Dolana

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Dolana

Treatment option: Pain, Chronic Pain

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 Dolana

Dolana is a medicinal product defined by its unique analgesic composition and central mechanism of action, designed for the management of pain.

Property Description
Active ingredient Tramadol Hydrochloride
Form Tablet, Capsule, Solution for injection
Pharmacological class Opioid analgesic, Central-acting analgesic
Common use Relief of moderate to severe pain
Origin Synthetic (opioid)

Core Composition and Classification

Dolana is a single-ingredient product whose active component is Tramadol Hydrochloride, a synthetic compound. This compound is categorized as a central-acting analgesic belonging to the opioid analgesic class.

The core composition is built around this active ingredient, which possesses a multimodal mechanism of action. Its synthetic origin distinguishes it chemically from traditional, naturally derived opioids. The compound is widely recognized for its clinical effectiveness in pain management protocols.

Type of Analgesic and General Purpose

Dolana belongs to the group of central-acting analgesics, meaning its general purpose is to provide pain relief by modulating how the brain and spinal cord process pain signals. The primary goal of this medicine is the management of moderate to severe pain.

Its action is achieved through a dual influence on the central nervous system involving two complementary mechanisms: the engagement of specific mu-opioid receptors and the inhibition of the reuptake of the neurotransmitters serotonin and norepinephrine. Tramadol is specifically approved for use in pain requiring an opioid analgesic. The medicine is a prescription-only product, reserved for serious discomfort that requires centralized management.

Available Forms

The medicinal entity Tramadol is manufactured under the name Dolana in various pharmaceutical preparations to enable flexible administration. The common dosage form(s) include the Tablet and Capsule intended for the oral route of administration, and the Solution for injection for parenteral (non-oral) administration. This flexibility allows the medicine to be utilized across different clinical settings, providing systemic pain relief tailored to patient needs.

Regulatory References

  1. StatPearls

What side effects are possible with Dolana?

Possible Side Effects and Safety Information for Dolana

The safety profile of Dolana (Tramadol Hydrochloride) is defined by officially documented adverse reactions classified by frequency and body system, as mandated by government regulatory agencies like the FDA and EMA.

Adverse reactions primarily affect the Nervous System and Gastrointestinal System. The most commonly reported effects include Nausea and Dizziness, which are categorized as Very Common (occurring in ge 1/10 patients). Common reactions (occurring in ge 1/100 to <1/10 patients) include Constipation, Vomiting, Dry mouth, Headache, Somnolence (Drowsiness), and Sweating (Hyperhidrosis).

Adverse Reaction Category Examples (Regulatory Classification)
Very Common Nausea, Dizziness
Common Constipation, Somnolence, Headache, Vomiting

Serious Adverse Reactions and Safety Constraints

The official labeling documents several serious risks, including Life-Threatening Respiratory Depression, which is a risk particularly upon treatment initiation or following a dose increase. Other documented serious risks are Serotonin Syndrome, Seizures (convulsions), and the potential for Opioid Use Disorder (OUD) and Physical Dependence with long-term exposure. Anaphylaxis and severe hypersensitivity reactions have also been reported.

Official safety constraints note that Dolana is contraindicated in children younger than 12 years of age and in patients with significant respiratory depression or those concurrently taking Monoamine Oxidase Inhibitors (MAOIs). For patients over 75 years of age or those with severe renal or hepatic impairment, the official safety notes indicate that the elimination of the substance may be delayed, which often necessitates cautious adjustment of the dosing interval. Prolonged use during pregnancy is associated with the risk of Neonatal Opioid Withdrawal Syndrome (NOWS).

Overdose and Emergency Response

Overdose Scope

Official regulatory documents identify overdose of Dolana by specific critical symptoms, including life-threatening respiratory depression and profound Central Nervous System (CNS) depression, which may progress to a state of coma. Other severe manifestations documented in labeling include generalized seizures, severe hypotension, and potential circulatory collapse. The official profile also cites the development of serotonin syndrome as a serious, potentially life-threatening outcome linked to the drug’s non-opioid activity.

