Indications : התוויות

1.       THERAPEUTIC INDICATIONS
Infections caused by amoxicillin ‐ susceptible organisms.
Prevention of bacteremia in patients at risk of developing bacterial endocarditis.

THERAPEUTIC CLASSIFICATION

Antibiotic

2        CONTRAINDICATIONS

Moxypen Forte is contraindicated in:
•   patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

•   patients with a history of a previous hypersensitivity reaction to any of the penicillins or cephalosporins.

•   in cases where infectious mononucleosis is either suspected or confirmed.

3        SERIOUS WARNINGS AND PRECAUTIONS BOX
Serious Warnings and Precautions Box

Hypersensitivity: Serious and occasionally fatal hypersensitivity (anaphylactic) and severe cutaneous adverse reactions (SCAR) have been reported in patients receiving therapy with beta‐lactams, including amoxicillin. (See 7 WARNINGS AND PRECAUTIONS, Hypersensitivity and 7 WARNINGS AND PRECAUTIONS, Skin).


4      DOSAGE AND ADMINISTRATION
With the exception of gonorrhea, treatment with Moxypen should be continued for a minimum of 48‐72 hours beyond the time at which the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

In the treatment of group A β‐hemolytic streptococcal infections, therapy with this drug should be continued for at least 10 days to help prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Upper Respiratory Tract and Chest Infections
Adults and Children over 10 Years of Age:
The recommended dosage is 250‐500 mg 3 times daily, every 8 hours.

Infants and Children under 10 Years of Age:
In infants under 2 years of age, the dosage is 62.5 mg 3 times daily, every 8 hours.
In children 2‐10 years of age, the dosage is 125 mg 3 times daily, every 8 hours. For more severe infections, the dosage may be increased to 250 mg 3 times daily.

The recommended dosage according to body weight is 20 mg/kg per day in divided doses every 8 hours. For more severe infections, the dosage may be increased to 40 mg/kg body weight per day every 8 hours.

Skin and Soft‐tissue Infections
Treat as for upper respiratory tract and chest infections.

Uncomplicated Lower Urinary Tract Infections
Adults
A single dose of 3 g may be administered.
Children
A single dose of 100 mg/kg body weight may be administered.
Gonorrhea
A single dose of 3 g may be administered.

Prophylaxis of Bacterial Endocarditis (in dental procedures)
Adults and Children over 10 Years of Age
A single dose of 3 g about 1 hour prior to the procedure, to prevent bacteremia.

Children under 10 Years of Age
Half the adult dose.
In order to obtain optimal absorption of drug from Moxypen Forte capsules they should be administered between meals with a glass of water (250 mL or 8 fl. oz.).

4.1    Reconstitution

Directions for Dispensing Oral Suspension:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Prepare these formulations at the time of dispensing. For ease in preparation, add water to the bottle in two portions and shake well after each addition. Add the total amount of water as directed on the labeling of the package being dispensed: 36 ml or 60 ml of distilled water to prepare 60 ml or 100 ml of suspension accordingly.

The reconstituted formulation is stable for 14 days under refrigeration (2‐8°C) or 14 days at room temperature (25°C).