1. Ingredients:
Each pack contains:
Amoxicillin (as Amoxicillin Trihydrate) ………………………………………………………………………. ……………………. 250mg
Clavulanic Acid (as Potassium Clavulanate with Mycrocrystallincellulose) …………………………………………….. 31.25mg
Sufficient excipients ………………………………………………………………………………………………………………………. qs 1 pack
2. Designation
Treatment of otitis media, tonsillitis, pharyngitis, laryngitis, bronchitis, sinusitis, pneumonia. It is also used to treat urinary tract infections, skin infections, and gonorrhea.
3. Contraindications
- People who are sensitive to the components of the drug.
- Allergy to penicillin.
- Cross allergy to cephalosporins.
- Infectious mononucleosis or lymphocytic leukemia.
4. Dosage & Administration Dosage
usually 250 mg – 500 mg (amoxicillin based), every 8 hours.
- Children up to 10 years old can be given a dose of 125 – 250 mg, every 8 hours.
- Children under 20 kg usually use a dose of 20-40 mg / kg body weight / day.
Higher doses, given as a single dose or in short bursts, are used in a number of conditions:
- Dose of 3 g, repeated every 8 hours for the treatment of periodontal abscess or repeated every 10-12 hours for the treatment of uncomplicated acute urinary tract infections.
For the prevention of endocarditis in susceptible individuals, a single dose of 3 g should be given 1 hour before procedures such as tooth extraction.
- Use a high-dose regimen of 3 g amoxicillin x 2 times / day for patients with severe or recurrent respiratory infections.
- If necessary, can give children 3 – 10 years old with otitis media with a dose of 750 mg / time, twice a day, for 2 days.
5. Overdose
Overdose symptoms may include abdominal pain, vomiting, diarrhea, rash, hyperactivity, drowsiness. If the casualty is unconscious or unable to breathe, call 911 immediately.
Concomitant use of Probenecid with Amoxicillin and Clavulanic acid may increase blood levels of Amoxicillin. Should not be used concurrently.
Oral anticoagulants: Concomitant use of oral anticoagulants with Amoxicillin and Clavulanic acid may cause abnormal prolongation of Prothrombin time. Dosage of oral anticoagulants should be adjusted. Amoxicillin may lead to a false-positive reaction in the urine glucose test.
6. Undesirable effects
Diarrhea, abdominal pain, vomiting, skin rash, itching, hives, trouble breathing or swallowing, wheezing, itching and vaginal discharge, yellowing of the skin or eyes. Amoxicillin and Clavulanic acid can cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.
7. Pregnancy and lactation
If you are pregnant or breastfeeding, think you may be pregnant, or are planning
having a baby, ask your doctor or pharmacist for advice before taking this medicine.
8. Driving and using machines
Amoxicillin can have side effects and symptoms (such as allergic reactions, dizziness, and seizures) that may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
9. Pharmacodynamic properties
Amoxicillin
- Amoxicillin is an aminopenicillin antibiotic with broad antibacterial activity.
Clavulanic
- Clavulanic acid is a broad-spectrum antibiotic often used in combination with Amoxicillin.
10. Pharmacokinetic properties
Amoxicillin
- Absorption: Amoxicillin is stable in acidic gastric juice. Absorption is not affected by food and is more rapidly and completely absorbed from the gastrointestinal tract than ampicillin.
- Distribution: Amoxicillin is rapidly distributed into most body fluids, except brain tissue and cerebrospinal fluid, but when the meninges are inflamed, amoxicillin readily diffuses. After taking a dose of 250mg of amoxicillin 1-2 hours, the concentration of amoxicillin in the blood reaches about 4-5mcg/ml, when taking 500mg, the concentration of amoxicillin reaches 8-10mcg/ml.
- Elimination: Approximately 60% of an oral dose of amoxicillin is excreted unchanged in the urine within 6-8 hours. The half-life of amoxicillin is approximately 1 hour, prolonged in neonates and the elderly. In patients with renal impairment, the half-life of amoxicillin is approximately 7-20 hours.
Clavulanic
- Clavulanate potassium is readily absorbed orally. The maximum concentration of the drug in the serum is reached 1-2 hours after taking the drug. At a dose of 250 mg (or 500 mg), there is approximately 3 mcg/mL of clavulanic acid in serum. After 1 hour of oral administration of 5 mg/kg clavulanic acid, there was an average of 3.0 mcg/mL clavulanic acid in serum.
- Absorption of the drug is not affected by food and is best taken immediately before a meal.
- The oral bioavailability of clavulanic acid is 75%.
- Approximately 30-40% of clavulanic acid is excreted in the urine as active form.
- Probenecid does not affect the elimination of clavulanic acid.
11. Storage
Store in a cool dry place, below 30°C, avoid direct sunlight, handle with care.
12. Expiration Date
36 months from date of manufacture.
13. Packing:
10 packs of powder x 10ml
