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Cocaine Topical

    Brands

    DEA Class;  Rx

    Common Brand Names; Goprelto, Numbrino

    • Local Anesthetics, Esters

    Local anesthetic of the ester type
    For use as a topical anesthetic of the oral, laryngeal, and nasal cavities
    Abuse can lead to physical dependence

    Indicated for local anesthesia and/or mucosal anesthesia prior to instrumentation or surgical procedures.

    For the treatment of epistaxis.
     

    Hypersensitivity to cocaine, other ester-type local anesthetics, or other product ingredients

    • Hypertension (78%)
    • Tachycardia (5%)
    • Headache (3%)
    • Bradycardia (3%)
    • Sinus tachycardia (2%)
    • QT prolonged (3%)
    • QRS prolonged (2%)
    • Epistaxis (1%)
    • Nervous system disorders: Headache, seizure
    • Cardiac disorders: Hypertension, tachycardia, atrial and ventricular arrhythmias, myocardial ischemia and infarction
    • Psychiatric disorders: Anxiety

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

    May lower convulsive threshold; risk may be higher in patients with history of seizures or with prior EEG abnormalities without seizures, but has been reported in patients with no prior history or EEG evidence of seizures; monitor for development of seizures

    Increases blood pressure and heart rate; monitor for changes in vital signs, including heart rate and rhythm; avoid with history of MI, CAD, CHF, arrhythmia, abnormal ECG, or uncontrolled hypertension

    Not for ophthalmic use; can cause sloughing of the corneal epithelium; pitting and ulceration of the cornea reported

    Data are not available on the use of cocaine for mucosal anesthesia in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

    Because of the potential for serious adverse reactions in breastfed infants, advise a lactating woman that breastfeeding is not recommended during treatment with and to pump and discard breastmilk for 48 hr after use

    Adults

    200 mg total dose topically (generic solution); 160 mg or 3 mg/kg total dose nasally (Goprelto and Numbrino nasal solutions).

    Geriatric

    200 mg total dose topically (generic solution); 160 mg or 3 mg/kg total dose nasally (Goprelto and Numbrino nasal solutions).

    Adolescents

    3 mg/kg total dose topically (generic solution). Safety and efficacy have not been established for Goprelto and Numbrino nasal solutions.

    Children

    3 mg/kg total dose topically (generic solution). Safety and efficacy have not been established for Goprelto and Numbrino nasal solutions.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Cocaine hydrochloride

    topical solution: Schedule II

    • 4% (40mg/mL)
    • 10% (100mg/mL)

    intranasal solution: Schedule II

    • 4% (Goprelto, Numbrino)