AMOXI-DENK 1000 Tablet

This medicine is an antibiotic (broad-spectrum penicillin) used in the treatment of acute and chronic bacterial infections if these are caused by pathogens that are susceptible to amoxicillin.

The indications are infections

- of the ear, nose and throat (otitis media, sinusitis, tonsillitis, pharyngitis),

- of the upper and lower respiratory tract,

- of the kidneys and lower urinary tract,

- of the reproductive organs (including gonorrhoea),

- of the bile ducts,

- of the gastrointestinal tract (including Helicobacter, pylori infection in the form of a threefold treatment),

- of the skin and soft tissues,

- endocarditis prophylaxis (preventative treatment of inflammatory processes of the endocardium including the heart valves),

- abdominal typhoid (including the sanitation of chronic carriers if antibiotics of the fluoroquinolone group cannot be used),

- osteitis, osteomyelitis,

- listeriosis (infectious disease).

Dosage

Orally.

This medicine should be taken at mealtimes, as this improves tolerability while not affecting the efficacy.

The dosage depends on the age, weight and renal function, severity and site of infection as well as the suspected or proven pathogens.

The recommended dose is:

Single doses are to be divided up evenly throughout the day if possible: if taking 3 times a day the single doses should be taken at 8-hour intervals, if taking twice a day at 12-hour intervals.

In children weighing less than 40kg dividing up the entire daily dose into 3 single doses (administration every 8 hours) is recommended. For higher doses the daily dose may be divided into 2 single doses (every 12 hours).

- Adults, adolescents and children weighing 40kg or more

1500-3000mg amoxicillin daily in 3-4 single doses. The entire daily dose may also be given in 2 single doses (dosage at 12 hour intervals). In these cases, however, the higher daily dose should be chosen in order to ensure a sufficient constant therapeutic level. The daily dosage of amoxicillin may be increased to 4000-6000mg in the case of severe infections.

- Children weighing less than 40kg: See the package insert about the details below

Special dosage recommendations

- Helicobacter pylori infection

- Adults, adolescents and children weighing 40kg or more

Threefold treatment: 1000mg amoxicillin twice a day over a period of 7 days in combination with a further antibiotic (as a rule clarithromycin or metronidazole) and a gastric acid blocker (PPI such as omeprazole).

- Children weighing less than 40kg: See the package insert about the details below.

Uncomplicated urinary tract infections in women

Single dose of 3000mg amoxicillin.

Uncomplicated gonorrhoea (the clap): single administration of 300mg amoxicillin, if necessary with probenecide.

Endocarditis prophylaxis

To prevent pathogens spreading in the bloodstream to the heat resulting in endocarditis as well as inflammation of the heart values, a risk associated with some illnesses or medically indicated surgery. Your physician will decide on the necessity, type and scale of such a preventative treatment.

- Adults, adolescents and children weighing 40kg or more

2000-3000mg amoxicillin 1 hour before surgery depending on body weight and risk of endocarditis. Additional 3000mg of oral amoxicillin 6 hours after surgery in patients at a particularly high risk of endocarditis.

In hospitalized patients the recommended parenteral dose is 2000mg amoxicillin 1 hour before the operation followed by 1000mg amoxicillin after 6 hours, in combination with another antibiotic (e.g. 1.5mg/kg gentamycin IV) if necessary.

- Children weighing less than 40kg: See the package insert about the details below.

Tonsillitis

Children weighing less than 40kg: receive 50mg/kg body weight/day in two divided doses.

Acute otitis media

In areas with reduced susceptibility of specific bacteria (pneuomococci) your doctor will adjust the dosage according to the local recommendations.

Early Lyme disease (isolated erythema migrans), an infectious disease transmitted by ticks

Children weighing less than 40kg: receive 50mg/kg body weight/day in three divided doses, over 14-21 days.

See the package insert about the details below:

- Impaired renal function

- Impaired hepatic function

Mode of administration

Swallow the tablet whole with sufficient fluids (e.g. a glass of water). Taking it with a meal does not interfere with efficacy.

Note: This tablet possesses its own odour that is specific to the active ingredient. This may vary in intensity and has no effect on efficacy.

Amoxicillin possesses its own product-specific taste. This has different levels of intensity and has no effect on efficacy.

Duration of administration

The treating physician decides how low the treatment will take.

This medicine should be taken as a rule for 7(-10) days, at least until 2-3 days after signs and symptoms have subsided.

