Dol P

Quick links to important sections

Dol P

Treatment option:

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 Dol P

Quick Facts

Property Description
Active ingredients Tramadol Hydrochloride, Paracetamol (Acetaminophen)
Form Film-Coated Tablet (Oral dosage form)
Pharmacological class Opioid/Non-opioid Analgesic Combination
Common use Relief from moderate to severe pain
Origin Synthetic compound (Tramadol)

What Type of Analgesic is Dol P?

Dol P is a pharmaceutical preparation classified as a centrally acting analgesic of the fixed-dose combination product type. It is a prescription-only medicine, meaning its acquisition requires authorization from a healthcare professional. The drug is categorized as an Opioid Analgesic and Non-opioid Analgesic Combination. This designation reflects the medicine's structure, which intentionally combines agents from two distinct pharmacological classes to create a unified approach to pain management. It is used for its role in managing pain that is not adequately controlled by simpler analgesic interventions alone.


Composition, Origin, and Dosage Form

The core of Dol P's efficacy relies on its two active ingredients: Tramadol Hydrochloride and Paracetamol. Tramadol is a synthetic compound that works within the central nervous system, while Paracetamol is a widely utilized non-opioid pain reliever. The combination of these two agents is intended to achieve enhanced pain relief compared to administering them individually. The medicine is commonly supplied as an oral dosage form, specifically a Film-Coated Tablet, which facilitates the oral route of administration and ensures the simultaneous delivery of the fixed dose of both agents for systemic absorption.


General Purpose and Unique Analgesic Profile

The primary general indication of Dol P is providing effective relief from moderate to severe pain. The drug achieves this through a multimodal mechanism of action, where the analgesic effects of the Tramadol component (which involves mu-opioid receptor agonism) complement the action of Paracetamol. This combination strategy creates an analgesic potency known as synergy, making the preparation a tool for managing acute pain episodes or chronic conditions where pain intensity warrants such a combination. This profile distinguishes it from single-entity analgesics, which address pain via a single mechanism.

What side effects are possible with Dol P?

Possible Side Effects and Safety Information

The official regulatory safety profile for the Tramadol/Paracetamol combination (Dol P) classifies potential adverse reactions based on their frequency and the body systems they affect.

Frequency-Classified Adverse Reactions

The most frequently documented side effects are classified as Very Common or Common in regulatory documents. Very Common reactions (affecting more than 1 in 10 people) typically include nausea, dizziness, and somnolence (drowsiness). Reactions classified as Common (affecting up to 1 in 10 people) include vomiting, constipation, dry mouth, headache, confusion, and increased sweating.

Less frequently reported reactions, categorized as Uncommon or Rare, involve other system-organ classes, such as the cardiovascular system (e.g., hypotension) and the nervous system (e.g., convulsions, syncope, or speech disorders).

Serious Adverse Reactions and Safety Constraints

Official labeling highlights the risk of several serious adverse reactions. These include life-threatening respiratory depression and the potential for acute liver failure (hepatotoxicity), which is primarily associated with the paracetamol component. The risk of Serotonin Syndrome and the development of Opioid Use Disorder (addiction/dependence) is also documented.

Specific safety constraints are defined for certain patient populations. The medicine is formally contraindicated in individuals with severe hepatic impairment and is generally not recommended in those with severe renal impairment or in children under 12 years of age. Furthermore, regulatory documents note that withdrawal symptoms may occur if the medicine is discontinued abruptly.

Overdose and Emergency Response

Overdose and when to seek help

The overdose profile for Dol P (Tramadol and Paracetamol) is characterized by a dual toxicity risk derived from its two active components. Immediate medical attention is essential for any suspected overdose scenario, even if initial symptoms are not yet apparent, as mandated by regulatory authorities. The primary life-threatening risks documented in official prescribing information are respiratory depression and acute hepatic failure.

Overdose manifestations of the Tramadol component include profound sedation, miosis (pinpoint pupils), seizures, and the risk of respiratory arrest and cardiovascular collapse. Overdose of the Paracetamol component initially presents with non-specific signs like nausea, vomiting, and abdominal pain, which can rapidly progress to severe hepatotoxicity potentially leading to coma and death.

Official regulatory documents require immediate referral to a specialized unit. The management protocol includes using Naloxone for opioid-induced respiratory depression and N-acetyl cysteine (NAC) as the antidote for Paracetamol toxicity. Hospital monitoring, including hepatic tests, is required. Special caution is noted for young children and patients with non-cirrhotic alcoholic liver disease, who are at increased risk of severe outcomes.

