Description
Atovaquone is used to prevent and treat Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole. PCP is a very serious type of pneumonia which occurs usually in patients with poor immune systems, (such as cancer, AIDS, and organ transplanted patients).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of atovaquone in children younger than 13 years of age. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of atovaquone have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azathioprine
- Bupropion
- Efavirenz
- Hydroxychloroquine
- Levoketoconazole
- Mercaptopurine
- Methotrexate
- Quizartinib
- Rifabutin
- Rifampin
- Ritonavir
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tetracycline
- Warfarin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease—Use with caution. May make this condition worse.
- Stomach or bowel problems—Atovaquone may not work properly in patients with these conditions.
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
Take this medicine with food so that it can work properly.
If you are using the oral liquid:
- This medicine is available in two forms: foil pouch and a bottle.
- If you are using the medicine in the foil pouch: Take the 5-mL medicine by placing the contents of one pouch directly into your mouth, or use a dosing spoon or cup. If you need a 10-mL dose, take the entire contents of two pouches.
- If you are using the medicine in the bottle: Shake the bottle gently before using this medicine. Use a specially marked measuring spoon, oral syringe, or medicine cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
Atovaquone tablets may be crushed if necessary to make it easier to swallow.
Because atovaquone tablets and oral suspension do not produce the same amount of medicine in the blood, the tablets and the suspension cannot be switched and used in place of each other.
To help clear up your infection completely, keep using your medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For prevention of Pneumocystis jiroveci pneumonia (PCP):
- For oral dosage form (suspension):
- Adults and children 13 years of age and older—1500 milligrams (mg) or 10 milliliters (mL) once a day with food.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
- For treatment of Pneumocystis carinii pneumonia (PCP):
- For oral dosage form (suspension):
- Adults and children 13 years of age and older—750 milligrams (mg) or 5 milliliters (mL) two times a day with food for 21 days.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—750 milligrams (mg) taken with a meal three times a day for 21 days.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Cough or hoarseness
- difficult or labored breathing
- fever or chills
- lower back or side pain
- painful or difficult urination
- tightness in the chest
Incidence not known
- Black, tarry stools
- bleeding gums
- bloating
- blood in the urine or stools
- bluish-colored lips, fingernails, or palms
- constipation
- dark urine
- dizziness or lightheadedness
- fast heartbeat
- headache
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- nausea
- noisy breathing
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- rapid heart rate
- sore throat
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abdominal or stomach pain
- diarrhea
- lack or loss of strength
- runny nose
- skin rash
- sneezing
- sore mouth or tongue
- stuffy nose
- sweating
- trouble sleeping
- white patches in the mouth, tongue, or throat
Incidence not known
- Blistering, peeling, or loosening of the skin
- eye irritation or redness
- itching or skin rash
- joint or muscle pain
- red skin lesions, often with a purple center
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20062055
