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Mesalamine

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Active ingredient
Mesalamine 0.375 g
Other brand names
Drug class
Aminosalicylate
Dosage form
Capsule, Extended Release
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 30, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Mesalamine 0.375 g
Other brand names
Drug class
Aminosalicylate
Dosage form
Capsule, Extended Release
Route
Oral
Prescription status
Rx (prescription)
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
November 30, 2024
Manufacturer
Zydus Lifesciences Limited
Registration number
ANDA208954
NDC root
70771-1625
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Mesalamine Extended-Release Capsules (0.375 g) are a prescription medication designed to help manage certain inflammatory bowel conditions, particularly ulcerative colitis. This medication works by reducing inflammation in the intestines, which can help alleviate symptoms and promote healing.

Each bottle contains 120 capsules, and they are formulated to release the active ingredient gradually, providing extended relief. If you have been prescribed mesalamine, it is important to follow your healthcare provider's instructions for use to achieve the best results.

Uses

Mesalamine Extended-Release Capsules are used to treat ulcerative colitis, a condition that causes inflammation and ulcers in the lining of the colon. If you have this condition, these capsules can help manage your symptoms and promote healing in your digestive tract.

It's important to note that the information provided does not indicate any specific risks of teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects. Always consult with your healthcare provider for personalized advice and information regarding your treatment options.

Dosage and Administration

When you need to take Mesalamine Extended-Release Capsules, you will be using the 0.375 g dosage. This medication is taken by mouth (orally). It's important to follow your healthcare provider's instructions on how to take it, ensuring you swallow the capsules whole without chewing or breaking them.

Make sure to take the capsules as directed, and if you have any questions about the timing or frequency of your doses, don’t hesitate to ask your doctor or pharmacist for clarification. Following these guidelines will help you get the most benefit from your treatment.

What to Avoid

It seems that there are no specific contraindications, controlled substance details, or instructions regarding abuse, misuse, or dependence provided in the information available. Therefore, there are no particular "do not take/use" instructions to share. If you have any concerns or questions about your medication, it's always best to consult with your healthcare provider for personalized advice and guidance. They can help ensure that you use your medication safely and effectively.

Side Effects

You may experience some side effects while taking mesalamine. Common reactions include abdominal pain, diarrhea, nausea, and headaches. Less frequently, you might notice vomiting, flatulence, rash, fever, or fatigue. In rare cases, more serious issues can arise, such as pancreatitis, liver failure, colitis, myocarditis (inflammation of the heart muscle), and pericarditis (inflammation of the lining around the heart).

It's important to be aware of potential serious reactions, including renal impairment (kidney issues) and hypersensitivity reactions, which can occur after the first dose or later. Severe allergic reactions, such as angioedema (swelling under the skin) and urticaria (hives), as well as hematologic (blood-related) and pulmonary (lung-related) reactions, have also been reported. Please monitor for any unusual symptoms and consult your healthcare provider if you have concerns.

Warnings and Precautions

It seems that specific warnings, precautions, and instructions for emergency help or contacting your doctor were 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 stop taking the medication and reach out to your doctor for guidance. Additionally, if you ever feel that you need immediate medical assistance, don’t hesitate to seek emergency help. Always prioritize your health and safety by staying informed and proactive in your care.

Overdose

If you or someone you know has taken too much mesalamine, it’s important to be aware of the possible symptoms. You may experience abdominal pain, nausea, vomiting, and diarrhea. Unfortunately, there is no specific antidote for mesalamine overdosage, so the focus will be on providing general supportive care.

If you suspect an overdose, it’s crucial to seek medical help immediately. Contact your healthcare provider or go to the nearest emergency room. They can provide the necessary support and treatment to help manage the symptoms effectively. Remember, acting quickly can make a significant difference in your care.

Pregnancy Use

When it comes to using mesalamine during pregnancy, the provided information does not include specific guidelines or recommendations. This means that there is no clear consensus on its safety for pregnant individuals. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider for personalized advice and to discuss any potential risks or benefits associated with this medication. They can provide you with the most accurate and up-to-date information tailored to your situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the provided information about Mesalamine Extended-Release Capsules does not include specific guidance for nursing mothers or lactation. This means there are no clear recommendations or warnings regarding the use of this medication while breastfeeding.

Since there is no detailed information available, it's best to consult your healthcare provider for personalized advice. They can help you weigh the benefits and risks of using this medication while nursing, ensuring the safety of both you and your baby.

Pediatric Use

Currently, the use of mesalamine extended-release capsules in children has not been established, meaning that there is no confirmed information on how safe or effective this medication is for young patients. As a parent or caregiver, it's important to be aware that the safety and effectiveness of this treatment in children have not been determined, so you should consult with a healthcare professional before considering this medication for your child. Always prioritize guidance from a doctor when it comes to treating pediatric patients.

