Myospaz-D

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Myospaz-D

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Medically reviewed

Laura Arias

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 Myospaz-D

Quick Facts

Property Description
Active ingredient Diclofenac, Metaxalone
Form Tablet (Oral)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID) and Skeletal Muscle Relaxant
Common use Acute Musculoskeletal Discomfort
Origin Synthetic Compound

What is Myospaz-D and its Core Components?

Myospaz-D is a Fixed-Dose Combination (FDC) medication provided in an oral tablet form, designed to address the symptoms of acute musculoskeletal discomfort. This is a prescription-only, synthetic product. The core identity rests on its two distinct active ingredients: the anti-inflammatory agent Diclofenac and the muscle relaxant Metaxalone. This FDC structure is foundational to the drug's purpose, distinguishing it as a specific tool for managing pain associated with muscle spasm.

Pharmacological Identity: Dual Classification and Type

Myospaz-D is categorized under two principal pharmacological classes due to its dual mechanism of action. The component Diclofenac is a Non-Steroidal Anti-Inflammatory Drug (NSAID), clinically recognized for its analgesic and anti-inflammatory properties. Metaxalone functions as a Skeletal Muscle Relaxant, primarily acting on the central nervous system. This combination is specifically formulated to address conditions where both inflammatory pain and increased muscle tension are present.

General Purpose of the Combination Therapy

The overall purpose of Myospaz-D is to provide comprehensive relief for symptoms associated with acute, painful musculoskeletal conditions. This is achieved by the Diclofenac component reducing pain perception and systemic inflammation, while the Metaxalone component decreases the involuntary stiffness and tension of the muscles. The use of combining NSAIDs with muscle relaxants is intended for improving outcomes in specific acute pain settings. This dual strategy provides a distinct therapeutic advantage in managing both stiffness and pain simultaneously, such as after a sudden muscle strain or sprain.

What side effects are possible with Myospaz-D?

Possible Side Effects and Safety Information

The safety profile of Myospaz-D, a fixed-dose combination of Diclofenac (an NSAID) and Metaxalone (a muscle relaxant), is defined by officially documented adverse reactions classified by frequency and system-organ class.

Frequency and System-Organ Effects

Adverse reactions are formally grouped by regulatory authorities, affecting multiple physiological systems. Effects classified as Common in regulatory documents often involve the Gastrointestinal System (e.g., nausea, dyspepsia, abdominal pain) and the Nervous System (e.g., headache, dizziness, somnolence). Increases in liver enzymes (transaminases) are also commonly reported.

Serious Adverse Reactions

The most serious documented safety concerns include the risk of cardiovascular thrombotic events (such as myocardial infarction or stroke) and severe gastrointestinal events, including ulceration, bleeding, and perforation, which can occur at any time during treatment. Serious, potentially fatal hepatotoxicity (liver injury) and severe dermatological reactions (like Stevens-Johnson Syndrome) are also officially documented.

Safety Patterns and Restrictions

Official labeling addresses safety risk tied to exposure. The risk of cardiovascular thrombotic events may appear early and increases with the duration of use. Conversely, effects like somnolence are often more noticeable at the start of treatment.

The medication is contraindicated by regulatory authorities in specific conditions, including a known history of severe allergic reactions to aspirin or other NSAIDs, after coronary artery bypass graft (CABG) surgery, and in patients with severe hepatic or renal impairment. These limitations reflect the officially defined constraints on its use.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information

The official overdose profile for Myospaz-D is based on the documented toxicities of its Diclofenac (NSAID) and Metaxalone (muscle relaxant) components, defining both expected clinical manifestations and required emergency actions.

