Patient Medication Information: uses, side effects, how to take - Sulfamethoxazole and Trimethoprim for Injection, USP (Auro Pharma)
Serious Warnings and Precautions
Sulfamethoxazole and Trimethoprim for Injection, USP can cause serious side effects. If you get any of these side effects, stop taking Sulfamethoxazole and Trimethoprim for Injection, USP and get immediate medical help:
For further information and symptoms see:
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What is Sulfamethoxazole and Trimethoprim for Injection, USP used for?
Sulfamethoxazole and Trimethoprim for Injection, USP 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 Sulfamethoxazole and Trimethoprim for Injection, USP treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, Sulfamethoxazole and Trimethoprim for Injection, USP should be used exactly as directed. Misuse or overuse of Sulfamethoxazole and Trimethoprim for Injection, USP could lead to the growth of bacteria that will not be killed by Sulfamethoxazole and Trimethoprim for Injection, USP (resistance). This means that Sulfamethoxazole and Trimethoprim for Injection, USP may not work for you in the future.
How does Sulfamethoxazole and Trimethoprim for Injection, USP work?
Sulfamethoxazole and Trimethoprim for Injection, USP 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 Sulfamethoxazole and Trimethoprim for Injection, USP can be given to prevent or to treat certain kinds of infectious diseases.
What are the ingredients in Sulfamethoxazole and Trimethoprim for Injection, USP?
Medicinal ingredients: trimethoprim and sulfamethoxazole
Non-medicinal ingredients: Benzyl alcohol, dehydrated alcohol, diethanolamine, Propylene glycol, sodium hydroxide, sodium metabisulphite and water for injection.
Sulfamethoxazole and Trimethoprim for Injection, USP comes in the following dosage forms:
Solution for the preparation of intravenous infusions: sulfamethoxazole (80 mg / mL) + trimethoprim (16 mg / mL).
Do not use Sulfamethoxazole and Trimethoprim for Injection, USP if:
- you are allergic to sulfamethoxazole, trimethoprim or any of the other ingredients, including sodium metabisulfite (a sulfite preservative), in Sulfamethoxazole and Trimethoprim for Injection, USP;
- 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, Sulfamethoxazole and Trimethoprim for Injection, USP 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 Sulfamethoxazole and Trimethoprim for Injection, USP.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sulfamethoxazole and Trimethoprim for Injection, USP. Talk about any health conditions or problems you may have, including if you:
- have severe allergies or asthma;
- don’t have enough folic acid (a vitamin) in your body called folate deficiency;
- are underweight or malnourished;
- have a disease called glucose-6-phosphate dehydrogenase deficiency;
- are at risk for a rare blood disorder called porphyria, which can affect your skin or nervous system;
- have been told by your healthcare professional that you have a high level of potassium in your blood;
- have been told by your healthcare professional that you have a low level of sodium or albumin in your blood;
- 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;
- have existing heart or lung disease, which may lead to a build-up of fluid in your body;
- have hereditary disorder called phenylketonuria and are not on a special diet to help your condition;
- are human immunodeficiency virus (HIV) positive or have a condition called Acquired Immunodeficiency Syndrome (AIDS);
- have kidney problems.
Other warnings you should know about:
Use in Young Children (less than 3 years old)
Young children (less than 3 years old) should not receive Sulfamethoxazole and Trimethoprim for Injection, USP for more than a week, unless advised by a healthcare professional.
Use in Patients with Liver or Kidney Problems
Ask your healthcare professional for advice if you have liver or kidney problems. This is because large amounts of benzyl alcohol can build-up in your body, which may lead to metabolic acidosis (acid in the blood).
Use in Elderly Patients
Elderly patients are more likely to get serious side effects when receiving Sulfamethoxazole and Trimethoprim for Injection, USP. 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 Sulfamethoxazole and Trimethoprim for Injection, USP 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 Sulfamethoxazole and Trimethoprim for Injection, USP. These may include rash, severe allergic reactions, fever or low blood cell counts.