Geriatric Use

As you age, your body may respond differently to medications, including mesalamine. Older adults often have increased sensitivity to the side effects of this drug, which means you might experience more pronounced effects than younger individuals. Additionally, if you have reduced kidney function (a common issue in older adults), your doctor may need to adjust your dosage to ensure safety and effectiveness.

It's important to note that the safety and effectiveness of mesalamine in older adults have not been fully established. Therefore, if you or a loved one is considering this medication, it's crucial to discuss any concerns with your healthcare provider and proceed with caution.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should not use mesalamine. To ensure your safety while on treatment, your healthcare provider will likely perform tests to monitor your kidney function before starting the medication and at regular intervals during your treatment. This helps to catch any potential issues early and adjust your care as needed.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your healthcare provider about all the medications you are taking, especially if you are prescribed mesalamine. This medication can interact with others that affect kidney function, which may increase the risk of kidney damage. Additionally, if you are using mesalamine alongside azathioprine or mercaptopurine, there is a heightened risk of bone marrow suppression, which can affect your blood cell production.

Moreover, mesalamine can interfere with certain lab tests, such as those measuring urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary p-hydroxyphenylacetate. Always keep your healthcare provider informed about your medications and any upcoming lab tests to ensure your safety and the accuracy of your results.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use to maintain its integrity.

Handling the product safely is also important. Always ensure that you are in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is Mesalamine Extended-Release Capsules used for?

Mesalamine Extended-Release Capsules are indicated for the treatment of ulcerative colitis.

How should I take Mesalamine Extended-Release Capsules?

You should administer Mesalamine Extended-Release Capsules orally, following the prescribed dosage as directed by your healthcare professional.

What are the common side effects of Mesalamine?

Common side effects include abdominal pain, diarrhea, nausea, and headache.

Are there any serious side effects associated with Mesalamine?

Yes, serious side effects may include renal impairment and hypersensitivity reactions, such as anaphylaxis.

Can Mesalamine affect my kidney function?

Yes, Mesalamine may cause renal impairment, and patients should be monitored for signs of kidney issues.

Is Mesalamine safe to use during pregnancy?

There are no specific statements regarding the use of Mesalamine during pregnancy; consult your healthcare provider for more information.

What should I know about using Mesalamine if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and you should not use Mesalamine if your creatinine clearance is less than 30 mL/min.

Are there any drug interactions I should be aware of?

Mesalamine may interact with medications that affect renal function and may increase the risk of nephrotoxicity.

How should I store Mesalamine Extended-Release Capsules?

Store the capsules at 20°C to 25°C (68°F to 77°F) and protect them from light.

Packaging Info

The table below lists all NDC Code configurations of Mesalamine, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mesalamine.
Details

FDA Insert (PDF)

This is the full prescribing document for Mesalamine, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Mesalamine Extended-Release Capsules contain 0.375 g of mesalamine per capsule. Each bottle contains 120 capsules. The product is available by prescription only and is identified by the National Drug Code (NDC) 70771-1625-7.

Uses and Indications

Mesalamine Extended-Release Capsules are indicated for the treatment of ulcerative colitis. This medication is intended for use in patients diagnosed with this condition to help manage and alleviate symptoms associated with ulcerative colitis.

There are no specific teratogenic or nonteratogenic effects associated with Mesalamine Extended-Release Capsules as per the available data.

Dosage and Administration

Mesalamine Extended-Release Capsules are to be administered orally. The recommended dosage is 0.375 g per capsule. Healthcare professionals should ensure that the capsules are taken as directed, adhering to the prescribed dosing regimen. It is important to instruct patients to swallow the capsules whole and not to crush or chew them, as this may affect the release mechanism of the medication.

Contraindications

There are no specific contraindications provided for this product. It is essential for healthcare professionals to evaluate individual patient circumstances and consider any potential risks associated with the use of this product.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular laboratory tests may be necessary to assess the patient's response to therapy and to ensure safety. Specific monitoring parameters should be established based on the individual patient's health status and the medication's profile.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers should instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Overall, vigilance in monitoring and patient education regarding the signs of potential complications are paramount to ensure safe and effective use of this medication.

Side Effects

Mesalamine has been associated with several serious adverse reactions that warrant careful monitoring. Notably, renal impairment, including acute interstitial nephritis, may occur at any time during treatment and can lead to renal failure. Additionally, hypersensitivity reactions, such as anaphylaxis, may manifest after the first dose or following subsequent doses.

Common adverse reactions reported among patients include abdominal pain, diarrhea, nausea, and headache. Less common adverse reactions observed include vomiting, flatulence, rash, fever, and fatigue. Rarely, patients may experience more severe reactions such as pancreatitis, hepatic failure, colitis, myocarditis, and pericarditis.

