Procaine

Procaine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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Overview

Procaine is a local anesthetic that is FDA approved for the {{{indicationType}}} of local Anesthetic for local infiltration and peripheral nerve block. Common adverse reactions include myocardial depression, hypotension and sometimes hypertension, bradycardia, ventricular arrhythmias, and cardiac arrest,nausea/vomiting, cutaneous lesions of delayed onset, urticaria, and edema related to allergic reactions , nervousness, dizziness, blurred vision, and tremors may occur due to systemic toxicity; however, drowsiness or convulsions with subsequent unconsciousness and respiratory arrest..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Parenteral route

Infiltration Anesthesia

• Procaine 0.25% to 0.5% solutions in doses of 350 to 600 milligrams may be used for Infiltration Anesthesia. Epinephrine may be added for vasoconstrictive effect to give a final concentration of 1:200,000.

Peripheral Nerve Block

• For, Procaine 0.5% solution (up to 200 milliliters), 1% solution (up to 100 milliliters), or 2% solution (up to 50 milliliters) is recommended. The 2% solution is generally limited to procedures requiring a small volume of anesthetic, ie, 10 to 25 milliliters (mL). An anesthetic solution of 0.5 mL to 1 mL of Epinephrine 1:1,000 per 100 mL may be used to promote vasoconstriction (1:200,000 or 1:100,000).
• To prepare 60 milliliters (mL) of a 0.5% solution (5 milligrams/mL), dilute 30 mL of the 1% solution with 30 mL sodium chloride 0.9% injection. To prepare 60 mL of a 0.25% solution (2.5 milligrams/mL), dilute 15 mL of the 1% solution with 45 mL sodium chloride 0.9% injection .

Anesthesia of the perineum

• A dose of procaine 50 milligrams of a 10% solution mixed with an equal amount of diluent may be used for Anesthesia of the perineum; 100 milligrams (1 milliliter) diluted with an equal amount of diluent for the perineum and lower extremities; and up to 200 milligrams (2 milliliters) with 1 milliliter of diluent for anesthesia of the costal margin.

Maximum Dose

• Usual total dose of Procaine during one treatment should not exceed 1000 milligrams.

Dosage in Renal Failure

• The serum half-life of Procaine has been prolonged in some uremic patients.

Dosage in Hepatic Insufficiency

• The serum half-life of Procaine has been prolonged in patients with liver disease; dosage reductions are recommended.

Dosage in Geriatric Patients

• Patient response to Procaine varies, and reduced doses should be given to elderly or acutely ill patients (Prod Info Novocain(R), 1990a).

Dosage in Other Disease States

• Procaine doses should be reduced in patients with cardiac disease.
• Reduced doses of procaine may be necessary for obstetric delivery and in patients with increased intra-abdominal pressure.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Procaine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Procaine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Parenteral route

• For Infiltration Anesthesia, the maximum recommended Procaine dose is 15 milligrams/kilogram of a 0.5% solution in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Procaine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Procaine in pediatric patients.

Contraindications

NOVOCAIN is contraindicated in patients with a known hypersensitivity to procaine, drugs of a similar chemical configuration, or para-aminobenzoic acid or its derivatives.

It is also contraindicated in patients with a known hypersensitivity to other components of solutions of NOVOCAIN.

Warnings

Contains acetone sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS.) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE, AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST, AND, POSSIBLY, DEATH.

It is essential that aspiration for blood or cerebrospinal fluid, where applicable, be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection.

Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity. Large doses of local anesthetics should not be used in patients with heartblock.

NOVOCAIN with epinephrine or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of NOVOCAIN containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension or disturbances of cardiac rhythm may occur.

Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.

Mixing or the prior or intercurrent use of any local anesthetic with NOVOCAIN cannot be recommended because of insufficient data on the clinical use of such mixtures.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Procaine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Procaine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Procaine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Procaine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Procaine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Procaine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Procaine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Procaine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Procaine in geriatric settings.

Gender

There is no FDA guidance on the use of Procaine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Procaine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Procaine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Procaine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Procaine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Procaine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Procaine Administration in the drug label.

Monitoring

There is limited information regarding Procaine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Procaine and IV administrations.

Overdosage

There is limited information regarding Procaine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Procaine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Procaine Mechanism of Action in the drug label.

Structure

There is limited information regarding Procaine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Procaine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Procaine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Procaine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Procaine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Procaine How Supplied in the drug label.

Storage

There is limited information regarding Procaine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Procaine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Procaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Procaine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Procaine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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