Contramal SR

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Contramal SR

Treatment option: Pain, Chronic Pain

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 Contramal SR

What is Contramal SR?

Contramal SR is a pharmaceutical formulation containing the active ingredient tramadol hydrochloride. It belongs to a class of medications known as opioid analgesics, which are primarily utilized for the management of pain. The "SR" in its name stands for sustained release, indicating that the medication is designed to release the active ingredient gradually into the bloodstream over an extended period.

Mechanism of Action

Tramadol, the core component of Contramal SR, works through a dual mechanism to modify the perception of pain. It acts on the central nervous system by:

  • Binding to mu-opioid receptors: It interacts with specific receptors in the brain and spinal cord to decrease the transmission of pain signals.
  • Inhibiting neurotransmitter reuptake: It inhibits the reuptake of norepinephrine and serotonin, two neurotransmitters involved in the body's natural pain-modulation pathways.

Purpose of the Sustained-Release Formulation

Unlike immediate-release versions of tramadol, which provide rapid but shorter-lived pain relief, the sustained-release mechanism of Contramal SR allows for a steady concentration of the medication to be maintained in the body. This characteristic is typically intended for individuals requiring continuous, around-the-clock management of moderate to moderately severe chronic pain. By providing a prolonged effect, this formulation reduces the frequency of administration compared to standard release tablets.

Regulatory References

  1. MedlinePlus

What side effects are possible with Contramal SR?

Possible side effects and safety information

Contramal SR (Tramadol Hydrochloride) has a safety profile organized by regulatory authorities into frequency categories and body systems affected. The official documentation defines the spectrum of possible adverse reactions from those commonly encountered to rare but serious events.


Frequency-Classified Adverse Reactions

Adverse reactions are formally classified by incidence rate:

  • Very Common (Affects 1 in 10 or more): Nausea, Dizziness.
  • Common (Affects 1 in 10 to 1 in 100): Vomiting, Constipation, Dry mouth, Somnolence (drowsiness), Headache, Sweating, Fatigue.
  • Uncommon to Rare: Less frequent effects include gastrointestinal irritation, cardiovascular disturbances, seizures (convulsions), and changes in mood or sensation.

System-Organ Classes and Serious Safety Concerns

Adverse reactions are systematically grouped across multiple physiological systems, including Nervous System Disorders, Gastrointestinal Disorders, and Psychiatric Disorders. The official label highlights several serious safety concerns inherent to the drug class, including Respiratory Depression, Serotonin Syndrome (a potentially life-threatening reaction), and the risks of Addiction, Dependence, and Abuse.


Safety Constraints and Population Notes

The safety documentation outlines restrictions, such as contraindications in patients with severe respiratory depression or acute intoxication from CNS depressants. Certain adverse effects, such as nausea and dizziness, are reported as more likely to occur during the initial phase of treatment or following dose escalation. Specific safety considerations are noted for older adults and individuals with renal or hepatic impairment due to increased susceptibility to adverse effects.

Overdose and Emergency Response

Overdose and When to Seek Help for Contramal SR

Contramal SR (tramadol sustained release) overdose is a medical emergency that can be life-threatening and potentially fatal. Immediate attention is required if an overdose is suspected.

Overdose presents with severe symptoms primarily affecting the central nervous system and cardiorespiratory function. Documented manifestations include severe respiratory depression, which can lead to inadequate breathing, and progression to coma. Other signs are muscle flaccidity, cold and clammy skin, and significant drops in heart rate and blood pressure.

Risk Factors and Required Actions

Overdose Context Immediate Action Statement
Sustained-Release Risk The tablet must be swallowed whole. Cutting, crushing, or chewing Contramal SR releases a potentially fatal dose of tramadol at once.
Accidental Ingestion Accidental ingestion of even one dose, particularly by a child, is a critical risk and can result in fatal overdose.
Concurrent CNS Depressants Combining this medication with other Central Nervous System depressants, including alcohol, benzodiazepines, or sedatives, drastically increases the risk of profound sedation, respiratory depression, coma, and death.

