GOPRELTO

COCAINE HYDROCHLORIDE

Manufacturer: Genus Lifesciences Inc.

Score: 144.0

Quick Summary

GOPRELTO (cocaine hydrochloride) 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 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 anesthetics. The recommended dose is two pledgets, each containing 40 mg of cocaine hydrochloride, applied to each nasal cavity, with a total dose not exceeding 160 mg or 3 mg/kg. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with caution advised due to potential adverse effects.

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
Local anesthetic of the ester type, preventing conduction in nerve fibers by reversibly blocking sodium channels

Important Safety Information

Warning

CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence

Contraindications

Known hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of the product

Adverse Reactions

Headache
Epistaxis

Dosing Recommendations

General Guidance

No dosage adjustment of GOPRELTO is needed in patients with reduced plasma cholinesterase

Induction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities

Adult Dose

Two pledgets, each containing 40 mg of cocaine hydrochloride, applied to each nasal cavity, with a total dose not exceeding 160 mg or 3 mg/kg

Pediatric Dose

Not evaluated in pediatric patients (17 years of age and younger)

Special Population Considerations

Pregnancy

No available data on the use of intranasal cocaine hydrochloride solution in pregnant women to inform a drug-associated risk adverse developmental outcomes

Nursing Mothers

No information available

Pediatric Use

The safety and effectiveness of GOPRELTO in pediatric patients (17 years of age and younger) has not been evaluated

Geriatric Use

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects

Similar Drugs

cocaine hydrochloride nasal

COCAINE HYDROCHLORIDE NASAL

OMNIVIUM PHARMACEUTICALS LLC.

Similarity: 70.4%