Ranofren

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Ranofren

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 Ranofren

Property Description
Active ingredient Ranolazine
Form Extended-release tablet/granules
Pharmacological class Antianginal Agent
Route of administration Oral (by mouth)
Origin Synthetic (Piperazine derivative)

What is Ranolazine and What Type of Drug Is It?

The active medicinal component in Ranofren is Ranolazine, which is recognized by the International Nonproprietary Name (INN) Ranolazine. It belongs to a high-level group of medicines called Antianginal Agents or anti-ischemic agents, clinically recognized for their role in managing heart conditions related to insufficient oxygen supply. Ranolazine is a synthetic medicine, chemically manufactured rather than being derived from natural sources.

As an Antianginal Agent, Ranolazine is distinct because it operates by modifying a specific function within the heart muscle cells, offering an alternative approach compared to older drug classes. This mechanism is associated with improving the heart's efficiency.

How Is the Medicine Composed and Supplied?

This medicine is most commonly supplied as a solid oral dosage form, specifically an extended-release tablet taken by mouth. The extended-release design is a key feature, strategically intended to provide consistent therapeutic levels of the drug over a prolonged period. The medication is designated as a single active ingredient product, containing only Ranolazine.

The composition includes the active ingredient alongside pharmaceutical excipients necessary to create the tablet structure and control this timed release. This controlled, oral route of administration via a sustained-release format is essential for the management of chronic, recurring symptoms.

What is the General Purpose of This Medicine?

The general purpose of Ranolazine is to help stabilize the function of the heart muscle, leading to the relief or prevention of recurring chest discomfort. It is intended to help improve a patient's capacity for activity and lessen symptoms in certain situations. This means the medicine is beneficial for reducing the severity of heart-related discomfort and supporting physical endurance, commonly used in individuals experiencing chronic, stable symptoms.

It achieves this by helping the heart muscle walls relax more effectively when they are under stress or strain, thereby improving the muscle's overall efficiency.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Ranofren?

Possible Side Effects and Safety Information

The safety profile of Ranofren (Ranolazine) is established through regulatory classifications that organize documented adverse reactions by frequency and physiological system, based on data from official sources like the FDA and EMA. This framework ensures a neutral description of the medicine’s risk profile.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by their incidence in clinical trials:

  • Common Reactions (may affect up to 1 in 10 people): Dizziness, Headache, Constipation, Nausea, and Asthenia (weakness) are frequently noted effects. These reactions primarily involve the Nervous System and Gastrointestinal Disorders.
  • Uncommon Reactions (may affect up to 1 in 100 people): Include Palpitations, Bradycardia (slow heart rate), Tinnitus (ringing in the ears), Blurred vision, and Dry mouth.

Serious Safety Considerations and Limitations

Regulatory documentation highlights specific, clinically significant safety concerns and limitations on use:

  • Serious Reactions: The medication is documented to cause a dose-related increase in the QT interval, a measure of the heart's electrical activity. Other serious effects include rare occurrences of Angioedema (severe swelling) and, particularly in vulnerable patients, Acute Renal Failure.
  • Population and Organ Impairment: The use of Ranofren is contraindicated (absolutely restricted) in patients with severe renal impairment or moderate-to-severe hepatic impairment. Older adults and individuals with low body weight (le 60 kg) are officially noted as having a higher incidence of adverse events.
  • Drug Interactions: Use is also contraindicated with medications classified as strong CYP3A inhibitors or strong CYP3A inducers due to the resulting risk of potentially harmful changes in Ranofren concentration.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes specific manifestations and required actions in the event of Ranolazine (Ranofren) overdose. No specific pharmacological antidote is known for this medication.

Documented Overdose Manifestations

Symptoms reported in regulatory documents may include gastrointestinal effects such as nausea and vomiting, and neurological disturbances like dizziness, confusion, double vision (diplopia), hallucinations, uncontrolled shaking (tremor), and fainting (syncope). Potential severe outcomes primarily affect the cardiovascular system, including low blood pressure (hypotension) and irregular heartbeats.

Required Emergency Actions

In the event of a suspected overdose, emergency medical attention must be sought immediately. Regulatory authorities advise contacting the national Poison Help line. Immediate emergency services must be called if the individual has severe symptoms such as collapse, experiences a seizure, has trouble breathing, or cannot be awakened.

Clinical Management Focus

Overdose management is restricted to general supportive therapy. Continuous ECG monitoring is mandated to observe for changes in cardiac rhythm, particularly the risk of dose-dependent QT interval prolongation. Patients with existing conditions such as hepatic or renal impairment may face an increased risk of severe adverse events due to altered drug exposure.

