COCAINE HYDROCHLORIDE
Generic: COCAINE HYDROCHLORIDE
Basic Information
Manufacturer
LXO US INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
NASAL
FDA Set ID
0fb0298f-9756-26e8-e063-6294a90ae8f2
Indications & Usage
1 INDICATIONS AND USAGE COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
( 1 )
COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (>0.5%) occurring in patients treated with COCAINE HYDROCHLORIDE nasal solution 4% were headache and epistaxis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US., INC.
at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
COCAINE HYDROCHLORIDE nasal solution has been evaluated in four Phase 1 studies and one Phase 3 study, which included 647 adult subjects who received a single topical intranasal 160 mg dose (four pledgets), of COCAINE HYDROCHLORIDE nasal solution.
The randomized, double-blind, controlled Phase 3 study was conducted in adult patients undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, of which 278 received COCAINE HYDROCHLORIDE nasal solution (4% solution), 275 received cocaine hydrochloride solution 8%, and 95 received placebo.
Safety was evaluated for up to 7 days after dosing.
The most commonly reported adverse reactions (>1 patient) to occur in the Phase 3 study with COCAINE HYDROCHLORIDE nasal solution (4% solution) were headache and epistaxis.
Two adverse reactions of headache were severe (Table 1).
No premature discontinuations due to an adverse event, serious adverse events, or deaths were reported in the Phase 3 clinical study.
Table 1: Common Adverse Reactions with COCAINE HYDROCHLORIDE nasal solution (4%) in >1 Patient System Organ Class / Preferred Term COCAINE HYDROCHLORIDE nasal solution (4% solution) (N=278) Cocaine Hydrochloride Solution 8% (N=275) Placebo (N=95) Nervous System Disorders Headache 7 (3%) 4 (2%) 1 (1%) Respiratory, Thoracic, and Mediastinal Disorders Epistaxis 3 (1%) 2 (1%) 0 Psychiatric Disorders Anxiety 0 2 (1%) 0
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US., INC.
at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
COCAINE HYDROCHLORIDE nasal solution has been evaluated in four Phase 1 studies and one Phase 3 study, which included 647 adult subjects who received a single topical intranasal 160 mg dose (four pledgets), of COCAINE HYDROCHLORIDE nasal solution.
The randomized, double-blind, controlled Phase 3 study was conducted in adult patients undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, of which 278 received COCAINE HYDROCHLORIDE nasal solution (4% solution), 275 received cocaine hydrochloride solution 8%, and 95 received placebo.
Safety was evaluated for up to 7 days after dosing.
The most commonly reported adverse reactions (>1 patient) to occur in the Phase 3 study with COCAINE HYDROCHLORIDE nasal solution (4% solution) were headache and epistaxis.
Two adverse reactions of headache were severe (Table 1).
No premature discontinuations due to an adverse event, serious adverse events, or deaths were reported in the Phase 3 clinical study.
Table 1: Common Adverse Reactions with COCAINE HYDROCHLORIDE nasal solution (4%) in >1 Patient System Organ Class / Preferred Term COCAINE HYDROCHLORIDE nasal solution (4% solution) (N=278) Cocaine Hydrochloride Solution 8% (N=275) Placebo (N=95) Nervous System Disorders Headache 7 (3%) 4 (2%) 1 (1%) Respiratory, Thoracic, and Mediastinal Disorders Epistaxis 3 (1%) 2 (1%) 0 Psychiatric Disorders Anxiety 0 2 (1%) 0