Sulfamethox/tmp 400-80mg/5ml Inj

Sulfamethoxazole inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA). Trimethoprim blocks the production of tetrahydrofolic acid by inhibiting the enzyme dihydrofolate reductase. This sequential blockade of two enzymes in the bacterial folic acid pathway results in a synergistic antibacterial effect, leading to bacterial cell death.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
Low blood sugar: Dizziness, headache, sleepiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Low sodium levels: Headache, difficulty focusing, memory problems, confusion, weakness, seizures, or balance changes.
Lung or breathing problems: Shortness of breath, trouble breathing, cough, or fever.
Pancreas problems (pancreatitis): Severe stomach pain, severe back pain, or severe nausea and vomiting.
Musculoskeletal issues: Muscle or joint pain.
Skin and mucous membrane issues: Purple patches on the skin or mouth.
Neurological issues: Hallucinations (seeing or hearing things that are not there), depression, or mood changes.
Numbness or tingling: Abnormal burning, numbness, or tingling sensations.
Hearing issues: Ringing in the ears.
Swollen glands: Enlarged lymph nodes.
Cardiovascular issues: Chest pain or pale skin.
Severe dizziness or fainting: Sudden loss of balance or consciousness.

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Rare but Serious Side Effects

Rarely, severe and potentially life-threatening side effects have occurred with sulfa drugs, including:

Liver problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes.
Blood problems: Unusual bruising or bleeding.
Severe skin reactions: Stevens-Johnson syndrome or toxic epidermal necrolysis, characterized by rash, red, swollen, blistered, or peeling skin, red or irritated eyes, mouth, throat, or nose sores, fever, chills, or sore throat.

Other Serious Side Effects

Aseptic meningitis: A severe brain problem that can cause headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, sleepiness, or confusion.
Hemophagocytic lymphohistiocytosis (HLH): A life-threatening immune system problem that can cause fever, swollen glands, rash, seizures, confusion, balance changes, or difficulty walking.

Infusion Site Reactions

If the medication leaks from the vein, it may cause irritation around the infusion site. Inform your nurse if you experience redness, burning, pain, swelling, or fluid leakage at the infusion site.

Common Side Effects

Many people experience no side effects or only minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Diarrhea
Stomach pain
Nausea
Vomiting
* Decreased appetite

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms.
A diagnosis of anemia caused by a lack of folic acid.
Presence of kidney disease or liver disease.
Any of the following health conditions: asthma, porphyria, thyroid disease, low folate levels, poor absorption, or poor nutrition.
Long-term alcohol consumption or current treatment with seizure medications.
A history of low platelet count when taking trimethoprim or sulfa (sulfonamide) drugs.
Concurrent use of the following medications: amantadine, cyclosporine, dofetilide, indomethacin, leucovorin, methotrexate, or pyrimethamine.
Recent or current use of the following drugs: benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.
* Use of diuretics (water pills).

Special Considerations for Children:
If your child is under 2 months of age, do not administer this medication. It is not approved for use in infants younger than 2 months.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Never start, stop, or modify the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and lab tests, as directed by your doctor, are crucial to monitor your condition. Be aware that this medication may interfere with certain lab tests, so it is vital to notify all your healthcare providers and lab personnel that you are taking this drug.

Do not exceed the recommended duration of treatment, as this may increase the risk of a second infection. If you have a deficiency of the enzyme G6PD (glucose-6-phosphate dehydrogenase), you may be more susceptible to anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent, so it is crucial to discuss this with your doctor.

If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication. It is also recommended to consult with your doctor before consuming alcohol. Additionally, this medication may increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and inform your doctor if you experience any unusual sunburn or sensitivity.

In rare cases, this medication can cause a severe and potentially life-threatening reaction, characterized by symptoms such as fever, rash, swollen glands, and problems with organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have any concerns or questions, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Women who are pregnant or become pregnant while taking this medication should contact their doctor immediately, as it may harm the unborn baby. If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

Individuals with a sulfite allergy should inform their doctor, as some products may contain sulfites. This medication contains propylene glycol, which can cause serious health problems, including nervous system problems, kidney problems, or other organ problems, if excessive amounts are consumed. If you have any questions or concerns, discuss them with your doctor.

