Category : GASTROINTESTINAL

Name : CLIDINIUM-C     Type & Dosage : F.C. Tab. ; 3 mg Package : 100

Pharmacologic Category Anticholinergic - sedative Mechanism Of Action Chlordiazepoxide – Benzodiazepines stimulate GABA receptors in the ascending reticular activating system . Since GABA is inhibitory , receptor stimulation increases inhibition and blocks both cortical and limbic arousal following stimulation of the brain stem reticular formation. In general , benzodiazepines act as depressants of CNS causing mild sedation to hypnosis to coma depending on dose. Clidinium – Anticholinergics inhibit the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves as well as smooth muscles that respond to acetylcholine but lack cholinergic innervation. Depending on the dose , anticholinergics may reduce the motility and secretory activity of the GI system . Indications Adjunct treatment of peptic ulcer ; Treatment of irritable bowel syndrome Side Adverse Effects a- Those indicating need for medical attention : Agranulocytosis , granulocytopenia , or leukopenia ; CNS depression ; Constipation ; Hypersensitivity reaction ; Increased intraocular pressure; Jaundice ; Paradoxical reaction (trouble in sleeping , nervousness , or irritability) b- Those indicating need for medical attention only if they continue or are bothersome : Bloated feeling ; Decreased sweating ; Dizziness; Drowsiness ; Dryness of mouth ; Headache ; Blurred vision ; Decreased sexual ability ; Loss of memory ; Nausea ; Unusual tiredness or weakness c- Those indicating possible withdrawal and the need for medical attention if they occur (usually within 2 weeks ) after medication is discontinued : Muscle cramps ; Nausea or vomiting ; seizures ; Stomach cramps ; Trembling Contraindications Hypersensitivity to clidinium , chlordiazepoxide , or any component of the formulation ; Glaucoma ; Prostatic hyperplasia ; Benign bladder neck obstruction ; Pregnancy Warnings Precautions Risk – benefit should be considered when the following medical problems exist : Cardiovascular instability , History of drug abuse or dependence , Hepatic function impairment , Hiatal hernia with reflux esophagitis , Hypertension , Hyperthyroidism , Intestinal atony of the elderly or debilitated , Intestinal obstruction , Mental depression , Myasthenia gravis , Psychoses , Severe chronic obstructive pulmonary disease , Renal function impairment , Severe ulcerative colitis , Xerostomia . Use with caution with ethanol or other CNS depressants . Do not abruptly discontinue after prolonged use ; taper dose gradually. Pregnancy FDA pregnancy risk category D . Use of anticholinergic and sedative combinations in pregnancy is generally not recommended . Chronic use of chlordiazepoxide during pregnancy may cause physical dependence with resulting withdrawal symptoms in the neonate . Chlordiazepoxide has been reported to increase the risk of congenital malformations when used during the first trimester of pregnancy . Use of chlordiazepoxide just prior to or during labor may cause neonatal flaccidity. Breast Feeding Chlordiazepoxide and its metabolites may be distributed into breast milk ; Use by nursing mothers may cause sedation in the infant . Clidinium may tend to inhibit lactation . Therefore ; Clidinium – C is contraindicated during lactation period. Drug Interactions Concurrent administration of antacids and adsorbent antidiarrheals may reduce therapeutic effects of clidinium because of particle adsorption ; allow at least 2 or 3 hours between doses of them. Concurrent use of anticholinergics with clidinium may intensify anticholinergic effects . Concurrent use of CNS depression – producing medications with chlordiazepoxide may intensify sedative effects . Concurrent long – term use of oral estrogen – containing contraceptives with chlordiazepoxide may result in reduced contraceptive reliability and increased incidence of breakthrough bleeding . Clidinium may increase GI pH ; concurrent administration of ketoconazole with clidinium may result in a marked reduction in absorption of ketoconazole ; patients should be advised to take clidinium at least 2 hours after ketoconazole . Concurrent use with clidinium may antagonize the effects of metoclopramide on GI motility . Concurrent use with potassium chloride may increase severity of GI lesions . Aminoglutethimide , carbamazepine , nafcillin , nevirapine , phenobarbital , phenytoin , and rifamycins may decrease the levels / effects of chlordiazepoxide . Azole antifungals , ciprofloxacin , clarithromycin , diclofenac , doxycycline , erythromycin , isoniazid , protease inhibitors , quinidine , and verapamil may increase the levels /effects of chlordiazepoxide. Monitoring Parameters CBC and hepatic function determinations may be required at periodic intervals for patients on prolonged therapy .Intraocular pressure determinations is recommended at periodic intervals. Dietary Considerations Clidinium- c should be taken 30 to 60 minutes before meals. Administration And Dosage Usual adult dose: Oral, 1 or 2 tablets 1 to 4 times a day. Usual adult prescribing limits: Up to a total of 8 tablets daily (40 mg of chlordizepoxide and 20 mg of clidinium) Usual pediatric dose: Dosage has not been established. Usual geriatric dose: Oral , initially no more than 1 tablet 2 times a day , the dosage then being adjusted as needed and tolerated How Supplied Each tablet contains 2.5 mg clidinium bromide and 5 mg chlordiazepoxide. Storage Store below 40°C(104°F), preferably between 15 and 30°C (59 and 86°F). Protect from light and moisture. References USP DI, 2004 Up To Date, Vol. 13.1 (2005) Martindale, The Complete Drug Reference, 33 rd edition 2002