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Glyciphage SR

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Glyciphage SR

Glyciphage SR_EN

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Glyciphage SR

Quick Facts: Glyciphage SR

Property Description
Active ingredient Metformin hydrochloride
Form Sustained-Release (SR) Oral Tablet
Pharmacological class Biguanide, Anti-hyperglycemic agent
General purpose Improving glycemic control in adults with Type 2 Diabetes Mellitus
Origin Synthetic

What Type of Medicine is Glyciphage SR?

Glyciphage SR is a specific brand of prescription-only, synthetic medicine used for the management of Type 2 Diabetes Mellitus. Its active component is Metformin hydrochloride, which is the established therapeutic substance for this condition. Metformin is classified as a biguanide, belonging to the group of oral anti-diabetic agents that target metabolic function.

This medication is widely recognized as the initial pharmaceutical choice for adults requiring improved metabolic regulation. It is a single-ingredient product designed for use in patients whose sugar levels are not adequately managed by diet and exercise alone.

Understanding the Sustained-Release (SR) Form

The designation SR stands for Sustained-Release (or Extended-Release). This means the oral tablet is engineered with specialized excipients to ensure the Metformin hydrochloride is delivered gradually into the bloodstream over a prolonged period. This dosage form is a differentiating factor, contrasting with immediate-release tablets. The benefit of the SR design—which is often clinically recognized for potentially enhancing patient adherence—is to help maintain consistent drug concentrations throughout the day, aligning with therapeutic goals for steady, predictable medication levels.

How Does This Medication Help with Blood Sugar?

Glyciphage SR’s general purpose is to help patients achieve and maintain better glycemic control by addressing the core issue of metabolic imbalance. As a biguanide, its core physiological action is to improve how the body manages glucose. The Metformin component primarily assists by reducing the excessive sugar production by the liver (hepatic glucose production) and by enhancing the body's response to its own insulin. These combined actions are crucial in stabilizing the metabolic environment that defines Type 2 Diabetes Mellitus.

Regulatory References

  1. MedlinePlus

What side effects are possible with Glyciphage SR?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and regulatory safety information for Glyciphage SR (metformin hydrochloride extended-release), strictly based on official government documents and labeling.

Serious Adverse Reactions and Key Warnings

The most serious safety risk is Lactic Acidosis, a very rare but life-threatening metabolic emergency. This complication is a primary focus of regulatory warnings and necessitates immediate medical attention if symptoms occur. Prolonged use may also be associated with Vitamin B12 deficiency, which, rarely, may lead to megaloblastic anemia.

Frequency-Classified Adverse Reactions

Side effects are categorized by how often they occur:

  • Very Common (Affects more than 1 in 10 people): Gastrointestinal disturbances, including diarrhea, nausea, vomiting, abdominal discomfort, and loss of appetite. These effects are most frequent upon starting treatment and are usually temporary.
  • Common (Affects up to 1 in 10 people): Taste disturbance (metallic taste).
  • Very Rare (Affects less than 1 in 10,000 people): Lactic acidosis, Vitamin B12 deficiency, abnormal liver function tests, hepatitis (reversible upon discontinuation), and skin reactions such as erythema, itching (pruritus), and hives (urticaria).

Safety-Related Restrictions and Limitations

Glyciphage SR must not be used if certain conditions exist, including severe renal impairment (eGFR < 30 mL/ min/1.73 m^2) or active metabolic acidosis. The medicine must be temporarily stopped for certain procedures, specifically before or during any test involving intravascular iodinated contrast agents, and prior to major surgery requiring restricted food/fluid intake. Excessive alcohol intake is restricted during therapy due to the increased risk of lactic acidosis. Special monitoring of kidney function is required for older patients.

Overdose and Emergency Response

Overdosing on Glyciphage SR, which contains metformin, poses a serious risk, primarily due to the potential for a rare but life-threatening condition known as lactic acidosis. This medical emergency occurs when there is an excessive build-up of lactic acid in the bloodstream.

