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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 2016
- 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 2016
- Label revision date
- December 20, 2024
- Manufacturer
- Walgreens
- Registration number
- M012
- NDC root
- 0363-0564
- 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 available in the form of a vapor inhaler. It is designed to provide temporary relief from nasal congestion caused by conditions such as the common cold, hay fever, or upper respiratory allergies. By acting as a nasal decongestant, it helps to clear your nasal passages, making it easier for you to breathe.
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.
Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this medication. This makes it a safer option for those who may be pregnant or planning to become pregnant.
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 product, such as burning, stinging, sneezing, or increased nasal discharge. It's important to note that sharing this product with others can lead to the spread of infection. To avoid complications, do not use it for more than 7 days, and follow the directions carefully, as frequent or prolonged use can worsen nasal congestion.
If your symptoms persist, stop using the product and consult a doctor. If you are pregnant or breastfeeding, please speak with a healthcare professional before using it. Additionally, keep this product out of reach of children, and seek immediate medical help or contact a Poison Control Center if it is swallowed.
Warnings and Precautions
When using this product, it’s important to follow the recommended dosage carefully. You may experience temporary burning, stinging, sneezing, or increased nasal discharge. Avoid sharing this container with others, as it can spread infection. Do not use the product for more than 7 days, and be aware that frequent or prolonged use may lead to worsening nasal congestion.
If your symptoms persist, stop using the product and consult your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product, and always keep it out of reach of children.
Overdose
If you or someone else has swallowed too much of this 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.
Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.
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
When using this medication for children, it's important to follow specific guidelines based on their age. For adults and children aged 12 and older, the recommended dose is 2 inhalations in each nostril. If your child is between 6 and 12 years old, they should receive 1 inhalation in each nostril, but this should be done under adult supervision to ensure safety.
For children younger than 6 years, you should consult a doctor before use. Additionally, this medication is not recommended for children under 2 years of age, so please avoid using it for that age group. Always prioritize your child's safety and consult a healthcare professional if you have any questions or concerns.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.
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 great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.
Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.
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 clean hands to maintain its safety and effectiveness. If you have any questions about disposal or further care, consult your healthcare provider for guidance.
Additional Information
No further information is available.
FAQ
What is the drug LEVMETAMFETAMINE used for?
LEVMETAMFETAMINE is a nasal decongestant used for temporary relief of nasal congestion due to the common cold, hay fever, or upper respiratory allergies.
How should I use the LEVMETAMFETAMINE inhaler?
Adults and children 12 years and over should take 2 inhalations in each nostril. Children aged 6 to under 12 years should take 1 inhalation in each nostril with adult supervision.
Are there any warnings when using this product?
Yes, temporary burning, stinging, sneezing, or increased nasal discharge may occur. Do not exceed the recommended dosage and do not use for more than 7 days.
What should I do if symptoms persist?
Stop use and ask a doctor if symptoms persist.
Can I use LEVMETAMFETAMINE if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before use.
What should I do if the inhaler is swallowed?
If swallowed, get medical help or contact a Poison Control Center right away.
How should I store the LEVMETAMFETAMINE inhaler?
Store the inhaler tightly closed at a temperature between 59°-86° F (15°-30° C).
Is there a risk of infection with this inhaler?
Yes, using this container by more than one person may spread infection.
Packaging Info
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine nasal decongestant). 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
NDC 0363-0564-53 is a vapor inhaler containing levmetamfetamine, a nasal decongestant. Each inhaler has a net weight of 0.007 oz (198 mg), with a total net weight of 0.021 oz (594 mg) for the package, which includes three inhalers. This product is recommended by Walgreens pharmacists for its efficacy as a nasal decongestant.
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, with adult supervision, the dosage is 1 inhalation in each nostril.
Administration should not occur more frequently than every 2 hours. It is advised that healthcare professionals consult a physician for children under 6 years of age, and the product should not be used 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
When using this product, it is imperative to adhere strictly to the recommended dosage to avoid potential adverse effects. Users may experience temporary burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this container with others may facilitate the spread of infection.
The product should not be used for more than 7 consecutive days, and it is essential to follow the usage instructions precisely. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.
Patients are advised to discontinue use and consult a healthcare professional if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
General precautions include consulting a healthcare professional prior to use if the individual is pregnant or breastfeeding. Furthermore, it is crucial to keep this product out of the reach of children to prevent accidental ingestion or misuse.
Side Effects
Patients using this product may experience temporary adverse reactions, including burning, stinging, sneezing, or increased nasal discharge. These reactions are generally mild and transient. It is important to note that the use of this container by more than one person may lead to the spread of infection.
The product should not be used for more than 7 days, and it is essential to adhere strictly to the directions provided. Frequent or prolonged use may result in the recurrence or worsening of nasal congestion. Patients are advised to discontinue use and consult a healthcare professional if symptoms persist.
For individuals who are pregnant or breastfeeding, it is recommended to seek advice from a health professional prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.
Drug Interactions
There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this medication 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 Vapor Inhaler (levmetamfetamine nasal decongestant). 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 aged 12 years and older may receive 2 inhalations in each nostril. For children aged 6 to under 12 years, the recommended dosage is 1 inhalation in each nostril, which should be administered under adult supervision.
Inhalation is not recommended for children under 6 years of age without consulting a doctor. Additionally, the product should not be used in children under 2 years of age.
Geriatric Use
There is no specific information available 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.
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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.
Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.
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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, they should seek medical help or contact a Poison Control Center immediately.
It is important to inform patients that this product should not be used for more than 7 days and must be used only as directed. They should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.
Patients should be instructed to stop using the product and consult a healthcare provider if their symptoms persist. When using this product, they should not exceed the recommended dosage. Patients may experience temporary side effects such as burning, stinging, sneezing, or increased nasal discharge. Additionally, it should be emphasized that the use of this container by more than one person may increase the risk of spreading infection.
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.