Drugplain

Chlordiazepoxide Hydrochloride 10 mg/1

Chlordiazepoxide Hydrochloride · CAPSULE · REMEDYREPACK INC.

No Recall History
Plain English

Chlordiazepoxide Hydrochloride is a capsule containing chlordiazepoxide hydrochloride at 10 mg/1, taken oral. Manufactured by REMEDYREPACK INC..

Key Facts

Brand Name
Chlordiazepoxide Hydrochloride
Generic Name
Chlordiazepoxide Hydrochloride
NDC Code (Product)
70518-1752
Manufacturer
REMEDYREPACK INC.
Strength
10 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
DEA Schedule
Schedule IV (Controlled)
Application #
ANDA083116
Marketing Start
12/27/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective12 reports
dizziness9 reports
fatigue9 reports
dry mouth7 reports
headache7 reports
nausea7 reports
overdose7 reports
somnolence7 reports
anxiety5 reports
asthenia5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: Chlordiazepoxide hydrochloride and clidinium bromide capsules is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Recommended Dosage Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hydrochloride and clidinium bromide capsules, USP 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, 3 or 4 times a day administered before meals and at bedtime. Recommended Geriatric Dosage 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 hydrochloride and clidinium bromide capsules, USP capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions (see PRECAUTIONS ). Discontinuation or Dosage Reduction of chlordiazepoxide hydrochloride and clidinium bromide To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide or reduce the dosage. If a patient develops withdrawal reactions, consider pausing th…

Warnings

WARNINGS: Risks From Concomitant Use with Opioids Concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs-in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe chlordiazepoxide hydrochloride and clidinium bromide capsules concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide hydrochloride and clidinium bromide capsules is used with opioids (see PRECAUTIONS ). Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochlor…

Contraindications

CONTRAINDICATIONS: Chlordiazepoxide hydrochloride and clidinium bromide capsules is 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.

Drug Interactions

Drug Interactions Opioids The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of chlordiazepoxide hydrochloride and clidinium bromide capsules and opioids, and follow patients closely for respiratory depression and sedation. Oral Anticoagulants 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, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules.

Adverse Reactions

ADVERSE REACTIONS: No side effects or manifestations not seen with either compound alone have been reported with the administration of chlordiazepoxide hydrochloride and clidinium bromide capsules. However, since chlordiazepoxide hydrochloride and clidinium bromide capsules contains 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…

Frequently Asked Questions

What is Chlordiazepoxide Hydrochloride used for?

Chlordiazepoxide Hydrochloride contains Chlordiazepoxide Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Chlordiazepoxide Hydrochloride a controlled substance?

Yes, Chlordiazepoxide Hydrochloride is classified as CIV under the DEA Controlled Substances Act.

What is the generic name for Chlordiazepoxide Hydrochloride?

The generic name for Chlordiazepoxide Hydrochloride is Chlordiazepoxide Hydrochloride. There are 6 other brand versions of Chlordiazepoxide Hydrochloride.

What is the NDC code for Chlordiazepoxide Hydrochloride 10 mg/1?

The NDC (National Drug Code) for Chlordiazepoxide Hydrochloride 10 mg/1 is 70518-1752, listed by REMEDYREPACK INC..

Product NDC

70518-1752

Package NDC

70518-1752-1

Other Chlordiazepoxide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)