Some products may also contain benzyl alcohol, which can cause serious side effects in newborns and infants. If possible, avoid products containing benzyl alcohol in these age groups, and consult with your doctor to determine if this product contains benzyl alcohol.

• Dofetilide (increased dofetilide levels, risk of QT prolongation and Torsades de Pointes)
• Methenamine (risk of crystalluria)

• Warfarin (potentiates anticoagulant effect, increased bleeding risk)
• Methotrexate (increased methotrexate levels, increased risk of myelosuppression)
• Phenytoin (increased phenytoin levels, increased toxicity)
• Digoxin (increased digoxin levels, especially in elderly)
• Cyclosporine (decreased cyclosporine levels, increased nephrotoxicity)
• ACE inhibitors/ARBs/Potassium-sparing diuretics (increased risk of hyperkalemia)
• Spironolactone (increased risk of severe hyperkalemia)
• Thiazide diuretics (increased risk of thrombocytopenia with purpura in elderly)
• Pyrimethamine (increased risk of megaloblastic anemia)

• Oral hypoglycemics (sulfonylureas - increased hypoglycemic effect)
• Rifampin (decreased trimethoprim levels)
• Amantadine (increased amantadine levels, increased toxicity)
• Procainamide (increased procainamide levels)
• Zidovudine (increased zidovudine levels, increased hematologic toxicity)
• Tricyclic antidepressants (increased TCA levels)

• Indomethacin (increased sulfamethoxazole levels)
• Diuretics (increased risk of thrombocytopenia in elderly)

• Skin rash (especially severe, blistering, or peeling)
• Fever
• Sore throat
• Unusual bleeding or bruising
• Jaundice (yellowing of skin or eyes)
• Dark urine
• Pale stools
• Severe diarrhea (especially if bloody or watery)
• Signs of superinfection (e.g., new or worsening fever, oral thrush, vaginal yeast infection)
• Signs of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, bradycardia)

Category D. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use during the first trimester due to potential teratogenic effects (folate antagonism) and near term due to risk of kernicterus in the newborn.

Excreted in breast milk. Use with caution. Risk of kernicterus in jaundiced, premature, or G6PD-deficient infants. Generally considered compatible with breastfeeding for healthy, full-term infants after the neonatal period (first 2 months), but monitor for adverse effects.

Contraindicated in infants less than 2 months of age due to the risk of kernicterus. Use with caution in children with G6PD deficiency due to risk of hemolytic anemia. Dosage is weight-based for children >2 months.

Increased risk of severe adverse reactions, including hyperkalemia, severe skin reactions, bone marrow depression, and renal impairment. Close monitoring of renal function, electrolytes, and CBC is essential. Use lower doses and monitor frequently.

• Always dilute the injection prior to administration and infuse over 60-90 minutes. Do NOT administer by rapid infusion or bolus injection.
• Ensure adequate hydration to prevent crystalluria and stone formation.
• Monitor for signs of hypersensitivity reactions, including severe skin rashes (SJS/TEN), which can be fatal. Discontinue at the first sign of rash.
• Be vigilant for hyperkalemia, especially in elderly patients, those with renal impairment, or those on concomitant medications that increase potassium.
• This drug can cause false elevations in creatinine levels due to interference with certain laboratory assays, without actual renal dysfunction.
• Consider folate supplementation in patients at risk for folate deficiency (e.g., elderly, malnourished, chronic alcoholics, long-term therapy) to mitigate hematologic side effects.

• For UTIs: Fluoroquinolones (e.g., ciprofloxacin, levofloxacin), Beta-lactams (e.g., amoxicillin/clavulanate, ceftriaxone), Nitrofurantoin, Fosfomycin.
• For PCP: Pentamidine (IV), Atovaquone, Clindamycin + Primaquine.
• For Nocardiosis: Imipenem, Amikacin, Linezolid.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.