SULFONAMIDESAND TRIMETHOPRIM (Systemic)
Some commonly used brand names are:
In the U.S.?
- Bactrim 2
- Bactrim DS 2
- Bactrim I.V. 2
- Bactrim Pediatric 2
- Cofatrim Forte 2
- Cotrim 2
- Cotrim DS 2
- Cotrim Pediatric 2
- Septra 2
- Septra DS 2
- Septra I.V. 2
- Septra Suspension 2
- Septra Grape Suspension 2
- Sulfatrim 2
- Sulfatrim-DS 2
- Sulfatrim Pediatric 2
- Sulfatrim S/S 2
- Sulfatrim Suspension 2
In Canada?
- Apo-Sulfatrim 2
- Apo-Sulfatrim DS 2
- Bactrim 2
- Bactrim DS 2
- Coptin 1
- Coptin 1 1
- Novo-Trimel 2
- Novo-Trimel D.S. 2
- Nu-Cotrimox 2
- Nu-Cotrimox DS 2
- Roubac 2
- Septra 2
- Septra DS 2
Other commonly used names are:
- Cotrimazine
- Cotrimoxazole
- SMZ-TMP
Note: | For quick reference, the following sulfonamide and trimethoprim combinationsare numbered to match the corresponding brand names. |
Category
- Antibacterial, systemic?Sulfadiazine and Trimethoprim; Sulfamethoxazole and Trimethoprim
- Antiprotozoal?Sulfamethoxazole and Trimethoprim
Description
Sulfonamide (sul-FON-ah-mide)and trimethoprim combinations are used to prevent and treat infections. Sulfadiazineand trimethoprim combination is used to treat urinary tract infections. Sulfamethoxazoleand trimethoprim combination is used to treat infections, such as bronchitis,middle ear infection, urinary tract infection, and traveler's diarrhea. Itis also used for the prevention and treatment of Pneumocystis carinii pneumonia (PCP). These medicines will not work for colds, flu,or other virus infections. They may also be used for other conditions as determinedby your doctor.
Sulfonamide and trimethoprim combinations are available only with yourdoctor's prescription, in the following dosage forms:
Oral- Sulfadiazine and Trimethoprim
- Oral suspension (Canada)
- Tablets (Canada)
- Sulfamethoxazole and Trimethoprim
- Oral suspension (U.S. and Canada)
- Tablets (U.S. and Canada)
Parenteral- Sulfamethoxazole and Trimethoprim
- Injection (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For sulfonamide andtrimethoprim combinations, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to sulfa medicines, furosemide (e.g., Lasix) or thiazidediuretics (water pills), oral antidiabetics (diabetes medicine you take bymouth), glaucoma medicine you take by mouth (for example, acetazolamide [e.g.,Diamox], dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane]),or trimethoprim (e.g., Trimpex). Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives (e.g.,sulfites), or dyes.
Pregnancy?Sulfamethoxazole and trimethoprim combination hasnot been reported to cause birth defects or other problems in humans. However,studies in mice, rats, and rabbits have shown that some sulfonamides causebirth defects, including cleft palate and bone problems. Studies in rabbitshave also shown that trimethoprim causes birth defects, as well as a decreasein the number of successful pregnancies. Sulfonamides are not recommendedfor use at the time of labor and delivery because these medicines may causeunwanted effects in the baby.
Breast-feeding?Sulfonamides and trimethoprim pass into the breastmilk. These medicines are not recommended for use during breast-feeding. Theymay cause liver problems, anemia, and other unwanted effects in nursing babies,especially those with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Children?Sulfadiazine and trimethoprim combination shouldnot be given to infants less than 3 months of age. Sulfamethoxazole and trimethoprimcombination should not be given to infants less than 2 months of age unlessdirected by the child's doctor. These combinations may cause unwanted effects.In special situations, sulfamethoxazole and trimethoprim combination may begiven to infants less than 2 months of age.
