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Mutual Pharmaceutical Company, Inc.
Serious side effects have been reported with Bactrim including the following:
- hypersensitivity (severe allergic reaction). Signs of a hypersensitivity reaction, which include the following:
- chest pain
- swelling of the face, eyes, lips, tongue, arms, or legs
- difficulty breathing or swallowing
- increased risk of bleeding. This may be due to thrombocytopenia, or when your platelet count level drops. Tell your healthcare provider right away if you have some or all of the following symptoms of bleeding:
- red or purple spots seen on skin
- bleeding that does not resolve within a few minutes
- abnormal or easy bruising
- diarrhea. Diarrhea is a common problem caused by antibiotics, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, contact your doctor, as this may be a sign of an infection of the bowels.
- hyperkalemia (high potassium levels in body). Hyperkalemia can cause an arrhythmia, or a rapid heart rate or rhythm. Tell your healthcare provider right away if you have some or all of the following symptoms of hyperkalemia:
- shortness of breath
- fast or slow heartbeat
- lightheadedness or dizziness
- chest pain
- skipping heartbeats
- kidney stones. To prevent kidney stones, it is recommended to drink plenty of fluids. Tell your healthcare provider right away if have some or all of the following symptoms of kidney stones:
- extreme pain in your back or side that will not go away
- blood in your urine
- fever and chills
- urine that smells bad or looks cloudy
- a burning feeling when you urinate
Do not take Bactrim if you:
- have a known allergic reaction to trimethoprim or sulfamethoxazole or to any of this medication's ingredients
- are less than 2 months of age
- have a specific type of bacterial infection (group A beta-hemolytic streptococcal bacteria)
- have a history of drug-induced immune thrombocytopenia (low platelet count) with use of trimethoprim and/or sulfa-containing drugs
- have a history of anemia (low red blood cell count) due to a folate deficiency
- have severe liver or kidney damage
- are pregnant or are breastfeeding
Bactrim Food Interactions
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bactrim, there are no specific foods that you must exclude from your diet when receiving Bactrim.
Bactrim and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Bactrim falls into category D. It is strongly not recommended (“contraindicated") for use in pregnant patients because sulfonamides cross the placental barrier, which may cause brain damage to the unborn child. In addition, sulfamethoxazole and trimethoprim may interfere with folic acid activity in the body. This may further negatively affect the unborn child.
In summary, Bactrim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Uses For Bactrim
Sulfamethoxazole and trimethoprim combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery). This medicine is also used to prevent or treat Pneumocystis jiroveci pneumonia or 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.
If OVERDOSE is suspected
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.
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, 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. 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.
Review Date: October 4, 2017
Indications and Usage for Bactrim
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethoxazole and trimethoprim) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Bactrim in pediatric patients under two years of age. Bactrim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Bactrim could offer some advantage over the use of a single antimicrobial agent.
Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.
Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
What other drugs will affect Bactrim?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Bactrim, especially:
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.
Response and Effectiveness
- Quickly absorbed with peak levels occurring within one to four hours after administration. Antibacterial effects persist for at least 12 hours.
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