Classes
DEA Class; Rx
Common Brand Names; Goprelto, Numbrino
- Local Anesthetics, Esters
Description
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
Indications
Indicated for local anesthesia and/or mucosal anesthesia prior to instrumentation or surgical procedures.
Contraindications
Hypersensitivity to cocaine, other ester-type local anesthetics, or other product ingredients
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
200 mg total dose topically (generic solution); 160 mg or 3 mg/kg total dose nasally (Goprelto and Numbrino nasal solutions).
200 mg total dose topically (generic solution); 160 mg or 3 mg/kg total dose nasally (Goprelto and Numbrino nasal solutions).
3 mg/kg total dose topically (generic solution). Safety and efficacy have not been established for Goprelto and Numbrino nasal solutions.
3 mg/kg total dose topically (generic solution). Safety and efficacy have not been established for Goprelto and Numbrino nasal solutions.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Cocaine hydrochloride
topical solution: Schedule II
- 4% (40mg/mL)
- 10% (100mg/mL)
intranasal solution: Schedule II
- 4% (Goprelto, Numbrino)
