Bactrim Pediatric Side Effects Center

Last updated on RxList: 7/22/2021
Bactrim Pediatric Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Bactrim Pediatric?

Bactrim pediatric suspension (sulfamethoxazole and trimethoprim) is a combination of an anti-bacterial sulfonamide (a "sulfa" drug) and a form of folic acid used to treat infections due to susceptible bacteria, such as urinary tract infections (UTIs), flares of chronic bronchitis due to bacteria, middle ear infections, to prevent infections due to pneumococcus in organ transplant recipients, to treat or prevent Pneumocystis carinii pneumonia, chancroid, and to prevent toxoplasma encephalitis in patients with AIDS.

What Are Side Effects of Bactrim Pediatric?

Side effects of Bactrim pediatric suspension include:

Dosage for Bactrim Pediatric

The usual adult dosage in the treatment of urinary tract infections is 4 teaspoonfuls (20 mL) of Bactrim pediatric suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The recommended dose for children with urinary tract infections (UTIs) or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 4 teaspoonfuls (20 mL) of Bactrim pediatric suspension every 12 hours for 14 days.

The recommended dosage of Bactrim pediatric suspension for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.

The recommended dosage for prophylaxis in adults is 4 teaspoonfuls (20 mL) of Bactrim pediatric suspension daily. For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week.

For the treatment of traveler’s diarrhea, the usual adult dosage is 4 teaspoonfuls (20 mL) of Bactrim pediatric suspension every 12 hours for 5 days


Bactrim Pediatric In Children

Bactrim pediatric suspension is contraindicated for infants younger than 2 months of age.

What Drugs, Substances, or Supplements Interact with Bactrim Pediatric?
 

Bactrim pediatric suspension may interact with other medicines such as:

  • diuretics,
  • warfarin,
  • phenytoin,
  • methotrexate,
  • cyclosporine,
  • digoxin,
  • indomethacin,
  • pyrimethamine,
  • tricyclic antidepressants (TCAs),
  • oral hypoglycemics (e.g., pioglitazone, repaglinide, rosiglitazone, glipizide, glyburide, or metformin),
  • amantadine,
  • memantine,
  • angiotensin converting enzyme (ACE) inhibitors,
  • zidovudine,
  • dofetilide, and
  • procainamide.

Tell your doctor all medications and supplements you use.


Bactrim Pediatric During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Bactrim pediatric suspension; because sulfamethoxazole and trimethoprim may interfere with folic acid metabolism, Bactrim pediatric suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The medications in Bactrim pediatric suspension pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Bactrim Pediatric Suspension (sulfamethoxazole and trimethoprim) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Bactrim Pediatric Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, cough, chest pain, shortness of breath, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, joint pain, muscle aches, severe weakness, pale skin, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
  • any skin rash, no matter how mild;
  • yellowing of your skin or eyes;
  • a seizure;
  • new or unusual joint pain;
  • increased or decreased urination;
  • swelling, bruising, or irritation around the IV needle;
  • increased thirst, dry mouth, fruity breath odor;
  • new or worsening cough, fever, trouble breathing;
  • high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
  • low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
  • low blood cell counts--fever, chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • nausea, vomiting, loss of appetite; or
  • skin 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.

Read the entire detailed patient monograph for Bactrim Pediatric (Sulfamethoxazole and Trimethoprim Suspension )

SLIDESHOW

Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow
Bactrim Pediatric Professional Information

SIDE EFFECTS

The following adverse reactions associated with the use of BACTRIM or sulfamethoxazole and trimethoprim were identified in clinical trials, postmarketing or published reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). Fatalities and serious adverse reactions, including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including BACTRIM (see WARNINGS).

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura.

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, rash, periarteritis nodosa, systemic lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized erythematous pustulosis (AGEP), and acute febrile neutrophilic dermatosis (AFND) (see WARNINGS).

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, renal insufficiency, oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

Metabolic and Nutritional: Hyperkalemia, hyponatremia (see PRECAUTIONS: Electrolyte Abnormalities), metabolic acidosis.

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

Psychiatric: Hallucinations, depression, apathy, nervousness.

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred.

Musculoskeletal: Arthralgia, myalgia, rhabdomyolysis.

