Amoxicillin Dispertab tablets 125 mg

Active substance, mg:

125 mg

250 mg

500 mg

1000 mg

Amoxicillin Trihydrate

(equivalent to Amoxicillin)

143.500

125.000

287.000

250.000

574.000

500.000

1148.000

1000.000

Excipients, mg:

Hypromellose

14.750

29.500

49.000

98.000

Crospovidone XL-10

8.400

16.800

33.600

67.200

Sodium stearyl fumarate

2.625

5.250

10.500

21.000

Lemon flavor

1.313

2.625

5.250

10.500

Tangerine flavor

1.050

2.100

4.200

8.400

Microcrystalline cellulose + Carmellose sodium mixture (Microcrystalline cellulose – 89 %; Carmellose sodium – 11 %)

0.875

1.750

3.500

7.000

Sucralose

0.350

0.700

1.400

2.800

Vanilla flavor

0.088

0.175

0.350

0.700

Microcrystalline cellulose 102

up to a tablet weight of:

200.000

400.000

700.000

1400.000

Microorganisms

MIC Breakpoint (mg/L)

Susceptible ≤

Resistant >

Enterobacteriaceae

8¹

8

Staphylococcus spp.

note²

note²

Enterococcus spp.³

4

8

Streptococcus groups A, B, C and G

note⁴

note⁴

Streptococcus pneumoniae

note⁵

note⁵

Viridans group streptococci

0.5

2

Haemophilus influenzae

2⁶

2⁶

Moraxella catarrhalis

note⁷

note⁷

Neisseria meningitidis

0.125

1

Gram-positive anaerobes, except Clostridium difficile⁸

4

8

Gram-negative anaerobes⁸

0.5

2

Helicobacter pylori

0.125⁹

0.125⁹

Pasteurella multocida

1

1

Non-species-specific breakpoints¹⁰

2

8

¹  Wild-type Enterobacteriaceae are categorized as susceptible to aminopenicillins. In some countries, wild-type E. coli and P. mirabilis isolates are categorized as intermediate. In this case, the MIC breakpoint S ≤ 0.5 mg/L is used.

²  Most staphylococci produce penicillinases and are resistant to amoxicillin. Methicillin-resistant staphylococci are almost universally resistant to all beta-lactam antibiotics.

³  Susceptibility to amoxicillin is inferred from ampicillin.

⁴  Susceptibility of streptococci groups A, B, C and G to penicillins is inferred from benzylpenicillin susceptibility.

⁵  Breakpoints refer to isolates from all infection types except meningitis. If an isolate is assessed as intermediate to ampicillin, amoxicillin should not be administered orally. Susceptibility is inferred from the ampicillin MIC.

⁶  Breakpoints are based on intravenous administration. Beta-lactamase-producing strains are resistant.

⁷  Beta-lactamase-producing microorganisms are resistant.

⁸  Susceptibility to amoxicillin is inferred from benzylpenicillin susceptibility.

⁹  Breakpoints are set at the epidemiological cut-off value (ECOFF), which distinguishes wild-type isolates from those with reduced susceptibility.

¹⁰  Non-species-specific breakpoints are based on doses of 0.5 g 3 or 4 times daily (1.5 to 2 g/day).

Usually Susceptible Microorganisms

Gram-positive aerobes:

Enterococcus faecalis

Beta-hemolytic streptococci (groups A, B, C and G)

Listeria monocytogenes

Microorganisms with Possible Acquired Resistance Mechanisms to Amoxicillin

Gram-negative aerobes:

Escherichia coli

Haemophilus influenzae

Helicobacter pylori

Proteus mirabilis

Salmonella typhi

Salmonella paratyphi

Shigella spp.

Pasteurella multocida

Gram-positive aerobes:

Coagulase-negative staphylococci

Staphylococcus aureus²

Streptococcus pneumoniae

Viridans group streptococci

Gram-positive anaerobes:

Clostridium spp.

Gram-negative anaerobes:

Fusobacterium spp.

Other:

Borrelia burgdorferi

Microorganisms with Natural Resistance¹

Gram-positive aerobes:

Enterococcus faecium¹

Gram-negative aerobes:

Acinetobacter spp.

Enterobacter spp.

Klebsiella spp.

Pseudomonas spp.

Gram-negative anaerobes:

Bacteroides spp. (some strains of Bacteroides fragilis are resistant)

Other:

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

¹ Natural intermediate susceptibility in the absence of acquired resistance mechanisms.

² Almost all strains of S. aureus are resistant to amoxicillin due to penicillinase production. Methicillin-resistant Staphylococcus aureus (MRSA) strains are also resistant to amoxicillin.

