Fomepizole SERB (Fomepizole)

Fomepizole SERB is a hospital antidote for acute ethylene glycol poisoning. Ethylene glycol is found in antifreeze and some de-icing and brake fluids. The European label says treatment should start as soon as poisoning is suspected, without waiting for the blood test result. In the US and in France, other fomepizole products are also approved for methanol poisoning, but that is not an approved use of Fomepizole SERB.

Fomepizole blocks alcohol dehydrogenase, the liver enzyme that turns ethylene glycol into the toxic acids that damage the kidneys and cause acidosis. The dose is worked out by body weight and kidney function: 15 mg/kg as a loading dose, then repeat doses every 12 hours until the ethylene glycol level falls below 0.2 g/L.

• Each dose must be diluted in 100–250 mL of 0.9% sodium chloride or 5% glucose and infused over 30–45 minutes. Never give it undiluted or as a bolus.
• In severe kidney impairment, haemodialysis is combined with a continuous infusion of 1 mg/kg per hour.
• Drowsiness and headache are very common. Dizziness, nausea, vomiting, visual disturbance and raised liver enzymes are also reported.
• Combining it with ethanol treatment is usually not recommended, because each slows the elimination of the other. Liver enzymes and blood count should be checked before treatment and one month later.

Who usually orders Fomepizole SERB?

It is an emergency antidote, so it is normally ordered by hospital emergency departments, ICUs and poison centres to keep in stock, not by individual patients.

How much stock does a hospital need?

Each box holds 5 ampoules of 100 mg. The loading dose is 15 mg/kg, so a 70 kg adult needs about 1,050 mg, which is around 11 ampoules for the first dose alone. More is needed for the 12-hourly doses that follow, so one box is not enough for a single adult patient.

What documents do we need?

• A hospital requisition or prescription from the emergency physician or toxicologist
• Details of the hospital or poison centre that will hold the stock
• Government-issued photo ID of the patient

We confirm the order only after the prescription has been checked.

How is it stored?

Do not freeze; the label gives no other storage condition, and the shelf life is 3 years. Each ampoule is for single use. Once diluted, the solution should be used straight away, and in any case within 24 hours.

For an antidote, delivery time matters most, so we tell hospitals honestly how quickly stock can be sourced and recommend keeping some on the shelf rather than ordering during an emergency. IPN sources Fomepizole SERB from authorised European distributors.

For Fomepizole SERB price and current lead time, call +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• Europe: Fomepizole SERB is authorised in 11 European countries, including Germany, Ireland, the Netherlands, Belgium, Austria and the Nordic countries.
• United States: Fomepizole SERB is not FDA-approved. Fomepizole itself was approved in the US in 1997 (as Antizol, now discontinued; generic versions are available).

Sources:

• Fomepizole SERB – package leaflet with prescriber information (HPRA, Ireland, revised 02/2022)
• Fomepizole SERB – SmPC (CBG-MEB, Netherlands)
• Drugs@FDA – Antizol (fomepizole), NDA 020696

Information last checked: October 2026.

Why is Fomepizole SERB prescribed?

Doctors prescribe Fomepizole SERB for acute ethylene glycol (antifreeze) poisoning. It is an alcohol dehydrogenase inhibitor used as an antidote.

Who is the maker of Fomepizole SERB?

It is made by SERB S.A. (Belgium), with manufacturing in France.

How does Fomepizole act in the body?

Fomepizole blocks alcohol dehydrogenase, the liver enzyme that turns ethylene glycol into the toxic acids that damage the kidneys and cause acidosis.

Can ethanol be given with fomepizole?

The label says earlier ethanol treatment does not prevent the use of fomepizole, but giving the two together is usually not recommended because each slows the other’s elimination.

Should fomepizole be started before the blood result is back?

Yes. The label says treatment should begin as soon as ethylene glycol poisoning is suspected, even without symptoms. The blood test should be taken on admission, but waiting for the result should not delay the first dose.

Is Fomepizole SERB FDA approved?

Fomepizole SERB itself is not FDA-approved. Generic fomepizole injection is FDA-approved in the US for ethylene glycol and methanol poisoning.