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Vapor Inhaler
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- Active ingredient
- Levmetamfetamine 50 mg
- Other brand names
- Dosage form
- Inhalant
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2021
- Label revision date
- December 20, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Levmetamfetamine 50 mg
- Other brand names
- Dosage form
- Inhalant
- Route
- Nasal
- 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 2021
- Label revision date
- December 20, 2024
- Manufacturer
- Dolgencorp Inc.
- Registration number
- M012
- NDC root
- 55910-265
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Levmetamfetamine is a nasal decongestant that helps temporarily relieve nasal congestion caused by the common cold, hay fever, or upper respiratory allergies. It is available in the form of a vapor inhaler, making it easy to use when you need quick relief from stuffiness and discomfort.
When you inhale levmetamfetamine, it works by opening up your nasal passages, allowing you to breathe more easily. This can be especially helpful during cold and allergy seasons when congestion can be particularly bothersome.
Uses
If you're dealing with nasal congestion from the common cold, hay fever, or upper respiratory allergies, this medication can provide you with temporary relief. It works by helping to clear your nasal passages, making it easier for you to breathe.
You can use this medication when you're feeling stuffy due to these conditions, allowing you to go about your day with less discomfort. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.
Dosage and Administration
When using this product, you will receive a dose of levmetamfetamine, which is a medication that helps relieve nasal congestion. Each time you use it, you will inhale 2 puffs (inhalations) in each nostril if you are an adult or a child aged 12 years and older. For children aged 6 to under 12 years, they should only take 1 puff in each nostril, and this should be done under adult supervision.
It's important to remember that you should not use this medication more often than every 2 hours. If you have a child under 6 years old, you should consult a doctor before using this product. Additionally, it is not safe for children under 2 years of age, so please avoid using it for that age group. Always follow these guidelines to ensure safe and effective use.
What to Avoid
It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than 7 days and must follow the directions provided. Using it frequently or for an extended period can lead to a return or worsening of nasal congestion. Additionally, be careful not to exceed the recommended dosage, as this can also pose risks to your health. Always prioritize your safety by adhering to these guidelines.
Side Effects
You may experience some temporary side effects when using this medication, such as burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and should resolve on their own. However, if your symptoms persist, it’s important to stop using the product and consult with your doctor for further guidance.
Warnings and Precautions
It's important to follow the recommended dosage when using this medication, as exceeding it can lead to unwanted effects. You may experience temporary burning, stinging, sneezing, or increased nasal discharge while using it. Additionally, sharing this container with others can spread infections, so it's best to keep it for your personal use only.
For your safety, do not use this medication for more than 7 days, and always follow the directions provided. Using it frequently or for an extended period may cause your nasal congestion to come back or even worsen. If you accidentally swallow the medication, seek emergency medical help or contact a Poison Control Center immediately. If your symptoms persist, stop using the medication and consult your doctor for further advice.
Overdose
If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.
Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
If you are considering this medication for your child, it's important to know that it should not be used in children under 2 years of age. For children aged 6 to under 12 years, you can administer 1 inhalation in each nostril, but make sure to supervise them during the process. For those who are 12 years and older, the recommended dosage is 2 inhalations in each nostril.
Always follow these guidelines to ensure the safety and effectiveness of the medication for your child. If you have any concerns or questions, consult with your healthcare provider.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.
Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.
Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.
Storage and Handling
To ensure the best performance of your inhaler, store it in a cool, dry place at temperatures between 59°-86° F (15°-30° C). It's important to keep the inhaler tightly closed when not in use to protect it from moisture and contamination.
Once you start using the inhaler, it remains effective for at least 3 months. Always handle it with care to maintain its integrity and effectiveness.
Additional Information
No further information is available.
FAQ
What is Levmetamfetamine?
Levmetamfetamine is a nasal decongestant used for the temporary relief of nasal congestion due to the common cold, hay fever, or upper respiratory allergies.
How should I use Levmetamfetamine?
For adults and children 12 years and older, use 2 inhalations in each nostril. For children aged 6 to under 12 years, use 1 inhalation in each nostril with adult supervision.
Are there any side effects of using Levmetamfetamine?