Use in patients who have taken sulfamethaxole-trimethoprim recently such as in the past days to weeks
If you have recently taken the medicines in Sulfamethoxazole and Trimethoprim for Injection, USP, sulfamethaxole and trimethoprim, you could get serious reactions after taking Sulfamethoxazole and Trimethoprim for Injection, USP. These include circulatory shock with fever, very low blood pressure and confusion. See the Serious side effects and what to do about them table for symptoms.
Gastrointestinal - C. difficile colitis
Sulfamethoxazole and Trimethoprim for Injection, USP 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 Sulfamethoxazole and Trimethoprim for Injection, USP you may feel weak, tired, dizzy, or confused. Before driving a vehicle or using machinery wait to see how you feel after being given Sulfamethoxazole and Trimethoprim for Injection, USP.
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 Sulfamethoxazole and Trimethoprim for Injection, USP:
- 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;
- medicine used to treat irregular heartbeats (arrhythmias), such as dofetilide;
- leucovorin, a medicine used to treat a type of pneumonia in patients with Acquired immunodeficiency syndrome (AIDS).
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 Sulfamethoxazole and Trimethoprim for Injection, USP:
- Sulfamethoxazole and Trimethoprim for Injection, USP will be given to you by a healthcare professional in a healthcare setting.
- It will be given to you as a continuous infusion into your vein. This is where a medicine is slowly given to you over a period of time. Your healthcare professional will dilute Sulfamethoxazole and Trimethoprim for Injection, USP before giving it to you. You should drink plenty of fluids while receiving Sulfamethoxazole and Trimethoprim for Injection, USP.
Usual dose:
- Your healthcare professional will decide how much Sulfamethoxazole and Trimethoprim for Injection, USP you will receive.
The dose you are given and how often you are given it will depend on:
- your infection;
- your weight;
- your age
Overdose:
If you have been given too much Sulfamethoxazole and Trimethoprim for Injection, USP 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 Sulfamethoxazole and Trimethoprim for Injection, USP, 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:
Your healthcare professional will inject this medicine into you. If you miss a scheduled injection talk to your healthcare professional as soon as possible.
What are possible side effects from using Sulfamethoxazole and Trimethoprim for Injection,
USP?
These are not all the possible side effects you may have when taking Sulfamethoxazole and Trimethoprim for Injection, USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Feeling weak or tired;
- Trouble sleeping;
- Vision problems;
- Hair loss;
- Nose bleed;
- Inflammation at the site of injection;
- 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);
Sulfamethoxazole and Trimethoprim for Injection, USP 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 tests | √ | ||||||
|---|---|---|---|---|---|---|---|
Acute febrile neutrophilic dermatosis (Sweet’s syndrome) (a serious skin condition): plum- | √ | ||||||
| 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 | ||||||
| coloured, raised, painful sores on the limbs and sometimes on the face and neck with a fever | |||||||
| Acute generalised exanthematous pustulosis (AGEP) (a serious skin condition): very rare cases of redness generalising to the whole body | √ | ||||||
| Lung problems: 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 | √ | ||||||
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| Fits (convulsions or seizures) | √ | ||||||
| Heart problems: increased heart rate, chest pain, shortness of breath | √ | ||||||
Pancreatitis (acute inflammation of the pancreas): including upper abdominal pain | √ | ||||||
| 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 | ||||||
| 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 | √ | ||||||
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| 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 blood in the urine or stool | √ | ||||||
| Haemophagocytic | |||||||
| 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 | ||||||
| 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 | √ | ||||||
| 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):
| √ | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
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| 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 | √ | ||||||
| Metabolic acidosis (acid in the blood): unexplained tiredness, loss of appetite, vomiting, irregular heartbeat and impaired consciousness | √ | ||||||
| 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, stomachache, vomiting and diarrhea, headache, trouble walking, trouble walking, feeling weak and bruising easily. This can be serious and lead to death. | √ |
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If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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:
Store Sulfamethoxazole and Trimethoprim for Injection, USP between 15° and 30°C. Protect from light. Keep out of reach and sight of children.
If you want more information about Sulfamethoxazole and Trimethoprim for Injection, USP:
- 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 www.auropharma.ca , or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.