SX1 MEDICATED POST-OPERATIVE SYSTEM- lidocaine hydrochloride kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Disponível em:

IT3 Medical LLC

DCI (Denominação Comum Internacional):

LIDOCAINE HYDROCHLORIDE

Composição:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Lidocaine HCI 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine HCI 2% Jelly. First aid to help prevent infection in: - Minor cuts - scrapes - burns First aid to help prevent infection in: - Minor cuts - scrapes - burns - if you are allergic to any of the ingredients - in the eyes - over large areas of the body - longer than 1 week unless directed by a doctor - Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs

Resumo do produto:

Lidocaine HCI 2% Jelly is supplied in the listed dosage forms. NDC 17478-840-30          30 mL aluminum tube NDC 17478-840-05          5 mL aluminum tube A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton. Storage: Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. PREMIERProRx® Manufactured by: Akorn, Inc. Lake Forest, IL 60045 PremierProRx® is a registered trademark of Premier Inc., used under license. PLD00N Rev. 10/15 Assembled and Distributed by IT3 Medical, LLC 4447 N Central Expy; Ste 110-106 Dallas, TX 75205 For questions or comments: [e-mail] www.IT3-Medical.com

Status de autorização:

Abbreviated New Drug Application

Características técnicas

SX1 MEDICATED POST-OPERATIVE SYSTEM- LIDOCAINE HYDROCHLORIDE
IT3 MEDICAL LLC
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SX1 MEDICATED POST-OPERATIVE SYSTEM
RX ONLY
DESCRIPTION
Lidocaine HCI 2% Jelly is a sterile, aqueous product that contains a
local anesthetic agent
and is administered topically. (See INDICATIONS for specific uses.)
Lidocaine HCI 2% Jelly contains lidocaine HCI which is chemically
designated as
acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride
and has the
following structural formula:
Its molecular formula is C
H
N O • HCI and its molecular weight is 270.80.
Lidocaine HCI 2% Jelly also contains hypromellose, and the resulting
mixture maximizes
contact with mucosa and provides lubrication for instrumentation. The
unused portion
should be discarded after initial use.
Composition of Lidocaine HCI 2% Jelly 30 mL and 5 mL tubes: Each mL
contains 20 mg
of lidocaine HCI. The formulation also contains methylparaben,
propylparaben,
hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust
pH between 6.0
to 7.0.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Lidocaine stabilizes the neuronal membrane by
inhibiting the
ionic fluxes required for the initiation and conduction of impulses,
thereby effecting local
anesthetic action.
ONSET OF ACTION: The onset of action is 3 to 5 minutes. It is
ineffective when applied to
intact skin.
HEMODYNAMICS: Excessive blood levels may cause changes in cardiac
output, total
peripheral resistance, and mean arterial pressure. These changes may
be attributable to
a direct depressant effect of the local anesthetic agent on various
components of the
14
22
2
a direct depressant effect of the local anesthetic agent on various
components of the
cardiovascular system.
PHARMACOKINETICS AND METABOLISM: Lidocaine may be absorbed following
topical
administration to mucous membranes, its rate and extent of absorption
depending upon
concentration and total dose administered, the specific site of
application, and duration
of exposure. In general, the rate of absorption of local anesthetic