Goprelto 40 mg/mL
cocaine hydrochloride · SOLUTION · LXO US Inc.
Goprelto is a solution containing cocaine hydrochloride at 40 mg/mL, taken nasal. Manufactured by LXO US Inc..
Key Facts
- Brand Name
- Goprelto
- Generic Name
- cocaine hydrochloride
- NDC Code (Product)
70839-359- Manufacturer
- LXO US Inc.
- Strength
- 40 mg/mL
- Dosage Form
- SOLUTION
- Route
- NASAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA209963
- Marketing Start
- 02/09/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GOPRELTO (cocaine hydrochloride) nasal solution is 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. GOPRELTO (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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For intranasal use only. ( 2.1 ) • Recommended dose: two pledgets, each containing 40 mg of cocaine hydrochloride,applied to each nasal cavity. ( 2.2 ) • Do not apply to damaged nasal mucosa. ( 2.1 ) • Preparation and Application: – In a small container, soak four pledgets in the full contents (4 mL) of one bottle of GOPRELTO until the solution is fully absorbed. Each pledget absorbs 1 mL of solution, equivalent to 40 mg cocaine hydrochloride. ( 2.2 , 2.3 ) – Following soaking, place two pledgets in each nasal cavity against the septum. ( 2.3 ) – Leave pledgets in p lace for up to 20 minutes. ( 2.3 ) 2.1 Important Dosage and Administration Instructions • GOPRELTO is for intranasal use only. • Do not apply GOPRELTO to damaged nasal mucosa. 2.2 Dosing Recommendation for Adults The recommended dose of GOPRELTO is two soaked cottonoid pledgets placed in each nasal cavity, equivalent to 40 mg cocaine hydrochloride per pledget, for a total dose of 160 mg for four pledgets. The total dose for any one procedure or surgery should not exceed 160 mg, or 3 mg/kg, cocaine hydrochloride. The recommended size of cottonoid pledgets for use with GOPRELTO measure 1.3 cm…
Contraindications
4 CONTRAINDICATIONS GOPRELTO is contraindicated in patients with a known history of hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of the product. Known hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of GOPRELTO. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Disulfiram : Increases plasma cocaine exposure. Avoid using GOPRELTO in patients taking disulfiram. ( 7 ) • Epinephrine, Phenylephrine : There have been reports of myocardial ischemia, myocardial infarction, and ventricular arrhythmias with concomitant use during nasal surgery. Avoid use of additional vasoconstrictor agents with GOPRELTO. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required. ( 5.3 , 7 ) 7.1 Disulfiram Published literature reported that disulfiram treatment increased plasma cocaine exposure, including both AUC and C max , by several fold after acute intranasal cocaine administration. Other literature reported that co-administration of disulfiram increased AUC of plasma cocaine by several fold after intravenous cocaine administration [see Clinical Pharmacology ( 12.3 )]. Avoid using GOPRELTO in patients taking disulfiram. Consider using other local anesthetic agents. 7.2 Epinephrine, Phenylephrine There are reports in the published literature of myocardial ischemia, myocardial infarction, and ventricular arrhythmias after concomitant administration of topical intranasal cocaine with epinephrine and phenyleph…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (>0.5%) occurring in patients treated with GOPRELTO (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. GOPRELTO 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 GOPRELTO. 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 GOPRELTO (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 re…
Frequently Asked Questions
What is Goprelto used for?
Goprelto contains cocaine hydrochloride. It is a solution taken nasal. Consult your doctor for specific uses.
Is Goprelto a controlled substance?
Yes, Goprelto is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Goprelto?
The generic name for Goprelto is cocaine hydrochloride. There are 3 other brand versions of cocaine hydrochloride.
What is the NDC code for Goprelto 40 mg/mL?
The NDC (National Drug Code) for Goprelto 40 mg/mL is 70839-359, listed by LXO US Inc..