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Extra Strength Pretat

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
April 28, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
April 28, 2020
Manufacturer
Ridge Properties
Registration number
part348
NDC root
69804-001
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

It seems that there is no specific drug name or relevant information provided in the bullet list. Without details about a particular medication, its uses, or how it works, I am unable to create a summary. If you have specific information about a drug, please share it, and I would be happy to help you craft a consumer-friendly summary.

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

If you have any questions or need further information about this medication, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

It seems that the specific dosage and administration information for the medication you are inquiring about is not available in the provided text. Typically, dosage instructions include how much of the medication to take, how often to take it, and the method of administration (like whether it’s taken by mouth or injected).

To ensure you use the medication safely and effectively, it’s important to refer to the official prescribing information or consult with your healthcare provider. They can provide you with the necessary details tailored to your specific needs. Always follow their guidance for the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

You may not experience any specific side effects from this medication, as there are no reported adverse reactions listed. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you notice anything unusual or have questions, don't hesitate to reach out for guidance.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. While specific warnings and general precautions are not detailed, you should always consult your healthcare provider about any concerns or questions you may have regarding your health and this medication.

If you experience any unusual symptoms or side effects, stop taking the medication and call your doctor immediately. Additionally, if you feel that you are having a medical emergency, seek emergency help right away. Regular check-ups and lab tests may be necessary to monitor your health while on this medication, so be sure to follow your doctor's recommendations.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. In fact, its use is contraindicated, meaning it should not be taken while pregnant due to potential risks to your developing baby. Always consult with your healthcare provider for guidance and to discuss any concerns you may have regarding medications during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage differences, or safety concerns outlined for pediatric patients (children). If you are considering this medication for a child, it is important to consult with a healthcare professional to ensure it is appropriate and safe for their specific needs. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

When it comes to using EXTRA STRENGTH PRETAT (lidocaine liquid) for older adults, there is no specific information available about dosage adjustments or safety concerns. This means that the drug insert does not provide special precautions tailored for elderly patients.

If you are caring for an older adult who may need this medication, it's important to consult with a healthcare professional. They can help determine the best approach and ensure that the treatment is safe and effective based on individual health needs. Always prioritize open communication with healthcare providers to address any concerns.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), your healthcare provider will closely monitor your condition. Regular renal function tests (tests that check how well your kidneys are working) should be performed to ensure your safety.

For those with significant renal impairment, a reduced dose of medication is recommended. Always communicate with your healthcare team about your kidney health to ensure you receive the appropriate care and adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. This means that, in general, you can take this medication without worrying about it affecting other treatments or test results.

However, it's always important to discuss any medications you are taking or any upcoming lab tests with your healthcare provider. They can provide personalized advice and ensure that your treatment plan is safe and effective for you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and use is contraindicated due to potential risks to the fetus.

What should I know about using this drug if I have kidney problems?

If you have renal impairment, dosage adjustments may be necessary, and you should be closely monitored. Regular renal function tests are recommended.

How should I store this drug?

Store at room temperature, protect from light, do not freeze, and discard after opening.

Are there any specific instructions for use or dosage?

No specific instructions for use or dosage are provided in the text.

What precautions should I take if I am a nursing mother?

There are no specific statements regarding nursing mothers in the provided text.

Are there any contraindications for this drug?

The only contraindication mentioned is its use during pregnancy.

What should I do if I experience side effects?

The text does not provide specific side effects or warnings, so consult your doctor for guidance.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Pretat (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Pretat.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Pretat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided. There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should evaluate the appropriateness of this drug based on individual patient needs and clinical judgment.

Dosage and Administration

Healthcare professionals are advised to refer to the accompanying image for comprehensive dosage and administration details. The image contains essential information regarding the specific dosing ranges, administration routes, methods, and frequency of administration. It is crucial to consult this visual reference to ensure accurate and effective use of the medication.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

Healthcare professionals should be aware of the critical importance of monitoring patients for potential adverse effects and ensuring safe use of the medication.

In the event of severe reactions or complications, it is imperative to seek emergency medical assistance immediately. Healthcare providers should instruct patients to discontinue use of the medication and contact their physician if they experience any concerning symptoms or side effects.

Regular laboratory tests may be necessary to monitor the patient's response to treatment and to identify any potential complications early. It is essential to establish a routine for these tests to ensure patient safety and effective management of therapy.

Healthcare professionals are encouraged to remain vigilant and proactive in assessing the patient's condition throughout the course of treatment, ensuring that any necessary precautions are taken to mitigate risks associated with the medication.

Side Effects

The available data does not specify any adverse reactions associated with the use of the product. No serious or common adverse reactions have been identified in clinical trials or postmarketing experiences. As such, healthcare professionals should remain vigilant and monitor patients for any unexpected effects during treatment, although no specific side effects have been documented in the provided information.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pretat (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Pretat.
Details

Pediatric Use

Pediatric patients do not have specific use information, recommended ages, dosing differences, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when considering the use of this medication in pediatric populations, as the absence of data limits the ability to make informed decisions regarding its safety and efficacy in children.

Geriatric Use

There is no specific information regarding the use of EXTRA STRENGTH PRETAT (lidocaine liquid) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors, including comorbidities and concurrent medications. Monitoring for efficacy and potential adverse effects is recommended in this population.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the risks and benefits when prescribing this medication to women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Additionally, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are crucial in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Pretat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Extra Strength Pretat, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.