cocaine hydrochloride nasal

COCAINE HYDROCHLORIDE NASAL

Manufacturer: OMNIVIUM PHARMACEUTICALS LLC.

Score: 144.0

Quick Summary

Cocaine Hydrochloride Nasal Solution is a local anesthetic used for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. It is available in a 4% concentration and is administered via cotton or rayon applicator pledgets. The recommended dose ranges from 40 mg to 160 mg, depending on the nasal surface area to be anesthetized and the procedure to be performed. Cocaine Hydrochloride Nasal Solution has a high potential for abuse and dependence, and its use is contraindicated in patients with a known history of hypersensitivity to cocaine hydrochloride or other ester-based local anesthetics. Adverse reactions include hypertension, tachycardia, and sinus tachycardia, and special precautions should be taken when administering the drug to geriatric patients or those with certain medical conditions.

Key Clinical Findings and Indications

Induction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities in adults
Available in a 4% concentration
Administered via cotton or rayon applicator pledgets

Important Safety Information

Warning

Cocaine Hydrochloride Nasal Solution has a high potential for abuse and dependence

Contraindications

Hypersensitivity to cocaine hydrochloride or other ester-based local anesthetics
Damaged nasal mucosa

Adverse Reactions

Hypertension
Tachycardia
Sinus tachycardia

Dosing Recommendations

General Guidance

No dosage adjustment is needed in patients with reduced plasma cholinesterase activity

Diagnostic procedures and surgeries on or through the nasal cavities

Adult Dose

40 mg to 160 mg, depending on the nasal surface area to be anesthetized and the procedure to be performed

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

No available data on the use of cocaine hydrochloride in pregnant women
Adverse maternal and fetal/neonatal outcomes have been seen in women with chronic cocaine abuse during pregnancy

Nursing Mothers

No information available

Pediatric Use

Safety and effectiveness not established in pediatric patients under the age of 18
Published studies state that in juvenile male rats, 30 mg/kg subcutaneous cocaine administration for longer than 7 days produced testicular necrosis

Geriatric Use

No untoward or unexpected adverse reactions were seen in elderly patients who received cocaine hydrochloride
Hypertension was observed in all geriatric subjects receiving cocaine hydrochloride
Special precaution should be given when determining the dose of cocaine hydrochloride for geriatric patients, commensurate with their age and physical status