Patient Medication Information: uses, side effects, how to take - Apo-Sulfatrim Oral Suspension
Serious Warnings and Precautions
APO-SULFATRIM ORAL SUSPENSION can cause serious side effects. If you get any of these side effects, stop taking APO-SULFATRIM ORAL SUSPENSION and get immediate medical help:
For further information and symptoms see:
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What is APO-SULFATRIM ORAL SUSPENSION used for?
APO-SULFATRIM ORAL SUSPENSION is used to treat:
- urinary tract infections;
- lung infections such as bronchitis or pneumonia (a lung infection caused by fungi);
- gastrointestinal (stomach and bowel) infections such as cholera or dysentery;
- nocardiosis, an infection of the lungs or other parts of the body;
- brucellosis which is a disease spread from animals to humans. When used to treat brucellosis it is used along with another medicine, gentamicin or rifampicin.
Antibacterial drugs like APO-SULFATRIM ORAL SUSPENSION treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, APO-SULFATRIM ORAL SUSPENSION should be used exactly as directed. Misuse or overuse of APO-SULFATRIM ORAL SUSPENSION could lead to the growth of bacteria that will not be killed by APO-SULFATRIM ORAL SUSPENSION (resistance). This means that APO-SULFATRIM ORAL SUSPENSION may not work for you in the future.
How does APO-SULFATRIM ORAL SUSPENSION work?
APO-SULFATRIM ORAL SUSPENSION contains two different antibiotics called sulfamethoxazole and trimethoprim. They work together to kill or to slow or stop the growth of bacteria or fungi that cause disease. This means that APO-SULFATRIM ORAL SUSPENSION can be given to prevent or to treat certain kinds of infectious diseases.
What are the ingredients in APO-SULFATRIM ORAL SUSPENSION?
Medicinal ingredients: Sulfamethoxazole and trimethoprim
Non-medicinal ingredients: Amaranth dye, artificial cherry flavour, carboxymethylcellulose, FD&C Yellow 6, glycerine, microcrystalline cellulose, polysorbate, purified water, sodium cyclamate and sorbitol solution.
APO-SULFATRIM ORAL SUSPENSION comes in the following dosage forms:
Oral suspension: containing 40 mg sulfamethoxazole and 8 mg trimethoprim in each mL. Supplied in bottles of 100 mL and 400 mL.
Do not use APO-SULFATRIM ORAL SUSPENSION if:
- you are allergic to sulfamethoxazole, trimethoprim or any of the other ingredients, in APO-SULFATRIM ORAL SUSPENSION;
- you are allergic to sulphonamide medicines. Examples include diabetes medicines (such as gliclazide and glibenclamide). Talk to your healthcare professional if you are allergic to a medicine and you are not sure if it is a sulphonamide medicine causing bruises or bleeding (thrombocytopenia);
- you have liver problems;
- you have kidney problems;
- you have blood problems;
- you are pregnant;
- you are breastfeeding;
- you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system.
Children
If it is for your child, APO-SULFATRIM ORAL SUSPENSION should not be given if they are less than 2 months old.
If you are not sure if any of the above apply to you, talk to your healthcare professional before being given APO-SULFATRIM ORAL SUSPENSION.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-SULFATRIM ORAL SUSPENSION. Talk about any health conditions or problems you may have, including if you:
- have severe allergies or asthma;
- you don’t have enough folic acid (a vitamin) in your body called folate deficiency;
- you are underweight or malnourished;
- you have a disease called glucose-6-phosphate dehydrogenase deficiency;
- you are at risk for a rare blood disorder called porphyria, which can affect your skin or nervous system;
- you have been told by your healthcare professional that you have a high level of potassium in your blood;
- you have been told by your healthcare professional that you have a low level of sodium or albumin in your blood;
- you have been told by your healthcare professional that you have any serious disorder of the blood or blood forming tissues such as low blood cell counts;
- you have existing heart or lung disease, which may lead to a build-up of fluid in your body;
- you have hereditary disorder called phenylketonuria and are not on a special diet to help your condition;
- you are human immunodeficiency virus (HIV) positive or have a condition called Acquired Immunodeficiency Syndrome (AIDS);
- if you have kidney problems.
Other warnings you should know about:
Use in Elderly Patients
Elderly patients are more likely to get serious side effects when receiving APO-SULFATRIM ORAL SUSPENSION. This is increased if you have kidney or liver disease or are taking some types of other medicines, such as diuretics.