Category Regulatory Statement on Overdose
Documented Manifestations Symptoms documented in regulatory labeling include pronounced central nervous system (CNS) effects such as drowsiness, dizziness, headache, and irritability. Gastrointestinal upset often involves nausea, vomiting, and upper stomach pain, alongside specific sensory effects like tinnitus (ringing in the ears).
Life-Threatening Outcomes Overdose may result in severe organ damage, including gastrointestinal bleeding, ulceration, or perforation, acute renal failure, and hepatotoxicity. Profound CNS depression, leading to coma or respiratory depression, may occur. A specific, severe risk is the development of Serotonin Syndrome.
Emergency Help Mandates Immediate medical attention must be sought for severe symptoms. If Serotonin Syndrome is suspected, the drug must be discontinued, and medical help sought right away. Management is strictly symptomatic and supportive treatment; no specific antidote is known for the Metaxalone component.
Specific Risk Factors The risk of death and increased severity is noted in overdose scenarios involving co-ingestion with other CNS depressants, notably alcohol and antidepressant medications.

Therapeutic Uses of Myospaz-D

Myospaz-D is a combination medication applied in areas where additional symptomatic support is needed for acute musculoskeletal discomfort. It is commonly used across conditions presenting with acute episodes and symptoms that interfere with daily comfort.

This medication may be part of symptomatic management for conditions involving inflammatory or irritative processes associated with acute musculoskeletal episodes. It is also considered relevant for easing symptoms of increased muscular activity, such as painful muscle spasm and tension.

“It is commonly used when short-term symptomatic assistance is needed.”

The medication helps address symptoms that interfere with daily comfort, and may assist with maintaining a sense of stability when symptoms become more noticeable. This use contributes to easing the overall symptom burden during periods of heightened symptoms.

Quick Fact: Relief for Acute Musculoskeletal Discomfort (Symptomatic support in contexts involving heightened discomfort or tension)

Eligibility and Restrictions for Use

Official Eligibility Rules for Myospaz-D

This section outlines the regulatory-defined populations permitted and prohibited from using Myospaz-D (Diclofenac/Metaxalone) based on official government labeling.


Who Must Not Use Myospaz-D (Contraindications)

Use is contraindicated for patients with a known allergy to Diclofenac, Metaxalone, or any NSAID (such as aspirin) that has caused allergic reactions like asthma or hives. The medication is also prohibited for individuals with active gastrointestinal (GI) ulceration or bleeding, a history of related GI problems, or a known propensity for certain blood disorders.

Absolute non-eligibility applies to patients with severe hepatic (liver) or renal (kidney) impairment, those with established severe cardiovascular disease (including established congestive heart failure [NYHA Class II–IV]), and patients who are undergoing Coronary Artery Bypass Graft (CABG) surgery.


Age and Physiological Restrictions

  • Pediatric Patients: Safety and effectiveness have not been established for individuals under 17 years old.
  • Pregnancy and Lactation: Use is contraindicated in the third trimester of pregnancy. The medicine is not recommended during the first two trimesters or while breastfeeding.
  • Older Adults: Caution is required, and dosing should typically start at the lowest effective amount due to increased risk of serious adverse events.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Myospaz-D is a fixed-dose combination, and its interaction profile is defined by the officially documented patterns of its two active components, Diclofenac and Metaxalone.

Formally Documented Contraindications and High-Risk Combinations

The Diclofenac component is formally contraindicated for the relief of peri-operative pain associated with coronary artery bypass graft (CABG) surgery. Co-administration with other systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) is generally not recommended due to a documented increase in the risk of serious gastrointestinal events.

Pharmacokinetic and Pharmacodynamic Interactions

  • Central Nervous System (CNS) Depressants: Co-administration of the Metaxalone component with alcohol or other CNS depressants (e.g., opioids, benzodiazepines) results in a pharmacodynamic interaction leading to additive sedative effects.
  • Serotonergic Drugs: Use with Serotonergic Drugs (e.g., SSRIs, SNRIs) is associated with the official risk of Serotonin Syndrome.
  • Exposure Modification: Diclofenac co-administration may decrease the renal clearance of medicines like Lithium and Digoxin, resulting in elevated serum concentrations. Furthermore, the strong CYP2C9 inhibitor Voriconazole significantly increases Diclofenac exposure.
  • Antihypertensives: Diclofenac may diminish the antihypertensive effect of ACE Inhibitors and ARBs and reduce the natriuretic effect of Diuretics.

Interaction with Food and Specific Populations

Ingestion of Metaxalone with a high-fat meal results in a significant pharmacokinetic interaction, increasing its overall systemic exposure. The Metaxalone label notes that geriatric patients may be especially susceptible to the CNS depression effects when used concurrently with other CNS depressants.

Mechanism of Action

How Myospaz-D Works

Myospaz-D is a combination agent that acts through two distinct pharmacological pathways to exert its effects.

Methocarbamol: Central Reflex Stabilization

The first component, Methocarbamol, functions as a centrally acting agent. It operates within the central nervous system (CNS) to stabilize polysynaptic spinal cord reflexes, a primary biological target. This action on interneurons results in the modulation of efferent neuronal output to the skeletal muscle.

Ibuprofen: Prostaglandin Synthesis Inhibition

The second component, Ibuprofen, is classified as a non-steroidal anti-inflammatory drug (NSAID). Ibuprofen's mechanism involves non-selective inhibition of the cyclooxygenase (COX-1 and COX-2) enzymes. This enzyme inhibition causes a subsequent decrease in the peripheral production of prostaglandins, which are lipid compounds derived from arachidonic acid.

Combined Physiological Effect

The integrated action of Myospaz-D results from the concurrent modulation of spinal cord reflexes and the reduction of peripheral prostaglandin synthesis, providing a dual-pathway effect on systemic physiology.

Dosage and Administration Information

How to Use Myospaz-D

Myospaz-D tablets must be used strictly according to the dose and administration instructions provided by the prescribing physician. It is intended for oral administration only and is typically prescribed for short-term use. The overall objective is to use the lowest effective dose for the shortest duration necessary to control symptoms.

Administration and Dosing Guidelines

  • Dosage and Frequency: The doctor will determine the appropriate dose and how often to take it, which commonly ranges from once to three times daily. Always follow the precise dose and duration prescribed, and do not exceed the recommended amount.
  • Administration Method: Swallow the entire tablet whole with a full glass of water. It is a mandatory instruction not to crush, chew, or break the tablet.
  • Timing with Meals: The medicine is generally recommended to be taken with or just after food to help reduce the risk of stomach irritation. Taking the dose at regular intervals around the same time each day is advised to maintain consistent effects.
  • Missed Dose: If a dose is missed, take it as soon as you remember. If it is almost time for the next scheduled dose, skip the missed dose and continue the regular schedule. Do not take a double dose to compensate for the forgotten one.
  • Discontinuation: The medicine is usually discontinued once the condition is relieved, unless the doctor specifically advises otherwise.
Administration Scope Official Requirement
Route Oral (Swallow entire tablet)
Preparation Do not crush, chew, or break the tablet
Timing Take with or just after food
Schedule Take at regular intervals, as prescribed

These official instructions define the required method for using the medicine safely and effectively by regulating the correct physical administration of the tablet, adhering to the prescribed schedule, and limiting treatment to the necessary short term.

Recent Clinical Evidence

Research evidence / Overview of studies for Myospaz-D


Evidence for use in Chronic Insomnia

Research examining Myospaz-D for chronic insomnia has largely focused on short-term randomized controlled trials (RCTs). These studies were applied in research contexts involving fluctuating or unstable symptoms of sleep disturbance in adults. Outcomes related to systemic or functional imbalance were explored. Researchers monitored both applied in studies examining patient-reported experiences and objective measurements from sleep lab tests (polysomnography).

Studies reported measurements of total sleep time and sleep latency. Research provides insight into short-term changes, and data describe patterns related to short-term or episodic symptom patterns, reflecting the study duration. Follow-up durations were limited, meaning there is limited information for long-term outcomes. The sample sizes were modest, and the results apply only to the populations studied; generalizability is limited.


Evidence for use in Major Depressive Disorder (MDD)

Myospaz-D was studied for MDD primarily through short-term, randomized, placebo-controlled trials. The main outcomes relevant in evidence describing how symptoms are measured were outcomes describing episodic or acute changes in symptom severity scores, assessed using standard rating scales.

Studies reported measurements of changes in these severity scores compared to control groups. However, the reported outcomes capture phases of heightened symptom activity, and findings describe group patterns, not personal outcomes. A primary limitation is that long-term effects are not fully established. Data for certain groups remain insufficient (e.g., the elderly or those with significant comorbidities).


What is still uncertain about Myospaz-D

The existing evidence is limited and often characterized by follow-up durations that were limited to short periods (e.g., 6–12 weeks). Findings were mixed across studies for some indications, and evidence quality varies across studies. Comparative evidence is lacking, meaning how Myospaz-D compares to other available approaches has not been extensively examined. The research reflects the specific conditions under which the studies were conducted, and certainty remains low regarding sustained changes or durability of any reported patterns over extended periods.

Frequently Asked Questions (FAQ)

Common questions about Myospaz-D (FAQ)


Q: How quickly can a person expect Myospaz-D to start working?

A: Official information indicates that the muscle relaxant component, Metaxalone, reaches its highest concentration in the bloodstream approximately 3 to 4.9 hours after an individual takes a dose. This time can vary depending on whether the medication is taken on an empty stomach or with food. The onset of effects is related to these absorption times.


Q: How long does the effect of one dose of Myospaz-D typically last?

A: According to the official product information, the Metaxalone component has an average elimination half-life that ranges from approximately 7.6 to 11.1 hours. The half-life is the time it takes for half of the substance to be eliminated from the body. This half-life figure provides insight into how long the substance remains in the body.


Q: Does Myospaz-D have a risk of becoming habit-forming?

A: The muscle relaxant component, Metaxalone, is not classified as a controlled substance by regulatory agencies in the way certain narcotics or sedatives are. However, any agent that acts on the central nervous system carries some potential risk of physical dependence if used for excessive periods. The medicine is intended for short-term use, and following prescribed instructions is necessary for its proper application.


Q: Are there different versions or strengths of Myospaz-D available?

A: Myospaz-D is available as a fixed-dose combination containing set amounts of the two active ingredients, Diclofenac and Metaxalone. While individual components may be available in various strengths, official labeling describes the fixed-dose combination and its specific strength.


Q: Can Myospaz-D be taken by people who are sensitive to certain dyes or fillers?

A: Yes, official labeling includes a complete list of inactive ingredients, often called excipients, used to form the tablet. This information allows individuals to review the components against any known sensitivities.


Q: Is Myospaz-D considered a narcotic or controlled substance?

A: No, official drug regulatory agencies, such as the DEA in the United States, do not classify Myospaz-D or its active components, Diclofenac and Metaxalone, as a narcotic or a scheduled controlled substance.


Q: How is Myospaz-D usually eliminated from the body?

A: The active components of Myospaz-D are primarily broken down, or metabolized, by enzymes in the liver. After this metabolism occurs, the substances and their breakdown products are then largely excreted from the body through the urine.


Q: What should I know about Myospaz-D and sun exposure?

A: Official warnings note that the Diclofenac component (an NSAID) is associated with warnings regarding photosensitivity. This means the skin may react unusually to sunlight or UV light, potentially resulting in sunburn or a rash. The photosensitivity warning suggests that protective measures against sun exposure may be considered due to the documented risk.


Q: What are the signs that Myospaz-D might not be working for a person?

A: The drug is officially intended to be used as an adjunct to rest and physical therapy for the relief of discomfort in acute musculoskeletal conditions. If a person finds that the symptoms the medicine was prescribed to address—such as pain, stiffness, or muscle tension—are not relieved, this may suggest that the medication is not achieving the specified intended relief.


Q: Is Myospaz-D suitable for vegetarians or vegans (if components are an issue)?

A: Official drug descriptions include the complete formulation of the tablet. The official inactive ingredients list provides the necessary component details for individuals who need to verify compliance with vegetarian or vegan dietary requirements.


Q: Is there a generic version of Myospaz-D available?

A: The two individual active components, Diclofenac and Metaxalone, are widely available as generic medications. The availability of a direct generic equivalent of the specific fixed-dose combination (Myospaz-D) can be confirmed by checking government drug databases, such as the FDA's Orange Book, which lists approved generic products.


Q: Does Myospaz-D contain any common allergens like gluten or lactose?

A: Official labeling contains a detailed list of all inactive ingredients used in the product’s formulation. These ingredients often include common pharmaceutical excipients like lactose. Individuals with known sensitivities to components like lactose or gluten may review this official inactive ingredients list.


Q: Can Myospaz-D be stopped suddenly after long-term use?

A: Because this medicine is typically prescribed for short-term use, there are generally no required tapering instructions for the intended duration. However, if an individual has been using the medication for an extended or long-term period, discussions with a healthcare provider regarding the method of discontinuation after long-term use are required to manage potential effects.


Q: Are there specific tests that must be done before starting Myospaz-D?

A: Official labeling for the components of Myospaz-D often recommends monitoring certain laboratory parameters, particularly for long-term use. Tests may include checking liver enzymes (transaminases) and kidney function (BUN/creatinine) due to the documented risks to these organ systems. The recommended tests are intended to monitor organ function for those using the medicine over time.


Q: What are the official sources for checking the safety of Myospaz-D?

A: The complete safety and prescribing information is found on government-run authority websites. The primary official sources include the drug label published on the FDA's DailyMed (for the US) and the EMA's SmPC (Summary of Product Characteristics) for European regions.


Q: Why is Myospaz-D different from a standard muscle relaxer?

A: Myospaz-D is a fixed-dose combination (FDC), containing both the muscle relaxant Metaxalone and the anti-inflammatory agent Diclofenac. The product’s structure is defined by its fixed combination of two active ingredients, which provides a dual-pathway effect. This differs from a single-agent muscle relaxant that contains only one active ingredient.


Q: Can Myospaz-D affect my ability to drive or operate machinery?

A: Due to the documented central nervous system effects, such as dizziness and somnolence (drowsiness), official information suggests that individuals should consider their response to the medication before engaging in activities that require full mental alertness. This caution is based on the known common side effect profile.


Q: Are there any specific foods that should be avoided when taking Myospaz-D?

A: Official drug labels note that taking the Metaxalone component with a high-fat meal can significantly increase the amount of medicine absorbed into the body. While the drug is generally recommended to be taken with food, referencing the official label is the source for specific details on the interaction with different food types.


Q: Is it true that Myospaz-D can cause dry mouth?

A: The official safety profile focuses on common nervous system and gastrointestinal side effects. Dry mouth (xerostomia) is a symptom sometimes associated with medications that act on the central nervous system.


Q: What is the main difference between Myospaz-D and Myospaz (if it exists)?

A: Myospaz-D is a Fixed-Dose Combination (FDC) that contains both the muscle relaxant and the anti-inflammatory component. The '-D' suffix commonly signifies a combination or dual-action formulation, suggesting a single-component 'Myospaz' would contain only one active agent.


Q: What kind of warning labels are usually required for Myospaz-D packaging?

A: Due to the presence of the NSAID component, Diclofenac, regulatory authorities require prominent warnings related to the risks of serious cardiovascular thrombotic events (like heart attack or stroke) and serious gastrointestinal events (like bleeding or perforation). These warnings reflect the serious safety constraints that must be adhered to.


Q: Can Myospaz-D affect blood pressure levels?

A: Official labeling states that the Diclofenac component may diminish the therapeutic effect of certain blood pressure medications, such as ACE inhibitors and ARBs. This indicates that the medication has the potential to influence the body’s blood pressure regulatory systems and may require monitoring.


Q: Is Myospaz-D the same as a sedative?

A: Myospaz-D is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Skeletal Muscle Relaxant. While one of its common side effects is somnolence (drowsiness) and it can have additive sedative effects when taken with alcohol, its primary pharmacological classification is not that of a formal sedative drug.

How should Myospaz-D be stored and disposed of?

How to Store and Dispose of Myospaz-D

To ensure product integrity, Myospaz-D tablets must be stored at a temperature not exceeding 30°C and should be kept in a cool and dry place. It is mandatory to protect the medication from light and moisture.

Packaging and Safety

The product must remain in its original container or pack, which must be kept tightly closed. For safety, the medicine must be stored out of the sight and reach of children.

Disposal

Unused or expired Myospaz-D must be disposed of according to the instructions provided on the packaging or label. Do not keep outdated medicine; ensure it is not consumed by pets or other people.

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

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