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Mesalamine

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Active ingredient
Mesalamine 1000 mg
Other brand names
Drug class
Aminosalicylate
Dosage form
Suppository
Route
Rectal
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
January 9, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Mesalamine 1000 mg
Other brand names
Drug class
Aminosalicylate
Dosage form
Suppository
Route
Rectal
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 2020
Label revision date
January 9, 2025
Manufacturer
Zydus Lifesciences Limited
Registration number
ANDA208953
NDC root
70771-1513
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 suppositories are a prescription medication that comes in a formulation of 1000 mg and is available in a package of 30 rectal suppositories. This medication is primarily used to treat inflammatory bowel diseases, such as ulcerative colitis, by helping to reduce inflammation in the intestines.

By delivering the active ingredient directly to the affected area, mesalamine works to alleviate symptoms and promote healing. If you have been prescribed mesalamine suppositories, it's important to follow your healthcare provider's instructions for use to achieve the best results.

Uses

Mesalamine suppositories are used to treat ulcerative colitis, a condition that causes inflammation in the lining of the colon. If you are dealing with this condition, these suppositories can help manage your symptoms and promote healing in the affected area.

It's important to note that mesalamine has no known teratogenic effects, meaning it does not cause birth defects. Additionally, it is not expected to harm a developing fetus, making it a safer option for those who are pregnant or planning to become pregnant.

Dosage and Administration

When using mesalamine suppositories, you will be using a 1000 mg dose. These suppositories are designed to be administered rectally, which means you will insert them into your rectum as directed by your healthcare provider.

It's important to follow your provider's instructions carefully regarding how often to use the suppositories. Make sure to ask any questions you may have about the process to ensure you are comfortable and understand how to use them properly.

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 potential risks, please discuss them with your doctor or pharmacist. They can provide you with the necessary guidance tailored to your situation.

Side Effects

You may experience some common side effects while taking this medication, including abdominal pain, diarrhea, nausea, vomiting, and headache. It's important to be aware of more serious side effects, which can include renal impairment (kidney issues), pancreatitis (inflammation of the pancreas), hepatic dysfunction (liver problems), and exacerbation of colitis (worsening of ulcerative colitis).

In rare cases, you might have an allergic reaction, which could manifest as a rash, itching, hives, or even anaphylaxis (a severe allergic reaction). Additionally, there have been reports of severe hypersensitivity reactions, myocarditis (inflammation of the heart), pericarditis (inflammation of the lining around the heart), and pulmonary fibrosis (lung scarring). It's crucial to monitor for signs of liver dysfunction, such as jaundice (yellowing of the skin or eyes) and elevated liver enzymes. If you notice any of these symptoms, please consult your healthcare provider.

Warnings and Precautions

While there are no specific warnings or precautions listed for this medication, it's always important to stay vigilant about your health. If you experience any unusual symptoms or side effects, it's a good idea to stop taking the medication and call 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 well-being and communicate openly with your healthcare provider about any concerns you may have.

Overdose

If you take too much mesalamine, you may experience symptoms like abdominal pain, cramping, and diarrhea. It's important to be aware of these signs, as they can indicate an overdose.

In the event of an overdose, there is no specific antidote available, so supportive care is essential. This means that healthcare providers will focus on monitoring your condition and treating any symptoms that arise. If you suspect an overdose or notice any concerning symptoms, seek medical help immediately to ensure you receive the appropriate care.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of mesalamine suppositories during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to their use in pregnant individuals have not been clearly established.

Before using mesalamine suppositories, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best decision for your health and your baby's health.

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 best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When considering mesalamine suppositories for your child, it's important to know that their use in children has not been established. This means that there is currently no confirmed information about how safe or effective these suppositories are for pediatric patients (children and adolescents).

As a parent or caregiver, you should consult with your child's healthcare provider for guidance and to discuss any alternative treatments that may be more appropriate for their needs. Always prioritize your child's safety and well-being when exploring medication options.