Signs and Symptoms of Lactic Acidosis

Symptoms of lactic acidosis are often non-specific but progress rapidly. Immediate emergency medical attention is required if any of the following signs are observed after taking this medication:

  • Extreme tiredness or weakness
  • Severe nausea, vomiting, or diarrhea
  • Rapid or shallow breathing (hyperpnea)
  • Muscle pain or cramping
  • Unusual abdominal discomfort or pain
  • Feeling cold, dizzy, or lightheaded
  • Slow or irregular heartbeat

When to Seek Help

Call for emergency medical services immediately if an overdose is suspected, even if the person does not yet show symptoms. Since Glyciphage SR is an extended-release formulation, the maximum level of medication in the blood may be delayed, and the onset of severe complications can be deferred. Treatment for a significant overdose focuses on supportive care and the prompt removal of metformin from the body, often requiring specialized procedures such as hemodialysis to correct the severe metabolic acidosis.

Therapeutic Uses of Glyciphage SR

What Glyciphage SR Treats: Main Uses and Benefits

Glyciphage SR is indicated for the long-term management of Type 2 Diabetes Mellitus in adults, a chronic condition characterized by persistent elevated blood glucose levels (hyperglycemia). It is widely considered an initial pharmaceutical choice, used as an adjunct to diet and exercise when non-pharmacological methods alone are insufficient for managing blood glucose levels. The medicine is applied in addressing the symptomatic domain of persistent high blood glucose.

In managing this core symptom pattern, the primary therapeutic goal is to support sustained metabolic regulation and assist with stabilizing blood sugar levels within target ranges. This first-line approach is relevant in clinical scenarios where the severity of metabolic dysregulation requires additional support. The medication is commonly used to help with the associated risk of severe long-term complications linked to chronic high blood sugar, such as complications linked to organ-specific functional stress.

“This supportive therapy may assist with maintaining patient stability during the chronic management phase.”

Relevant indications include Type 2 Diabetes Mellitus, persistent hyperglycemia, and the need for first-line metabolic support.

Quick Fact: Relief for Metabolic Imbalance

Property Description
Primary Indication Type 2 Diabetes Mellitus (Adults)
Symptom Domain Persistent Elevated Blood Glucose
Therapeutic Benefit Supports sustained stabilization of blood sugar
Clinical Context First-line pharmaceutical adjunct to lifestyle changes

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Population Eligibility for Glyciphage SR (Metformin Sustained-Release)

Glyciphage SR is officially approved for use in adults diagnosed with Type 2 Diabetes Mellitus. Eligibility for the medicine is strictly defined by regulatory authorities and centers on the patient’s underlying metabolic health and organ function.

Absolute Contraindications (Must Not Use)

Category Contraindication
Renal Function Severe renal impairment (eGFR below 30 mL/min/1.73 m^2)
Metabolic State Diabetic ketoacidosis or any acute/chronic metabolic acidosis
Other Conditions Hepatic insufficiency, acute unstable heart failure, or acute conditions causing tissue hypoxemia

Age and Restricted Use

Age Group Regulatory Status
Children/Adolescents Safety and effectiveness have not been established in those younger than 18 years of age for this formulation.
Older Adults Use requires caution and more frequent monitoring of renal function. Initiation is generally restricted in patients 80 years of age and older unless normal kidney function is confirmed.

Eligibility also requires temporary discontinuation for specific medical procedures, such as radiological studies using iodinated contrast agents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Glyciphage SR (Metformin hydrochloride) is determined by its elimination pathway and specific pharmacodynamic effects, as described in regulatory documentation.

Contraindicated Combination

Co-administration with Iodinated Contrast Media (radiographic contrast agents) is formally restricted in certain patient populations. Metformin must be temporarily discontinued at the time of, or prior to, the procedure and withheld for at least 48 hours afterward. Resumption is only permitted after stable renal function is confirmed, a restriction intended to mitigate the risk of Metformin accumulation and lactic acidosis.

Pharmacokinetic and Pharmacodynamic Effects

Several medicinal products are documented to increase Metformin exposure by reducing its clearance. These include Transporter Inhibitors such as Cimetidine, Ranolazine, Vandetanib, and Dolutegravir, which inhibit renal tubular transporters. Co-administration may lead to Metformin accumulation.

Excessive alcohol intake is formally documented to potentiate the effect of Metformin on lactate metabolism, significantly increasing the risk of lactic acidosis. Similarly, Carbonic Anhydrase Inhibitors may increase this risk.

