Bactrim

Serious side effects have been reported with Bactrim. See “Drug Precautions” section.

Common side effects of Bactrim include diarrhea, vomiting, anorexia, and skin reactions like hives or itching.

This is not a complete list of Bactrim side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Bactrim, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a known hypersensitivity to trimethoprim and/or sulfa-containing drugs
• have a history of drug-induced immune thrombocytopenia (low platelet counts) with use of trimethoprim and/or sulfa-containing drugs
• are being treated for HIV/AIDs
• have a history of anemia (low red blood cell count) due to folate deficiency
• have a condition called porphyria, which is when a compound in your body (heme) and its ability to carry oxygen around in your blood is impaired
• have a history of thyroid dysfunction
• have a decreased ability to ingest food, to absorb nutrients, or are malnourished
• have asthma
• have a deficiency of glucose-6-phosphate
• have liver damage
• have kidney dysfunction
• are pregnant or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

If you take too much Bactrim, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Take with or without food. Take with food if it causes an upset stomach.
• Take with a full glass of water.
• Take Bactrim at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Bactrim (sulfamethoxazole and trimethoprim) is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration.

Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:

Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:

Inactive ingredients: Docusate sodium 85%, sodium benzoate 15%, sodium starch glycolate, magnesium stearate and pregelatinized starch.

NDC 49708-146-01
100 TABLETS

Bactrim™ DS
sulfamethoxazole and trimethoprim
(double strength) tablets USP

800 mg/160 mg

DOUBLE STRENGTH

Rx Only

SUN
PHARMA

Take Bactrim exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Shake the oral Bactrim suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Bactrim will not treat a viral infection such as the common cold or flu.

Drink plenty of fluids to prevent kidney stones while you are taking trimethoprim and sulfamethoxazole.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Bactrim.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 Bactrim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Discontinue and seek urgent medical advice if a skin rash develops.
• Use only as directed by your doctor and do not share with anyone else as misuse can encourage the development of drug-resistant bacteria and reduce the effectiveness of Bactrim.
• Complete the full course as prescribed (unless instructed not to by your doctor) to reduce the risk of resistant bacteria developing.
• Should not be used in pregnant or lactating women or in babies less than two months old.
• Seek urgent medical advice if an unexplained cough, shortness of breath, sore throat, fever, muscle or joint pain, paleness or yellowing of the skin, or diarrhea develop.
• Like other antibiotics, Bactrim alters the normal flora of the colon and can lead to Clostridium difficile-associated diarrhea, a severe and persistent type of diarrhea. Contact your doctor if diarrhea develops either during treatment or soon after ending treatment.
• Maintain an adequate fluid intake to avoid the development of crystals in the urine or kidney stones.