AmiClean15 mg

AmiClean is a sulfur-donor antidote and chemoprotective agent used in the following settings:

Established / FDA-approved uses

• Acute cyanide poisoning (serious or life-threatening): AmiClean is given intravenously in sequence with sodium nitrite as part of the standard cyanide antidote protocol, after sodium nitrite has been administered.
• Reduction of cisplatin-induced ototoxicity: AmiClean injection is approved to reduce the risk of hearing loss associated with cisplatin chemotherapy in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Established supportive/adjunct use

• Extravasation of certain vesicant chemotherapy agents (e.g., mechlorethamine/nitrogen mustard): AmiClean solution is injected subcutaneously into and around the extravasation site as an inactivating/neutralizing agent, per oncology extravasation-management protocols.
• Topical antifungal use: topical AmiClean solution/lotion preparations are used for tinea versicolor (pityriasis versicolor).

Off-label uses (evidence-supported but not FDA-approved for these indications)

• Calciphylaxis (calcific uremic arteriolopathy), usually in patients with end-stage renal disease, as an adjunct given intravenously during or after hemodialysis sessions.
• Refractory uremic pruritus in dialysis patients, as an adjunct when standard measures fail.

AmiClean should only be used for these indications under direct medical/emergency or specialist supervision; it is not a self-administered medicine.

Sodium Thiosulfate is available (depending on brand/market) as:

• Sterile injectable solution for intravenous use, commonly as 10%, 12.5%, or 25% Sodium Thiosulfate solution in single-dose vials or ampoules, sometimes supplied as part of a two-component cyanide antidote kit together with sodium nitrite injection.
• A dedicated intravenous formulation specifically indicated and dosed for prevention of cisplatin-induced ototoxicity in pediatric patients (not interchangeable with other Sodium Thiosulfate injection products).
• Topical solution/lotion formulations (e.g., 20–25% Sodium Thiosulfate) for dermatological use.
• Low-strength oral tablets are also marketed in some countries, including Bangladesh; these are not equivalent to, and cannot substitute for, the intravenous antidote doses used in cyanide poisoning or chemoprotection.

The exact strength, pack size, and formulation of Sodium Thiosulfate should always be confirmed on the product label before use.

AmiClean is an inorganic sulfur-containing salt used medically mainly as an antidote and chemoprotective/detoxifying agent. Its best-established role is as the second agent (after sodium nitrite) in the intravenous treatment of acute, serious cyanide poisoning, where it helps the body convert toxic cyanide into a far less toxic compound that can be excreted in urine.

AmiClean injection is also approved to reduce the risk of permanent hearing loss (ototoxicity) caused by cisplatin chemotherapy in young children with certain solid tumors. Other uses include neutralizing certain chemotherapy extravasations, topical treatment of tinea versicolor, and, off-label, management of calciphylaxis and refractory uremic itching in dialysis patients.

Because of its narrow, specialized uses and the need for controlled intravenous administration and monitoring in most indications, AmiClean is used in hospital, emergency, oncology, or dialysis settings under direct medical supervision.

AmiClean belongs to the therapeutic class of antidotes and chemoprotective (detoxifying) agents, specifically classified as a cyanide antidote and an otoprotective agent used alongside platinum-based chemotherapy.

Sodium Thiosulfate acts mainly as a sulfur-donating substrate. In cyanide poisoning, it supplies sulfur to the mitochondrial enzyme rhodanese (thiosulfate sulfurtransferase), which catalyzes the conversion of cyanide ion to thiocyanate — a compound that is far less toxic and is cleared by the kidneys. This reaction is naturally slow-limited by available sulfur, which is why giving Sodium Thiosulfate accelerates detoxification, typically after sodium nitrite has already induced methemoglobin formation to bind circulating cyanide.

In the prevention of cisplatin-induced ototoxicity, Sodium Thiosulfate is thought to act systemically to reduce free-radical and platinum-related damage to the cochlear hair cells; when administered several hours after cisplatin (allowing cisplatin's antitumor activity to take effect first), it lowers the risk of hearing loss without significantly reducing chemotherapy efficacy in the approved population.

AmiClean for cyanide poisoning and for ototoxicity prevention is given only by slow intravenous injection or infusion in a monitored hospital/oncology setting, never as a rapid IV push, because fast administration increases the risk of hypotension and other adverse effects. It must not be mixed in the same line as hydroxocobalamin. For extravasation management it is given subcutaneously around the affected area, and for tinea versicolor it is applied topically to the skin. Oral tablet forms of AmiClean, where marketed, should be taken exactly as directed by the prescriber.

• Hydroxocobalamin: AmiClean is chemically incompatible with hydroxocobalamin; the two must not be administered simultaneously through the same intravenous line or mixed in the same solution.
• Sodium nitrite: when used together in the cyanide antidote protocol, correct sequencing (sodium nitrite first, then AmiClean) and dose limits are essential, since sodium nitrite itself can cause clinically significant methemoglobinemia; methemoglobin levels must be monitored.
• Other intravenous medicines: as with many concentrated salt solutions, AmiClean should not be mixed with other drugs in the same syringe or line unless compatibility has been confirmed; flush the line before and after administration.

Formal, systematic drug-interaction studies with AmiClean have not been conducted; the interactions above are the ones considered clinically significant.

• Nausea and vomiting, particularly with rapid intravenous administration or concentrated solutions
• Headache and disorientation
• Transient hypotension (low blood pressure), especially with fast infusion
• Injection-site discomfort, irritation, or reaction
• Osmotic disturbances; at high oral doses, a laxative (cathartic) effect
• Rarely, allergic-type reactions

AmiClean is generally well tolerated when given at the recommended rate and dose under medical supervision.

