Medication info

Baxter Metronidazole Injection 500mg

Prescription medication경구 · 정맥Approval withdrawn
Ingredient · strength
Metronidazole›500mg / 100mL
Manufacturer / importer
밴티브코리아주식회사
Appearance
A pale yellow, transparent liquid filled in a transparent plastic bag.
Packaging
100ml/bag
Approval status
Approval withdrawn

MFDS item code 200109020 · Notified 2001.01.09

This product's status changed to Approval withdrawn on 2025.03.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in treating trichomoniasis and anaerobic bacterial infections (such as in the abdomen, skin, gynecological) and in preventing post-surgical infections.
Who uses it
Adults · Children
Adult dosage
1. Trichomoniasis: Usually 250 mg orally 2 times a day for 10 days for adults. 2. Anaerobic bacterial infections 1) Treatment: Usually 500 mg orally 3 to 4 times a day for adults. The maximum daily dosage should not exceed 4 g, and treatment is generally for 7 to 10 days. 2) Post-surgical prophylaxis: Usually an initial dose of 1 g orally, administered as 250 mg 3 times a day for adults.
Children's dosage
(Injectable) 1. Treatment of anaerobic bacterial infections. 2) Children under 12 years: Administer 3 times a day, with a single intravenous dose of 7.5 mg (1.5 mL) per kg of body weight for oral administration.

Ingredients

Importer
밴티브코리아주식회사

Efficacy & effects

Effectiveness in treating trichomoniasis and anaerobic bacterial infections (such as in the abdomen, skin, gynecological) and in preventing post-surgical infections.

  • Trichomoniasis
  • anaerobic bacterial infections
  • peritonitis
  • intra-abdominal abscesses
  • liver abscesses
  • skin and soft tissue infections
  • endometritis
  • intrauterine abscesses
  • bacteremia
  • bone and joint infections
  • central nervous system infections
  • brain abscesses
View approved original text

This medication is used to treat parasitic infections such as trichomoniasis and amoebiasis, as well as various anaerobic bacterial infections. It is effective against infections caused by anaerobic bacteria, including peritonitis, liver abscesses, skin and soft tissue infections, gynecological infections like endometritis, bacteremia, bone and joint infections, and central nervous system infections. It is also used for lower respiratory tract infections such as pneumonia and lung abscesses, and for preventing infections after surgery. This drug is particularly effective against major anaerobic bacteria like Bacteroides and anaerobic Streptococcus. Overall, this medication is used to treat various symptoms of anaerobic bacterial infections and to prevent post-surgical infections.

Dosage and Administration

Adult dosage

1. Trichomoniasis: Usually 250 mg orally 2 times a day for 10 days for adults. 2. Anaerobic bacterial infections 1) Treatment: Usually 500 mg orally 3 to 4 times a day for adults. The maximum daily dosage should not exceed 4 g, and treatment is generally for 7 to 10 days. 2) Post-surgical prophylaxis: Usually an initial dose of 1 g orally, administered as 250 mg 3 times a day for adults.

Children's dosage

(Injectable) 1. Treatment of anaerobic bacterial infections. 2) Children under 12 years: Administer 3 times a day, with a single intravenous dose of 7.5 mg (1.5 mL) per kg of body weight for oral administration.

