SMZ-TMP DS

Sulfamethoxazole and trimethoprim doses are based on weight in children. Use only the recommended dose when giving this medicine to a child.

SMZ-TMP DS Tablet – Uses, Side Effects, and More

This medication is a combination of two antibiotics: sulfamethoxazole and trimethoprim. It is used to treat a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections). It is also used to prevent and treat a certain type of pneumonia (pneumocystis-type).This medication should not be used by children less than 2 months of age due to the risk of serious side effects.This medication treats only certain types of infections. It will not work for viral infections (such as flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How to use SMZ-TMP DS Tablet

Take this medication by mouth, as directed by your doctor, with a full glass of water (8 ounces / 240 milliliters). If stomach upset occurs, take with food or milk. Drink plenty of fluids while taking this medication to lower the unlikely risk of kidney stones forming, unless your doctor advises you otherwise. Dosage is based on your medical condition and response to treatment.

For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping it too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Tell your doctor if your condition lasts or gets worse.

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Side Effects

Nausea, vomiting, diarrhea, and loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 serious side effects, including: muscle weakness, mental/mood changes, signs of kidney problems (such as change in the amount of urine, blood in the urine), extreme drowsiness, signs of low blood sugar (such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet).

Get medical help right away if you have any very serious side effects, including: headache that doesn’t go away, neck stiffness, seizures, slow/irregular heartbeat.

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: sore throat or fever that doesn’t go away, cough that doesn’t go away, nausea/vomiting that doesn’t stop, skin rash/blisters, itching/swelling (especially of the face/tongue/throat), new or worsening lymph node swelling, paleness, joint pain/aches, trouble breathing, easy bleeding/bruising, yellowing eyes or skin, unusual fatigue, dark urine.

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast 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 or at www.fda.gov/medwatch.

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 this medication, tell your doctor or pharmacist if you are allergic to sulfamethoxazole or trimethoprim; or to sulfa medications; 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), history of blood disorders caused by trimethoprim or sulfa medications, vitamin deficiency (folate or folic acid), severe allergies, asthma, decreased bone marrow function (bone marrow suppression), a certain metabolic disorder (G6PD deficiency), underactive thyroid, mineral imbalances (such as high level of potassium or low level of sodium in the blood).

This medication may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using this medication before having any immunizations/vaccinations.

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. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness.

If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sulfamethoxazole/trimethoprim. This medication may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

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). Breast-feeding is not recommended for infants with these conditions. Consult your doctor before breast-feeding.

SMZ-TMP DS

SMZ-TMP DS (sulfamethoxazole and trimethoprim) is a combination antibiotic used to treat ear infections, urinary tract infections, bronchitis, traveler’s diarrhea, shigellosis, and Pneumocystis jiroveci pneumonia.

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

Important Information

You should not use SMZ-TMP DS if you have severe liver disease, kidney disease that is not being monitored, anemia caused by folic acid deficiency, if you take dofetilide, or if you have had low platelets caused by using trimethoprim or a sulfa drug.

You should not take SMZ-TMP DS if you are pregnant or breastfeeding.

Before taking this medicine

You should not use this medicine if you are allergic to sulfamethoxazole or trimethoprim, or if you have:

• severe liver disease;
• kidney disease that is not being treated or monitored;
• anemia (low red blood cells) caused by folic acid deficiency;
• a history of low blood platelets after taking trimethoprim or any sulfa drug; or
• if you take dofetilide (Tikosyn).

Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant.

Do not breastfeed while using this medicine.

This medicine should not be given to a child younger than 2 months old.

Tell your doctor if you have ever had:

• kidney or liver disease;
• a folate (folic acid) deficiency;
• asthma or severe allergies;
• a thyroid disorder;
• HIV or AIDS;
• malnourishment;
• alcoholism;
• high levels of potassium in your blood;
• porphyria, or glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• if you use a blood thinner (such as warfarin) and you have routine “INR” or prothrombin time tests.

How should I use SMZ-TMP DS?

SMZ-TMP DS is taken by mouth (oral).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Drink plenty of fluids to prevent kidney stones while you are using this medicine.

Sulfamethoxazole and trimethoprim doses are based on weight in children. Use only the recommended dose when giving this medicine to a child.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. This medicine will not treat a viral infection such as the flu or a common cold.

You may need frequent medical tests.

This medicine can affect the results of 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.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

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

Overdose symptoms may include loss of appetite, vomiting, fever, blood in your urine, yellowing of your skin or eyes, confusion, or loss of consciousness.

What should I avoid while using SMZ-TMP DS?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

SMZ-TMP DS could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

SMZ-TMP DS side effects

Get emergency medical help if you have signs of an allergic reaction (hives, cough, 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).

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);
• a 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;
• an electrolyte imbalance–headache, confusion, weakness, slurred speech, tingly feeling, chest pain, irregular heartbeats, loss of coordination or movement, 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
• 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.

What other drugs will affect SMZ-TMP DS?

You may need more frequent check- ups or medical tests if you also use medicine to treat depression, diabetes, seizures, or HIV.

Many drugs can interact, and some drugs should not be used together. Tell your doctor about all your current medicines, especially:

• amantadine, cyclosporine, indomethacin, leucovorin, methotrexate, pyrimethamine;
• an “ACE inhibitor” heart or blood presure medication (benazepril, enalapril, lisinopril, quinapril, ramipril, and others); or
• a diuretic or “water pill” (chlorthalidone, hydrochlorothiazide, and others).

This list is not complete and many other drugs may affect sulfamethoxazole and trimethoprim. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

• Your pharmacist can provide more information about sulfamethoxazole and trimethoprim.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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