Apo-Sulfatrim - Sulfamethoxazole/Trimethoprim (Oral Route)

    Apo-Sulfatrim – Sulfamethoxazole/Trimethoprim (Oral Route)

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    Description and Brand Names of Apo-Sulfatrim – Sulfamethoxazole/Trimethoprim (Oral Route)

    US Brand Name

    1. Bactrim
    2. Bactrim DS
    3. Septra
    4. Septra DS
    5. SMZ-TMP Pediatric
    6. Sulfatrim
    7. Sulfatrim Pediatric

    Canadian Brand Name

    1. Apo-Sulfatrim
    2. Novo-Trimel
    3. Nu-Cotrimox
    4. Septa Pediatric
    5. Septra Pediatric Suspension

    Descriptions

    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), a very serious kind of pneumonia. This type of pneumonia occurs more commonly in patients whose immune systems are not working normally, such as cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).

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

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

    This product is available in the following dosage forms:

    • Tablet
    • Suspension

    Before Using Apo-Sulfatrim – Sulfamethoxazole/Trimethoprim (Oral Route)

    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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in children 2 months of age and older. Because of the toxicity of the combination of sulfamethoxazole and trimethoprim, use in infants younger than 2 months of age is not recommended.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in the elderly. However, elderly patients are more likely to have a folate deficiency, age-related kidney or liver problems, and may be more likely to experience unwanted side effects (eg, severe skin rash, increased potassium in the body, or problems with blood clotting or the immune system). There may be an adjustment in the dose for elderly patients receiving sulfamethoxazole and trimethoprim combination.

    Pregnancy

    Breastfeeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bepridil
    • Cisapride
    • Dofetilide
    • Levomethadyl
    • Mesoridazine
    • Methenamine
    • Pimozide
    • Terfenadine
    • Thioridazine

    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
    • Acenocoumarol
    • Ajmaline
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amoxapine
    • Aprindine
    • Arsenic Trioxide
    • Astemizole
    • Azimilide
    • Bretylium
    • Chloral Hydrate
    • Chloroquine
    • Chlorpromazine
    • Clarithromycin
    • Dabrafenib
    • Desipramine
    • Dibenzepin
    • Disopyramide
    • Dolasetron
    • Doxepin
    • Droperidol
    • Eltrombopag
    • Enflurane
    • Erythromycin
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Foscarnet
    • Gemifloxacin
    • Halofantrine
    • Haloperidol
    • Halothane
    • Hydroquinidine
    • Ibutilide
    • Imipramine
    • Isoflurane
    • Isradipine
    • Leucovorin
    • Lidoflazine
    • Lorcainide
    • Mefloquine
    • Methotrexate
    • Nortriptyline
    • Octreotide
    • Pentamidine
    • Pirmenol
    • Prajmaline
    • Probucol
    • Procainamide
    • Prochlorperazine
    • Propafenone
    • Pyrimethamine
    • Quinidine
    • Risperidone
    • Sematilide
    • Sertindole
    • Sotalol
    • Spiramycin
    • Spironolactone
    • Sultopride
    • Tedisamil
    • Telithromycin
    • Trifluoperazine
    • Trimipramine
    • Vasopressin
    • Warfarin
    • 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
    • Amantadine
    • Anisindione
    • Chlorpropamide
    • Didanosine
    • Digoxin
    • Enalaprilat
    • Enalapril Maleate
    • Fosphenytoin
    • Glipizide
    • Glyburide
    • Phenytoin
    • Quinapril
    • Repaglinide
    • Rifabutin
    • Rosiglitazone
    • Tolazamide
    • Tolbutamide

    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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    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:

    • Alcohol abuse, history of or
    • Folate (vitamin B9) deficiency or
    • HIV or AIDS or
    • Kidney disease or
    • Liver disease or
    • Malabsorption syndrome (difficulty of absorbing food in the body) or
    • Malnutrition state (nutrition disorder) – Use with caution. May have an increased chance of serious side effects.
    • Anemia, megaloblastic (caused by low levels of folic acid in the body) or
    • Drug-induced thrombocytopenia (low platelets in the blood) after using this medicine or
    • Kidney disease, severe or
    • Liver disease, severe – Should not be used in patients with these conditions.
    • Asthma or
    • Diabetes or
    • Hyperkalemia (high potassium in the blood) or
    • Hyponatremia (low sodium in the blood) or
    • Porphyria (enzyme problem) or
    • Severe allergies or
    • Thyroid problems – Use with caution. May make these conditions worse.
    • Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) – May cause hemolytic anemia (blood disorder) in patients with this condition.
    • Streptococcal infection (group A β-hemolytic) – Sulfonamides should not be used in patients with this condition.

    Proper Use of Apo-Sulfatrim – Sulfamethoxazole/Trimethoprim (Oral Route)

    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. .

    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 and children weighing 40 kilograms (kg) or more – 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours for 10 to 14 days. Your doctor may adjust this dose if needed.
        • Children 2 months of age and older, and weighing up to 40 kg – 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.
        • Infants 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.
        • 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 traveler’s diarrhea:

        • Adults – 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim 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.