Older adults?Elderly people are especially sensitive to the effectsof sulfonamide and trimethoprim combinations. Severe skin problems and bloodproblems may be more likely to occur in the elderly. These problems may alsobe more likely to occur in patients who are taking diuretics (water pills)along with this medicine.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingsulfonamide and trimethoprim combinations, it is especially important thatyour health care professional know if you are taking any of the following:
- Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
- Amiodarone (e.g., Cordarone) or
- Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
- Androgens (male hormones) or
- Antithyroid agents (medicine for overactive thyroid) or
- Carbamazepine (e.g., Tegretol) or
- Carmustine (e.g., BiCNU) or
- Chloroquine (e.g., Aralen) or
- Dantrolene (e.g., Dantrium) or
- Daunorubicin (e.g., Cerubidine) or
- Disulfiram (e.g., Antabuse) or
- Divalproex (e.g., Depakote) or
- Estrogens (female hormones) or
- Etretinate (e.g., Tegison) or
- Gold salts (medicine for arthritis) or
- Mercaptopurine (e.g., Purinethol) or
- Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
- Oral contraceptives (birth control pills) containing estrogens or
- Other anti-infectives by mouth or by injection (medicine for infection)or
- Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine[e.g., Temaril]) or
- Plicamycin (e.g., Mithracin) or
- Valproic acid (e.g., Depakene)?Use of sulfonamide and trimethoprimcombinations with these medicines may increase the chance of side effectsaffecting the liver
- Acetohydroxamic acid (e.g., Lithostat) or
- Furazolidone (e.g., Furoxone) or
- Nitrofurantoin (e.g., Furadantin) or
- Primaquine or
- Procainamide (e.g., Pronestyl) or
- Quinidine (e.g., Quinidex) or
- Quinine (e.g., Quinamm) or
- Sulfoxone (e.g., Diasone)?Use of sulfonamide and trimethoprimcombinations with these medicines may increase the chance of side effectsaffecting the blood
- Anticoagulants (blood thinners) or
- Digoxin (e.g., Lanoxin)
- Ethotoin (e.g., Peganone) or
- Mephenytoin (e.g., Mesantoin) or
- Methotrexate (e.g., Mexate) or
- Phenytoin (e.g., Dilantin)?Use of sulfonamide and trimethoprimcombinations with these medicines may increase the chance of side effectsof these medicines
- Antidiabetics, oral (diabetes medicine you take by mouth)?Useof oral antidiabetics with sulfonamide and trimethoprim combinations may increasethe chance of side effects affecting the blood and/or the side effects ofthe oral antidiabetics
- Methenamine (e.g., Mandelamine)?Use of methenamine with sulfonamideand trimethoprim combinations may increase the chance of side effects of thesulfonamide
- Methyldopa (e.g., Aldomet)?Use of methyldopa with sulfonamideand trimethoprim combinations may increase the chance of side effects affectingthe liver and/or the blood
Other medical problems?The presence of other medicalproblems may affect the use of sulfonamide and trimethoprim combinations.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) deficiency?Patientswith these problems may have an increase in side effects affecting the blood
- Kidney disease or
- Liver disease?Patients with kidney and/or liver disease mayhave an increased chance of side effects
- Porphyria?This medicine may bring on an attack of porphyria
Proper Use of This Medicine
Sulfadiazine and trimethoprim combination should not be given to infants lessthan 3 months of age, and sulfamethoxazole and trimethoprim combination shouldnot be given to infants less than 2 months of age unless directed by the child'sdoctor. These medicines may cause unwanted effects in the baby. Inspecial situations, sulfamethoxazole and trimethoprim combination may be givento infants less than 2 months of age.
Sulfonamide and trimethoprim combinations are besttaken with a full glass (8 ounces) of water. Several additional glasses ofwater should be taken every day, unless otherwise directed by yourdoctor. Drinking extra water will help to prevent some unwanted effects ofsulfonamides.
For patients taking the oral liquid form ofthis medicine:
- Use a specially marked measuring spoon or other device to measureeach dose accurately. The average household teaspoon may not hold the rightamount of liquid.
To help clear up your infection completely, keep takingthis medicine for the full time of treatment, even if you begin tofeel better after a few days. If you stop taking this medicine too soon, yoursymptoms may return.
This medicine works best when there is a constant amount in the blood orurine. To help keep the amount constant, do not missany doses. Also, it is best to take the doses at evenly spaced times day andnight. If you need help in planning the best times to take your medicine,check with your health care professional.
Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.
The number of tablets or teaspoonfuls of suspension that you take dependson the strength of the medicine. Also, the number ofdoses you take each day, the time allowed between doses, and the length oftime you take the medicine depend on the medical problem for which you aretaking sulfonamide and trimethoprim combinations.
For sulfadiazine and trimethoprim combination- For oral dosage forms (suspension, tablets):
- For bacterial infections:
- Adults and teenagers?820 milligrams (mg) of sulfadiazine and180 mg of trimethoprim once a day.
- Infants less than 3 months of age?Use is not recommended.
- Infants 3 months of age and older and children up to 12 years ofage?Dose is based on body weight. The usual dose is 7 mg of sulfadiazineand 1.5 mg of trimethoprim per kilogram (kg) (3.2 mg of sulfadiazine and 0.7mg of trimethoprim per pound) of body weight every twelve hours.
