Josaxin® - SAJA Pharmaceuticals

Josaxin ® 

Josaxin ® film coated tablets is a 

macrolide antibiotic produced 

by a new variant of actinomycetes, 

streptomyces narbonensis 

var. josamyceticus. 

COMPOSITION 

Each Josaxin ® 500 tablet contains 

500 mg (potency) of 

josamycin FP. Each tablet also 

contains the following inactive 

ingredients: polyhydroxy-ethylene 

sorbitan fatty acid ester. 

INDICATIONS 

For the treatment of the upper 

respiratory tract infections, 

nasopharyngitis, tonsillitis, pharyngitis 

and sinusitis. Infections 

of the lower respiratory tract 

(bronchitis, bronchial pneumonia 

and atypical pneumonia). 

Infections caused by josamycinsusceptible 

staphylococcus sp., 

Streptococcus sp., Strepto-coccus 

pneumonia, Shigella sp., 

and Mycoplasma sp. 

DOSAGE AND ADMINIS- 

TRATION 

In the adult: 4 tablets per day, 

and as a general rule: 500 mg 

tablets: 2 in the morning and 2 

in the evening preferably to be 

taken before meals. 

PRECAUTIONS 

As a general rule, the duration 

of treatment with this product 

should be limited to a minimum 

required for the treatment of 

diseases, after the susceptibility 

being confirmed, in order to 

avoid possible occurrence of 

resistant bacteria. 

1 - Adverse Reactions 

Hypersensitivity 

Hypersensitive symptoms such 

as rashes may infrequently 

occur. If such symptoms occur, 

the administration of this product 

should be discontinued. 

Hepatic 

Allergic hepatic dysfunction may 

rarely occur. 

Gastrointestinal 

Symptoms such as anorexia, 

nausea, vomiting, abdomen 

enlarged feeling, abdominal 

pain, and diarrhea may infrequently 

occur. 

Others 

Stomatitis and tongue coat 

may rarely occur. 

2. Use in the Elderly 

Since the elderly often have a 

physiological hypofunction, it is 

advisable to take such measures 

as the reduction in the 

dose and the prolongation of 

the administration interval 

under careful supervision. 

3. Use during Pregnancy or 

Lactation 

Safety of this product in pregnant 

women has not been 

established. This product 

should only be used in pregnant 

women and women suspected 

of being pregnant 

provided that the expected 

therapeutic benefits are evaluated 

to outweigh the possible 

risk of treatment. 

Since this product is excreted 

into breast milk in humans, 

nursing mothers should discontinue 

breast feeding during 

treatment. 

PHARMACOKINETICS 

Blood concentration 

Josamycin absorption is very 

good. The average blood concentration 

reached maximum 

of 2.86 µg/ml at 1 hour after 

administration. It then decreased 

gradually but was still 

0.77 µg/ml at as long as 6 

hours after administration. 

Transfer to tissues 

Following oral administration of 

1g (potency) josamycin to 

patients, the drug concentration 

in tracheal sputum was 18 

µg/ml after 2 hrs and 9 µg/ml 

after 6 hrs, which were 8 to 9 

times higher than the plasma 

concentration. 

Orally administered josamycin 

is excreted into human milk 

considerably well and the timecourse 

of concentration was 

similar to that of plasma concentration. 

It was detected in 

the cord blood of pregnant 

women in a concentration several 

times lower than in the 

maternal plasma, but was not 

detected in the peripheral 

blood of newborns and fetuses. 

Excretion 

According to the data from 

healthy volunteers and from 

various facilities, 10% or less of 

orally administered josamycin 

was excreted in urine within 24 

hrs, as measured by microbiological 

assays. 

STORAGE 

Store below 30°C in tight containers. 

EXPIRATION DATE 

This product should be taken 

before expiration date as specified 

on the outer package. 

PACKAGING 

Josaxin ® tablets 500 mg boxes 

of 20 tablets. 

Manufactured by : 

SAJA Pharmaceuticals 

Saudi Arabian Japanese 

Pharmaceutical Co. Ltd. 

Jeddah, Saudi Arabia 

Under License from : 

ASTELLAS PHARMA INC. 

Tokyo - Japan 

THIS IS A MEDICAMENT 

- A drug is a product which 

acts on your health and its 

consumption could be 

dangerous when you do not 

follow the instructions . 

- Follow strictly the doctor's 

prescriptions, the method of 

use and the instructions of 

the pharmacist who sold the 

medicament. 

- The doctor and the pharmacist 

know the medicine, its 

benefits and risks. 

- Do not by yourself interrupt 

the period of treatment 

prescribed for you. 

- Do not repeat the same 

prescription without consulting 

your doctor. 

- Keep out of the reach of 

children. 

Revision Date: May 2007 

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Josaxin® - SAJA Pharmaceuticals

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