Cocaine is a medicine sold in the U.S. under 2 brand and generic names, for cough and pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Goprelto (application NDA209963). Other cocaine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 COCAINE HYDROCHLORIDE nasal solution 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 place for up to 20 minutes. ( 2.3 ) 2.1 Important Dosage and Administration Instructions • COCAINE HYDROCHLORIDE nasal solution is for intranasal use only. • Do not apply COCAINE HYDROCHLORIDE nasal solution to damaged nasal mucosa. 2.2 Dosing Recommendation for Adults The recommended dose of COCAINE HYDROCHLORIDE nasal solution 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 COCAINE HYDROCHLORIDE nasal solution measure 1.3 cm x 4 cm (sold separately). 2.3 Preparation and…
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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
COCAINE HYDROCHLORIDE nasal solution 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 COCAINE HYDROCHLORIDE nasal solution. ( 4 )
Disulfiram : Increases plasma cocaine exposure. Avoid using COCAINE HYDROCHLORIDE nasal solution 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 COCAINE HYDROCHLORIDE nasal solution. 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 Cmax, 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 COCAINE HYDROCHLORIDE nasal solution 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 phenylephrine during nasal and sinus surgery. Avoid use of additional vasoconstrictor agents such as epinephrine and…
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