Therapeutic Uses of Ranofren

What Ranofren Treats: Main Uses and Benefits

Ranofren (Ranolazine) is commonly used for the long-term management of chronic stable angina, a condition presenting with localized discomfort. It is relevant in clinical settings marked by the recurring pattern of chest discomfort, often used when supportive symptom management is appropriate. The medication is relevant in conditions marked by increased physiological stress and may be used as part of symptomatic management, either alone or with other medications, to help treat chronic angina.

The medication is applied in addressing anginal pain episodes and may help to ease the overall symptom burden. It is relevant for managing symptoms that create noticeable physiological strain, such as chest pressure or heaviness, and is helpful in situations where symptoms may become disruptive during flare-ups.

“Ranofren is relevant for easing symptoms that interfere with daily functioning, and may assist with maintaining a sense of stability.”

This supportive treatment assists with maintaining functional stability. The support provided may help patients cope more steadily with symptom fluctuations that interfere with daily functioning.


Quick Fact: Relief for Anginal Pain

Ranofren is commonly used to help with symptoms related to chronic stable angina, including recurring chest discomfort, chest pressure, and functional limitation.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Ranofren (ranolazine) is approved for use in the adult population. Eligibility for use is strictly defined by regulatory authorities based on organ function, concurrent medications, and specific pre-existing conditions.

Populations Excluded from Use (Contraindicated)

Official labeling mandates that Ranofren must not be used in patients who have severe renal impairment (creatinine clearance < 30 mL/ min) or moderate to severe hepatic impairment (including liver cirrhosis). Absolute exclusion also applies to patients taking strong inhibitors or inducers of the CYP3A4 enzyme (e.g., ketoconazole, rifampin) or certain Class Ia and Class III antiarrhythmic medicines [1.1, 1.4].

Conditional or Restricted Use

Caution is required when the medicine is used in specific groups, including elderly patients (ge 65 years), patients with mild renal or hepatic impairment, or those with a history of QT interval prolongation [1.2, 2.1]. The maximum dose is restricted for patients taking moderate CYP3A4 inhibitors (e.g., diltiazem) [1.7].

Ranofren is not recommended for the pediatric population (under 18 years) as its safety and effectiveness in children have not been established [4.1]. For pregnancy and lactation, adequate data are lacking, and the decision to use the medicine requires weighing the potential risks versus benefits [2.1].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents define the interaction profile of Ranolazine (Ranofren) based primarily on metabolic enzyme activity and drug transporter modulation. Co-administration is contraindicated with both Strong CYP3A Inhibitors (e.g., Ketoconazole, HIV protease inhibitors) and strong CYP3A Inducers (e.g., Rifampin, Phenytoin, the herbal product St. John’s Wort). These combinations risk significantly increasing or dramatically decreasing Ranolazine's plasma exposure, respectively.

Documented Interaction Mechanisms

Mechanism Interacting Substances Official Restriction
CYP3A/P-gp Inhibition Moderate CYP3A Inhibitors (e.g., Diltiazem, Verapamil); Grapefruit Juice Ranolazine dose limitation required.
P-gp/OCT2 Inhibition P-gp substrates (e.g., Digoxin); OCT2 substrates (e.g., Metformin) Dose limitation required for co-administered drug.
Pharmacodynamic QTc-prolonging agents (e.g., certain Antiarrhythmics) Risk of additive QTc interval prolongation.

Co-administration with alcohol is advised against when using the extended-release oral granules as it can alter the drug's release rate. Furthermore, use is formally contraindicated in specific patient populations, including those with moderate or severe hepatic impairment and severe renal impairment (creatinine clearance < 30 mL/min).

Mechanism of Action

Ranofren, containing the active substance olanzapine, exerts its mechanism of action primarily through antagonistic activity at multiple neuronal receptors within the central nervous system. Its main molecular targets include Dopamine D2 receptors and Serotonin 5-HT2 A receptors. Olanzapine functions as a selective antagonist, blocking the binding of endogenous dopamine and serotonin neurotransmitters to these postsynaptic receptors.

At the intracellular level, this competitive blockade leads to the inhibition of the typical G-protein-coupled receptor signaling cascades that would be activated by the respective agonists. The resultant modification of neurotransmission primarily affects the mesolimbic and nigrostriatal dopaminergic pathways, as well as the frontal cortical serotonergic circuits. This modulation of major monoamine pathways results in a system-level alteration of neural circuit activity and output, influencing diverse physiological processes related to arousal, emotion, and motor function.

Dosage and Administration Information

Ranofren, which contains the active ingredient Ranolazine, is administered as an oral, prolonged-release product and is intended for long-term use. Its administration is structured by established parameters and specific handling requirements.

Dosing Regimens and Schedules

The medication is typically taken twice daily (BID), which defines its overall use pattern. Dosing guidance varies, reflecting different established prescribing standards:

  • Starting Dose: The initial dose is typically 500 mg twice daily or 375 mg twice daily.
  • Titration: The dose is adjusted after a period of two to four weeks based on the patient’s clinical response.
  • Maximum Dose: The highest recommended daily dose is 1000 mg twice daily or 750 mg twice daily.

