Sulfatrim Pediatric (Oral)

Sulfamethoxazole and trimethoprim combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery). This medicine is also used to prevent or treat Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP), which is a very serious type of pneumonia. This pneumonia is more common in patients whose immune systems are not functioning normally, including cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).

Sulfamethoxazole and trimethoprim combination is an antibiotic. It works by killing the bacteria that cause many types of infections. This medicine will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check the progress of you or your child during regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use effective birth control to prevent pregnancy. If you think you have become pregnant while using the medicine, tell your doctor immediately.

This medicine may cause serious skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), or acute febrile neutrophilic dermatosis (AFND). Contact your doctor if you have a skin rash, blistering, peeling, loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions with a purple center, sore throat, sores, ulcers, white spots in the mouth or on the lips, black, tarry stools, chest pain, or painful or difficult urination.

Contact your doctor immediately if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be signs of a serious liver problem.

This medicine, especially if you are receiving high doses or using it for a long time, may lower your platelet count, which is needed for proper blood clotting. Because of this, you may bleed or get infections more easily. Talk with your doctor if you have black, tarry stools, bleeding gums, blood in urine or stools, pinpoint red spots on the skin, or unusual bleeding or bruising.

This medicine may cause diarrhea, which can be severe in some cases. Diarrhea may occur 2 months or more after stopping this medicine. Do not take any medicine for diarrhea without first checking with your doctor. If you have questions or if mild diarrhea continues or worsens, consult your doctor.

Contact your doctor immediately if you or your child have stomach cramps, bloating, watery and severe diarrhea that may be bloody, nausea or vomiting, or unusual tiredness or weakness. These may be signs of a serious intestinal infection.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Contact your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after using the medicine.

This medicine may cause electrolyte problems, including high potassium in the blood (hyperkalemia) and low sodium in the blood (hyponatremia). Tell your doctor right away if you have confusion, weakness, muscle twitching, an irregular heartbeat, numbness or tingling in the hands, feet, or lips, or trouble breathing.

This medicine may cause hypoglycemia (low blood sugar) in some patients. Consult your doctor if you have anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, trouble concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

Before any medical tests, inform the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Patients receiving anticonvulsant treatment (medicines to prevent seizures) may be at risk for a folate (vitamin B9) deficiency, which may increase the risk for side effects. Talk with your doctor if you have concerns about this.

Do not use this medicine if you are also using dofetilide (Tikosyn®).

Do not use this medicine for Pneumocystis jiroveci pneumonia (PCP) if you are also using leucovorin. Using these medicines together may cause them to not work as well for you.

Do not take other medicines unless discussed with your doctor. This includes leucovorin, other prescription or nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks of the medicine against the benefits it may provide. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research has not shown any pediatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in children aged 2 months and older. However, due to the risks associated with sulfamethoxazole and trimethoprim, it is not recommended for infants younger than 2 months old.

Geriatric

Research has not indicated any geriatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in elderly patients. However, older adults are more likely to have folate deficiency, age-related kidney or liver issues, and may be more prone to side effects (such as severe skin rash, increased potassium levels, or problems with blood clotting or the immune system). The dose may need to be adjusted for elderly patients taking sulfamethoxazole and trimethoprim combination.

Breast Feeding

Studies suggest that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a risk of interaction. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this one. The list below highlights significant interactions but is not exhaustive.

Using this medicine with any of the following is not recommended. Your doctor may choose not to prescribe this medication or may adjust your other medications.

• Dofetilide
• Levomethadyl
• Methenamine

Using this medicine with any of the following is usually not recommended but may be necessary in some situations. If both medicines are prescribed, your doctor may alter the dose or frequency of one or both medications.

