Apo-Sulfatrim

Generic Name: trimethoprim and sulfamethoxazole (Oral route)

sul-fa-meth-OX-a-zole, trye-METH-oh-prim

Commonly used brand name(s):

In the U.S.

  • Bactrim
  • Bactrim DS
  • Septra
  • Septra DS
  • 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

Uses For Apo-Sulfatrim

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 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.

Before Using Apo-Sulfatrim

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 older than 2 months of age. Safety and efficacy have not been established for infants less than 2 months of age.

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 age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving sulfamethoxazole and trimethoprim combination.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Sulfamethoxazole

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.

Trimethoprim

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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
  • 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
  • Desipramine
  • Dibenzepin
  • Disopyramide
  • Dolasetron
  • Doxepin
  • Droperidol
  • Eltrombopag
  • Enflurane
  • Erythromycin
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gemifloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Isoflurane
  • Isradipine
  • Lidoflazine
  • Lorcainide
  • Mefloquine
  • Methotrexate
  • Nortriptyline
  • Octreotide
  • Pentamidine
  • Pirmenol
  • Prajmaline
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Pyrimethamine
  • Quetiapine
  • Quinidine
  • Risperidone
  • Sematilide
  • Sertindole
  • Sotalol
  • Spiramycin
  • 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
  • Anisindione
  • Chlorpropamide
  • Didanosine
  • Digoxin
  • Enalaprilat
  • Enalapril Maleate
  • Fosphenytoin
  • Glipizide
  • Glyburide
  • Phenytoin
  • Quinapril
  • Repaglinide
  • Rifabutin
  • Rosiglitazone
  • Tolazamide
  • Tolbutamide

Interactions with Food/Tobacco/Alcohol

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:

  • Anemia, megaloblastic (caused by not enough folic acid)—Should not be used in patients with this condition.
  • Asthma or
  • Folate deficiency (vitamin B9) or
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
  • HIV or AIDS or
  • Kidney disease or
  • Liver disease or
  • Seizures, history of—Use with caution. May have an increased chance of side effects.

Proper Use of trimethoprim and sulfamethoxazole

This section provides information on the proper use of a number of products that contain trimethoprim and sulfamethoxazole. It may not be specific to Apo-Sulfatrim. Please read with care.

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 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.

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 40 kilograms (kg) of body weight or more—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours.
      • Infants 2 months of age and older, and children up to 40 kg of weight—Dose is based on body weight. The usual dose is 40 mg of sulfamethoxazole and 8 mg of trimethoprim per kg of body weight every 12 hours.
      • Infants below 2 months of age—Use and dose must be determined by your doctor.
    • For treatment of Pneumocystis carinii pneumonia (PCP):
      • Adults and children 2 months of age and older—Dose is based on body weight. The usual dose is 75 to 100 milligrams (mg) of sulfamethoxazole and 15 to 20 mg of trimethoprim per kilogram (kg) of body weight each day, given in equally divided doses every 6 hours.
      • Infants below 2 months of age—Use and dose must be determined by your doctor.
    • For prevention of Pneumocystis carinii pneumonia (PCP):
      • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim once a day.
      • Children and infants 2 months of age and older—Dose is based on body size and must be determined by your doctor. The usual dosing regimen is 750 mg of sulfamethoxazole and 150 mg of trimethoprim per square meter of body surface each day. This is given in equally divided doses two times a day for three days a week on consecutive days (e.g., Monday, Tuesday, Wednesday).
      • Infants below 2 months of age—Use and dose must be determined by your doctor.

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 While Using Apo-Sulfatrim

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.

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. Do not breastfeed while using the medicine.

Very rarely, this medicine has caused severe side effects. If you 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.

Check with your doctor right away if you 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 have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; shortness of breath; or chest pain after you use the medicine.

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

Apo-Sulfatrim 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:

Rare
  • Abdominal or stomach pain
  • black, tarry stools
  • blistering, peeling, or loosening of skin
  • changes in skin color
  • chest pain
  • chills
  • cough or hoarseness
  • dark urine
  • diarrhea
  • dizziness
  • fever with or without chills
  • general feeling of tiredness or weakness
  • headache
  • itching
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea
  • pain, tenderness, or swelling of foot or leg
  • painful or difficult urination
  • pale skin
  • rash
  • red irritated eyes
  • red skin lesions, often with a purple center
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • swollen or painful glands
  • tightness in chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known
  • Abdominal tenderness
  • back, leg, or stomach pains
  • bleeding gums
  • bleeding under the skin
  • blindness or vision changes
  • blisters hives or itching
  • bloating
  • blood in urine or stools
  • bluish-colored lips, fingernails, palms
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  • burning of face or mouth
  • chest pain
  • clumsiness or unsteadiness
  • cloudy urine
  • confusion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in ears
  • convulsions
  • cracks in the skin
  • decreased frequency or amount of urine
  • diarrhea
  • diarrhea, watery and severe, which may also be bloody
  • difficulty breathing
  • difficulty swallowing
  • fainting spells
  • general body swelling
  • general feeling of discomfort or illness
  • hair loss
  • hearing loss
  • hives
  • increased blood pressure
  • increased thirst
  • indigestion
  • irregular heartbeat
  • large, flat, blue or purplish patches in the skin
  • large, hive-like swelling on 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 hands, feet, or lips
  • pain or burning while urinating
  • painful knees and ankles
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on 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
  • rapid heart rate
  • red, swollen skin
  • redness of the white part of the eyes
  • redness, swelling, or soreness of tongue
  • scaly skin
  • shakiness and unsteady walk
  • sores, ulcers, or white spots on lips or in mouth
  • soreness of muscles
  • stiff neck or back
  • swelling of face, hands, legs, and feet
  • swelling or inflammation of the mouth
  • trouble breathing
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual weight loss
  • weakness in hands or feet
  • weakness or heaviness of legs
  • 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
  • Passing of gas
Incidence not known
  • Discouragement
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • increased sensitivity of skin to sunlight
  • irritability
  • lack of feeling or emotion
  • loss of interest or pleasure
  • nervousness
  • redness or other discoloration of skin
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • severe sunburn
  • sleeplessness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • 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.

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