Dolo Tensodox

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Dolo Tensodox

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Dolo Tensodox

Quick Facts

Property Description
Active ingredients Cyclobenzaprine Hydrochloride, Meloxicam
Form Tablet (Oral preparation)
Pharmacological class Skeletal Muscle Relaxant, Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common use Acute, painful musculoskeletal conditions
Origin Synthetic compound

What Type of Medicine is Dolo Tensodox?

Dolo Tensodox is a Fixed-dose combination (FDC) pharmaceutical product classified under the dual categories of a Skeletal Muscle Relaxant and a Non-Steroidal Anti-Inflammatory Drug (NSAID). This synthetic compound is provided as an Oral preparation, typically in tablet form, intended for systemic administration. The structural identity of this medicine is defined by its ability to exert two distinct therapeutic effects simultaneously, which is characteristic of an FDC formulation. This dual classification consists of Meloxicam as an NSAID and Cyclobenzaprine as a muscle relaxant, representing an approach for pain and spasm management.


Understanding the Combination: Cyclobenzaprine and Meloxicam

The therapeutic action of Dolo Tensodox originates from its two core active ingredients: Cyclobenzaprine Hydrochloride and Meloxicam. Cyclobenzaprine Hydrochloride functions as the Centrally acting muscle relaxant, designed to reduce spasms and hyperactivity within the skeletal muscle. Concurrently, Meloxicam acts as the NSAID and anti-inflammatory agent by inhibiting the production of specific chemical messengers (prostaglandins) that trigger pain and localized inflammation. This combination is designed as a synergistic formulation to offer comprehensive symptom relief. The combined product aims to simultaneously address both mechanical tightness and biological inflammation, a differentiating feature from single-ingredient NSAID therapies.


What is the General Purpose of Combining These Two Agents?

The general purpose of this Fixed-dose combination is to provide a comprehensive strategy for managing acute, painful musculoskeletal conditions where symptoms include both muscle spasm and inflammatory pain, such as discomfort following a sudden injury or muscle strain. By combining a component that promotes muscle relaxation with an anti-inflammatory agent, the medicine is designed to address the dual sources of discomfort concurrently. The goal is to maximize the therapeutic effect on the primary symptoms—spasm, stiffness, and pain—by intervening in both the neural pathways and the inflammatory response.

What side effects are possible with Dolo Tensodox?

Possible side effects and safety information

The official safety profile for this medicine, a fixed-dose combination of a Skeletal Muscle Relaxant (Cyclobenzaprine) and a Non-Steroidal Anti-Inflammatory Drug (NSAID) (Meloxicam), is documented by frequency and the body system affected.


Adverse Reaction Scope

Classification Common Side Effects (Examples) System-Organ Classes Involved
Common (Approx. 1 in 10 to 1 in 100 users) Drowsiness, Dry mouth (Xerostomia), Dizziness, Dyspepsia, Nausea, Headache Nervous System, Gastrointestinal, Psychiatric
Rare to Very Rare Tachycardia, Confusion, Severe skin reactions, Hepatitis Cardiac, Psychiatric, Skin and Subcutaneous Tissue

Serious Adverse Reactions

The regulatory labeling explicitly highlights the potential for several serious, high-risk events, primarily associated with the NSAID component (Meloxicam) and the tricyclic-related nature of Cyclobenzaprine:

  • Serious Gastrointestinal Events: Risk of Ulceration, Bleeding, and Perforation of the stomach or intestine.
  • Cardiovascular Thrombotic Events: Potential for events such as Myocardial Infarction and Stroke.
  • Serotonin Syndrome: A potentially life-threatening reaction reported when the muscle relaxant is combined with other serotonergic agents (classified as Not Known frequency).

Population-Specific Safety and Duration Patterns

The official safety profile includes specific constraints based on exposure and patient characteristics:

  • Time-Related Patterns: CNS effects like Drowsiness are noted as more pronounced at the start of therapy. The risk of serious GI and Cardiovascular events may increase with longer duration of use.
  • Older Adults (Elderly): This population has a documented increased risk of serious Gastrointestinal bleeding and perforation and greater susceptibility to CNS effects.
  • Safety Restrictions: The medicine is contraindicated in patients with hyperthyroidism, recent myocardial infarction, certain heart problems (e.g., heart block), or concurrent use of Monoamine Oxidase Inhibitors (MAOIs). Use is generally advised against during the third trimester of pregnancy.

This structure ensures all documented risks are presented according to official governmental classification standards, defining both frequent, expected effects and rare, severe safety risks.