• Acecainide
• Acenocoumarol
• Ajmaline
• Amiloride
• Amiodarone
• Amitriptyline
• Amoxapine
• Aprindine
• Arsenic Trioxide
• Astemizole
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Azimilide
• Benazepril
• Bretylium
• Candesartan Cilexetil
• Captopril
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Clarithromycin
• Desipramine
• Dibenzepin
• Digoxin
• Disopyramide
• Dolasetron
• Doxepin
• Dronedarone
• Droperidol
• Enalapril
• Enalaprilat
• Enflurane
• Eplerenone
• Eprosartan
• Erythromycin
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosinopril
• Fosphenytoin
• Gemifloxacin
• Glyburide
• Halofantrine
• Haloperidol
• Halothane
• Hydroquinidine
• Ibutilide
• Imipramine
• Irbesartan
• Isoflurane
• Isradipine
• Leucovorin
• Lidoflazine
• Lisinopril
• Lorcainide
• Losartan
• Mefloquine
• Mercaptopurine
• Methotrexate
• Moexipril
• Nortriptyline
• Octreotide
• Olmesartan Medoxomil
• Pentamidine
• Perindopril
• Phenytoin
• Pirmenol
• Porfimer
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Pyrimethamine
• Quinapril
• Quinidine
• Ramipril
• Risperidone
• Sapropterin
• Sematilide
• Sertindole
• Sotalol
• Spiramycin
• Spironolactone
• Sultopride
• Tedisamil
• Telithromycin
• Telmisartan
• Trandolapril
• Triamterene
• Trifluoperazine
• Trimipramine
• Valsartan
• Warfarin
• Zofenopril
• Zotepine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both drugs may be necessary for your treatment. If both medications are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Acetohexamide
• Amantadine
• Aminolevulinic Acid
• Anisindione
• Didanosine
• Repaglinide
• Rifabutin
• Rosiglitazone
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The list below highlights significant interactions but is not exhaustive.

Using this medicine with any of the following is usually not recommended but may be necessary in some cases. If used together, your doctor may adjust the dose or frequency of this medicine or provide specific instructions about food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical conditions may affect how this medicine works. Make sure to inform your doctor about any other medical problems you have, especially:

• Alcohol abuse, history of or
• Folate (vitamin B9) deficiency or
• HIV or AIDS or
• Kidney disease or
• Liver disease or
• Malabsorption syndrome (difficulty absorbing food) or
• Malnutrition state (nutritional disorder) or
• Slow acetylator—Use with caution. May have an increased chance of serious side effects.

• Anemia, megaloblastic (caused by low folic acid) or
• Drug-induced thrombocytopenia (low platelets) after using this medicine or
• Severe kidney disease or
• Severe liver disease—Should not be used in these patients.

• Asthma or
• Diabetes or
• Hyperkalemia (high potassium levels) or
• Hyponatremia (low sodium levels) or
• Porphyria (enzyme problem) or
• Severe allergies or
• Thyroid problems—Use with caution. May worsen these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme issue)—May lead to hemolytic anemia in these patients.

• Streptococcal infection (group A β-hemolytic)—Sulfonamides should not be used in patients with this condition.

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

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• changes in skin color
• chest pain or tightness
• chills
• clay-colored stools
• cough or hoarseness
• dark urine
• diarrhea
• dizziness
• fever
• general feeling of tiredness or weakness
• headache
• itching, skin rash
• joint or muscle pain
• light-colored stools
• loss of appetite
• lower back or side pain
• nausea
• pain, tenderness, or swelling of the foot or leg
• painful or difficult urination
• pale skin
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• swollen or painful glands
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• blindness or vision changes
• bloating
• blood in the urine or stools
• bluish-colored lips, fingernails, or palms
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• burning of the face or mouth
• cloudy urine
• clumsiness or unsteadiness
• confusion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• cracks in the skin
• decreased frequency or amount of urine
• difficulty with swallowing
• fainting spells
• fast, pounding, or irregular heartbeat or pulse
• general body swelling
• general feeling of discomfort or illness
• hair loss
• hearing loss
• hives
• increased thirst
• indigestion
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of heat from the body
• muscle or joint pain
• nosebleeds
• not able to pass urine
• numbness or tingling in the hands, feet, or lips
• pain or burning while urinating
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised red swellings on the skin, the buttocks, legs, or ankles
• redness of the white part of the eyes
• redness, swelling, or soreness of the tongue
• seizures
• soreness of the muscles
• stiff neck or back
• stomach tenderness
• swelling of the face, hands, legs, and feet
• unsteadiness, trembling, or other problems with muscle control or coordination
• weakness in the hands or feet
• weakness or heaviness of the legs
• weight gain or loss

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

• Passing of gas

Incidence not known

• Discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• increased sensitivity of the skin to sunlight
• lack of feeling or emotion
• loss of interest or pleasure
• muscle pain, stiffness, cramps, or spasms
• nervousness
• redness or other discoloration of the skin
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• severe sunburn
• trouble concentrating
• trouble sleeping
• uncaring
• weight loss

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.

In the U.S.

