Clidinium

Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists.

• 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.ICD-10: K58.9

• 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.contraindicated

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 the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS and DRUG ABUSE AND DEPENDENCE ).

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 hydrochloride and clidinium bromide capsules, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.

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 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.

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 hydrochloride and clidinium bromide capsules 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.

• Sep 1, 1966NDANDA012750Bausch
• Jul 7, 2020ANDAANDA211421Nuvo Pharms Inc
• Jul 29, 2020ANDAANDA210579Misemer
• Oct 20, 2020ANDAANDA213530Chartwell Rx
• Apr 26, 2021ANDAANDA214065Alkem Labs Ltd
• Oct 25, 2021ANDAANDA215555Amneal
• Jul 19, 2022ANDAANDA215835Micro Labs
• Sep 14, 2023ANDAANDA216419Aurobindo Pharma Ltd

1. 1Nausea1859.5%
2. 2Diarrhoea1839.4%
3. 3Fatigue1698.7%
4. 4Drug Ineffective1387.1%
5. 5Pain1326.8%
6. 6Headache1206.2%
7. 7Abdominal Pain1125.8%
8. 8Dizziness1125.8%
9. 9Vomiting1005.1%
10. 10Arthralgia975.0%
11. 11Asthenia964.9%
12. 12Weight Decreased964.9%
13. 13Abdominal Pain Upper934.8%
14. 14Dyspnoea934.8%
15. 15Constipation924.7%

The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Clidinium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Stellate Ganglion Block Versus Oral Medication in Treatment of Palmar Hyperhidrosis
  Completed · Interventional · 46 enrolled · Fayoum University
  NCT06731101updated 2026-02-06
• A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study
  Unknown · Interventional · 100 enrolled · Hospital Authority, Hong Kong
  NCT00516854updated 2010-07-07

Frequently asked questions

How does Clidinium work?

Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists.

What is Clidinium used for?

According to FDA labeling, Clidinium carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Clidinium?

Clidinium is classified as Anticholinergic, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Decreased Parasympathetic Acetylcholine Activity, Digestive/GI System Activity Alteration, GI Motility Alteration, Inhibition Gastric Acid Secretion.

What are the brand names for Clidinium?

Clidinium is marketed under brand names including Librax.

What are the contraindications for Clidinium?

Clidinium labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.