Septra DS

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

Call your doctor at once if you have:

• diarrhea that is watery or bloody;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• sudden weakness or ill feeling, fever, chills, sore throat, new or worsening cough;
• cold or flu symptoms, swollen gums, painful mouth sores, pain when swallowing, skin sores;
• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• liver problems--upper stomach pain, tired feeling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, loss of appetite; or
• mild itching or 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.

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 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. Sulfamethoxazole and trimethoprim 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 sulfamethoxazole and trimethoprim.

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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

In the U.S.

• Bactrim
• Bactrim DS
• Septra
• Septra DS
• SMZ-TMP Pediatric
• Sulfatrim
• Sulfatrim Pediatric

In Canada

• Apo-Sulfatrim
• Novo-Trimel
• Nu-Cotrimox
• Septa Pediatric
• Septra Pediatric Suspension

Available Dosage Forms:

• Tablet
• Suspension

Therapeutic Class: Sulfonamide Combination

Pharmacologic Class: Folic Acid Antagonist

Chemical Class: Sulfonamide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in children 2 months of age and older. Because of the toxicity of the combination of sulfamethoxazole and trimethoprim, use in infants younger than 2 months of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in the elderly. However, elderly patients are more likely to have a folate deficiency, age-related kidney or liver problems, and may be more likely to experience unwanted side effects (eg, severe skin rash, increased potassium in the body, or problems with blood clotting or the immune system). There may be an adjustment in the dose for elderly patients receiving sulfamethoxazole and trimethoprim combination.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide
• Levomethadyl
• Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Acenocoumarol
• Ajmaline
• Amiloride
• Amiodarone
• Amitriptyline
• Amoxapine
• Aprindine
• Arsenic Trioxide
• Astemizole
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Azimilide
• Benazepril
• Bretylium
• Candesartan Cilexetil
• Captopril
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Clarithromycin
• Desipramine
• Dibenzepin
• Digoxin
• Disopyramide
• Dolasetron
• Doxepin
• Droperidol
• Eltrombopag
• Enalapril
• Enalaprilat
• Enflurane
• Eplerenone
• Eprosartan
• Erythromycin
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosinopril
• Gemifloxacin
• Halofantrine
• Haloperidol
• Halothane
• Hydroquinidine
• Ibutilide
• Imipramine
• Irbesartan
• Isoflurane
• Isradipine
• Leucovorin
• Lidoflazine
• Lisinopril
• Lorcainide
• Losartan
• Mefloquine
• Mercaptopurine
• Methotrexate
• Moexipril
• Nortriptyline
• Octreotide
• Olmesartan Medoxomil
• Pentamidine
• Perindopril
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Pyrimethamine
• Quinapril
• Quinidine
• Ramipril
• Risperidone
• Sematilide
• Sertindole
• Sotalol
• Spiramycin
• Spironolactone
• Sultopride
• Tedisamil
• Telithromycin
• Telmisartan
• Trandolapril
• Triamterene
• Trifluoperazine
• Trimipramine
• Valsartan
• Vasopressin
• Warfarin
• Zofenopril
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetohexamide
• Amantadine
• Aminolevulinic Acid
• Anisindione
• Didanosine
• Fosphenytoin
• Phenytoin
• Repaglinide
• Rifabutin
• Rosiglitazone
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Folate (vitamin B9) deficiency or
• HIV or AIDS or
• Kidney disease or
• Liver disease or
• Malabsorption syndrome (difficulty of absorbing food in the body) or
• Malnutrition state (nutrition disorder)—Use with caution. May have an increased chance of serious side effects.

• Anemia, megaloblastic (caused by low levels of folic acid in the body) or
• Drug-induced thrombocytopenia (low platelets in the blood) after using this medicine or
• Kidney disease, severe or
• Liver disease, severe—Should not be used in patients with these conditions.

• Asthma or
• Diabetes or
• Hyperkalemia (high potassium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Porphyria (enzyme problem) or
• Severe allergies or
• Thyroid problems—Use with caution. May make these conditions worse.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (blood disorder) in patients with this condition.

• Streptococcal infection (group A β-hemolytic)—Sulfonamides should not be used in patients with this condition.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Very rarely, this medicine has caused severe side effects. If you or your child start to have a skin rash, or if you think you are having a severe skin reaction, stop taking this medicine and call your doctor right away. Symptoms of a severe reaction may include a skin rash, skin color that is very pale or yellow, or skin with purple spots, along with a sore throat, fever, muscle pain, cough, and trouble with breathing.

