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삼아제약㈜

Samasefprozil tablet (otitis media)

Samasefprozil tablet (otitis media)

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1) Efficacy, effect

This drug is used to treat patients with mild to moderate infections caused by the following susceptible strains:

1. Upper respiratory infection

- Pharyngitis/tonsillitis [Causing bacteria: Streptococcus pyogenes (Group A-beta-hemolytic)]

Note) The drug usually selected for the treatment and prevention of streptococcal infections, such as the prevention of rheumatic fever, is penicillin intramuscular injection. This drug is generally effective in eradicating Streptococcus pyogenes (Group A-beta-hemolytic) from the nasopharynx, but its effectiveness in preventing rheumatic fever has not yet been proven.

- Otitis media (causing bacteria: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis)

When treating otitis media caused by beta-lactamase-producing bacteria, the sterilization rate of this drug is somewhat lower than that of drugs containing specific beta-lactamase inhibitors. Therefore, this drug should be used taking into account the susceptibility pattern of causative bacteria commonly found in certain regions and the possibility of increased toxicity of drugs containing beta-lactamase inhibitors.

- Acute sinusitis [Causing bacteria: Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing bacteria), Moraxella catarrhalis (including beta-lactamase-producing bacteria)]

2. Also, secondary bacterial infection of acute bronchitis and acute bacterial infection of chronic bronchitis.

Seaghwa [Causative bacteria: Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing bacteria), and Moraxella catarrhalis]

3. Skin and soft tissue infections

Simple skin and soft tissue infections [causing bacteria: Staphylococcus (penicillinase-producing bacteria) and Streptococcus pyogenes (group A-beta-hemolytic)], abscess requiring surgical drainage

4. Simple urinary tract infections (including cystitis) (causing bacteria: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis)

If necessary, the causative bacteria should be cultured and a susceptibility test to this drug should be conducted.

2) Usage, dosage

○ Adults (age 13 or older)1) For pharyngitis and tonsillitis among upper respiratory infections, administer 500 mg (potency) once every 24 hours as cefprozil, and for acute sinusitis, administer 250 mg (potency) or 500 mg (potency).

Administer every 12 hours (in case of moderate or severe infection, the dose may need to be increased).

2) For lower respiratory tract infections, bacterial secondary infection of acute bronchitis or bacterial exacerbation of chronic bronchitis, administer 500 mg (potency) of this drug once every 12 hours.

3) For simple skin and soft tissue infections, administer 250 mg (potency) every 12 hours [or 500 mg (potency) every 24 hours] or 500 mg (potency) every 12 hours depending on symptoms.

4) For uncomplicated urinary tract infections, administer 500 mg (potency) of this drug every 24 hours.

○ Children (2-12 years old)1) Among upper respiratory infections, pharyngitis and tonsillitis are dosed at 7.5 mg (titer) per kg of body weight per time.

Administer every 12 hours.

2) For simple skin and soft tissue infections, administer 20mg (potency) per kg of body weight every 24 hours.

○ Infants and children (6 months to 12 years old)

Among upper respiratory infections, 15 mg per kg of body weight is administered every 12 hours for otitis media, and for acute sinusitis, 7.5 mg per kg of body weight is administered every 12 hours. However, if the dose needs to be increased due to a moderate or higher infection, 15 mg per kg of body weight is administered every 12 hours.

<Administration period>

It is usually administered for about 10 days, but in the case of pharyngitis/tonsillitis, an infection caused by Streptococcus pyogenes (Group A-beta-hemolytic), it is administered for more than 10 days. Also, for uncomplicated cystitis, it is administered for about 7 days.

○ Patients with renal impairment

1) If the creatinine clearance rate is 30 to 120 mL/min, administer according to the standard dosage method above.

2) If the creatinine clearance rate is less than 29mL/min, administer 50% of the standard amount, but the administration interval is the same as the standard dosage. However, since some of this drug is removed through hemodialysis, it should be administered after hemodialysis is completed.

Once dissolved, store in the refrigerator and consume within 14 days (syrup tablets only).

3) Packaging unit

30 tablets, 100 tablets (bottle)

4) Ingredients, content

250mg as cefprozil

5) Period of use

36 months from date of manufacture

6) Storage method

Store in a light-proof, airtight container at room temperature (1-30°C).

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