Dose-related or exposure-related factors: Accidental ingestion of even a single dose has been formally documented as resulting in a fatal overdose, particularly in children. Elderly or debilitated patients are officially identified as having an increased risk for life-threatening respiratory depression.

Emergency-response statements: Immediate medical attention is required for any suspected overdose. Emergency services must be contacted right away if the patient exhibits critical signs, such as slowed breathing, long pauses between breaths, blue-colored lips, or difficulty waking up. Opioid antagonists like naloxone can partially reverse respiratory depression, though regulatory information notes the administration of naloxone may increase the risk of seizure activity. Seizures must be managed with a benzodiazepine as part of the required symptomatic and supportive treatment.

Therapeutic Uses of Dolana

What Dolana Treats: Main Uses and Benefits

Dolana is considered relevant in clinical settings that involve acute or unstable symptom patterns. Its pharmacological category is studied for its potential role in chronic pain and inflammatory conditions. It is applied across domains where additional symptomatic support is needed.

The medication is commonly used to help with symptomatic relief across therapeutic domains, including symptoms related to physical discomfort (such as fibromyalgia and chronic arthritis), symptoms related to inflammatory or irritative states (such as inflammatory bowel issues), and symptoms related to systemic imbalance linked to endocrine concerns like thyroid dysfunction. It is relevant when supportive symptom management is appropriate. The medication provides support that helps ease the overall symptom burden.

Therapeutic Scope Overview

Dolana is used in situations involving symptoms that create noticeable physiological strain. It is often applied in conditions characterized by periods of heightened symptoms. The medication contributes to easing the overall symptom load and supports the patient during difficult episodes by easing distress.

Quick Fact: Relief for Chronic Discomfort
Dolana is commonly used to help manage symptoms related to chronic, persistent pain where underlying inflammatory or irritative states are present, contributing to improved comfort during symptomatic periods.

Eligibility and Restrictions for Use

The eligibility to use Dolana (Tramadol Hydrochloride) is strictly defined by government regulatory documents, focusing on age, organ function, and pre-existing health conditions.

Contraindicated Populations

The medicine is absolutely prohibited for use in the following groups, as per official labeling:

  • Children younger than 12 years of age.
  • Children younger than 18 years of age for postoperative pain management following tonsillectomy and/or adenoidectomy.
  • Patients with significant respiratory depression or acute, severe bronchial asthma.
  • Patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Patients concurrently taking Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping them.

Age and Condition Restrictions

Population Group Eligibility Status (Official Regulatory Wording)
Pediatric Use (12–17) Use should be avoided in adolescents with risk factors (e.g., obstructive sleep apnea) that increase sensitivity to respiratory effects.
Organ Impairment Use is not recommended in patients with severe renal impairment or severe hepatic impairment.
Geriatric Use (Over 75) Use requires cautious dosage limitation, as maximum daily dose is often restricted.
Pregnancy/Lactation Use is not recommended in pregnant or breastfeeding women due to the risk of Neonatal Opioid Withdrawal Syndrome (NOWS) and serious infant adverse effects, respectively.

Official labeling also restricts use in individuals who are suicidal or addiction-prone, or those with certain Central Nervous System (CNS) conditions like impaired consciousness or increased intracranial pressure.

What should I know about interactions with other medicines?

Dolana’s interaction profile is governed by officially documented patterns that define restrictions on co-administration. The profile establishes two primary areas of concern: severe pharmacodynamic risks and alterations to systemic exposure via metabolism.

The most critical restriction is the formal contraindication with Monoamine Oxidase Inhibitors (MAOIs), which requires a mandatory separation period: Dolana must not be used within 14 days of discontinuing an MAOI.

Pharmacodynamic interactions involve the additive effects of co-administered substances. Regulatory documents caution that combining Dolana with other Central Nervous System (CNS) Depressants may result in documented risks of profound sedation and respiratory depression. Co-administration with Serotonergic Drugs (e.g., SSRIs, SNRIs) is similarly associated with an enhanced risk of Serotonin Syndrome and seizure activity.

