What happens if I overdose Otipax 1%?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include apprehension; blurred vision; confusion; difficulty breathing; nervousness; ringing in the ears; seizures; sensations of heat, cold, or numbness; severe dizziness, drowsiness, or lightheadedness; slow or irregular heartbeat; tremor; twitching; unconsciousness; vomiting.
Proper storage of Otipax 1% ointment:
Store Otipax 1% ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Otipax 1% ointment out of the reach of children and away from pets.
Overdose of Otipax 1% in details
In adults following a single administration of Otipax 1%™ (lindocaine hydrochloride monohydrate) the plasma levels of Otipax 1% were below the limit of detection (5 ng/mL). Signs of central nervous system (CNS) toxicity may start at plasma concentrations of Otipax 1% as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels. Very high levels of Otipax 1% can cause respiratory arrest, coma, decreases in cardiac output, total peripheral resistance, and mean arterial pressure, ventricular arrhythmias, and cardiac arrest. The toxicity of coadministered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of Otipax 1% or other local anesthetics should be considered. The management of overdosage includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of Otipax 1%.
What should I avoid while taking Otipax 1%?
Otipax 1% injection can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after receiving this medicine.
Avoid eating or chewing within 1 hour after Otipax 1% injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with Otipax 1% injection.
Otipax 1% warnings
Accidental Exposure in Children
Even a used Otipax 1% Patch contains a large amount of Otipax 1% (at least 665 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Otipax 1% Patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose ofLidocaine Patch 5% out of the reach of children, pets and others.
Excessive Dosing
Excessive dosing by applying Otipax 1% Patch 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of Otipax 1% and high blood concentrations, leading to serious adverse effects. Otipax 1% toxicity could be expected at Otipax 1% blood concentrations above 5 mcg/mL. The blood concentration of Otipax 1% is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of Otipax 1%. With recommended dosing of Otipax 1% Patch 5%, the average peak blood concentration is about 0.13 mcg/mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.
What should I discuss with my healthcare provider before taking Otipax 1%?
Some medical conditions may interact with Otipax 1% ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a blood infection or severe injury of the mouth, throat, or other area where you are applying Otipax 1% ointment
- if you have heart, liver, or kidney problems
- if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine
Some MEDICINES MAY INTERACT with Otipax 1% ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiodarone, beta-adrenergic blockers (eg, metoprolol), cimetidine, or mexiletine because side effects, such as confusion, dizziness, lightheadedness, or tiredness, may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Otipax 1% ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Otipax 1% precautions
General
Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Otipax 1%, because of their inability to metabolize Otipax 1% normally.
Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Otipax 1%. However, Otipax 1% Patch 5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of Otipax 1% from increased absorption. Otipax 1% Patch 5% is only recommended for use on intact skin.
External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over Otipax 1% Patch 5% is not recommended as this has not been evaluated and may increase plasma Otipax 1% levels.
Eye Exposure: The contact of Otipax 1% Patch 5% with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Drug Interactions
Antiarrhythmic Drugs: Otipax 1% Patch 5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
Local Anesthetics: When Otipax 1% Patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis: A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of Otipax 1% Patch 5%.
Mutagenesis: Otipax 1% HCl is not mutagenic in Salmonella/mammalian microsome test nor clastogenic in chromosome aberration assay with human lymphocytes and mouse micronucleus test.
Impairment of Fertility: The effect of Otipax 1% Patch 5% on fertility has not been studied.
Pregnancy
Teratogenic Effects: Pregnancy Category B. Otipax 1% Patch 5% has not been studied in pregnancy. Reproduction studies with Otipax 1% have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to Otipax 1%. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Otipax 1% Patch 5% should be used during pregnancy only if clearly needed.
Labor and Delivery
Otipax 1% Patch 5% has not been studied in labor and delivery. Otipax 1% is not contraindicated in labor and delivery. Should Otipax 1% Patch 5% be used concomitantly with other products containing Otipax 1%, total doses contributed by all formulations must be considered.
Nursing Mothers
Otipax 1% Patch 5% has not been studied in nursing mothers. Otipax 1% is excreted in human milk, and the milk:plasma ratio of Otipax 1% is 0.4. Caution should be exercised when Otipax 1% Patch 5% is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
What happens if I miss a dose of Otipax 1%?
Since Otipax 1% is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
References
- DailyMed. "LIDOCAINE; TETRACAINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "lidocaine". http://www.drugbank.ca/drugs/DB00281 (accessed September 17, 2018).
- MeSH. "Anti-Arrhythmia Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
