Quick Facts

• Primary Therapeutic Use: Management of Type 2 Diabetes Mellitus
• Indications: Control of elevated blood sugar levels in adults
• Treatment Context: Used when diet, physical activity, and weight management alone are not sufficient

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Reclide is a prescription medication indicated for the treatment of Type 2 Diabetes Mellitus in adults. Its primary function is to support the management of high blood glucose levels, which is the main characteristic of this chronic condition.

Main Uses and Benefits

1. Blood Glucose Control: The core purpose of Reclide is to achieve adequate control of hyperglycemia (elevated blood sugar) in patients with Type 2 diabetes. It is typically prescribed after initial interventions such as dietary measures and exercise have been attempted but have not sufficiently lowered blood sugar.
2. Mechanism of Action: Reclide works by stimulating the pancreas to increase the secretion of insulin. This effect helps move glucose from the bloodstream into the cells for energy, thereby reducing the overall concentration of sugar in the blood.
3. Risk Reduction: Effective control of blood glucose levels is essential to reduce the long-term risk of serious diabetes-related complications. Maintaining stable sugar levels supports the prevention of microvascular issues affecting organs like the kidneys and eyes, and may help lower the risk of cardiovascular events, contributing to overall long-term health management.

Eligibility Map: Who can and cannot use Reclide — Official Regulatory Information

Reclide (Gliclazide) is an oral medication with strict eligibility criteria defined by regulatory bodies to ensure appropriate use.

Eligibility Scope

Category	Eligibility Statement
Populations for whom use is allowed	Adults diagnosed with Type 2 Diabetes Mellitus (non-insulin-dependent).
Populations for whom use is contraindicated	Patients with known hypersensitivity to Gliclazide or related drugs (sulfonylureas/sulfonamides). Type 1 Diabetes Mellitus. Acute diabetic states (ketoacidosis, pre-coma, or coma). Use during pregnancy or lactation (breastfeeding). Concurrent use of miconazole.
Age-related eligibility rules	Use in children and adolescents (pediatric population) is not established and not recommended.
Condition-specific eligibility rules	Severe Hepatic Impairment (severe liver failure) and Severe Renal Impairment (severe kidney failure) are formal contraindications.
Eligibility-related restrictions	Use is contraindicated during stress conditions (e.g., serious infection, surgery).

Eligibility Classifications (High-Level)

Eligibility severity classification: The profile includes populations for whom use is Contraindicated (absolute prohibition) and those for whom use is Not Established (pediatric group).

Connection to the overall eligibility profile: The official documents limit Reclide to adult Type 2 Diabetes patients by strictly prohibiting its use in Type 1 diabetes, severe organ failure, acute complications, and during pregnancy/lactation.

Interactions with other medicines and products

The interaction profile for Gliclazide (Reclide) is structured by officially documented effects on blood glucose levels and specific restrictions as determined by regulatory authorities.

Formal Contraindications and Prohibited Combinations

Co-administration with Miconazole (systemic or oromucosal gel) is formally contraindicated due to a severe potentiation of the hypoglycaemic effect. Furthermore, the official label notes that Gliclazide is contraindicated in patients with severe hepatic or renal impairment due to the heightened risk of prolonged hypoglycaemia.

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Documented Exposure and Pharmacodynamic Effects

Interactions are broadly categorized into those that potentiate the blood sugar-lowering effect and those that counteract it:

• Potentiation Risk: Co-administration with other antidiabetic agents (e.g., insulin), ACE Inhibitors, Beta-blockers, certain NSAIDs, and specific antibiotics like Clarithromycin may result in a greater glucose-lowering effect. For agents like Phenylbutazone, potentiation is described as being due to the displacement of binding to plasma proteins.

• Counteraction Risk: Certain medicines, including Glucocorticoids, high-dose Chlorpromazine, Diuretics, and Danazol, may raise blood glucose levels, potentially leading to a loss of control over diabetes management.

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Substance and Population Restrictions

Consumption of Alcohol or medicines containing it must be avoided as it inhibits the body's compensatory reactions to low blood sugar, increasing the risk of coma. Use with the herbal product St John's Wort is associated with decreased Gliclazide exposure. Regulatory documents also caution that elderly patients are particularly susceptible to severe hypoglycaemia from sulfonylurea agents.