Pharmacokinetic interactions affect exposure via the CYP2D6 and CYP3A4 metabolic pathways. Substances classified as CYP2D6 inhibitors increase the systemic exposure of the parent drug (Tramadol) while reducing the exposure of the active metabolite (M1). Conversely, CYP3A4 inducers (such as Carbamazepine) increase metabolism, which is formally noted to reduce the analgesic effect; co-administration with Carbamazepine is generally not recommended.

Non-medicinal restrictions include the prohibition of alcohol consumption due to the combined risk of severe CNS and respiratory depression. Furthermore, use is restricted in CYP2D6 Ultra-Rapid Metabolizers due to the risk of life-threatening respiratory depression from excessive M1 exposure.

Mechanism of Action

How Dolana Works: Mechanism of Action

Dolana's action is defined by a multimodal mechanism that engages two complementary systems in the central nervous system (CNS) to modulate nociceptive signaling at the molecular and physiological level.

Dual Mechanism: Opioid Receptor Agonism and Neurotransmitter Reuptake Inhibition

The drug acts through two distinct components. Firstly, the O-desmethyl-tramadol (M1) metabolite binds to and activates the mu-Opioid Receptor (mu-OR), a mechanism that inhibits the ascending transmission of nociceptive input. Secondly, the parent drug blocks the reuptake of the monoamine neurotransmitters Serotonin (5-HT) and Norepinephrine (NE), which enhances activity within the descending inhibitory pathway. This dual engagement produces a synergistic dampening of nociceptive signal transmission.

Mechanistic Constraints: The Role of CYP2D6

The full expression of the mu-OR-mediated effect is contingent upon the body's ability to metabolize the drug into the high-affinity M1 metabolite via the CYP2D6 enzyme system. This biological dependency means that individuals with certain genetic variations (poor metabolizers) may experience a diminished mu-OR-mediated effect, as the core mu-OR target is not adequately engaged by the active metabolite.

Dosage and Administration Information

How to Use Dolana: Administration Guidelines

Dolana, which contains Tramadol Hydrochloride, is administered based on the required speed of action and the duration of pain management, utilizing several distinct formulations. The medicine is provided for oral administration (tablets, capsules, and solution) and for parenteral administration (intravenous, intramuscular, or subcutaneous injection).


Dosage and Frequency Patterns

Formulation Type Standard Adult Dosing (Typical) Frequency Pattern
Immediate-Release (IR) 50 mg to 100 mg per dose Every 4 to 6 hours, as needed (PRN)
Extended-Release (ER) Starting dose of 100 mg Once daily, for continuous management

The maximum daily dose for Immediate-Release forms and injections is generally limited to 400 mg in non-impaired adults, while the limit for Extended-Release forms is typically 300 mg. Titration for IR forms may begin with 25 mg and increase slowly, while ER forms are not indicated for as-needed use.


Administration Requirements and Adjustments

Oral formulations of Dolana may be taken with or without food. A critical constraint for Extended-Release forms is that the tablets or capsules must be swallowed whole and must not be crushed, chewed, split, or dissolved to maintain the controlled release mechanism. For older adults (over 75 years) and patients with severe renal or hepatic impairment, specific dose adjustments are required; for example, the dosing interval for IR forms may be extended, and ER forms are generally not recommended for those with severe impairment. Treatment duration should be the shortest necessary, with periodic professional re-evaluation and advice to use gradual tapering when discontinuation is pursued.

Recent Clinical Evidence

Dolana is the trade name for the active pharmaceutical ingredient, lurasidone hydrochloride, an atypical antipsychotic agent approved for specific psychiatric conditions.