If overdose symptoms occur, immediately seek emergency medical assistance. Rush the patient to a hospital for emergency intervention. A specific treatment option is naloxone, which may reverse respiratory depression, though it may not fully reverse all other symptoms caused by tramadol overdosage.

Therapeutic Uses of Contramal SR

Contramal SR is a prescription analgesic utilized for the easing of moderate to severe pain, generally applied in situations where supportive, prolonged symptomatic assistance is needed.

This medication is commonly used to help with the management of chronic pain where symptoms demand supportive relief over an extended period. Its use is relevant across conditions characterized by periods of heightened symptoms, such as those conditions presenting with systemic or localized discomfort (e.g., osteoarthritis or chronic lower back pain), and is also applied in acute settings such as postoperative recovery. The sustained-release formula helps maintain a sense of stability when symptoms are more noticeable, assisting with maintaining functional stability.

The medication may be part of symptomatic management in situations where patients experience severe discomfort and alternative options, like NSAIDs, are inadequate or inappropriate. It provides supportive relief when symptoms interfere with routine activities, supports general well-being during symptomatic phases, and supports the patient during difficult episodes by helping to ease discomfort.

“A key aspect of its benefit is providing supportive relief that may assist patients with moderate to severe symptoms in managing their day-to-day comfort.”


Quick Fact: Support for Chronic and Acute Pain Symptoms

Contramal SR is relevant in therapeutic contexts where additional symptomatic support is needed to address symptoms that create noticeable functional strain.

Eligibility and Restrictions for Use

Who Can and Cannot Use Contramal SR?

The eligibility for Contramal SR is strictly defined by official regulatory guidelines, primarily restricting use to adults (18 years of age and older) for the management of chronic, severe pain requiring long-term treatment. Eligibility is determined by age, medical history, and physiological status.

Contramal SR is strictly contraindicated (must not be used) in several populations, including:

  • Pediatric patients younger than 12 years of age in all circumstances.
  • Adolescents younger than 18 years for post-operative pain management following tonsillectomy or adenoidectomy.
  • Patients with significant respiratory depression or acute, severe bronchial asthma.
  • Individuals in a state of acute intoxication with alcohol, hypnotics, or other centrally acting drugs.
  • Patients taking Monoamine Oxidase Inhibitors (MAOIs) or who have taken them within the last 14 days.

Use is generally not recommended for:

  • Patients with severe renal or hepatic impairment due to the risk of delayed elimination.
  • Breastfeeding women and women during labor and delivery.

What should I know about interactions with other medicines?

The official regulatory profile for Contramal SR (Tramadol Hydrochloride) documents several mandatory restrictions and potential drug-drug interactions based on pharmacodynamic and pharmacokinetic mechanisms.

Interaction Scope Official Regulatory Description
Contraindicated Combinations Co-administration is formally prohibited with Monoamine Oxidase Inhibitors (MAOIs), including for 14 days following the last MAOI dose. Alcohol (Ethanol) is also contraindicated due to the regulatory-documented risk of dose dumping from the sustained-release formulation, which can lead to rapid, uncontrolled drug delivery.
Pharmacodynamic Reinforcement Concomitant use with other Central Nervous System (CNS) Depressants (such as benzodiazepines or other opioids) is noted to increase the risk of profound sedation and respiratory depression. Combining with Serotonergic Drugs (e.g., SSRIs, triptans) carries an enhanced risk of adverse reactions, including Serotonin Syndrome and seizures.
Metabolic Pathway Alteration Interaction may occur via the Cytochrome P450 (CYP) enzyme system. CYP2D6 Inhibitors and CYP3A4 Inhibitors are documented to potentially increase tramadol plasma concentrations. Conversely, CYP3A4 Inducers (such as Carbamazepine) are listed as reducing the overall analgesic effect through increased metabolism.
Population-Specific Note The profile highlights a risk in CYP2D6 Ultra-Rapid Metabolizers, where genetic variation leads to an increased rate of conversion to the active metabolite (M1), potentially resulting in life-threatening respiratory depression. Clearance is also documented as delayed in patients with severe renal or hepatic impairment.

