1. FORMULA:
- Amoxicillin ............................................. 500 mg
- Excipients .............................................. 1 capsule
(Aerosil, sodium lauryl sulfate, talc, magnesium stearate).
2. DOSAGE FORM: Capsule.
3. PACKAGING: Box of 10 blisters x 10 capsules; Bottle of 200 capsules; Bottle of 500 capsules.
4. PHARMACOLOGY: Amoxicillin is an antimicrobial agent that works by inhibiting the synthesis of the bacterial cell wall mucopeptide in many Gram-positive and Gram-negative bacteria during active cell division. Bacteria sensitive to Amoxicillin include: Enterococcus faecalis, Staphylococcus spp. (only strains that do not produce beta-lactamase), Streptococcus pneumoniae, Streptococcus spp. (only alpha- and beta-hemolytic strains). Beta-lactamase-negative strains of Escherichia coli, Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis, and Helicobacter pylori.
5. PHARMACOKINETICS: Amoxicillin is stable in the acidic environment of the stomach. Its absorption is not affected by food. Amoxicillin is quickly absorbed and distributed to most tissues and fluids in the body, except for the brain and cerebrospinal fluid; however, it can diffuse easily when the meninges are inflamed.
6. INDICATIONS:
- Treatment of infections: Upper respiratory tract infections. Lower respiratory tract infections caused by streptococci, pneumococci, penicillinase-negative staphylococci, and H. influenzae.
- Uncomplicated urinary tract infections. Gonorrhea. Biliary tract infections. Skin and muscle infections caused by streptococci, staphylococci, and E. coli sensitive to Amoxicillin.
7. CONTRAINDICATIONS:
- In cases of hypersensitivity to Penicillins and Cephalosporins, infectious mononucleosis.
8. PRECAUTIONS: Regularly monitor liver and kidney function during prolonged treatment. Severe hypersensitivity reactions may occur in patients with a history of allergy to penicillins or other allergens; check allergy history before administration. If allergic reactions such as rash, Quincke's edema, anaphylaxis, or Stevens-Johnson syndrome occur, discontinue the medication, provide emergency treatment, and avoid using penicillins or cephalosporins in the future.
9. DRUG INTERACTIONS:
- Allopurinol increases the risk of Amoxicillin allergy.
- Nifedipine increases Amoxicillin absorption.
- Probenecid reduces Amoxicillin excretion in the renal tubules, potentially increasing blood levels and causing toxicity.
- There is antagonism between Amoxicillin and bacteriostatic agents such as Chloramphenicol and Tetracycline.
10. ADVERSE EFFECTS: Generally infrequent or rare, and mostly mild and temporary.
- Allergic reactions: itching, urticaria, rash, Quincke's edema, Stevens-Johnson syndrome.
- Digestive disturbances: nausea, vomiting, diarrhea, pseudomembranous colitis.
Report any adverse effects to your doctor.
11. OVERDOSAGE AND MANAGEMENT: No specific documentation found.
12. DOSAGE AND ADMINISTRATION: Can be taken with or without food.
- Mild to moderate infections: Adults and children over 12 years: 1 capsule 3 times a day, every 8 hours.
- Children 6 - 12 years: 1 capsule 2 times a day, every 12 hours.
- Treatment of peptic ulcers caused by Helicobacter pylori:
- Adults: 2 capsules 2 - 3 times a day, with intervals of 8 - 12 hours, for 14 days.
- Children under 6 years should not use due to difficulty in dividing the dosage.
- Children under 20 kg usually receive 20 – 40 mg/kg body weight/day
- Or as directed by a physician.
Read the instructions carefully before use.
For more information, consult a physician.
This medication is only to be used with a doctor's prescription.
Expiry Date: 36 months from the manufacturing date.
Storage Conditions: Store in a dry place at temperatures not exceeding 30°C.