Citanest Plain 40 mg/mL
prilocaine hydrochloride · INJECTION, SOLUTION · Dentsply Pharmaceutical Inc.
Citanest Plain is a injection, solution containing prilocaine hydrochloride at 40 mg/mL, taken submucosal. Manufactured by Dentsply Pharmaceutical Inc..
Key Facts
- Brand Name
- Citanest Plain
- Generic Name
- prilocaine hydrochloride
- NDC Code (Product)
66312-630- Manufacturer
- Dentsply Pharmaceutical Inc.
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Marketing Status
- Application #
- ANDA079235
- Marketing Start
- 11/18/1965
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION The dosage of 4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), 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 4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), is recommended for use in maxillary infiltration anesthesia for procedures in which the painful aspects can be completed within 15 minutes after the injection. 4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), is therefore especially suited to short procedures in the maxillary anterior teeth. For long procedures, or those involving maxillary poste…
Warnings
WARNINGS 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. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/ or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovas…
Contraindications
CONTRAINDICATIONS 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.
Drug Interactions
Clinically Significant Drug Interactions Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: EXAMPLES OF DRUGS ASSOCIATED WITH METHEMOGLOBINEMIA: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic Agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Adverse Reactions
ADVERSE REACTIONS Swelling and persistent paresthesia of the lips and oral tissues may occur. Persistent paresthesias 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: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest. The excitatory manifestations may be very brief or may not occur…
Frequently Asked Questions
What is Citanest Plain used for?
Citanest Plain contains prilocaine hydrochloride. It is a injection, solution taken submucosal. Consult your doctor for specific uses.
Is Citanest Plain a controlled substance?
Citanest Plain is not classified as a controlled substance by the DEA.
What is the generic name for Citanest Plain?
The generic name for Citanest Plain is prilocaine hydrochloride. There are no other listed brand versions of prilocaine hydrochloride.
What is the NDC code for Citanest Plain 40 mg/mL?
The NDC (National Drug Code) for Citanest Plain 40 mg/mL is 66312-630, listed by Dentsply Pharmaceutical Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)