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Mesalamine

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Active ingredient
Mesalamine 800 mg
Other brand names
Drug class
Aminosalicylate
Dosage form
Tablet, Delayed Release
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
November 30, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Mesalamine 800 mg
Other brand names
Drug class
Aminosalicylate
Dosage form
Tablet, Delayed 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 2018
Label revision date
November 30, 2024
Manufacturer
Zydus Lifesciences Limited
Registration number
ANDA203286
NDC root
70771-1110
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 delayed-release tablets are a medication that contains 800 mg of mesalamine, which is used primarily to treat inflammatory bowel diseases, such as ulcerative colitis. This medication works by reducing inflammation in the intestines, helping to alleviate symptoms and promote healing.

These tablets are available by prescription only and come in a bottle containing 180 tablets. If you have been prescribed mesalamine, it is important to follow your healthcare provider's instructions for use to ensure the best possible outcome for your condition.

Uses

Mesalamine is a medication used to treat ulcerative colitis, a condition that causes inflammation in the digestive tract. If you have proctosigmoiditis, which is inflammation of the rectum and the lower part of the colon, Mesalamine can also help manage this condition. Additionally, this medication is used to maintain remission in individuals who have previously experienced ulcerative colitis, helping to prevent flare-ups.

While there are no known teratogenic effects (which means it doesn't cause birth defects), it's important to note that Mesalamine may still pose some risks during pregnancy, as it could potentially harm the fetus. Always consult your healthcare provider for personalized advice and information regarding your treatment options.

Dosage and Administration

When you are prescribed Mesalamine Delayed-release Tablets, each tablet contains 800 mg of the medication. You will take this medication by mouth (orally), following the specific instructions provided by your healthcare professional.

It's important to adhere to the dosage and frequency recommended by your doctor to ensure the best results. Always consult with your healthcare provider if you have any questions about how to take your medication or if you experience any side effects.

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 the medication, it's always best to consult with your healthcare provider for personalized advice and guidance. They can provide you with the most accurate and relevant information based on your individual health needs.

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, or fever. There are also rare but serious side effects to be aware of, such as pancreatitis (inflammation of the pancreas), colitis (inflammation of the colon), hepatitis (liver inflammation), myocarditis (inflammation of the heart muscle), and pericarditis (inflammation of the lining around the heart).

It's important to monitor for more serious reactions, which can include severe allergic reactions (like anaphylaxis, a life-threatening allergic response), blood disorders (such as agranulocytosis, a dangerously low white blood cell count, and thrombocytopenia, a low platelet count), liver problems, and kidney issues. If you notice any unusual symptoms, please consult your healthcare provider 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 stop taking the medication and contact your doctor immediately. They can provide guidance tailored to your situation and ensure your safety. Always keep your healthcare provider informed about your health status and any other medications you may be taking.

Overdose

If you take too much mesalamine, you might experience symptoms like abdominal pain, nausea, vomiting, and diarrhea. It's important to know that there is no specific antidote for mesalamine overdose, so the best approach is to focus on general supportive care.

If you suspect an overdose, it's crucial to seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. They can provide the necessary support and treatment to help you feel better. Always remember, when in doubt, it's better to be safe and get professional advice.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that mesalamine is not recommended for use during pregnancy. There is a potential risk to your developing baby if you take this medication, and its safety for pregnant women has not been established.

If mesalamine is considered necessary for your treatment, your healthcare provider will need to monitor you closely. Additionally, while dosage adjustments may be required, specific guidelines for these changes are not provided. Always discuss any concerns or questions with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for Mesalamine delayed-release tablets does not provide specific information about its use during nursing. This means that there are no clear guidelines or data available regarding how this medication may affect you or your baby while you are breastfeeding.

As always, it's best to discuss any concerns or questions with your healthcare provider to ensure the safety and well-being of both you and your infant.

Pediatric Use

When considering Mesalamine delayed-release tablets for your child, it's important to know that their safety and effectiveness in children have not been established. This means that there hasn't been enough research to confirm whether this medication is safe or works well for kids. Always consult with your child's healthcare provider for guidance and to explore alternative treatment options that are appropriate for their age and condition.