Geriatric Use

When it comes to using mesalamine suppositories, it's important to note that there haven't been specific studies focused on older adults. If you or a loved one is elderly, be aware that kidney function may be lower, which could mean that the dosage needs to be adjusted. Additionally, older adults might be more sensitive to side effects, so it's crucial to monitor for any unusual reactions.

Because of these factors, caution is recommended when prescribing mesalamine to older patients. Always discuss any concerns with your healthcare provider to ensure safe and effective treatment tailored to individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the medication insert does not provide specific dosage adjustments or monitoring recommendations for renal impairment (kidney issues). This means that, as a patient, you may not need to change how you take the medication based on your kidney function. However, it's always best to discuss your individual situation with your healthcare provider to ensure your treatment is safe and effective. They can provide personalized advice based on your health 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, so don't hesitate to ask questions or express any concerns you may have.

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 quality and safety of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F) and keep it protected from light. It's important to leave the suppositories in their original package until you are ready to use them. Additionally, remember to discard any unused suppositories after their expiration date to avoid any potential risks. Following these guidelines will help maintain the effectiveness of the product.

Additional Information

No further information is available.

FAQ

What is Mesalamine suppositories used for?

Mesalamine suppositories are indicated for the treatment of ulcerative colitis.

What is the dosage for Mesalamine suppositories?

The dosage for Mesalamine suppositories is 1000 mg, administered rectally as directed by a healthcare provider.

Are there any known teratogenic effects of Mesalamine?

There are no known teratogenic effects associated with Mesalamine, and it is not expected to cause fetal harm.

What are common side effects of Mesalamine?

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

What serious side effects should I be aware of?

Serious side effects may include renal impairment, pancreatitis, hepatic dysfunction, and exacerbation of colitis.

Can Mesalamine cause allergic reactions?

Yes, Mesalamine may cause allergic reactions such as rash, pruritus, urticaria, and in rare cases, anaphylaxis.

Is Mesalamine safe for pediatric use?

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

What precautions should be taken for elderly patients using Mesalamine?

Elderly patients may have reduced kidney function and increased sensitivity to side effects, so caution is advised when prescribing.

How should Mesalamine suppositories be stored?

Store Mesalamine suppositories at 20°C to 25°C (68°F to 77°F), protect from light, and keep them in the original package until use.

What should I do if I experience severe side effects?

If you experience severe side effects, such as signs of liver dysfunction or renal failure, contact your healthcare provider immediately.

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 suppositories are formulated to deliver 1000 mg of mesalamine per suppository. Each package contains 30 rectal suppositories, intended for prescription use only.

Uses and Indications

Mesalamine suppositories are indicated for the treatment of ulcerative colitis. This medication is designed to provide localized anti-inflammatory effects in the rectum and lower colon, aiding in the management of this condition.

There are no known teratogenic effects associated with mesalamine, and it is not expected to cause fetal harm. Therefore, it may be considered for use in pregnant patients under the guidance of a healthcare professional.

Dosage and Administration

Mesalamine suppositories are to be administered rectally at a dosage of 1000 mg. Healthcare professionals should instruct patients to follow the prescribed regimen as directed. Proper administration technique should be emphasized to ensure effective delivery 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 in their clinical judgment.

Warnings and Precautions

Healthcare professionals should be aware that there are no specific warnings or general precautions associated with the use of this product as per the current regulatory information.

Additionally, there are no designated laboratory tests recommended for monitoring the use of this product.

In the event of any adverse reactions or concerns, it is imperative for patients to seek emergency medical assistance. Furthermore, if any unexpected symptoms arise, patients should discontinue use and consult their healthcare provider promptly.

It is essential for healthcare professionals to remain vigilant and ensure that patients are informed about the importance of monitoring their health and reporting any unusual changes.

