Rivo 75 mg
Chewable tablets
Composition :
Each tablet contains:
Active ingredients : Acetylsalicylic acid 75 mg
Inactive Ingredients : Maize Starch, Lactose Monohydrate. Mannitol, Gelatin, Orange dry flavour. Microcrystalline cellulose
(Avlcel pH 101). Colloidal anhydrous slllca (AerosiI 200), Sunset yellow 85%, Aspartame. Glyceryl behenate (Compritol 888).
Pharmaceutical form :
Chewable Tablet.
Clinical particulars: Therapeutic Indications:
For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery. The advice of a doctor should be sought before commandng therapy for the first time.
Posology and method of administrations :
Adults:
The usual dosage, for k>ng-term use, is 75 mg – 150 mg once daity. In some circumstances a higher dose may be appropriate. especially in short-term. and up to 300 mg a day may be used on the advice
of a doctor.
Children:
Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
Contraindications :
Active or history of peptic ulceration, haemophilia and other bleeding disorders, hypersensitivity to Riv075 mg.
Special warnings and precautions for use :
Rlvo 75 mg may induce gastro intestinal haemorrhage, occasionally major. Patients wfth hypertension should be carefully monitored.
There is a possible association between Rivo 75 mg and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this
reason Rivo 75 mg sould not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).
Warning of Aspartame :
Contains source of phenylalanine, may be harmful for people with phenylketonuria.
Interaction with other medicinal products and other forms of interaction:
A Rivo 75 mg may enhance the effects of anticoagulants and may inhibit the action of uricosurics. Experimental data suggest that ibuprofen may inhibit the effect of low dose Rivo 75 mg on platelet
aggregation when they are dosed concomitanUy. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the dinical situation imply that no firm conclusions can be made for regular ibuprofen use. and no dinically relevant effect is considered to be likely for occasional ibuprofen use.
Pregnancy and lactation :
There Is clinical and epidemiok)glcal evidence of safety in human pregnancy. Rivo 75 mg may prolong labour and contribute to maternal and neonatal bleeding, and should be avoided at term.
Undesirable effects on ability to drive and use machines:Non known.
Rivo 75 mg may enhance the effects of anticoagulants and may inhibit the action of uricosurics. Rivo 75 mg may precipitate bronchospasm and may induce attacks of asthma in susceptible subjects. Hypersensitivity reactions have been reported In susceptible individuals. Effects on ability to drive and use machines: Non known.
Precaution :
Gastrolntestlnal Risk:
NSAIDs cause an increased risk of serious gastrointestlnal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elder1y patients are at greater risk for serious gastrointestinal events .
Overdose :
Overdosage is unlikely due to the low level of Rivo 75 mg in Angettes. If necessary gastric lavage, forced alkaline diuresis and supportive therapy may be employed. Restoration of acidlbase balance may be required.
Pharmacolosical properties :
Pharmacodynamic properties :
Rivo 75 mg has antiplatelet, analgesic. antipyretic and anti-inflammatory properties. Experimental data st,lggest that ibuprofen may inhibit the effect of low dose Rivo 75 mg on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release Rivc 75 mg (61 mg), a decreased effect of Rivo 75 mg on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the
dinical situation imply that no firm conduslons can be made for regular ibuprofen use, and no dinically relevant effect is considered to be likely for occasional ibuprofen use.
Pharmacokinetic properties :
After a single oral dose of a salicylate, the plasma concentration becomes appreciable within 30 minutes. reaches a peak in about 2 hours and then slowly declines. The hlgb§..sLco_nc.entrations occur.Jn plasma.,..kk1ney, liver, heart-and lun91 From 50-80% of salicylic acid in plasma is bound to plasma proteins, mainly albumin.
Salicylate is matabolised chiefly in the smooth endoplasmic reticulum of liver cells.
Storage :
Store in dry place at temp. not exceeding 30 C .
Package :
Carton box containing 30 or 1000 tablets in strips.
Manufactured by :
The Arab Drug Company For Pharmaceutical and Chemical Industries (ADCO) Cairo -A.R.E.
