Mesalazine

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Generic Name of Mesalazine - Learn More

Mesalazine

Mesalazine Precaution - What You Need to Know

Mesalazine (also known as mesalamine) is an anti-inflammatory drug commonly used to treat inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s disease. Several precautions should be observed during its use:

- Special Populations:
- Pregnancy: Mesalazine falls under FDA pregnancy category B, suggesting that animal reproduction studies have shown no harm, but there are no well-controlled studies in humans. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
- Lactation: Mesalazine is excreted in breast milk, and although there is limited data on its effects on a breastfeeding infant, caution should be exercised. A healthcare provider should assess the risks versus benefits.
- Elderly: Older adults may have a higher risk of side effects such as kidney issues, and their renal function should be monitored closely.

- Renal Function Monitoring:
- Mesalazine can potentially cause renal impairment, especially in patients with pre-existing kidney disease. Baseline renal function tests should be performed before initiating therapy and periodically thereafter.

- Use in Patients with Allergies:
- Patients with a history of salicylate allergies or those who have had reactions to sulfasalazine may have an increased risk of adverse reactions to mesalazine.

- Potential for Misuse:
- Mesalazine does not carry a significant risk of misuse or dependency; however, it must be used according to prescribed guidelines to avoid complications from overuse or incorrect administration.

Patients should always consult their healthcare provider before starting mesalazine to ensure the medication is appropriate for their condition and to mitigate any risks.

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Mesalazine Indication - Uses and Benefits

Mesalazine is primarily used to treat inflammatory bowel diseases, where it exerts its therapeutic effects by reducing inflammation in the digestive tract.

- Approved Indications:
- Ulcerative Colitis: Mesalazine is indicated for both the induction and maintenance of remission in patients with ulcerative colitis, especially in mild to moderate forms of the disease.
- Crohn’s Disease: It may be used in some patients with Crohn’s disease to manage mild flare-ups, although its efficacy in this condition is less robust than in ulcerative colitis.
- Proctitis: For patients with inflammation localized to the rectum (proctitis), mesalazine is commonly prescribed as it can target this area directly.

- Off-Label Uses:
- Other Inflammatory Conditions: Some clinicians may use mesalazine off-label for other gastrointestinal inflammatory conditions, although this is less common.
- Prevention of Colorectal Cancer: In patients with a long history of ulcerative colitis or Crohn’s disease, mesalazine has been used off-label as a preventive measure for colorectal cancer due to its anti-inflammatory effects.

Mesalazine’s ability to target the gut directly with relatively few systemic side effects makes it a first-line therapy for conditions like ulcerative colitis.

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Mesalazine Contraindications - Important Warnings

Certain conditions and factors make the use of mesalazine contraindicated:

- Hypersensitivity to Mesalazine or Salicylates: Patients with known allergies to mesalazine, salicylates (such as aspirin), or any of its components should avoid mesalazine, as it may trigger severe allergic reactions.
- Severe Renal Impairment: Mesalazine is contraindicated in patients with severe renal dysfunction (e.g., renal failure) due to the risk of nephrotoxicity. Renal function should be monitored regularly during therapy.
- Active Peptic Ulcer Disease: Mesalazine should be avoided in patients with active peptic ulcers, as it may exacerbate the condition.

- Patients with G6PD Deficiency: Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at an increased risk of hemolysis with mesalazine use.

- Age Considerations:
- Children: Mesalazine can be used in pediatric patients with ulcerative colitis, but dosing and monitoring must be tailored based on the child's weight and age.
- Elderly: The elderly may require careful dose adjustments, especially if they have pre-existing renal or hepatic issues.

Before starting mesalazine, patients should discuss any pre-existing conditions with their healthcare provider to avoid potential contraindications.

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Mesalazine Side Effects - What to Expect

Mesalazine can cause a range of side effects, which may vary in severity:

- Common Side Effects:
- Gastrointestinal: Nausea, vomiting, diarrhea, and abdominal cramping are frequently reported. These symptoms can sometimes be alleviated by taking the medication with food.
- Headache: Some patients may experience mild to moderate headaches during treatment.

- Serious Side Effects:
- Renal Toxicity: Mesalazine can cause kidney damage, including interstitial nephritis, which can be severe in some cases. Renal function should be monitored regularly.
- Blood Dyscrasias: Rarely, mesalazine may cause blood-related side effects such as anemia, leukopenia, or thrombocytopenia, requiring periodic blood tests.
- Liver Dysfunction: Elevations in liver enzymes or hepatitis can occur. Liver function should be monitored if symptoms like jaundice appear.