For sulfamethoxazole and trimethoprim combination- For oral dosage forms (suspension, tablets):
- For bacterial infections:
- Adults and children 40 kilograms (kg) of body weight (88 pounds)and over?800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprimevery twelve hours.
- Infants less than 2 months of age?Use is not recommended.
- Infants 2 months of age and older and children up to 40 kg of weight(88 pounds)?Dose is based on body weight. The usual dose is 20 to 30mg of sulfamethoxazole and 4 to 6 mg of trimethoprim per kg (9.1 to 13.6 mgof sulfamethoxazole and 1.8 to 2.7 mg of trimethoprim per pound) of body weightevery twelve hours.
- For the treatment of Pneumocystis carinii pneumonia(PCP):
- Adults and children older than 2 months?Dose is based on bodyweight. The usual dose is 18.75 to 25 mg of sulfamethoxazole and 3.75 to 5mg of trimethoprim per kg (8.5 to 11.4 mg of sulfamethoxazole and 1.7 to 2.3mg of trimethoprim per pound) of body weight every six hours.
- For the prevention of Pneumocystis cariniipneumonia (PCP):
- Adults and teenagers?800 mg of sulfamethoxazole and 160 mgof trimethoprim once a day.
- Infants and children 4 weeks of age and older?Dose is basedon body size and must be determined by your doctor. There are several dosingregimens available that your doctor may choose from. One dosing regimen is375 mg of sulfamethoxazole and 75 mg of trimethoprim per square meter of bodysurface two times a day, three times a week on consecutive days (e.g., Monday,Tuesday, Wednesday).
- For injection dosage form:
- For bacterial infections:
- Adults and children older than 2 months?The usual total dailydose is 40 to 50 mg of sulfamethoxazole and 8 to 10 mg of trimethoprim perkg (18.2 to 22.7 mg of sulfamethoxazole and 3.6 to 4.5 mg of trimethoprimper pound) of body weight. This total daily dose may be divided up and injectedinto a vein every six, eight, or twelve hours.
- Infants less than 2 months of age?Use is not recommended.
- For the treatment of Pneumocystis carinii pneumonia(PCP):
- Adults and children older than 2 months?The usual dose is 18.75to 25 mg of sulfamethoxazole and 3.75 to 5 mg of trimethoprim per kg (8.5to 11.4 mg of sulfamethoxazole and 1.7 to 2.3 mg of trimethoprim per pound)of body weight. This is injected into a vein every six hours.
- Infants less than 2 months of age?Use is not recommended.
Missed dose?If you miss a dose of this medicine, take it assoon as possible. This will help to keep a constant amount of medicine inthe blood or urine. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store the tablet form of this medicine in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
- Keep the oral liquid form of this medicine from freezing.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is very important that your doctor check your progress atregular visits. This medicine may cause blood problems, especiallyif it is taken for a long time.
If your symptoms do not improve within a few days, or if they become worse,check with your doctor.
Sulfonamide and trimethoprim combinations may cause blood problems. Theseproblems may result in a greater chance of certain infections, slow healing,and bleeding of the gums. Therefore, you should be careful when using regulartoothbrushes, dental floss, and toothpicks. Dental work should be delayeduntil your blood counts have returned to normal. Check with your medical doctoror dentist if you have any questions about proper oral hygiene (mouth care)during treatment.
Sulfonamide and trimethoprim combinations may cause your skin to be moresensitive to sunlight than it is normally. Exposure to sunlight, even forbrief periods of time, may cause a skin rash, itching, redness or other discolorationof the skin, or a severe sunburn. When you begin taking this medicine:
- Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
- Wear protective clothing, including a hat and 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 aboutthis, check with your health care professional.
- Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
- Do not use a sunlamp or tanning bed or booth.
If you have a severe reaction from the sun, check withyour doctor.
This medicine may also cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you are dizzy or are not alert. If this reaction is especially bothersome, check with your doctor.
Side Effects of This Medicine
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 mayneed medical attention.
Also, checkwith your doctor as soon as possible if the following side effect occurs:
Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, sulfamethoxazole and trimethoprim combination is used in certainpatients for the following medical conditions:
- Bile infections
- Bone and joint infections
- HIV-related infections in Africa
- Sexually transmitted diseases, such as gonorrhea
- Sinus infections
- Toxoplasmosis (prevention of)
- Urinary tract infections (prevention of)
- Whipple's disease
Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.
Revised: 08/08/2000
