Spirometro

Composition:
SPIROMETRO is the trade name of spiramycin,a macrolide antibiotic;and metro
Spiramycin 750,000 international units (IU)
Metronidazole 125 mg.

Excipients:
Maize starch, Anhydrous citric acid, Microcrystalline cellulose 180 micrometer, Sodium starch glycolate (type A), Dried Aluminium hydroxide Gel, Magnesium stearate, Opadry OY-1350 pink, White Bees wax

Pharmaceutical dosage form : F.C.Tablet

PHARMACOLOGICAL ACTION:

SPIROMETRO is a combination of Spiramycin, a macrolide antibiotic; and Metronidazole, a 5-nitro-imidazole antibiotic. The combination covers a large spectrum of pathogens. Species sensitive to the components include aerobic gram-positive and gram-negative bacteria and anaerobic pathogens. Furthermore, the combination of Spiramycin and Metronidazole provides a synergistic antibacterial effect as shown from average minimum inhibitory concentration (MIC) values for the two components isolated and combined. For example, MIC on Bacteroides fragilis for the combination is 16 and 4 times less than the respective values for Spiramycin and Metronidazole alone. Consequently, the combination is especially advantageous for buccodental infections.

CONTRAINDICATIONS

Hypersensitivity to imidazoles and/or macrolides.
Concurrent use of disulfiram or alcohol (see Drug Interactions).
The Tablet dosage form is not suitable for children below 6 years.

Category:
PHARMACOKINETICS
INDICATIONS
DOSAGE
DRUG INTERACTIONS
USE IN PREGNANCY
USE IN LACTATION
HOW SUPPLIED
STORAGE

PHARMACOKINETICS

Spiramycin is rapidly but incompletely absorbed from the gastrointestinal tract. Metronidazole is well absorbed orally. Both Spiramycin and Metronidazole concentrate in saliva, gingival tissue, and alveolar bone. Both components are excreted in urine, and Spiramycin is excreted also in bile. Gingival fluid contains concentrations of spiramycin and metronidazole higher than those needed to inhibit the growth of periodontopathic bacteria. The absolute bioavailability of oral spiramycin is generally within the range of 30 to 40%. After a 1g oral dose, the maximum serum drug concentration was found to be within the range 0.4 to 1.4 mg/L. Metronidazole has an oral bioavailability approaching 100 %. Rectal and vaginal administration result in a smaller amount of drug absorption and lower serum concentrations. The tissue distrebution of spiramycin is extensive. The volume of distrebution is in excess of 300L, and concentrations achieved in bone, muscle, respiratory tract and saliva exceed those found in serum. The intracellular penettration of spiramycin is also rabid and extensive. With the concentrations in alveolar marcophages 10 to 20 times greater the simultaneous serum concentrations. Metronidazole has limited plasma protein binding but contain verry favorable tissue distrebution, including into the central nervous system. The drug is extensively metabolised by the liver to form 2 primary oxidative metabolites: the hydroxy and acetic acid metabolites. Spiramycin is less metabolised than some of the other macrolides. The renal excretion of  spiramycin is low, with 4 to 20 of the dose being excreted by this route. High concentrations of spiramycin are achieved in bile, which is an important route of elimination. The kidney is responsible for the elimination of only a small amount of the parent metronidazole; however, normal excretion of the 2 metabolites is dependent on the integrity of kidney function.

INDICATIONS

SPIROMETRO is indicated in acute, chronic or repeating stomatologic infections including dental abscesses, phlegmons, cellulitis perimaxillaires, pericoronitis, gingivitis, stomatitis, periodontitis, parotitis, and submaxillaritis. Preventive treatment of the postoperative local infectious complications in odontostomatologic surgery. Note The effectiveness in the prevention of infectious endocarditis has not been demonstrated.

DOSAGE

Usual adult dose: Curative treatment and preventive treatment of the postoperative local infectious complications in odontostomatologic surgery: 4 to 6 SPIROMETRO Tablets daily divided in 2-3 doses, during meals. In curative treatment, dosage may be increased to 8 Tablets daily in severe cases. Usual Pediatric Dose 6 to 10 years: One SPIROMETRO Tablet 2 times daily. 10 to 15 years: One SPIROMETRO Tablet 3 times daily.

DRUG INTERACTIONS

Disulfiram: Hot flushes and a state of confusion may result from concomitant administration with Metronidazole. Concomitant use is not advisable. Alcohol: An antabuse effect may be provoked. Patients should refrain from alcoholic drinks and medications containing alcohol while using Metronidazole. Oral anticoagulants (warfarin): Metronidazole may potentiate oral anticoagulants via reducing their hepatic catabolism. Prothrombin ratio and International Normalization Ratio (INR) should be closely monitored. Oral anticoagulant dose should be adjusted during Metronidazole treatment and 8 days after its cessation. Levodopa and carbidopa combination: Spiramycin inhibits the absorption of carbidopa resulting in reduced plasma concentrations of levodopa. Metronidazole reduces flurouracil clearance resulting in increased toxicity.  

USE IN PREGNANCY

Neither Spiramycin nor Metronidazole are teratogenic in animals. In humans, it is recommended that Spiramycin and Metronidazole combination be avoided because it passes the placenta.

USE IN LACTATION

Metronidazole and Spiramycin are distributed into breast milk. Therefore, their combination is avoided during lactation.

HOW SUPPLIED

Carton box containing 1, 2, 3 PVC-Al blisters. Each contains 10 F.C.Tablets + pamphlet

STORAGE

Store at temperature not exceeding 30 oC in dry place

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