Drug Interaction:
Fomeprazole -- oral doses of fomeprazole via alcohol dehydrogenase inhibition significantly reduced
elimination of fomeprazole
Ethanol- ethanol decreased elimination of fomeprazole
Indication:
LIST OF NEW DRUG APPROVED FROM 01-01-2016 To TILL DATE
BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
3. Fomepizole Bulk & 1.5gm Ampoule 14-03-2016
100/150mg
As an antidote for Ethylene glycol or Methanol used
poisoning or for use in suspected Ethylene glycol or
Methanol ingestion, either alone or in combination
Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2016 To Till Date)
Ethylene Glycol or methanol poisoning
Adverse Reaction:
Adverse reactions - headache 14% nausea 11% dizziness. increased drowsiness and
bad taste/metallic taste 6%
Cardiovascular- sinus bradycardia, bradycardia, tachycardia, phelebitis, shock,
hypotension, phebosclerosis
CNS- seizure, vertigo, lightheadedness, nystagmus, agitation, facial flush,
anxiety, feeling of drunkeness, strange feeling, decreased enviromental
awareness
GI- vomiting, diarrhea, dyspepsia, decreased appetite, transcient aminitis,
heartburn
Hematologic/lymphatic - lymphangitis, eosinophillia, hyperesionophillia,
disseminated coagulated , anemia
Respiratory - hiccups. blurred vision
Special senses- abnormal smell, speech /visual disturbances, roar in the ear,
transcient blurred vision.
Miscellaneous- abdominal pain, fever, multiorgan system failure, pain during
fomeprazole injection, inflammation at injection site,
anuria, lumbalgia/backache, hangover, rash, application site reaction.
Contra-Indications:
Serious hypersensitivity reactions to fomepizole or other pyrazoles.
Special precautions-
Administration- do not give fomeprazole undiluted or by bolus injection .
Venous irritation and phlesclerosis occurred in few patients
Allergic reactions- minor allergic reactions ( mild rash. eosinophillia) have been reported.
Monitor patients for allergic reactions
Pregnancy- give to pregnant women only if clearly needed
Lactation- exercise caution when fomepizole is administered to a breast feeding woman.
Children- safety and efficacy have not been established.
Elderly- safety and effectiveness in elderly patients have not been established
Monitoring- patients intoxicated with ethylene glycol and methanol must be managed for
metabolic acidosis, acute renal failure, ( ethylene glyol) adult respiratory distress syndrome,
visual disturbances ( methanol ) and hypocalcemia. fluid therapy and sodium bicarbonate
administration are potential supportive therapies.
Potassium and calcium supplementation and oxygen administration are usually necessary.
Monitor serum methanol concentration in patients poisoned with methanol.
Dosages/ Overdosage Etc:
Indication-
Ethylene Glycol or methanol poisoning
Dosage-
Administer a loading dose of 15mg/kg followed by doses of 10mg/kg every 12 hours for 4 doses,
then 15mg/kg every 12 hours thereafter until ethylene glycol or methanol concentrations are
indetectable or have reduced to less than 20mg/mg/dL and the patient is asymptomatic with
normal pH.
Administer all doses as a slow IV infusion to over 30 minutes.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Fomepizole is a competetive inhibitor of alcohlol dehydogenase that catalyses the oxidation
of ethanol to acetyaldehde. Alcohol dehydrogenase also catalyses the initial steps in the
metabolism of ethylene glycol and methanol and their toxic metabolites.
Pregnancy and lactation:
Pregnancy-
Give to pregnant women only if clearly needed
Lactation-
Exercise caution when fomepizole is administered to a breast feeding woman.
Children-
Safety and efficacy have not been established.
Elderly-
Safety and effectiveness in elderly patients have not been established