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Lidocaine Hydrochloride
Overview
What is DX1 OraGenomic Medicated DNA Collection Screen?
Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Made in China www.myselectonline.com
What does DX1 OraGenomic Medicated DNA Collection Screen look like?
What are the available doses of DX1 OraGenomic Medicated DNA Collection Screen?
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What should I talk to my health care provider before I take DX1 OraGenomic Medicated DNA Collection Screen?
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How should I use DX1 OraGenomic Medicated DNA Collection Screen?
Indications and Usage
Dosage and Administration
Administration
Dosage
What interacts with DX1 OraGenomic Medicated DNA Collection Screen?
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.
What are the warnings of DX1 OraGenomic Medicated DNA Collection Screen?
EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS 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.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.
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Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
What are the precautions of DX1 OraGenomic Medicated DNA Collection Screen?
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- For patients under 3 years of age, special care must be given to accurately measuring the prescribed dose and not administering the product more often than prescribed.
- To ensure accuracy, we recommend you use a measuring device to carefully measure the correct volume.
- The product should only be used for the prescribed indication.
- To reduce the risk of accidental ingestion, the product container should be tightly closed and the product should be stored well out of reach of all children immediately after each use.
- If the patient shows signs of systemic toxicity (e.g., lethargy, shallow breathing, seizure activity) emergency medical attention should be sought immediately and no additional product should be administered.
- Unused product should be discarded in a manner that prevents possible exposure to children and pets. All patients should be aware that when topical anesthetics are used in the mouth or throat, the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. For this reason food and/or chewing gum should not be used while the mouth or throat area is anesthetized.
Information for Patients
Parents and caregivers should be cautioned about the following:
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General
The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (See and ). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug and/or its metabolites. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age, weight and physical condition. Lidocaine should also be used with caution in patients with severe shock or heart block.
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Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
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Pregnancy:
Teratogenic Effects.
Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
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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 is administered to nursing women.
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Pediatric Use:
Dosages in children should be reduced, commensurate with age, body weight and physical condition. (See ).
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What are the side effects of DX1 OraGenomic Medicated DNA Collection Screen?
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:
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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.
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Cardiovascular System:
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
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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 the methylparaben and/or propylparaben used in this 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, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using DX1 OraGenomic Medicated DNA Collection Screen?
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.
Warning:
For Oral Use Only.
What might happen if I take too much DX1 OraGenomic Medicated DNA Collection Screen?
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See , , and).
How should I store and handle DX1 OraGenomic Medicated DNA Collection Screen?
Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F). Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Keep this and all medications out of the reach of children.SHAKE WELL BEFORE USE.Package not child-resistantManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:07 03/15Assembled and Distributed by IT3 Medical, LLCFor questions or comments:
