Clavomed (Amoxicilin & Clavulanic acid)
COMPOSITION
Each 5 ml of suspension contain:
For dosage 156.25 mg/5 ml amoxicillin 125 mg, clavulanic acid 31.25 mg.
For dosage 312.5 mg/5ml amoxicillin) 250 mg, clavulanic acid 62.5 mg
THERAPEUTIC INDICATIONS
- Upper respiratory tract infections (acute and
chronic sinusitis, acute and chronic otitis media, tonsillopharyngitis);
- Lower respiratory tract infections (acute and chronic bronchitis and
pneumonias, empyema);
- Urinary tracts infections (including cystitis, urethritis and pyelonephritis);
- Gynecological infections (including salpingitis, salpingoophoritis,
endometritis, septic abortion, pelvioperitonitis);
- Bone and connective tissues infections (including chronic osteomyelitis);
- Skin and soft tissues infections (including phlegmon, traumatic fever);
- Biliary tracts infections (cholecystitis, cholangitis);
- Sexually transmitted diseases (gonorrhea, chancroid);
- Odontogenic infections;
- Infection prophylaxis after surgical operation.
CONTRAINDICATIONS
- Hypersensitivity to penicillin antibiotics;
- Cholestatic jaundice or hepatitis;
- Liver impairment;
- Infectious monoucleos, lymphatic leukemia.
ADVERSE EFFECTS
Side effects are weak and quickly passing in most
cases.
From the digestive system: appetite loss, nausea, vomiting, diarrhoeia.
Such undesirable effects can be avoided by taking Clavomed suspension while
eating.
Allergic reactions: itch, appearance of skin rash; in single cases:
Stevens-Johns syndrome.
Others: single reports about the appearance of cholestatic jaundice, hepatitis,
liver dysfunction, superinfection development (including candidosis), reversible
augmentation of prothrombine time.
DOSAGE AND ADMINISTRATION
Clavomed suspension should be used while eating
for possible side digestive reactions prevention.
For infants and children under 3 months: standard dose makes 30 mg
(amoxicillin)/kg of body weight/day, divided in 2 doses.
Children from 3 months and older (body weight is less than 40 kg):
The recommended doses of suspensions (156.25 mg/ml and 312.5 mg/ml) are
determined against the body weight of children and infection severity. Usage: 3
times/day.
Body weight
(kg) |
Age |
Moderate
infections |
Severe
infections |
Suspension |
Suspension |
156.25 mg/5
ml |
312.5 mg/5ml |
156.25 mg/5
ml |
156.25 mg/5
ml |
Single dose
(measuring spoon) |
5-10 |
3-12 months |
½ |
¼ |
¾ |
¼ - ½ |
10-12 |
1-2 years |
¾ |
¼ - ½ |
1¼ |
½ - ¾ |
12-15 |
2-4 years |
1 |
½ |
1½ |
¾ |
15-20 |
4-6 years |
1 ¼ |
½ - ¾ |
1¾ - 2 |
1 |
20-30 |
6-10 years |
1 ¼ |
¾ - 1 |
- |
1¼ - 1½ |
30-40 |
10-12 years |
- |
1¼ |
- |
1¾ - 2 |
> 40 |
> 12 years |
Tablets
dosage form is used. |
Maximum daily dose of amoxicillin makes for
adults 6 g and 45 mg/kg of body weight for children.
Maximum daily dose of clavulanic acid (as potassium salt) makes for adults 600
mg and 10 mg/kg of body weight for children.
DRUG INTERACTIONS
Co-application of Clavomed suspension and
methotrexate raises the toxicity of the last. The prescription with allopurinol
raises the frequency of appearance skin rash (exanthema). In some cases Clavomed
suspension can prolong the prothrombin time; in connection with it one should be
cautious at concomitant prescription of anticoagulants and Clavomed. One should
avoid the co-application with disulphiram. It is shown that antibiotics lower
the effectiveness of peroral contraceptives. Probenecid lowers the elimination
of amoxicillin, increasing its serum concentration.
PREGNANCY AND LACTATION
Clavomed can be taken during the pregnancy, if
expected benefit for mother exceeds its potential risk for fetus.
Only small amounts of amoxicillin and clavulanic acid are excreted in breast
milk, therefore during the treatment with Clavomed one should cease the breast
feeding.
MANUFACTURED FORM
Powder for preparation of suspension for oral use
156.25 mg/5ml or 312.5 mg/5 ml. Polyethylene vial 100 ml, closed by stopper with
protection ring. 1 vial with measuring spoon in carton box together with enclosed insert.
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