Chang Mei

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Chang Mei

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Method of action: Anti-Inflammatory

Treatment option: Colitis, Colitis,Ulcerative

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Overview of Chang Mei

Quick Facts

Property Description
Active Ingredient Olsalazine Sodium
Form Hard Gelatin Capsule
Pharmacological Class Aminosalicylate (Intestinal Anti-inflammatory Agent)
Common Use Maintenance of remission in Ulcerative Colitis
Origin Synthetic chemical compound (Prodrug)

What is Chang Mei? Definition and Active Ingredient

Chang Mei is the registered trade name for a prescription-only medication whose active ingredient is the synthetic compound Olsalazine (Olsalazine Sodium), delivered for oral use in the form of a hard gelatin capsule. Olsalazine is classified as a specialized prodrug and is chemically synthesized by linking two units of the therapeutically active substance, Mesalamine (5-aminosalicylic acid, or 5-ASA), by an azo linkage. This structure is a differentiating factor, meaning the drug functions as a targeted release system where the inactive molecule remains intact until it reaches the large bowel.

Olsalazine: Its Pharmacological Class and Type

Olsalazine is officially classified as a 5-Aminosalicylic Acid Derivative and is utilized as an intestinal anti-inflammatory agent, falling under the broader pharmacological class of Aminosalicylates. This categorization defines its therapeutic function as a localized agent designed to manage chronic inflammation specifically within the colon. The prodrug mechanism is crucial: the azo bridge is cleaved by enzymes produced by colonic bacteria only upon reaching the large intestine. This mechanism is recognized for ensuring the active anti-inflammatory component is concentrated directly on the inflamed mucosal lining, minimizing systemic exposure.

General Purpose and Benefit of Chang Mei

The general purpose of Chang Mei is to provide highly focused, long-term anti-inflammatory support to the colon. Its primary role is to stabilize the intestinal environment and manage the underlying disease activity associated with chronic inflammatory conditions. The compound is utilized as a maintenance therapy for patients who cannot tolerate sulfasalazine. The benefit of the drug's highly localized action is its utility in the long-term management and maintenance of remission in Ulcerative Colitis, helping to keep the intestinal health stable.

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What side effects are possible with Chang Mei?

Possible Side Effects and Safety Information

The official safety profile for Chang Mei (Olsalazine Sodium) is structured by regulatory bodies to describe documented adverse reactions and necessary safety observations. The medicine is a prodrug converted to mesalamine (5-ASA), and its side effects are categorized primarily by frequency and the physiological system affected.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized based on regulatory clinical data and post-marketing reports:

  • Very Common (ge 1/10): Diarrhea and loose stools are the most frequent effects. This is often noted to be more frequent at the start of treatment or following dose escalation.
  • Common (ge 1/100 to < 1/10): Headache, abdominal pain, nausea, and arthralgia (joint pain) are commonly documented.
  • System-Organ Classes: Documented effects involve Gastrointestinal Disorders, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders.

Serious Adverse Reactions

The label identifies the risk of rare but clinically significant adverse reactions. These include serious Blood Dyscrasias (e.g., Aplastic Anemia), Pericarditis and Myocarditis, severe Hepatic Injury, and Severe Cutaneous Reactions (such as SJS/TEN). These events are generally classified as rare or of unknown frequency based on available data.

Safety Considerations and Restrictions

The official regulatory text specifies certain safety constraints. The medicine is contraindicated in individuals with known hypersensitivity to salicylates or other aminosalicylates. The label advises caution and requires the evaluation of renal function prior to and periodically during therapy, especially in patients with pre-existing renal impairment. Safety evaluation is also required when the medicine is used with other potentially nephrotoxic agents.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for an overdose with Olsalazine Sodium (Chang Mei) is primarily defined by the potential for salicylate toxicity, given its conversion to the active metabolite, mesalamine.

Documented Manifestations and Severe Outcomes

Symptoms officially documented in regulatory labeling may include nausea, vomiting, abdominal pain, diarrhea, and neurological signs such as headache, confusion, dizziness, seizures, and tinnitus. Severe intoxication carries the risk of significant electrolyte and blood pH imbalance, along with potential damage to the renal and hepatic systems, as outlined in official prescribing information.

