Antizol

Name: Antizol

Fomepizole Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness.
  • severe nausea, severe dizziness or spinning sensation; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • headache;
  • dizziness, drowsiness;
  • nausea; or
  • unpleasant or metallic taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fomepizole Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with fomepizole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Manufacturer

  • Jazz Pharmaceuticals, Inc.

  • Paladin Laboratories (usa) Inc

What happens if I miss a dose?

Because you will receive fomepizole in a clinical setting, you are not likely to miss a dose.

Interactions for Antizol

Metabolized by mixed-function oxidases (cytochrome P-450 system).b Potent inducer of CYP-mediated drug elimination; induces own metabolism.a b

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP isoenzymes: Potential pharmacokinetic interaction; however, no studies to date.b

Specific Drugs

Drug

Interaction

Comments

Alcohol

Decreased elimination rate of fomepizole and alcohol (possibly due to inhibition of alcohol dehydrogenase)1 2 4 5 7 22 23 24 25 26 33 b

Antizol Pharmacokinetics

Absorption

Bioavailability

Immediately and completely bioavailable following IV administration.a

Distribution

Extent

Rapidly distributes to total body water following IV infusion.b

Not known whether fomepizole is distributed into milk.b

Elimination

Metabolism

Metabolized in the liver.b

Induces own metabolism; elimination rate increases after about 30–40 hours.b

Elimination Route

Excreted in urine mainly as metabolites; only 1–3.5% of administered dose excreted in urine as unchanged drug. b

Fomepizole is dialyzable.1 25

Half-life

Not determined, but varies with dose.b

Special Populations

Pharmacokinetics not studied in patients with hepatic or renal impairment or in geriatric patients.1

What are some things I need to know or do while I take Antizol?

  • Tell all of your health care providers that you take Antizol. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You will need to have your heart checked before starting this medicine and while taking it. This includes an ECG. Talk with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Antizol while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How do I store and/or throw out Antizol?

  • If you need to store Antizol at home, talk with your doctor, nurse, or pharmacist about how to store it.

Contraindications

Antizol® should not be administered to patients with a documented serious hypersensitivity reaction to Antizol® or other pyrazoles.

Where can i get more information?

Your doctor or pharmacist can provide more information about fomepizole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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For Healthcare Professionals

Applies to fomepizole: intravenous solution

General

The most common adverse events were headache, nausea, dizziness, increased drowsiness, and bad taste/metallic taste.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (11%)
Common (1% to 10%): Abdominal pain, vomiting, diarrhea, dyspepsia, heartburn[Ref]

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness, increased drowsiness, bad taste/metallic taste, lightheadedness, seizure, agitation, feeling drunk, vertigo, nystagmus, anxiety, "felt strange", decreased environmental awareness, abnormal smell, roar in ear[Ref]

Other

Common (1% to 10%): Fever, multiorgan system failure, hangover, speech/visual disturbances[Ref]

Cardiovascular

Common (1% to 10%): Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension[Ref]

Hematologic

Common (1% to 10%): Eosinophilia/hypereosinophilia, lymphangitis, disseminated intravascular coagulation, anemia[Ref]

Hepatic

Common (1% to 10%): Transient transaminitis[Ref]

Local

Common (1% to 10%): Pain during injection, inflammation at injection site, application site reaction[Ref]

Genitourinary

Common (1% to 10%): Anuria[Ref]

Respiratory

Common (1% to 10%): Hiccups, pharyngitis[Ref]

Ocular

Common (1% to 10%): Transient blurred vision[Ref]

Dermatologic

Common (1% to 10%): Facial flush, rash[Ref]

Musculoskeletal

Common (1% to 10%): Lumbalgia/backache[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Some side effects of Antizol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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