Prilocaine Hydrochloride With Epinephrine label

Prilocaine Hydrochloride With Epinephrine

Prilocaine Hydrochloride With Epinephrine Recall

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Side Effects & Adverse Reactions

DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES THAT MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE.

To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided.

Prilocaine HCl 4% with Epinephrine 1:200,000 injection contains sodium metabisulfite, a sulfite that may cause allergic -type reactions including anaphylactic symptoms and life-threating or less sever 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 non-asthmatic people.

Methemoglobinemia

Prilocaine has been associated with the development of methemoglobinemia. Very young patients, patients with congenital or idiopathic methemoglobinemia, or patients with glucose-6-phosphate deficiencies are more susceptible to methemoglobinemia.

Patients taking drugs associated with drug induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, napthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine are also at greater risk for developing methemoglobinemia.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 injection is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.

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History

There is currently no drug history available for this drug.

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Other Information

Prilocaine Hydrochloride 4% with epinephrine 1:200,000 injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1.

Prilocaine Hydrochloride 4% with epinephrine 1:200,000 injection contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl)-2-(propylamino)-,monohydrochloride and has the following structural formula:

1.jpgChemical Structure

Epinephrine bitartrate is (-)-3,4-Dihydroxy-a-[(methylamino)methyl] benzyl alcohol and has the following formula:

2.jpgChemical Structure

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

The specific quantitative composition is shown in Table 1.

TABLE 1. COMPOSITION
Ingredients       Prilocaine HCl          Epinephrine      Citric Acid      Sodium Metabisulfite          pH
Formula (mg/mL)        40.0 mg/mL   0.005 mg/mL   0.2 mg/mL         0.5 mg/mL   3.3 to 5.5 

Note: Sodium hydroxide or hydrochloric acid may be used to adjust the pH of Prilocaine Hydrochloride  4% with epinephrine 1:200,000 injection.

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Prilocaine Hydrochloride With Epinephrine Manufacturers

  • Septodont Inc.
    Prilocaine Hydrochloride With Epinephrine | Septodont Inc.
    No Recall

    Prilocaine Hydrochloride With Epinephrine | Septodont Inc.

    Prilocaine Hydrochloride With Epinephrine | Septodont Inc.

    The dosage of Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 Injection varies and depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia. The least volume of injection that results in effective local anesthesia should be administered. For specific techniques and procedures of local anesthesia in the oral cavity, refer to standard textbooks.

    Inferior Alveolar Block

    There are no practical clinical differences between prilocaine with and without epinephrine when used for inferior alveolar blocks.

    Maxillary Infiltration

    Prilocaine Hydrochloride 4% without epinephrine is recommended for use in maxillary infiltration anesthesia for procedures in which the painful aspects can be completed within 15 minutes after the injection. Prilocaine Hydrochloride 4% without epinephrine is therefore especially suited to short procedures in the maxillary anterior teeth. For long procedures, or those involving maxillary posterior teeth where soft tissue numbness is not troublesome to the patient, Prilocaine HCl 4% with epinephrine 1:200,000 is recommended.

    For most routine procedures, initial dosages of 1 to 2 mL of Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 Injection will usually provide adequate infiltration or major nerve block anesthesia.

    The maximum recommended dose that should ever be administered within a two-hour period in normal healthy adults should be calculated based upon the patient's weight as follows:

    Weight Maximum recommended dose <150 lbs 4 mg/lb (<70 kg) (8 mg/kg) ≥150 lbs 600 mg (15 mL) or (≥70 kg) 8 cartridges

    In children under 10 years of age it is rarely necessary to administer more than one-half cartridge (40 mg) of Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 injection per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug will allow treatment of the teeth in an entire quadrant.

    ASPIRATION PRIOR TO INJECTION IS RECOMMENDED, since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failure to a minimum.

    NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

    Any unused portion of a cartridge should be discarded.

    Maximum Recommended Dosages

    In patients weighing <150 lbs (70 kg), no more than 4 mg/lb (8 mg/kg) should be administered. In patients weighing <150 lbs, no more than 600 mg (8 cartridges) of prilocaine HCl should be administered as a single injection.

    Children

    It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of prilocaine hydrochloride should not exceed 150 to 200 mg (6.6 to 8.8 mg/kg or 3 to 4 mg/lb of body weight) when calculated according to Clark's rule.

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