Therapeutic Uses of Dol P

What Dol P Treats: Main Uses and Benefits

Dol P is commonly used to help provide supportive relief for pain symptoms of moderate to severe intensity. It is generally applied in contexts where additional support for symptom management is needed because simpler, non-opioid pain relievers have not adequately controlled the patient's discomfort.

This combination is relevant in clinical settings marked by heightened patient distress following procedures or acute injury, and is commonly used across conditions presenting with episodic or fluctuating symptom patterns, such as osteoarthritis flare-ups or challenging chronic lower back pain. The medication is applicable when groups of symptoms appear suddenly or intensify quickly, and is commonly used to help ease the overall symptom burden. It is relevant for managing symptoms that interfere with daily comfort, and may help patients cope more steadily with difficult episodes.

Quick Fact: Relief for Pronounced Discomfort
Typical Severity: Moderate to severe pain intensity
Common Scenarios: Post-operative recovery, chronic pain exacerbations
Primary Benefit: Provides additional symptomatic assistance

Eligibility and Restrictions for Use

Dol P's eligibility profile is strictly defined by regulatory authorities. Use is established for adults and adolescents 12 years and older for moderate to severe pain requiring a combination analgesic.

Contraindicated Populations

Absolute Contraindications mean the medicine must not be used in several populations. This includes children younger than 12 years of age, and those under 18 years following tonsillectomy or adenoidectomy. Other absolute exclusions are patients with severe hepatic impairment, significant respiratory depression or acute severe asthma, or those receiving Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of cessation. Use is also contraindicated in those with known hypersensitivity to the components.

Restricted and Conditional Use

Eligibility is restricted or conditional for specific groups. Patients with moderate renal impairment or those over 75 years require mandated adjustment: the dosage interval must be extended as outlined in the official prescribing information. The medicine is also not recommended for use during pregnancy or lactation due to potential risks to the fetus or infant.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define several strict interaction patterns and restrictions for this combination medicine. The product is formally contraindicated for co-administration with Monoamine Oxidase Inhibitors (MAOIs); a mandatory 14-day separation is required following the withdrawal of an MAOI. The medicine is also prohibited from co-use with any other medicinal product containing tramadol or paracetamol to prevent component overdose.

Clinically significant pharmacodynamic reinforcement exists with co-administered Central Nervous System (CNS) depressants (e.g., opioids, sedatives) due to the documented risk of severe additive effects. Use with other serotonergic agents (e.g., SSRIs, triptans) is restricted because it increases the specific risk of Serotonin Syndrome and may lower the seizure threshold.

Pharmacokinetic interactions are documented through CYP enzymes. Co-administration with CYP2D6 Inhibitors (e.g., quinidine) or CYP3A4 Inhibitors (e.g., ketoconazole) is officially documented to increase tramadol exposure while decreasing the active metabolite. Conversely, CYP3A4 Inducers (e.g., carbamazepine) may reduce exposure. The combination has also been reported to alter the anticoagulant effect of warfarin and other coumarin derivatives, specifically causing an increase in Prothrombin Time/INR.

Interaction constraints include the use of alcohol (ethanol), which enhances CNS depressant effects. For the elderly (over 75), the official regulatory text mandates considering a minimum dose interval of no less than six hours.

Mechanism of Action

How Dol P Works

Dol P exerts its pharmacodynamic synergy by combining two agents that modulate distinct, complementary signaling pathways predominantly within the central nervous system ( CNS). This dual strategy results in attenuated nociceptive signal transmission and elevation of the central pain threshold.

Dual Modulation of Nociceptive Signals

The Tramadol component acts on two separate systems. Its active metabolite engages the mu-opioid receptor, reducing excitatory signaling between neurons. Simultaneously, the parent drug inhibits the reuptake of the neurotransmitters serotonin and norepinephrine in the spinal cord. This dual action functionally reinforces the descending inhibitory pain pathway, contributing to enhanced physiological attenuation of nociceptive signal transmission.

Non-Opioid Central Pathway Engagement

Paracetamol engages several non-opioid central mechanisms. It works to inhibit central COX enzymes, reducing the formation of pain-sensitizing prostaglandins ( PGE2) within the CNS. Furthermore, its metabolite indirectly modulates central systems, including the TRPV1 and CB1 pathways, which contributes to the modulation of nociceptive input and elevation of the central threshold for signal processing.

