KOVANAZE- tetracaine hydrochloride and oxymetazoline hydrochloride spray

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV), OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)

Dostupno od:

St. Renatus

INN (International ime):

TETRACAINE HYDROCHLORIDE

Sastav:

TETRACAINE HYDROCHLORIDE 30 mg in 1 mL

Administracija rute:

NASAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

KOVANAZE TM is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more. KOVANAZE is contraindicated in patients with a history of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, p -aminobenzoic acid (PABA), oxymetazoline, or any other component of the product [see Warnings and Precautions ( 5.5)] . Risk Summary Limited published data on tetracaine use in pregnant women are not sufficient to inform any risks. Published epidemiologic studies of nasal oxymetazoline used as a decongestant during pregnancy do not identify a consistent association with any specific malformation or pattern of malformations [see Data] . In animal reproduction and development studies, oxymetazoline given subcutaneously to rats during the period of organogenesis caused structural abnormalities at a dose approximately 7.6 times the exposure

Proizvod sažetak:

KOVANAZE Nasal Spray is supplied as pre-filled, single-dose sprayers containing a clear aqueous solution of 30 mg/mL of tetracaine hydrochloride (equivalent to 26.4 mg/mL tetracaine) and 0.5 mg/mL of oxymetazoline hydrochloride (equivalent to 0.44 mg/mL oxymetazoline). Each sprayer delivers 0.2 mL. The product is available as: Store between 2° and 8°C (36° and 46°F); excursions permitted between 0° and 15°C (32° and 59°F) [see USP controlled cold temperature]. Discard any unused solution. DO NOT use if drug is left out at room temperature for more than 5 days.

Status autorizacije:

New Drug Application

Svojstava lijeka

KOVANAZE- TETRACAINE HYDROCHLORIDE AND OXYMETAZOLINE HYDROCHLORIDE
SPRAY
ST. RENATUS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KOVANAZE NASAL SPRAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KOVANAZE NASAL
SPRAY.
KOVANAZE (TETRACAINE HCL AND OXYMETAZOLINE HCL) NASAL SPRAY
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Warnings and Precautions, Methemoglobinemia ( 5.1) 11/2018
INDICATIONS AND USAGE
KOVANAZE contains tetracaine HCl, an ester local anesthetic, and
oxymetazoline HCl, a vasoconstrictor. KOVANAZE is
indicated for regional anesthesia when performing a restorative
procedure on Teeth 4-13 and A-J in adults and children
who weigh 40 kg or more ( 1).
DOSAGE AND ADMINISTRATION
KOVANAZE is for intranasal use only ( 2). Administer KOVANAZE
ipsilateral (on the same side) to the maxillary tooth on
which the dental procedure will be performed.
AGE GROUP
DO SE
Adults (≥ 18 years old)
2 sprays (0.2 mL per spray),
4 to 5 minutes apart
1 additional spray (0.2 mL) if adequate anesthesia has not been
achieved 10 minutes after the second spray
Children who weigh 40 kg or more
2 sprays (0.2 mL per spray),
4 to 5 minutes apart
DOSAGE FORMS AND STRENGTHS
Nasal spray in pre-filled, single-dose sprayer: 6 mg tetracaine HCl
and 0.1 mg oxymetazoline HCl (equivalent to 5.27 mg
tetracaine and 0.088 mg oxymetazoline) in each 0.2 mL spray ( 3).
CONTRAINDICATIONS
Known hypersensitivity to tetracaine, benzyl alcohol, other ester
local anesthetics, _p_-aminobenzoic acid (PABA),
oxymetazoline, or any other component of the product ( 4).
WARNINGS AND PRECAUTIONS
Methemoglobinemia: Cases of methemoglobinemia have been reported in
association with local anesthetic use ( 5.1)
Hypertension and Thyroid Disease: Shown to increase blood pressure in
some clinical trial patients. Monitor blood
pressure. Use in patients with inadequately controlled hypertension or
active thyroid disease is not advised ( 5.2).
Epistaxis: Use is not recommended in patien