Pronunciation:

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

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Sulfonamide Combination

Pharmacologic—

Folic Acid Antagonist

Chemical—

Sulfonamide

Uses of This Medicine:

Sulfamethoxazole and trimethoprim combination is used to treat intestinal or urinary tract infections. It is also used to 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 This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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

Other medicines—

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 receiving 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
• Cyclosporine
• 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 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
• Aminolevulinic Acid
• Anisindione
• Didanosine
• Repaglinide
• Rifabutin
• Rosiglitazone
• 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:

• 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 This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

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, call your doctor or nurse 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 get the injection.

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.

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 may need medical attention.

Check with your doctor or nurse 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, or palms

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

burning of face or mouth

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, watery and severe, which may also be bloody

difficulty breathing

difficulty swallowing

dizziness or lightheadedness

fainting spells

general body swelling

general feeling of discomfort or illness

hair loss

hearing loss

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

pains in the stomach, side, or abdomen, possibly radiating to the back

painful knees and ankles

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

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

Hives or welts

passing of gas

redness of skin

stomach pain, fullness, or discomfort

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

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.