Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3506 Limassol, Cyprus
Pharyngotonsillitis, acute sinusitis, acute otitis media, community-acquired pneumonia, uncomplicated skin and soft tissue infections, cutaneous Lyme infection, tooth abscess.
Official guidelines for the appropriate use of antibacterial agents should be considered.
12.5 mg/kg body weight and dose opportunity. If necessary, the dose may be increased to a maximum of 50 mg/kg per day. Treatment time in case of pharyngotonsillitis: 10 days. For other indications: 7-10 days.
| Weight | Tablet strength | Dosage |
|---|---|---|
| 10-20 kg | 250 mg | 1 tablet, 2-3 times daily |
| 20-40 kg | 250 mg | 2 tablets, 2-3 times daily |
| 40 kg | 250 mg | 4 tablets, 2-3- times daily |
25 mg/kg body weight per dose.
Duration of treatment for acute otitis media: 5 days, however in patients at risk for complications: 5-10 days, for recurrent acute otitis media: 10 days, acute sinusitis and tooth abscess: 7-10 days.
| Weight | Tablet strength | Dosage |
|---|---|---|
| 10-20 kg | 250 mg | 2 tablets, 2-3 times daily |
| 20-40 kg | 250 mg | 4 tablets 2-3 times, daily |
For patients 40 kg: 1600 mg, 2-3 times daily should be taken. For this group of patients another more appropriate strength of the product should be used.
Adults and children over 12 years: 1 g 3 times daily for 10 days.
Children under 12 years: 25 mg/kg body weight 3 times daily for 10 days.
For adults with uncomplicated acrodermatitis, a 2 or 3-gram dose is given three times daily for three weeks.
In order to avoid complications (rheumatic fever), infections caused by beta-hemolysing streptococci are treated for 10 days.
PK/PD data indicate that a three-times per day dose gives an increased clinical efficacy and it is therefore always recommended for serious infections such as pneumonia and erysipelas, and at least in the initial phase of other infections (see section 5.1).
Tablets should be taken on an empty stomach, or one hour before, or two hours after a meal.
In children, the compliance is improved if administration occurs with food.
Large doses are well tolerated. Acute reactions are mainly due to hypersensitivity. Certain risk of hyperkalemia in very severe overdose of penicillin in the potassium salt.
Toxic reactions; nausea, vomiting, diarrhoea, dyselectrolytemia, decreased consciousness, muscle fasciculations, myoclonia, convulsions, coma, haemolytic reactions, renal failure, acidosis.
In exceptional cases, anaphylactic shock may occur within 20-40 minutes.
If necessary gastric lavage, charcoal. Symptomatic treatment. In severe cases, hemoperfusion or haemodialysis.
Epinephrine (adrenaline) 0.1-0.5 mg slowly IV, hydrocortisone 200 mg intravenously, possibly promethazine 25 mg IV, liquid, correction of acidosis.
5 years.
Store below 25°C, protected from light and moisture.
PVC/Aluminium blisters. Pack sizes of 100, 500 and 1000 film-coated tablets
PP containers with PE closure. Pack sizes of 500 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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