Biseptol

Know the basics

What is Biseptol® (Sulfamethoxazole and Trimethoprim) used for?

Biseptol® is an antibiotic combination, commonly used for treat infections, including:

• Urinary tract infections;
• Middle ear infections (otitis media);
• Bronchitis;
• Traveler’s diarrhea;
• Shigellosis (bacillary dysentery).

Biseptol® can be used to prevent or treat pneumonia caused by infection of Pneumocystis jiroveci or Pneumocystis carinii pneumonia (PCP).

How should I take Biseptol® (Sulfamethoxazole and Trimethoprim)?

For orally taken form, you should:

• Take Biseptol® by mouth as directed by your doctor concerning: dose, schedule.
• Read the label carefully before using Biseptol®.
• Consult your doctor for any information on the label that you do not clearly understand.

How do I store Biseptol® (Sulfamethoxazole and Trimethoprim)?

Biseptol® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Biseptol® in the bathroom or the freezer. There may be different brands of Biseptol® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Biseptol® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Know the precautions & warnings

What should I know before using Biseptol® (Sulfamethoxazole and Trimethoprim)?

Before using Biseptol®, tell your doctor if you have:

• Allergic reaction: to Biseptol®, excipients using for dosage form containing Biseptol®. The information is detailed in the leaflet.
• Allergic reaction to any other medicines, foods, dyes, preservatives, or animals.
• Pediatric.
• Geriatric.
• Used any other health conditions, drugs that have a risk of interaction with Biseptol® as listed below.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Biseptol® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Biseptol®. Biseptol® is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk;
• B=No risk in some studies;
• C=There may be some risk;
• D=Positive evidence of risk;
• X=Contraindicated;
• N=Unknown.

Know the side effects

What side effects can occur from Biseptol® (Sulfamethoxazole and Trimethoprim)?

As taking others medicines, taking Biseptol® can cause some side effects. Most of them are rarely occurring and do not need any supplementary treatment. However, it is always important for you to consult your doctor if you have any problem after taking this medicine.

Some of the side effects are listed below: :

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Know the interactions

What drugs may interact with Biseptol® (Sulfamethoxazole and Trimethoprim)?

Biseptol® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval, such as:

Does food or alcohol interact with Biseptol® (Sulfamethoxazole and Trimethoprim)?

Biseptol® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Biseptol® (Sulfamethoxazole and Trimethoprim)?

Biseptol® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

• Alcohol abuse;
• Folate (vitamin B9) deficiency;
• HIV or AIDS;
• Kidney disease;
• Liver disease;
• Malabsorption syndrome (difficulty of absorbing food in the body);
• Malnutrition state (nutrition disorder);
• Anemia, megaloblastic (caused by low levels of folic acid in the body);
• Drug-induced thrombocytopenia (low platelets in the blood) after using this medicine;
• Kidney disease, severe;
• Liver disease, severe;
• Asthma;
• Diabetes ;
• Hyperkalemia (high potassium in the blood);
• Hyponatremia (low sodium in the blood);
• Porphyria (enzyme problem);
• Severe allergies;
• Thyroid problems;
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• Streptococcal infection (group A β-hemolytic).

Understand the dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Biseptol®.

What is the dose of Biseptol® (Sulfamethoxazole and Trimethoprim) for an adult?

Consult your doctor for information about the dose of Biseptol® hydrochloride.

Recommended doses in some cases are listed below:

• For treatment of bacterial infections: adults weighing 40 kilograms (kg) or more: can use 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours for 10 to 14 days. In some case, your doctor may adjust this dose depending on the efficacy of treatment.
• For treatment of Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP): dose is based on body weight and must be determined by your doctor. The usual dose is 75 to 100 milligrams (mg) per kilogram of body weight of sulfamethoxazole and 15 to 20 milligrams (mg) per kilogram of body weight of trimethoprim each day, given in equally divided doses every 6 hours for 14 to 21 days.
• For prevention of Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP): usual dose for adults is 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim once a day.
• For traveler’s diarrhea: usual dose for adults is 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours for 5 days.

What is the dose of Biseptol® (Sulfamethoxazole and Trimethoprim) for a child?

Consult your doctor for information about the dose of Biseptol® hydrochloride.

Recommended doses in some cases are listed below:

For treatment of bacterial infections:

• Children weighing 40 kilograms (kg) or more can take 800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours for 10 to 14 days. Your doctor may adjust this dose if needed.
• Children aged more than 3 months, and weighing up to 40 kg: dose is calculated based on body weight and must be determined by your doctor. The usual dose is 40 milligrams (mg) per kilogram of body weight of sulfamethoxazole and 8 milligrams (mg) per kilogram of body weight of trimethoprim, given in two divided doses every 12 hours for 10 days.
• Infants younger than 2 months of age: the use of Biseptol® is not recommended

For treatment of Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP):

• Children aged more than 3 months, the dose is calculated based on body weight and must be determined by your doctor. The usual dose is 75 to 100 milligrams (mg) per kilogram of body weight of sulfamethoxazole and 15 to 20 milligrams (mg) per kilogram of body weight of trimethoprim each day, given in equally divided doses every 6 hours for 14 to 21 days.
• Children younger than 2 months of age the use of Biseptol® is not recommended.

For traveler’s diarrhea:

• Children 2 months of age and older: use and dose must be determined by your doctor.
• Children younger than 2 months of age: the use of Biseptol® is not recommended.

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Biseptol® (Sulfamethoxazole and Trimethoprim) available?

Biseptol® is available in the following dosage forms and strengths:

• Tablet of 400 mg sulfamethoxazole and 80 mg of trimethoprim.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services (115) or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Biseptol®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.