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Diclofast

COMPOSITION
Diclofast 25 mg tablet: Pink coloured round film coated tablet with a score on one side. Each film-coated tablet contains Diclofenac Potassium 25mg.
Diclofast 50 mg tablet: Brown coloured round film coated tablet with a score on one side. Each film-coated tablet contains Diclofenac Potassium 50mg.

ACTIONS
Diclofenac potassium is a nonsteroidal anti-inflammatory drug with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic properties. It is an inhibitor of prostaglandin biosynthesis (prostaglandin is important in the pathogenesis of inflammation, pair. and fever) and modulator of arachidonic acid release and uptake.

In rheumatic conditions, diclofenac is effective against chest pain, pain on movement, morning stiffness, swelling of the joints and functional performance.

Diclofenac potassium rapidly relieves spontaneous pain and pain on movement and reduces inflammatory swelling and wound oedema in post-traumatic and postoperative inflammatory conditions.

In migraine attacks, diclofenac is found to be effective in relieving the headache and in improving the accompanying symptom of nausea.
Diclofenac potassium has also shown marked analgesic effect in moderate and severe painful states of non-rheumatic origin.

In vitro, diclofenac potassium does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.

Diclofenac potassium has a rapid onset of action and is therefore suitable for the treatment of acute episodes of pain and inflammation. It is also found to exert a pronounced analgesic effect in moderately and severely painful states.

Diclofenac potassium relieves the pain and reduces the extent of bleeding in primary dysmenorrhoea.

PHARMACOKINETICS
Absorption: Diclofenac is rapidly and completely absorbed. Food intake does not affect extent of absorption, but time taken to reach Cmax is longer.

Distribution: Peak plasma concentration after one 50mg tablet was 1.2 ug/mL (3.9 umol/L) after 20-60 min. The plasma concentrations show a linear relationship to the size of the dose. Administration of 50mg 3 times daily for a week does not lead to cumulation of diclofenac in the plasma.

Diclofenac is highly bound to serum proteins (99.7%), mainly albumin (99.4%).

Diclofenac enters the synovial fluid, and peak concentrations are measured 2-4 hrs after peak plasma levels have been reached. The apparent elimination half-life from the synovial fluid is 3-6 hrs. This shows that the concentrations in the synovial fluid are already higher than plasma concentrations 4-6 hrs after administration, and they remain higher for up to 12 hrs.

Metabolism: Roughly half of diclofenac potassium undergoes first-pass metabolism; consequently, the areas under the concentration curves (AUCs) after an oral dose are only about half as large as after a parenteral administration of a same dose.

The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

Elimination: The total systemic clearance of diclofenac in plasma is 263 56 mL/min (mean value SD). The terminal half-life in plasma is 1-2 hrs. About 60% of the dose is excreted via the kidneys in the form of metabolites; <1% is excreted as unchanged substance. The remainder is eliminated as metabolites via the bile in the faeces.

Elderly: No relevant age-dependent differences have been observed in absorption, metabolism and excretion.

Impaired renal function: No accumulation of the unchanged active substance can be inferred from the single-dose kinetics under the usual dosage schedule. In patients with a creatinine clearance of <10 mL/min, the theoretical steady-state plasma levels of metabolites are about 4 times higher than in healthy subjects. The metabolites are nevertheless ultimately cleared via the bile.

Impaired hepatic function (chronic hepatitis, nondecompensated liver cirrhosis): The kinetics and metabolism of diclofenac are the same as in healthy patients.

INDICATIONS
As short-term treatment for acute painful conditions where fast onset of action (within 30 minutes) is desired: Post-traumatic inflammatory states (eg due to sprains), postoperative inflammation and pain (eg following dental or orthopaedic surgery), painful and/or inflammatory conditions in gynaecology (eg primary dysmenorrhoea or adnexitis), painful syndromes of the vertebral column, non-articular rheumatism, and as an adjuvant in severe painful inflammatory infections of the ear, nose or throat (eg pharyngotonsillitis, otitis).

In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate.

DOSAGE AND ADMINISTRATION
Adults:
100-150mg daily.
In milder cases and for children >14 years: 75-100mg daily.
The daily dosage should be prescribed in 2-3 fractional doses.
In primary dysmenorrhea, the daily dosage is 50-150mg. A dose of 50-100mg should be given initially and raised in the course of several menstrual cycles up to a maximum of 200mg/day if necessary.
Treatment should be started upon appearance of the first symptoms and depending on the symptomology, continued for a few days. The tablets should be taken with liquid, preferably before meals.
In migraine an initial dose of 50mg should be taken at the first signs of an attack. In cases where pain relief within 2 hours after the first dose is not sufficient, further dose of 50mg may be taken at intervals 4-6 hours, if needed. The total dose should not exceed 200mg in any 24 hours period.
Children: Diclofast tablets are not recommended for use in children.
After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.

CONTRAINDICATIONS
Peptic ulcer. Hypersensitivity to diclofenac. Similar to other nonsteroidal anti-inflammatory agents, it is contraindicated in patients whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other drugs with prostaglandin synthetase-inhibiting activity.

ADVERSE EFFECTS
Gastrointestinal Tract
Occasional: Epigastric pain, other gastrointestinal disorders (eg nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, anorexia).
Rare: Gastrointestinal bleeding, haematemesis, melena, peptic ulcer with or without bleeding or perforation, bloody diarrhoea.
Isolated cases: Lower gut disorders (eg nonspecific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), aphthous stomatitis, glossitis, oesophageal lesions, constipation.

Central (and Peripheral) Nervous System
Occasional: Headache, lightheadedness, vertigo.
Rare: Drowsiness
Isolated cases: Disturbances of sensation including paraesthesia, memory disturbances, disorientation, disturbances of vision (reduced visual acuity, diplopia), impaired hearing, tinnitus, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions, taste alteration disorders.

Skin
Occasional: Rashes or skin eruptions.
Rare: Urticaria
Isolated cases: Bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reactions, purpura (including allergic purpura).

Kidney
Isolated cases: Acute renal failure, haematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

Liver
Occasional: Elevation of serum aminotranferases (SGOT, SGPT),
Rare: Hepatitis with or without jaundice.
Isolated cases: Fulminant hepatitis.

Blood
Isolated cases: Thrombocytopenia, leucopenia, agranulocytosis, haemolytic anaemia, aplastic anaemia.

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