Xilosten Overdose

How do you administer this medicine?
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What happens if I overdose Xilosten?

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 Xilosten ointment:

Store Xilosten 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 Xilosten ointment out of the reach of children and away from pets.

Overdose of Xilosten in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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In adults following a single administration of Xilosten™ (lindocaine hydrochloride monohydrate) the plasma levels of Xilosten were below the limit of detection (5 ng/mL). Signs of central nervous system (CNS) toxicity may start at plasma concentrations of Xilosten as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels. Very high levels of Xilosten 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 Xilosten 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 Xilosten.

What should I avoid while taking Xilosten?

Xilosten 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 Xilosten 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 Xilosten injection.

Xilosten warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Accidental Exposure in Children

Even a used Xilosten Patch contains a large amount of Xilosten (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 Xilosten 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 Xilosten Patch 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of Xilosten and high blood concentrations, leading to serious adverse effects. Xilosten toxicity could be expected at Xilosten blood concentrations above 5 mcg/mL. The blood concentration of Xilosten 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 Xilosten. With recommended dosing of Xilosten 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 Xilosten?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Xilosten, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Xilosten or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because of Xilosten's toxicity, it should be used with extreme caution in children younger than 3 years of age, only after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy. Do not give Xilosten viscous topical solution for teething pain.

Appropriate studies have not been performed on the relationship of age to the effects of Xilosten skin patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of Xilosten topical in geriatric patients. However, because of Xilosten's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Xilosten, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Xilosten with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Xilosten. Make sure you tell your doctor if you have any other medical problems, especially:

Xilosten precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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General

Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Xilosten, because of their inability to metabolize Xilosten normally.

Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Xilosten. However, Xilosten 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 Xilosten from increased absorption. Xilosten 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 Xilosten Patch 5% is not recommended as this has not been evaluated and may increase plasma Xilosten levels.

Eye Exposure: The contact of Xilosten 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: Xilosten 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 Xilosten 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 Xilosten Patch 5%.

Mutagenesis: Xilosten 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 Xilosten Patch 5% on fertility has not been studied.

Pregnancy

Teratogenic Effects: Pregnancy Category B. Xilosten Patch 5% has not been studied in pregnancy. Reproduction studies with Xilosten 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 Xilosten. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Xilosten Patch 5% should be used during pregnancy only if clearly needed.

Labor and Delivery

Xilosten Patch 5% has not been studied in labor and delivery. Xilosten is not contraindicated in labor and delivery. Should Xilosten Patch 5% be used concomitantly with other products containing Xilosten, total doses contributed by all formulations must be considered.

Nursing Mothers

Xilosten Patch 5% has not been studied in nursing mothers. Xilosten is excreted in human milk, and the milk:plasma ratio of Xilosten is 0.4. Caution should be exercised when Xilosten 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 Xilosten?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since Xilosten 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

  1. 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).
  2. DrugBank. "lidocaine". http://www.drugbank.ca/drugs/DB00281 (accessed September 17, 2018).
  3. 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

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