Trimethoprim / Sulfamethoxazole

Generic Name: Trimethoprim / Sulfamethoxazole

SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium starch glycolate.

Each SEPTRA DS (double strength) Tablet contains 160 mg trimethoprim and 800 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.8 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium starch glycolate.

Each teaspoonful (5 mL) of SEPTRA Suspension contains 40 mg trimethoprim and 200 mg sulfamethoxazole and the inactive ingredients alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid, FD&C Red No. 40 and Yellow No. 6, flavor, glycerin, microcrystalline cellulose, polysorbate 80, saccharin sodium, and sorbitol. Each teaspoonful (5 mL) of SEPTRA Grape Suspension contains 40 mg trimethoprim and 200 mg sulfamethoxazole and the inactive ingredients alcohol 0.26%, methylparaben 0.1%, and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid, FD&C Red No. 40 and Blue No. 1, flavor, glycerin, microcrystalline cellulose, polysorbate 80, saccharin sodium, and sorbitol. Both tablet and suspension forms are for oral administration.

Trimethoprim is 5-[(3,4,5-trimeth-oxyphenyl)methyl]-2,4- pyrimidinediamine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32, and the molecular formula C14H18N4O3. The structural formula is:

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Sulfamethoxazole inhibits the synthesis of dihydrofolic acid. Trimethoprim inhibits thymidine and DNA synthesis. These two agents act synergistically in inhibiting folic acid synthesis.

Co-trimoxazole was claimed to be more effective than either of its components individually in treating bacterial infections, although this was later disputed. Because it has a higher incidence of adverse effects, including allergic responses, its use has been restricted in many countries to very specific circumstances where its improved efficacy has been demonstrated. It may be effective in a variety of upper and lower respiratory tractinfections, kidney and urinary tract infections, gastrointestinal tract infections, skin and wound infections, sepsis, and other infections caused by sensitive organisms. Co-trimoxazole decreases the risk of recurrence of retinochoroiditis. The global problem of advancing antimicrobial resistance has led to a renewed interest in the use of co-trimoxazole more recently.

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 the 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 the foot or leg
  • painful or difficult urination
  • pale skin
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen or painful glands
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood
  • wheezing
  • yellow eyes or skin

Incidence not known

  • Abdominal or stomach tenderness
  • back, leg, or stomach pains
  • bleeding gums
  • blindness or vision changes
  • blisters, hives, or itching
  • 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
  • chest pain
  • cloudy urine
  • confusion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • convulsions
  • cracks in the skin
  • decreased frequency or amount of urine
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing
  • difficulty with swallowing
  • fainting spells
  • general body swelling
  • general feeling of discomfort or illness
  • hair loss
  • hearing loss
  • hives
  • increased thirst
  • indigestion
  • irregular heartbeat
  • 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
  • sores, ulcers, or white spots on the lips or in the mouth
  • soreness of the muscles
  • stiff neck or back
  • swelling of the face, hands, legs, and feet
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual weight loss
  • weakness in the hands or feet
  • weakness or heaviness of the 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 the skin to sunlight
  • irritability
  • lack of feeling or emotion
  • loss of interest or pleasure
  • 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.

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.

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.

  • Dofetilide
  • Levomethadyl
  • Methenamine

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
  • 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
  • Droperidol
  • Eltrombopag
  • Enalapril
  • Enalaprilat
  • Enflurane
  • Eplerenone
  • Eprosartan
  • Erythromycin
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Fosinopril
  • Gemifloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Irbesartan
  • Isoflurane
  • Isradipine
  • Leucovorin
  • Lidoflazine

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.

Some epidemiologic studies suggest that exposure to sulfamethoxazole/trimethoprim during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot. If sulfamethoxazole/trimethoprim is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus.

Hypersensitivity And Other Fatal Reactions

Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasias.

Sulfonamides, including sulfonamide-containing products such as sulfamethoxazole/trimethoprim, should be discontinued at the first appearance of skin rash or any sign of adverse reaction. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders (see PRECAUTIONS). Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

Thrombocytopenia

Sulfamethoxazole/trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole/trimethoprim.

Streptococcal Infections And Rheumatic Fever

The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Clostridium Difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including SEPTRA, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adjunctive Treatment With Leucovorin For Pneumocystis jiroveci pneumonia

Treatment failure and excess mortality were observed when trimethoprim-sulfamethoxazole was used concomitantly with leucovorin for the treatment of HIV positive patients with Pneumocystis jiroveci pneumonia in a randomized placebo controlled trial.7 Co-administration of trimethoprim-sulfamethoxazole and leucovorin during treatment of Pneumocystis jiroveci pneumonia should be avoided.

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