C_max

T_max^*

AUC_{(0-24 h)}

T ½

(µg/ml)

(h)

(µg × h/ml)

(h)

3.3±1.12

1.5 (1.0-2.0)

26.7±4.56

1.36±0.56

* Median value (range)

Indication*

Dose*

Acute bacterial sinusitis

250-500 mg every 8 hours or 750 mg - 1 g every 12 hours

For severe infections 750 mg - 1 g every 8 hours

For acute cystitis, 3 g twice daily is an option

Asymptomatic bacteriuria during pregnancy

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute cystitis

Acute otitis media

500 mg every 8 hours or 750 mg - 1 g every 12 hours

For severe infections 750 mg - 1 g every 8 hours for 10 days

Acute streptococcal tonsillitis and pharyngitis

Exacerbation of chronic bronchitis

Community-acquired pneumonia

500 mg - 1 g every 8 hours

Typhoid and paratyphoid fever

500 mg - 2 g every 8 hours

Prosthetic joint infections

500 mg - 1 g every 8 hours

Prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract

2 g orally, single dose 30-60 minutes before the surgical procedure in the oral cavity and upper respiratory tract

Eradication of Helicobacter pylori

750 mg - 1 g twice daily in combination with a proton pump inhibitor (e.g., omeprazole) and another antibiotic (e.g., clarithromycin, metronidazole) for 7 days

Lyme disease

Early stage: 500 mg - 1 g every 8 hours, maximum daily dose 4 g, divided into several doses, for 14 days (10 to 21 days)

Late stage (systemic infection): 500 mg - 2 g every 8 hours, maximum daily dose 6 g, divided into several doses, for 10-30 days

*Official clinical guidelines for each indication should be considered.

Indication*

Dose*

Acute bacterial sinusitis

20-90 mg/kg/day, divided into 2-3 doses**

Acute otitis media

Community-acquired pneumonia

Acute cystitis

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute streptococcal tonsillitis and pharyngitis

40-90 mg/kg/day, divided into  2-3 doses**

Typhoid and paratyphoid fever

100 mg/kg/day, divided into 3 doses

Prosthetic joint infections

500 mg - 1 g every 8 hours

Prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract

50 mg/kg orally, single dose 30-60 minutes before the surgical procedure in the oral cavity and upper respiratory tract

Lyme disease

Early stage: 25-50 mg/kg/day, divided into 3 doses, for 10-21 days.

Late stage (systemic infection): 100 mg/kg/day, divided into 3 doses, for 10-30 days.

* Official guidelines for each indication should be considered.

**Only when amoxicillin is prescribed in the upper dose range should twice-daily administration be considered.

Glomerular Filtration Rate (ml/min)

Adults and children ≥ 40 kg

Children < 40 kg*

More than 30

No adjustment necessary

No adjustment necessary

10-30

Maximum 500 mg twice daily

15 mg/kg twice daily (maximum 500 mg twice daily)

Less than 10

Maximum 500 mg daily

15 mg/kg once daily (maximum 500 mg daily)

* Parenteral treatment is preferred in most cases

Hemodialysis

Adults and children ≥ 40 kg

15 mg/kg/day as a single dose.

One additional dose of 15 mg/kg should be administered prior to hemodialysis. An additional dose of 15 mg/kg should be administered after hemodialysis to restore circulating drug levels.

Infections and infestations

Very rare

candidiasis of the skin and mucous membranes.

Blood and lymphatic system disorders

Very rare

reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia;

prolonged bleeding time and prothrombin time.

Immune system disorders

Very rare

severe allergic reactions such as angioedema, anaphylaxis, serum sickness and allergic vasculitis.

Not known

Jarisch-Herxheimer reaction, hypersensitivity-associated acute coronary syndrome (Kounis syndrome).

Nervous system disorders

Very rare

hyperkinesia, dizziness, convulsions.

Not known

aseptic meningitis.

Gastrointestinal disorders

Clinical Trial Data

* Common

diarrhea and nausea.

* Uncommon

vomiting.

Post-registration Data

Very rare

antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black "hairy" tongue;

superficial tooth discoloration.**

Hepatobiliary disorders

Very rare

hepatitis, cholestatic jaundice, moderate increase in plasma aspartate aminotransferase and/or alanine aminotransferase activity.

Skin and subcutaneous tissue disorders

Clinical Trial Data

* Common

skin rash.

* Uncommon

urticaria, pruritus.

Post-registration Data

Very rare

skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Renal and urinary disorders

Very rare

interstitial nephritis, crystalluria.

* The frequency of these adverse reactions was obtained from clinical trials covering a total of approximately 6000 adults and children taking amoxicillin.

** Superficial tooth discoloration has been reported in children. Good oral hygiene helps prevent tooth discoloration, which can be removed by teeth cleaning.