Numbrino

Last updated on RxList: 2/4/2020
Numbrino Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Numbrino?

Numbrino (cocaine hydrochloride) is an ester local anesthetic used for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.

What Are Side Effects of Numbrino?

Side effects of Numbrino include:

Dosage for Numbrino

The recommended dose of Numbrino ranges from 40 mg to 160 mg, depending on the nasal surface area to be anesthetized and the procedure to be performed.

Numbrino In Children

The safety and effectiveness of Numbrino in pediatric patients under the age of 18 have not been established.

What Drugs, Substances, or Supplements Interact with Numbrino?

Numbrino may interact with other medicines such as:

  • epinephrine,
  • phenylephrine,
  • disulfiram,
  • CNS stimulants,
  • cholinesterase inhibitors,
  • sympathomimetics,
  • postganglionic blocking agents,
  • tricyclic antidepressants, and
  • monoamine oxidase inhibitors (MAOIs)

Tell your doctor all medications and supplements you use.

Numbrino During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Numbrino; it is unknown how it would affect a fetus. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with Numbrino. Lactating women are advised to pump and discard breast milk for 48 hours after use of Numbrino.

Additional Information

Our Numbrino (cocaine hydrochloride) Nasal Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Numbrino Professional Information

SIDE EFFECTS

The following treatment-emergent adverse events are discussed in more detailed in other sections of the labeling:

  • Increases in Blood Pressure and Heart Rate [see WARNINGS AND PRECAUTIONS]

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.

NUMBRINO nasal solution has been evaluated in one Phase 1 study, one QT study and two Phase 3 studies, which included 702 adult subjects who received a single application of NUMBRINO nasal solution 4%, NUMBRINO nasal solution 10%, or placebo. The randomized, double-blind, placebo controlled Phase 3 studies were conducted in adult patients undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, of which 316 received NUMBRINO nasal solution 4%, 318 received NUMBRINO nasal solution 10%, and 168 received placebo. Safety was evaluated for up to 7 days after dosing.

In a Phase 3 study, patients received a mean dose of 126 mg (80 to 160 mg, N=259) of cocaine hydrochloride using NUMBRINO nasal solution 4% and a mean dose of 319 mg (200 to 400 mg, N=259) of cocaine hydrochloride using NUMBRINO nasal solution 10% as a single application.

The most common adverse reactions reported with NUMBRINO 4% are included in Table 1 (preexisting nasal conditions are not included). There were two patients treated with NUMBRINO nasal solution 4% who withdrew due to an adverse reaction. One patient developed anxiety and systolic hypertension and one patient developed intermittent paroxysmal tachycardia. Both patients developed symptoms within 10 minutes of nasal pledget application. Three patients treated with NUMBRINO nasal solution 10% required premature removal of pledgets due to nausea and diastolic hypertension; mild intermittent paroxysmal hypertension and paroxysmal tachycardia; and vasovagal syncope with bradycardia.

Table 1. Common Adverse Reactions with NUMBRINO in > 1% of Treated Patients

MedDRA System Organ Class and Preferred TermNUMBRINO, 4%
(N=259) n, %
NUMBRINO, 10%
(N=259) n, %
Placebo
(N=128) n, %
Vascular Disorders203 (78)224 (87)86 (67)
Hypertension201 (78)220 (85)85 (66)
Cardiac Disorders31 (12)47 (18)10 (8)
Tachycardia12 (5)28 (11)1 (1)
Bradycardia8 (3)1 (0.4)5 (4)
Sinus tachycardia6 (2)9 (4)0
Investigations13 (5)30 (12)8 (6)
QRS prolonged4 (2)8 (3)3 (2)
QT interval prolonged7 (3)10 (4)3 (2)

Postmarketing Experience

The following adverse reactions have been identified during use of Cocaine Hydrochloride Nasal Solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous system disorders: Headache, Seizure

Cardiac disorders: Hypertension, Tachycardia, Atrial and Ventricular arrhythmias, Myocardial Ischemia and Infarction

Psychiatric disorders: Anxiety

Read the entire FDA prescribing information for Numbrino (Cocaine Hydrochloride Nasal Solution)

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© Numbrino Patient Information is supplied by Cerner Multum, Inc. and Numbrino Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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