Bactrim DS

Name: Bactrim DS

What is sulfamethoxazole and trimethoprim, and how does it work (mechanism of action)?

Bactrim is a combination of two synthetic (man-made) antibiotics, sulfamethoxazole and trimethoprim. Both drugs reduce the ability of some bacteria to utilize folic acid for growing. Sulfamethoxazole is an anti-bacterial sulfonamide, a "sulfa" drug. It disrupts the production of dihydrofolic acid while trimethoprim disrupts the production of tetrahydrofolic acid. Dihydrofolic acid and tetrahydrofolic acid are forms of folic acid that bacteria and human cells use for producing proteins. Trimethoprim inhibits production of tetrahydrofolic acid by inhibiting the enzyme responsible for making tetrahydrofolic acid from dihydrofolic acid. By combining both drugs, two important steps required in the production of bacterial proteins are interrupted, and the combination is more effective than either drug alone. Bactrim was approved by the FDA in 1973.

Is sulfamethoxazole and trimethoprim safe to take if I'm pregnant or breastfeeding?

Use of sulfonamides may cause bilirubin to be displaced from proteins in the infant's blood. Displacement of bilirubin can lead to jaundice and a dangerous condition called kernicterus in the infant. For this reason, sulfamethoxazole/trimethoprim should not be used near term (late in pregnancy) among women.

Sulfamethoxazole/trimethoprim should not be used by nursing mothers because sulfamethoxazole is excreted in milk and can cause kernicterus.

How is this medicine (Bactrim DS) best taken?

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 DS 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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Muscle or joint pain.
  • Purple patches on the skin or mouth.
  • Shortness of breath.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • It is common to have diarrhea when taking Bactrim DS (sulfamethoxazole and trimethoprim tablets). Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

What are some other side effects of Bactrim DS?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Bactrim DS, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bactrim DS. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Bactrim DS.

Review Date: October 4, 2017

Bactrim DS Description

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.

Overdosage

Acute: The amount of a single dose of BACTRIM that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage.

Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression.

General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and the administration of intravenous fluids if urine output is low and renal function is normal. Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating sulfamethoxazole and trimethoprim.

Chronic: Use of BACTRIM at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 to 15 mg daily until normal hematopoiesis is restored.

PRINCIPAL DISPLAY PANEL - 400 mg/80 mg Tablet Bottle Label

NDC 49708-145-01
100 TABLETS

Bactrim™
sulfamethoxazole and trimethoprim
tablets USP

400 mg/80 mg

Rx Only

SUN
PHARMA

For Healthcare Professionals

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

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