Smz-tmp ds

You should not use this medication if you are allergic to sulfamethoxazole or trimethoprim, or if you have:

• severe liver or kidney disease;

• anemia (low red blood cells) caused by folic acid deficiency; or

• a history of low blood platelets caused by taking trimethoprim or any sulfa drug.

To make sure sulfamethoxazole and trimethoprim is safe for you, tell your doctor if you have:

• kidney or liver disease;

• a folic acid deficiency;

• asthma or severe allergies;

• a thyroid disorder;

• HIV or AIDS;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency); or

• if you are malnourished.

FDA pregnancy category D. Do not use sulfamethoxazole and trimethoprim if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 2 months old.

Serious side effects may be more likely in older adults, especially those who take other medications such as digoxin or certain diuretics.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking this medication and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. This medication can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• diarrhea that is watery or bloody;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• sudden weakness or ill feeling, fever, chills, sore throat, new or worsening cough;

• cold or flu symptoms, swollen gums, painful mouth sores, pain when swallowing, skin sores;

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

• liver problems--upper stomach pain, tired feeling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, loss of appetite; or

• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with sulfamethoxazole and trimethoprim, especially:

• leucovorin; or

• methotrexate.

This list is not complete. Other drugs may interact with sulfamethoxazole and trimethoprim, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to sulfamethoxazole / trimethoprim: intravenous solution, oral suspension, oral tablet

Cardiovascular

Rare (0.01% to 0.1%): Thrombophlebitis
Very rare (less than 0.01%): Polyarteritis nodosa, syncope
Postmarketing reports: QT prolongation resulting in ventricular tachycardia and torsade de pointes[Ref]

Dermatologic

Common (1% to 10%): Skin rash, urticaria
Very rare (less than 0.01%): Photosensitivity, exfoliative dermatitis, fixed drug eruption, erythema multiforme, erythema nodosum, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis, bullous dermatitis, purpura, angioedema
Frequency not reported: Pruritus[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, anorexia
Very rare (less than 0.01%): Constipation, glossitis, stomatitis, pseudomembranous colitis, pancreatitis, abdominal pain
Frequency not reported: Sore mouth, moniliasis[Ref]

Hematologic

Very rare (less than 0.01%): Leucopenia, neutropenia, thrombocytopenia, pancytopenia, bone marrow depression, agranulocytosis, aplastic anemia, hemolytic anemia, eosinophilia, purpura, hemolysis
Frequency not reported: Megaloblastic anemia, methemoglobinemia, hypoprothrombinemia, granulocytopenia[Ref]

Hepatic

Rare (0.01% to 0.1%): Jaundice
Very rare (less than 0.01%): Hepatitis (including cholestatic jaundice and hepatic necrosis), disturbance in liver enzymes, elevated serum transaminases, elevated bilirubin[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity, anaphylaxis, anaphylactoid reaction drug fever, chills, allergic vasculitis resembling Henoch-Schonlein purpura
Frequency not reported: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, conjunctival and scleral injection, photosensitivity, pruritus, urticaria, rash, periarteritis nodosa, systemic lupus erythematosus (SLE)[Ref]

Immunologic

Common (1% to 10%): Monilial overgrowth[Ref]

Local

Rare (less than 0.1%): Local reaction, pain, slight irritation[Ref]

Metabolic

Very common (10% or more): Hyperkalemia (particularly in the elderly and in HIV patients)
Very rare (less than 0.01%): Hypoglycemia, hyponatremia, metabolic acidosis[Ref]

Musculoskeletal

Rare (less than 0.1%): Rhabdomyolysis (mainly in AIDS patients)
Frequency not reported: Arthralgia, myalgia[Ref]

Nervous system

Very common (10% or more): Headache
Very rare (less than 0.01%): Aseptic meningitis (rapidly reversible on withdrawal of therapy but can reoccur on rechallenge), convulsions, peripheral neuritis, ataxia, vertigo, dizziness, tremor, lethargy, paresthesia, convulsions, peripheral neuritis, tinnitus[Ref]

Ocular

Very rare (less than 0.01%): Uveitis[Ref]

Psychiatric

Very rare (less than 0.01%): Depression, hallucination, confusional state, agitation, anxiety, abnormal behavior, insomnia, nightmares[Ref]

Renal

Very rare (less than 0.01%): Renal tubular acidosis, Impaired renal function (sometimes reported as renal failure), hematuria
Frequency not reported: Serum creatinine increased, blood urea nitrogen increased
Postmarketing reports:
Frequency not reported: Renal failure, interstitial nephritis, elevated BUN and serum creatinine, toxic nephrosis with oliguria and anuria, tubular necrosis, crystalluria, aggravation of renal disease, azotemia, hyperkalemic renal tubular acidosis, overestimations of normal creatinine values[Ref]

Respiratory

Very rare (less than 0.01%): Cough, dyspnea, lung infiltration, shortness of breath, wheezing, epistaxis[Ref]

Some side effects of SMZ-TMP DS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.