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Propranolol Sintofarm

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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.

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Overview of Propranolol Sintofarm

Property Description
Active ingredient Propranolol hydrochloride
Form Tablet, capsule (extended-release), oral liquid solution
Pharmacological class Non-selective beta-blocker
Origin Synthetic
General Purpose Modulating sympathetic nervous system activity

Propranolol Sintofarm is a medication whose core active component is the synthetic drug entity Propranolol, primarily classified as a beta-adrenergic receptor-blocking agent. It functions by moderating the activity of the sympathetic nervous system, specifically by blocking certain receptor sites that respond to the body's stress hormones. As a single-ingredient product, it is an established pharmacological tool used for the management of conditions involving elevated cardiac stress and rhythm instability. The drug is a non-selective beta-blocker clinically recognized for its ability to decrease heart rate and reduce the force of myocardial contraction.


What Type of Medicine is Propranolol Sintofarm?

Propranolol Sintofarm belongs to the pharmacological class known as a beta-blocker, and it is specifically categorized as a non-selective agent. This means the drug targets both beta1 receptors, mainly associated with the heart, and beta2 receptors, found in various other tissues like the blood vessels and lungs. This type of medication is clinically recognized for its utility in helping to reduce strain on the heart and blood vessels. Being a synthetic compound, its non-selective nature provides a broad spectrum of physiological moderation, differentiating it from cardioselective beta-blockers, which concentrate their action primarily on the heart.


Composition and Physical Preparations

The active chemical substance in this medication is Propranolol hydrochloride, which is delivered in multiple preparations to suit different therapeutic needs, including the conventional tablet form and specialized extended-release capsules. Propranolol Sintofarm is commonly available as these tablets, extended-release capsules designed for sustained delivery, and an oral liquid solution. The availability of the oral liquid solution facilitates precise titration for patient groups who may require adjustable quantities. The primary route of entry is oral administration, utilizing a solid excipient base or an aqueous vehicle for the solution, ensuring controlled systemic absorption of the drug.

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What side effects are possible with Propranolol Sintofarm?

Possible side effects and safety information

Official regulatory documents classify the possible adverse reactions of Propranolol across several body systems, primarily focusing on its non-selective impact on beta-adrenergic receptors. Safety information is typically organized by frequency and the System-Organ Class (SOC) affected, strictly based on data reported to health authorities like the FDA and EMA.

Frequency-Classified Adverse Reactions

Adverse effects listed as Common in regulatory labeling often include fatigue, bradycardia (slowed heart rate), cold extremities, and mild gastrointestinal disturbances (such as nausea and diarrhea). Effects classified as Rare include dizziness, paraesthesia, hallucinations, psychosis, sleep disturbances, and specific skin reactions like alopecia or the exacerbation of psoriasis.

System-Organ-Class and Serious Reactions

The most frequently cited SOC groups in official safety profiles are Cardiac disorders (e.g., bradycardia, heart block), Vascular disorders (e.g., cold extremities), Nervous system disorders (e.g., dizziness), and Psychiatric disorders. The regulatory framework explicitly documents Serious Adverse Reactions that include the worsening of heart failure, severe bradycardia, and in very rare instances, severe blood disorders like agranulocytosis.

Population-Specific Safety and Restrictions

Official safety statements note specific concerns for certain groups, particularly the risk of hypoglycaemia (low blood sugar) in paediatric patients and the older adult population. The non-selective nature of the drug dictates a restriction against its use in patients with conditions like severe bronchial asthma or uncontrolled heart failure, which are classified as contraindications. Furthermore, regulatory information notes that abrupt treatment cessation may lead to a risk of symptom exacerbation, necessitating a gradual reduction documented as a safety measure.

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Overdose and Emergency Response

A suspected overdose of Propranolol Sintofarm requires immediate medical attention. The official regulatory labeling documents that an overdose may present with exaggerated physiological effects consistent with the drug's class as a non-selective beta-blocker.

Documented Overdose Manifestations

The officially described clinical signs of overdose primarily involve severe cardiovascular depression, including profound bradycardia (abnormally slow heart rate) and marked hypotension (low blood pressure). These effects can rapidly escalate to life-threatening outcomes such as cardiogenic shock or cardiac arrest. Other recognized manifestations include bronchospasm and central nervous system (CNS) effects such as dizziness, confusion, and potentially seizures or coma. A specific metabolic risk noted in regulatory documents is hypoglycemia (low blood sugar), which can be severe, particularly in children or patients in a fasting state.

Mandated Emergency Actions

Governmental guidance mandates that you contact emergency services immediately if any overdose is suspected or if severe manifestations, such as difficulty breathing, profound dizziness, or loss of consciousness, occur. Regulatory documentation emphasizes that management is primarily symptomatic and supportive, as no specific antidote is known. Procedures documented for managing severe effects include the administration of agents such as glucagon or isoproterenol to address cardiac function, and the use of activated charcoal to reduce drug absorption. Continuous hospital monitoring of vital signs and the electrocardiogram (ECG) is required for severe presentations.

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Therapeutic Uses of Propranolol Sintofarm

Main Uses and Therapeutic Benefits of Propranolol Sintofarm

Propranolol Sintofarm is considered relevant for managing symptom domains primarily driven by symptoms related to heightened physiological activity, and is applied in addressing symptoms that appear suddenly or fluctuate. This medication is commonly used to treat high blood pressure, heart rhythm disorders, and certain tremors.