Pregnancy and Breastfeeding
Talk to your healthcare professional before taking this medicine if you are planning to get pregnant or planning to breastfeed. You should not receive APO-SULFATRIM ORAL SUSPENSION if you are pregnant or are breastfeeding.
Use in Patients with Acquired Immunodeficiency Syndrome (AIDS)
If you have AIDS, you may be more likely to get side effects when receiving APO-SULFATRIM ORAL SUSPENSION. These may include rash, severe allergic reactions, fever or low blood cell counts.
Gastrointestinal - C. difficile colitis
APO-SULFATRIM ORAL SUSPENSION may increase your risk of being infected with a bacteria called C. difficile. Symptoms include watery diarrhea that happens three or more times per day or diarrhea associated with abdominal cramping.
Driving and using machines
After you are given APO-SULFATRIM ORAL SUSPENSION you may feel weak, tired, dizzy, or confused. Before driving a vehicle or using machinery wait to see how you feel after being given APO-SULFATRIM ORAL SUSPENSION.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-SULFATRIM ORAL SUSPENSION:
- medicines to remove excess water from the body knows as diuretics (water pills) such as spironolactone;
- medicines to treat malaria such as pyrimethamine;
- medicines to treat Human Immunodeficiency Virus (HIV) such as zidovudine or lamivudine;
- medicines to thin the blood such as warfarin;
- medicines to treat epilepsy (fits) and seizures such as phenytoin;
- medicines to treat cancer or arthritis such as methotrexate;
- medicines to treat heart conditions such as digoxin or procainamide;
- medicines that can increase the amount of potassium in your blood, such as steroids (like prednisolone) and heart and high blood pressure medicines;
- medicines used after organ transplantation such as cyclosporine;
- medicines to treat Parkinson’s disease, multiple sclerosis, the flu or shingles such as amantadine;
- medicines to treat diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas) and repaglinide;
- medicines to treat bacterial infections such as rifampicin;
- medicines used after cancer treatment or to help with low levels of folate such as folinic acid;
- medicines to help prevent pregnancy such as contraceptives.
Drug-Food Interactions
- Tell your healthcare professional if you have special dietary needs, especially if you are following a potassium rich diet. Potassium rich foods include beans, dark leafy greens, potatoes, squash, yogurt, fish, avocados, mushrooms and bananas.
How to take APO-SULFATRIM ORAL SUSPENSION:
- Be sure to drink lots of fluids while taking APO-SULFATRIM ORAL SUSPENSION.
- Your healthcare professional will decide how much APO-SULFATRIM ORAL SUSPENSION you should take and for how long you should take it.
- Although you may feel better early in treatment, APO-SULFATRIM ORAL SUSPENSION should be used exactly as directed.
- Misuse or overuse of APO-SULFATRIM ORAL SUSPENSION could lead to the growth of bacteria that will not be killed by APO-SULFATRIM ORAL SUSPENSION (resistance). This means that APO-SULFATRIM ORAL SUSPENSION may not work for you in the future.
- Do not share your medicine.
Usual dose:
- Your healthcare professional will decide how much APO-SULFATRIM ORAL SUSPENSION you will receive.
The dose you are given and how often you are given it will depend on:
- your infection;
- your weight;
- your age.
Children under 12 years old:
- Your doctor will tell you how much APO-SULFATRIM ORAL SUSPENSION to give your child. This dose will be based on your child’s weight.
Overdose:
If you have been given too much APO-SULFATRIM ORAL SUSPENSION, you may have the following signs or symptoms:
- anorexia (extreme fear of gaining weight);
- colic (severe pain in the abdomen caused by gas);
- nausea and vomiting;
- dizziness, drowsiness or confusion;
- fainting;
- headache;
- pyrexia (fever);
- hematuria (blood in urine);
- crystalluria (cloudy urine);
- jaundice (yellowing of the skin or whites of the eye);
- feeling depressed.
| If you think you, or a person you are caring for, have taken too much APO-SULFATRIM ORAL SUSPENSION, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
- If you miss a dose, take it as soon as you remember.
- If it is almost time for your next dose, skip the missed dose and resume your usual dosing schedule.
- Never take two doses to make up for a missed dose.
What are possible side effects from using APO-SULFATRIM ORAL SUSPENSION?
