Axcel Dicyclomine-S

Axcel Dicyclomine-S

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Dicyclomine hydrochloride, simethicone.
Description
Each 5ml contains Dicyclomine hydrochloride 5mg; Simethicone 50mg.
0.1% w/v Methylparaben as preservative.
Action
Pharmacology: Mechanism of Action: Dicyclomine Hydrochloride is a tertiary amine with antimuscarinic effects similar to but weaker than those atropine; it also has a direct anti-spasmodic action. Simethicone lowers surface tension and when administered by mouth causes bubbles of gas in the gastro-intestinal tract to coalesce, thus aiding their dispersion.
Pharmacokinetics: Dicyclomine is used in gastrointestinal spasm, particularly that associated with the irritable bowel syndrome, and is also given in association with antacids as an adjunct in the treatment of peptic ulcer. Simethicone is used to relieve flatulence and abdominal discomfort due to excess gastrointestinal gas and also used as defoaming agent in radiography or endoscopy of the gastrointestinal tract.
Indications/Uses
Relief of gastro-intestinal colic, flatulence & abdominal discomfort due to entrapped gas.
Dosage/Direction for Use
To be taken orally, 15 minutes before meal.
Adults: 10-20ml, 3-4 times a day;
Children (2-12 years): 10ml, 3-4 times daily, (6 months-2 years): 5-10ml, 3-4 times daily, total daily dose should not exceeding 40ml.
Overdosage
Symptoms of overdose include: tachycardia, rapid respiration, hyperpyrexia, CNS stimulation marked by confusion, excitement, ataxia and occasionally seizure. Rashes may appear on the face or upper trunk. Overdosage occurred when taken by mouth, the stomach should be emptied. The giving of activated charcoal to reduce absorption has also been suggested. Supportive therapy should be given as required.
Contraindications
SHOULD NOT BE GIVEN TO INFANTS YOUNGER THAN 6 MONTHS OF AGE.
Contraindicated in patients with closed-angle glaucoma, urinary or GI obstruction, intestinal atony, paralytic ileus, hypersensitivity to Dicyclomine, unstable cardiovascular status in acute hemorrhage and reflux oesophagitis.
Special Precautions
Due to the risk of provoking hyperpyrexia, it should not be given to patients, especially children when the ambient temperature is high. It should also be used cautiously in patient with fever, asthma, hiatal hemia, serious hepatic or renal disease. Precaution in acute myocardial infarction, hypertension. Elderly and in conditions characterized by tachycardia & in debilitate patients with COPD.
Use in Pregnancy and Lactation: The safety use of Axcel Dicyclomine-S Syrup during pregnancy has not been fully established. Pregnant patients should take with precaution.
Use In Pregnancy & Lactation
The safety use of Axcel Dicyclomine-S Syrup during pregnancy has not been fully established. Pregnant patients should take with precaution.
Side Effects
Increase of intra-occular pressure especially in patients with closed-angle glaucoma. Dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturation, as well as reduction in the tone and motility of gastro-intestinal tract leading to constipation, elevated body temperature and CNS excitation that is caused by the antimuscarinic effect. Occasionally vomiting may also occur.
Drug Interactions
Anticholinergic activity may be increased by other parasympatholytics. Guanethidine, histamine & reserpine can antagonise the inhibitory effects of anticholinergics on gastric acid secretion. Antacids may impair absorption.
Storage
Keep container well closed. Store below 30°C. Protect from light.
ATC Classification
A03ED - Antispasmodics in combination with other drugs ; Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Syr (orange coloured and orange flavoured) 60 mL x 1's, 100 mL x 1's.
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