Administration Conditions

  • Food Relation: The medication may be taken either with or without meals.
  • Tablet Handling: To maintain the controlled, extended-release mechanism, the tablets must be swallowed whole and must not be crushed, broken, or chewed.
  • Missed Dose: If a scheduled dose is missed, the patient should continue with the next dose at the regular time; the next dose should not be doubled.

Contextual Use Adjustments

Specific dose adjustments are specified for certain scenarios. The maximum dose is limited to 500 mg twice daily when the medicine is co-administered with moderate CYP3A inhibitors, such as diltiazem or verapamil. Additionally, careful dose titration is advised in older adults, patients with low body weight, or those with mild hepatic or mild-to-moderate renal impairment. The use of grapefruit or grapefruit juice is also explicitly advised against during the use of this medicine.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ranofren

This section provides a factual overview of the clinical research conducted on the medicine Ranolazine (Ranofren), focusing only on the types of studies performed, the outcomes they measured, and what remains uncertain, based on official regulatory and scientific documents.

Research Evidence for Chronic Stable Angina

The core research for this medicine was studied for anginal symptoms in a number of large, short-term, placebo-controlled Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over time when Ranolazine was administered to adult patients experiencing chest discomfort, often while they were already receiving other standard heart therapies.

Researchers examined outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level. Studies monitored how the observed measurements evolved in the group receiving Ranolazine compared to the group receiving placebo. The research provides insight into short-term changes in these symptoms and functional measures. The evidence level for these symptomatic and functional outcomes is typically described as High in official scientific literature, based on the volume of data from multiple RCTs.

Evidence in Patients with Co-existing Conditions

Ranolazine was studied for specific patient groups that may present unique symptom burdens. For instance, research examined patients with chronic stable angina who also had Type 2 Diabetes Mellitus. This condition is associated with functional limitations and specific metabolic concerns.

In this diabetic subgroup, research examined both standard anginal outcomes and additional outcomes related to systemic or functional imbalance, such as Glycated hemoglobin ( HbA1c) levels. The studies report how symptoms evolved in the observed populations parallel to the main research.

Evidence Gaps and Areas of Uncertainty

A key aspect of the research is acknowledging what is still uncertain. For high-risk individuals or those with certain acute syndromes, research examined major cardiovascular events (like heart attack or cardiovascular death). However, the evidence is limited regarding these outcomes monitoring physiological strain or stress. The results apply only to the populations studied in the pivotal research, and long-term effects are not fully established by the higher-certainty randomized trial data.

Key Studies & References

  1. Ranolazine: MedlinePlus Drug Information (General Patient Information)

Frequently Asked Questions (FAQ)

Common questions about Ranofren (FAQ)

Q: How quickly should a person expect to notice any change after starting Ranofren?

A: Clinical studies found that observed improvements in measures like exercise tolerance were noted after approximately six weeks of treatment. Because dose adjustments are often part of the treatment plan based on clinical response, the full effect of the medicine may be observed over time.

Q: Is Ranofren safe to use long-term?

A: Official labeling states that Ranofren is intended for use in the long-term management of chronic conditions. However, the regulatory evidence regarding high doses and very long-term effects is limited in the current randomized trial data.

Q: What are the most common reasons why a doctor might prescribe Ranofren?

A: Ranofren is prescribed to help manage the symptoms of chronic angina (ongoing chest discomfort or pressure). It helps reduce symptoms and supports a patient's capacity for activity. Official documents clarify that it is not indicated for the treatment of acute (sudden) episodes of chest pain.

Q: Does Ranofren cause weight gain or loss?

A: According to official side effect lists, unusual changes in body weight, including both weight gain and weight loss, have been reported. These weight changes are typically classified as less common or rare side effects in official safety documents.

Q: Can Ranofren affect sleep patterns?

A: Official product information suggests the medicine may affect sleep patterns. Both insomnia (difficulty sleeping) and somnolence (drowsiness) are listed as uncommon side effects that have been reported.

Q: What happens if I stop taking Ranofren suddenly?

A: Clinical trial summaries indicate that when the medicine was stopped abruptly in the research setting, rebound increases in angina symptoms were not reported. Any changes to the medication regimen should be managed under the guidance of a healthcare professional.

Q: Does Ranofren interact with supplements like St. John's Wort or melatonin?

A: Ranofren must not be taken with the herbal product St. John's Wort due to the risk of dangerous interactions. Patients are generally informed that all supplements, vitamins, and herbal products should be reviewed with a healthcare professional before starting treatment.

Q: Is there a generic version of Ranofren available?

