Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
prilocaine hydrochloride (UNII: MJW015BAPH) (prilocaine - UNII:046O35D44R), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)
Septodont Inc.
prilocaine hydrochloride
prilocaine hydrochloride 40 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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. Prilocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type and in those rare patients with congenital or idiopathic methemoglobinemia.
Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 Injection (NDC 0362-9013-50) is dispensed in 1.8 mL cartridges, packed 50 per box. Sterilization, Storage and Technical Procedures:
Abbreviated New Drug Application
PRILOCAINE HYDROCHLORIDE WITH EPINEPHRINE - PRILOCAINE AND EPINEPHRINE INJECTION, SOLUTION SEPTODONT INC. ---------- PRILOCAINE HCL 4% WITH EPINEPHRINE 1:200,000 INJECTION For Local Anesthesia in Dentistry Rx only DESCRIPTION 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.jpg Epinephrine bitartrate is (-)-3,4-Dihydroxy-a-[(methylamino)methyl] benzyl alcohol and has the following formula: 2.jpg 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 Citric Sodium Ingredients HCl Epinephrine Acid 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. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Prilocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. ONSET AND DURATION OF ACTION When used for infiltration injection in dental patients, the time of onset of anesthesia averages less than 2 minutes with an average duration of soft tissue anesthesia of approximately 2.25 hours. When used for inferior alveolar nerve block, the time of onset averages less than three minutes with an average duration of soft tissue anesthesia of approximatelty 3 hours. HEMODYNAMICS Excessiv Soma hati kamili