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Adults and children over 12 years: 1 tablet three times a day before or after meals. The next year, Hoechst Marion Roussel, which by that time had acquired the business, granted a license to Endo Pharmaceuticals. Lactose monohydrate Maize Starch Povidone K-30 Magnesium stearate Talc. They are available in opaque PVC/PVDC/aluminium blisters … d. Adults GI Motility Disorders Oral. [2] Use in pregnancy appears to be safe while use during breastfeeding is not recommended. Symptoms of Dicycloverine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin. Adults: 10-20mg three times daily before or after meals. Sedatives (e.g., Short-acting barbiturates, benzodiazepines) may be used for the management of overt signs of excitement. As antispasmodic drug Dicycloverine causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract, urinary bladder & ureter. Animal studies indicate that this action is achieved via a dual mechanism; (1) a specific anticholinergic effect (antimuscarinic at the ACh-receptor sites) and, (2) a direct effect upon smooth muscle (musculotropic). So, Dicycloverine is contraindicated in lactating mother. Products containing dicycloverine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. To view the changes to a medicine you must sign up and log in. The signs and symptoms of overdosage are headache, nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation. The principal route of elimination is via the urine. Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicycloverine. Store in a cool and dry place. Each tablet contains 20 mg of Dicycloverine hydrochloride. Hypersensitivity to dicycloverine hydrochloride or any of the excipients listed in Section 6.1. Treatment may include emetics, gastric lavage and symptomatic therapy if indicated. [2], Dicycloverine was approved for medical use in the United States in 1950. Side-effects seldom occur with dicycloverine tablets. Oral dicycloverine Hydrochloride should be started as soon as possible Intramuscular dosage form-Adults: Intramuscular injection. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Because many drugs are excreted in human milk, caution should be exercised when dicycloverine is administered to a nursing mother. Active substance(s): DICYCLOVERINE HYDROCHLORIDE, PDF options:  View Fullscreen   Download PDF. After a single oral 20mg dose of dicycloverine hydrochloride in volunteers, peak plasma concentration reached a mean value of 58ng/ml in 1 to 1.5 hours. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), Wolters Kluwer™ (updated 30 Sep 2020) and others. Adults:10 to 20 mg three times a day. Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders; Synthetic anticholinergics, esters with tertiary amino group. To prevent fading, avoid exposure to direct sunlight. This information is intended for use by health professionals, Dicycloverine Hydrochloride 20 mg Tablets. Children <6 months of age: Dose must be determined by the doctor. Pediatric Patients GI Motility Disorders Oral. It is not known whether dicycloverine is secreted in human milk. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: After a single oral 20mg dose of dicycloverine hydrochloride in volunteers, peak plasma concentration reached a mean value of 58ng/ml in 1 to 1.5 hours. Dicycloverine Hydrochloride 20 mg Tablets contain lactose. However, in susceptible individuals, dry mouth, thirst and dizziness may occur. 9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE, 12    INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE), 2    QUALITATIVE AND QUANTITATIVE COMPOSITION, 4.2    Posology and method of administration. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine. Date of first authorisation/renewal of the authorisation. Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders, ATC code: A03AA07. To bookmark a medicine you must sign up and log in. By continuing to browse the site you are agreeing to our policy on the use of cookies. 10–20 mg 3 times a day. Dicycloverine, also known as dicyclomine, is a medication that is used to treat spasms of the intestines such as occur in irritable bowel syndrome. Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicycloverine hydrochloride. White to off-white, round flat bevelled edged tablets with ‘20’ embossed on one side and scoring on the other. White to off white, round, biconvex tablets, engraved with “20” on one side and plain on the other. 84 tablets are packed in opaque blue PVC/PVdC//Aluminium blisters. [2] Serious side effects may include psychosis and breathing problems in babies. Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract. If indicated, an appropriate cholinergic agent may be used as an antidote. For the full list of excipients, see section 6.1. Each tablet contains dicycloverine hydrochloride 20mg. Protect from light. Dicycloverine Hydrochloride 20mg Tablets. 14C labelled studies demonstrated comparable bioavailability from oral and intravenous administration. Treatment may include emetics, gastric lavage and symptomatic therapy if indicated. While it has been used in baby colic and enterocolitis, evidence does not support these uses.. Common side effects include dry mouth, blurry vision, weakness, sleepiness, and lightheadedness. [9], Because dicycloverine is known to impair thinking and coordination, people taking the drug should avoid driving or operating machinery. Start typing to retrieve search suggestions. [7], It should not be given to children or infants with colic due to the risks of convulsions, difficult breathing, irritability, and restlessness,[8] and there is little evidence to support the efficacy in such use in any case. [7], Dicycloverine can cause a range of anticholinergic side effects such as dry mouth, nausea, blurred vision, dizziness, confusion, severe constipation, stomach pain, heart palpitations, difficulty urinating, and seizures. Symptoms of Dicycloverine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin. It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Available as dicyclomine hydrochloride; dosage expressed in terms of the salt. Dicycloverine, also known as dicyclomine, is a medication that is used to treat spasms of the intestines such as occur in irritable bowel syndrome. Mylan manufactures DICYCLOMINE HYDROCHLORIDE Tablets, USP in strengths of 20 mg. This information is intended for use by health professionals, Dicycloverine Hydrochloride 20 mg Tablets. Dicycloverine hydrochloride 20 mg Tablets contains lactose monohydrate. Continue, 2. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if the benefit outweighs the risk. Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. d. Children†: 10 mg 3 or 4 times daily. Irritable bowel syndrome (Diarrhea Predominant), Obstructive disease of the gastrointestinal tract, Unstable cardiovascular status in acute hemorrhage, Evidence of prior hypersensitivity to dicycloverine hydrochloride or other ingredients of this formulation.

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