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Chlordiazepoxide Hydrochloride and Clidinium Bromide
Overview
What is Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Chlordiazepoxide HCl and Clidinium Bromide combines in a single capsule formulation the antianxiety action of Chlordiazepoxide Hydrochloride and the anticholinergic/spasmolytic effects of Clidinium Bromide.
Each Chlordiazepoxide HCl and Clidinium Bromide Capsule for oral administration contains 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide. Each capsule also contains D&C Yellow #10, FD&C Green #3, gelatin, lactose, starch, talc, and titanium dioxide.
Chlordiazepoxide Hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.
Chlordiazepoxide Hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1, 4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of Chlordiazepoxide Hydrochloride is as follows:
Clidinium Bromide is 3-hydroxy-1-methylquinuclidinium bromide benzilate, a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally Clidinium Bromide is:
What does Chlordiazepoxide Hydrochloride and Clidinium Bromide look like?
What are the available doses of Chlordiazepoxide Hydrochloride and Clidinium Bromide?
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What should I talk to my health care provider before I take Chlordiazepoxide Hydrochloride and Clidinium Bromide?
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How should I use Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide HCl and Clidinium Bromide Capsules varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules orally, 3 or 4 times a day administered before meals and at bedtime.
What interacts with Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Chlordiazepoxide HCl and Clidinium Bromide Capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Chlordiazepoxide Hydrochloride and/or Clidinium Bromide.
What are the warnings of Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Methimazole can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state. Because the drug readily crosses placental membranes, methimazole can cause fetal goiter and cretinism when administered to a pregnant woman. For this reason, it is important that a sufficient, but not excessive, dose be given during pregnancy (see ).
Usage in Pregnancy
An increased risk of congenital malformations associated with the use of minor tranquilizers (Chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, 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 (see).
What are the precautions of Chlordiazepoxide Hydrochloride and Clidinium Bromide?
In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide HCl and Clidinium Bromide Capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide HCl and Clidinium Bromide Capsules and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed – particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.
Paradoxical reactions to Chlordiazepoxide Hydrochloride, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Chlordiazepoxide HCl and Clidinium Bromide therapy. The usual precautions are indicated when Chlordiazepoxide Hydrochloride 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. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and Chlordiazepoxide Hydrochloride.
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 has not been established.
Geriatric Use
Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide HCl and Clidinium Bromide Capsules. 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 (see). Chlordiazepoxide HCl and Clidinium Bromide Capsules are contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see).
What are the side effects of Chlordiazepoxide Hydrochloride and Clidinium Bromide?
No side effects or manifestations not seen with either compound alone have been reported with the administration of Chlordiazepoxide HCl and Clidinium Bromide Capsules. However, since Chlordiazepoxide HCl and Clidinium Bromide Capsules contain Chlordiazepoxide Hydrochloride and Clidinium Bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.
When Chlordiazepoxide Hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients – particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.
Other adverse reactions reported during therapy with Chlordiazepoxide Hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Chlordiazepoxide Hydrochloride treatment. Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with Chlordiazepoxide Hydrochloride. When Chlordiazepoxide Hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.
Adverse effects reported with use of Chlordiazepoxide HCl and Clidinium Bromide Capsules are those typical of anticholinergic agents, ie, dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Chlordiazepoxide HCl and Clidinium Bromide Capsules therapy has been combined with other spasmolytic agents and/or a low residue diet.
What should I look out for while using Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Chlordiazepoxide HCl and Clidinium Bromide Capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Chlordiazepoxide Hydrochloride and/or Clidinium Bromide.
As in the case of other preparations containing CNS-acting drugs, patients receiving Chlordiazepoxide HCl and Clidinium Bromide Capsules 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.
What might happen if I take too much Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Manifestations of Chlordiazepoxide Hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. 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 Hydrochloride overdosage.
While the signs and symptoms of Chlordiazepoxide HCl and Clidinium Bromide overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of Clidinium Bromide. 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. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute. This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.
Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (seesection).
How should I store and handle Chlordiazepoxide Hydrochloride and Clidinium Bromide?
Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Chlordiazepoxide HCl and Clidinium Bromide Capsules are available in light green capsules, imprinted with "607", each containing 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide.Bottle of 100 Bottle of 250 Bottle of 1000 Chlordiazepoxide HCl and Clidinium Bromide Capsules are available in light green capsules, imprinted with "607", each containing 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide.Bottle of 100 Bottle of 250 Bottle of 1000 Chlordiazepoxide HCl and Clidinium Bromide Capsules are available in light green capsules, imprinted with "607", each containing 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide.Bottle of 100 Bottle of 250 Bottle of 1000 Chlordiazepoxide HCl and Clidinium Bromide Capsules are available in light green capsules, imprinted with "607", each containing 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide.Bottle of 100 Bottle of 250 Bottle of 1000
Clinical Information
Chemical Structure
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Non-Clinical Toxicology
Chlordiazepoxide HCl and Clidinium Bromide Capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Chlordiazepoxide Hydrochloride and/or Clidinium Bromide.As in the case of other preparations containing CNS-acting drugs, patients receiving Chlordiazepoxide HCl and Clidinium Bromide Capsules 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.
Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.
In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide HCl and Clidinium Bromide Capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide HCl and Clidinium Bromide Capsules and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed – particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.
Paradoxical reactions to Chlordiazepoxide Hydrochloride, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Chlordiazepoxide HCl and Clidinium Bromide therapy. The usual precautions are indicated when Chlordiazepoxide Hydrochloride 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. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and Chlordiazepoxide Hydrochloride.
No side effects or manifestations not seen with either compound alone have been reported with the administration of Chlordiazepoxide HCl and Clidinium Bromide Capsules. However, since Chlordiazepoxide HCl and Clidinium Bromide Capsules contain Chlordiazepoxide Hydrochloride and Clidinium Bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.
When Chlordiazepoxide Hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients – particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.
Other adverse reactions reported during therapy with Chlordiazepoxide Hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Chlordiazepoxide Hydrochloride treatment. Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with Chlordiazepoxide Hydrochloride. When Chlordiazepoxide Hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.
Adverse effects reported with use of Chlordiazepoxide HCl and Clidinium Bromide Capsules are those typical of anticholinergic agents, ie, dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Chlordiazepoxide HCl and Clidinium Bromide Capsules therapy has been combined with other spasmolytic agents and/or a low residue diet.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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