International Brand Management, LLC
LDO Plus™ is a medicated Hydrogel wound dressing in a Metered Dose (MDOSE™) bottle containing lidocaine 4%, an amide type local anesthetic, indicated for: Painful wounds such as post-surgical incisions, cuts and abrasions.
Apply to the affected area as directed. Maximum 12 pumps per day.
LDO Plus is a topical medicated hydrogel wound dressing. Each gram of LDO Plus contains 4% Lidocaine HCl USP (40mg).
Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components.
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
For External Use Only. Avoid Contact with Eyes. If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
LDO Plus should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP.
Most common adverse reactions are redness or swelling at the application site. Less common side effects, such as sluggishness, confusion, slow breathing, low blood pressure, or slow heartbeat, may occur. To report SUSPECTED ADVERSE REACTIONS, contact Gensco Pharma at 866-608-6284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Prilocaine, Bupivacaine, Amyl nitrates/sodium nitrate/sodium thiosulfate, Dofetilide. Lomitapide, Beta-blockers (e.g., atenolol), Cimetidine, or Class 1 antiarrhythmic drugs (ex. Mexiletine). This may not be a complete list of all interactions that may occur. Ask your health care provider if LDO Plus may interact with other medicines that you take.
Use in Pregnancy: Teratogenic Effects — Pregnancy Category B.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine Hydrochloride USP is administered to a nursing woman.
Pediatric use: Dosage in children should be reduced, commensurate with age, body weight and physical condition.
Geriatric use: No overall clinical differences in safety or effectiveness have been observed between the healthy elderly and other adult patients.
WARNING | 1 INDICATIONS AND USAGE | 2 DOSAGE AND ADMINISTRATION 2.1 Dosage for children 2.2 Administration | 3 DOSAGE FORMS AND STRENGTHS | 4 CONTRAINDICATIONS | 5 WARNINGS AND PRECAUTIONS | 6 ADVERSE REACTIONS 6.1 Central nervous system 6.2 Cardiovascular system 6.3 Allergic | 7 DRUG INTERACTIONS 7.1 Serious interactions 7.2 General interactions | 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use | 9 OVER DOSAGE 9.1 Management of local anesthetic emergencies | 10 DESCRIPTION 10.0 Active Ingredients 10.2 Inactive Ingredients | 11 CLINICAL PHARMACOLOGY 11.1 Mechanism of Action 11.2 Onset of Anesthesia 11.3 Hemodynamics 11.4 Pharmacokinetics and Metabolism | 12 NONCLINICAL TOXICOLOGY 12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility | 13 HOW SUPPLIED / STORAGE AND HANDLING
* Sections or subsections omitted from the prescribing information are not listed.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.
Painful wounds such as post-surgical incisions, ulcers, cuts and abrasions.
Each pump of the LDO Plus MDOSE bottle (30mL Airless Metered Dose bottle) (NDC:35781-0500-3) will deliver 0.25 mL of LDO Plus (10 mg Lidocaine Hydrochloride USP), enough to cover a 2 inch by 2 inch area of skin. A single application should not exceed 4 pumps of the MDOSE bottle, equal to 1 gram of LDO Plus, (40 mg of Lidocaine Hydrochloride USP).
No more than 12 pumps of the MDOSE bottle, approximately 3 grams of LDO Plus (120 mg Lidocaine Hydrochloride USP,) should be administered in any one day.
Although the incidence of adverse effects with LDO Plus 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.
The recommend dose of LDO Plus 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 (approximately 1.9 to 2.5 grams of LDO Plus) when calculated according to Clark’s rule. In general, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight of the child. Do not use on children under 2 unless directed by a physician.
Apply as directed. Do not exceed 12 pumps in a twenty-four-hour (24-hour) period. One pump covers an area of 2 x2 inches.
LDO Plus is a topical medicated hydrogel wound dressing. Each gram of LDO Plus contains 4% Lidocaine Hydrochloride USP (40mg).
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LDO Plus.
Do not use LDO Plus on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LDO Plus should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact poison control center right away.
Adverse experiences following the administration of Lidocaine Hydrochloride USP 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:
CNS manifestations of Lidocaine toxicity 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 Hydrochloride USP is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.
Cardiovascular manifestations of Lidocaine toxicity are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
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