Posaconazole

Posaconazole is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole delayed-release tablets are used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole oral suspension is also used to treat yeast infections of the mouth and throat including yeast infections in adults and teenagers 13 years of age and older that could not be treated successfully with other medications. Posaconazole is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.

Posaconazole comes as an immediate-release oral suspension (liquid), as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) tablet, and as a delayed-release oral suspension to take by mouth. The delayed-release tablets are usually taken with or without food twice daily on the first day and then once a day. The delayed-release oral suspension is usually taken with food twice daily on the first day and then once a day. The immediate-release oral suspension is usually taken one to three times a day with a full meal or within 20 minutes after a meal. If you cannot take the immediate-release oral suspension with a full meal, take it with a liquid nutritional supplement or an acidic carbonated drink such as ginger ale. Your doctor will determine how long you need to use this medication. Take posaconazole at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take posaconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the oral suspension well before each use to mix the medication evenly.

Always use the dosing spoon that comes with posaconazole immediate-release oral suspension to measure your dose. You may not receive the correct amount of medication if you use a household spoon to measure your dose. The spoon should be rinsed thoroughly with water after each use and before storing.

Swallow the posaconazole delayed-release tablets whole; do not split, chew, or crush them. If you cannot swallow the delayed-release tablets whole, tell your doctor.

If you or your child are using the delayed-release oral suspension, only use the mixing liquid that comes with the kit to prepare it. Add 9 mL of the mixing liquid to the delayed-release oral suspension powder. Shake the powder and liquid in the mixing cup vigorously for 45 seconds to mix. The mixture should look cloudy and not have any clumps. Once mixed, measure the dose with the syringe provided with the kit. Take the mixture with food within 1 hour of mixing. If you or your child are unable to take all of the dose or if some of the dose is spit out, call your doctor.

Each posaconazole product releases the medication differently in your body and cannot be used interchangeably. Only take the posaconazole product prescribed by your doctor and do not switch to a different posaconazole product unless your doctor says that you should.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking posaconazole,

• tell your doctor and pharmacist if you are allergic to posaconazole; other antifungal medications such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Onmel, Sporanox, Tolsura), ketoconazole, or voriconazole (Vfend); simethicone; any other medications; or any of the ingredients in posaconazole products. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with posaconazole. Make sure you have discussed any medications you are currently taking or plan to take before starting posaconazole with your doctor and pharmacist. Before starting, stopping or changing any medications while taking posaconazole, please get the advice of your doctor or pharmacist.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking posaconazole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have a fructose intolerance (an inherited condition in which the body lacks the protein needed to break down fructose [a fruit sugar found in certain sweeteners such as sorbitol]), Your doctor will probably tell you not to take posaconazole delayed-release oral suspension if you have a fructose intolerance.
• tell your doctor if you have or have ever had a slow or irregular heartbeat; a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); problems with blood circulation; low levels of calcium, magnesium, or potassium in your blood; or kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking posaconazole, call your doctor.
• ask your doctor about the safe use of alcoholic beverages while you are taking posaconazole delayed-release oral suspension. Alcohol can make the side effects from posaconazole worse.

Unless your doctor tells you otherwise, continue your normal diet.

If you are taking the immediate-release or delayed-release oral suspension, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you are taking the delayed-release tablets, take the missed dose as soon as you remember it. However, if it is within 12 hours of your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Posaconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fever
• headache
• chills or shaking
• dizziness
• weakness
• swelling of the hands, feet, ankles, or lower legs
• diarrhea
• vomiting
• stomach pain
• constipation
• heartburn
• rash
• itching
• back or muscle pain
• sores on the lips, mouth, or throat
• difficulty falling asleep or staying asleep
• increased sweating
• nosebleeds
• cough
• sore throat

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• extreme tiredness, loss of appetite, nausea, yellowing of the skin or eyes, pain in the upper right part of the stomach, dark urine, pale stools, or flu-like symptoms
• unusual bruising or bleeding
• fast, pounding, or irregular heartbeat
• sudden loss of consciousness
• shortness of breath

Posaconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze the immediate-release oral suspension.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to posaconazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. If you still have symptoms of infection after you finish taking posaconazole, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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