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Diurex
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- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2001
- Label revision date
- May 7, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- 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 2001
- Label revision date
- May 7, 2025
- Manufacturer
- Kobayashi Healthcare International, Inc.
- NDC root
- 52389-349
- Drug Information (PDF)
- Prescribing information, PDF file
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Drug Overview
I'm sorry, but it seems that the information provided does not include any specific details about a drug, such as its name, general description, or mechanism of action. Without these key facts, I am unable to create a summary about what the drug is or what it is used for. If you have more specific information or another set of details, please share, and I would be happy to help!
Uses
It seems that there are no specific indications or usage details provided for this medication. This means that the information about what this drug is used for is not available at this time. If you have any questions or need further clarification about this medication, it's best to consult with your healthcare provider for personalized advice and information.
Dosage and Administration
You will take this medication by mouth, which means you will swallow it. Each dose contains 50 mg of the active ingredient called pamabrom. Make sure to follow the instructions provided by your healthcare provider regarding how often to take it. Always ensure you are taking the correct dosage as directed for the best results.
What to Avoid
It seems that the information provided does not specify any particular contraindications, controlled substance details, risks of abuse or misuse, or concerns about dependence. Additionally, there are no explicit instructions on what you should not take or use.
If you have any specific questions or need guidance on a particular medication or health concern, please consult your healthcare provider for personalized advice and information. They can help ensure your safety and well-being.
Side Effects
You may experience some common side effects, including nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness. It's important to be aware of more serious reactions as well, such as allergic reactions that can cause rash, itching, swelling, severe dizziness, or trouble breathing.
In addition, you might notice symptoms like palpitations (a feeling of your heart racing), increased heart rate, nervousness, insomnia, dry mouth, thirst, or urinary retention (difficulty urinating). While rare, there have been reports of severe allergic reactions, including anaphylaxis (a life-threatening allergic reaction), and liver damage (hepatotoxicity). If you experience any severe symptoms, please seek medical attention promptly.
Warnings and Precautions
It seems that specific warnings, precautions, and instructions for emergency help or stopping use are not provided in the information available. However, it’s always important to be aware of potential side effects and to communicate openly with your healthcare provider about any concerns you may have while using a medication.
If you experience any unusual symptoms or reactions, it’s crucial to seek medical attention promptly. Always consult your doctor before making any changes to your medication regimen, and ensure you have regular check-ups to monitor your health while on treatment.
Overdose
If you suspect an overdose, it’s crucial to seek medical attention immediately. Overdose symptoms can include nausea (feeling sick), vomiting (throwing up), and abdominal pain (discomfort in your stomach area).
If you experience any of these symptoms after taking medication, don’t hesitate to contact a healthcare professional or go to the nearest emergency room. Your health and safety are the top priority, so getting help quickly is essential.
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 may not find detailed information about how certain medications or treatments could affect you or your baby.
If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.
Pediatric Use
When considering DIUREX MAX (pamabrom) for your child, it's important to note that its use in children has not been established. This means that there is no information available on how safe or effective this medication is for pediatric patients (children and adolescents). As a parent or caregiver, you should consult with a healthcare professional before giving this medication to ensure the best care for your child.
Geriatric Use
When it comes to using this medication in older adults, there are no specific guidelines or recommendations regarding age-related dosage adjustments or safety concerns. This means that, while the medication can be prescribed to older patients, healthcare providers may not have tailored information to guide them in making decisions about your treatment.
It's always important for you or your caregivers to discuss any concerns with your healthcare provider, especially regarding how this medication may affect you based on your overall health and any other medications you may be taking. Your provider can help ensure that your treatment is safe and effective.
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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.
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 ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.
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 alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.
Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.
Storage and Handling
To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to maintain its integrity and protect it from light exposure, which can affect its quality.
Once you open the container, please remember to discard it after use to ensure safety and effectiveness. Following these simple storage and handling guidelines will help you use the product safely and effectively.
Additional Information
No further information is available.
FAQ
What is the active ingredient in DIUREX MAX?
The active ingredient in DIUREX MAX is pamabrom, with a dosage of 50 mg.
How should I take DIUREX MAX?
You should take one tablet of DIUREX MAX orally as needed.
What are common side effects of DIUREX MAX?
Common side effects include nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness.
What serious side effects should I be aware of?
Serious side effects may include allergic reactions such as rash, itching, swelling, severe dizziness, and trouble breathing.
Is DIUREX MAX 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 do if I experience severe allergic reactions?
If you experience severe allergic reactions, seek emergency medical help immediately.
How should I store DIUREX MAX?
Store DIUREX MAX at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.
Is there any information on pediatric use of DIUREX MAX?