Temporary burning, stinging, sneezing, or increased nasal discharge may occur. If symptoms persist, stop use and consult a doctor.
Can I use Levmetamfetamine if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using Levmetamfetamine.
How often can I use Levmetamfetamine?
Do not use Levmetamfetamine more often than every 2 hours and do not exceed the recommended dosage.
How long can I use Levmetamfetamine?
Do not use Levmetamfetamine for more than 7 days, as frequent or prolonged use may cause nasal congestion to recur or worsen.
What should I do if I accidentally swallow Levmetamfetamine?
If swallowed, get medical help or contact a Poison Control Center immediately.
What is the storage requirement for Levmetamfetamine?
Store Levmetamfetamine at 59°-86° F (15°-30° C) and keep the inhaler tightly closed.
Is there any information on drug interactions with Levmetamfetamine?
No specific drug interactions have been mentioned for Levmetamfetamine.
What should I do if I experience side effects?
If you experience side effects like burning or sneezing, and they persist, stop using the product and consult a doctor.
Packaging Info
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Inhalant | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Vapor Inhaler, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Levmetamfetamine is a nasal decongestant formulated to relieve nasal congestion. The product is provided in a net weight of 0.007 ounces (198 mg).
Uses and Indications
This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or upper respiratory allergies.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
The product delivers 0.04 to 0.150 mg of levmetamfetamine in each 800 ml of air. For adults and children aged 12 years and older, the recommended dosage is 2 inhalations in each nostril. For children aged 6 to under 12 years, under adult supervision, the dosage is 1 inhalation in each nostril.
It is important to note that the product should not be used more frequently than every 2 hours. For children under 6 years of age, consultation with a healthcare professional is advised prior to use. The product is contraindicated in children under 2 years of age.
Contraindications
Use of this product is contraindicated in the following situations:
Prolonged use beyond 7 days is not recommended, as it may lead to nasal congestion recurrence or worsening.
The product should only be used as directed; exceeding the recommended dosage is contraindicated. Frequent or prolonged use may exacerbate symptoms.
Warnings and Precautions
Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product to ensure patient safety and efficacy.
Warnings It is imperative that the recommended dosage is not exceeded, as doing so may lead to adverse effects. Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge upon application. Additionally, the use of this container by more than one individual poses a risk of spreading infection.
General Precautions This product should not be used for more than 7 consecutive days. It is essential to adhere strictly to the directions provided. Frequent or prolonged use may result in the recurrence or worsening of nasal congestion.
Emergency Situations In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.
Consultation with Healthcare Provider Patients are advised to discontinue use and consult a healthcare provider if symptoms persist. This precaution is vital to ensure appropriate management and to prevent potential complications.
Side Effects
Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge following the use of the product. These reactions are generally mild and transient.
In the event that symptoms persist, patients are advised to stop use and consult a healthcare professional for further evaluation and guidance.
Drug Interactions
There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Inhalant | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 2 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 1 inhalation in each nostril, to be administered under adult supervision. In contrast, adults and children aged 12 years and older may receive 2 inhalations in each nostril. Careful adherence to these dosing guidelines is essential to ensure safety and efficacy in pediatric populations.
Geriatric Use
There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this demographic, given the lack of targeted data.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.
Overdosage
In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.
Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.
Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.
Nonclinical Toxicology
No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.
It is important to inform patients that the medication should not be used for more than 7 days and must be used only as directed. Emphasize that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Patients should be counseled to stop using the medication and consult a doctor if their symptoms persist.
Healthcare providers should also remind patients not to exceed the recommended dosage, as doing so may increase the risk of adverse effects. Patients should be made aware that temporary side effects such as burning, stinging, sneezing, or increased nasal discharge may occur during use.
Finally, it is crucial to inform patients that the use of this container by more than one person may spread infection, and they should avoid sharing it with others.
Storage and Handling
The inhaler is supplied in a configuration that ensures its effectiveness for a minimum of three months following the first use. It is essential to keep the inhaler tightly closed when not in use to maintain its integrity and efficacy.
For optimal storage conditions, the inhaler should be kept at a temperature range of 59° to 86° F (15° to 30° C). Proper adherence to these storage guidelines will help ensure the product remains effective throughout its intended use period.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Vapor Inhaler, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.