DYCLOPRO- dyclonine hydrochloride solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O)

Dostępny od:

Septodont Inc

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DYCLOPRO- DYCLONINE HYDROCHLORIDE SOLUTION
SEPTODONT INC
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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