These are not all the possible side effects you may feel when taking APO-SULFATRIM ORAL SUSPENSION. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Feeling weak or tired;
- Trouble sleeping;
- Vision problems;
- Hair loss;
- Nose bleed;
- Swelling of body tissues with fluid;
- Chills;
- Sensitivity to sunlight;
- Palpitations (heart beat that feels too fast, strong or irregular);
- Cold sores, ulcers, or soreness of your tongue or inside of your mouth;
- Dry mouth;
- Heartburn;
- Abdominal pain or gas;
- Constipation;
- Nausea, vomiting and diarrhea;
- Loss of appetite;
- Passing more or less urine than usual; difficulty reaching bathroom in time;
- Muscle and joint pain or muscle weakness;
- Tingling or numbness in your hands and feet;
- Problems controlling your movements;
- Uncontrollable shaking;
- Vertigo (sensation of movement or feeling off balance);
- Ringing or other unusual sounds in your ears;
- Headache;
- Inflammation of your eye that causes pain and redness;
- Depression;
- Apathy (indifference and a lack of motivation);
- Feeling unsteady or dizzy;
- Anorexia (extreme fear of gaining weight);
- Tooth and/or tongue discoloration.
APO-SULFATRIM ORAL SUSPENSION can cause abnormal blood test results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Allergic reactions: swelling of face, mouth, tongue or throat which may be red and painful and/or cause difficulty in swallowing; red patches on the skin; rash; hives; fever (high temperature); joint pain; feeling sick (nausea); being sick (vomiting); chest pain. | √ | ||
| Stevens-Johnson syndrome (severe skin rash); redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands. | √ | ||
| Toxic Epidermal Necrolysis (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | √ | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect more than one organ): fever, severe skin rash, peeling skin, and abnormal blood and liver function | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| tests | |||
| Difficulty breathing, cough, wheezing, shortness of breath, tightness of the chest. | √ | ||
| Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by infection): including sudden headache or stiffness of your neck, accompanied by fever, nausea, vomiting, sensitivity to light. | √ | ||
| Acute inflammation of the small and large intestine Pseudomembranous colitis: including watery or bloody diarrhea, abdominal cramps, pain or tenderness, fever, nausea, dehydration. | √ | ||
| Fits (convulsions or seizures) | √ | ||
| Heart problems: Increased heart rate, chest pain, shortness of breath). | √ | ||
| Pancreatitis (Acute inflammation of the pancreas): including upper abdominal pain that spreads to the back, swollen and tender abdomen, nausea, vomiting, fever. | √ | ||
| Hypoglycaemia (an abnormally low level of sugar in the blood): including dizziness or light-headedness, shakiness, nervousness or anxiety, feeling confused, sweating, chills. | √ | ||
| Problems with your urine; pain or difficulty passing urine, blood or cloudiness in your urine. | √ | ||
| Hepatitis (inflammation of the liver): fatigue, fever, body ache, abdominal pain, dark urine or pale stools, difficulty to urinate. | √ | ||
| Jaundice (yellowing of the skin and whites of the eyes). | √ | ||
| An infection called thrush or candidiasis which can affect your mouth or vagina. | √ | ||
| Hallucinations: Seeing, hearing, smelling, tasting or feeling things that don't exist outside your mind. | √ | ||
| Immune thrombocytopenia: including being easily bruised, a rash on the skin that appears tiny pinpoint-sized reddish or purple spots, usually on the lower legs, bleeding from the gums or nose, and | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| blood in the urine or stool. | |||
| Aplastic anemia: including feeling tired, feeling short of breath, pale skin, unexplained or easy bruising, fever, chills, sore throat, and a general feeling of being unwell. | √ | ||
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
| √ | ||
| Angioedema: swelling of the face, hands, feet, genitals, tongue or throat, difficulty swallowing or breathing; swelling of the digestive tract which may cause diarrhea, nausea or vomiting | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning | √ | ||
| Haemophagocytic lymphohistiocytosis (condition where your white blood cells attack your organs and other blood cells): fever, enlarged liver and spleen, swollen lymph nodes, skin rashes, yellowing of your skin and eyes, breathing problems, stomach ache, vomiting and diarrhea, headache, trouble walking, feeling weak and bruising easily. This can be serious and lead to death. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
APO-SULFATRIM ORAL SUSPENSION should be stored at room temperature between 15°C to 30°C. Protect from light.
Keep out of reach and sight of children.
If you want more information about APO-SULFATRIM ORAL SUSPENSION:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.