Antispasmodic drugs and Anti emetics

  • Chemical Composition

    Chlordizeboxide HCL 5 mg - Clidinium bromide 2,5 mg

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Excipients Magnesium stearate ‚ Lactose, Maize starch, Talc,Crosscarmellose Na, Opadry Green.
Mechanism Of Action Chlordiazepoxide and clidinium bromide combines in a single film coated tablet formulation the antianxiety action of chlordiazepoxide and the anticholinergic/spasmolytic effects of clidinium bromide.
INDICATIONS Effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
CONTRAINDICATIONS Glaucoma, prostatic hypertrophy and benign bladder neck obstruction. hypersensitivity to chlordiazepoxide and/or clidinium bromide.
Side EFFECTS Drowsiness, ataxia, confusion, syncope, skin eruptions, edema, minor menstrual irregularities, nausea, constipation, extrapyramidal symptoms, increased and decreased libido, Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction. When chlordiazepoxide treatment isprotracted, periodic blood counts and liver function tests are advisable. Adverse effects reported with use of Chlordiazepoxide and clidinium bromide are those typical of anticolinergic agents, ie, dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Chlordiazepoxide and clidinium bromide therapy has been combined with other spasmolytic agents and/or a low residue diet.
WARNINGS As in the case of other preparations containing CNS-acting drugs, patients receiving Chlordiazepoxide and clidinium bromide should be cautioned about possible combined effects with alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. Precautions: In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount. The usual precautions in treating patients with impaired renal or hepatic function should be observed. Paradoxical reactions to chlordiazepoxide, eg, excitement, stimulation and acute rage, been reported in psychiatric patients and should be watched for during Chlordiazepoxide and clidinium bromide therapy. The usual precautions are indicated when chlordiazepoxide is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Information For Patients: To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide hydrochloride and clidinium bromide. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated.
DRUG INTERACTIONS Concomitant administration of Chlordiazepoxide and clidinium bromide and other psychotropic agents is not recommended. variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide. consideration should be given to the pharmacology of the agents to be employed
Pregnancy And lactations An Increased risk of congenital malformations associated with the use of chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. As with all anticholinergic drugs, an inhibiting effect on lactation may occur
Dosage And Administration The usual maintenance dose is 1 or 2 film coated tablet, 3 or 4 times a day administered before meals and at bedtime. Geriatric Dosing Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Chlordiazepoxide and clidinium bromide film coated tablets per day, to be increased gradually as needed and tolerated.
OVERDOSE Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide overdosage. The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation. General supportive measures should be employed, along with immediate gastric lavage. physostigmine and Intravenous fluids should be administered and an adequate airway maintained. Drug Abuse And Dependence Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed.
Storage Conditions Store below 30° c, in a dry place Keep out of reach of children Prescription only medicine