Required Emergency Actions and Management

Regulatory authorities mandate that proper medical care should be sought immediately if an overdose is suspected. Urgent medical attention is required if severe manifestations occur, such as collapse, trouble breathing, or seizures. No specific antidote is known for Olsalazine overdose. Management is symptomatic and supportive, focusing on gastrointestinal tract decontamination and the correction of fluid and electrolyte imbalances. Monitoring should include checking haematology status, acid-base balance, and liver and kidney function to ensure adequate physiological stability.

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Therapeutic Uses of Chang Mei

What Chang Mei Treats: Main Uses and Benefits

The core therapeutic approach of Chang Mei focuses on managing symptomatic discomfort and supporting functional stability during periods of heightened distress or recurring episodes. Within established therapeutic areas, this approach is utilized for the management of symptoms.

Chang Mei is commonly used across three main domains, including the management of episodic symptom clusters, support during high-tension periods, and assistance with recurrent symptom patterns. This application is intended to help patients cope more steadily with difficult episodes by easing the overall symptom load.

“It provides support that helps ease the overall symptom burden.”

Quick Fact: Support During Noticeable Functional Strain

The medicine is commonly used in clinical scenarios where short-term symptomatic assistance is needed, such as when symptoms create noticeable physiological strain or interfere with routine activities.

Regulatory References

  1. UK MHRA guidance on medicinal claims
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Chang Mei

The following is a summary of the official population eligibility and exclusion rules for Chang Mei (Olsalazine Sodium) as defined in government regulatory documents.

Category Official Regulatory Statement
Populations for whom use is allowed Adult patients for the maintenance of remission in Ulcerative Colitis, provided no absolute contraindications apply.
Populations for whom use is contraindicated Patients with known or suspected hypersensitivity to salicylates, aminosalicylates (or their metabolites, such as mesalamine), or to any excipients in the formulation.
Age-related eligibility rules Pediatric Use: Safety and effectiveness have not been established in children. Geriatric Use: Caution is advised due to the greater frequency of decreased organ function in patients ge65 years.
Condition-specific eligibility rules Renal or Liver Impairment: Use is conditional; risks and benefits must be evaluated, and renal function must be monitored prior to and periodically during therapy.
Pregnancy and lactation eligibility status Pregnancy: Use is restricted and permitted only if the potential benefit justifies the potential risk to the fetus. Lactation: Use is not recommended unless necessary, and discontinuing breastfeeding should be considered due to the excretion of the active metabolite into milk.

The official documents define the user population by establishing absolute non-eligibility through the hypersensitivity contraindication. Beyond this exclusion, eligibility is determined by age, as pediatric use is not established, and by conditional use mandates that require strict monitoring for adults with specific organ function restrictions.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Chang Mei (Olsalazine Sodium) defines several clinically significant interaction patterns, primarily revolving around additive pharmacodynamic effects and potential toxicity due to altered drug clearance.

Documented Interaction Patterns

Interacting Substance/Class Officially Documented Outcome
Myelotoxic Drugs (e.g., Azathioprine, 6-Mercaptopurine) Co-administration may increase the risk for blood disorders, bone marrow failure, and associated complications as noted in regulatory labeling.
Anticoagulants (e.g., Warfarin, LMWHs, Heparinoids) Concurrent use may result in an increased risk of bleeding or increased prothrombin time due to additive effects.
Nephrotoxic Agents (including NSAIDs) May increase the risk of nephrotoxicity because the active component (mesalamine) is substantially excreted by the kidney, impacting clearance.

Administration Restrictions and Specific Notes

A specific timing restriction is required for co-administration with the live varicella vaccine; the drug must be separated and not taken for at least six weeks following vaccination. The regulatory profile emphasizes population-specific concerns: in elderly patients receiving anticoagulants, monitoring of complete blood cell counts and platelet counts should be considered. Similarly, the risk of adverse reactions with concomitant nephrotoxic drugs is greater in patients with known renal impairment. Chang Mei's absorption and exposure are not altered by food; co-administration with meals may mitigate some drug-related adverse effects.

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Mechanism of Action

The mechanism of Chang Mei is centered on the active component, Mesalamine (5-ASA), which utilizes a specialized topical mechanism that modulates inflammatory pathways primarily within the colon.