Connection to the overall interaction profile: Regulatory documents establish the drug’s interaction structure by classifying strict prohibitions (MAOIs, alcohol) and requiring careful consideration for agents that either enhance the depressant effects or alter the drug's metabolic clearance via the CYP system.

Mechanism of Action

Dual-Mode Action on Central and Spinal Pathways

Contramal SR's mechanism of action is defined by two complementary biological domains that operate in synergy within the central nervous system. This dual approach facilitates the modulation of nociceptive signaling across central and spinal pathways.


Central mu-Opioid Receptor Engagement

This domain covers the drug's activity on the mu-opioid receptor (MOR), a mechanism primarily driven by the active metabolite, O-desmethyltramadol (M1), which requires metabolic conversion by the CYP2D6 enzyme. Activating these receptors initiates a physiological cascade that directly modifies neuronal excitability, resulting in the modification of supraspinal processing of nociceptive input.


Enhancement of Descending Inhibitory Pathways

This domain focuses on the drug's non-opioid action, which involves blocking the reuptake of the neurotransmitters serotonin and norepinephrine from the synaptic cleft. This increases the availability of these monoamines, enhancing the activity of the descending inhibitory pathways. This physiological effect promotes the inhibition of ascending nociceptive transmission at the level of the spinal cord.

Dosage and Administration Information

How to Use Contramal SR

Contramal SR (Tramadol Hydrochloride sustained-release tablets) is administered based on fixed-schedule patterns to provide continuous, long-acting symptomatic relief. The usage instructions are strictly defined, focusing solely on the administrative protocol, not on clinical decision-making or therapeutic claims.


Official Administration Protocol

The approved route of administration is oral, with the tablets designed to be swallowed whole. A critical procedural rule is the absolute instruction not to crush, chew, split, or dissolve the tablets. This preserves the sustained-release (SR) mechanism, which is essential for controlled delivery of the medication over an extended duration.

Usage Parameter Regulatory Principle
Dosing Frequency Typically once daily or twice daily (e.g., 12 hours apart).
Initial Dose A low dose, such as 100 mg once daily, is typically used at the start of treatment.
Maximum Dose The total daily dose should generally not exceed 300 mg per day for the extended-release form in certain regions.
Relation to Food The tablets may be taken with or without food.
Discontinuation The medication should be tapered gradually to stop treatment; abrupt cessation is not advised.

Population-Specific Adjustments

High-level dose adjustments are specified for certain patient groups. For older adults (over 75 years), the dosage interval may need to be extended due to changes in elimination. Furthermore, the use of prolonged-release tablets is generally not recommended in patients with severe renal or hepatic impairment.

Recent Clinical Evidence

Contramal SR: Recent Clinical Evidence

Recent clinical research on the sustained-release (SR) formulation of tramadol, often used for chronic moderate to severe pain, has focused on its efficacy, tolerability over extended periods, and performance compared to other analgesics.


Phase 3 Trials: Primary Endpoints

Research examined primary pain endpoints in adult subjects using large-scale, randomized controlled trials (RCTs). These studies investigated whether the compound was associated with changes in measured pain intensity and functional capacity across various chronic pain conditions.

  • Assessed Administration Levels: Studies assessed varied administration levels. Evidence remains limited regarding the target therapeutic index, though higher assessed levels were associated with reports of gastrointestinal side effects.
  • Duration of Observed Changes: Trials exploring the duration of effect suggested a variability in the time-to-peak change across different studies, reflecting the sustained-release profile designed for extended relief.

Safety and Tolerability Profile

Clinical trials assessed the overall safety and tolerability of the compound. Reported adverse events often included temporary nausea, dizziness, and constipation, particularly during initial therapy.

  • Extended-Period Tolerability: Studies assessed tolerability over extended periods. The reported rates of discontinuation due to adverse events were consistent across the extended-duration studies, supporting the formulation's use in long-term treatment plans.
  • Co-Administration: Research explored interactions with common medications and evaluated whether co-administration altered the metabolism of certain other widely used compounds. Studies also noted that the sustained-release formulation provides a smoother plasma concentration profile compared to immediate-release formulations.

