COMPOSITION

Chlorhexid. Digluconas 0,2 g - Menthol. - Camphor. - Eucalypt. aetherol. - Menth. piper. aetherol. - Natr. Saccharinas - Aethanol. - Aqua purific. q.s. ad 100 ml.

PROPERTIES

Chlorhexidine gluconate solution is bactericidal (wide spectrum) and antifungal.
Its active principle, chlorhexidine, is from the biguanides group.
Spectrum of activity: in less than 5 minutes, chlorhexidine produces, in vitro, a bactericidal action over Gram + germs, and to a lesser degree, over Gram -.
Chlorhexidine Gluconate Minimum Inhibitory Concentrations for main pathogenic microorganisms in the oral cavity.

Micro organism                                                                                 MIC of chlorhexidine gluconate in mcg/ml

Streptococcus pyogenes                                                                  0,19 - 0,39
Streptococcus mutans                                                                      0,19
Streptococcus sanguis                                                                      0,39
Streptococcus faecalis                                                                      0,39 - 1,56
Streptococcus pneumoniae                                                               7,0
Corynebacterim diphteriae                                                                5,0
Candida albicans                                                                               7,0 - 15,0

MECHANISM OF ACTION


Chlorhexidine (Cl.H.) acts on the wall of microorganisms. It is absorbed immediately (in vitro) when added to a bacterial suspension. Its effect on cells depends on Cl.H. concentration, number and type of microorganisms and suspension liquid properties. Bacteriostatic concentrations decompose the microorganism's wall, leading to the loss of the cell's components.
With bactericidal concentrations (100 to 500 µg/ml), Cl.H. penetrates into the cytoplasm and creates precipitation of the endocellular components.
Resistance from some strains of Pseudomonas is associated with a decreased amount of lipopolysaccharides in the membrane, limiting possible absorption by the bacterial cell.
Cl.H. action is partially inhibited by organic material (serum, blood, …) and phospholipids.
Its action is potentiated by alcohol (excipient).

PHARMACOKINETICS


There is practically no intestinal and cutaneous absorption.
In case of systemic absorption, excretion of chlorhexidine is renal or biliary, with no previous metabolization; half-life is approximately 4 days.

INDICATIONS

BAXIL is indicated in the symptomatic treatment of the following oropharyngeal diseases: pharyngitis, ulcerative aphtha, simple and ulcerative gingivitis, simple and aphthous stomatitis and other infections in the oral cavity.

DOSAGE AND INSTRUCTIONS FOR USE

1 to 2 applications every 2 hours.
Instructions for use: this solution is ready for use and is not to be further diluted. Spray in the mouth or more deeply in the throat, holding breath while doing so.

CONTRAINDICATIONS

• Hypersensitivity to chlorhexidine (or its chemical class) (possible eczema)
• Do not spray in ears because of the ototoxicity risk (in case of eardrum perforation)

ADVERSE EFFECTS

The following adverse effects have been reported with chlorhexidine
• Staining of teeth and dental prosthesis with a repeated use.
• Allergic reactions (erythema, urticaria, dyspnea, anaphylactic shock).
• Staining of tongue
• Irritation of mucosa.

PRECAUTIONS

• Avoid contact with the eyes.
• If product comes into contact with the eyes, rinse thoroughly.
• Oral spray is not recommended for children.
• As much as possible, avoid treatment during a prolonged period of time.

INCOMPATIBILITY

• Precipitation with metal ions, phospholipids, tannins, serum and blood. Precipitation with metal ions and tannins can cause teeth and dental prosthesis to take a brownish coloration (if used with tea).
• Physico-chemical incompatibility with all anion-active derivatives: soap, some antiseptic.

PREGNANCY AND LACTATION

No toxicity has been reported during pregnancy and lactation, due to the mild absorption of the product.
As a precaution, this product should be used only as an absolute necessity during pregnancy and lactation.

INTERACTIONS

Anion-active derivatives (soap, tooth paste, some antiseptic) can reduce the efficiency of Cl.H.

OVERDOSAGE

Since there is very little absorption of chlorhexidine in the digestive tract, accidental ingestion is very unlikely to cause systemic effects, except in the case of a massive ingestion.
Gastro-intestinal irritation can be observed, and hepatotoxicity with a massive ingestion.
To treat overdosage, drink water or milk to dilute the ingested liquid.
Gastric lavage can be performed if ingested amount is significant.

STORAGE

Store at room temperature (15-25°C).

AVAILABILITY

In pharmacies, over the counter