Each film-coated tablet contains:
Active ingredients:
| Spiramycin | 1.500.000IU |
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Sefutin 1.5M
201912-0029 • 2809 Views • Box of 2 blisters x 10 film-coated tablets
COMPOSITION
Spiramycin is indicated for the infections induced by micro-organisms susceptible:
- Pharyngitis caused by group A beta-hemolytic streptococcal infections, as an alternative to beta-lactam therapy, especially when it can not
be used.
· Acute sinusitis. Given the microbiological profile of these infections, macrolides are indicated when treatment with beta-lactam is not possible.
· Superinfections of acute bronchitis.
· Exacerbations of chronic bronchitis.
· Community-acquired pneumonia in subjects:
+ without risk factors,
+ without signs of clinical severity,
+ lack of clinical factors associated with pneumococcal etiology.
In case of suspicion of atypical pneumopathy, the macrolides are indicated whatever the gravity and the ground.
· Benign skin infections: impetigo, impetiginization of dermatoses, ecthyma, infectious dermohypodermatitis (in particular, erysipelas), erythrasma.
- Stomatological infections.
- Non-gonococcal genital infections.
- Chemoprophylaxis of RAA relapses in case of beta-lactam allergy.
- Toxoplasmosis of the pregnant woman.
- Prophylaxis of meningococcal meningitis in case of contraindication to rifampicin:
+ the goal is to eradicate the germ (Neisseria meningitides) from the nasopharynx,
+ spiramycin is not a treatment for meningococcal meningitis,
+ it is recommended for prophylaxis at:
++ the patient ax his curative treatment and before his reintegration into the community
++ subjects who have been exposed to oropharyngeal secretions within ten days prior to hospitalization.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In patients with normal renal function:
In general :
Adults: 6 to 9 million IU/24 hours, 4 to 6 tablets per day, divided into 2-3 times.
∙ Children 6 years old and over: 1.5 to 3 million IU per 10 kg of weight and per day, divided into 2-3 times.
The duration of treatment for the throat is 10 days.
Prophylaxis of meningococcal meningitis:
Adults : 3 million IU/12 hours in 5 days
Children 6 years old and over: 75,000 IU/kg/12 hours in 5 days
During 5 days.
In patients with renal insufficiency:
No dosage adjustment is necessary.
Method of administration
For oral use, the tablets may be swallowed with a glass of water.
CONTRAINDICATIONS
Hypersensitivity to spiramycin or to any ingredient in the drug product.
Children under 6 years old because the tablet form is not suitable
WARNINGS AND PRECAUTIONS
Cases of severe skin reactions including Stevens-Johnson syndrome, Lyell syndrome, and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with spiramycin. Patients should be informed of the signs and symptoms and close skin monitoring should be practiced.
The occurrence of signs or symptoms of Stevens-Jonhson Syndrome, Lyell Syndrome (e.g. progressive rash often accompanied by bullae or mucosal lesions), or AGEP (generalized febrile erythema associated with pustules) requires treatment discontinuation of treatment and contraindicates any new administration of spiramycin alone or in combination.
Drugs are not excreted from the kidney, no dose adjustment is required in patients with renal impairment.
Since very rare cases of hemolytic anemia have been reported in patients with Glucose-6-Phosphate-Dehydrogenase deficiency, the use of spiramycin in this patient population is not recommended.
QT interval prolongation
Cases of QT interval prolongation have been reported in patients taking macrolides, including spiramycin. Caution is advised during treatment with spiramycin, in patients with known risk factors for prolonging the QT interval such as:
+ uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesemia)
+ congenital long QT syndrome,
+ heart conditions (eg heart failure, myocardial infarction, bradycardia).
+ concomitant treatment with medicines known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, certain antibiotics, certain antipsychotics),
+ the elderly, newborns and women may be more sensitive to QT prolongation.
SHELF-LIFE
36 months from the manufacturing date. Do not use after the expiry date
Box of 2 blisters x 10 film-coated tablets
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