Gavisco
Sodium Alginate USP + Sodium Bicarbonate BP
Prescription only
+ Calcium Carbonate BP
Presentation
Gavisco suspension: Each 10 ml contains 500 mg Sodium Alginate USP, 267 mg
Sodium Bicarbonate BP and 160 mg Calcium Carbonate BP.
Pharmacology
The mode of action of the product is physical and does not depend on absorption into
the systemic circulation. On ingestion, the product reacts rapidly with gastric acid to
form a raft of Alginic Acid gel having a near neutral pH and which floats on the stomach
contents quickly and effectively impeding gastro-esophageal reflux, for up to 4 hours.
In severe cases, the raft itself may be refluxed into the esophagus in preference to the
stomach contents and exert a demulcent effect.
Indications
Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of
pregnancy, all cases of epigastric and retrosternal distress were the underlying cause
is gastric reflux.
Dosage and Administration
For oral administration. Adult and children over 12 years: 10-20 ml after meals and at
bedtime, up to four times a day. Children 6 to 12 years: 5-10 ml after meals and at
bedtime, up to four times a day. Children under 6 years: Not recommended. Elderly: No
dosage modification is required for this age group.
Contraindications
This product is contraindicated in patients with known or suspected hypersensitivity to
the active ingredients or to any of the excipients.
Precautions
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
Each 10 ml dose has a Sodium content of 141 mg (6.2 mmol). This should be taken
into account when a highly restricted salt diet is recommended. e.g in some cases of
congestive cardiac failure and renal impairment. Each 10 ml dose contains 160 mg
(1.6 mmol) of Calcium Carbonate. Care needs to be taken in treating patients with
hypercalcemia. nephrocalcinosis and recurrent calcium containing renal calculi.
Side Effects
In addition to the desired effect of the drug, some side effects may appear such as:
constipation, flatulence, stomach cramp or belching. In these cases, consult a
physician. It too big dose has been taken, there might appear a sensation of swelling.
In this case it is advisable to consult a physician.
Use in Pregnancy and Lactation
Clinical studies in more than 500 pregnant women as well as a large amount of data
from post-marketing experience indicate no malformative nor feto/neonatal toxicity of
the active ingredients. This drug can be used during pregnancy, if clinically needed. No
effects of the active substances have been shown in breastfed newborns/infants of
treated mothers. This drug can be used during breast-feeding.
Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on
parental or offspring fertility or reproduction. Clinical data do not suggest that this drug
has an effect on human fertility.
Drug Interactions
A time-interval of 2 hours should be considered. between this drug intake and the
administration of other medicinal products, especially Tetracyclines, Digoxine,
Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones,
Penicillamine, beta-blockers (Atenolol, Metoprolol. Propranolol, Glucocorticoid
Chloroquine and Biphosphonates (Diphosphonates) and Estramustine.
Overdosage
In the event of over dosage symptomatic treatment should be given.
Pharmaceutical Precautions
Store at below 30°C in a dry place, protected from light. Keep out of the reach of
children. Do not refrigerate or freeze.
Commercial Pack
Gavisco Suspension: Each box contains Amber PET bottle containing 200 ml
suspension with measuring cup.
Manufactured by:
POPULAR PHARMACEUTICALS LTD.
164, TONGI INDUSTRIAL AREA, GAZIPUR, BANGLADESH
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