This medicine, especially if you are receiving high doses or for a long period of time, may lower the number of platelets in your body, which are necessary for proper blood clotting. Because of this, you may bleed or get infections more easily. Talk with your doctor if you have concerns about this.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you or your child have abdominal or stomach cramps, bloating, watery and severe diarrhea, which may also be bloody, nausea or vomiting, or unusual tiredness or weakness. These may be symptoms of a serious intestinal infection.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, shortness of breath, or chest pain after you use the medicine.

This medicine may cause electrolyte problems, such as high potassium in the blood (hyperkalemia) and low sodium in the blood (hyponatremia). Tell your doctor right away if you have any of the following symptoms while using this medicine: confusion, weakness, muscle twitching, an irregular heartbeat, numbness or tingling in the hands, feet, or lips, or trouble breathing.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Patients receiving anticonvulsant therapy (medicines to prevent seizures) may be at risk for a folate (vitamin B9) deficiency, which may increase the risk for side effects. Talk with your doctor if you have concerns about this.

Do not use this medicine for Pneumocystis jiroveci pneumonia (PCP) if you are also using leucovorin. Using these medicines together may cause these medicines to not work as well for you.

Do not take other medicines unless they have been discussed with your doctor. This includes leucovorin, other prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

You should not use this medication if you have severe liver or kidney disease, anemia caused by folic acid deficiency, or a history of low blood platelets caused by taking trimethoprim or any sulfa drug.

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

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

Call your doctor at once if you have:

• diarrhea that is watery or bloody;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• sudden weakness or ill feeling, fever, chills, sore throat, new or worsening cough;

• cold or flu symptoms, swollen gums, painful mouth sores, pain when swallowing, skin sores;

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

• liver problems--upper stomach pain, tired feeling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, loss of appetite; or

• mild itching or 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.

Applies to sulfamethoxazole / trimethoprim: oral suspension, oral tablet

Other dosage forms:

• intravenous solution

Along with its needed effects, sulfamethoxazole / trimethoprim may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sulfamethoxazole / trimethoprim:

• Abdominal or stomach pain
• black, tarry stools
• blistering, peeling, or loosening of the skin
• changes in skin color
• chest pain
• chills
• cough or hoarseness
• dark urine
• diarrhea
• dizziness
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• itching
• joint or muscle pain
• light-colored stools
• loss of appetite
• lower back or side pain
• nausea
• pain, tenderness, or swelling of the foot or leg
• painful or difficult urination
• pale skin
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• shortness of breath
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen or painful glands
• tightness in the chest
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood
• wheezing
• yellow eyes or skin

• Abdominal or stomach tenderness
• back, leg, or stomach pains
• bleeding gums
• blindness or vision changes
• blisters, hives, or itching
• bloating
• blood in the urine or stools
• bluish-colored lips, fingernails, or palms
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• burning of the face or mouth
• chest pain
• cloudy urine
• confusion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• convulsions
• cracks in the skin
• decreased frequency or amount of urine
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing
• difficulty with swallowing
• fainting spells
• general body swelling
• general feeling of discomfort or illness
• hair loss
• hearing loss
• hives
• increased thirst
• indigestion
• irregular heartbeat
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of heat from the body
• muscle or joint pain
• nosebleeds
• not able to pass urine
• numbness or tingling in the hands, feet, or lips
• pain or burning while urinating
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised red swellings on the skin, the buttocks, legs, or ankles
• redness of the white part of the eyes
• redness, swelling, or soreness of the tongue
• sores, ulcers, or white spots on the lips or in the mouth
• soreness of the muscles
• stiff neck or back
• swelling of the face, hands, legs, and feet
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual weight loss
• weakness in the hands or feet
• weakness or heaviness of the legs
• weight gain

Some side effects of sulfamethoxazole / trimethoprim may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Passing of gas

• Discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• increased sensitivity of the skin to sunlight
• irritability
• lack of feeling or emotion
• loss of interest or pleasure
• nervousness
• redness or other discoloration of the skin
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• severe sunburn
• trouble concentrating
• trouble sleeping
• uncaring
• weight loss

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