Triclonam Elixir

/ CTS

For insomnia:
Adults and children over 12 years: 10 ml daily, in certain cases a higher dosage may be required – up to 20 ml daily.
Children 6-12 years: 5-10 ml daily.
Children 1-5 years: 2.5-5 ml daily.
Infants up to 1 year: 1-2.5 ml daily.
As a sedative:
Adults and children over 12 years: 5 ml twice daily.
Children 6-12 years: 5 ml daily.
Children 1-5 years: 2.5 ml daily.
Infants up to 1 year: 1 ml daily.

Insomnia, daytime sedation and pre-medication in EEC.

Hypersensitivity to the active substance, to chloral hydrate [TRICLONAM is converted to trichloroethanol in the body the same way as chloral hydrate] or to any of the excipients listed in section Pharmaceutical Particulars.
Patients with acute intermittent porphyria [TRICLONAM exacerbates the symptoms of porphyria].

Extra care should be taken when administering to the following patients:
(1) Patients with hepatic disorder or renal disorder [TRICLONAM is hydrolyzed in the liver, converting it to trichloroethanol, then excreted by the kidneys, leading to risk in exacerbating adverse reactions in patients due to maintained and increased blood concentration].
(2) Children.
(3) Weak patients [may cause respiratory depression]
(4) Patients with reduced respiratory function [may cause respiratory depression]
(5) Patients with serious heart disease or arrhythmia [may exacerbated symptoms due to inhibited cardiac function]
(6) Elderly patients
Important precautions
(1) Monitor patients carefully due to risk of respiratory depression. Especially in children, careful attention must be given to respiratory rate, heart rate, percutaneous arterial blood oxygen saturation, etc., through monitoring.
(2) As chloral hydrate is converted into the in vivo metabolite trichloroethanol, in the same way as TRICLONAM, combined use may cause overdosage.
(3) Patients administered TRICLONAM must be warned not to engage in operating dangerous machinery, such as motor vehicles.
(4) Since prolonged administration may cause drug dependency, avoid long-term use through random, continued administration. Take careful consideration of therapeutic necessity when continuing administration.

Headache, hangover, drowsiness, lightheadedness, vertigo, malaise and nightmares, gastrointestinal upsets, flatulence, nausea and vomiting, urticaria, relative eosinophilia and reduction in total white blood cell count, theoretically, excitement and delirium are possible.

Pregnancy: Preferably, TRICLONAM should not be administered to pregnant women or woman who may be pregnant.

Signs and symptoms: Respiratory arrest, bradycardia and decreased blood pressure were found. (See 6. Important Precautions, Reasons and Measures)
Treatment: In the event of overdose, monitor respiration, pulse, blood pressure, percutaneous arterial blood oxygen saturation, and take appropriate measures, such as securing the airway. There have been reports that hemodialysis and blood perfusion are effective.
Acute overdose: Similar to symptoms of acute barbiturates poisoning. In addition, effects as a stimulant appear. The first symptom is vomiting followed by stomach necrosis that progresses to stenosis. There have been reports of cardiac arrhythmias. Jaundice leads to liver disorder. Renal disorder is accompanied by Alb urine.
Chronic oral ingestion at high dose: Gastritis, skin rash, teleangiectasia, hypotension, reduced myocardial function, renal disorder.
Sudden discontinuation of drug causes withdrawal symptoms such as tremors and delirium.
Treatment: Administer palliatives such as liquid paraffin, in order to relieve stomach and esophageal irritation. Administer lidocaine hydrochloride (xylocaine) to manage heart arrhythmia. Forced diuresis or dialysis are effective for severe toxicity.