DYCLOPRO Topical solution Ref.[10046] Active ingredients: Dyclonine

IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER LOCAL ANESTHETIC AGENTS, SUCH AS DYCLONINE, ARE ADMINISTERED TO MUCOUS MEMBRANES.

Dyclonine HCl Topical Solution, USP should not be injected into tissue or used in the eyes because of highly irritant properties.

Dyclonine HCl Topical Solution, USP should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application since under such conditions there is the potential for rapid systemic absorption.

Adverse experiences following the administration of dyclonine are similar in nature to those observed with other local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

The following types are those most commonly reported:

Central nervous system:

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of dyclonine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular system:

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic:

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to the other ingredients used in this formulation. Allergic reactions, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Local reactions include irritation, stinging, urethritis with and without bleeding.

The safety and effectiveness of dyclonine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see WARNINGS and ADVERSE REACTIONS). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of dyclonine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients and children should be given reduced doses commensurate with their age, weight and physical condition. Dyclonine should also be used with caution in patients with severe shock or heart block.

Dyclonine HCl Topical Solution, USP should be used with caution in persons with known drug sensitivities.

When topical anesthetics are used in the mouth or throat, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. When Dyclonine HCl Topical Solution, USP is used to relieve the pain of oral ulcers or stomatitis which interferes with eating, patients should be warned about the risk of biting trauma before they accept this treatment; caution should be exercised in selecting food and eating. Following other uses in the mouth and throat area, food and/or chewing gum should not be used while the area is anesthetized.

Dyclonine HCl Topical Solution, USP should not be used in cystoscopic procedures following intravenous pyelography because an iodine precipitate occurs which interferes with visualization.

Teratogenic Effects

Pregnancy Category C.

Animal reproduction studies have not been conducted with dyclonine hydrochloride. It is also not known whether dyclonine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dyclonine hydrochloride should be given to pregnant women only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dyclonine is administered to a nursing woman.

Safety and effectiveness in children under the age of 12 have not been established.