When treating infections caused by Streptococcus pyogenes (bacteria that also cause scarlet fever for example), a treatment of at least 10days s required in order to prevent late complications, which occur predominantly in the kidneys or joints (e.g. rheumatic fever, glomerulonephritis).

In the case of proven hypersensitivity (allergy) to amoxicillin or other penicillins or to any of the other ingredients.

Infections

Long-term and/or repeated use may lead to super infections and colonization with resistant bacteria or fungi.

Haematology

Leukopenia, thrombocytopenia, prolonged bleeding and pro-thrombin time, thrombocytopenic purpura, (haemolytic) anaemia, pancytopenia, agranulocytosis, eosinophilia.

Nervous system

Overexicitability or light-headache, fear, insomnia, confusion, seizures.

Gastrointestinal tract

Gastrointestinal disturbances are very common and depend on the dose: stomach pain, nausea, vomiting, meteorism, soft stool, diarrhoea. Impaired taste, stomatitis, teeth discolouration (in children) and pseudomembranous colitis may occur.

Hepatic and bile ducts

Increase in transaminase, hepatic dysfunction and cholestasis with and without jaundice, hepatitis.

Skin and hypersensitivity reactions

Allergic skin reactions such as rash, itchiness and hives are common. Further, anaphylactic reactions such as swelling of the head and neck area (e.g. Quincke’s disease), allergic shock, severe skin reactions (exfoliative dermatitis, Lyell’s syndrome) and other allergic illness (serum disease, haemolytic anaemia, allergic vasculitis or nephritis) may occur.

Kidneys and lower urinary tract

Acute interstitial nephritis, acute renal failure with crystalluria.

Countermeasures

Some of the adverse reactions named may be acutely life-threatening; Inform your physician if you experience any such incident.

Pseudomembranous colitis: if there is any suggestion of this intestinal inflammation this medicine is to be discontinued immediately and suitable therapy should be initiated. Drugs that inhibit peristalsis are not to be used.

Severe acute hypersensitivity reaction (e.g. anaphylaxis): Treatment is to be discontinued immediately.

The usual emergency measures are to be initiated by the doctor on call

(See the package insert about the details below.)

The following interactions with this Amoxi-Denk 1000 have been described under concomitant administration of:

Other antibiotics and/or chemotherapeutic agents: Other antibiotics that inhibit bacterial growth (bacteriostatic antibiotics such as tetracyclines, macrolides, sulfonamides or chloramphenicol)

Drugs containing probenecide (for gout)

Drugs containing allopurinol (for gout)

Dehydrating drugs (diuretics)

Cardiotonic drugs (digoxin)

Anticoagulants (cumarine)

Birth control medication (contraceptives)

Effect on laboratory diagnostic examinations

Pregnancy

Amoxicillin crosses the placenta. As a precaution you should only use this tablet during pregnancy after your physician has undertaken to carefully assess the benefits and risks. Studies on humans have not shown any sign of harm to the unborn child or neonate to date. Only in one individual study on women with premature aminorrhexis it was reported that prophylactic treatment with amoxicillin and clavulanic acid was associated with a higher risk of a certain intestinal inflammation (necrotising enterocolitis) in neonates. Animal experimental studies revealed no sign of harm to the fetus.

Lactation

Amoxicillin is excreted in human milk. Breast-fed infants may therefore suffer from diarrhoea and fungal colonization of the mucosa, which means that the infant may have to be weaned. The possibility of a sensitisation should be considered.

However, you are allowed to take this medicine in the nursing period after your physician has assessed the potential benefits and risks accordingly. Ask your doctor or pharmacist for advice before taking any medicine.

Talk to your doctor or pharmacist before taking this medicine

- if you tend to have hypersensitivity reactions. There may be a cross-allergy with other betalactam antibiotics (e.g. cephalosporins). If you suffered from a fungal infection prior to commencing treatment you may suffer from an allergic reaction just after the first dose of penicillin.

- in the case of renal dysfunction (dosage adjustment).

- if you also suffer from a viral infection (particularly in the case of infectious mononucleosis) or chronic lymphatic leukaemia. There is increased risk of occurrence of allergic reactions in such cases.

- in the event of persistent severe diarrhoea during treatment. Please inform your physician, as this could be a sign of a life-threatening intestinal inflammation (pseudomembranous colitis).