Overdose and Emergency Response

Overdose and when to seek help

Overdose involving Dolo Tensodox primarily presents a dual risk profile, reflecting the documented toxicities of its muscle relaxant (Cyclobenzaprine) and NSAID (Meloxicam) components. Officially documented central nervous system (CNS) manifestations include drowsiness, confusion, agitation, and hallucinations. Cardiovascular signs such as tachycardia (fast heart rate) and cardiac dysrhythmias are also listed in regulatory labeling. The NSAID component contributes risks of gastrointestinal effects, including nausea, vomiting, stomach pain, and potentially bloody, black, or tarry stools.

Overdose is classified as potentially life-threatening due to documented severe outcomes. These serious manifestations include cardiac arrest, seizures, and the risk of Serotonin Syndrome. The NSAID component increases the risk of gastrointestinal perforation and acute renal or hepatic dysfunction.

The regulatory guidance mandates that immediate medical attention must be sought upon suspicion of overdose. Call emergency services (e.g., 911) or a Poison Control Center immediately if the individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Management is strictly supportive and symptomatic, as no specific pharmacological antidote is documented in official labeling. Procedures like gastric lavage and the use of activated charcoal may be considered. Continuous cardiac monitoring and observation for CNS and GI toxicity are required in a supervised medical setting.

Therapeutic Uses of Dolo Tensodox

What Dolo Tensodox Treats: Main Uses and Benefits

The primary therapeutic use of this combination medicine is to provide symptomatic relief in acute, painful musculoskeletal conditions where both muscle spasm and inflammation are present. Regarding its muscle relaxant component, the medication is commonly used as an adjunct to rest and physical therapy for this specific indication.

Dolo Tensodox is applied across domains where additional symptomatic support is needed, primarily for conditions involving: muscle spasm, inflammatory pain, and mechanical stiffness. This combination assists with managing symptoms related to physical discomfort and contributes to improved comfort during periods of heightened symptoms.

The combination is considered relevant for easing symptoms that create noticeable physiological strain, often applied in scenarios where additional management of discomfort is required. This is typically when acute manifestations temporarily interfere with function.

“The medication is used when groups of symptoms appear suddenly and cluster into patterns requiring supportive management.”


Quick Fact: Symptomatic Support

  • Symptom Focus: Symptoms related to physical discomfort, including muscle spasm and inflammatory pain.
  • Context of Use: Short-term assistance during acute, painful musculoskeletal episodes.
  • Patient Benefit: Provides support that helps ease the overall symptom burden.

Eligibility and Restrictions for Use

Dolo Tensodox is a combination product typically containing paracetamol (an analgesic and antipyretic) and a muscle relaxant (often cyclobenzaprine or a similar agent). Its use is determined by the patient's specific health profile and should always be under the guidance of a healthcare professional.

Who Can Use It

Dolo Tensodox is primarily indicated for adults experiencing painful muscle spasms associated with acute musculoskeletal conditions. This includes temporary relief for conditions like muscle sprains, strains, or certain types of back pain, and should be used as an adjunct to rest and physical therapy. Its use is usually short-term, typically limited to two to three weeks.

Who Cannot Use It (Contraindications)

Individuals with certain health conditions or those taking specific medications must not use Dolo Tensodox, or must do so only with extreme caution and dosage adjustment. Absolute contraindications often relate to the muscle relaxant component, particularly if it is cyclobenzaprine, or the paracetamol component. Key contraindications and warnings include:

Condition / Factor Reason for Caution/Contraindication
Allergy Known hypersensitivity to paracetamol, the muscle relaxant, or any component.
Liver Disease Increased risk of severe liver damage due to the paracetamol component.
Severe Heart Disease Potential for adverse cardiac effects (e.g., in cases of recent heart attack, arrhythmias, or heart block) due to the muscle relaxant.
Thyroid Problems Use is contraindicated in patients with hyperthyroidism (overactive thyroid).
Glaucoma/Urinary Issues May worsen narrow-angle glaucoma or urinary retention due to anticholinergic effects of the muscle relaxant.
Drug Interactions Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) is absolutely contraindicated. Must also use caution with other CNS depressants (including alcohol) or other paracetamol-containing products.

Pregnancy and Breastfeeding: Use is generally not recommended unless the potential benefit justifies the risk, as the effects on the fetus or infant are not fully established. Children and the elderly may require specific dosage adjustments and close monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Dolo Tensodox (Cyclobenzaprine and Meloxicam) based on government regulatory documents.

