BOSDOGYL

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration

For oral use, drink the tablet with meals and drink plenty of water when taking the medicine.

Posology

-Adults:

4-6 tablets/day, divided into 2-3 times (spiramycin 3 - 4.5 MIU and metronidazole 500 - 750 mg).

In case of severe infection, the dose can be increased to 8 tablets/day.

- Children:

Children from 6 to 10 years old: 2 tablets/day (spiramycin 1,500,000 IU and metronidazole 250 mg).

Children from 10 to 15 years old: 3 tablets/day (spiramycin 2,250,000 IU and metronidazole 375 mg).

No definitive information is available on the maximum dose of this combination.

CONTRAINDICATIONS

Hypersensitivity to  metronidazole, spiramycin, other antibiotics of the imidazole class, or to any ingredient in the drug product.

Children under 6 years old because of inappropriate dosage form

WARNINGS AND PRECAUTIONS

•Scope of use

Single-antibiotic regimens are considered suitable for the treatment of most oral infections, so the need for a fixed-dose combination of spiramycin - metronidazole should be weighed against the possibility of using each type separately. antibiotic. The recommended first-line treatment for oral infections is an antibiotic with an optimal benefit-risk ratio.

• Hypersensitivity

Allergic reactions, including anaphylaxis, can occur and be life-threatening. In these cases, metronidazole should be discontinued and appropriate treatment instituted.

Severe skin reactions including Stevens-Johnson syndrome, Lyell's syndrome, and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazol/spiramycin. When using the drug, patients should be informed of the signs and symptoms of AGEP and closely monitored for skin reactions.

If signs or symptoms of Stevens-Johnson syndrome, Lyell's syndrome (Expanded rash with bullae or mucosal lesions) or acute generalized exanthematous pustulosis (AGEP) are present, Discontinue the drug and contraindicated the use of drugs containing spiramycin and metronidazole as a single component or in combination.

•Central nervous system

If symptoms suggestive of encephalopathy or cerebellar syndrome occur, the patient should be re-evaluated immediately and metronidazole discontinued.

Encephalopathy has been reported when metronidazole was marketed. MRI changes associated with encephalopathy have also been observed. In which, most of the observed lesions are in the cerebellum (especially in the dentate nucleus) and around the corpus callosi (splenium corporis callosi). Most of these cases were reversible upon discontinuation of metronidazole therapy, but a few exceptions were fatal.

Monitoring for symptoms suggestive of encephalopathy should be observed in patients with CNS disease.

In cases where aseptic meningitis has been associated with the use of metronidazole in a patient, re-use of metronidazole-containing products is not recommended or a benefit-risk assessment should be made in the case of severe infections. .

• Peripheral nervous system

Monitor for signs suggestive of peripheral neuropathy, particularly during prolonged therapy or in patients with advanced, severe, or chronic peripheral neuropathy.

•Psychosis

Psychiatric reactions to potentially hazardous behaviors can occur at the start of treatment, especially if the patient has a history of psychiatric problems. The use of metronidazole should be discontinued, and the doctor should be informed so that necessary treatment measures can be taken immediately.

•Blood

In the case of patients with a history of hematologic disorders, during high doses or prolonged therapy, frequent blood tests are recommended, with particular attention to the white blood cell count.

In the case of leukopenia, consideration should be given to the severity of the infection to decide whether to continue treatment with the drug.

• Prolong QT . interval

Cases of prolongation of the QT interval have been reported in patients receiving macrolide antibiotics, including spiramycin.

Caution should be exercised when administering spiramycin to patients with risk factors for QT prolongation such as:

Electrolyte imbalance (eg, hypokalemia, hypomagnesemia).

Congenital QT interval prolongation syndrome.

Heart disease (eg, heart failure, myocardial infarction, bradycardia).

Concomitant use with drugs known to prolong the QT interval (eg, class IA or III antiarrhythmics, tricyclic antidepressants, some antibiotics, and some antipsychotics).

Elderly patients, neonates, and women may be more sensitive to drugs known to prolong the QT interval.

• Problems on the liver

Cases of severe hepatotoxicity/acute liver failure, including deaths and rapid onset, have been reported following the initiation of systemic metronidazole-containing products in patients with Cockayne syndrome. In this population, metronidazole should be used only after a thorough benefit-risk assessment and other treatment options are not available. Liver function tests should be performed before, during and after treatment, until liver function returns to normal or pre-treatment values.

Patients with Cockayne syndrome should be instructed to immediately report any symptoms suggestive of liver damage to their physician and to discontinue metronidazole.

• G6PD enzyme deficiency

In patients with G6PD enzyme deficiency, cases of acute hemolysis have been reported with both oral and parenteral use of spiramycin. Therefore, do not use the drug in these patients and use other drugs instead.

In cases where other drugs cannot be substituted, the benefits of treatment should be weighed against the risks for the patient. If medication is necessary, care should be taken to monitor the occurrence of hemolysis.

•Drug interactions

Concomitant use of metronidazole with alcohol, busulfan, and disulfiram is not recommended (see Drug Interactions).

• Interactions with laboratory tests

Metronidazole can immobilize Treponema, thereby falsifying the results of the Nelson test.

• Be careful with excipients

BOSDOGYL contains the excipient ponceau 4R lake, which may cause allergic reactions.

Shelf-life

36 months from the manufacturing date. Do not use after the expiry date

- Al/PVC blisters. Box of 2 blisters x 10 film-coated tablets.

- Al/PVC blisters. Box of 5 blisters x 10 film-coated tablets. 

- Al/PVC blisters. Box of 10 blisters x 10 film-coated tablets.