Синдранол

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Синдранол

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Medically reviewed

Rosario Oropesa

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 Синдранол

Quick Facts

Property Description
Active ingredient Ropinirole
Form Oral Tablet (Immediate and Extended-Release)
Pharmacological class Dopamine Agonist
Common Use Neurological functional support
Origin Synthetic, Non-ergoline derivative

What Type of Medicine is Синдранол?

Синдранол is a synthetic, single-component pharmaceutical agent containing the active substance Ropinirole, and it is classified as a prescription-only drug for neurological support. The medicine belongs to the dopamine agonist class of drugs, which are characterized by their ability to influence signaling in the central nervous system. Ropinirole is specifically a non-ergoline derivative, a chemical structure that differs significantly from older dopamine agonists derived from ergot fungi, such as bromocriptine.


Composition and Available Forms of Ropinirole

The composition of Синдранол centers on the active ingredient Ropinirole, typically formulated as the hydrochloride salt, combined with necessary solid pharmaceutical excipients for its production as an oral dosage form. This medicine is available in two distinct preparations: the immediate-release tablet and the extended-release tablet. The key distinction, which allows for different therapeutic strategies, is the release profile; the extended-release form is specifically designed to deliver Ropinirole gradually over a prolonged period, helping to achieve consistent presence of the agent in the bloodstream.


General Function and Primary Therapeutic Purpose

Ropinirole functions by binding to and stimulating specific dopamine receptors in the brain, notably the D2 and D3 subtypes, effectively mimicking the action of the body's natural neurotransmitter, dopamine. As a stimulator of post-synaptic dopamine receptors, the primary therapeutic purpose of the agent is to provide functional support to the neurological pathways. This action aids in stabilizing circuits involved in coordinating muscle control and mitigating involuntary sensory phenomena, a typical scenario where this class of medicine is utilized.

What side effects are possible with Синдранол?

Possible side effects and safety information

The safety profile of Ropinirole (Синдранол) is structured by regulatory bodies, primarily involving effects on the nervous and gastrointestinal systems, which are common to the dopamine agonist class. Adverse reactions are classified by frequency as documented in official prescribing information.

Frequency-Classified Adverse Reactions

Adverse reactions that are Very Common (affecting more than 1 in 10 users) include Nausea, Somnolence (sleepiness), and Dyskinesia (involuntary movements), particularly when used alongside other Parkinson’s treatments. Common reactions (affecting 1 to 10 in 100 users) include Dizziness, Vomiting, Headache, Syncope (fainting), Postural Hypotension (blood pressure drop upon standing), Hallucinations, Constipation, and Peripheral Edema (swelling).

Serious Safety Considerations

The label documents serious, clinically important safety concerns that warrant observation. These include the potential for Sudden Onset of Sleep (falling asleep during activities without warning) and the manifestation of Impulse Control Disorders (ICDs), such as pathological gambling, hypersexuality, or compulsive shopping. Orthostatic Hypotension and Syncope are also listed as serious risks, often occurring at the start of treatment or during dose escalation.

Contextual Safety Notes

The regulatory documents note that certain reactions, such as low blood pressure and nausea, are often associated with the initial phase of treatment or dose escalation. Conversely, symptoms resembling Neuroleptic Malignant Syndrome can be reported following the rapid reduction or cessation of the medication. The drug's clearance is reduced in older adults, who may also be more susceptible to confusion and hallucinations. Safety and effectiveness have not been established for pediatric use.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents state that an overdose of Синдранол (Ropinirole) may present with documented symptoms primarily linked to its effect as a dopamine agonist.

Symptom Category Documented Manifestations (Official Sources)
CNS/Psychiatric Confusion, agitation, hallucinations, nightmares, dizziness, and drowsiness.
Motor/Cardiovascular Uncontrolled movements (dyskinesia), chest pain, fast or irregular heartbeat, and light-headedness or fainting due to low blood pressure (hypotension).
Gastrointestinal Nausea and vomiting.

Urgent Medical Attention is Required

Immediate medical assistance must be sought when severe manifestations are observed. Contact emergency services (e.g., 911) if the individual has collapsed, had a seizure, exhibits trouble breathing, or cannot be awakened. For any suspected overdose that does not present with these life-threatening signs, contact the Poison Help line for official guidance.

The official management approach is purely symptomatic and supportive. Regulatory sources confirm there is no specific, officially documented antidote for Ropinirole overdose. Furthermore, special considerations apply to patients with end-stage renal disease (ESRD) on hemodialysis, for whom regulatory guidelines specify caution due to altered drug clearance.

Therapeutic Uses of Синдранол

Quick Facts

  • Supports the management of motor symptoms associated with Parkinson's disease.
  • Assists in reducing the uncomfortable sensations and urge to move the limbs linked to moderate-to-severe primary Restless Legs Syndrome (RLS).

