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Advanced DNA Medicated Collection Kit II
Overview
What is Advanced DNA Medicated Collection Kit II?
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6-dimethylphenyl)- , monohydrochloride and has the following structural formula:
The molecular formula of lidocaine is CHNO. The molecular weight is 234.34.
Each mL contains 20 mg of lidocaine HCl. In addition each mL contains the following inactive ingredients: Carboxymethylcellulose sodium, methylparaben, natural orange flavor, propylparaben, purified water, saccharin sodium. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide.
What does Advanced DNA Medicated Collection Kit II look like?
What are the available doses of Advanced DNA Medicated Collection Kit II?
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What should I talk to my health care provider before I take Advanced DNA Medicated Collection Kit II?
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How should I use Advanced DNA Medicated Collection Kit II?
Directions:Tear open where indicated and remove one stick at a time. Swab mouth as needed. Discard stick after single use.
Remove one stick at a time. Swab mouth as needed. Discard stick after single use.
What interacts with Advanced DNA Medicated Collection Kit II?
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 Advanced DNA Medicated Collection Kit II?
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
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.
What are the precautions of Advanced DNA Medicated Collection Kit II?
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.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.
Information for patients
When topical anesthetics are used in the mouth or throat, the patient should be aware that 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.
PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO DOSING INSTRUCTIONS, AND TO KEEP THE SUPPLY OF MEDICATION OUT OF THE REACH OF CHILDREN.
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.
Pregnancy
Pregnancy Category B. 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.
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.
Pediatric use
Dosages in children should be reduced, commensurate with age, body weight and physical condition. (See ).
What are the side effects of Advanced DNA Medicated Collection Kit II?
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 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 Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Advanced DNA Medicated Collection Kit II?
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.
Caution:if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.
What might happen if I take too much Advanced DNA Medicated Collection Kit II?
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 Advanced DNA Medicated Collection Kit II?
Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light.Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light.Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light.Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light.Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light.Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light.Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08Lidocaine 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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08Lidocaine 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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08Lidocaine 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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08Lidocaine 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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08Lidocaine 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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08Lidocaine 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.The solution should be stored at controlled room temperature 15°- 30°C (59°- 86°F).SHAKE WELL BEFORE USE.Manufactured by: Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Rev. 775:04 11/08
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
Non-Clinical Toxicology
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.Caution:if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.
Additives may be incompatible with the fluid dispensed from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store.
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.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.
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:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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