- Rare and Severe Reactions:
- Cardiovascular: Mesalazine has been associated with pericarditis or myocarditis, although this is uncommon.
- Severe Allergic Reactions: In rare cases, mesalazine can cause hypersensitivity reactions, including rashes, fever, and even more severe symptoms like anaphylaxis.

If any severe side effects such as difficulty breathing, chest pain, or a rash appear, patients should seek immediate medical attention.

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Mesalazine Pregnancy Category ID - Safety Information

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Mesalazine Mode of Action - How It Works

Mesalazine works by reducing inflammation in the gastrointestinal tract. Its mechanism of action is as follows:

- Inhibition of Pro-inflammatory Cytokines: Mesalazine is thought to reduce the production of pro-inflammatory cytokines, which are proteins involved in the immune response that contribute to the inflammation seen in IBD.
- COX Inhibition: Mesalazine inhibits cyclooxygenase (COX), which is involved in the synthesis of prostaglandins that promote inflammation.
- Local Action: Unlike other systemic medications, mesalazine is delivered directly to the gut, where it acts locally to reduce inflammation and tissue damage, especially in the colon.

This localized action reduces the potential for widespread side effects, making mesalazine a preferred treatment option for conditions like ulcerative colitis.

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Mesalazine Drug Interactions - What to Avoid

Mesalazine can interact with other drugs, potentially affecting its efficacy or leading to side effects:

- Drug-Drug Interactions:
- Azathioprine or Mercaptopurine: These immunosuppressive agents can interact with mesalazine, increasing the risk of bone marrow suppression. Close monitoring is required if they are co-administered.
- Antacids or H2 Antagonists: Medications that reduce stomach acidity, such as antacids or H2 blockers, may alter the absorption of mesalazine. It is generally recommended to separate the administration of mesalazine and acid-reducing agents by several hours.
- Methotrexate: Combining methotrexate with mesalazine can increase the risk of hepatotoxicity, so caution is advised.

- Food Interactions:
- Mesalazine does not have major interactions with food. However, taking the medication with food can sometimes minimize gastrointestinal discomfort.

- Alcohol: While mesalazine does not have a direct interaction with alcohol, drinking excessive amounts of alcohol can increase the risk of gastrointestinal irritation, which may worsen the side effects of mesalazine, such as nausea or stomach discomfort.

Patients should inform their healthcare provider about all other medications (prescription, over-the-counter, or supplements) they are taking to avoid adverse interactions.

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Mesalazine Adult Dose - Recommended Dosage

The standard adult dose of mesalazine varies based on the severity of the disease and the specific formulation used:

- Ulcerative Colitis:
- Induction of Remission: The usual dose is 2.4 to 4.8 grams per day, taken in divided doses.
- Maintenance of Remission: After remission is achieved, the dose is typically reduced to 1.2 to 2.4 grams per day.

- Other Dosage Forms:
- Mesalazine is available in oral tablets, oral suspension, and rectal formulations (such as enemas or suppositories). The exact dose depends on the form being used and the severity of the disease.

- Administration: Mesalazine tablets should be taken whole and not crushed, as this could affect their release mechanism.

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Mesalazine Child Dose - Dosage for Children

For pediatric patients, mesalazine dosing is based on weight and the severity of the condition:

- Ulcerative Colitis:
- Children (≥ 5 years): The usual starting dose is 30 mg/kg/day, divided into multiple doses, with a typical maximum dose of 2.4 grams per day.

- Safety and Monitoring:
- Children on mesalazine require careful monitoring for side effects, especially those related to kidney function, as they may be more susceptible to renal issues.

Pediatric dosing should always be supervised by a healthcare provider to ensure safety and efficacy.

Mesalazine Renal Dose - Dosage for Kidney Conditions

Mesalazine should be used with caution in patients with renal impairment:

- Mild Renal Impairment: Standard doses may be used, but regular renal function monitoring is necessary.
- Moderate to Severe Renal Impairment: In cases of moderate to severe renal dysfunction, mesalazine should either be dose-adjusted or avoided due to the increased risk of nephrotoxicity.

Renal function (including serum creatinine and BUN levels) should be regularly monitored during therapy.

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