| EXCIPIENT |
| Corn starch, Povidone K30, Croscarmellose sodium, Silica colloidal anhydrous, sorbitol, Magnesium stearate, Microcrystalline cellulos, hypromellose, Macrogol 6000, Titanium dioxide. |
| COMPOSITION |
Each film coated tablet contains:
Spiramycin1,5 MIU equivalent to 341 mg(4401 IU/mg min) + Metronidazole 250 mg.
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| PHARMACODYNAMIC EFFECTS |
| This drug is a combination of spiramycin ,an antibiotic belonging to the macrolide group. And metronidazol, an antibiotic belonging to the 5-nitroimidazole group, for oral and dental infectious diseases. |
| PHARMACOKINETICS |
Absorption:
Spiramycin: is rapidly ,though incompletely absorbed. Food has no effect on its absorption.
Metronidazol: After oral administration is rapidly absorbed ie, at least 80% in 1 hr. Bioavailability is 100% via the oral route. This is not significantly affected by simultaneous food intake.
Distribution:
Spiramycin: does not penetrate into cerebrospinal fluid (CSF) It is excreted in breast milk. Plasma protein-binding is law (10%). Drug distribution in saliva and tissue is excellent.
Metronidazol: Plasma protein-binding is law <20% metronidazol crosses the placental barrier and is excreted in breast milk.
Metabolism:
Spiramycin: is metabolized in the liver.
Metronidazol: metabolism takes place mainly in the liver. Two principal compounds are formed by oxidation : the "alcohol" metabolite (major metabolite) with antibacterial activity against anaerobic bacteria that is approximately 30% that of metronidazole, and an elimination half-life of approximately 11 hours; the "acid" metabolite , in small quantities with antibacterial activity of approximately 5% that of metronidazol.
Excretion:
Spiramycin: the plasma half-life is close to 8 hrs. Urinary excretion account for 10% of the administered does. Appreciable amount of spiramycin can be found in faces.
Metronidazol: the plasma half-life is close to 8-10 hrs. fecal excretion is law. Excretion is mainly via the urinary route, as metronidazole and its oxidized metabolites found in the urine account for approximately 35-56% of the administered dose. Both components are concentrated in the saliva, gingival tissue and alveolar bone.
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| INDICATIONS |
| This drug is indicated for the treatment of acute, chronic or recurrent oral infections eg, dental abscess, phlegmon, cellulites of the jaw, pericoronitis, gingivitis, stomatitis, periodontitis, parotitis, submaxillaritis. It is also indicated for the preventive treatment of local, postoperative infectious complication following dental and oral surgery. |
| CONTRAINDICATIONS |
- Hypersensitivity to imidazole, spiramycin, or any of the excipients of the drug.
- Children <6 years, due to the pharmaceutical form.
- Use of the product is generally not recommended in combination with disulfiram, alcohol and medicinal product containing alcohol.
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| ADVERSE EFFECTS |
Spiramycin:
Gastrointestinal Tract: Stomach pain, nausea, vomiting, diarrhea and very rarely, pseudomembranous colitis.
Skin and Appendages: Rash, urticaria, pruritus. Very rarely, angioedema, anaphylactic shock. Very rare cases of acute generalized exanthematous pustosis.
Central and Peripheral nervous System: Occasional and transient paresthesias.
Hepatic Symptoms: Very rare cases of abnormal liver function test results.
Hematological Effects: Very rare cases of hemolytic anemia have been reported.
Metronidazole:
Gastrointestinal Tract: Benign gastrointestinal disorders (epigastric pain, nausea, vomiting, diarrhea); glossitis with a feeling of dry mouth, stomatitis, metallic taste, anorexia; exceptionally, pancreatitis which is reversible on treatment discontinuation.
Skin and Appendages: Flushing, pruritus, rashes, sometimes with fever; urticaria, angioedema, exceptionally anaphylactic shock.
Central and Peripheral nervous System Effects: Headache, peripheral sensory neuropathy, seizure, dizziness, ataxia.
Psychiatric Disorders: Confusion, hallucinations.
