Apo-Sulfatrim

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.

Along with its needed effects, a medicine 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:

• 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

-Sulfamethoxazole-trimethoprim 800 mg-160 mg (1 double strength tablet) orally once a day
-Maximum dose: The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim

Use: For prophylaxis against P jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P jiroveci pneumonia

Sulfamethoxazole-trimethoprim 800 mg-160 mg (1 double strength tablet) orally every 12 hours for 10 to 14 days

Use: Otitis media (off-label use in adults)

Sulfamethoxazole-trimethoprim 800 mg-160 mg (1 double strength tablet) orally every 12 hours

Duration: Acute, 10 to 14 days; chronic, 1 to 3 months

Comments:
-Off-label use.

5 mg/kg (based on the trimethoprim component) IV every 12 hours

Duration: 4 weeks to 6 months or more, depending on the nature and severity of the infection; patients with AIDS are usually given high dose therapy for 4 to 6 weeks then maintained on oral trimethoprim-sulfamethoxazole for life

Comments:
-Off-label use.

Sulfamethoxazole-trimethoprim 800 mg-160 mg (1 double strength tablet) orally every 12 hours

Comments:
-Off-label use.

2 months or older:
-Oral: 4 mg/kg (based on the trimethoprim component) orally every 12 hours for 10 to 14 days
-IV:
Severe infection: 8 to 10 mg/kg/day (based on the trimethoprim component) IV in 2 to 4 equally divided doses every 6, 8, or 12 hours for 10 to 14 days; maximum recommended dose is 960 mg (based on the trimethoprim component) per day

Use: For the treatment of severe or complicated urinary tract infections due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris

• Sulfamethoxazole/trimethoprim is a combination antibiotic used to treat infections such as those affecting the ear, urinary tract, lungs, or gastrointestinal tract.
• Active against a wide range of susceptible strains of gram-positive and gram-negative bacteria, such as Streptococcus pneumoniae, Escherichia coli, Klebsiella species, Enterobacter species, Haemophilus influenzae, and others.
• Effective concentrations of both sulfamethoxazole and trimethoprim are reached in the gastrointestinal tract, urinary tract, lungs, mouth, middle ear, and vagina. Both antibiotics also cross the placenta and are excreted in human milk.
• Bacterial resistance is less likely to develop with the combination of sulfamethoxazole and trimethoprim than if either ingredient (sulfamethoxazole or trimethoprim) is taken alone.
• Generic sulfamethoxazole/trimethoprim is available.

• May be taken with or without food. Swallow tablets with a big glass of water.
• Take only as directed by your doctor and do not share with anyone else as misuse can encourage the development of drug-resistant bacteria and reduce the effectiveness of sulfamethoxazole/trimethoprim. Sulfamethoxazole/trimethoprim will not treat viral infections, such as a cold.
• Discontinue and seek urgent medical advice if a skin rash develops.
• Complete the full course as prescribed (unless instructed not to do so by your doctor) to reduce the risk of resistant bacteria developing.
• Should not be used in pregnant or lactating women or in babies less than two months old.
• Seek urgent medical advice if an unexplained cough, shortness of breath, sore throat, fever, muscle or joint pain, paleness or yellowing of the skin, or diarrhea develop.
• Like other antibiotics, sulfamethoxazole/trimethoprim can change the natural balance of bacteria present in your gut and may cause a severe and persistent diarrhea, associated with a bacteria called Clostridium difficile. Contact your doctor if diarrhea develops either during treatment or within a couple of months of ending treatment.
• Keep well hydrated with fluids to avoid the development of crystals in the urine or kidney stones.