In pharmacodynamic interactions, the risk of hypoglycemia is increased when Metformin is used with other Glucose-Lowering Agents, such as insulin or sulfonylureas. Conversely, certain agents like Corticosteroids and Diuretics may reduce the glucose-lowering effect, potentially necessitating closer observation of glycemic control.

Mechanism of Action

Glyciphage SR, containing metformin, is a biguanide that primarily regulates systemic energy metabolism by targeting multiple pathways associated with glucose homeostasis. The drug accumulates preferentially within hepatic cells, where it initiates its main action.

Modulation of Hepatic Glucose Output

Metformin activates AMP-activated protein kinase (AMPK) within the liver, triggering a signaling cascade that suppresses the enzymatic activity required for gluconeogenesis (endogenous glucose production). This pathway modulation results in a decreased rate of glucose release from the hepatic tissue into the circulation.

Enhancement of Peripheral Insulin Sensitivity

In muscle and adipose tissues, metformin modulates the efficiency of insulin signaling. This effect increases the transport and subsequent utilization of glucose substrates by peripheral cells, which helps lower plasma glucose concentrations.

Decreased Intestinal Glucose Absorption

The medication modulates the activity of transporters in the gastrointestinal tract. This action limits the absorption of glucose molecules across the intestinal membrane, thereby modulating the initial nutrient load entering the systemic circulation.

Dosage and Administration Information

Administration Route and Physical Handling

The required route of administration for Glyciphage SR, an Extended-Release (ER) tablet, is strictly oral. The design of the prolonged-release formulation dictates that the tablet must be swallowed whole and must not be crushed, cut, or chewed, a specific instruction necessary to maintain the intended drug delivery mechanism over time.

Standard Dosing and Frequency

The standard usage pattern is once daily (qDay), and standard clinical protocols specify that the dose is to be taken with the evening meal. Treatment for adults typically begins with a starting dose of 500 mg once daily. The dose is then gradually increased, a process known as titration, usually in 500 mg increments every one to two weeks, based on individual response, up to the maximum recommended daily dose of 2000 mg once daily. If a dose is missed, patients should not take two doses on the same day but must resume the usual scheduled amount.

Procedural Constraints

Glyciphage SR is intended for use as part of a long-term management plan. The use of the medication is subject to high-level procedural constraints related to renal function. Specifically, the treatment must be discontinued if the patient’s estimated glomerular filtration rate (eGFR) falls below 30 mL/min/1.73 m^2. A procedural constraint also requires temporary discontinuation at the time of, or prior to, certain radiological studies involving intravascular iodinated contrast.

Recent Clinical Evidence

Research evidence / Overview of studies for Glyciphage SR

This section outlines the types of official research that have explored the use of metformin, the active component in Glyciphage SR, for managing Type 2 Diabetes Mellitus and describes the evidence related to its sustained-release (SR) formulation. The findings describe group patterns observed in studies, not personal outcomes or advice.

Evidence for use in Type 2 Diabetes Mellitus (T2DM) in Adults

Research examining the active ingredient, metformin, focuses on how studies measure changes in the body's management of blood sugar over time. For metformin, the evidence base includes large-scale, long-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies primarily measure changes in Glycated Hemoglobin (HbA1c) and Fasting Plasma Glucose (FPG), which are the standard measurements used in these research settings. The research examined these outcomes for adult populations with T2DM.

These extensive research efforts observed measurement patterns related to measurements of blood sugar levels over many months and years. Long-term follow-up studies, which monitor patients for up to a decade or more, were evaluated in research exploring outcomes related to physical discomfort and systemic or functional imbalance, such as major macrovascular events (like heart attack or stroke) and all-cause mortality. Findings describe patterns observed in the studies related to the measured outcomes for these long-term clinical events.

Comparing Sustained-Release (SR) and Immediate-Release (IR) Formulations

The sustained-release (SR) tablet was evaluated in head-to-head RCTs against the standard immediate-release formulation in patients with T2DM. Research examined the outcomes related to core blood sugar measurements for the SR formulation. Studies that compared the SR and IR formulations reported measurements of comparable changes in the core blood sugar markers (HbA1c and FPG) over defined time intervals, typically lasting up to one year.

Gaps in the Research: What Remains Uncertain

While there is extensive research for the active ingredient, certain scientific questions regarding the specific sustained-release (SR) formulation remain. Comparative evidence is lacking for long-term outcomes of the SR tablet in reducing serious chronic complications, as the most definitive long-term trials used the immediate-release tablet. Follow-up durations were limited in many of the studies that directly compared the SR formulation to the IR formulation; these studies focused on demonstrating similar short-term efficacy rather than long-term clinical differences.

Key Studies & References

  1. Drug Information for Metformin Hydrochloride (Extended-Release)
  2. Type 2 diabetes mellitus: management and monitoring (NICE Guideline NG28)

Frequently Asked Questions (FAQ)

Common questions about Glyciphage SR (FAQ)

Q: Does Glyciphage SR help with weight management?

Glyciphage SR is officially approved for the management of Type 2 Diabetes Mellitus to help improve blood sugar control. The medicine is not officially indicated or approved by regulatory bodies for the purpose of weight management.

Q: Is Glyciphage SR used for conditions other than Type 2 diabetes?

According to the official product information, the approved indication for Glyciphage SR is to improve glycemic control in adults diagnosed with Type 2 Diabetes Mellitus. No other conditions are listed on the official regulatory label for this product.

Q: Can Glyciphage SR cause low blood sugar (hypoglycemia)?

When Glyciphage SR is used as the only medication to control blood sugar (monotherapy), the risk of low blood sugar is generally described in official information as low. However, this risk is significantly increased when the medicine is used in combination with other anti-diabetic agents, such as insulin or a sulfonylurea.

Q: Are older adults more likely to experience side effects from Glyciphage SR?

Official warnings state that the risk of the most serious safety concern, lactic acidosis, increases with patient age (typically 65 years and older) due to the greater likelihood of reduced kidney, liver, or heart function. Regulatory documents mandate more frequent monitoring of kidney function in older adult patients.

Q: How is Glyciphage SR different from other diabetes medicines like sulfonylureas?

Glyciphage SR belongs to a class of medicines called biguanides, which primarily work by reducing the amount of glucose (sugar) produced by the liver. Sulfonylureas are a different class that primarily works by stimulating the pancreas to produce more insulin, offering a different physiological approach to managing blood sugar.

Q: Can Glyciphage SR be taken alongside insulin injections?

Official documents confirm that Glyciphage SR can be used alongside insulin injections. However, the product information notes that using Glyciphage SR with other glucose-lowering agents, including insulin, increases the potential risk of low blood sugar, which may require closer medical monitoring.

Q: What types of allergic reactions are associated with Glyciphage SR?

Official drug labels list certain skin reactions, such as redness (erythema), itching, and hives, as very rare adverse reactions associated with the medicine. Signs of a severe allergic reaction are considered a medical concern that warrants prompt review, as described in official information.

Q: Why do official guidelines stress the importance of diet and exercise while taking Glyciphage SR?

The official product information indicates that Glyciphage SR is prescribed as an adjunct, meaning it is meant to be used in addition to diet and exercise to improve blood sugar control. These lifestyle measures are considered foundational to the management plan for Type 2 Diabetes Mellitus.

Q: Is Glyciphage SR appropriate for pre-diabetic patients?

Glyciphage SR is officially approved for the treatment of Type 2 Diabetes Mellitus in adults. According to the official regulatory label, it is not approved for the treatment or prevention of pre-diabetes.

Q: Does Glyciphage SR interact with common painkillers like ibuprofen?

Official warnings state that the use of Glyciphage SR with nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen may increase the risk of the serious, rare side effect of lactic acidosis.

Q: Does Glyciphage SR cause hair loss?

Hair loss (alopecia) is not listed as a recognized adverse effect in the official prescribing information or regulatory documents for Glyciphage SR.

Q: Can Glyciphage SR impact my liver function tests?

Regulatory documents list abnormal liver function tests and a condition called hepatitis (inflammation of the liver) as very rare adverse reactions. The medicine is contraindicated (must not be used) in patients who have hepatic insufficiency (poor liver function).

Q: Can women who are planning to become pregnant continue taking Glyciphage SR?

Regulatory documents focus on the established risk to the mother and fetus associated with poorly controlled diabetes during pregnancy. Official information emphasizes that maternal blood sugar levels should be well controlled prior to conception and throughout pregnancy. Data are not sufficient to fully inform a drug-associated risk, but the need for close monitoring is emphasized in official guidance.

