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 ½ - ¾
12-15 2-4 years 1 ½ 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 - - 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.

Anti-İnfectives for Systemic Use

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