LIDOCAINE ointment

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Northstar Rx LLC

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Lidocaine ointment, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment, 5%.

Ապրանքի ամփոփագիր:

Lidocaine Ointment USP, 5% is available in 35.44 g (1¼ oz) laminate tubes with a child-resistant cap (NDC 16714-878-01) and 50 g jar (NDC 16714-878-02). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513, India To report SUSPECT ADVERSE REACTIONS, Contact NorthStar Rx LLC 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fdagov/medwatch November 2019

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

LIDOCAINE- LIDOCAINE OINTMENT
NORTHSTAR RX LLC
---------- LIDOCAINE OINTMENT, 5% FOR TOPICAL USE DO NOT USE IN THE EYES RX ONLY
DESCRIPTION
Lidocaine Ointment USP, 5% contains a local anesthetic agent and is
administered topically. See
INDICATIONS AND USAGE for specific uses.
Lidocaine Ointment USP, 5% contains lidocaine, USP, which is
chemically designated as acetamide, 2-
(diethylamino)-_N_-(2,6-dimethylphenyl)-, and has the following
structural formula:
Composition of lidocaine ointment USP, 5%: acetamide,
2-(diethylamino)-_N_-(2,6-dimethylphenyl)-, (lidocaine,
USP) 5% in a water miscible ointment vehicle containing polyethylene
glycols.
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 ANESTHESIA
Lidocaine ointment, 5% effects local, topical anesthesia. 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 cardiovascular system.
PHARMACOKINETICS AND METABOLISM
Lidocaine may be absorbed following topical administration to mucous
membranes, its rate and extent of
absorption depending upon the specific site of application, duration
of exposure, concentration, and total
dosage. In general, the rate of absorption of local anesthetic agents
following topical application occurs most
rapidly after intratracheal administration. Lidocaine is also
well-absorbed from the gastrointestinal tract, but
little intact drug appears in the circulation because of
biotransformation in the liver.
Lidocaine is metabolized rapidly by the liver, and metabolites and
unchanged drug are excreted by the
kidneys. Biotransformation includes oxidative N-dealkylation, ring
hydroxylation, clea