Sulfamethox/tmp 800-160mg/10ml Inj

Sulfamethoxazole (SMX) inhibits bacterial dihydrofolate synthesis by competing with para-aminobenzoic acid (PABA) for the enzyme dihydropteroate synthase. Trimethoprim (TMP) inhibits bacterial dihydrofolate reductase, an enzyme that reduces dihydrofolic acid to tetrahydrofolic acid. This sequential blockade of two enzymes in the bacterial folic acid synthesis pathway results in a synergistic bactericidal effect, preventing the formation of essential purines, thymidine, and DNA.

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 Reaction: 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.
Other Serious Side Effects:
+ Muscle or joint pain
+ Purple patches on the skin or mouth
+ Hallucinations (seeing or hearing things that are not there)
+ Depression or mood changes
+ Burning, numbness, or tingling sensations
+ Ringing in the ears
+ Swollen glands
+ Chest pain
+ Pale skin
+ Severe dizziness or fainting

Antibiotic-Associated Diarrhea:

Diarrhea is a common side effect of antibiotics. However, a severe form called Clostridioides difficile-associated diarrhea (CDAD) can occur, which may 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.

Rare but Serious Side Effects:

Sulfa Drug Reactions: Liver problems, blood problems, and severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) can occur. Seek medical help if you experience a rash, red, swollen, blistered, or peeling skin, red or irritated eyes, mouth, throat, nose, or eye sores, fever, chills, sore throat, cough, fatigue, weakness, bruising, or bleeding, or signs of liver problems (dark urine, tiredness, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes).
Aseptic Meningitis: This medication may increase the risk of a severe brain problem called aseptic meningitis. Contact your doctor immediately if you experience headache, fever, chills, severe nausea and vomiting, stiff neck, rash, sensitivity to light, sleepiness, or confusion.
Hemophagocytic Lymphohistiocytosis (HLH): This is a rare, life-threatening immune system problem. Seek medical help if you experience fever, swollen glands, rash, seizures, confusion, balance changes, or difficulty walking.

Vein Irritation:

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

Other Side Effects:

Most people do not experience severe side effects, but some may occur. Contact your doctor if you experience any of the following:

Diarrhea
Stomach pain
Nausea and vomiting
* Decreased appetite

These are not all the possible 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 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 and situations 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 reactions you have experienced.
A diagnosis of anemia caused by a lack of folic acid.
Presence of kidney disease or liver disease.
Certain health conditions, including:
+ Asthma
+ Porphyria
+ Thyroid disease
+ Folate deficiency
+ Malabsorption
+ Poor nutrition
Long-term alcohol consumption or use of antiseizure 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
+ Pyrimethamine
Recent or current use of the following drugs:
+ Benazepril
+ Captopril
+ Enalapril
+ Fosinopril
+ Lisinopril
+ Moexipril
+ Perindopril
+ Quinapril
+ Ramipril
+ Trandolapril
Use of diuretics (water pills).
For children: If your child is under 2 months of age, do not administer this medication, as it is not recommended for infants younger than 2 months.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. This will help ensure your safety while taking this medication. Never start, stop, or change the dose 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 laboratory tests should be conducted as directed by your doctor, as this drug may interfere with certain lab tests. Be sure to notify all healthcare providers and laboratory personnel that you are taking this medication.

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 glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Additionally, consult with your doctor before consuming alcohol.

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 excessive sunburning while taking this medication.

In rare cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms such as fever, rash, swollen glands, and organ dysfunction (including liver, kidney, blood, heart, muscle, joint, or lung problems). 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 immediately contact their doctor, as it may harm the unborn baby. If you are breastfeeding, consult with your doctor to discuss potential risks to your baby.

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

Some products may contain benzyl alcohol, which can cause serious side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. Consult with your doctor to determine if this product contains benzyl alcohol and to discuss alternative options.

