Septra

DRUG DESCRIPTION

SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA (trimethoprim and sulfamethoxazole) Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium starch glycolate.

Each SEPTRA (trimethoprim and sulfamethoxazole) DS (double strength) Tablet contains 160 mg trimethoprim and 800 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.8 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium starch glycolate.

Each teaspoonful (5 mL) of SEPTRA (trimethoprim and sulfamethoxazole) Suspension contains 40 mg trimethoprim and 200 mg sulfamethoxazole and the inactive ingredients alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid, FD&C Red No. 40 and Yellow No. 6, flavor, glycerin, microcrystalline cellulose, polysorbate 80, saccharin sodium, and sorbitol. Each teaspoonful (5 mL) of SEPTRA (trimethoprim and sulfamethoxazole) Grape Suspension contains 40 mg trimethoprim and 200 mg sulfamethoxazole and the inactive ingredients alcohol 0.26%, methylparaben 0.1%, and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid, FD&C Red No. 40 and Blue No. 1, flavor, glycerin, microcrystalline cellulose, polysorbate 80, saccharin sodium, and sorbitol. Both tablet and suspension forms are for oral administration.

Trimethoprim is 5-[(3,4,5-trimeth-oxyphenyl)methyl]-2,4- pyrimidinediamine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32, and the molecular formula C14H18N4O3. The structural formula is:

Trimethoprim structural formula illustration

Sulfamethoxazole is 4-amino-N-(5-methyl-3-isoxazolyl)benzenesulfonamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28, and the molecular formula C10H11N3O3S. The structural formula is:

Sulfamethoxazole structural formula illustration

What are the possible side effects of sulfamethoxazole and trimethoprim?

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

Call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • pale skin, easy bruising or bleeding;
  • cough, feeling short of breath;
  • diarrhea that is watery or...

Read All Potential Side Effects and See Pictures of Septra

What are the precautions when taking trimethoprim and sulfamethoxazole (Septra)?

Before taking sulfamethoxazole with trimethoprim, tell your doctor or pharmacist if you are allergic to sulfa medications or trimethoprim; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, certain blood disorders (such as porphyria, anemia due to folate vitamin deficiency), severe allergies, asthma, decreased bone marrow function (bone marrow suppression), a certain metabolic disorder (G6PD deficiency).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,...

Read All Potential Precautions of Septra


Septra Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, or loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any unlikely but serious side effects, including: muscle weakness, mental/mood changes, blood in the urine, change in the amount of urine.

Get medical help right away if any of these rare but serious side effects occur: persistent headache, neck stiffness, seizures.

This medication may rarely cause serious (possibly fatal) allergic reactions and other side effects such as a severe peeling skin rash (such as Stevens-Johnson syndrome), blood disorders (such as agranulocytosis, aplastic anemia), liver damage, or lung injury. If you notice any of the following, get medical help right away: skin rash/blisters, itching/swelling (especially of the face/tongue/throat), persistent sore throat or fever, paleness, joint pain/aches, persistent cough, trouble breathing, easy bleeding/bruising, yellowing eyes or skin, persistent nausea/vomiting, unusual fatigue, dark urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur while receiving treatment or even weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sulfamethoxazole with trimethoprim, tell your doctor or pharmacist if you are allergic to sulfa medications or trimethoprim; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, certain blood disorders (such as porphyria, anemia due to folate vitamin deficiency), severe allergies, asthma, decreased bone marrow function (bone marrow suppression), a certain metabolic disorder (G6PD deficiency).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the side effects of this drug, especially skin reactions, blood disorders, easy bleeding/bruising, and a high potassium blood level.

Patients with AIDS may be more sensitive to the side effects of this drug, especially skin reactions, fever, and blood disorders.

During pregnancy, this medication should be used only when clearly needed. This medication should not be used near the expected delivery date because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. While there have been no reports of harm to healthy infants, this drug may have undesirable effects on infants who are ill or premature or have certain disorders (jaundice, high blood levels of bilirubin, G6PD deficiency). Therefore, breast-feeding is not recommended for infants with these conditions. Consult your doctor before breast-feeding.


Septra Patient Information Including Side Effects

Brand Names: Bactrim, Bactrim DS, Septra, Septra DS, SMZ-TMP DS, Sulfatrim Pediatric

Generic Name: sulfamethoxazole and trimethoprim (Pronunciation: SUL fa meth OX a zole and trye METH oh prim)

  • What is sulfamethoxazole and trimethoprim (Septra)?
  • What are the possible side effects of sulfamethoxazole and trimethoprim?
  • What is the most important information I should know about sulfamethoxazole and trimethoprim?
  • What should I discuss with my healthcare provider before taking sulfamethoxazole and trimethoprim?
  • How should I take sulfamethoxazole and trimethoprim?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking sulfamethoxazole and trimethoprim?
  • What other drugs will affect sulfamethoxazole and trimethoprim?
  • Where can I get more information?

What is sulfamethoxazole and trimethoprim (Septra)?

Sulfamethoxazole and trimethoprim are both antibiotics that treat different types of infection caused by bacteria.

The combination of sulfamethoxazole and trimethoprim is used to treat ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia.

Sulfamethoxazole and trimethoprim may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sulfamethoxazole and trimethoprim?

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

Call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • pale skin, easy bruising or bleeding;
  • cough, feeling short of breath;
  • diarrhea that is watery or bloody;
  • feeling restless or irritable, confusion, hallucinations, seizure;
  • slow heart rate, weak pulse, severe tingling, numbness, muscle pain or weakness;
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • painful or swollen tongue;
  • dizziness, spinning sensation;
  • ringing in your ears;
  • joint pain; or
  • sleep problems (insomnia).

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.

What is the most important information I should know about sulfamethoxazole and trimethoprim?

You should not use this medication if you are allergic to sulfamethoxazole or trimethoprim, if you are pregnant or breast-feeding, or if you have anemia (lack of red blood cells) caused by folic acid deficiency.

Before using sulfamethoxazole and trimethoprim, tell your doctor if you have kidney or liver disease, a folic acid deficiency, asthma or severe allergies, AIDS, a glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency), or if you are malnourished.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Sulfamethoxazole and trimethoprim will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight, sunlamps, or tanning beds. This medication can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

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