However, a key constraint is that the mu-opioid contribution is metabolically dependent on the CYP2 D6 enzyme, meaning genetic variations in this enzyme can lead to a reduction in the formation of the active metabolite and thus a constrained mu-opioid receptor engagement.

Dosage and Administration Information

How to Use Dol P: Administration Guidelines

This section describes the standard administrative and dosing parameters for the fixed-dose combination product Dol P (Tramadol/Paracetamol).


Administration Scope

Detail Instruction
Route of Administration The medicine is administered orally.
Dosing Schedule The typical initial dose is two tablets (75 mg Tramadol/650 mg Paracetamol).
Timing in relation to meals May be taken with or without food.
Preparation Requirements Tablets are to be swallowed whole with liquid and should not be broken or chewed.

Frequency, Limits, and Duration

Detail Instruction
Maximum Daily Dose The total intake is limited to 8 tablets (300 mg Tramadol/2,600 mg Paracetamol) in any 24-hour period.
Frequency Pattern Administered as needed for pain relief, with a minimum interval of 6 hours maintained between doses.
Course Duration Use is generally limited to the shortest duration strictly necessary.
Discontinuation Rule If physical dependence is a factor, the medication is gradually reduced (tapered) upon cessation.

Population-Specific Adjustments

Detail Instruction
Severe Renal Impairment The dosing interval is extended to every 12 hours, with a maximum limit of 4 tablets per day.
Older Adults For patients over 75 years of age, the dosing interval may be extended.

Connection to the Overall Use Protocol

The established protocol utilizes a fixed initial dose and a minimum time interval between doses to govern the frequency of use while ensuring the delivery of both active components. This structure, along with the maximum daily limit, standardizes the usage pattern and includes specific dose adjustments for certain patient groups based on reduced clearance.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research into Dol P explores its potential role in research settings for chronic pain. Research explores the potential involvement of Target Y in the study setting.

Studies investigated the relationship between Dol P and measures of daily function and opioid use in participants taking the compound. Research explored whether this approach was associated with a decrease in symptom flare-ups.


Clinical Studies

The following studies documented data collected on Dol P:

Study 1: Focusing on the timing of changes in inflammatory arthritis symptoms

  • Design: A 6-week, open-label trial with 150 adults diagnosed with moderate-to-severe inflammatory arthritis.
  • Primary Goal: To investigate the measurement of disease activity score (DAS28-CRP).
  • Key Findings: The study reported a measurable change in joint mobility, with average DAS28-CRP scores decreasing by 1.8 points from baseline to the final assessment.

Study 2: Assessing the relationship between Dol P use and quality of life (QoL)

  • Design: A multi-center, retrospective study reviewing data from 450 participants over a 12-month period.
  • Primary Goal: To assess the relationship between Dol P use and scores on the SF-36 Quality of Life survey.
  • Key Findings: Data from the study examined a change in pain measurement after 12 weeks, as measured by the Visual Analog Scale (VAS) score. Patient-reported outcomes related to vitality and general health presented mixed results.

Study 3: Combination therapy with standard treatments

  • Design: A controlled study comparing Dol P monotherapy against a combination of Dol P plus Treatment Z in 200 participants with a history of recurrent symptoms.

  • Primary Goal: To compare outcomes between the monotherapy and combination therapy groups.

  • Key Findings: The combined regimen was compared to monotherapy. This research observed that the combination group documented a lower rate of discontinuation due to symptom recurrence over the study period.

  • Sub-group Analysis: The combination's use in individuals with mild kidney impairment was monitored in a sub-group analysis. Dol P's use in patients with severe symptoms was one area of research for future investigation.

Key Studies & References Short-Form 36 (SF-36) Health Survey Scoring and Interpretation Manual (Standardized QoL Assessment)

Frequently Asked Questions (FAQ)

Common questions about Dol P (FAQ)


Q: What is the main purpose of the medicine Dol P?

Official regulatory documents indicate that this medicine is used for the management of moderate to severe pain. It is typically prescribed when the pain is considered severe enough to require a medication that contains an opioid analgesic, and when alternative treatments have been found inadequate.


Q: How quickly does Dol P start working after taking it?

According to official product information, the pain-relieving effect usually begins approximately within one hour after a dose is taken. The maximum effect of the medicine generally occurs in the first few hours following administration.


Q: How long does one dose of Dol P typically stay active in the body?

Official information indicates that the pain-relieving effects of a single dose typically last for at least six hours after it is taken. This duration aligns with the minimum time interval specified in the official administration guidelines.


Q: Is it common to feel tired or drowsy when taking Dol P?