Pediatric use has not been established, and safety and effectiveness in pediatric patients have not been determined.
Are there any known drug interactions with DIUREX MAX?
No specific drug interactions are mentioned for DIUREX MAX.
Packaging Info
Below are the non-prescription pack sizes of Diurex (pamabrom). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 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 Diurex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The product is identified by the SPL code 34089-3. No additional specific details regarding its chemical composition, dosage form, or physical characteristics are available in the provided information.
Uses and Indications
This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage details provided.
Healthcare professionals should be aware that there are no documented teratogenic or nonteratogenic effects associated with this drug. Further research may be necessary to establish comprehensive indications and usage guidelines.
Dosage and Administration
The recommended route of administration for this medication is oral. The active ingredient, pamabrom, is provided at a dosage of 50 mg.
Healthcare professionals should ensure that the patient adheres to the prescribed dosage regimen. It is important to instruct patients on the proper method of administration, which includes taking the medication with a full glass of water to facilitate swallowing and absorption.
Dosing intervals and any specific preparation requirements should be determined based on individual patient needs and clinical judgment. Regular monitoring of the patient's response to therapy is advised to ensure optimal outcomes.
Contraindications
There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with potential risk factors or underlying conditions.
Warnings and Precautions
Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.
While specific warnings and general precautions are not detailed in the provided information, it is imperative for healthcare providers to remain vigilant regarding potential adverse effects and contraindications that may arise during treatment. Continuous assessment of the patient's overall health status and response to therapy is essential.
In the absence of specified laboratory tests, healthcare professionals are encouraged to consider routine monitoring parameters relevant to the patient's condition and the medication's pharmacological profile. This may include, but is not limited to, assessments of organ function, electrolyte levels, and any other pertinent laboratory evaluations that could inform treatment decisions.
In the event of any concerning symptoms or adverse reactions, healthcare providers should instruct patients to seek emergency medical assistance promptly. Additionally, if a patient experiences significant side effects or if there are any changes in their health status, they should be advised to discontinue use of the medication and consult their healthcare provider immediately.
It is crucial for healthcare professionals to maintain open lines of communication with patients regarding the importance of adherence to prescribed therapies and the need for timely reporting of any unusual symptoms or health changes.
Side Effects
Patients may experience a range of adverse reactions while using the medication. Common adverse reactions reported include nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness. These reactions are generally mild to moderate in severity.
Serious side effects have also been observed, including allergic reactions characterized by symptoms such as rash, itching, swelling, severe dizziness, and difficulty breathing. In rare instances, patients have reported severe allergic reactions, including anaphylaxis, which necessitates immediate medical attention.
Additional adverse reactions noted in clinical observations include palpitations, increased heart rate, nervousness, insomnia, dry mouth, thirst, and urinary retention.
Postmarketing experience has revealed rare cases of hepatotoxicity, indicating potential liver damage associated with the medication. It is essential for healthcare providers to monitor patients for these adverse reactions and manage them appropriately.
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 Diurex (pamabrom). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 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 use of DIUREX MAX (pamabrom) has not been established. Safety and effectiveness in pediatric patients have not been determined, and therefore, caution is advised when considering this medication for children and adolescents.
Geriatric Use
Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. 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 therapeutic response, given the lack of targeted data for this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of this medication for elderly patients.
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 benefits and risks when prescribing this medication to women of childbearing potential. It is essential to discuss alternative treatment options with patients who are pregnant or planning to become pregnant.
Lactation
There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.
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 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, it is imperative to seek medical attention immediately. Prompt intervention is crucial to mitigate potential adverse effects.
Symptoms
Patients experiencing an overdosage may present with a range of symptoms, including but not limited to nausea, vomiting, and abdominal pain. These symptoms can vary in severity and may require immediate medical evaluation.
Management
Upon recognition of an overdosage, healthcare professionals should initiate appropriate management protocols. This may involve supportive care and symptomatic treatment tailored to the patient's specific symptoms and clinical status. Continuous monitoring and assessment are essential to ensure patient safety and effective management of any complications that may arise.
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
Patients should be advised to maintain adequate hydration by drinking plenty of fluids while taking this medication. It is important for healthcare providers to inform patients that this medication may cause drowsiness. Therefore, patients should be cautioned against driving or operating heavy machinery until they are aware of how the medication affects them.
Additionally, patients should be encouraged to communicate with their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. It is essential for patients to consult their healthcare provider if they experience any unusual symptoms or side effects during the course of treatment.
Storage and Handling
The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).
To ensure the integrity of the product, it must be protected from light and kept in a tightly closed container. Additionally, it is important to discard the product after opening to maintain safety and efficacy.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Diurex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.