Respiratory: Cough, shortness of breath and pulmonary infiltrates, acute eosinophilic pneumonia, acute and delayed lung injury, interstitial lung disease, acute respiratory failure (see WARNINGS).

Cardiovascular System: QT prolongation resulting in ventricular tachycardia and torsades de pointes, circulatory shock (see WARNINGS).

Miscellaneous: Weakness, fatigue, insomnia.

DRUG INTERACTIONS

Potential For BACTRIM To Affect Other Drugs

Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of BACTRIM with drugs that are substrates of CYP2C8 and 2C9 or OCT2.

Table 1: Drug Interactions with BACTRIM

Drug(s) Recommendation Comments
Diuretics Avoid concurrent use In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported.
Warfarin Monitor prothrombin time and INR It has been reported that BACTRIM may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when BACTRIM is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed.
Phenytoin Monitor serum phenytoin levels BACTRIM may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate). BACTRIM, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.
Methotrexate Avoid concurrent use Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations.
Cyclosporine Avoid concurrent use There have been reports of marked but reversible nephrotoxicity with coadministration of BACTRIM and cyclosporine in renal transplant recipients.
Digoxin Monitor serum digoxin levels Increased digoxin blood levels can occur with concomitant BACTRIM therapy, especially in elderly patients.
Indomethacin Avoid concurrent use Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin.
Pyrimethamine Avoid concurrent use Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if BACTRIM is prescribed.
Tricyclic Antidepressants (TCAs) Monitor therapeutic response and adjust dose of TCA accordingly The efficacy of tricyclic antidepressants can decrease when coadministered with BACTRIM.
Oral Hypoglycemics Monitor blood glucose more frequently Like other sulfonamide-containing drugs, BACTRIM potentiates the effect of oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted.
Amantadine Avoid concurrent use In the literature, a single case of toxic delirium has been reported after concomitant intake of BACTRIM and amantadine (an OCT2 substrate). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported.
Angiotensin Converting Enzyme Inhibitors Avoid concurrent use In the literature, three cases of hyperkalemia in elderly patients have been reported after concomitant intake of BACTRIM and an angiotensin converting enzyme inhibitor.5,6
Zidovudine Monitor for hematologic toxicity Zidovudine and BACTRIM are known to induce hematological abnormalities. Hence, there is potential for an additive myelotoxicity when coadministered.7
Dofetilide Concurrent administration is contraindicated Elevated plasma concentrations of dofetilide have been reported following concurrent administration of trimethoprim and dofetilide. Increased plasma concentrations of dofetilide may cause serious ventricular arrhythmias associated with QT interval prolongation, including torsade de pointes.8,9
Procainamide Closely monitor for clinical and ECG signs of procainamide toxicity and/or procainamide plasma concentration if available Trimethoprim increases the plasma concentrations of procainamide and its active N-acetyl metabolite (NAPA) when trimethoprim and procainamide are coadministered. The increased procainamide and NAPA plasma concentrations that resulted from the pharmacokinetic interaction with trimethoprim are associated with further prolongation of the QTc interval.10

REFERENCES

5. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. Gerontol. 45:209–212.

6. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. J. Nephrol. 14:410–414.

7. Moh R, et al. Haematological changes in adults receiving a zidovudine-containing HAART regimen in combination with cotrimoxazole in Côte d'Ivoire. Antivir Ther. 2005;10(5):61524.

8. Al-Khatib SM, LaPointe N, Kramer JM, Califf RM. What Clinicians Should Know About the QT Interval. JAMA. 2003;289(16):2120-2127.

9. Boyer EW, Stork C, Wang RY. Review: The Pharmacology and Toxicology of Dofetilide. Int J Med Toxicol. 2001;4(2):16.

10. Kosoglou T, Rocci ML Jr, Vlasses PH. Trimethoprim alters the disposition of procainamide and N-acetylprocainamide. Clin Pharmacol Ther. Oct 1988;44(4):467-77.

Read the entire FDA prescribing information for Bactrim Pediatric (Sulfamethoxazole and Trimethoprim Suspension )

© Bactrim Pediatric Patient Information is supplied by Cerner Multum, Inc. and Bactrim Pediatric Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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