Postmarketing experience has revealed additional adverse reactions associated with mesalamine. These include severe allergic reactions, such as angioedema and urticaria, as well as hematologic reactions like agranulocytosis and thrombocytopenia. Pulmonary reactions, including eosinophilic pneumonia, and cardiovascular events, such as myocardial infarction, have also been reported.

Furthermore, mesalamine may lead to skin reactions, including exfoliative dermatitis and erythema multiforme. It is essential for healthcare providers to monitor patients for signs of renal impairment and hypersensitivity reactions throughout the course of treatment.

Drug Interactions

Concomitant use of mesalamine with medications that affect renal function may elevate the risk of nephrotoxicity. It is advisable to monitor renal function closely in patients receiving mesalamine alongside such agents.

The combination of mesalamine with azathioprine or mercaptopurine may heighten the risk of bone marrow suppression. Clinicians should consider dosage adjustments and increased monitoring of blood counts in patients taking these medications concurrently.

Additionally, mesalamine has the potential to interfere with certain laboratory tests. Specifically, it may affect the accuracy of tests for urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary p-hydroxyphenylacetate. It is recommended that healthcare providers be aware of this interaction when interpreting test results.

Packaging & NDC

The table below lists all NDC Code configurations of Mesalamine, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mesalamine.
Details

Pediatric Use

Pediatric use of mesalamine extended-release capsules has not been established. The safety and effectiveness of this medication in pediatric patients remain undetermined. Therefore, caution is advised when considering the use of mesalamine extended-release capsules in children and adolescents.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of mesalamine. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy. It is important to note that the safety and efficacy of mesalamine in geriatric patients have not been established; therefore, caution is advised when prescribing this medication to individuals aged 65 and older. Regular monitoring of renal function and patient response is recommended to mitigate risks associated with treatment in this demographic.

Pregnancy

There are no specific statements regarding the use of mesalamine during pregnancy in the provided text. Healthcare professionals are advised to refer to additional resources or the full prescribing information for comprehensive details on pregnancy-related considerations. It is essential to evaluate the potential risks and benefits of mesalamine therapy in pregnant patients, considering the lack of specific data on its safety profile during pregnancy. Women of childbearing potential should be counseled regarding the importance of effective contraception while undergoing treatment and the need to discuss any plans for pregnancy with their healthcare provider.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Mesalamine Extended-Release Capsules. Therefore, the effects on breastfed infants and the excretion of Mesalamine in breast milk remain undetermined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Dosage adjustments may be necessary for patients with renal impairment. Specifically, patients with a creatinine clearance of less than 30 mL/min should not use mesalamine. It is recommended that renal function tests be performed prior to and periodically during treatment in patients with renal impairment to monitor their condition effectively.

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 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 cases of overdosage, patients may present with a range of symptoms including abdominal pain, nausea, vomiting, and diarrhea. These manifestations are indicative of the body's response to excessive amounts of the medication.

It is important to note that there is no specific antidote available for mesalamine overdosage. Therefore, the management of such cases should focus on general supportive measures. Healthcare professionals are advised to monitor the patient's condition closely and provide symptomatic relief as necessary. This may include hydration and electrolyte management, as well as addressing any gastrointestinal disturbances that arise.

In summary, the approach to managing mesalamine overdosage is primarily supportive, emphasizing the importance of monitoring and alleviating symptoms to ensure patient safety and comfort.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted in these studies, indicating a lack of non-teratogenic effects.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: abdominal pain, diarrhea, nausea, vomiting, headache, and rash. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Patients should be advised to take mesalamine extended-release capsules with food to enhance absorption and minimize gastrointestinal discomfort. It is important to instruct patients to swallow the capsules whole, emphasizing that they should not chew or crush them, as this may affect the medication's efficacy.

Patients should be informed that they may experience side effects, which can include abdominal pain, diarrhea, and headache. They should be counseled to report any signs of allergic reactions, such as rash, itching, or difficulty breathing, to their healthcare provider immediately, as these may require prompt medical attention.

Healthcare providers should emphasize the importance of adhering to the prescribed dosing schedule for optimal effectiveness of the medication. Additionally, patients should be informed that mesalamine may cause changes in kidney function; therefore, regular monitoring of kidney function is recommended.

Patients should also be advised to maintain adequate hydration while taking mesalamine to support overall health and kidney function. Finally, it is crucial to inform patients that they should not take mesalamine if they are allergic to mesalamine or any of its components, as this could lead to serious adverse reactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light and ensure that the container remains tightly closed to maintain its integrity.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Mesalamine as submitted by Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mesalamine, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA208954) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.