LIDOCAINE OINTMENT USP, 5%, DO NOT USE IN THE EYES, Rx Only

/LIDOCAINE OINTMENT USP, 5%, DO NOT USE IN THE EYES, Rx Only
LIDOCAINE OINTMENT USP, 5%, DO NOT USE IN THE EYES, Rx Only2018-09-06T09:12:40+00:00

Prescription Drug Name:

LIDOCAINE OINTMENT USP, 5%, DO NOT USE IN THE EYES, Rx Only

ID:

3b09ef48-5bc0-4fda-bf20-fdaec235cc91

Code:

34391-3

DESCRIPTION


id: 34478bd1-85c0-44b0-99f4-b89f27bfc4b2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula: Composition of Lidocaine Ointment 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycols.

INDICATIONS AND USAGE


id: 84378d53-5ed1-4f7a-8c99-f67e7cb2f894
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

CONTRAINDICATIONS


id: 5f49239e-fffc-4830-bb60-49740507652d
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment 5%.

WARNINGS


id: 06bbf48f-8293-4e98-8d71-86006c23103d
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

ADVERSE REACTIONS:


id: dec5f7e0-45cf-4671-815b-ca3a187839c0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Adverse experiences following the administration of lidocaine 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 or rapid absorption, 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 at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular system: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. To report SUSPECTED ADVERSE REACTIONS, please call Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE


id: d3844c31-756a-4db9-ba0a-71e82abfc238
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (see ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ). Management of local anesthetic emergencies: 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 administration. 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 (e.g., 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. Dialysis is of negligible value in the treatment of acute overdosage with lidocaine. The oral LD50 of lidocaine HCI in non-fasted female rats is 459 (346-773) mg/kg (as the salt) and 214 (159-324) mg/kg (as the salt) in fasted female rats.

DOSAGE AND ADMINISTRATION


id: 750bdfde-a343-4aab-887a-54af5d5ac1b7
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Adult: A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube, approximately 17-20 g of ointment or 850-1000 mg lidocaine base, should be administered in any one day. Although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. Dosage for 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 less than ten years who have a normal lean body mass and a normal lean 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 a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark’s rule. In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Administration: For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue. Apply to the tube prior to intubation. In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment. For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa. IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughout the fitting period.

HOW SUPPLIED


id: 5a19d9ab-ad8b-4780-9883-24a334d678d5
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lidocaine Ointment USP, 5% is available in 35.44 g (1¼ oz) and 50.00 g (1¾ oz) laminate tubes with a child-resistant cap. NDC numbers for different packaging sizes are as following:

35.44 g tube NDC 50742-306-35
50.00 g tube NDC 50742-306-50
Store at 25ºC (77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Manufactured for:

Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408 Made in Canada Rev. 05/2018 IN-30635 ingenus