Posology : מינונים

4.2     Posology and method of administration

Dosage in Adult Patients
The dose of MEGAXIN is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
Table 1: Dosage and Duration of Therapy in Adult Patients

Type of Infectiona                                        Dose                       Durationb Every 24 hours             (days)
Acute Bacterial Sinusitis (ABS)                             400 mg                     10 Acute Bacterial Exacerbation of Chronic Bronchitis
(ABECB)                                                      400 mg                     5 Community -Acquired Pneumonia                                400 mg                     7-14 Uncomplicated Skin and Skin Structure Infections
(SSSI)                                                       400 mg                     7 Complicated Skin and Skin Structure Infections
(SSSI)                                                       400 mg                     7-21 a) Due to the designated pathogens [see Therapeutic Indications (4.1)].
b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician 
Conversion of Intravenous to Oral Dosing in Adults

Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with MEGAXIN IV may be switched to MEGAXIN Tablets when clinically indicated at the discretion of the physician.

Important Administration Instructions

MEGAXIN Tablets
With Multivalent Cations

Administer MEGAXIN Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Interactions with medicinal Products (4.5) and Clinical Pharmacology (12.3)].

With Food
MEGAXIN Tablets can be taken with or without food, drink fluids liberally.

MEGAXIN IV Solution for Infusion
Administer by Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Avoid rapid or bolus intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer MEGAXIN IV if particulate matter and/or discoloration is observed.

Discard any unused portion because the glass bottles are for single-use only.
2.3     Drug and Diluent Compatibilities

Because only limited data are available on the compatibility of MEGAXIN IV with other intravenous substances, additives or other medications should not be added to MEGAXIN IV or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of MEGAXIN IV with an infusion solution compatible with MEGAXIN IV as well as with other drug(s) administered via this common line.

Compatible Intravenous Solutions: MEGAXIN IV is compatible with the following intravenous solutions at ratios from 1:10 to 10:1:

0.9% Sodium Chloride Injection, USP
1 Molar Sodium Chloride Injection
5% Dextrose Injection, USP
Sterile Water for Injection, USP
10% Dextrose for Injection, USP
Lactated Ringer’s for Injection