A: The active ingredient, ranolazine, is subject to a regulatory status known as an Abbreviated New Drug Application (ANDA) in the US. This is the regulatory application for generic drug approval.

Q: Why does Ranofren require a prescription?

A: Ranofren is classified as a prescription-only medicine. This classification is based on the requirement for clinical monitoring due to factors such as potential effects on the heart's electrical activity and complexity of its interactions with other medicines.

Q: Can Ranofren cause anxiety or mood changes?

A: Yes, psychological side effects have been reported in official documents. Side effect lists include anxiety, a confusional state, and hallucinations as uncommon effects of the medication.

Q: Does Ranofren affect liver function?

A: Ranofren is processed extensively by the liver. Official labeling states that use is absolutely restricted (contraindicated) for patients with moderate to severe liver impairment. For patients with mild impairment, the need for clinical monitoring should be considered.

Q: Is it safe to drive or operate machinery while taking Ranofren?

A: The official product information advises caution. Due to the potential for affected alertness or coordination, official information suggests avoiding driving or operating hazardous machinery until the individual is aware of the medicine's effects.

Q: Can I take Ranofren if I have a history of heart problems?

A: It is important that a healthcare professional is aware of any heart history, especially concerning the heart's electrical activity, such as a prolonged QT interval. Caution and monitoring are required, and the medicine is restricted (contraindicated) with certain other heart rhythm drugs.

Q: How long does Ranofren stay in the body after the last dose?

A: The official pharmacokinetic data for the extended-release formulation indicate that the average terminal elimination half-life is approximately seven hours after the patient reaches steady-state concentrations.

Q: Are there any genetic factors that affect how Ranofren works?

A: Genetic factors can be relevant to the safety profile of Ranofren. The doctor needs to know if there is a family history of heart rhythm problems, as certain potassium channel variants may impact the risk of a prolonged QT interval.

Q: Is Ranofren likely to cause allergic reactions?

A: Ranofren is documented to potentially cause serious allergic reactions, including severe swelling (angioedema). Patients are advised to monitor for signs like hives, swelling of the face or throat, or difficulty breathing.

Q: What kind of follow-up monitoring is usually needed when taking Ranofren?

A: Follow-up monitoring may be performed to assess several factors. This includes checks on the heart's electrical activity (QT interval), kidney function, and blood glucose levels, particularly when the medicine is used alongside certain other drugs.

Q: Is Ranofren used for long-term prevention or only acute treatment?

A: Ranofren is used for the long-term management of chronic, stable angina symptoms. It is not indicated for the treatment of acute (sudden) episodes of chest pain.

Q: Can Ranofren affect my blood sugar levels?

A: Evidence from clinical studies suggests the medicine may be associated with a reduction in HbA1c levels (a measure of long-term blood sugar control) in observed patient populations with diabetes.

Q: Why are there different strengths of Ranofren tablets available?

A: Different strengths are made available to support the dose adjustment process. This process allows for initial treatment with a lower dose and subsequent adjustment based on the clinical response, up to the maximum recommended dose.

Q: Does Ranofren have an effect on blood pressure?

A: While the drug is not primarily a blood pressure medicine, side effects related to blood pressure have been reported. These include hypotension (low blood pressure) and orthostatic hypotension (a drop in blood pressure when standing up).

Q: Can men and women use Ranofren equally?

A: Official data indicates that there are no apparent gender differences in how the body processes the medicine (pharmacokinetics). However, some clinical data suggests that observed improvements in exercise tolerance were smaller in women compared to men.

Q: Is Ranofren generally well-tolerated?

A: Based on official safety reviews, Ranofren is typically managed by patients without major difficulty. In clinical trials, a small percentage of patients discontinued use due to side effects, most commonly due to dizziness and nausea.

Q: Does Ranofren cause 'brain fog' or difficulty concentrating?

A: The official side effect lists include 'confusional state' and 'dizziness.' Furthermore, the patient information advises that the medicine may affect your alertness and coordination, which could be perceived as difficulty concentrating.

Q: What should I do if I think Ranofren is causing a severe side effect?

A: If you suspect a severe side effect, such as a fast or irregular heartbeat, difficulty breathing, or swelling, official patient information indicates that emergency medical attention should be sought.

How should Ranofren be stored and disposed of?

How to Store and Dispose of Ranofren

The storage and disposal of Ranofren (ranolazine) extended-release tablets are governed by regulatory requirements to ensure product stability and safety.


Official Storage Requirements

The medication must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). It must be protected from excess heat, moisture, and direct light, and must not be allowed to freeze. Store the tablets in the original container and keep the container tightly closed.

Disposal and Safety

For safety, Ranofren must be kept out of the sight and reach of children.

To dispose of unused or expired medicine, patients should consult a healthcare professional or pharmacist for proper instructions. Regulatory guidance typically advises against keeping outdated medication.

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

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