ACTION AND MECHANISM

Antiseptic. Chlorophenylbiguanide derivative. It has a relatively broad antibacterial spectrum (bacteriostatic; at higher concentrations, it is bactericidal), with particular activity against Gram-positive bacteria. It is sporostatic, preventing spore germination. It does not usually induce microbial resistance. It is also active against fungi and yeasts. It is not virucidal. - Mechanism of action: Chlorhexidine is believed to form compounds with the cell surface of microorganisms, disrupting their semipermeable barrier and coagulating the cell's cytoplasmic contents. In contrast to chemotherapeutic agents, which exert a high degree of selectivity for certain bacterial species, antiseptics are highly toxic to all types of cells. - Antimicrobial spectrum: Microorganisms highly sensitive to chlorhexidine include some staphylococci, Streptococcus mutans, Streptococcus salivarius, Candida albicans, Escherichia coli, Selenomonas, and anaerobic propionic bacteria. Streptococcus sanguis has moderate sensitivity. Microorganisms with low sensitivity to chlorhexidine include Pseudomonas, Klebsiella, Proteus strains, and Veillonella-like Gram-negative cocci.

SENIORS

The safety and efficacy of chlorhexidine use in the elderly have not been specifically established; however, no specifically geriatric problems have been described. Its use is generally accepted.

PATIENT ADVICE

PATIENT ADVICE: - Allow the tablet to dissolve slowly in the mouth. Do not chew or swallow, as its action is entirely local. - Maintain good oral hygiene to reduce discoloration of teeth, mouth, dental fillings, dentures, or other oral prostheses, and to prevent tartar buildup. - A temporary change in the sense of taste may occur.

CONTRAINDICATIONS

- Allergy to chlorhexidine.

PREGNANCY

FDA Pregnancy Category B. Studies in rats and rabbits, using doses 300 and 40 times higher than the dose a person would receive by ingesting 30 mL of chlorhexidine mouthwash daily, have not shown adverse fetal effects. There are no adequate and well-controlled studies in humans. Due to poor systemic absorption, the fetal risk appears to be minimal when using moderate doses for short periods of time; however, the use of this drug is only acceptable when safer therapeutic alternatives are unavailable.

PHARMACOKINETICS

- Absorption: Studies in humans and animals have shown that chlorhexidine is poorly absorbed from the gastrointestinal tract. In humans, the mean plasma level of chlorhexidine reached a maximum of 0.206 µg/g 30 minutes after a 300 mg oral dose. No detectable plasma levels were observed 12 hours after ingestion of the drug. - Elimination: Following administration of 300 mg oral doses of chlorhexidine, elimination occurred primarily via the feces (approximately 90%); less than 1% of the drug was eliminated in the urine.

INDICATIONS

[ORAL INFECTION], [PHARYNGITIS]: Local symptomatic relief of mild oropharyngeal infections without fever such as [ORAL CANKER SORES], throat irritation.

INTERACTIONS

The effectiveness of chlorhexidine is reduced by alkaline pH, the presence of organic matter, anionic detergents, and tannins. Elevated temperature, neutral pH, non-ionic detergents, alcohol, and quaternary ammonium salts enhance its effectiveness.

LACTATION

It is unknown whether this drug is excreted in breast milk. Due to poor systemic absorption, minimal excretion in breast milk is expected, and therefore the risk to the infant is not significant. Generally accepted use.

CHILDREN

The safety and efficacy of chlorhexidine use in children have not been established. No specific pediatric problems are anticipated in this age group.

GUIDELINES FOR PROPER ADMINISTRATION

Allow the tablet to dissolve slowly in the mouth. The tablets should not be chewed or swallowed, as their action is entirely local and their activity is only evident if the product is in direct contact with the affected area.

POSOLOGY

- Adults and children over 12 years: Usual dose: 1 tablet every 2-3 hours or 4 or 5 times a day, allowing the tablet to dissolve slowly in the mouth. Do not take more than 8 tablets per day. - Children over 6 years: Usual dose: 1 tablet every 4-5 hours, allowing the tablet to dissolve slowly in the mouth. Maximum dose: 6 tablets per day.

PRECAUTIONS

- In patients with periodontitis, chlorhexidine causes an increase in supragingival calculus.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.

ADVERSE REACTIONS

The adverse effects of chlorhexidine are generally mild and transient. The most characteristic adverse reactions are: - Frequently (10-25%): During prolonged treatments (more than one week), reversible changes in tooth color and fillings, and tongue discoloration, increased tartar (calculus) on the teeth. Discoloration of fillings may be permanent. - Occasionally (1-9%): At the start of treatment, transient dysgeusia and a burning sensation at the tip of the tongue may appear; superficial scaly lesions (oral irritation) have been described in children aged 10 to 18 years; the lesions are transient and may be painless. - Rarely (<1%): Swelling of the parotid glands, which disappears upon discontinuation of treatment.

COMPOSITION

CHLORHEXIDINE (STOMATOLOGICAL): 5 MILLIGRAMS - DICHLORHYDRATE
SUCROSE (EXCIPIENT): 860 MILLIGRAMS