Approved Indications and Efficacy

Clinical trials have established two primary indications for Dolana in adults and adolescents (aged 13–17 for one indication):

  • Schizophrenia (Adults and Adolescents): Studies, including short-term, placebo-controlled trials, indicate its effectiveness in managing the symptoms of schizophrenia. The recommended dose range for this use in adults is typically 40 mg to 160 mg per day. Trials involving adolescents (13–17 years) also supported its use in this population.
  • Bipolar Depression (Adults): Dolana is also approved for treating major depressive episodes associated with Bipolar I Disorder. Evidence supports its use as both monotherapy and as adjunctive therapy (added to existing treatment with lithium or valproate). The effective dose range for this indication is typically 20 mg to 120 mg per day.

Clinical Trial Outcomes

Key studies reviewed by regulatory bodies demonstrated that in patients receiving Dolana compared to those receiving a placebo, there were statistically significant improvements in primary clinical rating scales used to measure symptom severity in both schizophrenia and bipolar depression. These clinical effects are dose-dependent, meaning the magnitude of the effect often correlates with the dose administered within the approved range. Data also suggest that the drug's absorption is significantly enhanced when administered with food, which is an important consideration for clinical management.

Frequently Asked Questions (FAQ)

Common questions about Dolana (FAQ)


Q: Is Dolana a type of painkiller or is it for something else?

According to official regulatory classifications, Dolana’s active ingredient, tramadol, is classified as an opioid analgesic and a central-acting analgesic. This means its primary function is to provide relief for moderate to severe pain by acting on the central nervous system.


Q: Is it normal to feel a little dizzy when first starting Dolana?

Yes, regulatory documents list dizziness as a very common side effect of Dolana. Adverse effects like dizziness and drowsiness may be more noticeable when starting the medication. Official information suggests that these effects may lessen over the first week or two as the body adjusts, but individual experiences vary.


Q: Can taking Dolana cause stomach upset or heartburn?

Official information indicates that gastrointestinal issues are common with Dolana. Side effects like nausea, vomiting, and constipation are frequently reported. While general stomach upset is covered by these common symptoms, heartburn is not specifically named in the common adverse reactions list.


Q: How long does one dose of Dolana usually last?

The duration of effect depends on the formulation used. Immediate-Release (IR) Dolana is typically dosed every 4 to 6 hours as needed. The Extended-Release (ER) form is designed to be taken once daily for continuous pain management.


Q: Can people who are generally healthy take Dolana for occasional issues?

Dolana is indicated for the management of moderate to severe pain. As a prescription-only product, it is reserved for pain management requiring a prescription opioid analgesic. It is not typically used for minor, occasional discomfort.


Q: Is Dolana safe for older adults to use?

Official guidelines advise that use in older adults, particularly those over 75 years of age, requires cautious dosage limitation. Because the maximum daily dose is often restricted in this population, regulatory guidance stresses the need for careful monitoring for potential opioid-related side effects.


Q: Are there specific symptoms that mean I should stop taking Dolana right away?

Regulatory warnings highlight several serious risks. Regulatory documents advise seeking immediate medical attention if an individual experiences signs of life-threatening respiratory depression (slow or shallow breathing) or Serotonin Syndrome (agitation, hallucinations, rapid heart rate, or high fever).


Q: Can Dolana cause trouble sleeping if taken too late in the day?

Official adverse reaction reports for Dolana include insomnia (trouble sleeping) as a common side effect. Although drowsiness is also a possibility, insomnia can occur, and this effect may be more noticeable if the dose is taken close to bedtime.


Q: Is there a generic version of Dolana available?

Yes, the active pharmaceutical ingredient, Tramadol Hydrochloride, is widely available. Regulatory agencies like the FDA have approved generic versions of this ingredient in various forms and strengths.


Q: What is the maximum number of days in a row someone can safely take Dolana?

Official product information advises that the duration of treatment should be the shortest necessary to manage the pain. For any continuous use, a professional re-evaluation of the need for the medication should be performed periodically.


Q: Does the effectiveness of Dolana wear off over time?

Prolonged use of any opioid analgesic, including Dolana, carries the risk of developing tolerance. Tolerance is a condition where a higher dose may be needed over time to achieve the same level of pain relief.


Q: Does taking Dolana affect the results of any common lab tests?

Yes, the active ingredient in Dolana, Tramadol, is a substance monitored in various drug-screening panels. It is possible for the substance to be detected through standard urine drug testing.


Q: Is the 'loading dose' concept relevant for starting Dolana?

While the official prescribing information does not use the term 'loading dose,' it does state that the starting dosage for Immediate-Release forms may be very low (e.g., 25 mg) and then increased slowly as the body tolerates the medication.


Q: How long after stopping Dolana does it completely leave the body?

The complete elimination time of Dolana varies by person and dosage used. Anti-doping guidelines sometimes use a reference washout period of approximately 24 hours to minimize the risk of a positive test for the substance.


Q: Do people who have kidney issues need to avoid Dolana?

Official safety warnings indicate that Dolana is not recommended for patients with severe renal impairment (severe kidney problems). This restriction is in place because kidney issues can delay the elimination of the drug and its active metabolite from the body.


Q: What are some natural remedies that interact negatively with Dolana?

Regulatory guidance often cautions against combining Dolana with many herbal remedies and supplements. This is because non-prescription substances are not typically tested for serious drug interactions in the same way as approved medicines, and combining them may increase the risk of side effects.


Q: Is there a public warning or alert associated with Dolana recently?

Regulatory agencies have historically issued advisories concerning the active ingredient, Tramadol Hydrochloride. These alerts often focus on the risks associated with counterfeit versions or unregistered products sourced from outside official dispensing channels.


Q: Does taking Dolana with milk change how it's absorbed?

Official administration requirements state that oral formulations of Dolana may be taken with or without food. There are no specific warnings in the regulatory labeling that mandate avoiding milk or dairy products when taking this medication.


Q: What percentage of people report experiencing the most common side effect of Dolana?

The most common side effects, such as Nausea and Dizziness, are categorized as Very Common in official documents. This classification means they are reported to occur in 10% or more of patients participating in clinical studies.


Q: Is the main use of Dolana short-term or long-term management?

Dolana is intended for pain management, and the guidance is to keep the duration of treatment the shortest necessary. While it can be prescribed for continuous management, its use is generally focused on managing pain that requires opioid analgesia.


Q: Can a person with a history of heart issues generally use Dolana?

Official labeling includes warnings about the potential for severe hypotension (low blood pressure) and advises monitoring patients, particularly during dosage changes. Use is generally restricted for patients with conditions such as circulatory shock.


Q: Is Dolana chemically similar to any banned substances?

The active ingredient in Dolana, Tramadol, is a synthetic opioid analgesic that is chemically related to other opioids like codeine. It is classified as a controlled substance in many regions due to its risk profile and potential for dependence.


Q: Is it normal to have a dry mouth while taking Dolana?

Yes, Dry Mouth (Xerostomia) is listed as a common side effect of Dolana. This means that regulatory data indicates it is reported in at least 1% of patients.


Q: Does Dolana have an effect on mental clarity or focus?

Yes, Dolana can affect mental processes. Common side effects include Somnolence (Drowsiness) and Headache, and the medication is officially associated with cognitive impairment, all of which can affect mental clarity and focus.

How should Dolana be stored and disposed of?

Storage Requirements

Dolana (Tramadol Hydrochloride), an opioid analgesic, must be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). The product must be protected from excessive heat and moisture to maintain product stability. Per regulatory mandate, all forms must be secured in a locked area and kept out of the sight and reach of children at all times to prevent fatal accidental ingestion.

Handling and Disposal

Extended-release tablets must be swallowed whole and must not be crushed, chewed, or split. Unused or expired Dolana must be disposed of in compliance with controlled substance regulations.

The primary disposal method is using DEA-authorized drug take-back programs.

If a take-back option is not immediately available, the FDA permits flushing the medicine down the toilet to immediately remove the drug from the home and prevent accidental exposure.

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

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