    Precautions

    It is very important that your doctor check the progress of you or your child at regular visits to make sure 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 an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

    Very rarely, this medicine has caused severe side effects. If you or your child start to have a skin rash, or if you think you are having a severe skin reaction, stop taking this medicine and call your doctor right away. Symptoms of a severe reaction may include a skin rash, skin color that is very pale or yellow, or skin with purple spots, along with a sore throat, fever, muscle pain, cough, and trouble with breathing.

    This medicine, especially if you are receiving high doses or for a long period of time, may lower the number of platelets in your body, which are necessary for proper blood clotting. Because of this, you may bleed or get infections more easily. Talk with your doctor if you have concerns about this.

    This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

    Check with your doctor right away if you or your child have abdominal or stomach cramps, bloating, watery and severe diarrhea, which may also be bloody, nausea or vomiting, or unusual tiredness or weakness. These may be symptoms of a serious intestinal infection.

    This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, shortness of breath, or chest pain after you use the medicine.

    This medicine may cause electrolyte problems, such as high potassium in the blood (hyperkalemia) and low sodium in the blood (hyponatremia). Tell your doctor right away if you have any of the following symptoms while using this medicine: confusion, weakness, muscle twitching, an irregular heartbeat, numbness or tingling in the hands, feet, or lips, or trouble breathing.

    Before you have any medical tests, tell 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 therapy (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 for Pneumocystis jiroveci pneumonia (PCP) if you are also using leucovorin. Using these medicines together may cause these medicines to not work as well for you.

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

    Side Effects of Apo-Sulfatrim – Sulfamethoxazole/Trimethoprim (Oral Route)

    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:

    Rare

    1. Abdominal or stomach pain
    2. black, tarry stools
    3. blistering, peeling, or loosening of the skin
    4. changes in skin color
    5. chest pain
    6. chills
    7. cough or hoarseness
    8. dark urine
    9. diarrhea
    10. dizziness
    11. fever with or without chills
    12. general feeling of tiredness or weakness
    13. headache
    14. itching
    15. joint or muscle pain
    16. light-colored stools
    17. loss of appetite
    18. lower back or side pain
    19. nausea
    20. pain, tenderness, or swelling of the foot or leg
    21. painful or difficult urination
    22. pale skin
    23. rash
    24. red skin lesions, often with a purple center
    25. red, irritated eyes
    26. shortness of breath
    27. sore throat
    28. sores, ulcers, or white spots in the mouth or on the lips
    29. swollen or painful glands
    30. tightness in the chest
    31. unpleasant breath odor
    32. unusual bleeding or bruising
    33. vomiting of blood
    34. wheezing
    35. yellow eyes or skin

    Incidence not known

    1. Abdominal or stomach tenderness
    2. back, leg, or stomach pains
    3. bleeding gums
    4. blindness or vision changes
    5. blisters, hives, or itching
    6. bloating
    7. blood in the urine or stools
    8. bluish-colored lips, fingernails, or palms
    9. burning, crawling, itching, numbness, painful, prickling, “pins and needles”, or tingling feelings
    10. burning of the face or mouth
    11. chest pain
    12. cloudy urine
    13. confusion
    14. constipation
    15. continuing ringing or buzzing or other unexplained noise in the ears
    16. convulsions
    17. cracks in the skin
    18. decreased frequency or amount of urine
    19. diarrhea, watery and severe, which may also be bloody
    20. difficulty with breathing
    21. difficulty with swallowing
    22. fainting spells
    23. general body swelling
    24. general feeling of discomfort or illness
    25. hair loss
    26. hearing loss
    27. hives
    28. increased thirst
    29. indigestion
    30. irregular heartbeat
    31. large, flat, blue, or purplish patches in the skin
    32. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    33. loss of heat from the body
    34. muscle or joint pain
    35. nosebleeds
    36. not able to pass urine
    37. numbness or tingling in the hands, feet, or lips
    38. pain or burning while urinating
    39. pinpoint red spots on the skin
    40. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    41. raised red swellings on the skin, the buttocks, legs, or ankles
    42. redness of the white part of the eyes
    43. redness, swelling, or soreness of the tongue
    44. sores, ulcers, or white spots on the lips or in the mouth
    45. soreness of the muscles
    46. stiff neck or back
    47. swelling of the face, hands, legs, and feet
    48. unsteadiness, trembling, or other problems with muscle control or coordination
    49. unusual weight loss
    50. weakness in the hands or feet
    51. weakness or heaviness of the legs
    52. weight gain

    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

    1. Passing of gas

    Incidence not known

    1. Discouragement
    2. feeling of constant movement of self or surroundings
    3. feeling sad or empty
    4. increased sensitivity of the skin to sunlight
    5. irritability
    6. lack of feeling or emotion
    7. loss of interest or pleasure
    8. nervousness
    9. redness or other discoloration of the skin
    10. seeing, hearing, or feeling things that are not there
    11. sensation of spinning
    12. severe sunburn
    13. trouble concentrating
    14. trouble sleeping
    15. uncaring
    16. 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.