Pregnancy: AmiClean is classified under the older FDA pregnancy category C. Controlled studies in pregnant women are lacking, though animal reproduction data have not shown clear evidence of embryotoxicity. In a life-threatening emergency such as cyanide poisoning, AmiClean should not be withheld from a pregnant patient; outside of emergency use, it should be used only if the potential benefit justifies the potential risk to the fetus, and only under medical advice.

Lactation: it is not known whether AmiClean is excreted in human breast milk. When AmiClean is used for a life-threatening indication such as cyanide poisoning, breastfeeding should not be a reason to withhold treatment, but breastfeeding is generally not recommended during and immediately after treatment; a physician should advise on when breastfeeding can safely resume.

• Renal impairment: AmiClean and its metabolite thiocyanate are cleared by the kidneys; patients with renal impairment (including many elderly patients) require close monitoring, as thiocyanate can accumulate and cause toxicity.
• Rate of administration: intravenous AmiClean must be given slowly, at the recommended rate, because rapid administration can cause transient hypotension.
• Use with sodium nitrite: when used in the sequential cyanide antidote protocol, correct dosing and timing relative to sodium nitrite must be followed, and methemoglobin level should be monitored because of the risk of nitrite-induced methemoglobinemia (see Interactions).
• Formulation-specific products: some AmiClean injection products (e.g., those specifically approved for cisplatin ototoxicity prevention) are not interchangeable with other AmiClean injection products; using the wrong product or diluent can cause serious harm.
• Sulfite-sensitive patients: certain AmiClean products may contain trace sodium sulfite; this should not delay emergency treatment of cyanide poisoning, but should be noted for non-emergency use.
• Diagnostic uncertainty: in suspected but unconfirmed cyanide poisoning, the decision to give AmiClean and sodium nitrite should be made cautiously, balancing the urgency of the clinical picture against the risks of nitrite-induced methemoglobinemia.

Data on AmiClean overdose in humans are limited. Reported effects of excessive dosing include a transient reduction in blood oxygen saturation, osmotic/electrolyte disturbances, low blood pressure, and gastrointestinal symptoms such as nausea, vomiting, or (with high oral doses) a laxative effect. If an overdose of AmiClean is suspected, seek immediate medical attention or contact emergency services/poison control; treatment is supportive and should be provided in a monitored medical setting. Do not attempt to manage a suspected AmiClean overdose at home.

Store AmiClean injection at controlled room temperature, between 20°C and 25°C (68–77°F); protect from direct light and do not freeze. Keep all forms of AmiClean, including tablets or topical preparations, out of the reach of children, and follow any specific storage instructions on the product label.

• Pediatric patients: AmiClean is used with weight-based dosing for cyanide poisoning and is specifically approved (in a dedicated formulation) for prevention of cisplatin-induced ototoxicity in patients 1 month of age and older with localized, non-metastatic solid tumors; safety and efficacy of other uses in children have not been established.
• Elderly patients: use with caution, particularly monitoring renal function, since age-related decline in renal clearance can increase the risk of thiocyanate accumulation.
• Renal impairment: requires closer monitoring due to reduced clearance of AmiClean and its metabolites (see Precautions).
• Hepatic impairment: specific dose-adjustment data are limited; use cautiously under medical supervision.
• Pregnant and breastfeeding women: see Pregnancy and Lactation.

For acute cyanide poisoning, AmiClean is typically given as one or two doses (an initial dose, with a possible half-dose repeat after about 30 minutes) during the emergency treatment episode, not as an ongoing course. For prevention of cisplatin-induced ototoxicity, AmiClean is given with each qualifying cisplatin cycle for the duration of the chemotherapy protocol, as directed by the oncology team. For off-label uses such as calciphylaxis or refractory uremic pruritus, and for topical treatment of tinea versicolor, the duration is individualized by the treating physician based on clinical response, and is usually a defined, limited course rather than indefinite therapy.

Sodium Thiosulfate is classified as an antidote (specifically a cyanide antidote) and as a chemoprotective/otoprotective agent used with platinum-based chemotherapy; it also functions as a topical antifungal agent in dermatological formulations.

Sodium Thiosulfate works chiefly by donating a sulfur atom to the enzyme rhodanese, which uses this sulfur to convert toxic cyanide ion into thiocyanate, a much less toxic compound that the kidneys can excrete — this is the basis of its antidotal action in cyanide poisoning, generally used after sodium nitrite has helped sequester circulating cyanide as cyanmethemoglobin. In the prevention of cisplatin-induced ototoxicity, Sodium Thiosulfate is understood to reduce oxidative and platinum-related injury to cochlear structures when administered systemically at an appropriately delayed interval after cisplatin, thereby protecting hearing without significantly blunting the drug's antitumor effect at the approved dose and timing.

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AmiClean has two well-defined pediatric roles. First, in acute cyanide poisoning, it is dosed on a weight basis (approximately 400 mg/kg, maximum 12.5 g) after age/weight-appropriate sodium nitrite, under emergency medical supervision. Second, a dedicated AmiClean injection formulation is FDA-approved to reduce the risk of ototoxicity (hearing loss) from cisplatin chemotherapy in pediatric patients 1 month of age and older who have localized, non-metastatic solid tumors, dosed by body surface area and given intravenously after the cisplatin infusion according to the oncology protocol. Outside of these established uses, the safety and efficacy of AmiClean in children have not been established, and it should only be used in pediatric patients under direct specialist supervision.