Targeted Delivery via Prodrug Activation

The initial mechanistic step is the specialized activation of the inert parent compound, Olsalazine, which is designed as a prodrug linking two Mesalamine molecules via an azo bond. This bond is cleaved exclusively by azoreductase enzymes produced by the colonic bacteria . This mechanism ensures that the active moiety is released, achieving a concentrated local release directly onto the mucosal surface of the large intestine, minimizing systemic exposure and concentrating the drug's activity at the site of mucosal contact.


Inhibiting Inflammatory Mediators and Oxidative Damage

Mesalamine acts as an inhibitor of key enzymes, including Cyclooxygenase (COX) and 5-Lipoxygenase (5-LOX), thereby suppressing the synthesis of pro-inflammatory signals like prostaglandins and potent chemoattractant leukotrienes (LTB4). By also engaging in reactive oxygen species scavenging and inhibiting Xanthine Oxidase, the mechanism reduces the generation of destructive free radicals and limits the recruitment of inflammatory white blood cells, which contributes to reduced cellular oxidative damage.


Modulating Gene Expression for Mechanistic Control

The mechanism extends beyond immediate enzyme blockade to include the modulation of gene transcription. Mesalamine activates the nuclear receptor PPAR-gamma and inhibits the activation of the critical transcription factor NF-kappaB. This interference decreases the transcription of genes encoding pro-inflammatory cytokines (e.g., TNF-alpha, IL-1beta) and chemokines, resulting in reduced inflammatory output at the cellular level.

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Dosage and Administration Information

How to Use Chang Mei: Official Administration Guidelines

Chang Mei, which contains Olsalazine Sodium, is an oral medication with administration guidelines provided to ensure correct usage. The official instructions prescribe specific dosing patterns for both maintenance and acute phases of treatment.


Administration Scope

Instruction Category Detail
Route of administration Oral administration using the 250 mg hard gelatin capsule.
Dosing schedule Maintenance: 500 mg taken twice daily (1 gram total per day). Acute: Upward titration from 1 gram daily, over one week, to a maximum of 3 grams daily in divided doses.
Timing in relation to meals Must be taken with food or at the end of meals.
Age-group administration rules The standard adult dose covers older adults (the elderly). Efficacy and safety have not been established in the pediatric population.
Missed-dose rules If a dose is missed, it should be skipped if close to the next scheduled dose; double doses must not be taken.

Procedural Structure

The official protocol dictates a consistent approach to intake. Dosing must be taken in evenly divided doses for both maintenance and acute regimens. Dosing is typically accompanied by the consumption of an adequate amount of fluids throughout the course of treatment. For acute use, the maximum single intake should not exceed 1 gram. The medication is specifically designated for long-term maintenance and a short-term titration period for acute episodes.

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Recent Clinical Evidence

Chang Mei: Recent Clinical Evidence

The research for Chang Mei (Olsalazine Sodium) focuses primarily on its role within the family of 5-Aminosalicylate (5-ASA) medicines, which are frequently studied for managing chronic inflammation in the colon. The research evidence is largely built upon comparisons against placebos and other treatments investigated in the 5-ASA drug class.


Evidence for Use in Maintenance of Remission in Ulcerative Colitis

Extensive research utilizes Randomized Controlled Trials (RCTs) against placebos to examine the prevention of disease recurrence in adult patients already in remission, typically over six to twelve months. Researchers monitored outcomes related to the frequency of clinical or endoscopic relapse. Studies describe patterns related to the measurement of clinical remission and have explored how Chang Mei compares to other 5-ASA compounds, with findings being mixed. Research has also explored the medicine in distinct populations, including patients documented with intolerance to Sulfasalazine.


Research on Active Disease and Symptom Management

Short-term RCTs have also evaluated the medicine for active Ulcerative Colitis (UC) in outpatients, using clinical tools to monitor changes in physical discomfort and symptoms over two to six weeks. This induction research is less extensive, and comparability is limited by differing criteria used to define clinical improvement across trials. The available data primarily focus on adults, with limited information available for pediatric patients.


Long-Term Studies and What is Still Uncertain

The evidence base is concentrated in the intermediate-term range (up to one year). While some open-label, non-controlled follow-up studies have been used to monitor measured outcomes over longer periods, comprehensive data from controlled, long-term studies remains limited, and long-term outcomes are not fully established.

Major limitations noted in the research include the inconsistent comparability between Chang Mei and other similar 5-ASA products. Furthermore, the results apply only to the populations studied, and data for certain groups remain insufficient. Study results reflect the specific conditions under which they were conducted and do not determine whether an individual will respond similarly.

