ESBRIET 267 mg Price

Overview

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This medicine contains an important and useful components, as it consists of
Pirfenidoneis available in the market in concentration

Name

5 Aminosalicylic Acid (Mesalamine)

Precaution

- **Pregnancy and Breastfeeding**: Mesalamine is considered a **Category B** drug in pregnancy, meaning it is **not expected** to harm the fetus based on animal studies. However, pregnant women should use mesalamine only if the potential benefit justifies the potential risk to the fetus. It is also excreted into **breast milk**, but the effects on a nursing infant are not well understood. **Caution** is advised, and the benefits of use should be weighed against any potential risks. - **Renal Function**: **Renal impairment** is an important consideration when prescribing mesalamine. It is metabolized and excreted through the kidneys, and **renal dysfunction** can increase the risk of mesalamine-induced **nephrotoxicity**, including conditions like **acute interstitial nephritis**. Kidney function should be regularly monitored, especially in patients with a history of kidney disease. - **Liver Function**: Patients with **liver disease**, particularly those with **hepatic dysfunction**, may require caution, as mesalamine can sometimes affect liver function, especially with long-term use. Monitoring of **liver enzymes** is advisable in these patients. - **Hypersensitivity Reactions**: Mesalamine can cause hypersensitivity reactions, including **fever**, **rash**, and **eosinophilia**. Patients should be monitored for signs of such reactions, and treatment should be discontinued if any severe reactions occur. - **Monitoring**: Routine monitoring should include **renal function** tests (serum creatinine, blood urea nitrogen, and glomerular filtration rate), **liver function tests**, and complete blood counts to assess for potential adverse effects, particularly when using mesalamine for long-term management of inflammatory bowel disease (IBD). - **Misuse or Dependency**: Mesalamine is not known to cause **dependence** or **misuse**. Its primary purpose is for the treatment of **inflammatory bowel diseases**, such as **ulcerative colitis** and **Crohn’s disease**.

Indication

- **Primary Indication**: Mesalamine is primarily used to treat **inflammatory bowel diseases** (IBD), especially **ulcerative colitis**. It works as an **anti-inflammatory** agent in the gut, targeting the colon to reduce **inflammation**, **ulceration**, and other symptoms associated with IBD. - Mesalamine is used in both **acute flares** of **ulcerative colitis** and for **maintenance therapy** to prevent relapses in patients with **remission**. - It can be used to treat **proctitis** (inflammation of the rectum) or **left-sided colitis**, where the inflammation is limited to the descending colon. - **Off-label Uses**: Mesalamine may also be used **off-label** in the treatment of **Crohn's disease**, particularly in cases where inflammation is isolated to the **ileum** or **colon**. While not as commonly used for Crohn's disease, it may still be effective for mild cases or as part of combination therapy. - Mesalamine has also been used to treat other inflammatory gastrointestinal conditions, such as **pouchitis** (inflammation of the ileal pouch after colectomy).

Contra indication

- **Hypersensitivity**: Mesalamine is **contraindicated** in patients who have a known **hypersensitivity** to **mesalamine**, **sulfasalazine**, or any components of the formulation. **Sulfasalazine** is a similar drug that contains mesalamine and can cause **allergic reactions** that may cross-react with mesalamine. - **Severe Renal Impairment**: In patients with **severe renal impairment**, mesalamine should be avoided, as the drug is excreted through the kidneys, and impaired kidney function can lead to toxicity. - **Active GI Bleeding**: In patients with **active gastrointestinal bleeding**, mesalamine should be used with caution or avoided, as the drug may further irritate the gastrointestinal tract and complicate bleeding. - **History of Severe Hepatic Disease**: While mesalamine is generally well-tolerated in most patients, those with a **history of severe hepatic disease** should be carefully monitored, as mesalamine can affect liver function in some cases. - **Age Considerations**: There are no strict **age restrictions** for mesalamine use, but **pediatric patients** (especially infants and young children) should be monitored closely due to potential gastrointestinal side effects and the need for accurate dosing.