Geriatric Use

When it comes to using mesalamine, it's important to note that there haven't been specific studies focused on older adults. If you or a loved one is elderly, keep in mind that kidney function may be lower, which can impact how the body processes the medication. This means that the drug may stay in the system longer, potentially increasing the risk of side effects.

Because older adults can be more sensitive to these side effects, your healthcare provider may need to adjust the dosage based on kidney function. Always consult with your doctor to ensure that the treatment is safe and effective for you or your loved one.

Renal Impairment

It's important to keep an eye on your kidney function if you have renal impairment (kidney problems) while undergoing treatment. Your healthcare provider will likely monitor your renal function periodically to ensure everything is working as it should.

If you have kidney issues, you may need to adjust your medication dosage. Specifically, if your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should not use mesalamine, as it may not be safe for you. Always consult with your healthcare provider for personalized advice and adjustments based on your kidney health.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that mesalamine can interact with other medications, especially those that affect kidney function, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs that can harm the kidneys. If you are taking mesalamine along with azathioprine or mercaptopurine, you should be cautious, as this combination may increase the risk of bone marrow suppression, which can affect your blood cell production.

Additionally, mesalamine may interfere with certain lab tests, including those that measure urinary pH and levels of 5-aminosalicylic acid. To ensure your safety and the effectiveness of your treatment, it's crucial to discuss all medications and any upcoming lab tests with your healthcare provider. They can help you navigate these interactions and monitor your health appropriately.

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.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of your product.

Additional Information

No further information is available.

FAQ

What is Mesalamine used for?

Mesalamine is indicated for the treatment of ulcerative colitis, proctosigmoiditis, and for the maintenance of remission of ulcerative colitis.

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 acute intolerance syndrome, renal impairment, and hepatic impairment.

Can Mesalamine be used during pregnancy?

Mesalamine is contraindicated in pregnancy, and there is a potential risk to the fetus.

How should Mesalamine be taken?

Mesalamine Delayed-release Tablets USP should be taken orally as directed by a healthcare professional.

What should I do if I have renal impairment?

If you have renal impairment, your renal function should be monitored periodically, and dosage adjustments may be necessary.

Is Mesalamine safe for pediatric use?

The safety and effectiveness of Mesalamine in pediatric patients have not been established.

What storage conditions are recommended for Mesalamine?

Store Mesalamine at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep the container tightly closed.

Can Mesalamine interact with other medications?

Yes, Mesalamine may interact with medications that affect renal function, such as NSAIDs, and caution is advised when used with azathioprine or mercaptopurine.

What should I monitor while taking Mesalamine?

You should be monitored for signs of serious side effects, including severe allergic reactions, blood disorders, liver problems, and kidney problems.

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 Delayed-release Tablets USP contain 800 mg of mesalamine per tablet. The product is available in a bottle containing 180 tablets. The National Drug Code (NDC) for this formulation is 70771-1110-8.

Uses and Indications

Mesalamine is indicated for the treatment of ulcerative colitis and proctosigmoiditis. Additionally, it is indicated for the maintenance of remission in patients with ulcerative colitis.

There are no known teratogenic effects associated with Mesalamine. However, it is important to note that Mesalamine may cause fetal harm, although specific nonteratogenic effects have not been detailed.

Dosage and Administration

Mesalamine Delayed-release Tablets USP are to be administered orally at a dosage of 800 mg. Healthcare professionals should direct the specific dosing regimen based on individual patient needs. It is essential to follow the prescribed instructions for administration to ensure optimal therapeutic outcomes.

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 in their clinical judgment.

Warnings and Precautions

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

It is imperative to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular assessments and laboratory tests should be conducted as clinically indicated to ensure patient safety and therapeutic efficacy.

In the event of severe side effects or unexpected reactions, immediate medical attention is warranted. Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience any concerning symptoms.

Due diligence in patient monitoring and communication is essential to mitigate risks and enhance treatment outcomes.

Side Effects

Patients receiving mesalamine may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions associated with mesalamine include acute intolerance syndrome, renal impairment, and hepatic impairment. These conditions necessitate careful monitoring of patients for any signs of deterioration in renal or liver function.

Common adverse reactions reported in clinical trials include abdominal pain, diarrhea, nausea, and headache. These reactions are typically mild to moderate in severity and may resolve with continued treatment.

Less common adverse reactions that have been observed include vomiting, flatulence, rash, and fever. While these reactions are not as frequently reported, they may still occur in some patients.

