PHARMACOLOGICAL CLASSIFICATION: A 3.1 Antirheumatics (Anti-inflammatory agents).
PHARMACOLOGICAL ACTION: Veltex is a non-steroidal compound with antirheumatic, anti-inflammatory, analgesic and antipyretic action. In vitro its active substance strongly inhibits prostaglandin synthetase and also has an inhibitory effect on platelet aggregation. Veltex inhibits prostaglandin biosynthesis and this inhibition has an important bearing on its mechanism of action. Prostaglandins appear to play a major role in causing inflammation, pain and fever.
ABSORPTION: The micro-pellets contained in the VELTEX CR CAPSULES will be released in the stomach and mixed with its contents reaches the intestinal tract, where dissolution occurs slowly. Serum peak levels are achieved within 1 to 3 hours and due to the quantity of diclofenac presented in these micro-pellets an extended plasma concentration is maintained.
INDICATIONS: VELTEX is indicated in:
Osteoarthrosis and spondylarthritis.
Painful musculoskeletal conditions.
Acute attacks of gout.
Painful post-operative and post-traumatic inflammation and swelling.
Pain following dental surgery.
Symptomatic treatment of primary dysmenorrhoea. Note: S2 in the emergency treatment of acute gout attacks, treatment of post-traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days.
VELTEX Ampoules are specifically used as initial therapy for inflammatory and degenerative rheumatic disease as well as for painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout.
CONTRA-INDICATIONS: It is contra-indicated in people with known sensitivity to diclofenac, in asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other medicine with prostaglandin-synthetase inhibiting activity. Diclofenac should not be used in patients with porphyria. Not recommended in children under 2 years. Not recommended in children unable to swallow capsules.
WARNINGS: Diclofenac must be given with care to patients with asthma or bronchospasm, bleeding disorders, patients with peptic ulceration or a history of such ulceration, and with cardiovascular disease.
Patients with gastro-intestinal symptoms or with severe hepatic or renal damage should be kept under close surveillance during therapy.
INTERACTIONS Diclofenac must be given with care to people who are receiving coumarin anticoagulants. Serious interactions have been reported after the use of high doses of methotrexate in combination with diclofenac.
When given with preparations containing lithium or digoxin it may raise the plasma concentrations of these compounds. Acute allergic reactions have been reported. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds. Plasma concentrations are significantly decreased by the concomitant administration of doses of aspirin.
Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents, may aggravate gastro-intestinal side-effects.
Dosages may have to be reduced in the elderly.
PREGNANCY AND LACTATION: Diclofenac should not be given to pregnant or lactating women.
Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.
DOSAGE AND DIRECTIONS FOR USE:
Adults: The capsule should be swallowed intact with some fluid. The pellets should never be chewed. The initial daily dosage is 100 to 150 mg.
In milder cases as well as for maintenance therapy 75 to 100 mg is usually sufficient. The maximal daily dose is 150 mg. This dosage is usually administered in two to three fractional doses.
When used as an analgesic, the daily dosage should be adjusted to the individual need of the patient and special circumstances e.g. for the treatment of primary dysmenorrhoea or post-operative pain. In these cases the dosage is 75 to 150 mg and the treatment should commence with the first symptoms and, depending on the severity, continued for a few days. In cases where the symptoms are most pronounced during the night or in the early morning. VELTEX 100 CR should be taken preferably in the evening. Children: Recommended daily dose of 1 to 3 mg per kg body weight in children able to swallow capsules. VELTEX AMPOULES: The directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injectin site. After inserting the needle, the plunger should be pulled back to avoid inadvertant intra-arterial injection. NOT TO BE ADMINISTERED BY INTRAVENOUS INJECTION.
The usual adult dose is 75 mg (3 mL) by deep intra-gluteal injection into the upper outer quadrant once daily. This dose may be repeated after a few hours if required in severe or hospitalised patients. Each injection must be administered at a different site. Parenteral administration should not be continued for more than two days. Treatment may be continued with oral therapy.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal disturbances such as nausea, vomiting, abdominal discomfort and diarrhoea may occur.
Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include nervousness, headache, dizziness, depression, drowsiness, insomnia, blurred vision and tinnitus. Oedema and skin reactions, such as rashes, urticaria, pruritus and eczema have been reported.
Abnormalities of liver function tests, impairment of renal functions, agranulocytosis, aplastic anaemia and thrombocytopenia have been observed. Sensitivity reactions such as bronchospasm or anaphylactoid reactions, jaundice, hepatitis, renal failure and nephrotic syndrome, may occur. Other side-effects that may occur are minor hearing disorders, irritability, agitation, palpitations, tiredness and increased serum transaminase levels.
PRECAUTIONS: In view of the products inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Patients suffering from impaired hepatic, cardiac, or renal functions should be carefully monitored. If peptic ulceration or gastro-intestinal bleeding occurs while under treatment the medicine must be withdrawn.
VELTEX may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Injections of VELTEX may cause local pain and irritation; abscesses and local necrosis have been reported.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See side-effects and special precautions.
There is no known antidote.
Treatment should be symptomatic and supportive.
Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating VELTEX because of its extensive protein binding rate and metabolism.
IDENTIFICATION: VELTEX 75 CR CAPSULES: Size 2 hard gelatin capsule with opaque light blue cap, and body.
VELTEX 100 CR CAPSULES: Size 2 hard gelatin capsule with opaque red cap and opaque ivory body.
VELTEX AMPOULES: 3 mL amber labelled ampoule.
PRESENTATION: VELTEX 75 CR CAPSULES: Amber glass bottles of 10, 30 and 120 capsules.
VELTEX 100 CR CAPSULES: Amber glass bottles of 30 and 120 capsules.
VELTEX AMPOULES: Packs of 5 x 3 mL and 50 x 3 mL ampoules.
STORAGE INSTRUCTIONS: VELTEX CAPSULES: Store below 25°C. Protect from light and moisture.
VELTEX AMPOULES: Protect from heat and light. Store between 15°C and 25°C. Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.