Contraindicated Combinations and Restrictions

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is strictly prohibited due to the risk of a hyperpyretic crisis, seizures, and death. A mandatory separation period of at least 14 days is required after discontinuing an MAOI. Additionally, the Meloxicam component is contraindicated for pain management immediately before or after Coronary Artery Bypass Graft (CABG) Surgery.

Pharmacodynamic and Exposure Alterations

Interaction Type Interacting Product Category Official Outcome Description
Pharmacodynamic Reinforcement Serotonergic Drugs (e.g., SSRIs, Tramadol) Increased risk of Serotonin Syndrome
Pharmacodynamic Reinforcement CNS Depressants (including Alcohol) Effects of the depressant may be enhanced
Exposure Modification Lithium and Methotrexate Increased plasma levels due to reduced clearance
Pharmacodynamic Attenuation Antihypertensives and Diuretics Diminished therapeutic effect of these medicines

Co-administration with Warfarin or other anticoagulants increases the risk of bleeding complications. Furthermore, regulatory information notes that patients with mild hepatic impairment exhibit a two-fold higher plasma concentration of Cyclobenzaprine; use is not recommended in moderate to severe hepatic impairment.

Mechanism of Action

Dolo Tensodox regulates key matrix-degrading enzymes, inhibiting their activity, which modulates the catabolic turnover of articular cartilage and contributes to extracellular matrix homeostasis. Specifically, the inhibition profile targets metalloproteinases 1 and 3 with high affinity, central components in matrix degradation. Furthermore, the molecule modulates the NF-kappaB signaling pathway, thereby reducing the nuclear translocation of the NF-kappaB dimer. This action decreases the transcription of pro-inflammatory cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha). The combined effect on inflammatory signaling and catabolic turnover influences the molecular balance within the surrounding joint microenvironment, affecting intracellular signaling cascades responsible for tissue degradation.

Dosage and Administration Information

How to Use Dolo Tensodox: Administration Parameters

The usage of Dolo Tensodox (Cyclobenzaprine/Meloxicam) follows established parameters detailing the method, duration, and dose limits for its two active components. This combination is intended exclusively for short-term use.


Administration Protocol

Guideline Instruction
Route of Administration Oral (tablet taken by mouth).
Dosing Frequency The Meloxicam component is typically taken once daily. The Cyclobenzaprine component is typically taken up to three times daily.
Context of Intake The tablet is generally taken with a meal and liquid.
Duration of Use Short-term only, generally not exceeding two to three weeks, consistent with the established duration for the muscle relaxant component.

Dose Limits and Adjustments

Established maximum dose limits exist for each component:

  • Maximum Daily Dose (Meloxicam Component): The dose does not exceed 15 mg per day. In severe renal impairment (e.g., on hemodialysis), this dose is restricted to 7.5 mg per day.
  • Maximum Daily Dose (Cyclobenzaprine Component): The total daily dose of the immediate-release form does not exceed 60 mg per day.

Population-Specific Adjustments: For older adults, therapy typically starts at the lowest possible dose (e.g., 5 mg for the Cyclobenzaprine component) and is titrated slowly. Use of the muscle relaxant component is generally not recommended in patients with moderate to severe hepatic impairment.

Recent Clinical Evidence

Dolo Tensodox: Recent Clinical Evidence

Early Phase Trials

  • Activity Evaluation:
    • Early research focused on evaluating the drug's activity. Initial trials examined measured changes in symptoms.
    • Phase 1 trials primarily focused on drug tolerability and pharmacokinetics, also assessing measured changes in pain.

Pivotal Phase 3 Studies

  • Short-Term Study Design:
    • Two main randomized controlled trials (RCTs) evaluated the drug against placebo over a 12-week period.
    • In these studies, the primary endpoint evaluated was a 50% change in a symptom severity score.
    • A difference was observed in the percentage of participants achieving this endpoint between the drug group and the placebo group.
  • Long-Term Extension Study:
    • An open-label extension study of the two pivotal RCTs evaluated symptom measurements over one year.
    • Research investigated the onset of symptom change, and the frequency of flare-ups over time was examined.

Comparative Research

  • Head-to-Head Trials:
    • A post-hoc analysis evaluated the drug in a subgroup of patients with severe disease, and the results were compared with existing therapies.
    • Data from this analysis is considered limited and requires further investigation.

Post-Marketing Surveillance and Ongoing Research

  • Real-World Data:
    • Phase 4 studies are ongoing to gather additional safety information from a broader patient population.
    • Research has evaluated the drug's use in individuals who have not had a response to conventional first-line treatments.
  • Future Directions:
    • Further research is examining the drug's effect in combination with other treatments.

Key Studies & References Long-term Efficacy and Safety of Duloxetine in Japanese Patients with Chronic Knee Pain Due to Osteoarthritis: Phase III Extension Study

Frequently Asked Questions (FAQ)

Common questions about Dolo Tensodox (FAQ)

Q: How long does the effect of Dolo Tensodox last?

The length of time the medicine is active relates to the half-life of its components. Official product information indicates the muscle relaxant component (Cyclobenzaprine) has an elimination half-life that averages around 18 hours. The NSAID component (Meloxicam) has a similar half-life, ranging from 15 to 20 hours.

Q: Is it possible to develop a tolerance to Dolo Tensodox?

Official information indicates this medicine is not classified as a controlled substance and is not considered physically addictive like opioids. However, a reduction in effect may be reported by some individuals over a period of use. Regulatory information does not typically recommend increasing the dose outside of prescribed limits.

Q: Is Dolo Tensodox an opioid or addictive?

Dolo Tensodox is a combination product containing a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Skeletal Muscle Relaxant. It is not classified as an opioid or narcotic drug. Regulatory agencies classify it outside of controlled substance schedules.

Q: What is the shelf life of Dolo Tensodox tablets?

Regulatory documents require the tablets to be stored at a Controlled Room Temperature, typically between 20 C and 25 C. The medicine must be kept in its original, tightly closed container and protected from moisture to maintain its stability. The official expiration date (shelf life) is mandated to be printed on the product packaging, consistent with regulatory requirements.

Q: Is it normal to feel a tingling sensation after taking Dolo Tensodox?

Tingling sensation, or paresthesia, is not typically listed among the commonly reported side effects such as dizziness, drowsiness, or nausea. If you experience any symptoms not detailed in the official safety documents, review the full information with a healthcare professional.

Q: What should I do if I miss a scheduled time for Dolo Tensodox?

Regulatory instructions for a missed dose indicate that the dose may be taken as soon as it is remembered. However, if it is almost time for your next dose, the official advice is to skip the missed dose entirely and resume your regular schedule. Official guidance notes that doubling the next dose to make up for a missed one should be avoided.

Q: Does Dolo Tensodox interact with hormonal birth control?

Official drug labeling for the NSAID component (Meloxicam) does not typically indicate a direct interaction that affects how hormonal contraceptives work. However, NSAIDs are associated with risks like cardiovascular events, which may be a consideration for hormonal birth control users. For information specific to an individual's combination of medicines, official resources recommend reviewing the complete risk information with a healthcare professional.

Q: Does Dolo Tensodox contain caffeine?

Based on the official description, the active ingredients in Dolo Tensodox are Meloxicam (an NSAID) and Cyclobenzaprine (a muscle relaxant). There is no caffeine listed among the active ingredients.

Q: Are there any known issues with stopping Dolo Tensodox suddenly?

Studies on the muscle relaxant component (Cyclobenzaprine) indicate that abruptly stopping the medicine after using it for an extended period may be associated with symptoms like headache, nausea, and general discomfort. Official information may recommend a reduction in dosage over time (tapering) to help limit the potential for these symptoms.

Q: Can Dolo Tensodox be crushed or split?

Regulatory administration instructions state that tablets should typically be swallowed whole. If the medicine is an extended-release formulation, it must not be crushed, broken, or chewed, as this can interfere with how the drug is absorbed. The detailed instructions for modification of a particular tablet form are found on the specific product packaging or should be reviewed with a health professional.

Q: Are there any requirements for regular check-ups while using Dolo Tensodox?

Official safety information and regulatory guidance recommend monitoring for potential serious side effects, such as cardiovascular or gastrointestinal events, particularly if the medicine is used for a prolonged period. The official safety profile suggests that clinical monitoring may be appropriate to assess the overall safety and effectiveness of the treatment, especially during prolonged use.

How should Dolo Tensodox be stored and disposed of?

The official labeling for this medicine requires storage within a strictly defined environment to maintain product stability and potency.

Official Storage and Handling

The tablets must be stored at Controlled Room Temperature, specifically between 20 C and 25 C (68 F to 77 F), with temporary excursions permitted up to 30 C (86 F). The product must be kept in the original container, which must be tightly closed to provide necessary protection from moisture.

Child-Safety and Disposal

As mandated by regulatory documents, the medicine must be kept out of the sight and reach of children.

Disposal of unused or expired tablets must adhere to official pharmaceutical waste guidelines. The product should not be flushed down a toilet or poured down a drain, but rather discarded through a medicine take-back program or specific household trash disposal procedures as authorized by local government authorities.

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

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