Precautions

This medication has been associated with tumor formation in rodent studies, so unnecessary use should be avoided. Patients with known allergies to this medication or its components, or to amidazol derivatives, should not use this medication. Patients with blood disorders should not be treated with this medication. Patients with neurological diseases such as hypothyroidism or adrenal insufficiency should avoid using this medication. Pregnant women in the first trimester should not receive this medication. Patients currently taking a medication called mizolastine should not use this medication in combination. This medication may cause serious psychiatric reactions when taken with disulfiram, so it should not be administered to patients who have taken disulfiram within the past two weeks. Alcohol consumption should be avoided for at least three days during and after treatment, as taking this medication with alcohol may cause side effects such as nausea, vomiting, headache, and flushing. Patients with cocaine syndrome should avoid using this medication, as it may cause serious hepatic toxicity or acute liver failure. Caution is advised for patients with reduced liver function, as this medication and its metabolites may accumulate in the body and dose adjustment may be needed. Even pregnant women beyond three months should be treated with caution, using this medication only when the benefits outweigh the risks. Patients with central nervous system infections may experience neurological symptoms when using this medication, so caution is necessary. Patients with heart or kidney function issues should also be treated with caution, and in cases of severe renal impairment, monitoring is needed as this medication and its metabolites may accumulate in the body. This medication may cause gastrointestinal side effects such as nausea, vomiting, diarrhea, and loss of appetite, and pancreatitis may occur rarely. Blood-related side effects such as leukopenia and thrombocytopenia may also occur. Skin reactions such as rash, itching, urticaria, and in rare cases severe hypersensitivity reactions like anaphylaxis may occur. Central nervous system side effects may include headache, dizziness, seizures, and sensory disturbances, and in severe cases, administration should be halted. Thrombosis may occur at the intravenous injection site. Psychiatric symptoms such as confusion, hallucinations, and depressive moods may be present. Transient vision impairment or optic nerve damage has been reported. Liver function abnormalities may rarely occur, and if severe rashes or swelling appear on the skin, administration should be stopped immediately. Palpitations or increased heart rate may be observed. Symptoms like dyspnea, myalgia, injection site reactions, fatigue, and swelling of the face or body may also occur. In patients with liver disease, blood concentration of this medication may increase, warranting dose adjustment and caution, and candidiasis may worsen. The administered dose should not exceed 2g within 24 hours, and regular check-ups are required for treatment durations exceeding 10 days. Patients should be informed that reddish-brown urine may occur during treatment. Drowsiness, confusion, hallucinations, seizures, and vision disturbances may occur, so caution should be exercised when driving or operating machinery. In patients with hepatic encephalopathy, accumulation of this medication may worsen neurological side effects, and dose adjustments may be necessary. If serious skin adverse reactions occur, administration should be stopped immediately. This medication may enhance the effect of anticoagulants like warfarin, necessitating dose adjustments based on blood tests conducted during and up to 8 days after treatment. When taken with lithium, lithium levels may increase, posing a risk of kidney damage. Severe side effects may occur when used with alcohol, so alcohol consumption should be avoided during and for three days following treatment. Phenytoin and phenobarbital may enhance elimination of this medication. This medication may affect the efficacy and side effects of certain anticancer drugs. When taken with some drugs that inhibit specific liver enzymes, toxicity of this medication may increase. Using drugs that prolong the QT interval may result in cardiac side effects. During pregnancy, this drug may cross the placenta, so it should not be used in early pregnancy, and breastfeeding should be discontinued during treatment. It may interfere with blood test results, so caution should be exercised when interpreting test results. In case of overdose, symptoms may include vomiting and neurologic toxicity, and there is no specific antidote; thus, treatment should be discontinued immediately, and general care should be provided. This intravenous injection is for infusion only and should be used immediately after opening. Unused solution should not be utilized, and it should not be mixed with other medications for simultaneous injection. Avoid using instruments in contact with aluminum, and coadministration with certain medications is prohibited.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic shock, thrombocytopenia, agranulocytosis, pancytopenia, neutropenia, leukopenia, erythema multiforme, aseptic meningitis, convulsions, seizure-like attacks, encephalopathy, subacute cerebellar syndrome, psychiatric disorders, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin-mucosal syndrome, jaundice, hepatitis, acute generalized exanthematous pustulosis, respiratory distress, venous thrombosis, fever (high fever), reddish-brown urine, urination difficulties.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • oral mucositis
  • taste disturbances
  • loss of appetite
  • stomatitis
  • constipation
  • discoloration of the tongue
  • upper abdominal pain
Show 26 more
  • increased serum amylase
  • itching
  • fever
  • rash
  • headache
  • dizziness
  • coordination problems
  • fainting
  • sensory numbness
  • paresthesia
  • confusion
  • hallucinations
  • depressive moods
  • diplopia
  • myopia
  • optic neuropathy
  • facial swelling
  • sweating
  • vesicular dermatitis
  • fixed drug eruptions
  • tachycardia
  • palpitations
  • myalgia
  • muscle cramps
  • weakness
  • injection site reactions.

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

Storage

This medication may be sensitive to light; therefore, it should be stored away from direct sunlight. Additionally, it is important to maintain a suitable storage temperature between 15 to 25 degrees Celsius (room temperature) to ensure the medication's effectiveness and safety.

Appearance and packaging

Appearance

A pale yellow, transparent liquid filled in a transparent plastic bag.

Package unit

100ml/bag

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.