Side Effect

- **Common Side Effects**: - **Gastrointestinal**: The most common side effects are related to the gastrointestinal tract, including **nausea**, **vomiting**, **abdominal pain**, and **diarrhea**. These are usually mild and transient, but if they persist, medical consultation is advised. - **Headache**: Some patients experience **headaches**, which may be mild to moderate in severity. - **Rash**: A mild **skin rash** can occur, particularly during the early stages of therapy. - **Serious Side Effects**: - **Renal Toxicity**: One of the more serious side effects of mesalamine is **renal toxicity**, including **interstitial nephritis**, which can present with **fever**, **rash**, **elevated creatinine**, and **blood in the urine**. Regular renal function monitoring is recommended to detect early signs of nephrotoxicity. - **Liver Toxicity**: Although rare, mesalamine can cause **hepatotoxicity** in some patients, which may present as **jaundice**, **abnormal liver enzymes**, or **hepatitis**. - **Myocarditis and Pericarditis**: Rarely, mesalamine has been associated with inflammation of the heart, including **myocarditis** or **pericarditis**, which can present with chest pain, shortness of breath, or palpitations. - **Management of Side Effects**: If **severe side effects** occur, mesalamine should be **discontinued**, and the patient should be evaluated for other treatment options. Mild side effects such as nausea or headache can often be managed symptomatically, and dose adjustments may be necessary.

Pregnancy Category ID

2

Mode of Action

Mesalamine works as an **anti-inflammatory** agent specifically in the **colon**. The precise mechanism of action is not fully understood, but it is believed to inhibit **cyclooxygenase (COX)** enzymes and **lipoxygenase** pathways, leading to a reduction in the production of pro-inflammatory **prostaglandins** and **leukotrienes**. This reduces the inflammation, pain, and ulceration characteristic of conditions like **ulcerative colitis**. - **Localized Action**: Mesalamine is **topically active** in the gastrointestinal tract and specifically targets the inflamed areas of the colon, providing localized anti-inflammatory effects without significant systemic absorption. This is especially beneficial for treating colonic conditions like **ulcerative colitis**. - **Pharmacokinetics**: Mesalamine is poorly absorbed in the upper gastrointestinal tract and is primarily **absorbed in the colon**. Various formulations (e.g., oral, enema, suppository) are designed to deliver the drug to the site of inflammation. **Azo compounds** and other delivery systems allow the mesalamine to be released in the colon for targeted action.

Interaction

- **Drug-Drug Interactions**: - **Azathioprine** or **mercaptopurine**: Concomitant use of mesalamine with **immunosuppressive drugs**, such as azathioprine or mercaptopurine, can increase the risk of **bone marrow suppression** and **myelosuppression**. Caution and close monitoring of blood counts are advised when these drugs are used together. - **Other Anti-inflammatory Drugs**: The use of mesalamine alongside **nonsteroidal anti-inflammatory drugs (NSAIDs)** may increase the risk of **gastrointestinal side effects**, such as **ulcers** or **bleeding**, especially in patients with IBD or a history of gastrointestinal issues. - **Antacids and H2-blockers**: Medications that affect **gastric pH**, such as **antacids** or **H2 receptor antagonists**, may interfere with mesalamine's effectiveness, especially in formulations that release the drug in the colon. - **Food and Alcohol Interactions**: - **Food**: Taking mesalamine with food may **slow down** the absorption slightly but is unlikely to affect its overall effectiveness. In general, mesalamine can be taken with or without food. - **Alcohol**: Alcohol consumption can **irritate** the gastrointestinal tract and may exacerbate symptoms of **ulcerative colitis** or other forms of IBD, potentially undermining the effects of mesalamine. Patients should be advised to limit alcohol intake while on mesalamine therapy.

Pregnancy Category Note

Information not available

Adult Dose

- **Ulcerative Colitis**: - The typical **oral dose** of mesalamine for **active ulcerative colitis** is **4.8 grams per day**, taken in divided doses (usually 1-2 grams 2-3 times per day). - For **maintenance therapy** to prevent relapse, the dose is often **1.6-2.4 grams per day**. - **Rectal Formulations**: For **proctitis** or **left-sided colitis**, **rectal mesalamine** formulations (enemas or suppositories) may be used. The typical dose for **rectal enemas** is **4 grams per night** for 3-6 weeks.

Child Dose

- **Pediatric Dosage**: Mesalamine is used for the treatment of **pediatric ulcerative colitis** in children over the age of **5 years**. The typical starting dose is **30-50 mg/kg/day** for children with active disease, divided into multiple doses. For maintenance therapy, the dose may be reduced to **15-30 mg/kg/day**. - **Rectal formulations** can also be used for pediatric patients, and dosing should be adjusted based on weight and severity of the condition. Mesalamine is a crucial agent in managing inflammatory bowel diseases, offering localized action with a relatively mild side-effect profile. It requires careful monitoring, particularly in terms of renal and liver function, to ensure its safe and effective use.

Renal Dose

- **Renal Impairment**: Mesalamine should be used with caution in patients with **renal dysfunction**. There is no specific renal dose adjustment, but close monitoring of **renal function** (creatinine, glomerular filtration rate) is necessary during treatment. If there is any sign of **nephrotoxicity**, mesalamine should be discontinued.

Administration

Information not available