Comparison to Existing Treatments

Research compared the effects of the compound to both placebo and other standard treatments in head-to-head trials. The primary focus was on changes in clinical disease activity scores over time.

  • Head-to-Head Outcomes: In comparisons, the mean change in clinical pain scores for the sustained-release compound was numerically higher than that observed in the placebo group. Comparative studies found the compound's effect on pain relief to be generally similar to that of some non-steroidal anti-inflammatory drugs (NSAIDs) in certain chronic pain populations, though heterogeneity was observed across reviews.

Frequently Asked Questions (FAQ)

Common questions about Contramal SR (FAQ)

Q: What kind of pain is Contramal SR used to treat?

A: According to the official product information, Contramal SR is indicated for the management of moderate to severe pain. It is a sustained-release formulation, which means the active ingredient is released slowly over time to provide long-lasting pain relief.

Q: How does Contramal SR work to relieve pain?

A: Regulatory documents state that the active substance in Contramal SR works as an opioid analgesic. It acts on specific nerve receptors in the central nervous system to reduce the body's perception of pain. Additionally, it affects the levels of certain natural substances like noradrenaline and serotonin in the body, which also play a role in pain control.

Q: Can Contramal SR be used for pain that comes and goes, or only for constant pain?

A: Official product information indicates that Contramal SR is designed for the management of moderate to severe pain that requires continuous, around-the-clock treatment for an extended period. Because it is a sustained-release formulation, it provides consistent relief. This feature means it is typically used for persistent pain rather than pain that requires rapid, short-term management.

Q: Is Contramal SR the same as other pain relievers I can buy without a prescription?

A: According to official sources, Contramal SR is an opioid analgesic and is available only by prescription. It works differently and is used for pain that is more severe than what non-prescription pain relievers are typically designed to treat. Therefore, it belongs to a different class of medicine than many over-the-counter options.

Q: Is it safe to suddenly stop taking Contramal SR after using it for a while?

A: Studies and official information indicate that abruptly stopping Contramal SR after extended use is generally not recommended. Stopping suddenly may lead to withdrawal symptoms and the return of pain. Regulatory guidelines indicate that the dose should be gradually reduced under the direction of a healthcare professional, rather than stopping abruptly.

Q: How long does the pain relief from Contramal SR usually last?

A: Regulatory documents state that Contramal SR is a sustained-release formulation, meaning it is designed to release the medicine slowly to provide pain relief over an extended period. This extended action typically lasts 12 hours, allowing for a less frequent dosing schedule compared to immediate-release formulations.

Q: Can I take Contramal SR with food?

A: According to the official product information, Contramal SR tablets should be swallowed whole with a sufficient amount of liquid. It is indicated that the tablets can be taken independently of meals (with or without food). Official information emphasizes that the sustained-release nature of the tablets requires them to be swallowed whole, not crushed or chewed.

Q: What should I do if I forget to take a dose of Contramal SR?

A: Official information advises on a procedure for missed doses, typically suggesting that a dose be taken as soon as the lapse is noticed. However, if the time for the next scheduled dose is near, the official guidance is usually to skip the missed dose. The product label cautions against taking a double dose to compensate for a missed dose due to the increased risk of adverse effects.

How should Contramal SR be stored and disposed of?

Storage and Disposal of Contramal SR

Contramal SR (tramadol hydrochloride extended-release) must be stored according to regulatory requirements to maintain product stability and ensure public safety.


Storage Requirements

The tablets must be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). The medicine must be kept in its original container, tightly closed, and protected from excess heat and moisture; do not freeze the product. Due to the risk of accidental overdose, store Contramal SR securely, out of the sight and reach of children.


Disposal Instructions

Unused or expired medicine should be disposed of promptly. The preferred method is using a drug take-back program or an authorized collector. If a take-back option is unavailable, some authorities advise mixing the tablets with an undesirable substance, sealing them in a bag, and placing them in the household trash, or, in some cases, flushing them down the toilet to prevent accidental exposure.

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

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