Q: Why are people asked about their heart health before starting Glyciphage SR?

Heart health is a key factor because one of the absolute contraindications (reasons the drug must not be used) is acute unstable heart failure. This condition increases the patient's risk of lactic acidosis, which is a serious metabolic emergency.

Q: What happens if Glyciphage SR is taken on an empty stomach?

Official instructions specify that Glyciphage SR should be taken once daily with the evening meal. Taking the extended-release formulation on an empty stomach may disrupt its sustained-release mechanism and could increase the risk of gastrointestinal side effects.

Q: Does taking Glyciphage SR affect the risk of cardiovascular events?

Long-term follow-up research for the active ingredient has examined measured outcomes related to chronic complications, including macrovascular events such as heart attack or stroke. Findings describe patterns observed in the studies related to these long-term clinical events.

Q: Is it possible to become resistant to the effects of Glyciphage SR over time?

Clinical evidence from long-term trials supports the medicine's continued effectiveness in improving blood sugar control over many years of use in adults with Type 2 Diabetes Mellitus. The drug remains a foundational medicine for managing this condition over the long term.

Q: Is the medication absorbed differently if I have a history of gastric bypass surgery?

Published clinical research indicates that the absorption and bioavailability of the active ingredient may be higher in patients who have undergone gastric bypass surgery. This change in absorption may require careful consideration when determining appropriate usage.

Q: Are there generic versions of Glyciphage SR available?

Yes, the active ingredient in Glyciphage SR, Metformin hydrochloride extended-release, is widely available from multiple manufacturers as a generic product in many regions. Generic availability is listed in official government drug product lists.

Q: Why is my doctor switching me from immediate-release to Glyciphage SR?

Clinical study overviews indicate that the sustained-release (SR) formulation offers the advantage of once-daily dosing. The SR design has been documented to mitigate the frequency of gastrointestinal side effects compared to the immediate-release version, an effect which is often associated with improved tolerability.

Q: Can Glyciphage SR change the taste of certain foods?

Official drug documents list taste disturbance, specifically the report of a metallic taste, as a common side effect of the medicine. This temporary change in taste perception can affect the perceived flavor of foods.

Q: What is the official classification of Glyciphage SR during pregnancy?

The US FDA is phasing out its numerical pregnancy category system, and the medicine is currently 'Not Assigned' a category. However, other regulatory bodies, like the Australian TGA, have previously classified the active ingredient as Category C.

Q: How does the SR formulation minimize digestive side effects?

The sustained-release design is intended to deliver the active ingredient gradually over a longer period of time. This mechanism of slow, controlled release has been documented in studies to help mitigate the frequency of gastrointestinal side effects compared to the immediate-release formulation.

Q: Is Glyciphage SR a lifelong medication?

According to official product information, Glyciphage SR is intended for use as part of a long-term management plan for Type 2 Diabetes Mellitus. The duration of use is typically determined by the individual's condition and ongoing treatment strategy.

Q: Does Glyciphage SR interact with common cold or flu medicines?

The official drug interactions profile includes warnings about agents that may reduce the medicine's glucose-lowering effect, such as certain corticosteroids and diuretics. These are classes of ingredients that are sometimes found in over-the-counter cold and flu preparations.

Q: What should I know about drug monitoring while taking Glyciphage SR?

Patients taking this medicine require regular monitoring of their kidney function due to potential safety risks. Additionally, for individuals using the medicine over a long period, official guidelines recommend monitoring Vitamin B12 levels.

How should Glyciphage SR be stored and disposed of?

The official storage and disposal requirements for Glyciphage SR (Metformin Hydrochloride Extended-Release) are specified in regulatory documents to maintain the product's quality and ensure public safety.

Storage Conditions

Requirement Official Labeled Mandate
Temperature Range Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F), with excursions permitted up to 30 C [FDA/DailyMed].
Container & Protection Keep in the original container to protect it from moisture and light.
Child Safety Must be stored out of the reach and sight of children.

Disposal Instructions

Regulatory documents state that any unused or expired product must be disposed of in accordance with local requirements for pharmaceutical waste. This includes following instructions from local waste disposal services or a pharmacist regarding proper discard procedures.

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

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