DYCLOPRO

DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) topical anesthetics contain a local anesthetic agent and are administered topically. See INDICATIONS for specific uses. DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) contain dyclonine HCl, which is chemically designated as 4’-butoxy-3-piperidinopropiophenone HCl. Dyclonine HCl is a white crystalline powder that is sparingly soluble in water and has the following structural formula: Structural Formula

: Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.

: As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. A maximum dose of 30 mL of Dyclonine HCl Topical Solution, USP 1% topical anesthetic (300 mg of dyclonine HCl) may be used, although satisfactory anesthesia is usually produced within the range of 4 to 20 mL. For specific techniques and procedures refer to standard textbooks. Although as much as 300 mg of Dyclonine HCl Topical Solution USP (as a 1% solution) have been tolerated, this dosage as a 0.5% solution has not been administered primarily because satisfactory anesthesia in endoscopic procedures can usually be produced by lesser amounts. For specific techniques for endoscopic procedures refer to standard textbooks. Dyclonine HCl Topical Solution, USP can be used for a period of 7 days after open.

: Dyclonine HCl Topical Solution, USP is contraindicated in patients known to be hypersensitive (allergic) to the local anesthetic or to other components of Dyclonine HCl Topical Solution, USP .

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.