Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV), OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)
St. Renatus
TETRACAINE HYDROCHLORIDE
TETRACAINE HYDROCHLORIDE 30 mg in 1 mL
NASAL
PRESCRIPTION DRUG
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
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.
New Drug Application
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 Soma hati kamili