Medication info

Cotrim Injection

Prescription medication정맥Approval withdrawn
Ingredient · strength
Sulfamethoxazole›80mg / 1mLTrimethoprim›16mg / 1mL
Manufacturer / importer
대원제약(주)
Appearance
A colorless and transparent liquid filled in a brown ampoule
Packaging
5mL/ampoule X 10
Approval status
Approval withdrawn

MFDS item code 200606446 · Notified 2006.10.27

This product's status changed to Approval withdrawn on 2024.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urogenital (cystitis, gonorrhea) infections
Who receives it
Adults · Children
Adult administration
Adults and children over 12 years old should receive 10 mL intravenously twice daily at 12-hour intervals. In case of severe infections, 15 mL should be administered. For patients with kidney impairment, adjust the dosage according to creatinine clearance; normal dosage for clearance over 30, half the normal dosage for 15-30, and administration is not recommended for clearance under 15. For Pneumocystis carinii pneumonia, administer 20 mg of trimethoprim per kg of body weight.
Child administration
Children under 12 years old should be administered 6 mg of trimethoprim and 30 mg of sulfamethoxazole per kg of body weight, divided into two doses daily. Ages 6 to 11: 5 mL once, twice a day. Ages 6 months to 5 years: 1.25 mL once, twice a day.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia) and urogenital (cystitis, gonorrhea) infections

  • Acute/chronic bronchitis
  • bronchiectasis
  • pneumonia
  • sinusitis
  • otitis media
  • acute/chronic cystitis
  • pyelonephritis
  • urethritis
  • prostatitis
  • gonorrhea
  • typhoid fever
  • paratyphoid fever
View approved original text

This medication is effective against various bacterial infections. It is used for respiratory infections such as acute and chronic bronchitis, bronchiectasis, and pneumonia. It is also effective for upper respiratory infections, including sinusitis and otitis media. It helps treat urogenital infections such as acute and chronic cystitis, pyelonephritis, urethritis, prostatitis, and gonorrhea. It is used for treating intestinal infections such as typhoid fever, paratyphoid fever, enteritis, and bacillary dysentery. This medication is used for treating infections caused by various bacteria.

How it is given

Adult administration

Adults and children over 12 years old should receive 10 mL intravenously twice daily at 12-hour intervals. In case of severe infections, 15 mL should be administered. For patients with kidney impairment, adjust the dosage according to creatinine clearance; normal dosage for clearance over 30, half the normal dosage for 15-30, and administration is not recommended for clearance under 15. For Pneumocystis carinii pneumonia, administer 20 mg of trimethoprim per kg of body weight.

Child administration

Children under 12 years old should be administered 6 mg of trimethoprim and 30 mg of sulfamethoxazole per kg of body weight, divided into two doses daily. Ages 6 to 11: 5 mL once, twice a day. Ages 6 months to 5 years: 1.25 mL once, twice a day.

Precautions

This medication can cause severe skin reactions and serious blood, liver, and kidney diseases. If any symptoms such as fever, skin rash, sore throat, or jaundice occur during use, discontinuation is required. This medication is not suitable for treating certain bacterial infections, and should not be used for treatment of streptococcal pharyngitis. When breaking the ampoule of the injection, glass fragments may contaminate the solution, so care must be taken when using it, especially in children and the elderly. The preservatives contained in this medication can cause allergic reactions or exacerbation of asthma in some patients, so caution is necessary. Propylene glycol, the solvent ingredient, may cause kidney damage or central nervous system abnormalities when administered in high doses, so dosage and patient condition must be closely monitored. Benzyl alcohol, which is added, can cause fatal respiratory problems in premature infants, so it should not be given to newborns or premature babies. Those with hypersensitivity to this medication, pregnant women, newborns, and patients with certain blood disorders should not be administered this medication, and it should be used cautiously in patients with significantly impaired liver or kidney function. During administration, regular blood tests and liver and kidney function tests should be conducted to detect adverse reactions early and respond appropriately. There are many drug interactions with this medication, especially with anticoagulants, antidiabetic drugs, and immunosuppressants, so it is necessary to verify concurrent use with other medications. Pregnant or lactating women should not use this medication, and it is also unsafe to administer it to newborns and infants. Elderly patients should have careful dosage adjustments and monitoring due to the risk of drug accumulation in the body caused by decreased kidney function. Overdose may lead to symptoms such as vomiting, diarrhea, confusion, and blood abnormalities, and in such cases, immediate notification to medical personnel is required for appropriate treatment. If the injection solution leaks outside the blood vessel, it may cause local inflammation, so the injection site must be carefully monitored, and if any abnormalities are found, the injection should be stopped and moved to a different site. This medication carries a risk of serious side effects when used for prolonged periods or in high doses, and it should only be administered for the minimum duration necessary with ongoing monitoring of the patient’s condition.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions including anaphylaxis, high fever with severe rash, blistering, peeling of skin, mouth/eye mucosal pain, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), mucosal skin syndrome, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), generalized symptoms.

Mild side effects

  • Occasionally granulocytopenia, hemolytic anemia, pancytopenia, thrombocytopenia, rarely leukopenia, aplastic anemia, megaloblastic anemia, methemoglobinemia, neutropenia, hypoprothrombinemia, eosinophilia.
  • Rarely anaphylaxis, shock symptoms (discomfort, mouth discomfort, wheezing, dizziness, diarrhea, tinnitus, sweating, etc.), acute febrile neutrophilic dermatosis, conjunctival and scleral injection, occasional rash, itching, candidiasis.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a container that does not allow light in. It should be stored at room temperature, ideally between 1 and 30 degrees Celsius, in order to maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

A colorless and transparent liquid filled in a brown ampoule

Package unit

5mL/ampoule X 10

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.