the well established pharmacotherapeutic effects of diclofenac potassium.

CHEMICAL NAME:

Potassium - {0-[(2-6-diclorophenyl)-amino]phenyl}acetate.

PHARMACEUTICAL GROUP:

Immediate Release Film coated Tablet.

PHARMACOLOGICAL GROUP:

Non-steroidal anti-inflammatory drug (NSAID).

COMPOSITION:

LUXAFEN-K Immediate Release Tablet:
Each Immediate Release Film Coated Tablet contains:
Diclofenac Potassium -------- 50mg

MECHANISM OF ACTION:

LUXAFEN-K Immediate Release Tablet acts mainly by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, Pain and fever.

INDICATIONS:

LUXAFEN-K Immediate Release Tablet rapid onset of action makes it particularly indicative in short term treatment of acute painful and inflammatory conditions like:
  • Condition of acute pain, inflammation and swelling following surgical intervention, e.g., Dental extraction, tonsillectomy, orthopaedic surgery, abdominal surgery.
  • Painful and inflammatory conditions in gynaecological cases, e.g., Primary dysmenorrhoea, adnexitis.
  • Acute pain, inflammation and swelling following traumatic conditions, e.g., Due to sprain.
  • Painful conditions of vertebral column.
  • Non articular rheumatism.
  • As an adjuvant to appropriate basic therapy for severe painful, inflammatory condition due to infections of ear, nose and throat e.g., influenza, pharyngotonsillitis, otitis.

DOSAGE:

For pain and soft tissue inflammation:
Adults: 100-150mg daily in 2-3 divided doses.
In mild cases and children over 14 years of age:
75-100mg daily in 2-3 divided doses.
For primary dysmenorrhoea:
50-150mg daily in 2-3 divided doses, raised upto a maximum of 200mg/day.
Treatment should be started upon appearance of the first symptom and depended on the symptomatology continued for a few days.

SIDE EFFECTS:

Most Common: Gastro - intestinal disorder, nausea, vomiting, diarrhea, abdominal cramps.
Occasional: Headache, dizziness, vertigo, skin rashes, Elevation of aminotransterase values in liver.

Rarely: Gastric or intestinal ulcer with or without bleeding or perforation, drowsiness, hepatitis with or without bleeding or perforation, drowsiness, hepatitis with or without jaundice, hypersensitivity, urticaria oedema.

Isolated cases: Disorientation, insomnia, irritability, anxiety, convulsions, agranulocytosis, aplastic anemia, thrombocytopenia, hemotolytic anemia, palpitation, chest pain and congestive heart failure.

PRECAUTIONS:

Vigilant medical supervision is necessary in patient with history of gastric or intestinal ulcer, ulcerative colitis, hepatitis, impaired cardiac and renal functions. Patients receiving long term treatment should be advised for periodic blood counts.

OVER DOSAGE:

Management of acute poisoning with NSAID’s consists essentially of supportive and symptomatic measures.
There is no typical clinical picture associated with over dosage of diclofenac.
The following therapeutic measure should be taken in cases of over dosage.
Supportive and symptomatic treatment are indicated for complications such as hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression.
Specific measure such as forced diuresis, dialysis or haemoperfusion are unlikely to be helpful in eliminating NSAID’s because of their high protein-binding rate and extensive metabolism.

INTERACTIONS:

LUXAFEN-K Immediate Release Tablets when co-administered with other anti-inflammatory drugs, pharmacokinetic interaction may occur, increasing the frequency of adverse effects.

ABSORPTION AND FATE:

From potassium salt, Diclofenac is rapidly and completely absorbed when given orally. Mean peak plasma concentration of 3.8µ ml/litre reaches after 20-60 minutes. About 50-60% of drug reaches to systemic circulation from liver after first pass metabolism.

ELEMINATION:

The drug is metabolism to 3-hydroxy-diclofenac, 5-hydroxy-diclofenac, 4-hydroxy-diclofenac and 4,5- hydroxy-diclofenac. It is then excreted mainly in the urine in the form of glucuronide and sulphur conjugates less than 1% is exerted unchanged. The rest of the drug is eliminated as metabolism through the bile in the faeces.

CONTRA-INDICATIONS:

Diclofenac Potassium is contra-indicated in patients with suggestive history of gastric or intestinal ulcer, asthma, hypersensitivity to Diclofenac.

PATIENTS INFORMATION:

Self medication is not advisable. Use LUXAFEN-K Immediate Release Tablet according to the advice of your physician. Swallow LUXAFEN-K Immediate Release Tablet with a glass of water or other liquid preferable before meals. In case of any discomfort, consult your physician.

SHELF LIFE:

LUXAFEN-K Immediate Released Tablet may be stored for 3 years.

STORAGE: Protect from moisture and heat, store below 30°C.

PRESENTATION:

LUXAFEN-K Immediate Release Tablet: Blister Pack of 2x10’s.