CHLORDIAZEPOXIDE CLIDINIUM
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chlordiazepoxide hydrochloride and
clidinium bromide capsule
River's Edge Pharmaceuticals, LLC
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RE CHLORDIAZEPOXIDE/CLIDINIUM1 INDICATIONS AND USAGE:
The FDA has classified this drug as “possibly” effective for the following indications: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Final classification of the less-than-effective indications requires further investigation.
2 DOSAGE AND ADMINISTRATION
An individualized dosage of RE Chlordiazepoxide/Clidinium Capsules should be made to achieve the most beneficial results. The usual maintenance dose is one (1) or two (2) capsules, three (3) or four (4) times a day, administered before meals and at bedtime.
Geriatric Dosing: Dosage should be limited to the smallest effective amount to minimize CNS effect and to preclude the development of ataxia, excessive sedation or confusion. The initial does should not exceed two (2) RE Chlordiazepoxide/Clidinium Capsules per day to be increased gradually as needed and/or tolerated.
4 CONTRAINDICATIONS:
RE Chlordiazepoxide/Clidinium Capsules are contraindicated in patients with glaucoma, prostatic hypertrophy and/or benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.
5 WARNINGS AND PRECAUTIONS
RE Chlordiazepoxide/Clidinium Capsules may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery.
Use caution when prescribing RE Chlordiazepoxide/Clidinium Capsules concurrently with psychotropic agents, especially those that include MAO inhibitors and phenothiazines. Patients with impaired renal or hepatic function should be observed, along with patients being treated for anxiety or depression. Paradoxical reactions to chlordiazepoxide hydrochloride, e.g. excitement, stimulation and acute rage have been reported in psychiatric patients and should be considered during RE Chlordiazepoxide/Clidinium Capsules therapy.
6 ADVERSE REACTIONS:
When chlordiazepoxide hydrochloride has been used alone, drowsiness, ataxia and confusion have been reported in some patients, particularly the elderly and debilitated. These effects can be avoided in almost all instances by adjusting the dosage, and have occasionally been observed at the lower dosage ranges. In a few instances, syncope has been reported. Also reported are isolated instances of skin eruptions, edema, nausea and constipation, extrapyramidal symptoms, minor menstrual irregularities, 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 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.Typical of anlichalinergic agents, adverse effects reported with use of RE Chlordiazepoxide/Clidinium Capsules may include dry mouth, blurred vision, urinary hesitancy and constipation. Constipation occurred most often when combined with other spasinolytic agents and/or a restrictive, low residue diet.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
8 USE IN SPECIFIC POPULATIONS:
8.1 Pregnancy: Several studies suggest an increased risk of congenital analformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy. Use during the first trimester should almost always be avoided unless indicated by their prescribing physician. Patients should be advised to communicate with their physicians. If they are pregnant become pregnant during therapy or intend to become pregnant.
8.2 Nursing Mothers: Lactation may be inhibited, as with all anticholinergic drugs. Patients should be advised to consider the importance of the drug against the known benefits of breastfeeding.
8.3 Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
8.4 Geriatric Use: Elderly subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving RE Chlordiazepoxide/Clidinium Capsules. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. (See DOSAGE AND ADMINISTRATION).
10 OVERDOSAGE:
10.1 Signs and symptoms
The symptoms of overdosage of clidinium bromide are excessive dry mouth, blurred vision, urinary hesitancy and constipation which are caused by the anticholinergic actions.
10.2 Treatment
Chlordiazepoxide hydrochloride overdosage symptoms include: drowsiness, confusion, coma and diminished reflexes. Call you doctor or local Poison Control Center if overdosage is suspected.
11 DESCRIPTION:
RE Chlordiazepoxide/Clidinium Capsules is a single capsule formulation that includes the antianxiety action of chlordiazepoxide hydrochloride and the anticholinerglo/spasmolytic effects of clidinium bromide.
RE Chlordiazepoxide/Clidinium Capsules contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, along with lactose, starch, talc, titanium dioxide, FD/C yellow #5 and FD/C yellow #6.
12 CLINICAL PHARMACOLOGY:
Chlordiazepoxide hydrochloride is prescribed for the relief of anxiety and tension, it is indicated when the anxiety, tension or apprehension are significant components of the clinical profile.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.
Clidinium bromide is a synthetic anticholinergic agent that has antispasmodic and antisecretory effect on the gastrointestinal tract.
16 HOW SUPPLIED:
RE Chlordiazepoxide/Clidinium Capsules NDC# 68032-369-10 are available as yellow capsules in bottles of 100. Each yellow capsule contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide and is imprinted with RE 369.
17 INFORMATION FOR PATIENTS:
To assure the safe and effective use of benzodiazepines, patients should be informed that because 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.
PACKAGING:
| CHLORDIAZEPOXIDE CLIDINIUM
chlordiazepoxide hydrochloride, clidinium bromide capsule |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 06/02/2009 | 03/31/2012 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |