Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Mesalamine

Last content change checked dailysee data sync status

Active ingredient
Mesalamine 1.2 g
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 2017
Label revision date
November 30, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Mesalamine 1.2 g
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 2017
Label revision date
November 30, 2024
Manufacturer
Zydus Lifesciences Limited
Registration number
ANDA091640
NDC root
70771-1071
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 (1.2 g) are a prescription medication primarily used 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.

If you have been prescribed mesalamine, it is important to follow your healthcare provider's instructions for use to ensure the best possible outcome in managing your condition.

Uses

Mesalamine is a medication used to treat ulcerative colitis, a condition that causes inflammation and ulcers in the digestive tract. If you have ulcerative colitis, mesalamine can help manage your symptoms and promote healing.

In addition to treating active ulcerative colitis, mesalamine is also used to help maintain remission, which means it can keep the condition under control and prevent flare-ups after you've experienced improvement. This can be an important part of your ongoing care if you have this condition.

Dosage and Administration

When you take this medication, it is important to know that it is administered orally, meaning you will swallow it as a tablet. Each tablet contains 1.2 grams of the active ingredient called mesalamine, which is used to help manage certain bowel conditions.

Make sure to follow your healthcare provider's instructions regarding how many tablets to take and how often to take them, as this information is crucial for the medication to work effectively. Always take the tablets with a full glass of water to help with swallowing and absorption.

What to Avoid

It seems that the specific details regarding what to avoid while using this medication are not provided. However, it's important to remember that certain medications can have risks associated with misuse or dependence (which means relying on a substance in a way that can be harmful).

To ensure your safety, always follow your healthcare provider's instructions closely. If you have any concerns about how to use this medication or its potential risks, please discuss them with your doctor or pharmacist. They can provide you with the most accurate and personalized advice.

Side Effects

You may experience some side effects while taking this medication. Serious reactions can include severe allergic responses, such as anaphylaxis (a life-threatening allergic reaction), severe liver injury, and renal impairment, which can involve acute interstitial nephritis (inflammation of the kidneys).

Common side effects include abdominal pain, diarrhea, nausea, and headaches. Less common reactions may involve vomiting, flatulence, rashes, and fever. Rarely, you could experience more serious conditions like pancreatitis (inflammation of the pancreas), myocarditis (inflammation of the heart), or hemolytic anemia (destruction of red blood cells). It's important to note that mesalamine can affect kidney function, especially if you have existing kidney issues, so regular monitoring of your renal function is advised during treatment.

Warnings and Precautions

It's important to stay informed about your health and any medications you may be taking. While there are no specific warnings or precautions listed for this medication, it's always a good idea to monitor how you feel and report any unusual symptoms to your healthcare provider.

If you experience any concerning side effects or have questions about your treatment, don't hesitate to reach out to your doctor. They can provide guidance tailored to your individual health needs. Remember, your well-being is a priority, and open communication with your healthcare team is essential.

Overdose

If you suspect an overdose of mesalamine, you may notice symptoms like abdominal pain, nausea, vomiting, and diarrhea. It's important to remember that there is no specific antidote for mesalamine overdose, so treatment will focus on relieving these symptoms and providing supportive care.

In such cases, healthcare professionals will monitor you for signs of toxicity (harmful effects from the drug) and take appropriate actions as needed. If you or someone you know is experiencing these symptoms, seek medical help immediately to ensure proper care and management.

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 needed, specific guidelines for these changes are not provided. Always discuss any concerns or questions with your healthcare professional to ensure the best care for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of Mesalamine delayed-release tablets for nursing mothers or during breastfeeding. This means that the effects on breast milk and nursing infants have not been clearly studied or documented.

If you are breastfeeding and considering this medication, it’s important to consult with your healthcare provider to discuss any potential risks and to ensure the safety of both you and your baby.

Pediatric Use

When considering mesalamine delayed-release tablets for your child, it's important to know that their safety and effectiveness have not been established in children. This means that there hasn't been enough research to confirm that this medication is safe or works well for kids. Additionally, mesalamine is not recommended for children under 5 years old. Always consult with your child's healthcare provider for guidance on appropriate treatments and medications.

Geriatric Use

You can feel reassured that there are no specific concerns or special precautions for older adults regarding this medication. The information provided does not indicate any need for dosage adjustments or safety considerations unique to elderly patients. This means that, generally, you can use this medication without additional worries about its effects based on age. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Renal Impairment

It’s important to monitor your kidney function before starting treatment and throughout your therapy. If you have kidney problems, your doctor may need to adjust your dosage to ensure your safety and the effectiveness of the medication. Specifically, if your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should not use mesalamine.

Additionally, regular renal function tests are necessary during your treatment to keep track of how well your kidneys are working. Always discuss any concerns with your healthcare provider to ensure you receive the best care tailored to your needs.

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, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking or any lab tests you may undergo. In this case, there are no known drug interactions or laboratory test interactions associated with this medication. However, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be involved with. Always feel free to ask questions and share your complete health history to get the best care possible.

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 as close to the recommended range as possible. Make sure to protect the product from light and always keep the container tightly closed when not in use to maintain its integrity.

