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|Noxafil Suspension

Noxafil Suspension

Noxafil Suspension is used for:

Preventing certain types of fungal infections in patients with severely weakened immune systems. It may also be used for other conditions as determined by your doctor.

Noxafil Suspension is an azole antifungal. It works by killing sensitive fungi.

Do NOT use Noxafil Suspension if:

• you are allergic to any ingredient in Noxafil Suspension
• you are taking a 5-HT receptor agonist (eg, eletriptan), cisaparide, conivaptan, an ergot alkaloid (eg, ergotamine), erythromycin, certain H₁ antagonists (eg, astemizole, terfenadine), halofantrine, pimozide, a quinazoline (eg, alfuzosin), or quinidine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Noxafil Suspension:

Some medical conditions may interact with Noxafil Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are allergic to other azole antifungals (eg, itraconazole)
• if you have a history of liver or kidney problems or heart problems (eg, irregular heartbeat, abnormal heart function tests)
• if you have abnormal blood electrolyte (eg, potassium, magnesium, calcium) levels
• if you have severe diarrhea or vomiting

Some MEDICINES MAY INTERACT with Noxafil Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, cisapride, dofetilide, erythromycin, certain H₁ antagonists (eg, astemizole, terfenadine), halofantrine, levomethadyl, pimozide, or quinidine because the risk of severe heart effects, including irregular heartbeat, may be increased
• HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of severe muscle problems may be increased
• Cimetidine because it may decrease Noxafil Suspension"s effectiveness
• Phenytoin or rifabutin because the risk of their side effects may be increased by Noxafil Suspension; they may also decrease Noxafil Suspension"s effectiveness
• 5-HT receptor agonists (eg, eletriptan), aldosterone blockers (eg, eplerenone), benzodiazepines (eg, midazolam, alprazolam), buspirone, calcium channel blockers (eg, nifedipine), cinacalcet, conivaptan, cyclophosphamide, cyclosporine, ergot alkaloids (eg, ergotamine, dihydroergotamine), erlotinib, eszopiclone, gefitinib, HIV protease inhibitors (eg, ritonavir), muscarinic receptor antagonists (eg, tolterodine), narcotic pain medicines (eg, fentanyl), phosphodiesterase inhibitors (eg, sildenafil), quinazolines (eg, alfuzosin), ranolazine, sirolimus, sulfonylureas (eg, glipizide), tacrolimus, tyrosine kinase receptor inhibitors (eg, dasatinib), or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Noxafil Suspension
• Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Noxafil Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Noxafil Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Noxafil Suspension:

Use Noxafil Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Noxafil Suspension by mouth with food.
• Shake well before each use.
• Use the measuring spoon marked for medicine dosing that comes with Noxafil Suspension. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Rinse the measuring spoon with water after each use and before storage.
• Take Noxafil Suspension on a regular schedule to get the most benefit from it. Taking this medicine at the same times each day will help you remember to take it.
• Continue to take Noxafil Suspension even if you feel well. Do not miss any doses.
• If you miss a dose of Noxafil Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Noxafil Suspension.

Important safety information:

• Noxafil Suspension may cause dizziness or blurred vision. Its effects may be worse if you take it with alcohol or certain medicines. Use Noxafil Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Contact your doctor if you experience severe diarrhea or vomiting. The effectiveness of Noxafil Suspension may be decreased.
• Noxafil Suspension only works against fungi; it does not treat viral infections (eg, the common cold) or bacterial infections.
• Be sure to use Noxafil Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Noxafil Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Noxafil Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Diabetes patients- Noxafil Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including liver function and heart function tests, may be performed while you use Noxafil Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Noxafil Suspension should be used with extreme caution in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Noxafil Suspension can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Noxafil Suspension while you are pregnant. It is not known if Noxafil Suspension is found in breast milk. If you are or will be breast-feeding while you use Noxafil Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Noxafil Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; coughing; diarrhea; dizziness; headache; muscle, joint, or back pain; nausea; sore throat; stomach pain or upset; tiredness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mouth inflammation; pale stools; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the ankles, feet, or hands; tremor; unusual bruising or bleeding; vaginal bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Noxafil Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Noxafil Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Noxafil Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Noxafil Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Noxafil Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.