• Bactrim
• Bactrim DS
• Septra
• Septra DS
• SMZ-TMP Pediatric
• Sulfatrim
• Sulfatrim Pediatric

In Canada

• Apo-Sulfatrim
• Novo-Trimel
• Nu-Cotrimox
• Septa Pediatric
• Septra Pediatric Suspension

Available Dosage Forms:

• Tablet
• Suspension

Therapeutic Class: Sulfonamide Combination

Pharmacologic Class: Folic Acid Antagonist

Chemical Class: Sulfonamide

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Sulfamethoxazole and trimethoprim combination is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects (eg, crystals in the urine)..

For patients taking the oral liquid, 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.

To help clear up your infection completely, keep using 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.

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 forms (liquid or tablets): For treatment of bacterial infections: Adults—1 tablet (DS tablet) of 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim, 2 tablets of 400 mg of sulfamethoxazole and 80 mg of trimethoprim, or 4 teaspoonfuls or 20 milliliters (mL) of oral liquid every 12 hours for 10 to 14 days. Your doctor may adjust this dose if needed. Children 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 40 milligrams (mg) per kilogram of body weight of sulfamethoxazole and 8 milligrams (mg) per kilogram of body weight of trimethoprim, given in two divided doses every 12 hours for 10 days. Weighing 40 kilograms (kg)—4 teaspoonfuls (20 mL) of oral liquid or 2 tablets (or 1 DS tablet) 2 times a day for 10 days. Weighing 30 kg—3 teaspoonfuls (15 mL) of oral liquid or 1 ½ tablet 2 times a day for 10 days. Weighing 20 kg—2 teaspoonfuls (10 mL) of oral liquid or 1 tablet 2 times a day for 10 days. Weighing 10 kg—1 teaspoonful (5 mL) of oral liquid 2 times a day for 10 days. Children younger than 2 months of age—Use is not recommended. For treatment of bronchitis: Adults—1 tablet (DS tablet) of 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim, 2 tablets of 400 mg of sulfamethoxazole and 80 mg of trimethoprim, or 4 teaspoonfuls or 20 milliliters (mL) of oral liquid every 12 hours for 14 days. Children 2 months of age and older—Use and dose must be determined by your doctor. Children younger than 2 months of age—Use is not recommended. For treatment of Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP): Adults and children 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 75 to 100 milligrams (mg) per kilogram of body weight of sulfamethoxazole and 15 to 20 milligrams (mg) per kilogram of body weight of trimethoprim each day, given in equally divided doses every 6 hours for 14 to 21 days. Weighing 80 kilograms (kg)—10 teaspoonfuls (50 milliliters (mL)) or 5 tablets (or 2 ½ DS tablets) 4 times a day for 14 to 21 days. Weighing 64 kg—8 teaspoonfuls (40 mL) or 4 tablets (or 2 DS tablets) 4 times a day for 14 to 21 days. Weighing 48 kg—6 teaspoonfuls (30 mL) or 3 tablets (or 1 ½ DS tablets) 4 times a day for 14 to 21 days. Weighing 40 kg—5 teaspoonfuls (25 mL) or 2 ½ tablets 4 times a day for 14 to 21 days. Weighing 32 kg—4 teaspoonfuls (20 mL) or 2 tablets (or 1 DS tablet) 4 times a day for 14 to 21 days. Weighing 24 kg—3 teaspoonfuls (15 mL) or 1 ½ tablets 4 times a day for 14 to 21 days. Weighing 16 kg—2 teaspoonfuls (10 mL) or 1 tablet 4 times a day for 14 to 21 days. Weighing 8 kg—1 teaspoonful (5 mL) 4 times a day for 14 to 21 days. Children younger than 2 months of age—Use is not recommended. For prevention of Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP): Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim once a day. Children 2 months of age and older—Dose is based on body size and must be determined by your doctor. The usual dose is 750 mg of sulfamethoxazole and 150 mg of trimethoprim per square meter (m[2]) of body surface each day. This is given in equally divided doses two times a day for 3 days a week on consecutive days (eg, Monday, Tuesday, Wednesday). However, the dose is usually not more than 1600 mg of sulfamethoxazole and 320 mg of trimethoprim per day. Children younger than 2 months of age—Use is not recommended. For treatment of traveler's diarrhea: Adults—1 tablet (DS tablet) of 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim, 2 tablets of 400 mg of sulfamethoxazole and 80 mg of trimethoprim, or 4 teaspoonfuls or 20 milliliters (mL) of oral liquid every 12 hours for 5 days. Children 2 months of age and older—Use and dose must be determined by your doctor. Children younger than 2 months of age—Use is not recommended.

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 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.

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