Amoxicillin trihydrate ... equivalent to 250 mg of anhydrous amoxicillin
Excipients q.s...................................................................... 1 sachet
(Aspartame, strawberry-flavored powder, sorbitol).
DOSAGE FORM: Powder.
PRESENTATION: Box of 24 sachets x 1.5 g.
PHARMACODYNAMICS: Amoxicillin is antibacterial against Gram-positive and Gram-negative organisms during the stage of active multiplication by inhibiting biosynthesis of cell wall mucopeptide. Organisms being susceptible to amoxicillin includes: Enterococcus faecalis, Staphylococcus spp (non-beta-lactamase-producing strains only), Streptococcus pneumoniae, Streptococcus spp (a- and b- hemolytic strains only). Non-beta-lactamase-producing strains of Escherichia coli, Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis. Helicobacter pylori.
PHARMACOKINETICS: Amoxicillin is stable in the presence of gastric acid. Amoxicillin is rapidly absorbed and diffused into most body tissues and fluids, with the exception of brain tissues and spinal fluid, but Amoxicillin is readily diffused when meninges are inflamed.
INDICATIONS: Infections of the upper respiratory tract. Infections of the lower respiratory tract due to Streptococcus spp., S. pneumoniae, nonpenicillinase-producing Staphylococcus and H. influenzae.
Uncomplicated genitourinary tract infections, gonorrhoea, biliary tract infection.
Skin and skin structure infections due to Streptococcus spp, Staphylococcus spp, E. coli sensitive to Amoxicillin.
CONTRAINDICATIONS: Patients with a history of alleric reaction to any of the penicillins and the cephalosporins. Patients with infectious mononucleosis. Patients with receiving allopurinol therapy.
PRECAUTIONS: Renal and hepatic functions should be observed in case of long-term administration. A hypersensitive reaction may occur in patients with a history of penicillin allergy, so their history of allergy to cephalosporin or penicillin should be observed carefully before they are administered the drug.
The safety of amoxicillin in pregnant women has not been determined; therefore, just use in case of really needs. However, the harms of Amoxicillin in foetus have not been proven.
Amoxicillin have been shown to be excreted in human milk. Caution should be exercised when amoxicillin is administered to a nursing woman.
INTERACTIONS: Allopurinol is reported to enhance risks of allergic reactions of amoxicillin.
Probenecid reduces renal tubular secretion of amoxicillin and may enhance the blood amoxicillin level causing toxicity.
ADVERSE EFFECTS: Allergic reactions: pruritus, urticaria, skin rashes, Stevens-Johnson's syndrome.
Gastrointestinal disturbances: nausea, vomiting, diarrhoea.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: No documents have been reported.
DOSAGE & ADMINISTRATION:
Children from 10 years may use 125 mg - 250 mg once every 8 hrs. Children weighed under 20 kg may use 20 mg – 40 mg / kg of body-weight daily. In details as follows:
- Children under 1 year of age: ½ sachet twice daily.
- Children from 1 to 5 years of age: 1 sachet twice daily.
- Children from 5 to 10 years of age: 1 sachet x 3 times daily.
The dose can be increased in severe infections.
The dose should be reduced following the creatinine clearance in patients with impaired renal function.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 300C.