AmiClean 7.5 mg (Tablet)

Indications

• Sequential use with sodium nitrite for treatment of acute cyanide poisoning
• Use with caution if the diagnosis of cyanide poisoning is uncertain

Pharmacology

• Sodium thiosulfate acts as an antidote in the treatment of cyanide poisoning
• Acts as a sulphur-donating substrate for the enzyme rhodanese
• Speeds up the conversion of cyanide to thiocyanide

Dosage & Administration

• Adult: To be given after 300 mg of sodium nitrite over 5-20 min
• Child: To be given after 4-10 mg/kg of sodium nitrite (max: 300 mg)
• Methaemoglobin concentration should not exceed 30-40%
• If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses

Interaction

• Formal drug interaction studies have not been conducted with AmiClean

Side Effects

• Osmotic disturbances
• Oral: catharsis (at high doses)

Pregnancy & Lactation

• Pregnancy Category C
• Sodium Thiosulfate Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Not known whether sodium thiosulfate is excreted in human milk
• Breast-feeding is not a contraindication to its use
• Caution should be exercised following Sodium Thiosulfate Injection administration to a nursing woman
• No data to determine when breastfeeding may be safely restarted following administration of sodium thiosulfate

Precautions & Warnings

• AmiClean drug product may contain trace impurities of sodium sulfite
• Presence of sulfites in AmiClean should not deter administration of the drug for treatment of emergency situations, even if the patient is sulfite-sensitive

Use in Special Populations

• Case reports in medical literature of sodium nitrite administered to pediatric patients with cyanide poisoning
• No clinical studies to evaluate the safety or efficacy of AmiClean in the pediatric population
• AmiClean is known to be substantially excreted by the kidney
• Risk of adverse reactions may be greater in patients with impaired renal function
• Elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

Overdose Effects

• Limited information about the effects of large doses of AmiClean in humans
• Oral administration of 3 g AmiClean per day for 1-2 weeks resulted in reductions in room air arterial oxygen saturation to as low as 75%
• Rightward shift in the oxygen hemoglobin dissociation curve
• Subjects returned to baseline oxygen saturations 1 week after discontinuation of AmiClean
• Single intravenous administration of 20 mL of 10% AmiClean reportedly did not change oxygen saturations

Therapeutic Class

• Antidote preparations

Storage Conditions

• Store at controlled room temperature between 20°C and 25°C
• Protect from direct light
• Do not freeze

Related Brands

• Thiotab 15 mg (Tablet) - sonear-laboratories-ltd
• Thiotab 7.5 mg (Tablet) - sonear-laboratories-ltd