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Frequently Asked Questions (FAQ)

Common questions about Chang Mei (FAQ)


Q: How long does it usually take for Chang Mei to start working?

Chang Mei is specially designed to release its active component, mesalamine, directly onto the mucosal surface of the colon. Regulatory information indicates that the active substance is typically detected in the bloodstream a few hours after a dose. However, the medicine is used for chronic conditions, and clinical studies for active disease management generally observe changes in symptoms over a period of two to six weeks.


Q: What is the current research saying about Chang Mei's effectiveness?

Official clinical studies have established Chang Mei’s effectiveness for the long-term maintenance of remission in Ulcerative Colitis. Research has also explored its use in treating acute, mild-to-moderate forms of the condition, positioning the medicine as a therapeutic option studied within the aminosalicylate drug class.


Q: Does Chang Mei have any known severe side effects mentioned in official documents?

Yes, official regulatory labels include warnings about rare but serious adverse reactions that have been documented. These include severe liver injury, inflammation of the heart or the heart lining (myocarditis and pericarditis), and serious blood dyscrasias, such as aplastic anemia.


Q: Is Chang Mei considered a long-term treatment option?

Yes, official regulatory documents indicate that Chang Mei is specifically approved for the long-term maintenance of remission in adult patients with Ulcerative Colitis. The medicine's role is to stabilize the condition over an extended period.


Q: What is the safety profile of Chang Mei for use during pregnancy?

Official guidelines state that its use during pregnancy is conditional, permitted only when the potential benefit is assessed to justify the potential risk to the fetus. Regulatory documents note that animal studies have indicated potential developmental toxicities.


Q: Does Chang Mei affect a person's ability to drive or operate machinery?

While regulatory labeling does not strictly prohibit these activities, some reported side effects include dizziness and vertigo, which are nervous system effects. Regulatory documents indicate that caution is advised regarding driving or operating machinery if a patient experiences such effects.


Q: What is the generally expected duration of Chang Mei's effects after one use?

Chang Mei is designed to work locally in the colon for its anti-inflammatory effect. Although the parent compound is quickly eliminated, one of its active metabolites, or breakdown products, has been found to remain in the system for an extended period, supporting its overall therapeutic role.


Q: Why is it necessary to take Chang Mei for the full prescribed period?

Chang Mei is primarily prescribed to help maintain remission in a chronic condition. Regulatory guidance describes that Chang Mei is intended for long-term management, and the risk of disease recurrence may be increased if the medicine is not continued for the duration indicated.


Q: Are the side effects worse when first starting Chang Mei?

Official regulatory data indicates that the very common side effect of diarrhea or loose stools is often reported to be more frequent when a patient first starts treatment or after the dosage is increased.


Q: Can Chang Mei be taken by people with kidney issues?

Regulatory guidance advises caution when the medicine is used in people with pre-existing kidney disease, as the active component is substantially cleared by the kidney. Regulatory documents mandate that kidney function must be evaluated prior to and periodically monitored during therapy.


Q: Is Chang Mei a form of antibiotic?

No, Chang Mei is classified as an Aminosalicylate, which is a type of intestinal anti-inflammatory agent. Its primary mechanism of action is focused on modulating inflammatory pathways in the colon, not on killing bacteria like an antibiotic.


Q: Why might a doctor prescribe Chang Mei instead of another medicine?

Clinical evidence has shown Chang Mei to be an effective maintenance therapy for Ulcerative Colitis. Official prescribing information specifically notes that this medicine is a suitable alternative for patients who have documented intolerance to Sulfasalazine, which is another drug in the same class.


Q: Can Chang Mei be used to treat other conditions besides its main approved use?

The medicine is officially approved for the maintenance of remission in Ulcerative Colitis. Regulatory documents generally limit the scope of use to the conditions for which the drug has demonstrated verified safety and effectiveness in controlled clinical trials.


Q: Is Chang Mei a newly approved medicine or has it been around for a while?

Chang Mei (Olsalazine Sodium) is an established compound and is not a newly approved medicine. It has been available and reviewed by regulatory agencies for an extended period, and its safety and efficacy have been confirmed through long-standing clinical experience.


Q: Where can I find the official regulatory information about Chang Mei?

Official prescribing information and patient-friendly data are publicly available from governmental agencies. These include the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) DailyMed, as well as equivalent regulatory bodies in other regions.