Side Effects

Patients may experience a range of adverse reactions while using the medication. Common adverse reactions reported include abdominal pain, diarrhea, nausea, vomiting, and headache. These reactions are generally mild and may resolve with continued treatment.

Serious side effects have also been observed, including renal impairment, pancreatitis, hepatic dysfunction, and exacerbation of colitis, particularly in patients with a history of ulcerative colitis. It is crucial for healthcare providers to monitor patients for these serious conditions.

Allergic reactions, although less common, can occur and may manifest as rash, pruritus, urticaria, or, in rare cases, anaphylaxis.

Postmarketing experience has revealed additional severe hypersensitivity reactions, as well as cases of myocarditis, pericarditis, and pulmonary fibrosis.

Furthermore, mesalamine has the potential to cause severe side effects, including renal failure and blood dyscrasias. Healthcare professionals should remain vigilant for signs of liver dysfunction, such as jaundice and elevated liver enzymes, during treatment.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no 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 suppositories has not been established, and the safety and effectiveness in pediatric patients have not been determined. Therefore, caution is advised when considering the use of this medication in children and adolescents.

Geriatric Use

Clinical studies have not specifically evaluated the use of mesalamine suppositories in geriatric patients. Therefore, the safety and efficacy of this medication in this population remain undetermined.

Elderly patients may exhibit reduced kidney function, which could necessitate dosage adjustments to avoid potential toxicity. Additionally, there is an increased sensitivity to side effects in this demographic, warranting careful monitoring and consideration when prescribing mesalamine.

Due to the potential for renal impairment in elderly patients, caution is advised when initiating treatment with mesalamine. Healthcare providers should assess renal function prior to and during therapy to ensure appropriate dosing and to mitigate the risk of adverse effects.

Pregnancy

There is no specific information available regarding the use of mesalamine suppositories during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they are pregnant or plan to become pregnant while using mesalamine.

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 do not require specific dosage adjustments or monitoring recommendations as outlined in the prescribing information. It is important for healthcare professionals to consider the overall clinical context when treating patients with reduced kidney function, as individual patient factors may influence therapeutic decisions.

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

Overdosage of mesalamine may lead to a range of symptoms, including abdominal pain, cramping, and diarrhea. These manifestations are indicative of the body's response to excessive amounts of the medication.

In the event of an overdosage, it is essential to provide supportive care to the patient. This approach is crucial as there is no specific antidote available for mesalamine overdosage. Healthcare professionals should ensure that patients are closely monitored for any signs of toxicity. Appropriate treatment should be administered based on the observed symptoms and the patient's clinical condition.

Prompt recognition and management of overdosage are vital to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted in these studies, and there was no increase in fetal malformations. The findings suggest a favorable safety profile regarding developmental toxicity in the tested animal models.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to use mesalamine suppositories strictly as directed by their healthcare provider. It is crucial to inform patients that they must not use mesalamine suppositories if they have a known allergy to mesalamine or any of the ingredients contained in the product.

Healthcare providers should counsel patients to report any signs of allergic reactions, such as rash, itching, or difficulty breathing, to their healthcare provider immediately. Additionally, patients should be made aware of the importance of maintaining regular follow-up appointments to monitor their condition and response to treatment.

Patients should be informed that they may experience side effects while using mesalamine suppositories. They should be encouraged to report any unusual symptoms or side effects to their healthcare provider promptly.

It is also important to advise patients on the proper storage of mesalamine suppositories, recommending that they be kept at room temperature, away from moisture and heat. Furthermore, healthcare providers should instruct patients on the correct technique for administering the suppository to ensure effective treatment.

Storage and Handling

The product is supplied in its original packaging, which should be retained until use to ensure optimal stability and efficacy. It is essential to store the suppositories at a temperature range of 20°C to 25°C (68°F to 77°F) and to protect them from light exposure. Any unused suppositories should be discarded after the expiration date to maintain safety and effectiveness.

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 (ANDA208953) 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.