What Синдранол Treats: Main Uses and Benefits

Синдранол is a prescription medication indicated for the management of certain conditions that affect movement and sensation. Its primary function involves supporting the control of symptoms associated with specific neurological disorders. The medication is utilized under the guidance of a healthcare professional as part of a comprehensive treatment plan.

The uses of Синдранол include assisting in the treatment of Parkinson's disease. This involves supporting the management of the motor symptoms linked to the condition, such as stiffness, slowed movements, and difficulties with balance. The medication may be utilized as initial therapy or in combination with other established treatments to maintain effective control of signs.

Additionally, Синдранол is a treatment option for individuals with moderate-to-severe primary Restless Legs Syndrome (RLS). In this context, the medication assists in reducing the uncomfortable sensations in the legs and the strong, often disruptive, urge to move the limbs, particularly when resting or during the evening.

Regulatory References

  1. NIH MedlinePlus guidance on Ropinirole uses

Eligibility and Restrictions for Use

The eligibility for using Синдранол (Ropinirole) is strictly defined by regulatory authorities based on known patient conditions and age groups.

Contraindicated Populations

Use of this medicine is contraindicated (must not be used) in patients with a known hypersensitivity or allergic reaction to Ropinirole or any of the inactive ingredients. Some regulatory labeling also lists absolute contraindications for patients with severe hepatic impairment and severe renal impairment who are not on regular hemodialysis.

Age and Condition Eligibility

Category Regulatory Status
Established Use Adults with idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS).
Pediatric Use Not recommended; safety and efficacy are not established in children and adolescents under 18 years of age.
Pregnancy/Lactation Not recommended during pregnancy or for nursing mothers, as Ropinirole may suppress lactation.
Renal Impairment Use is permitted in moderate impairment (CrCl 30–50 mL/min) with no routine dose adjustment. Use in end-stage renal disease (ESRD) on hemodialysis is permitted with specific maximum daily dose limits.
Hepatic Impairment Caution is advised in mild to moderate impairment, as the drug is metabolized by the liver and has not been formally evaluated in this group.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Ropinirole (Синдранол) is defined by its hepatic metabolism and pharmacodynamic effects, according to government regulatory information.


Documented Pharmacokinetic Interactions

The primary mechanism involves Cytochrome P450 1A2 (CYP1A2). Substances that inhibit this enzyme can increase Ropinirole exposure, potentially requiring dose adjustment.

  • CYP1A2 Inhibitors (e.g., Ciprofloxacin, Fluvoxamine, Enoxacin): Co-administration with Ciprofloxacin is documented to increase Ropinirole's concentration (AUC by 84% and Cmax by 60%). Dosage adjustment may be required upon starting or stopping these agents.
  • Estrogens (Hormone Replacement Therapy): High doses of estrogens are documented to reduce Ropinirole's oral clearance by approximately 36%, increasing its plasma concentrations. Dose management is advised if HRT is initiated or discontinued.
  • Smoking: As smoking is known to induce CYP1A2, a change in a patient's smoking status may require a dose adjustment due to altered drug clearance.

Pharmacodynamic Interactions

  • Dopamine Antagonists (e.g., Metoclopramide, Neuroleptics): These agents may counteract and diminish the effectiveness of Ropinirole; concomitant use should be avoided.
  • Alcohol: Caution is required as alcohol may enhance the CNS depressant effects of Ropinirole.
  • Levodopa: Ropinirole co-administration may potentiate the dopaminergic side effects of Levodopa, including the risk of causing or exacerbating dyskinesia.

Other Official Interaction Notes

Food: Ingestion of a high-fat meal does not affect the total amount of Ropinirole absorbed, but it can delay the time to maximum concentration (Tmax) for the extended-release tablet.

Special Populations: The use of Ropinirole in patients with severe renal impairment has not been adequately studied. Patients with moderate hepatic impairment require close monitoring.

Mechanism of Action

Синдранол (Sindranol) is a non-ergoline dopamine receptor agonist with its primary molecular target being the D2 and D3 dopamine receptor subtypes. The molecule exhibits a selective affinity for these G-protein coupled receptors, particularly concentrating its activity within the caudate-putamen system of the striatum in the central nervous system.

Activation of the D2 and D3 receptors by Синдранол modulates neuronal signaling. At a molecular level, D2-like receptor activation is coupled to inhibitory Gi protein complexes, which leads to a downstream inhibition of adenylyl cyclase enzyme activity. This reduction in adenylyl cyclase consequently decreases the intracellular concentration of the second messenger cyclic adenosine monophosphate (cAMP).

The resulting reduction in cAMP-dependent protein kinase A (PKA) activity modifies the phosphorylation status of various target proteins, ultimately leading to a change in the electrical properties and excitability of striatal neurons. This intracellular cascade modifies the efferent activity of the basal ganglia, which translates to a system-level modulation of motor control pathways.

Dosage and Administration Information

How to Use Синдранол

Синдранол (ropinirole) is administered exclusively by the oral route and is available in distinct Immediate-Release (IR) and Extended-Release (ER) tablet formulations. The usage protocol is defined by the indication and requires careful, gradual dose adjustment.


Dosing and Frequency Patterns

The medicine is initiated at low doses and slowly titrated over several weeks, with the required daily dosage and frequency differing based on the clinical context:

Indication Formulation Starting Dose / Frequency Maximum Recommended Daily Dose
Parkinson's Disease (PD) Immediate-Release (IR) 0.25 mg three times daily (TID) 24 mg
Parkinson's Disease (PD) Extended-Release (ER) 2 mg once daily (QD) 24 mg
Restless Legs Syndrome (RLS) Immediate-Release (IR) 0.25 mg once daily (QD) 4 mg

Standard dosing schedules exist for this medication, where the maximum dose for PD is higher than that for RLS. The ER formulation is not approved for RLS.


Administration and Procedural Rules

Administration may occur with or without food. However, the time of day is critical for RLS, where the IR tablet should be taken 1 to 3 hours before bedtime.

Special Handling: The Extended-Release tablets must be swallowed whole and must not be crushed, split, or chewed to ensure the medication is released over the intended duration.

Dose Adjustment: If treatment is interrupted for a significant period, retitration to the effective dose is warranted. For planned discontinuation, the dosage must be tapered gradually over a minimum of seven days, particularly when used for PD.

Specific Populations: In patients with end-stage renal disease on hemodialysis, the maximum recommended dose for PD is limited to 18 mg per day, and for RLS, to 3 mg per day.

Recent Clinical Evidence

Syndranol (dronabinol oral solution) is a cannabinoid medication indicated for the treatment of anorexia associated with weight loss in adult patients with Acquired Immune Deficiency Syndrome (AIDS). It is also approved for the treatment of nausea and vomiting associated with cancer chemotherapy in adult patients who have not responded adequately to conventional antiemetic treatments.

Recent clinical and regulatory data have affirmed the drug's role in these approved uses. Studies supporting its indications focused on its efficacy in improving appetite and weight maintenance in AIDS patients, and its ability to control severe chemotherapy-induced nausea and vomiting.

Clinical trials have established dosage guidelines for Syndranol. The drug is typically initiated at a low dose and may be gradually increased based on the patient's response and tolerance. Due to the potential for central nervous system (CNS) adverse reactions, which are dose-related, patient monitoring is essential, particularly regarding feelings of being high, dizziness, confusion, and somnolence.


Approved Adult Indications

Indication Therapeutic Goal
Anorexia associated with weight loss in AIDS Appetite stimulation, weight stabilization
Chemotherapy-induced Nausea and Vomiting (refractory) Anti-emetic control where conventional treatments failed

While the main focus remains on the approved indications, caution is advised regarding potential interactions with other medications and the risk of hemodynamic instability and seizures. It is important for patients to discuss their full medical history and current medications with a healthcare provider before initiating treatment.

Frequently Asked Questions (FAQ)

Common questions about Синдранол (FAQ)

Q: Is Синдранол a medication that cures a condition or helps manage symptoms?

A: Official product information indicates that this drug is used for the management or treatment of symptoms associated with Parkinson's disease and Restless Legs Syndrome (RLS). It functions to provide functional support to neural pathways. Regulatory documents do not describe the drug as a cure.

Q: How long has Синдранол been available for patient use?

A: The active ingredient, ropinirole, was initially approved for use by the U.S. Food and Drug Administration (FDA) in 1997. This initial approval was for the management of Parkinson's disease. The medicine has been available for patient use globally since that time.

Q: How is Синдранол different from similar medicines used for the same conditions?

A: Синдранол (ropinirole) is classified as a non-ergoline dopamine agonist, a structural classification that distinguishes it from older agonists. Its mechanism involves selectively stimulating the D2 and D3 dopamine receptors. This pharmacological classification is detailed in official regulatory materials.

Q: Can taking Синдранол cause changes in weight, like weight gain or loss?

A: According to official adverse event reports, unusual weight gain or loss is listed as a less common reported effect during the use of this medication. Rapid weight gain is also among the side effects noted in official regulatory documents.

Q: Does official information state that Синдранол affects sleep quality?

A: Regulatory information indicates the drug is associated with effects on alertness and sleep regulation. These effects include common somnolence (sleepiness) and, more seriously, the potential for falling asleep during activities of daily living without warning.

