Pharmox IMP 500 mg
Manufacturer
Branch of Imexpharm Corporation - Vinh Loc Hi-Tech Pharmacetical Antibiotic Plant
Applicant company
Imexpharm Pharmaceutical Joint Stock Company
Active ingredient
Amoxicilin (as amoxicilin trihydrat compacted)
Content
500 mg
Shelf life
36 months
Dosage Form
Hard capsule
Package
Box of 10 blisters x 10 hard capsules
Visa Number
893110596024
Issuing Date
24/07/2024
Therapeutic area
Antibiotics
Indication
Amoxicillin is indicated for the treatment of the following infections in adults and children.
- Acute bacterial sinusitis
- Acute otitis media
- Acute streptococcal tonsillitis and pharyngitis
- Acute exacerbations of chronic bronchitis
- Community acquired pneumonia
- Acute cystitis
- Asymptomatic bacteriuria in pregnancy
- Acute pyelonephritis
- Typhoid and paratyphoid fever
- Dental abscess with spreading cellulitis
- Prosthetic joint infections
- Helicobacter pylori eradication
- Lyme disease
Amoxicillin is also indicated for the prophylaxis of endocarditis.
Dosage
The dose of Amoxicillin that is selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to antibacterial agents
• The severity and the site of the infection
• The age, weight and renal function of the patient (as shown below)
The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see the section on Warnings and Precautions for medication use, Prolonged Treatment).
Adults and children ≥ 40 kg
| Indication | Dose |
|---|---|
| Acute bacterial sinusitis | 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours Acute cystitis may be treated with 3g twice daily for one day |
| Asymptomatic bacteriuria in pregnancy | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| Acute cystitis | |
| Acute otitis media | 500 mg every 8 hours, 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours for 10 days |
| Acute streptococcal tonsillitis and pharyngitis | |
| Acute exacerbations of chronic bronchitis | |
| Community acquired pneumonia | 500 mg to 1 g every 8 hours |
| Typhoid and paratyphoid fever | 500 mg to 2 g every 8 hours |
| Prosthetic joint infections | 500 mg to 1 g every 8 hours |
| Prophylaxis of endocarditis | 2 g orally, single dose 30 to 60 minutes before procedure |
| Helicobacter pylori eradication | 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days |
| Lyme disease (see the section on Warnings and Precautions when using the medication) | Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days |
Amoxicillin can be used in the form of hard capsules, dispersible tablets, oral suspension, or sachets for children. The oral suspension form is recommended for children under 6 months of age.
Children weighing 40 kg or more should be given the same dosage as adults.
Recommended dosage:
| Indication | Dose |
|---|---|
| Acute bacterial sinusitis | 20 to 90 mg/kg/day in divided doses |
| Acute otitis media | |
| Community acquired pneumonia | |
| Acute cystitis | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| Acute streptococcal tonsillitis and pharyngitis | 40 to 90 mg/kg/day in divided doses |
| Typhoid and paratyphoid fever | 100 mg/kg/day in three divided doses |
| Prophylaxis of endocarditis | 50 mg/kg orally, single dose 30 to 60 minutes before procedure |
| Lyme disease (see the section on Warnings and Precautions for medication use) | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days |
No dose adjustment is considered necessary.
Renal impairment
| GFR (ml/min) | Adults and children ≥ 40 kg | Children < 40 kg# |
|---|---|---|
| Greater than 30 | No adjustment necessary | No adjustment necessary |
| 10 to 30 | Maximum 500 mg twice daily | 15 mg/kg given twice daily (maximum 500 mg twice daily) |
| Less than 10 | Maximum 500 mg/day | 15 mg/kg given as a single dose (maximum 500 mg) |
| # In the majority of cases, parenteral therapy is preferred. | ||
Amoxicillin may be removed from the circulation by haemodialysis.
| Haemodialysis | |
|---|---|
| Adults and children over 40 kg | 500 mg every 24 h Prior to haemodialysis one additional dose of 500 mg should be administered. In order to restore circulating drug levels, another dose of 500 mg should be administered after haemodialysis. |
| Children under 40 kg | 15 mg/kg/day given as a single daily dose (maximum 500 mg). Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis. |
Amoxicillin maximum 500 mg/day.
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals (see the sections on Warnings and Precautions for medication use and Adverse Effects).
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