Chloral Betaine

Chloral Betaine is used in the short-term management of insomnia. It dissociates in the stomach to release chloral hydrate, therefore, has actions and uses similar to those of chloral hydrate.

Chloral Betaine is primarily indicated in conditions like Insomnia, Postoperative sedation, Pre-operative sedation.

Chloral Betaine is contraindicated in conditions like Renal failure, Gastritis, Hepatic failure, Cardiac disease, Porphyria.

The severe or irreversible adverse effects of Chloral Betaine, which give rise to further complications include Bradycardia, Eosinophilia, CNS depression, Hypoprothorombinemia, Hepatic encephalopathy exacerbation. Chloral Betaine produces potentially life-threatening effects which include Hepatic coma, Leukopenia. which are responsible for the discontinuation of Chloral Betaine therapy. The signs and symptoms that are produced after the acute overdosage of Chloral Betaine include Cardiac arrhythmias, Coma, Ataxia, Respiratory depression, Lethargy. The symptomatic adverse reactions produced by Chloral Betaine are more or less tolerable and if they become severe, they can be treated symptomatically, these include Drowsiness, Confusion, Skin Rash, GI symptoms, Disorientation.

Concerns related to adverse effects: • CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). • Diarrhea: May be a sign of incomplete intestinal obstruction, treatment should be discontinued if this occurs. • Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise. • Psychosis: Has been reported in patients with an extreme sensitivity to anticholinergic effects; usually resolves with discontinuation of treatment. Disease-related concerns: • Cardiovascular disease: Use with caution in patients with coronary artery disease, tachycardia, arrhythmias, heart failure, or hypertension; evaluate tachycardia prior to administration. • Gastric ulcer treatment: Use of anticholinergics in gastric ulcer treatment may cause a delay in gastric emptying due to antral stasis. • Hepatic impairment: Use with caution in patients with hepatic impairment. • Hiatal hernia: Use with caution in patients with hiatal hernia with reflux esophagitis; may aggravate condition. • Hyperthyroidism: Use with caution in patients with hyperthyroidism. • Neuropathy: Use with caution in patients with autonomic neuropathy. • Prostatic hyperplasia: Use with caution in patients with prostatic hyperplasia. • Renal impairment: Use with caution in patients with renal impairment. • Ulcerative colitis: Use with caution in patients with ulcerative colitis; may precipitate/aggravate toxic megacolon. Special populations: • Elderly: Use with caution in the elderly; increased risk for anticholinergic effects, confusion, and hallucinations. Dosage form specific issues: • Tartrazine: Some products may contain tartrazine.

Concerns related to adverse effects: • CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). • Diarrhea: May be a sign of incomplete intestinal obstruction, treatment should be discontinued if this occurs. • Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise. • Psychosis: Has been reported in patients with an extreme sensitivity to anticholinergic effects; usually resolves with discontinuation of treatment. Disease-related concerns: • Cardiovascular disease: Use with caution in patients with coronary artery disease, tachycardia, arrhythmias, heart failure, or hypertension; evaluate tachycardia prior to administration. • Gastric ulcer treatment: Use of anticholinergics in gastric ulcer treatment may cause a delay in gastric emptying due to antral stasis. • Hepatic impairment: Use with caution in patients with hepatic impairment. • Hiatal hernia: Use with caution in patients with hiatal hernia with reflux esophagitis; may aggravate condition. • Hyperthyroidism: Use with caution in patients with hyperthyroidism. • Neuropathy: Use with caution in patients with autonomic neuropathy. • Prostatic hyperplasia: Use with caution in patients with prostatic hyperplasia. • Renal impairment: Use with caution in patients with renal impairment. • Ulcerative colitis: Use with caution in patients with ulcerative colitis; may precipitate/aggravate toxic megacolon. Special populations: • Elderly: Use with caution in the elderly; increased risk for anticholinergic effects, confusion, and hallucinations. Dosage form specific issues: • Tartrazine: Some products may contain tartrazine.

700 to 1400 mg (1000 (1050)) 24 hourly PO — Should be taken 15-30 min before bed time.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Monitor therapy Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Consider therapy modification Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Avoid combination Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Tabs Store in a well closed container, . Protect from Sunlight, Moisture and Heat.