Full Description:
AmoxiClav-Denk 1000/125 is an antibiotic consisting of the penicillin amoxicillin and the β lactamase inhibitor clavulanic acid. AmoxiClav-Denk 1000/125 is used in the treatment of acute and chronic infections that are receptive to oral therapy. Gram-positive and gram-negative microorganisms are possible pathogens whose resistance to β-lactam antibiotics is caused by β-lactamases, which are however sensitive to the combination of amoxicillin and clavulanic acid. If there is a reasonable suspicion that the afore-mentioned pathogens could be the cause of a certain infection, treatment with AmoxiClav-Denk 1000/125 can be commenced even before receiving the result of the susceptibility test (antibiogram). This medicine is suitable for treatment of the following indications:
- infections of the upper and lower respiratory tract including:
– middle ear infection (otitis media)
– acute infection of the paranasal sinuses (acute sinusitis)
– acute exacerbations of chronic bronchitis
– lung infection (pneumonia)
- kidney and lower urinary tract infections
- genital infections.
What Amoxiclav-denk 1000/125 contains:
The active substance is amoxicillin trihydrate and clavulanic potassium. One package contains 1148 mg of amoxicillin trihydrate, equivalent to 1000 mg of amoxicillin and 148.9 mg of clavulanic potassium, which corresponds to 125 mg of clavulanic acid.
Auxiliary substances are silicon dioxide, sucrose, xanthan stone, sodium saccharin, orange flavor.
Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of adverse drug reactions is classified as follows:
Very common: More than 1 in 10 patients treated
Common: Less than 1 in 10, but more than 1 in 100 patients treated
Uncommon: Less than 1 in 100, but more than 1 in 1000 patients treated
Rare: Less than 1 in 1000, but more than 1 in 10,000 patients treated
Very rare: Less than 1 in 10,000 patients treated, including individual cases
Not known: Cannot be estimated from the available data
The following adverse drug reactions have been observed to date:
Infections
Common: Increased colonisation of the skin and mucosae with yeast fungus (candidiasis). Prolonged and repeated use of amoxicillin/ clavulanic acid can result in an infection or colonization with resistant bacteria or yeasts.
Blood and lymphatic system disorders
Rare: Changes in blood count such as reduction in the number of white blood cells (leukopenia including neutropenia), reduction in number of platelets (thrombocytopenia).
Very rare: Changes in blood count manifested by a reduction in the number of certain white blood cells (granulocytopenia, agranulocytosis), reduction in number of all blood cells (pancytopenia), haemolytic anaemia, suppression of blood cell production by the bone marrow (myelosuppression) and prolongation of the bleeding and prothrombin time.
These manifestations are reversible upon discontinuation of therapy.
Immune system disorders
Very rare: Severe allergic reactions resulting from sensitisation to 6-amino penicillic acid group, e.g. in the form of drug fever, increase in special blood cells (eosinophilia), painful swelling of the skin and mucosa (Quincke’s edema), hypersensitivity reactions of every severity, sometimes resulting in allergic shock (anaphylaxis), serum sickness, allergic vessel and renal complaints (vasculitis and/or nephritis) and internal swelling of the larynx with airway restriction and laboured breathing (laryngeal oedema). Hypersensitivity reactions of every severity, sometimes resulting in anaphylactic shock, have been observed in association with the administration of penicillins. Severe anaphylactoid reactions may require appropriate emergency measures (see Countermeasures in the event of life-threatening adverse drug reactions).
Nervous system disorders
Uncommon: Headache, dizziness.
Very rare: Reversible hyperactivity, anxiety, insomnia, confusion, aggression and convulsions. As with other penicillins, cerebral convulsions may occur in patients with impaired renal function or in patients receiving high doses of amoxicillin/clavulanic acid. Care must therefore be taken to ensure an appropriate dosage, especially in patients with compromised renal function.
Gastrointestinal disorders
Very common: Diarrhoea.
Common: Nausea (increases with higher dose), vomiting, stomach ache, flatulence and soft stool. These are generally of a mild nature and recede upon discontinuation of therapy. AmoxiClav-Denk 1000/125 is tolerated better when taken with meals.
Uncommon: Upper abdominal complaints (dyspepsia).
Rare: Increased colonisation of the intestine with yeast fungus (intestinal candidiasis).
Very rare: Intestinal infection caused by antibiotics (antibiotic-associated enterocolitis including pseudomembranous enterocolitis and haemorrhagic enterocolitis) which may be life-threatening. In the event of severe persistent diarrhoea occurring during or in the first few weeks after treatment, the diagnosis of pseudomembranous enterocolitis should be considered (in most cases caused by the pathogen Clostridium difficile) (see Countermeasures in the event of life-threatening adverse drug reactions). Black tongue.
A single study in women with premature rupture of the amnion reported that prophylactic treatment with amoxicillin/clavulanic acid can be associated with a severe form of intestinal infection (necrotising enterocolitis) in neonates.
Hepatobiliary disorders
Uncommon: Moderate, asymptomatic rise in liver enzyme values (AST, ALT, alkaline phosphatase). However, this is not necessarily a sign of liver damage associated with amoxicillin/clavulanic acid.
Very rare: Transitory liver infection and jaundice caused by bile obstruction (cholestatic jaundice). These reactions have also been observed in association with other penicillins or cephalosporins. Symptoms of liver impairment (unusually severe itching, yellowing of the skin and whites of the eyes, darker urine and paler stools than usual) may occur during and shortly after treatment with amoxicillin/clavulanic acid. In some cases, however, they do not become apparent until several weeks after treatment cessation. Liver impairment may be severe and occurs predominately in males and elderly patients (aged 60 and over) or with treatment courses exceeding 14 days. It is usually temporary. However, in extremely rare cases a fatal outcome has been reported. These have mostly occurred in patients with a serious underlying illness or in patients taking other medicines at the same time. Liver impairment also has been observed in children in very rare cases.
How to take:
Single doses are to be taken at regular intervals throughout the day. The content of a sachet is to be dispersed in a half glass of water before drinking. AmoxiClav-Denk 1000/125 is best taken at the start of a meal, after you have taken your first bite. Taken in this way, AmoxiClav-Denk 1000/125 is most effective and tolerated best. However, AmoxiClav-Denk 1000/125 is also effective when taken before or after meals.
