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Cocaine Hydrochloride
Overview
What is Cocaine Hydrochloride?
Each mL contains:
Cocaine hydrochloride 40 mg or 100 mg as aqueous solution.
The topical solution contains the following inactive ingredients: citric acid, D&C Yellow No. 10, FD&C Green No. 3, sodium benzoate, and water.
NOTE (for Glass Bottle):
Cocaine hydrochloride USP is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips. Cocaine hydrochloride is a local anesthetic.
What does Cocaine Hydrochloride look like?
What are the available doses of Cocaine Hydrochloride?
Sorry No records found.
What should I talk to my health care provider before I take Cocaine Hydrochloride?
Sorry No records found
How should I use Cocaine Hydrochloride?
Cocaine hydrochloride topical solution is indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities.
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Cocaine hydrochloride topical solution can be administered by means of cotton applicators or packs, instilled into a cavity, or as a spray.
What interacts with Cocaine Hydrochloride?
Cocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to the drug or to the components of the topical solution.
What are the warnings of Cocaine Hydrochloride?
Rarely, a reversible reduction of the white blood cell count with a primary effect on the granulocytes has been seen. The granulocyte count returned promptly to normal on discontinuance of the drug. Rare cases of granulocytopenia have been reported. In each instance, upon stopping the drug, the white cell count returned to normal. Reversible thrombocytopenia has occurred rarely.
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Carcinogenesis, Mutagenesis
Long-term studies to determine the carcinogenic and mutagenic potential of cocaine are not available.
Pregnancy
Animal reproduction studies have not been conducted with cocaine. It is also not known whether cocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cocaine should be given to a pregnant woman only if needed.
What are the precautions of Cocaine Hydrochloride?
The safety and effectiveness of cocaine hydrochloride topical solution depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various anesthetic procedures.
The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status.
Cocaine hydrochloride topical solution should be used with caution in patients with severely traumatized mucosa and sepsis in the region of the proposed application. Use with caution in persons with known drug sensitivities.
What are the side effects of Cocaine Hydrochloride?
Adverse reactions may be due to high plasma levels as a result of excessive and rapid absorption of the drug. Reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system. A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
CNS reactions are excitatory and/or depressant, and may be characterized by nervousness, restlessness and excitement. Tremors and eventually clonic-tonic convulsions may result. Emesis may occur. Central stimulation is followed by depression, with death resulting from respiratory failure.
Small doses of cocaine slow the heart rate, but after moderate doses, the rate is increased due to central sympathetic stimulation.
Cocaine is pyrogenic, augmenting heat production in stimulating muscular activity and causing vasoconstriction which decreases heat loss. Cocaine is known to interfere with the uptake of norepinephrine by adrenergic nerve terminals, producing sensitization to catecholamines, causing vasoconstriction and mydriasis.
Cocaine causes sloughing of the corneal epithelium, causing clouding, pitting, and occasionally ulceration of the cornea. The drug is not meant for ophthalmic use.
What should I look out for while using Cocaine Hydrochloride?
Cocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to the drug or to the components of the topical solution.
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED.
What might happen if I take too much Cocaine Hydrochloride?
The fatal dose of cocaine has been approximated at 1.2 g., although severe toxic effects have been reported from doses as low as 20 mg.
Symptoms
Treatment
How should I store and handle Cocaine Hydrochloride?
Topiramate extended-release capsules should be stored in a tightly-closed container at 20 to 25°C (68 to 77°F). Excursions permitted between 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Protect from moisture.4% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-1664% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1728-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1728-73: of 10 mL.10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.NDC 0527-1729-74: Unit-of-Use filled to contain 4 mL, one 4 mL bottle per carton.NDC 0527-1729-73: of 10 mL.DEA Order Form Required.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Avoid freezing.Keep out of reach of children.Manufactured by:Cody Laboratories, Inc.a subsidiary of Lannett Company, Inc.Cody, WY 82414Made in the USA Revised 03/16, Revision 4 11-166
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Cocaine blocks the initiation or conduction of the nerve impulse following local application, thereby effecting local anesthetic action.
Cocaine is absorbed from all sites of application, including mucous membranes and the gastrointestinal mucosa. Cocaine is degraded by plasma esterases, with the half-life in the plasma being approximately one hour.
Non-Clinical Toxicology
Cocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to the drug or to the components of the topical solution.RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED.
When administered concomitantly with midodrine hydrochloride tablets, cardiac glycosides may enhance or precipitate bradycardia, A.V. block or arrhythmia.
The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). Avoid concomitant use of drugs that increase blood pressure. If concomitant use cannot be avoided, monitor blood pressure closely.
Avoid use of MAO inhibitors or linezolid with midodrine.
Midodrine hydrochloride tablets have been used in patients concomitantly treated with salt-retaining steroid therapy (i.e., fludrocortisone acetate), with or without salt supplementation. The potential for supine hypertension should be carefully monitored in these patients and may be minimized by either reducing the dose of fludrocortisone acetate or decreasing the salt intake prior to initiation of treatment with midodrine hydrochloride tablets. Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine hydrochloride tablets.
The safety and effectiveness of cocaine hydrochloride topical solution depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various anesthetic procedures.
The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status.
Cocaine hydrochloride topical solution should be used with caution in patients with severely traumatized mucosa and sepsis in the region of the proposed application. Use with caution in persons with known drug sensitivities.
Adverse reactions may be due to high plasma levels as a result of excessive and rapid absorption of the drug. Reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system. A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
CNS reactions are excitatory and/or depressant, and may be characterized by nervousness, restlessness and excitement. Tremors and eventually clonic-tonic convulsions may result. Emesis may occur. Central stimulation is followed by depression, with death resulting from respiratory failure.
Small doses of cocaine slow the heart rate, but after moderate doses, the rate is increased due to central sympathetic stimulation.
Cocaine is pyrogenic, augmenting heat production in stimulating muscular activity and causing vasoconstriction which decreases heat loss. Cocaine is known to interfere with the uptake of norepinephrine by adrenergic nerve terminals, producing sensitization to catecholamines, causing vasoconstriction and mydriasis.
Cocaine causes sloughing of the corneal epithelium, causing clouding, pitting, and occasionally ulceration of the cornea. The drug is not meant for ophthalmic use.
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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