Zyvox

DRUG DESCRIPTION

ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide.

The empirical formula is C 16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:

ZYVOX  (linezolid) Structural Formula Illustration

ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are sodium citrate, citric acid, and dextrose in an aqueous vehicle for intravenous administration. The sodium (Na+) content is 0.38 mg/mL (5 mEq per 300-mL bag; 3.3 mEq per 200-mL bag; and 1.7 mEq per 100-mL bag).

ZYVOX Tablets for oral administration contain 400 mg or 600 mg linezolid as film-coated compressed tablets. Inactive ingredients are corn starch, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and carnauba wax. The sodium (Na+) content is 1.95 mg per 400-mg tablet and 2.92 mg per 600-mg tablet (0.1 mEq per tablet, regardless of strength).

ZYVOX for Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid. Inactive ingredients are sucrose, citric acid, sodium citrate, microcrystalline cellulose and carboxymethylcellulose sodium, aspartame, xanthan gum, mannitol, sodium benzoate, colloidal silicon dioxide, sodium chloride, and flavors (see PATIENT INFORMATION). The sodium (Na+) content is 8.52 mg per 5 mL (0.4 mEq per 5 mL).

What are the possible side effects of linezolid (Zyvox)?

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

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • diarrhea that is watery or bloody;
  • blurred vision, trouble seeing colors
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • seizure...

Read All Potential Side Effects and See Pictures of Zyvox

What are the precautions when taking linezolid (Zyvox)?

Before using linezolid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood disorders (e.g., low blood counts), certain tumor or related conditions (e.g., pheochromocytoma, carcinoid syndrome), untreated overactive thyroid disease (hyperthyroidism), seizure.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney...

Read All Potential Precautions of Zyvox


Zyvox Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site may occur. Also, diarrhea, headache, nausea, vomiting, dizziness, trouble sleeping, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: deep/fast breathing, drowsiness, mental/mood changes, fever, uncontrolled movements, tingling or numbness of hands/feet, easy bruising/bleeding, severe headache, severe dizziness, vision changes (including loss of vision), persistent sore throat, unusual tiredness, seizure.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using linezolid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood disorders (e.g., low blood counts), certain tumor or related conditions (e.g., pheochromocytoma, carcinoid syndrome), untreated overactive thyroid disease (hyperthyroidism), seizure.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Zyvox Patient Information Including Side Effects

Brand Names: Zyvox

Generic Name: linezolid (Pronunciation: lin EZ oh lid)

  • What is linezolid (Zyvox)?
  • What are the possible side effects of linezolid (Zyvox)?
  • What is the most important information I should know about linezolid (Zyvox)?
  • What should I discuss with my healthcare provider before using linezolid (Zyvox)?
  • How is linezolid used (Zyvox)?
  • What happens if I miss a dose (Zyvox)?
  • What happens if I overdose (Zyvox)?
  • What should I avoid while using linezolid (Zyvox)?
  • What other drugs will affect linezolid (Zyvox)?
  • Where can I get more information?

What is linezolid (Zyvox)?

Linezolid is an antibiotic that fights bacteria in the body.

Linezolid is used to treat different types of bacterial infections, such pneumonia, skin infections, and infections that are resistant to other antibiotics.

Linezolid may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of linezolid (Zyvox)?

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

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • diarrhea that is watery or bloody;
  • blurred vision, trouble seeing colors
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • seizure (convulsions); or
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Less serious side effects may include:

  • headache, dizziness;
  • nausea, vomiting, constipation, stomach pain or upset;
  • sleep problems (insomnia);
  • mild rash or itching;
  • discolored tongue, unusual or unpleasant taste in the mouth;
  • vaginal itching or discharge; or
  • yeast infection in the 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.

What is the most important information I should know about linezolid (Zyvox)?

Do not use linezolid if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use linezolid before the MAO inhibitor has cleared from your body.

You also should not use linezolid if you are also using buspirone (BuSpar), meperidine (Demerol), a diet pill or other stimulant, pseudoephedrine (a decongestant), ADHD medication such as Adderall or Dexedrine, migraine or cluster headache medications ("triptans") such as Imitrex or Zomig and others, medication to treat Parkinson's disease or restless leg syndrome, or an antidepressant such as Celexa, Prozac, Paxil, Zoloft, and others.

You should not use linezolid if you have untreated or uncontrolled high blood pressure, a carcinoid tumor, adrenal gland tumor, or a severely overactive thyroid.

Before using linezolid, tell your doctor if you have high blood pressure, a seizure disorder, kidney or liver disease, bone marrow suppression, or a weak immune system.

Eating tyramine while you are using linezolid can raise your blood pressure to dangerous levels. Avoid foods that have a high level of tyramine, such as aged cheeses or meats, pickled or fermented meats, smoked or air-dried meats, sauerkraut, soy sauce, tap beer, red wine, or any meat, cheese, or other protein-based food that has been improperly stored.

Some people have developed a life-threatening condition called lactic acidosis while taking linezolid. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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