LIDOCAINE ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)

Tilgjengelig fra:

ATLANTIC BIOLOGICALS CORP.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Lidocaine Ointment USP, 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 USP, 5%.

Produkt oppsummering:

Lidocaine Ointment USP, 5% is available in a 50 g Jar with a child-resistant cap (NDC 51672-3008-5). NOTE - JARS ARE FILLED BY WEIGHT NOT VOLUME. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Pharmacist: Dispense in tight containers as specified in USP. If dispensed to a consumer, provide child-resistant package for dispensing. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep Tightly Closed.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LIDOCAINE- LIDOCAINE OINTMENT
ATLANTIC BIOLOGICALS CORP.
----------
LIDOCAINE OINTMENT USP, 5% (SPEARMINT FLAVORED)
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,
which is chemically designated as acetamide,
2-(diethylamino)_-N-_(2,6-dimethylphenyl)-, and has the
following structural formula:
Composition of Lidocaine Ointment USP, 5%: Each gram of the flavored
ointment contains lidocaine, 50
mg, polyethylene glycol 400, polyethylene glycol 3350, propylene
glycol and spearmint flavor.
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 USP, 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,