Hematological Effects: Very rare cases of neutropenia. Agranulocytosis and thrombocytopenia.
Hepatic Effects: Very rare cases of reversible liver function disorders and cholestatic hepatitis.
Others: Urine can appear reddish-brown as water-soluble pigments may be found due to metabolism of the drug.
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| WARNINGS & PRECAUTIONS |
As very rare cases of hemolytic anemia have been reported in patients with glucose-6-phosphate dehydrogenase deficiency, the use of spiramycin is not recommended in this patient population.
In patient with a history of hematological disorders and in those receiving high dose and/or prolonged treatment, blood tests should be performed regularly, in particular differential WBC counts. In patients with leucopenia, continuation of treatment depends on the appearance of signs suggestive of central or peripheral neurological reaction (paresthesias, ataxia, vertigo, seizure).
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
patients should be warned of the possible risk of dizziness, confusion, hallucinations or seizure and be advised not to drive vehicles or use machines if these disorders occur.
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| DRUG INTERACTIONS |
Related to spiramycin:
Levodopa (Combined with Carbidopa): the absorption of carbidopa is inhibited with decrease levodopa plasma levels. Clinical parameters should be monitored and the levodopa dosage be adjusted if necessary.
Related to metronidazol:
Inadvisable Combinations: Disulfiram: Acute transient delusional disorder, confusion.
Alcohol: Antabuse effect (heat, flushing, vomiting, tachycardia). Alcoholic beverages or medicinal products containing alcohol should be avoided.
Oral Anticoagulants :potentiation of the oral anticoagulant, with increased risk of bleeding due to decreased hepatic metabolism. Prothrombin times should be checked more frequently and the INR monitored. Oral anticoagulant dosage should be adjusted during treatment with this drug and for 8 days after its discontinuation.
Fluorouracil: Increased fluorouracil toxicity due to clearance.
Laboratory Tests: metronidazole can be result in false positives in the Nelson test.
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| PREGNANCY & LACTATION |
| If necessary ,this drug can be used during pregnancy, whatever the stage. As metronidazole and spiramycin are excreted in breast milk, this drug should not be administered during breastfeeding. |
| DOSAGE & ADMINISTRATION |
Curative Treatment and Preventive Treatment of Local, Postoperative Infectious Complications Following Dental and Oral Surgery:
Adults: 4-6 tablets of (Spiramycin750,000 IU equivalent to 170.5 mg+ Metronidazole 125 mg) ,or 2-3 tablets of (Spiramycin1,5 MIU equivalent to 341 mg + Metronidazole 250 mg) daily in 2-3 doses, during meals. For curative treatment in severe cases, dosage may be increase to 8 tablets of (Spiramycin750,000 IU equivalent to 170.5 mg+ Metronidazole 125 mg) or 4 tablets of (Spiramycin1,5 MIU equivalent to 341 mg + Metronidazole 250 mg)
Children 10-15 years: 3 tablets of (Spiramycin750,000 IU equivalent to 170.5 mg+ Metronidazole 125 mg) daily.
Children 6-10 years : 2 tablets of (Spiramycin750,000 IU equivalent to 170.5 mg+ Metronidazole 125 mg) daily.
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| OVERDOSAGE |
There is no specific antidote for spiramycin and metronidazole. If overdose occurs, symptomatic treatment should be given.
Effects related to spiramycin: there is no known toxic dose of spiramycin. Gastrointestinal signs can be expected after a high dose ie, nausea, vomiting, diarrhea. Cases of prolonged QT interval that abated on treatment discontinuation were observed in neonates treated with high doses of spiramycin and after IV administration of spiramycin in subjects at risk for prolonged QT intervals.
Effect related to metronidazol: cases of administration of single doses of up to 12 g have been reported during suicide attempts and accidental overdose . the symptoms were limited to vormiting, ataxia and mild disorientation.
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| STORAGE |
Do not store above 25°C.
Keep out of the reach of children. |
| PACKAGE |
| Spiradent– Fort: Pack of 20 coated tablets. |