Q: What are the signs of a severe allergic reaction to Синдранол?

A: Signs of a severe allergic reaction (hypersensitivity) may include developing a rash, intense itching, or swelling of the face, lips, tongue, or throat. Official product information notes this as a contraindication. Difficulty swallowing or breathing are signs that require immediate medical attention.

Q: How long does it typically take for a person to notice the effects of Синдранол?

A: The drug's concentration is expected to reach a steady level in the body within about two days after starting use. However, because treatment requires a gradual increase in dose, achieving the optimal therapeutic effect (titration) may take several weeks before a full benefit is noticed.

Q: What happens if a person misses a time to use Синдранол?

A: Instructions for a missed dose vary depending on the drug formulation and the condition being managed. Regulatory information indicates that for the immediate-release tablet used for Restless Legs Syndrome, instructions may advise skipping the dose. The official instructions for other formulations and indications may advise taking the dose as soon as remembered, unless it is almost time for the next scheduled dose. Regulatory documents specify that patients should not double the dose.

Q: Does Синдранол need to be used consistently every day to be effective?

A: Consistent daily use is generally required to help the body reach and maintain steady drug concentrations, which is important for managing symptoms. Regulatory guidelines state that if a significant interruption in therapy occurs, the dose will likely need to be gradually restarted (re-titration).

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

A: Official regulatory analysis has shown that commonly administered medications, such as the over-the-counter pain reliever ibuprofen, did not significantly affect the oral clearance of ropinirole. The Interactions section of the official label details substances that are known to alter drug concentration.

Q: Are there any specific foods or supplements that should be avoided when using Синдранол?

A: The official product information specifically notes that there is currently insufficient information available to confirm the safety of using complementary or herbal remedies alongside this drug. Disclosing all supplements and remedies to a healthcare provider is important.

Q: Does Синдранол interfere with the effectiveness of common birth control methods?

A: Available information does not report that the drug stops the effectiveness of common hormonal contraception. However, a known pharmacokinetic interaction exists where estrogen-containing contraceptives may reduce the drug's clearance from the body. This interaction may necessitate monitoring or adjustment of the drug's dose.

Q: Is Синдранол considered safe for patients with a pre-existing heart condition?

A: The official warnings and precautions section notes that the drug may cause effects relevant to heart health. These include syncope (fainting), hypotension (low blood pressure), and changes in heart rate. It is important that patients with pre-existing heart conditions disclose their full medical history to a healthcare provider.

Q: Is Синдранол a generic drug, or is it still protected by patent?

A: The active ingredient, ropinirole, is currently available as a generic prescription drug. It is offered in both immediate-release and extended-release forms.

Q: Where can I find the official summary of clinical trial results for Синдранол?

A: The full data supporting the drug's use and effectiveness, including dose-finding information, is contained within the official Prescribing Information. This detailed summary is typically found under the section titled Clinical Studies (Section 14) of the regulatory documents.

Q: Has there been any research published on the long-term effects of using Синдранол?

A: Safety information concerning long-term use is compiled through both initial clinical trials and mandatory ongoing post-marketing surveillance. This monitoring is specifically focused on identifying effects that may occur over time, such as the development of impulse control disorders.

Q: What are the inactive ingredients listed in the composition of Синдранол?

A: The list of inactive ingredients (excipients) can vary by the specific formulation and manufacturer. However, they commonly include substances such as croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose, often along with various coloring agents.

Q: Why do some sources refer to Синдранол by a different chemical name?

A: The primary reason for a different name in chemical or regulatory documents is that the drug is often referred to by its full chemical designation, which is the hydrochloride salt. Therefore, the official label refers to the substance as Ropinirole Hydrochloride, reflecting the stable formulation used in the tablet.

Q: Does the package insert for Синдранол contain warnings about operating machinery?

A: Yes. Official regulatory warnings are provided due to the risk of somnolence and the potential for sudden onset of sleep without warning. Official warnings state that patients should avoid driving and operating hazardous machinery until they have determined how the medication affects their alertness.

How should Синдранол be stored and disposed of?

Storage and Disposal of Синдранол (Ropinirole) Tablets

Синдранол tablets must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). To ensure product stability, the medication must be kept in the original container, which must be closed tightly after each use.

Protection and Handling

Requirement Condition
Temperature Range 20 C to 25 C (68 F to 77 F)
Environmental Protection Protect from light and moisture
Child Safety Keep out of the sight and reach of children

Disposal

Unused or expired tablets must be disposed of according to local regulatory requirements. The use of a designated drug take-back program is typically recommended. The medicine should not be disposed of via household waste or wastewater unless specifically authorized by local regulations.

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

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