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Levmetamfetamine
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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 2023
- 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 2023
- Label revision date
- December 20, 2024
- Manufacturer
- Meijer, Inc.
- Registration number
- M012
- NDC root
- 79481-0300
- 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 conditions such as the common cold, hay fever, and upper respiratory allergies. It works by opening up the nasal passages, making it easier for you to breathe.
This medication is available in a vapor inhaler form, allowing for direct application to the nasal passages for quick relief. If you're experiencing discomfort from nasal congestion, Levmetamfetamine may provide the relief you need.
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, only 1 puff in each nostril is recommended, and this should be done under adult supervision.
It's important to wait at least 2 hours before using the product again to avoid overuse. If your child is under 6 years old, you should consult a doctor before using this medication. Additionally, it is not safe for children under 2 years of age, so please do not use it for them. 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 never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, it's advised not to use this medication for more than 7 days. Following these guidelines will help you avoid potential risks and ensure the medication works effectively for you.
Side Effects
You may experience some temporary side effects, such as burning, stinging, sneezing, or increased nasal discharge. If you use the product frequently or for a long time, you might find that nasal congestion returns or worsens. It's important to stop using the product and consult a doctor if your symptoms persist.
If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Additionally, keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.
Warnings and Precautions
It's important to follow the recommended dosage when using this medication. Exceeding the dosage can lead to unwanted side effects, such as temporary burning, stinging, sneezing, or increased nasal discharge. You should not use this product for more than 7 days, and it is meant for individual use only to prevent the spread of infection. Frequent or prolonged use may actually worsen nasal congestion.
If your symptoms persist, stop using the medication and consult your doctor. Additionally, if you accidentally swallow the product, 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 medication.
Overdose
If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance.
Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek medical help right away. Remember, it’s always better to be safe and get professional advice 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 make sure an adult supervises this process.
For children younger than 6 years, you should consult a doctor before use. Additionally, this medication is not safe 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 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 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.
Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.
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 differently due to your liver health.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.
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 used for?
Levmetamfetamine is a nasal decongestant used for temporary relief of nasal congestion due to the common cold, hay fever, and upper respiratory allergies.
How should I use Levmetamfetamine?
Adults and children 12 years and older 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 side effects of using Levmetamfetamine?
Temporary burning, stinging, sneezing, or increased nasal discharge may occur. Frequent or prolonged use may cause nasal congestion to recur or worsen.
How often can I use Levmetamfetamine?
You should not use Levmetamfetamine more often than every 2 hours and not for more than 7 days.
What should I do if symptoms persist?
If symptoms persist, you should stop using Levmetamfetamine and ask a doctor for advice.
Can I use Levmetamfetamine if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using Levmetamfetamine.
What should I do if Levmetamfetamine is swallowed?
If swallowed, you should get medical help or contact a Poison Control Center right away.
How should I store Levmetamfetamine?
Store Levmetamfetamine at 59°-86° F (15°-30° C) and keep the inhaler tightly closed.
Packaging Info
Below are the non-prescription pack sizes of 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 Levmetamfetamine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Levmetamfetamine is a nasal decongestant formulated as a vapor inhaler. It is indicated for the temporary relief of nasal congestion associated with colds, hay fever, and upper respiratory allergies. Each inhaler contains a net weight of 0.007 ounces (198 mg) of the active ingredient. The product is designed for direct inhalation to provide symptomatic relief.
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
There are no specific contraindications identified for this product. However, it is essential to adhere to the following guidelines to ensure safe use:
Do not exceed the recommended dosage.
Do not use for more than 7 days.
Failure to comply with these instructions may lead to adverse effects or diminished efficacy.
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.
Dosage and Administration It is imperative that the recommended dosage is not exceeded. The product should only be used as directed, and patients should be advised against using it for more than 7 consecutive days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.
Potential Side Effects Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge upon application. These effects are generally mild but should be monitored.
Infection Control The use of this container by multiple individuals may facilitate the spread of infection. It is advisable to instruct patients to avoid sharing the product.
Symptom Monitoring Patients should be advised to discontinue use and consult a healthcare provider if symptoms persist. This is crucial for ensuring that underlying conditions are appropriately addressed.
Emergency Situations In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
Special Populations For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to assess potential risks and benefits.
By adhering to these warnings and precautions, healthcare professionals can help mitigate risks and promote safe usage of the product among patients.
Side Effects
Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge following the use of this medication. It is important to note that 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. Additionally, individuals who are pregnant or breastfeeding should seek guidance from a health professional prior to use.
To ensure safety, this medication 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 recommended.
Drug Interactions
There are currently no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
Packaging & NDC
Below are the non-prescription pack sizes of 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, 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 is contraindicated in children under 2 years of age.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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. 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 drug in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.
Renal Impairment
Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.
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 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
There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a health professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.
Postmarketing Experience
No postmarketing experience details are provided in the insert.
Patient Counseling
Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.
Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to adhere to the recommended dosage and not exceed it. Patients may experience temporary side effects such as burning, stinging, sneezing, or increased nasal discharge. It is important to note that the use of this container by more than one person may lead to the spread of infection.
Patients should be cautioned against using the product for more than 7 days and to use it only as directed. Frequent or prolonged use may result in the recurrence or worsening of nasal congestion.
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, the inhaler should be kept at a temperature range of 59° to 86° F (15° to 30° C). Proper adherence to these storage conditions is crucial for preserving the product's performance and safety.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Levmetamfetamine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.