When handling the product, be mindful of these storage conditions to ensure safety and effectiveness. Proper storage and handling will help you get the most out of your product.

Additional Information

No further information is available.

FAQ

What is Mesalamine used for?

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

How is Mesalamine administered?

Mesalamine delayed-release tablets are administered orally.

What are the common side effects of Mesalamine?

Common adverse reactions include abdominal pain, diarrhea, nausea, and headache.

What serious side effects should I be aware of?

Serious side effects may include severe allergic reactions, liver injury, and renal impairment.

Is Mesalamine safe to use during pregnancy?

Mesalamine is contraindicated in pregnancy, with potential risks to the fetus.

Are there any precautions for patients with renal impairment?

You should monitor renal function prior to and during treatment, and dosage adjustments may be necessary.

What should I do if I experience severe side effects?

If you experience severe side effects, such as severe allergic reactions or liver injury, seek emergency medical help.

Is Mesalamine recommended for children?

Mesalamine is not recommended for use in children under 5 years of age, as safety and effectiveness have not been established.

How should I store Mesalamine?

Store Mesalamine at 20°C to 25°C (68°F to 77°F) and protect it 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 Delayed-release Tablets are formulated to contain 1.2 g of mesalamine per tablet. Each bottle contains 120 tablets and is available by prescription only. The product is identified by the National Drug Code (NDC) 70771-1071-1.

Uses and Indications

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

There are no specific teratogenic or nonteratogenic effects associated with mesalamine as per the available data.

Dosage and Administration

The active ingredient in this formulation is mesalamine, with each tablet containing a strength of 1.2 g. The recommended route of administration is oral.

Healthcare professionals should determine the appropriate dosage based on individual patient needs and clinical response. It is essential to follow established guidelines for dosing intervals and to monitor patients for efficacy and tolerability.

Prior to administration, ensure that the patient is adequately informed about the medication, including potential side effects and the importance of adherence to the prescribed regimen.

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

There are currently no specific warnings or general precautions associated with the use of this product. Additionally, no laboratory tests are required or suggested for safe use. Healthcare professionals are advised to remain vigilant and monitor patients for any unforeseen reactions or complications, although no specific instructions for emergency medical help or cessation of use have been provided. It is essential for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this product.

Side Effects

Patients may experience a range of adverse reactions while receiving treatment. Serious side effects include severe allergic reactions, such as anaphylaxis, severe liver injury, and renal impairment, which may manifest as acute interstitial nephritis.

Common adverse reactions reported among participants include abdominal pain, diarrhea, nausea, and headache. Less common reactions may occur, including vomiting, flatulence, rash, and fever.

Rare adverse reactions have also been noted, such as pancreatitis, myocarditis, pericarditis, hemolytic anemia, and thrombocytopenia.

Postmarketing experience has revealed additional concerns, including hepatic failure, colitis, and various allergic reactions, which may present as angioedema or urticaria. Pulmonary reactions, particularly eosinophilic pneumonia, have also been reported.

It is important to note that mesalamine may cause renal impairment, especially in patients with pre-existing renal conditions. Therefore, renal function should be monitored periodically during treatment to ensure patient safety.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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, and safety and effectiveness in pediatric patients have not been determined. Therefore, mesalamine is not recommended for use in children under 5 years of age.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, safety concerns, or special precautions outlined in the provided information. Therefore, healthcare providers may not need to implement any additional measures when prescribing this medication to geriatric patients. However, it is always advisable to monitor elderly patients closely for any potential adverse effects, given the general increased sensitivity of this population to medications.

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 breast 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 prior to and 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. Additionally, renal function tests should be performed periodically throughout the course of treatment to assess any changes in kidney function.

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 the event of an overdose, patients may present with a range of symptoms including abdominal pain, nausea, vomiting, and diarrhea. These manifestations are indicative of potential toxicity and warrant immediate attention.

There is currently no specific antidote available for mesalamine overdose. Therefore, the management of such cases should focus on symptomatic and supportive care. Healthcare professionals are advised to monitor patients closely for any signs of toxicity, ensuring that appropriate measures are implemented as necessary to address the symptoms and maintain patient safety.

Prompt recognition and management of overdose symptoms are crucial in mitigating potential complications and ensuring optimal patient outcomes.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted in these studies.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included pancreatitis, elevations in liver enzymes, and renal impairment. Additionally, cases of hypersensitivity reactions, such as anaphylaxis, have been documented. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. Furthermore, pulmonary adverse reactions, specifically interstitial lung disease, have been noted. Hematologic abnormalities, including agranulocytosis and thrombocytopenia, have been observed in some patients.

Patient Counseling

Patients should be advised to take mesalamine delayed-release tablets with food to enhance absorption and minimize gastrointestinal discomfort. It is important to instruct patients to swallow the tablets whole, emphasizing that they should not crush, chew, or break 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, headache, and nausea. They should be encouraged 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.

Counseling should also include the importance of adhering to the prescribed dosing schedule to ensure optimal effectiveness of the treatment. Patients should be made aware that mesalamine may cause changes in kidney function, and they should be monitored for any signs of kidney problems during therapy.

Additionally, patients should be advised to maintain adequate hydration while taking mesalamine to support overall health and kidney function. 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 (ANDA091640) 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.