Rare but serious adverse reactions include pancreatitis, colitis, hepatitis, myocarditis, and pericarditis. These conditions require immediate medical attention and intervention.

Postmarketing experience has revealed additional adverse reactions, including severe allergic reactions (such as anaphylaxis), hematologic reactions (including agranulocytosis and thrombocytopenia), liver enzyme elevations, and interstitial nephritis.

It is important for healthcare providers to monitor patients for signs of these serious side effects, which may include severe allergic reactions, blood disorders, liver problems, and kidney problems. Regular assessment and vigilance can help mitigate the risks associated with mesalamine therapy.

Drug Interactions

Mesalamine may interact with various medications and laboratory tests, necessitating careful consideration during concurrent use.

Pharmacodynamic Interactions Caution is advised when mesalamine is used in conjunction with azathioprine or mercaptopurine, as this combination may increase the risk of bone marrow suppression. Monitoring of blood counts is recommended to detect any potential hematological adverse effects.

Pharmacokinetic Interactions Mesalamine may interact with medications that affect renal function, including nonsteroidal anti-inflammatory drugs (NSAIDs) and other nephrotoxic agents. It is advisable to monitor renal function closely in patients receiving mesalamine alongside these agents to mitigate the risk of renal impairment.

Laboratory Test Interactions Mesalamine may interfere with certain laboratory tests, specifically those assessing urinary pH and measuring levels of 5-aminosalicylic acid. Clinicians should be aware of this potential interference 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 delayed-release tablets 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 in children and adolescents.

Geriatric Use

Clinical studies have not specifically evaluated the use of mesalamine in geriatric patients. However, it is important to consider that elderly patients may exhibit reduced kidney function, which can impact the clearance of mesalamine.

Additionally, these patients may demonstrate increased sensitivity to the side effects associated with the medication. Therefore, careful monitoring of renal function is recommended, and dosage adjustments may be necessary to ensure safety and efficacy in this population. Healthcare providers should exercise caution when prescribing mesalamine to elderly patients, taking into account their overall health status and any potential for altered drug metabolism.

Pregnancy

Mesalamine is contraindicated in pregnancy due to potential risks to the fetus. The safety of mesalamine in pregnant women has not been established, and there is a potential risk to the fetus associated with its use during pregnancy. While dosage adjustments may be necessary for pregnant patients, specific recommendations for such modifications are not provided. If mesalamine is deemed necessary for treatment, pregnant women should be closely monitored to assess any potential adverse effects on fetal outcomes.

Lactation

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

Renal Impairment

Patients with renal impairment require careful monitoring of renal function periodically during treatment. Dosage adjustments may be necessary for these patients to ensure safety and efficacy. Specifically, patients with a creatinine clearance of less than 30 mL/min should not use mesalamine, as its use in this population is contraindicated.

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 mesalamine overdosage, patients may present with a range of symptoms including abdominal pain, nausea, vomiting, and diarrhea. These manifestations should be closely monitored as they can indicate the severity of the overdosage.

There is currently no specific antidote available for mesalamine overdosage. Therefore, the management of such cases should focus on general supportive measures. Healthcare professionals are advised to ensure that the patient is stabilized and to provide symptomatic relief as necessary. This may include hydration and electrolyte management, as well as monitoring for any complications that may arise from the symptoms experienced.

It is essential for healthcare providers to remain vigilant and to implement appropriate interventions based on the clinical presentation of the patient.

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 provided data.

Patient Counseling

Patients should be advised to take Mesalamine delayed-release tablets with food to enhance absorption. It is important for patients to swallow the tablets whole and not to crush, chew, or break them. Patients should be informed that they may experience side effects, including abdominal pain, diarrhea, and headache, and should report any severe or persistent symptoms to their healthcare provider.

Counsel patients on the importance of adhering to the prescribed dosing schedule to achieve optimal therapeutic effects. They should also be advised to maintain adequate hydration while taking this medication. It is crucial to inform patients that they should not take Mesalamine if they are allergic to mesalamine or any of the ingredients in the formulation.

Additionally, patients should be advised to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. They should also be counseled to inform their healthcare provider of any other medications they are taking to avoid potential drug interactions.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. 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 to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

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 (ANDA203286) 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.