Procaine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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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
1) 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 [8][9][3].
2) For PERIPHERAL NERVE BLOCK, 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) [8].
3) 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 [8].
4) 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 [3].
5) To avoid high serum concentrations of procaine and possible adverse effects, the lowest effective dosage should be used. Patient response to procaine varies, and reduced doses should be given to elderly or acutely ill patients (Prod Info Novocain(R), 1990a).
MAXIMUM DOSE
1) Usual total dose of PROCAINE during one treatment should not exceed 1000 milligrams [8].
Dosage in Renal Failure
A) The serum half-life of procaine has been prolonged in some uremic patients [3].
Dosage in Hepatic Insufficiency
A) The serum half-life of procaine has been prolonged in patients with liver disease; dosage reductions are recommended [8][3].
Dosage in Geriatric Patients
A) 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
A) PROCAINE doses should be reduced in patients with cardiac disease [8]. B) Reduced doses of procaine may be necessary for obstetric delivery and in patients with increased intra-abdominal pressure [10].
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
1) For INFILTRATION ANESTHESIA, the maximum recommended PROCAINE dose is 15 milligrams/kilogram of a 0.5% solution in pediatric patients [8].
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
There is limited information regarding Procaine Contraindications in the drug label.
Warnings
There is limited information regarding Procaine Warnings' in the drug label.
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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