prilocaine hydrochloride and epinephrine bitartrate (Citanest Forte)

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Trade Name: Citanest Forte

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Dentsply Pharmaceutical Inc.

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 40; .005 mg/mL; mg/mL

Storage and handling

PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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For Local Anesthesia in Dentistry

Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with or without epinephrine (as bitartrate) and is administered parenterally by injection. See n n n for specific uses. The quantitative composition of each available injection is shown in Table 1.n nn
Citanest Dental injections contain prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula:
Cn n n Hn n n Nn n n o u2219 HCl molecular wt = 256.77n nn
Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol and has the following structural formula:
Cn n n Hn n n NOn n n molecular wt = 183.21n nn
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The specific quantitative composition of each available injection is shown in Table 1.
Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of Citanest Dental Injections. Filled under nitrogen.

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4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are 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.

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.
Citanest Dental with epinephrine injections contain sodium metabisulfite, 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.
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, naphthalene, 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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Swelling and persistent paresthesia of the lips and oral tissues may occur. Persistent paresthesia lasting weeks to months, and in rare instances paresthesia lasting greater than one year have been reported.
Adverse experiences following the administration of prilocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or unintentional intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see n n n , n n n , and n n n ).n nn
The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.
The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (eg, ephedrine).
If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.
Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.
Dialysis is of negligible value in the treatment of acute overdosage with prilocaine.
The development of methemoglobinemia is generally dose related but may occur at any dose in susceptible individuals. While methemoglobin values of less than 20% do not generally produce any clinical symptoms, the appearance of cyanosis at 2u20134 hours following administration should be evaluated in terms of the general health status of the patient.
Methemoglobinemia can be reversed when indicated by intravenous administration of methylene blue at a dosage of 1u20132 mg/kg given over a five minute period.
The subcutaneous LDn n n of prilocaine HCl in female mice is 550 (359u2013905) mg/kg.n nn

The dosage of Citanest Plain Dental Injection and Citanest Forte Dental 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.

4% Citanest Plain Dental Injection (NDC 66312-520-14 or 66312-520-16) and 4% Citanest Forte Dental Injection with epinephrine 1:200,000 (NDC 66312-540-14 or 66312-540-16) are dispensed in 1.7 mL cartridges, packed 50 or 100 per box. Not all pack sizes may be marketed.
Sterilization, Storage and Technical Procedures:

CITANEST is a trademark of the AstraZeneca groupn n n Manufactured by Novocol Pharmaceutical of Canada, Inc.n n n for DENTSPLY Pharmaceutical, York, PA 17404n nn
2659-1n n n Rev 05/2012n nn

NDC 66312-540-16
DENTSPLY
4n n n Citanestn n n Forte n n n n- with epinephrine 1:200,000
(prilocaine HCl and epinephrinen n n injection, USP) 40 mg/mLn n n
COLORn n n CODEDn n n
For dental block and infiltration injections only.
Store at room temperature,n n n 25u00b0C (77u00b0F) or below.n n n DO NOT PERMIT TO FREEZE.n n n n n 50 Cartridges, 1.7 mL eachn nn
STERILE AQUEOUSn n n SOLUTION FOR INJECTIONn nn
DENTSPLY Reorder #: 48816

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of prilocaine hydrochloride and epinephrine bitartrate (Citanest Forte) which is also known as Citanest Forte and Manufactured by Dentsply Pharmaceutical Inc.. It is available in strength of 40; .005 mg/mL; mg/mL.

prilocaine hydrochloride and epinephrine bitartrate (Citanest Forte) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.