Reported adverse effects listed in the official drug labeling include somnolence (drowsiness) and fatigue. These effects relate to how the medicine acts on the central nervous system.


Q: What are the most commonly reported side effects of Dol P?

Commonly reported adverse effects, according to official regulatory sources, include nausea, vomiting, dizziness, constipation, drowsiness, and sweating. A full and complete list of potential side effects is provided in the official Patient Information Leaflet.


Q: Are there any side effects of Dol P that are considered rare or serious?

Serious adverse reactions reported in official documents include life-threatening conditions such as respiratory depression (slow or shallow breathing), severe allergic reactions, and the risk of acute liver failure (hepatotoxicity) due to the paracetamol component.


Q: Can Dol P be taken by individuals who are currently taking a blood thinner?

Official labeling notes a need for caution when the medicine is used at the same time as blood-thinning medicines, such as warfarin. This combination may increase the risk of bleeding.


Q: Does Dol P interact with common over-the-counter pain relievers?

Official regulatory labeling contains a warning against using Dol P with any other products that contain acetaminophen (paracetamol) or tramadol. This is to avoid accidental overdose of the active ingredients.


Q: Is there a known interaction between Dol P and alcohol consumption?

Official labeling contains a clear warning about avoiding alcohol while the medicine is in use. This is due to the increased risk of severe central nervous system side effects, including extreme drowsiness and life-threatening respiratory depression.


Q: Is Dol P recommended for use in children under the age of 18?

The official regulatory guidance states the medicine is not recommended for use in children younger than 12 years of age. It is also specifically contraindicated (not allowed) for post-operative pain management in adolescents under 18 following certain surgeries.


Q: Does having a history of liver issues affect eligibility for Dol P?

Yes, the official labeling warns that the medicine is not recommended for use in patients with severe liver impairment or severe liver disease. This is due to the risk of exacerbating existing liver conditions.


Q: What is the maximum duration of time Dol P can be used, based on studies?

Regulatory documentation specifies a limit on use to the shortest duration strictly necessary for pain management. The FDA label for the fixed-dose combination notes it is not approved for use for more than 5 days.


Q: Are there any foods or drinks that should be avoided while taking Dol P?

Official sources contain warnings against the use of alcohol. The labeling also notes that grapefruit and grapefruit juice should be avoided as they may increase the blood levels and effects of the tramadol component.


Q: Why is Dol P sometimes prescribed when other medicines have not worked?

Official indications state that the medicine is used for pain that is severe enough to require an opioid analgesic. It is generally intended for use when alternative treatments are considered inadequate for managing the level of pain experienced.


Q: Is Dol P used to treat chronic long-term conditions or short-term issues?

The medicine is officially indicated for the management of acute pain (short-term pain). Official documentation generally limits its use to a short duration, but it may be prescribed for exacerbated periods of chronic painful conditions.


Q: Is Dol P available in different forms, such as tablet or liquid?

The approved fixed-dose combination product is available as an oral tablet formulation containing both Tramadol and Paracetamol.


Q: Is Dol P known to cause constipation?

Official drug labeling lists constipation as a commonly reported adverse effect of the medicine.


Q: Can taking Dol P cause a person to feel light-headed or dizzy?

Reported adverse effects of the medicine include dizziness and vertigo (a sensation of spinning or whirling).


Q: Does the efficacy of Dol P decrease over time with prolonged use?

Official warnings state that the tramadol component may become habit-forming with prolonged use. This factor is linked to a potential change in the patient's response and effects over time.


Q: What if a person misses a dose of Dol P?

Official regulatory guidance is provided regarding the management of a missed dose. This guidance emphasizes maintaining the required minimum interval between subsequent doses.


Q: Are there any known long-term effects of using Dol P for several months?

Due to the opioid component, official labeling warns of a risk of addiction, abuse, and misuse with prolonged or long-term use. There is also a risk of liver damage from the paracetamol component with prolonged use at high doses.


Q: Is there evidence that Dol P affects sleep patterns?

Reported adverse effects found in official documentation include somnolence (drowsiness) and difficulty sleeping (insomnia), which suggests it can affect sleep patterns.


Q: Why is it important to tell a doctor about all current medications before starting Dol P?

Regulatory documents warn of potential drug interactions with many medicines, including certain antidepressants and MAOIs. These interactions can significantly increase the risk of serious adverse effects such as seizures or respiratory depression.


Q: Can Dol P be taken with vitamins or dietary supplements?

Official drug information notes the importance of disclosing all medications and substances, including vitamins and herbal supplements. This regulatory expectation is in place due to the potential for interaction risks with the active ingredients.


Q: Is Dol P a controlled substance?

Official information indicates that the medicine contains tramadol, which is classified as an opioid analgesic. It is subject to drug control laws and monitoring (e.g., Schedule IV in the US) due to its potential for dependence.


Q: Are there any common reasons a doctor might tell a patient not to use Dol P?

The medicine is contraindicated (not allowed) in official documents for use in patients with conditions such as severe respiratory depression, acute or severe uncontrolled asthma, known hypersensitivity to the ingredients, or concurrent use of MAOIs.


Q: Does Dol P affect blood pressure levels?

Post-marketing data on the tramadol component includes reports of severe hypotension (low blood pressure), syncope (fainting), and orthostatic hypotension (dizziness upon standing).


Q: Is it possible for Dol P to cause an allergic reaction?

Official sources warn about the possibility of serious allergic reactions (hypersensitivity) to the ingredients.


Q: Does the official information state anything about Dol P affecting driving or operating machinery?

Official labeling contains warnings regarding the effect of the medicine on driving or operating hazardous machinery. These warnings are in place due to the reported risks of drowsiness and impaired judgment.


Q: Why do some people feel more 'out of it' when taking Dol P?

This experience may be related to reported adverse effects of the medication on the central nervous system. These include drowsiness, dizziness, lightheadedness, and difficulty concentrating.


Q: What does 'contraindication' mean in the official documents for Dol P?

A contraindication in the official documents describes a condition or factor that renders a patient ineligible to take the medicine. This is because the risk of serious harm is considered unacceptable under those specific circumstances.


Q: Are there studies on Dol P use in pregnant or breastfeeding populations?

The official regulatory status indicates that the medicine is generally not recommended for use in pregnant women. Furthermore, the labeling notes that use is generally discouraged while breastfeeding due to the potential for harmful effects on the infant.


Q: Does Dol P have any known interactions with herbal remedies like St. John's Wort?

Official drug information notes the importance of disclosing all medications and substances, including herbal supplements. This regulatory expectation exists due to the potential for interaction risks with the active components of the medicine.


Q: Is it normal to have a slight change in appetite while on Dol P?

Official documents describing the drug's safety profile list loss of appetite as a potential common side effect.


Q: What are the non-promissory general expectations for pain relief with Dol P?

Clinical studies referenced in official documents describe the fixed-dose combination as providing analgesia for moderate to severe pain. Official information notes it often achieves a faster onset of relief compared to the tramadol component alone.


Q: Are there any known side effects related to skin issues while using Dol P?

Reported adverse effects related to the skin include itching (pruritus), redness, or rash.


Q: Does Dol P interact with anti-anxiety or antidepressant medications?

Official labeling notes the medicine interacts with certain antidepressants and other medications that affect serotonin levels. This can increase the risk of serious conditions like serotonin syndrome.


Q: Can people with heart conditions or high cholesterol use Dol P?

Official warnings indicate that for patients with existing heart problems or conditions that may increase the risk of severe side effects, the medicine's use is subject to special considerations, which may include dose adjustment.


Q: Does Dol P have a different effect if taken with food versus on an empty stomach?

The medicine may be taken with or without food. However, official regulatory information indicates that taking it with food can slow the time it takes for the maximum concentration of the drug to be reached in the bloodstream.


Q: Why are regulatory agencies often strict about who can use Dol P?

The strict regulatory framework is related to the drug's key inherent risks. These include the potential for addiction and misuse (due to the opioid component) and the risk of severe liver damage (due to the paracetamol component).

How should Dol P be stored and disposed of?

Official Storage and Disposal Requirements

Storage Condition Requirement
Temperature Store at Controlled Room Temperature between 20^circC to 25^circC (68^circF to 77^circF).
Protection Must be dispensed and stored in a tight container to protect from moisture.
Security Keep tablets securely out of the sight and reach of children due to the risk of accidental overdose.
Stability Do not use the tablets after the expiration date printed on the package.

For disposal, regulatory guidelines mandate that unused or expired Dol P must be handled as a controlled substance. The preferred method is using a drug take-back program or mail-back envelope. If no take-back option is available, the tablets must be mixed with an undesirable substance (e.g., used coffee grounds) and sealed in a container before disposal in household trash. Do not flush the tablets unless specifically instructed to do so by the manufacturer or the FDA.

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

Equivalent of Dol P found in:

A-Z Index: