Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O)
Septodont Inc
TOPICAL
PRESCRIPTION DRUG
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. 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 . Safety and effectiveness in children under the age of 12 have not been established.
Clear and colorless sterile solution, in one fluid ounce bottles. Multi dose Dyclonine HCl Topical Solution 0.5% (NDC 0362-3971-05) Dyclonine HCl Topical Solution 1% (NDC 0362-3918-10). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep upright and preserve in tight and light-resistant container. Avoid excessive heat (temperatures above 40ºC [104ºF]). Subject to damage by freezing.
Abbreviated New Drug Application
DYCLOPRO- DYCLONINE HYDROCHLORIDE SOLUTION SEPTODONT INC ---------- DYLCLOPRO (DYCLONINE HYDROCHLORIDE TOPICAL SOLUTION, USP, 0.5% AND 1%) TOPICAL ANESTHETIC RX ONLY DESCRIPTION: _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: COMPOSITION OF DYCLONINE HCL TOPICAL SOLUTION, USP, 0.5% AND 1% TOPICAL ANESTHETICS: Each mL of _Dyclonine HCl Topical Solution, USP, 0.5%_ contains dyclonine HCl, 5 mg. Each mL of _Dyclonine HCl Topical Solution, USP, 1%_ contains dyclonine HCl, 10 mg. Both solutions also contain chlorbutanol hydrous and sodium chloride, and the pH is adjusted 3.0-5.0 by means of hydrochloric acid. CLINICAL PHARMACOLOGY: _Dyclonine HCl Topical Solution, USP _ effects surface anesthesia when applied topically to mucous membranes. Effective anesthesia varies with different patients, but usually occurs from 2 to 10 minutes after application and persists for approximately 30 minutes. INDICATIONS AND USAGE: _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. CONTRAINDICATIONS: _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_. WARNINGS: IN ORDER TO MANAGE POSSIBLE ADVERSE REAC Прочитайте повний документ