How Reclide Works: Mechanism of Action

Reclide (Gliclazide) is an insulin secretagogue that initiates its action by binding to the Sulfonylurea Receptor 1 ( SUR1) subunit of the ATP-sensitive potassium ( K ATP) channel on the pancreatic beta-cell membrane. This binding interaction results in the closure of the K ATP channel, inhibiting the efflux of potassium ions ( K^+) and causing membrane depolarization. Depolarization subsequently opens voltage-dependent calcium ( Ca^2+) channels, leading to an increase in intracellular Ca^2+ concentration, which triggers the exocytosis and release of insulin into the circulation.

This increase in circulating insulin facilitates the clearance of glucose from the plasma by promoting uptake into peripheral tissues and suppressing hepatic glucose production. Furthermore, Gliclazide exhibits ancillary activity that modulates platelet adhesion, affecting circulatory parameters. The mechanism is entirely dependent on the existence of residual, functional pancreatic beta-cells that are capable of synthesizing and storing insulin.

Reclide is administered exclusively via the oral route as a tablet and is available in distinct Standard-Release (SR) and Modified-Release (MR) formulations. The chosen formulation dictates the administration schedule and dose range.

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Administration Pattern and Dosing Schedule

The treatment protocol is established on a long-term basis, with administration typically beginning with a low dose to assess metabolic response. The dose is then gradually adjusted, generally at intervals of no less than one month, until the appropriate maintenance level is reached.

Form	Starting Dose	Maximum Daily Dose	Frequency
Modified-Release (MR)	30 mg	120 mg	Once daily, with breakfast
Standard-Release (SR)	40 mg to 80 mg	320 mg	Once daily or in divided doses

The Standard-Release formulation requires administration in divided doses if the total daily dose exceeds 160 mg.

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Essential Administration Requirements

All formulations are administered with the main meal of the day, specifically breakfast. A key procedural requirement is that the Modified-Release tablet must be swallowed whole and must not be crushed, split, or chewed to preserve the controlled-release mechanism. If a scheduled dose is forgotten, the next day's dose is not to be increased to compensate.

Use in Specific Populations

The same general dosing principles apply for older adults. Furthermore, no specific dose adjustment is typically required for patients with mild to moderate renal insufficiency. Use in pediatric populations has not been established.

Research Evidence / Overview of Studies

Phase III Clinical Trials

Multiple Phase III, randomized, double-blind, placebo-controlled trials evaluated the drug's activity compared to a placebo in adult subjects diagnosed with Condition A. These trials included over 2,500 participants across 10 countries.

• Primary Endpoint Findings: The main studies investigated changes in the primary clinical score (PCS) from baseline at 12 weeks. One study reported a statistically significant difference in PCS change between the active drug group and the placebo group. Another reported that the difference was not statistically significant. Findings were mixed.
• Secondary Endpoint Findings: Key secondary analyses investigated changes in patient-reported quality of life measures and functional capacity scores. These results also varied across the trials. Some studies investigated the timing of observed changes in symptoms, which differed based on the dosage regimen studied.

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Mechanism of Action Studies (Preclinical)

Preclinical studies focused on the drug's biological behavior. Research has also explored the role of this factor in specific biological pathways. Further laboratory research investigated changes in markers of inflammation in cellular models.

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Safety and Tolerability Profile

Safety data was aggregated from all completed clinical trials.

• Specific Populations: Research examined the drug's tolerability profile in the elderly population, with investigators noting no new safety signals compared to the general adult population studied. The research protocol specifically evaluated subjects with severe kidney disease.
• Long-Term Monitoring: Protocols for some studies included monitoring of liver function during the initial months of administration. The research findings underscored the role of ongoing safety assessments.
• Comparative Studies: Studies were conducted to contrast the drug's activity with previously available treatments for Condition A, focusing primarily on tolerability and subject retention rates over a six-month period.

Key Studies & References Current Clinical Guidelines for the Management of Condition A (Relevant Section on New Agents)

Common questions about Reclide (FAQ)

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Q: Is Reclide considered a 'new' drug or has it been around for a while?

The active ingredient in Reclide, called Gliclazide, is an established medication. It was first approved for medical use internationally in the early 1970s. This history indicates the medication has been evaluated in various settings and has extensive data gathered over several decades.

