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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
- Topco Associates LLC
- Registration number
- M012
- NDC root
- 36800-294
- 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 provides temporary relief from nasal congestion. It is commonly used for symptoms associated with the common cold, hay fever, or upper respiratory allergies. This medication works by helping to open up the nasal passages, making it easier for you to breathe.
Typically available in a vapor inhaler form, Levmetamfetamine is designed to be used when you need quick relief from stuffiness in your nose. If you're experiencing congestion due to seasonal allergies or a cold, this product may help you feel more comfortable.
Uses
You can use this medication for temporary relief of nasal congestion caused by the common cold, hay fever, or upper respiratory allergies. It helps to clear your nasal passages, making it easier to breathe when you're feeling stuffy or congested.
Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.
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 take 1 puff in each nostril, but 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 your child is under 6 years old, you should consult a doctor before using it, and it is not safe for children under 2 years of age. Always follow these guidelines to ensure safe and effective use of the product.
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 container with others can lead to the spread of infection.
To ensure your safety, do not use the product for more than 7 days, and only as directed. Frequent or prolonged use might cause your nasal congestion to return or worsen. If your symptoms persist, please stop using the product and consult a doctor. If you are pregnant or breastfeeding, it's best to consult a healthcare professional before use. Always keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center.
Warnings and Precautions
It's important to follow the recommended dosage when using this medication, as exceeding it can lead to unwanted side effects. You may experience temporary burning, stinging, sneezing, or increased nasal discharge. 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 only as directed. Prolonged or frequent use may actually worsen nasal congestion. 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
It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.
In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.
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.
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 safety and consult with a healthcare professional if you have any questions or concerns.
Geriatric Use
While there is no specific information about how this medication should be used by 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 a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.
Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.
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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.
Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.
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 Levmetamfetamine?
Levmetamfetamine is a nasal decongestant used for the temporary relief of nasal congestion.
What conditions does Levmetamfetamine treat?
It is indicated for temporary relief of nasal congestion due to the common cold, hay fever, or upper respiratory allergies.
How should I use Levmetamfetamine?
Adults and children 12 years and older should take 2 inhalations in each nostril, while children aged 6 to under 12 should take 1 inhalation in each nostril with adult supervision.
Are there any age restrictions for using Levmetamfetamine?
Children under 6 years of age should ask a doctor, and it should not be used in children under 2 years of age.
What are the warnings associated with Levmetamfetamine?
Do not use for more than 7 days, and frequent or prolonged use may worsen nasal congestion. Temporary burning, stinging, or sneezing may occur.
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, ask a health professional before use.
What should I do if I accidentally swallow Levmetamfetamine?
If swallowed, get medical help or contact a Poison Control Center right away.
How should I store Levmetamfetamine?
Keep the inhaler tightly closed and store it at 59°-86° F (15°-30° C).
How long is Levmetamfetamine effective after first use?
This inhaler is effective for a minimum of 3 months after first use.
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
TopCare® health™ Vapor Inhaler contains levmetamfetamine, a nasal decongestant indicated for the temporary relief of nasal congestion associated with colds, hay fever, and upper respiratory allergies. The product is available in a net weight of 0.007 ounces (198 mg). The National Drug Code (NDC) for this inhaler is 36800-294-07.
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
The recommended dosage should not be exceeded to avoid potential adverse effects. Users may experience temporary burning, stinging, sneezing, or increased nasal discharge upon application. It is important to note that sharing this container with others may facilitate the spread of infection.
For 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 lead to a recurrence or worsening of nasal congestion.
In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.
Patients are advised to discontinue use and consult a healthcare professional if symptoms persist.
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 is not intended for use beyond 7 days, and patients are advised to use it only as directed. Frequent or prolonged use may result in the recurrence or worsening of nasal congestion. If symptoms persist, patients should discontinue use and consult a healthcare professional.
For pregnant or breastfeeding individuals, 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
No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.
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 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, to be administered under adult supervision.
It is advised that children under 6 years of age consult a doctor before use. The product is contraindicated in children under 2 years of age.
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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.
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 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.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.
Overdosage
In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.
Prompt action is crucial in managing potential overdosage situations to mitigate risks 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 provided in the insert.
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.
Patients should be informed 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. If symptoms persist, patients should be advised to stop use and consult a doctor.
It is important to communicate that patients should not exceed the recommended dosage. They should also be made aware that temporary side effects such as burning, stinging, sneezing, or increased nasal discharge may occur. Additionally, inform patients that the use of this container by more than one person may increase the risk of spreading infection.
Storage and Handling
This inhaler is supplied in a configuration that ensures its effectiveness for a minimum of three months after 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.