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GOPRELTO

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Overview

What is GOPRELTO?

GOPRELTO (cocaine hydrochloride) nasal solution for intranasal use contains a 4% solution, 160 mg/4 mL (40 mg/mL), equivalent to 142.4 mg/4mL (35.6 mg/mL) cocaine free-base, an ester local anesthetic.

The chemical name for cocaine hydrochloride is methyl (1S,3S,4R,5R)-3-benzoyloxy-8-methyl-8-azabicyclo[3.2.1]octane-4-carboxylate hydrochloride. The molecular formula is CHNO∙HCl and the molecular weight is 339.81. The structural formula is:

Inactive ingredients are anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, sodium benzoate, and purified water.



What does GOPRELTO look like?



What are the available doses of GOPRELTO?

Nasal solution: 160 mg/4 mL (40 mg/mL or 4%) cocaine hydrochloride, equivalent to 142.4 mg/4mL (35.6 mg/mL) cocaine free-base, in a single-use bottle.

What should I talk to my health care provider before I take GOPRELTO?

How should I use GOPRELTO?

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.

For intranasal use only.

Recommended dose: two pledgets, each containing 40 mg of cocaine hydrochloride, applied to each nasal cavity.

Do not apply to damaged nasal mucosa.

Preparation and Application:


What interacts with GOPRELTO?

Sorry No Records found


What are the warnings of GOPRELTO?

Sorry No Records found


What are the precautions of GOPRELTO?

Sorry No Records found


What are the side effects of GOPRELTO?

Sorry No records found


What should I look out for while using GOPRELTO?

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.

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

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Drug Interactions:


What might happen if I take too much GOPRELTO?

No cases of overdose with GOPRELTO were reported in clinical trials. Blood pressure and heart rate increases were greater with cocaine hydrochloride solution 8% than with GOPRELTO.

In the case of an overdose, consult with a certified poison control center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to cocaine varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Manifestations of cocaine overdose associated with illicit use of cocaine reported in literature and based on reports in FDA's Adverse Events Reporting System (AERS) database include death, cardio-respiratory arrest, cardiac arrest, respiratory arrest, tachycardia, myocardial infarction, agitation, aggression, restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Because cocaine is significantly distributed to tissues and rapidly metabolized, dialysis and hemoperfusion are not effective. Acidification of the urine does not significantly enhance cocaine elimination.


How should I store and handle GOPRELTO?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.GOPRELTO (cocaine hydrochloride) nasal solution is a clear, green colored liquid available as one dosage strength:160 mg/4 mL (40 mg/mL or 4%) cocaine hydrochloride, equivalent to 142.4 mg/4mL (35.6 mg/mL) cocaine free-baseNDC # 64950-359-04: Single-use 4 mL bottleGOPRELTO (cocaine hydrochloride) nasal solution is a clear, green colored liquid available as one dosage strength:160 mg/4 mL (40 mg/mL or 4%) cocaine hydrochloride, equivalent to 142.4 mg/4mL (35.6 mg/mL) cocaine free-baseNDC # 64950-359-04: Single-use 4 mL bottleGOPRELTO (cocaine hydrochloride) nasal solution is a clear, green colored liquid available as one dosage strength:160 mg/4 mL (40 mg/mL or 4%) cocaine hydrochloride, equivalent to 142.4 mg/4mL (35.6 mg/mL) cocaine free-baseNDC # 64950-359-04: Single-use 4 mL bottle


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Cocaine hydrochloride is a local anesthetic of the ester type. Cocaine hydrochloride prevents conduction in nerve fibers by reversibly blocking sodium channels and preventing the transient rise in sodium conductance necessary for generation of an action potential.

Non-Clinical Toxicology
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.

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

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Central nervous system (CNS) stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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