LIDOCAINE ointment

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987)

Tilgængelig fra:

Fougera Pharmaceuticals Inc.

INN (International Name):

lidocaine

Sammensætning:

lidocaine 50 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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%.

Produkt oversigt:

Lidocaine Ointment USP, 5% is available in 35.44 g (11 /4 oz) laminate tubes with a child-resistant cap, NDC 0168-0204-37. Store at controlled room temperature 15°-30°C (59°-86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46231517A R10/18 #277

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LIDOCAINE- LIDOCAINE OINTMENT
FOUGERA PHARMACEUTICALS INC.
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LIDOCAINE OINTMENT USP, 5%
DO NOT USE IN THE EYES
RX ONLY
DESCRIPTION
Lidocaine Ointment 5% contains a local anesthetic agent and is
administered topically.
See INDICATIONS AND USAGE for specific uses.
Lidocaine Ointment 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 5%: acetamide,
2-(diethylamino)-_N_-(2,6-
dimethylphenyl)-, (lidocaine) 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 - 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, cleavage of the amide linka