Chlordiazepoxide-Clidinium (chlordiazepoxide/clidinium bromide)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Chlordiazepoxide is a benzodiazepine.
Clidinium bromide is a synthetic quaternary ammonium antimuscarinic.
Clidinium bromide, as the fixed-combination with chlordiazepoxide hydrochloride, has been used as an adjunct in the treatment of peptic ulcer disease. However, current epidemiologic and clinical evidence supports a strong association between gastric infection with Helicobacter pylori and the pathogenesis of duodenal and gastric ulcers, and the American College of Gastroenterology (ACG), the National Institutes of Health (NIH), and most clinicians currently recommend that all patients with initial or recurrent duodenal or gastric ulcer and documented H. pylori infection receive anti-infective therapy for treatment of the infection. For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection, see Uses: Helicobacter pylori Infection, in Clarithromycin 8:12.12.92.
Generic name: chlordiazepoxide/clidinium bromide
Pronunciation: (kli-DIN-ee-um/KLOR-dye-AZ-e-POX-ide)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Chlordiazepoxide-Clidinium
Indications
The following indications are listed for Chlordiazepoxide-Clidinium:
- Adjunct Therapy For Acute Enterocolitis
- Adjunct Therapy For Irritable Bowel Syndrome
- Adjunct Therapy For Peptic Ulcer Disease
Also known as: Acute Enterocolitis Adjunct, Adjunct Therapy For Ibs, Adjunct Therapy For Pud, Irritable Bowel Syndrome Adjunct, Peptic Ulcer Disease Adjunct.
Dosing
On the basis of molecular weight, 89 mg of chlordiazepoxide is equivalent to 100 mg of chlordiazepoxide hydrochloride; however, the manufacturer of chlordiazepoxide base claims that chlordiazepoxide and its hydrochloride salt may be used interchangeably on a milligram-for-milligram basis.
Dosage must be individualized, and the smallest effective dosage should be used (especially in geriatric or debilitated patients and in those with liver disease or low serum albumin) to avoid oversedation.
Since chlordiazepoxide and its metabolites have long elimination half-lives, time to reach steady-state plasma concentrations should be considered when dosage adjustments are made.
Commercially available preparations containing chlordiazepoxide or its hydrochloride salt in fixed combination with an anticholinergic (clidinium) or an antidepressant (amitriptyline) generally should not be used as initial therapy in patients who require both drugs. Dosage should first be adjusted by administering each drug separately. If it is determined that the optimum maintenance dosage corresponds to the ratio in a commercial combination preparation, such a product may be used. When dosage adjustment is necessary, the drugs should be administered separately.
In patients who have received prolonged (e.g., for several months) chlordiazepoxide hydrochloride therapy, abrupt discontinuance of the drug should be avoided since manifestations of withdrawal can be precipitated; if the drug is to be discontinued in such patients, it is recommended that dosage be gradually tapered.
Clidinium bromide, as a fixed-combination preparation containing chlordiazepoxide hydrochloride, is administered orally. The drug is usually administered 3 or 4 times daily before meals and at bedtime.
Geriatric or debilitated patients may receive 5 mg of chlordiazepoxide hydrochloride orally 2-4 times daily; the initial dose should not exceed 10 mg daily. When chlordiazepoxide hydrochloride is used in fixed combination with clidinium bromide, the recommended initial geriatric dosage of chlordiazepoxide hydrochloride is 10 mg daily, which may be increased gradually as needed and tolerated. (See Cautions: Geriatric Precautions.)
Chlordiazepoxide and its hydrochloride salt are usually administered orally in 3 or 4 doses daily. After dosage has been stabilized, most clinicians believe that the drug may be administered in 1 or 2 doses daily. Although chlordiazepoxide hydrochloride also has been administered parenterally+, a parenteral dosage form of the drug is no longer commercially available in the US.
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Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
A boxed warning has been included in the prescribing information for all benzodiazepines describing the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with all drugs in this class. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs. Frequent follow-up with patients receiving benzodiazepines is important. Reassess patients regularly to manage their medical conditions and any withdrawal symptoms. Clinicians should assess a patient's risk of abuse, misuse, and addiction. Standardized screening tools are available (https://nida.nih.gov/nidamed-medical-health-professionals/screening-tools- resources/chart-screening-tools). To reduce the risk of acute withdrawal reactions, use a gradual dose taper when reducing the dosage or discontinuing benzodiazepines. Take precautions when benzodiazepines are used in combination with opioid medications.
Chlordiazepoxide shares the toxic potentials of the benzodiazepines, and the usual precautions of benzodiazepine administration should be observed. (See Cautions in the Benzodiazepines General Statement.) The precautions and contraindications associated with antimuscarinics or tricyclic antidepressants also should be considered when commercially available preparations containing chlordiazepoxide or its hydrochloride salt in fixed combination with clidinium or amitriptyline are used.(See Cautions in the Antimuscarinics/Antispasmodics General Statement 12:08.08 and also see Cautions in the Tricyclic Antidepressants General Statement 28:16.04.28.)
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No enhanced messaging available.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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