EN

Pregalin-X SR 75

Quick links

Choose a section

Quick links to important sections

Advertisements

Pregalin-X SR 75

Pregalin-X SR 75_EN
Advertisements
Advertisements

Treatment option:

Advertisements

Overview of Pregalin-X SR 75

Pregalin-X SR 75 is a Fixed-Dose Combination (FDC) medicine, recognized in medical practice for its dual approach to chronic nerve discomfort management. This is a prescription-only oral formulation combining the active ingredients Pregabalin and Mecobalamin.

Pregabalin is classified pharmacologically as an Anticonvulsant, with its action characterized by its specific binding to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. The FDC design distinguishes it from monotherapy agents, offering the benefit of two complementary mechanisms in a single tablet.

Composition, Origin, and Sustained Release (SR) Form

The two primary components of the medication are the synthetic compound Pregabalin and the essential, biologically active Vitamin B12 derivative, Mecobalamin. Mecobalamin is considered important for neurological function and is utilized by the body for maintaining nerve health, a property utilized in B-vitamin metabolism.

The medicine is presented as an oral tablet featuring a Sustained Release (SR) design. This SR formulation is a key differentiator, engineered to provide a controlled, slow rate of release of the active ingredients, which is intended for achieving consistent relief throughout the day.

The General Purpose of This Combination Medicine

The overall purpose of Pregalin-X SR 75 is the targeted management of chronic discomfort and pain arising from nerve damage, commonly known as neuropathic pain. The combination utilizes Pregabalin's capacity to stabilize the abnormal hyperexcitability of damaged nerve cells, thereby reducing persistent pain signals often perceived as shooting or burning sensations.

The integration of Mecobalamin serves a supportive function by providing necessary material for maintaining the health and structural integrity of the nerve sheath, distinguishing this FDC from agents that focus purely on nerve signal modulation.

Advertisements

What side effects are possible with Pregalin-X SR 75?

Possible Side Effects and Safety Information

The safety profile of Pregalin-X SR 75, a fixed-dose combination, is primarily defined by the Pregabalin component, with side effects officially classified by frequency and system-organ class.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped based on regulatory frequency standards. The most common effects are associated with the Nervous System:

  • Very Common (Affecting ge 1 in 10 patients): Dizziness, somnolence (drowsiness).
  • Common (Affecting ge 1 in 100 to < 1 in 10 patients): Peripheral edema (swelling of hands/feet), weight gain, blurred vision, dry mouth, constipation, and feelings of euphoria or confusion.

Serious Adverse Reactions and Class Warnings

Official regulatory documents highlight the potential for Serious Adverse Reactions (SARs). These include Angioedema (swelling of the face, mouth, or throat) and Serious Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome. Additionally, as with other antiepileptic drugs, the official label includes a warning regarding the risk of suicidal behavior and ideation.

Population-Specific Safety Considerations

The prescribing information includes specific notes for certain groups. For Older Adults, there is an increased risk of falls due to dizziness and somnolence. Patients with Renal Impairment require dose adjustment because the drug is primarily cleared by the kidneys. Concomitant use with other CNS depressants may increase the risk of severe respiratory depression.

Discontinuation Note

Regulatory safety protocols stipulate that the medication should be gradually withdrawn over at least one week to reduce the risk of withdrawal symptoms.

Advertisements

Overdose and Emergency Response

The overdose profile for Pregalin-X SR 75 is primarily based on the documented effects of the active component, Pregabalin, as described in official regulatory labeling.

Documented Overdose Manifestations

Acute overdose of the primary component has been associated with central nervous system (CNS) manifestations. These documented signs include somnolence (extreme sleepiness), a confusional state, dizziness, and episodes of agitation or restlessness. More serious manifestations reported in regulatory post-marketing experience include loss of consciousness, seizures, and the occurrence of heart block.

Serious Outcomes and When to Seek Urgent Help

The most critical concerns documented in official statements are respiratory depression (severe breathing difficulties) and the potential for progression to coma or death. These severe outcomes are specifically noted when the medication is consumed in combination with other CNS depressants. Immediate medical attention must be sought for any sign of severe CNS or respiratory involvement, such as difficulty breathing, unresponsiveness, or swelling of the face, throat, or upper airway (angioedema).

Management and Regulatory Constraints

No specific antidote is known for Pregabalin overdose. Management procedures described in official documents are symptomatic and supportive. This includes continuous monitoring of vital signs and consideration of interventions such as gastric lavage or hemodialysis, which can remove the drug from circulation. Official labeling indicates that overdose risk is increased for the elderly and individuals with compromised respiratory function.

Advertisements

Therapeutic Uses of Pregalin-X SR 75

What Pregalin-X SR 75 Treats: Main Uses and Benefits

The core component, Pregabalin, is utilized in the symptomatic management of neuropathic pain, a chronic discomfort arising from nerve damage. Pregalin-X SR 75 is commonly used in the management of chronic nerve discomfort associated with several key conditions, including Diabetic Peripheral Neuropathy (DPN) and Post-Herpetic Neuralgia (nerve pain after shingles).

Targeting Chronic Nerve Pain Conditions

The medication is generally applied in conditions characterized by periods of heightened symptoms such as DPN and persistent pain after shingles. The combination may assist with offering supportive relief during the long-term management of symptoms related to physical discomfort.

Relief of Intense Sensory Manifestations

This combination therapy helps address symptom clusters that may become intense or disruptive, including difficult-to-tolerate manifestations like burning, shooting, or electric shock-like sensations, along with abnormal pain responses such as hypersensitivity. Addressing these pronounced symptoms assists with maintaining functional stability and supports patients during difficult episodes.

Supporting Nerve Health and Function

Beyond symptom control, the Mecobalamin component offers supportive therapeutic benefit relevant for the maintenance of nerve health. This is relevant for conditions where nerve structural support is needed, assisting with the long-term management of nerve damage, which may help patients cope more steadily with symptom fluctuations.

“Supportive management is important when chronic discomfort significantly interferes with daily functioning and rest.”

Quick Fact: Used for Managing Intense Neuropathic Symptoms

Regulatory References

  1. NIH MedlinePlus overview
Advertisements

Eligibility and Restrictions for Use

Eligibility Profile: Official Regulatory Rules

Pregalin-X SR 75 is officially restricted to use in adults (17 years and older) for its labeled indications. The drug's eligibility profile is strictly defined by official regulatory documentation, outlining who is prohibited from use and who requires specific conditions for treatment.

Classification Population or Condition
Absolute Contraindication Patients with a known hypersensitivity to the active substance, Pregabalin, or any of the formulation’s components.
Conditional Use Patients with renal impairment (kidney issues) require mandatory dose adjustment due to the primary pathway of drug elimination. Elderly patients may also require dose reduction due to likely decreased renal function.
Use Not Established Children and adolescents (under 18 years) are generally not recommended to use the medicine for neuropathic pain indications due to insufficient regulatory data on safety and efficacy in these age groups.
Restricted Status Pregnancy and Lactation are restricted. The medicine should not be used during pregnancy unless the physician determines the benefit clearly outweighs the potential risk. Breastfeeding is not recommended as the substance is excreted into human milk.

Women of childbearing potential are officially required to use effective contraception during treatment. Use is generally permitted for patients with hepatic impairment, as no dose adjustment is mandated based on liver function.

Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes official interaction patterns documented in regulatory information, focusing on changes to the drug's effects or absorption. No interactions involving the Cytochrome P450 (CYP) liver enzyme system are expected, as the Pregabalin component is primarily eliminated unchanged by the kidneys.

Pharmacodynamic and Additive Effects

Co-administration with other Central Nervous System (CNS) depressants, including Opioids, Benzodiazepines, and Alcohol, results in an additive pharmacodynamic effect. This significantly increases the risk of severe reactions such as respiratory depression and somnolence. Official documents note that co-use with Opioids is associated with an increased risk of opioid-related death.

Additional additive risks include an increased likelihood of angioedema when combined with ACE-Inhibitors, and an increased risk of peripheral edema or weight gain when combined with Thiazolidinedione antidiabetic agents.

Pharmacokinetic and Absorption Restrictions

  • Mandatory Administration Rule: Due to its Sustained Release (SR) design, the tablet must be taken after the evening meal and not on an empty stomach, as food alters the absorption profile (maximum concentration ( C max) and time to peak ( T max)).
  • Mecobalamin Absorption: Certain medicines, including gastric acid inhibitors, various Antibiotics, and aminosalicylic acid, are documented to reduce the absorption of the Mecobalamin ( B12) component.
  • Population Risk: The risk of severe CNS depression is documented as heightened in elderly patients and individuals with compromised respiratory or renal function.
Advertisements

Mechanism of Action

How Pregalin-X SR 75 Works

Pregalin-X SR 75, which contains pregabalin, exerts its action primarily within the central nervous system (CNS) tissues by selectively engaging a specific molecular target. The active compound binds with high affinity to the alpha-2-delta (alpha2delta) subunit of presynaptic voltage-gated calcium channels (VGCCs).

This specific ligand-protein interaction modulates the function of the calcium channel, leading to a conformational change that results in a reduction of calcium ion ( Ca^2+) influx into the presynaptic terminal upon neuronal depolarization. The decreased Ca^2+ entry acts as a downstream cascade, directly inhibiting the depolarization-induced release of several excitatory neurotransmitters, including glutamate, norepinephrine, and Substance P, into the synaptic cleft.

At a system level, the resulting decrease in excitatory neurotransmitter availability modifies the processing of electrical signals across neuronal pathways. This modulation stabilizes hyperexcitable neural circuits and reduces aberrant signaling transmission in the brain and spinal cord, which is the sole mechanistic consequence described, without reference to clinical outcomes.

Advertisements

Dosage and Administration Information

How to Use Pregalin-X SR 75: Administration Guidelines

Pregalin-X SR 75 contains an extended-release formulation of Pregabalin and is intended to be used according to prescribed instructions to ensure its correct pharmacological effect.

Administration Method and Schedule

Instruction Category Guideline
Route Oral Use (by mouth)
Dosing Frequency Once Daily (QD)
Timing Taken after an evening meal to support the extended-release mechanism.

Handling and Procedural Steps

The extended-release tablet requires specific handling to maintain its function. The tablet must be swallowed whole. It is important not to split, crush, or chew the tablet, as this would alter the slow, controlled release of the medication.

Dose Adjustment and Discontinuation

Specialized dosing protocols are indicated for certain populations:

  • Renal Function: The dose is adjusted for patients with impaired kidney function (renal impairment). The daily dose is determined based on the individual's creatinine clearance.
  • Elderly Patients: Individuals aged 65 and older may require a dose adjustment due to age-related changes in kidney function.
  • Discontinuation: Treatment is not typically stopped abruptly. The dose is usually tapered gradually over a minimum of one week (or at least 7 days) to discontinue the medication.

Instructions for a Missed Dose

If a dose is missed, specific protocols are followed based on when the omission is noticed:

  1. If missed after an evening meal, the dose is taken prior to bedtime following a snack.
  2. If missed before bedtime, the dose is taken following a morning meal.
Advertisements

Recent Clinical Evidence

Research evidence / Overview of studies for Pregalin-X SR 75

This overview describes the types of clinical research that have been conducted for the fixed-dose combination (FDC) of Pregabalin and Mecobalamin, known as Pregalin-X SR 75. It focuses only on what the studies explored, what findings were observed, and what remains uncertain, based on reports from authoritative scientific and regulatory sources.

Research Evidence for Diabetic Peripheral Neuropathy (DPN)

Research on this FDC has explored its use in adults studied for nerve pain related to diabetes. The evidence landscape includes Randomized Controlled Trials (RCTs), though high-quality evidence is primarily focused on the Pregabalin monotherapy. Studies monitored outcomes related to physical discomfort (pain intensity scales) and daily functioning (sleep interference scores).

FDC-specific studies show patterns related to patient-reported outcomes describing perceived discomfort. However, comparative evidence is lacking to define the separate effect of the combination over the monotherapy alone, and long-term effects are not fully established for this indication. Dedicated research is often derived from smaller studies, meaning the results apply only to the populations studied.

Research Evidence for Post-Herpetic Neuralgia (PHN)

Research has explored the FDC in adult patients who experience PHN (pain following a shingles infection). Studies included RCTs and limited comparative studies that monitored how symptoms changed in the observed populations, focusing on outcomes describing episodic or acute changes in symptoms like burning or shooting pain.

Limited comparative studies reported patterns observed in the studies that showed minimal statistical differences in outcomes related to physical discomfort when the FDC was compared to monotherapy. Dedicated comparative evidence is lacking to fully define the separate effect of the Mecobalamin component in this specific context, and long-term outcomes are limited for this group.

Gaps and Areas of Uncertainty in the Research

The research base describes an overall pattern where evidence quality varies across studies. Key points of uncertainty are that long-term effects are not fully established, and comparative evidence is lacking to define the separate effect of the Mecobalamin component in the FDC for all studied neuropathies. Data for vulnerable groups like children and adolescents remain insufficient, indicating where research is ongoing and more data is needed.

Key Studies & References

  1. A Meta-analysis of Randomized Controlled Trials Comparing the Efficacy and Safety of Pregabalin and Gabapentin in the Treatment of Postherpetic Neuralgia
  2. Efficacy and safety of methylcobalamin, alpha lipoic acid and pregabalin combination versus pregabalin monotherapy in improving pain and nerve conduction velocity in type 2 diabetes associated impaired peripheral neuropathic condition. [MAINTAIN]: Results of a pilot study.
  3. Pregabalin - StatPearls [Internet] (Authoritative Review/Monograph on Pregabalin Evidence)
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Pregalin-X SR 75 (FAQ)

Q: What is the difference between Pregalin-X SR 75 and regular Pregalin?

Pregalin-X SR 75 is described in official regulatory documents as a Fixed-Dose Combination medicine. This means it contains two active ingredients: Pregabalin and Mecobalamin (a form of Vitamin B12). It also comes in an Extended-Release (SR) tablet form, which provides a controlled, slow rate of release of the active ingredients over time.

Q: How quickly does Pregalin-X SR 75 start to work?

Studies and official information indicate that for some conditions, improvement in symptoms has been observed as early as the first week after starting treatment. This timeframe reflects observations from clinical studies, and individual response varies.

Q: What is the expected duration of the effect of Pregalin-X SR 75?

The sustained-release (SR) design of the tablet is formulated to release the active ingredients slowly over approximately 24 hours. This mechanism is the basis for its once-daily administration schedule described in official documents.

Q: What happens if I miss a scheduled dose?

Official patient information provides conditional steps for handling missed doses. These instructions detail when the dose should be taken if it is missed after an evening meal or if it is missed before bedtime. These specific instructions, found in the official patient leaflet, should be followed to maintain the treatment regimen.

Q: What research evidence supports the use of Pregalin-X SR 75 for its main purpose?

Clinical trials and controlled studies have primarily examined the use of this fixed-dose combination in adults for nerve pain related to specific conditions. The evidence base includes research on its use for Diabetic Peripheral Neuropathy (DPN) and Post-Herpetic Neuralgia (PHN) (pain following a shingles infection).

Q: Does Pregalin-X SR 75 affect mood?

Yes, official safety documents list potential effects on the nervous system, which include mood-related changes. These commonly reported effects include feelings of euphoria or confusion. Additionally, the official label includes a warning regarding the risk of suicidal behavior and ideation.

Q: Can Pregalin-X SR 75 affect my ability to drive?

The medication is frequently associated with common adverse effects such as dizziness and somnolence (drowsiness). Due to this, official safety information includes a caution regarding driving or operating complex machinery, reflecting the potential impact of these side effects.

Q: Can Pregalin-X SR 75 cause confusion or memory issues?

Official labeling for this medicine includes cognitive side effects as potential adverse reactions. These commonly reported effects include confusion and instances of memory impairment or difficulty with concentration, which are noted to occur more frequently at higher doses.

Q: Can Pregalin-X SR 75 be used for anxiety?

The specific fixed-dose combination (FDC) of Pregalin-X SR 75 may have approved indications focusing on nerve pain. However, the active ingredient, pregabalin, is authorized for the treatment of Generalized Anxiety Disorder (GAD) by some major international regulatory bodies.

Q: Can I take Pregalin-X SR 75 with common over-the-counter pain relievers?

Regulatory interaction data does not indicate a known major interaction between pregabalin (the primary component) and common pain relievers. This includes over-the-counter medicines such as acetaminophen (paracetamol) or ibuprofen.

Q: Are there any specific foods or drinks I need to avoid while on this medication?

Official administration guidelines state that the tablet is taken after an evening meal, which supports the proper absorption of the sustained-release formula. Additionally, co-administration with alcohol is subject to caution, due to the risk of additive central nervous system (CNS) effects.

Q: What is known about long-term use of Pregalin-X SR 75?

Clinical trials on the specific Fixed-Dose Combination (FDC) note that long-term effects are not fully established in the research literature. Official safety guidance focuses on the need for careful, continued patient monitoring and the required gradual withdrawal when stopping treatment.

Q: What is the mechanism by which Pregalin-X SR 75 is thought to act?

The primary active component, pregabalin, works by binding to a specific site on nerve cells in the central nervous system. This action reduces the release of certain chemical signals (neurotransmitters) that can cause the persistent pain signals associated with neuropathic pain.

Q: Is there any research on Pregalin-X SR 75 use in children?

Official regulatory documents indicate that the use of this medicine is not established in children and adolescents (under 18 years) for neuropathic pain indications. This is due to insufficient regulatory data available on the safety and effectiveness for these specific age groups.

Q: Does Pregalin-X SR 75 interact with birth control pills?

Regulatory information and official patient leaflets do not indicate that the active components, pregabalin or mecobalamin, interact with or reduce the effectiveness of oral contraceptives (birth control pills).

Q: Can Pregalin-X SR 75 be used by people with diabetes?

Yes, one of the key conditions studied and regulated for management is nerve pain associated with diabetic peripheral neuropathy (DPN). This indicates that it is a treatment option specifically evaluated for individuals managing diabetes who experience nerve pain.

Q: What is the purpose of the 75 mg strength?

Official dosing guidelines indicate that 75 mg is a common strength used for dose titration in the treatment of neuropathic pain. For some standard dosing regimens, this strength is also used as an initial dose.

Q: Are there any cardiovascular risks associated with Pregalin-X SR 75?

Official safety documents list the adverse effect of peripheral edema (swelling of hands/feet) and weight gain. Since these effects can contribute to fluid retention, official guidance advises caution for patients with existing heart problems.

Q: Can I take Pregalin-X SR 75 if I have liver problems?

The primary component, pregabalin, is eliminated from the body by the kidneys (renal excretion) and is not significantly metabolized by the liver. Therefore, official regulatory guidance indicates that no dose adjustment is typically mandated for patients with liver problems (hepatic impairment).

Q: Are allergic reactions to Pregalin-X SR 75 common?

Official documents note the potential for Serious Adverse Reactions (SARs) such as Angioedema (severe swelling) and Serious Cutaneous Adverse Reactions. However, the frequency classification for these most severe allergic reactions is generally in the uncommon or rare categories.

Q: Is the medication designed for short-term or long-term management?

The drug is officially authorized for the management of chronic conditions like neuropathic pain. This purpose implies that it is intended for a duration of treatment extending beyond acute, short-term use, though long-term effects are still under research.

Q: What is the typical time frame to see full benefits from Pregalin-X SR 75?

Studies indicate that the full benefits of the medicine may not be felt right away. The time required to see the maximum effects can take several weeks or longer for some patients to experience.

Q: What are the reported effects of Pregalin-X SR 75 withdrawal?

Regulatory safety protocols require that the dose be reduced gradually to mitigate withdrawal symptoms. Reported effects following rapid discontinuation include trouble sleeping (insomnia), headache, nausea, diarrhea, and feelings of anxiety or nervousness.

Q: Is Pregalin-X SR 75 addictive or habit-forming?

The main component, pregabalin, is officially classified as a Schedule V controlled substance in the United States. This classification indicates that the medicine has a low potential for abuse compared to other controlled substances, but a potential for misuse and dependence still exists.

Advertisements

How should Pregalin-X SR 75 be stored and disposed of?

Official Storage and Disposal Instructions

Pregalin-X SR 75 (Pregabalin/Mecobalamin extended-release tablets) must be stored and disposed of strictly according to regulatory label requirements to maintain product stability and ensure public safety.

Storage & Disposal Scope Official Regulatory Requirement
Temperature Requirements Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F), generally not exceeding 30 C.
Environmental Protection Keep the container away from excess heat and moisture and protect the product from light.
Packaging Rules Tablets must be kept in the original container and the container must be kept tightly closed.
Child Safety The medication must be kept out of the sight and reach of children in a secure location, as it is a controlled substance.
Disposal Protocol Dispose of unused or expired product using a formal drug take-back program or by following the FDA's method for household trash (mixing with an undesirable substance, sealing, and discarding), as it is not on the flush list.

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

Equivalent of Pregalin-X SR 75 found in:

A-Z Index: