Medication info
Pramox Tablet 500 mg (Amoxicillin Trihydrate · Sulbactam Conglomerate)

Pramox Tablet 500 mg (Amoxicillin Trihydrate · Sulbactam Conglomerate)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletSulbactam Pivoxil›250mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200703663 · Notified 2007.03.30 · Insurance code 663602310

Summary

Main use
Treatment of upper and lower respiratory infections, urinary tract infections, and skin infections
Who takes it
Adults · Children
Adult dose
1 dose of amoxicillin and sulbactam conglomerate of 500 to 1000 mg (potency), taken orally three times a day.
Child dose
Children aged 12 and older: Administer 1 dose of amoxicillin and sulbactam conglomerate of 500 to 1000 mg (potency), taken orally three times a day.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment of upper and lower respiratory infections, urinary tract infections, and skin infections

  • Otitis media
  • sinusitis
  • tonsillitis
  • pharyngitis
  • laryngitis
  • bronchitis
  • pneumonia
  • upper and lower urinary tract infections
  • skin infections
  • wound infections
  • gynecological infections
  • abdominal infections
View approved original text

This medication is effective against various bacteria, including Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli. It is used to treat inflammations such as otitis media, sinusitis, and tonsillitis in upper respiratory infections. Additionally, it is employed in lower respiratory infections like bronchitis and pneumonia. It is also effective for treating urinary tract infections, skin and wound infections, gynecological infections, and abdominal infections. This medication is used to improve and treat symptoms caused by various infections.

How to take

Adult dose

1 dose of amoxicillin and sulbactam conglomerate of 500 to 1000 mg (potency), taken orally three times a day.

Child dose

Children aged 12 and older: Administer 1 dose of amoxicillin and sulbactam conglomerate of 500 to 1000 mg (potency), taken orally three times a day.

Precautions

This medication is a penicillin-based antibiotic and should not be used by patients who have had an allergy to this drug or other penicillin-based drugs. Patients with allergies to cephalosporins should also be cautious, as there is an increased risk of rash in patients with viral infections like infectious mononucleosis. This medication contains lactose, and patients with lactose intolerance or related genetic disorders should avoid it. It should be used with caution in patients with a history of gastrointestinal diseases or who have experienced multiple allergic reactions, including those with allergic predispositions like bronchial asthma. Patients with severely impaired kidney function may have increased drug concentrations, so adjustments to dosing intervals are necessary. Caution is also required for the elderly or patients in poor general condition. While taking this medication, gastrointestinal symptoms such as nausea, vomiting, diarrhea, and abdominal pain may occur. In severe cases, pseudomembranous colitis may develop, so it is important to discontinue immediately if symptoms worsen. Severe allergic reactions, such as skin rash, urticaria, and anaphylactic shock, can rarely occur, so it is vital to consult healthcare professionals if any abnormal symptoms arise. Kidney and liver function abnormalities, as well as hematological symptoms, may occur, requiring regular testing. Long-term therapy necessitates particular caution. The use of antibiotics can lead to microbial dysbiosis due to excessive proliferation of fungi or resistant bacteria, so it’s important to report any symptoms. This medication can interact with other medications; therefore, patients should inform their healthcare providers of all current medications, particularly with methotrexate, probenecid, allopurinol, and oral contraceptives. During pregnancy, the risk to the fetus is low but should be administered only when necessary. During lactation, it should be used cautiously as it may affect infants. In children, especially infants under 6 months, caution is advised as their kidney function may not be fully developed, leading to slower drug excretion. The elderly may have a higher risk of side effects due to decreased physiological functions, necessitating dosage and interval adjustments along with close monitoring of their condition. In the case of overdose, neurological symptoms or renal failure may occur, requiring immediate medical attention. This medication and aminoglycoside antibiotics may exhibit decreased effectiveness when mixed, so they should be administered at different sites or with a time gap between doses.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), wheals, Quincke's edema, serum sickness-like reactions, anaphylactic shock, pseudomembranous colitis, severe colitis with bloody stools, anaphylactoid shock, interstitial nephritis, urinary retention, dysuria, acute renal failure, anemia, hemolytic anemia, platelet abnormalities, neutropenia, agranulocytosis, drug reaction (DRESS), acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • reduced appetite
  • upper abdominal pain
  • rash
  • itching
  • headache
  • fatigue
  • lethargy
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  • chills
  • temporary taste changes
  • dry mouth
  • nosebleeds
  • reduced appetite
  • pruritus
  • gastritis
  • hiccups

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

Storage

This medication should be stored in a tightly sealed container to prevent air from entering and should be kept at room temperature between 1 to 30 degrees Celsius. This storage helps maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle

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

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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.