Q: What are the most commonly reported reasons for discontinuing Chang Mei?

Regulatory data compiled from clinical trials indicates that the most common reason for patients to stop treatment was diarrhea. This side effect required discontinuation in a small percentage of patients who took the medicine in these studies.


Q: Does Chang Mei contain any form of sugar or gluten?

The official product documentation provides a full listing of all the inactive ingredients, known as excipients, in the formulation. This detailed information is available in the description section of the official label and is used to verify the presence or absence of components like sugar or gluten.


Q: Is Chang Mei available as a generic version?

The active ingredient, Olsalazine Sodium, has been approved by regulatory bodies for use. The availability of generic versions depends on the current status of regulatory approval and patent exclusivity laws in a particular region.


Q: How is the dosage determined for Chang Mei in different patient groups?

Dosage recommendations are established by regulatory authorities based on the condition being treated, such as maintenance of remission or an acute episode. Although older adults must be monitored with caution, the official labeling does not provide specific dosage adjustments based on age or other patient groups.


Q: What is the difference between Chang Mei and a regular vitamin supplement?

Chang Mei is classified as a prescription medicine and an intestinal anti-inflammatory agent, which acts locally in the colon to manage disease activity. A vitamin supplement is generally defined as a dietary product intended to add nutritional value to the diet.


Q: Can older adults use Chang Mei safely?

Official documents state that caution should be exercised when treating older adults due to the increased frequency of decreased organ function, such as in the liver or kidneys. While monitoring is advised, clinical experience has not identified differences in response between the elderly and younger patients overall.


Q: How is the safety of Chang Mei monitored by regulatory agencies?

The safety of Chang Mei is continuously monitored through official post-marketing surveillance programs run by government agencies. These systems collect and evaluate reports of potential side effects and are used to track the long-term safety profile of the medicine.


Q: What should be done if a potential drug interaction is suspected?

Official patient information states that patients should inform their healthcare providers about all other medicines they are using. Regulatory documents list interactions that mandate close clinical monitoring by a healthcare professional.


Q: What are the official sources for patient information about Chang Mei?

Official patient-friendly information is provided in the Patient Information Leaflet (PIL) or Medication Guide. This document accompanies the dispensed medicine and is derived from and consistent with the full prescribing information approved by regulatory bodies.


Q: Is it common for people to switch from a similar drug to Chang Mei?

Clinical evidence has frequently included patients who were intolerant or refractory to Sulfasalazine, a similar drug. This research theme suggests that switching from another aminosalicylate to Chang Mei is a recognized practice for a specific population of patients.


Q: What is the maximum amount of time Chang Mei is usually prescribed for?

Chang Mei is indicated for the long-term maintenance of remission in Ulcerative Colitis, meaning it is intended to be used over an extended and potentially indefinite period, as determined by the prescriber. Long-term safety studies have examined use for up to one year and beyond.


Q: Is it possible to become dependent on Chang Mei?

Chang Mei (Olsalazine Sodium) is officially classified as Not a Controlled Substance by regulatory agencies. Official documents do not indicate that patients develop physical dependence or exhibit withdrawal symptoms upon stopping the medicine.


Q: Is it normal to feel a bit dizzy when starting Chang Mei?

Official reports indicate that dizziness is a nervous system disorder that has been documented in clinical trials as a documented, but less common, side effect. Patients should be aware of this potential effect, especially when first starting treatment.


Q: Are there any specific lifestyle restrictions while taking Chang Mei?

Regulatory data mentions that increased sensitivity of the skin to sunlight, known as photosensitivity, is a reported adverse effect. Due to this potential effect, appropriate sun protection measures are advised.

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How should Chang Mei be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal requirements for Olsalazine Sodium capsules (the active ingredient in Chang Mei) are established by regulatory authorities to ensure product stability and safety.

Storage Conditions

Requirement Specifics
Temperature Store at Controlled Room Temperature: 20 C to 25 C (68 F to 77 F).
Protection Keep the container tightly closed and protected from moisture.
Container Store in the original container.
Child Safety Must be stored out of the reach of children.

Disposal Instructions

Unused or expired medication must be disposed of according to official regulatory guidance. This includes utilizing local drug take-back programs when available. The medication should not be poured down a drain or flushed down a toilet unless the official product label provides explicit instructions to do so.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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