• Dofetilide (increased dofetilide concentrations, risk of QT prolongation and Torsades de Pointes)

• Warfarin (potentiates anticoagulant effect, increased INR and bleeding risk)
• Methotrexate (increased methotrexate toxicity due to displacement from protein binding and inhibition of renal tubular secretion)
• Phenytoin (increased phenytoin levels due to inhibition of metabolism)
• Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene) - increased risk of severe hyperkalemia
• ACE inhibitors / Angiotensin Receptor Blockers (ARBs) - increased risk of hyperkalemia
• Cyclosporine (increased risk of nephrotoxicity, decreased cyclosporine levels)
• Lamivudine (increased lamivudine levels)
• Procainamide (increased procainamide levels)

• Digoxin (increased digoxin levels, especially in elderly patients)
• Sulfonylureas (e.g., glipizide, glyburide) - increased risk of hypoglycemia
• Thiazide diuretics (increased risk of thrombocytopenia with purpura in elderly patients)
• Rifampin (decreased trimethoprim levels)
• Amantadine (increased amantadine levels, risk of toxicity)
• Memantine (increased memantine levels, risk of toxicity)
• Tricyclic antidepressants (TCAs) - increased TCA levels
• Pyrimethamine (increased risk of megaloblastic anemia)

• Oral contraceptives (potential for reduced efficacy, though clinical significance is debated)
• Indomethacin (increased sulfamethoxazole levels)

• Skin rash (including severe forms like Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis)
• Fever
• Sore throat
• Unusual bleeding or bruising
• Jaundice (yellowing of skin or eyes)
• Dark urine
• Severe diarrhea
• Signs of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, palpitations)
• Signs of hypersensitivity reactions (e.g., swelling of face/tongue, difficulty breathing)

Category D. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid, especially in the first and third trimesters.

Both sulfamethoxazole and trimethoprim are excreted into breast milk. Use with caution. Avoid in premature infants, jaundiced infants, infants with G6PD deficiency, or infants with hyperbilirubinemia due to the risk of kernicterus.

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

Increased risk of severe adverse reactions, including severe skin reactions (SJS/TEN), bone marrow suppression (especially thrombocytopenia with purpura when co-administered with thiazide diuretics), hyperkalemia, and renal impairment. Dose adjustment is often necessary due to age-related decline in renal function. Close monitoring of renal function, electrolytes, and CBC is crucial.

• Sulfamethoxazole/Trimethoprim IV must be diluted prior to infusion. It should be diluted in 5% Dextrose in Water (D5W) and infused over 60-90 minutes. Do NOT administer by rapid infusion or bolus.
• Do NOT administer intramuscularly (IM).
• Compatibility with other IV fluids is limited; D5W is the preferred diluent. Avoid mixing with solutions containing sodium chloride or other electrolytes, especially Lactated Ringer's solution, as precipitation may occur.
• Crystalluria and renal stone formation can occur, especially with inadequate hydration. Ensure adequate fluid intake during therapy.
• This combination is a common cause of drug-induced hyperkalemia, particularly in patients with renal impairment, elderly patients, or those on ACE inhibitors, ARBs, or potassium-sparing diuretics.
• High doses (e.g., for PCP treatment) are associated with a higher incidence of adverse effects, including rash, fever, bone marrow suppression, and hyperkalemia.
• Resistance to SMX/TMP is increasing, particularly in community-acquired MRSA and some Gram-negative bacteria. Susceptibility testing is crucial for guiding therapy.
• Consider folate supplementation (e.g., leucovorin) in patients receiving high-dose or prolonged therapy, or those at risk for folate deficiency, to mitigate hematologic toxicity, especially if bone marrow suppression occurs.

• Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin) for UTIs, respiratory infections
• Beta-lactam antibiotics (e.g., Ceftriaxone, Piperacillin/Tazobactam) for various severe infections
• Carbapenems (e.g., Meropenem, Imipenem/Cilastatin) for severe or resistant infections
• Clindamycin + Primaquine or Pentamidine for PCP treatment (in cases of SMX/TMP intolerance or failure)
• Doxycycline or Minocycline for Nocardiosis

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.