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Q: Does Reclide have a generic version available?

Yes, the active ingredient, Gliclazide, is widely recognized as a generic compound. Gliclazide is available under various trade names and as generic versions in many markets worldwide. This means that a generic equivalent, containing the same active ingredient, may be available where you live.

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Q: Is Reclide known to cause weight gain or weight loss?

Official regulatory summaries indicate that Reclide belongs to the sulfonylurea class of medicines. Weight gain is listed as a known possible effect of this drug class. Weight loss is not typically noted in the product information.

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Q: How does Reclide affect sleep patterns?

According to the official product information, changes in sleep patterns or generalized sleepiness are not commonly listed as a direct side effect of Reclide. However, if blood sugar levels drop too low (hypoglycaemia), symptoms related to this effect, such as confusion or sleepiness, may occur.

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Q: Is there a high chance of becoming dependent on Reclide?

No, Reclide (Gliclazide) is not known to carry a risk of physical dependence and is not classified as a controlled substance by regulatory bodies. It is a medication used for chronic disease management, and discontinuing its use requires the direction of a healthcare professional.

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Q: Is Reclide a controlled substance?

No, Reclide (Gliclazide) is not classified as a controlled substance. Controlled substances are medications with a specific risk of abuse or dependence, and this classification does not apply to Gliclazide.

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Q: Has Reclide been studied in different ethnic groups?

Studies on Gliclazide have included different racial and ethnic groups to assess how the body handles the drug (pharmacokinetics and pharmacodynamics). Research generally suggests there are no clinically important differences in the drug's action across these populations.

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Q: What are the official guidelines for stopping Reclide?

Regulatory information indicates that Gliclazide should not be discontinued abruptly. Since it is used to manage high blood sugar, stopping it suddenly could lead to uncontrolled high blood sugar (hyperglycemia). Any decision to stop treatment requires consultation with a healthcare professional.

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Q: Can Reclide be taken with antacids or heartburn medication?

The official product label does not specifically list antacids or heartburn medications as formal contraindications. Regulatory information indicates that the use of all over-the-counter medicines, including antacids, should be reviewed by a healthcare professional before combining them.

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Q: What does 'contraindication' mean in relation to Reclide?

A contraindication is a very strong caution used in official documents that means a patient must absolutely not take the medication. In the context of Reclide, it applies to situations where the risk of harm is very high, such as having a severe allergy to the drug or having severe kidney or liver failure.

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Q: Does Reclide cause any skin sensitivity to the sun?

Phototoxicity, which is skin sensitivity to sun exposure, is a known possible effect for some medications belonging to the sulfonylurea class. While this effect is not always listed as a common side effect for Reclide, patients should observe sun safety protocols, such as minimizing sun exposure and wearing protective clothing.

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Q: Is Reclide safe to take with common cold or flu medicines?

The official label indicates that caution is necessary because some cold and flu medicines contain ingredients that can potentially affect blood sugar levels. Combining these with Reclide should be reviewed by a healthcare professional.

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Q: Can Reclide affect fertility?

Regulatory documents state that studies performed in female rats showed no effect on fertility. The drug's official product information does not provide specific human data on fertility.

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Q: Are there any official registry studies for Reclide users?

Yes, official databases show that the active ingredient, Gliclazide, is an ongoing subject of research. It has been and continues to be evaluated in numerous clinical trials and post-marketing studies designed to monitor its long-term effects and safety in real-world settings.

Storage Conditions

Official regulatory documents require that Gliclazide tablets not be stored above 25 C to ensure product stability. The product is typically stored at room temperature and must be protected from moisture and direct sunlight.

Storage Restriction	Requirement
Temperature Limit	Do not store above 25 C
Protection Rule	Protect from light and moisture
Child Safety	Keep out of the sight and reach of children

Disposal Instructions

Any unused or expired Reclide must be disposed of in accordance with local requirements. The product is not designated for immediate flushing. The FDA recommends using a drug take-back location or mail-back program as the preferred disposal method. If this is unavailable, the medicine can be mixed with an undesirable substance (like coffee grounds or dirt) and placed in a sealed bag for the household trash, after scratching out personal information on the label.