"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Pediazole Consumer (continued)
Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell the doctor right away if your child has any serious side effects, including: sun sensitivity (sunburn), muscle weakness, slurred speech, blurred vision, drooping eyelids, eye redness, hearing loss, joint pain/aches, new lump/growth in the neck (goiter), change in the amount of urine, painful urination, pink/bloody urine, mental/mood changes (such as confusion), numbness or tingling of the hands/feet.
This medication may rarely decrease bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease the body's ability to fight an infection, or cause easy bruising/bleeding. Tell the doctor immediately if your child develops any of the following rare (possibly fatal) symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bleeding/bruising.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell the doctor right away if your child develops: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in stool.
Do not use anti-diarrhea products or narcotic pain medications if your child has any of these symptoms because these products may make them worse.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact the doctor if you notice white patches in your child's mouth, a change in vaginal discharge, or other new symptoms.
This medication may rarely cause very serious (possibly fatal) side effects. Get medical help right away if your child has any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat, signs of lung injury (such as persistent cough), seizures, blue lips/skin, signs of liver disease (such as persistent nausea/vomiting, yellowing eyes or skin, dark urine, severe stomach/abdominal pain).
A very serious (possibly fatal) allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 child's 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.
Read the Pediazole (erythromycin and sulfisoxazole) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking erythromycin with sulfisoxazole, tell the doctor or pharmacist if your child is allergic to it; or to other macrolide antibiotics (such as azithromycin, clarithromycin) or sulfa medications; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your child's pharmacist for more details.
Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: severe allergies, asthma, blood disorders (such as porphyria, bone marrow suppression/low blood cell counts), a certain genetic condition (glucose-6-phosphate dehydrogenase/G6PD deficiency), kidney disease, liver disease, a certain type of muscle disease (myasthenia gravis).
Erythromycin/sulfisoxazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if your child has certain medical conditions or is taking other drugs that may cause QT prolongation. Before using erythromycin/sulfisoxazole, tell the doctor or pharmacist of all the drugs your child takes and if your child has any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your child's risk of QT prolongation. This risk may increase if your child uses certain drugs (such as diuretics/"water pills") or if your child has conditions such as severe sweating, diarrhea, or vomiting. Talk to the doctor about using erythromycin/sulfisoxazole safely.
This medication may make your child more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Have your child use a sunscreen and wear protective clothing when outdoors.
Erythromycin/sulfisoxazole may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your child's doctor.
Before having surgery, tell your child's doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially hearing loss and QT prolongation (see above).
Infants may be more sensitive to the side effects of this drug, especially a stomach problem called IHPS (infantile hypertrophic pyloric stenosis). Contact your child's doctor immediately if your child has persistent vomiting or increased irritability with feeding.
During pregnancy, this medication should be used only when clearly needed. This medication must not be used near the time of delivery because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. It may have undesirable effects on infants who are ill or premature or have certain disorders (jaundice, high blood levels of bilirubin, G6PD deficiency). Therefore, breast-feeding is not recommended for infants with these conditions. Consult your doctor before breast-feeding.
Additional Pediazole Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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