Clavomed Tab. (Co-amoxiclav)
Pharmaceutical Form
Tablets for oral use, film coated.
COMPOSITION
One film coated tablet contains:
Amoxicillin trihydate equivalent to 875 mg of
amoxicillin
Potassium clavulanate equivalent to 125 mg of
clavulanic acid.
INDICATIONS
Clavomed is prescribed for treatment of the
following infections, caused by susceptible to combination of amoxicillin/
clavulanic acid strains:
- Infections of upper air passages (acute and
chronic sinusitis, acute and chronic middle otitis, tonsillitis- pharyngitis)
- Infections of low air passages (acute and
chronic bronchitis and pneumonia, pleural empyema)
- Infections of urinary tract (including
cystitis, urethritis, pyelonephritis)
- Infections in gynaecology (including
salpingitis, salpingo-oothecitis, endometritis, septic abortion,
pelviperitonitis)
- Infections of bone and connective tissues (including
chronic osteomyelitis)
- Infections of skin and soft tissues (including
phlegmon, traumatic infection)
- Infections of biliary tracts (cholecystitis,
cholangitis)
- Diseases passed by sexual ways (gonorrhea,
chancroid)
- Odontogenous infections
- Prevention of infections at surgery.
CONTRAINDICATIONS
- Hypersensitivity to penicillin antibiotics
- Cholestatic jaundice and hepatitis
- Liver impairment
- Infectious mononucleosis, lymphatic leukemia.
PRECAUSIONS
Due to possible crossed sensitivity development
patients with allergic reactions to cephalosporins are prescribed with caution.
Caution is necessary at prescriptions to
patients with severe liver function impairment.
Patients with severe renal function impairment
require adequate correction of dose or interval prolongation between dosing.
In connection with that erythematous rash
development have been observed at big amount of patients suffering from
infectious mononucleosis and lymphatic leukemia, taking anpicillin,
application of ampicillin group antibiotics for such patients is not
recommended.
PREGNANCY AND LACTATION
Either Amoxicillin or clavulanic acid in small
quantities penetrate into breast milk, therefore breast feeding should be
stopped during treatment with Clavomed. Clavomed may be taken during pregnancy,
if supposed benefit for mother exceeds possible risk for fetus.
DRUG AND OTHER INTERACTIONS
Co-application of Clavomed and methotrexate
increases toxicity of methotrexate. Prescription with allopurinol increases
rate of exanthema development.
In some cases Clavomed may extend prothrombin
time, therefore caution should be complied at simultaneous prescription of
anticoagulating agents and Clavomed.
Simultaneous application with disulfiram should
be avoided.
Clavomed should not be used in combination with
bacteriostatic antibiotics (macrolides, tetracyclines) due to possible
efficacy reduction of Clavomed.
Combination with riphampicin is antagonistic.
It is demonstrated that antibiotics reduce
efficacy of peroral contraceptives.
Probenecid reduces amoxicillin excretion
increasing its concentration in plasma.
OVERDOSAGE
Fatal outcome or appearance of life threatening
side effects because of Clavomed overdose have not been reported.
In case of overdose a patient must be under
surveillance, treatment is symptomatic.
In most cases overdose symptoms include
disorders from gastrointestinal tract side (abdominal pain, diarrhea, vomiting).
In case of recent use (less than 4 hours) remove
Clavomed from gastrointestinal tract by means of gastric lavage, then by
intake of activated carbon for reduction of absorption. Amoxicillin /
Potassium clavulanate is removed by hemodialysis.
SIDE EFFECTS
Side effects in most cases are slight and
temporary. Among registered side effects impairments of gastrointestinal tract
have been reported most of all (appetite loss, nausea, vomiting, diarrhea).
Unwished side effects can be avoided when Clavomed is taken during meal.
Allergic reactions can appear (itch, skin rash):
at sensitive patients development of acute hypersensitivity reaction is
possible. Seldom transient increase of transaminase level can be observed.
Single cases of cholestatic jaundice, hepatitis,
lever function impairment are reported.
DOSAGE AND ADMINISTRATION
Adults and children over 12 years old:
Patients with severe infection should take
Clavomed by one tablet 1.0 g twice a day.
Clavomed tablets for children younger 12 years
old are not recommended.
For patients with severe renal impairment (creatinine
clearance 10-30 ml/min) dose should be adequately reduced or interval between
dosing is to be increased:
|
creatinine clearance
Interval between dosing
|
> 30
8 hours
|
30-10
12 hours
|
< 10
24 hours
|
Treatment with Clavomed can last for 14 days,
after that patient should be examined by doctor.
DOSAGE FORM
Box with 10 tablets by 1.0 g.
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