E.S.P.

It also may be used for other problems as determined by your doctor . It will not work for colds, flu, or other virus infections.

Erythromycin and sulfisoxazole combination is available only with your doctor`s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although this use is not specifically included in product labeling, erythromycin and sulfisoxazole combination is used in certain patients with the following medical condition:

• Sinusitis (sinus infection)

This product is available in the following dosage forms:

• Powder for 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

This medicine has been tested in children over the age of 2 months and has not been shown to cause different side effects or problems than it does in adults. This medicine should not be given to infants under 2 months of age unless directed by the child`s doctor, because it may cause unwanted effects.

Geriatric

This medicine is intended for use in children and is not generally used in adult patients.

Pregnancy

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

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole


• Bepridil


• Cisapride


• Dihydroergotamine


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Methylergonovine


• Methysergide


• Pimozide


• Sparfloxacin


• Terfenadine


• Thioridazine


• Ziprasidone

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.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Atorvastatin


• Azimilide


• Bretylium


• Cerivastatin


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Clarithromycin


• Clindamycin


• Colchicine


• Desipramine


• Dibenzepin


• Digoxin


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Encainide


• Enflurane


• Eplerenone


• Everolimus


• Fentanyl


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Imipramine


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Lidoflazine


• Lorcainide


• Lovastatin


• Mefloquine


• Methotrexate


• Moxifloxacin


• Nortriptyline


• Octreotide


• Pazopanib


• Pentamidine


• Pirmenol


• Pitavastatin


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Protriptyline


• Quinidine


• Ranolazine


• Risperidone


• Sematilide


• Sertindole


• Sertraline


• Simvastatin


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Tadalafil


• Tedisamil


• Telithromycin


• Theophylline


• Tolvaptan


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Troleandomycin


• Vasopressin


• Verapamil


• Voriconazole


• Warfarin


• Zolmitriptan


• Zotepine

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.

• Acetohexamide


• Alfentanil


• Alprazolam


• Anisindione


• Bexarotene


• Budesonide


• Buspirone


• Carbamazepine


• Cilostazol


• Clozapine


• Cyclosporine


• Diazepam


• Dicumarol


• Fesoterodine


• Methylprednisolone


• Midazolam


• Phenprocoumon


• Salmeterol


• Sildenafil


• Sirolimus


• Tacrolimus


• Tolterodine


• Triazolam


• Trimetrexate


• Valproic Acid


• Warfarin


• Zafirlukast

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:

• Anemia or other blood problems or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiencya€”Erythromycin and sulfisoxazole may increase the chance of blood problems

• Heart diseasea€”High doses of erythromycin and sulfisoxazole may increase the chance of side effects in patients with a history of an irregular heartbeat

• Kidney disease or


• Liver diseasea€”Patients with liver or kidney disease may have an increased chance of side effects

• Loss of hearinga€”High doses of erythromycin and sulfisoxazole may increase the chance for hearing loss in some patients

• Porphyriaa€”Erythromycin and sulfisoxazole may increase the chance of a porphyria attack

Proper Use

Erythromycin and sulfisoxazole combination is best taken with extra amounts of water and may be taken with food. Additional amounts of water should be taken several times every day, unless otherwise directed by your doctor . Drinking extra water will help to prevent some unwanted effects (e.g., kidney stones) of sulfa medicines.

Do not give this medicine to infants under 2 months of age, unless otherwise directed by your doctor . Sulfa medicines may cause liver problems in these infants.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid .

Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

To help clear up your infection completely, keep taking this 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.

This medicine works best when there is a constant amount in the blood . To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional .

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 oral dosage form (suspension):
  
  
  
  • For infections caused by bacteria:
    
    
    
    • Adults and teenagersa€”This medicine is used only in children.
    
    
    • Children up to 2 months of agea€”Use is not recommended .
    
    
    • Children 2 months of age and oldera€”Dose is based on body weight:
      
      
      For the four-times-a-day dosing schedule
      
      • Children weighing less than 8 kilograms (kg) (under 18 pounds): Dose must be determined by your doctor .
      
      
      • Children weighing 8 to 16 kg (18 to 35 pounds): 1/2 teaspoonful (2.5 milliliters [mL]) every six hours for ten days.
      
      
      • Children weighing 16 to 24 kg (35 to 53 pounds): 1 teaspoonful (5 mL) every six hours for ten days.
      
      
      • Children weighing 24 to 32 kg (53 to 70 pounds): 1 1/2 teaspoonfuls (7.5 mL) every six hours for ten days.
      
      
      • Children weighing more than 32 kg (over 70 pounds): 2 teaspoonfuls (10 mL) every six hours for ten days.
      
      
      
      
      
      For the three-times-a-day dosing schedule
      
      • Children weighing less than 6 kg (under 13 pounds): Dose must be determined by your doctor .
      
      
      • Children weighing 6 to 12 kg (13 to 26 pounds): 1/2 teaspoonful (2.5 mL) every eight hours for ten days.
      
      
      • Children weighing 12 to 18 kg (26 to 40 pounds): 1 teaspoonful (5 mL) every eight hours for ten days.
      
      
      • Children weighing 18 to 24 kg (40 to 53 pounds): 1 1/2 teaspoonfuls (7.5 mL) every eight hours for ten days.
      
      
      • Children weighing 24 to 30 kg (53 to 66 pounds): 2 teaspoonfuls (10 mL) every eight hours for ten days.
      
      
      • Children weighing more than 30 kg (over 66 pounds): 2 1/2 teaspoonfuls (12.5 mL) every eight hours for ten days.
      
      
      
      
    
    
    
    
  
  
  
  

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 in the refrigerator. Do not freeze .

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine, especially if you will be taking this medicine for a long time.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor .

Erythromycin and sulfisoxazole may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional .


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

Erythromycin and sulfisoxazole combination may cause blood problems . These problems may result in a greater chance of infection, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal . Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment .

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

• Itching


• Skin rash

Less common

• Aching of joints and muscles


• Difficulty in swallowing


• Nausea or vomiting


• Pale skin


• Redness, blistering, peeling, or loosening of skin


• Skin rash


• Sore throat and fever


• Stomach pain, severe


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Yellow eyes or skin

Rare

• Blood in urine


• Dark or amber urine


• Irregular or slow heartbeat


• Temporary loss of hearing (with kidney disease and high doses)


• Lower back pain


• Pain or burning while urinating


• Pale stools


• Recurrent fainting


• Severe stomach pain


• Swelling of front part of neck

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Increased sensitivity to sunlight

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 cramping and discomfort


• Diarrhea


• Headache


• Loss of appetite


• Nausea or vomiting

Less common

• Sore mouth or tongue

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.