Therapeutic Focus and Symptom Relief

This medication is applied across domains where additional symptomatic support is needed, most commonly in conditions presenting with acute episodes like hypertension, angina pectoris, tachyarrhythmias, essential tremor, and for the prophylaxis of migraine. It may be part of symptomatic management in situations where patients experience physical manifestations of stress or systemic imbalance, such as those related to thyrotoxicosis or performance anxiety. The primary benefit is that it supports patients during periods of heightened symptoms by assisting with managing the overall symptom load and supports general well-being during symptomatic phases.


Quick Fact: Symptom Management

Propranolol is relevant in clinical settings that involve acute or unstable symptom patterns, helping to manage symptoms that interfere with daily functioning, such as the racing heart and tremor associated with sympathetic overdrive.

Regulatory References

  1. NIH MedlinePlus Drug Information overview
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Eligibility and Restrictions for Use

Propranolol Sintofarm's eligibility is strictly defined by regulatory documents, primarily focusing on cardiac, respiratory, and metabolic status. The medication is contraindicated and must not be used in patients with severe, pre-existing conditions, including cardiogenic shock, overt (decompensated) heart failure, sinus bradycardia and greater than first-degree heart block (unless a pacemaker is present), or bronchial asthma. Use is also prohibited in patients with severe peripheral arterial circulatory disturbances and metabolic acidosis.

Condition-Based Restrictions

Population Status Regulatory Rule
Hepatic or Renal Impairment Use requires caution due to potential for altered drug clearance.
Diabetes/Fasting Use requires caution as the drug may mask signs of acute hypoglycemia.

Age and Life Stage

The medicine is generally approved for adults. Specific liquid formulations are approved for infants aged 5 weeks to 5 months for a limited indication, and use is not recommended outside of this specific age window. The FDA classifies use during pregnancy as Category C; the medicine is excreted into human milk, requiring monitoring of the infant during lactation.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Propranolol Sintofarm documents several critical interaction patterns. Co-administration with inhibitors of CYP enzymes (CYP2D6, CYP1A2, CYP2C19), such as fluoxetine or ciprofloxacin, is stated to increase the systemic exposure to propranolol. Conversely, inducers like rifampin or substances like smoking formally decrease plasma levels by acting on CYP1A2, potentially reducing efficacy.

The pharmacodynamic profile requires attention when combined with agents that affect cardiac conduction. The co-administration of calcium channel blockers (like diltiazem or verapamil) and cardiac glycosides (like digoxin) carries an increased risk of significant bradycardia and negative inotropic effects. A mandatory 48-hour separation rule is enforced for the intravenous administration of verapamil or diltiazem after discontinuing the beta-blocker.

Additionally, the drug's label notes that co-administration with warfarin officially increases its bioavailability and prothrombin time. Concerning other substances, acute alcohol consumption may increase plasma levels, while chronic alcohol use may cause a decrease. Propranolol is formally contraindicated during states of prolonged fasting due to the officially recognized risk of hypoglycemia.

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Mechanism of Action

Propranolol Sintofarm functions as a non-selective beta-adrenergic receptor antagonist, exhibiting high affinity for both the beta1 and beta2 receptor subtypes. It is a competitive inhibitor, binding to these receptors primarily located in cardiac, smooth muscle, and renal tissues, and within the central nervous system.

At the molecular level, propranolol occupies the beta-receptor binding sites, preventing the endogenous catecholamine ligands, epinephrine and norepinephrine, from activating the receptor. This blockade inhibits the subsequent Gs-protein-mediated intracellular signaling cascade. Specifically, the conversion of adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP) by adenylyl cyclase (AC) is reduced. The resulting decrease in intracellular cAMP levels diminishes the activation of protein kinase A (PKA).

In cardiac myocytes, this suppression of PKA activity leads to reduced phosphorylation of calcium channels and regulatory proteins. This action ultimately decreases the flux of Ca^2+ ions, resulting in a reduction in heart rate (negative chronotropy) and a decrease in the force of cardiac contraction (negative inotropy). Systemically, beta2 antagonism in the bronchial smooth muscle results in bronchoconstriction, and beta1 antagonism in the juxtaglomerular apparatus of the kidney reduces renin release. These actions collectively modulate cardiovascular and pulmonary physiology.

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Dosage and Administration Information

Official Administration Guidelines

Propranolol is available for use through oral administration (tablet, extended-release capsule, and solution) and the intravenous (IV) route, which is generally reserved for acute, monitored settings.

Dosing and Scheduling

Dosage depends on the specific form and intended use, but is always initiated at a low dose and titrated (gradually increased) over intervals of several days (e.g., 3 to 7 days) until an adequate response is achieved.

Form Type Standard Adult Frequency Typical Maintenance Dose Range
Immediate-Release (IR) Two to four times per day 120 mg to 320 mg per day
Extended-Release (ER) Once daily 120 mg to 160 mg once daily

Procedural and Handling Rules

  • Extended-Release Capsules: These must be swallowed whole and must not be crushed, split, or chewed.
  • Timing: Oral forms should be taken consistently—either always with or always without food—to maintain stable absorption. For certain uses, IR forms are specifically taken before meals and at bedtime.
  • Discontinuation: If treatment must be stopped, the dosage must be reduced gradually over a period of a few weeks (e.g., 7 to 14 days). Abrupt cessation is strictly documented as an inappropriate use pattern.
  • Special Populations: Guidance suggests using the lowest possible initial dose and titrating carefully for older patients and those with hepatic or renal impairment. Specialized oral solutions for infants are dosed by weight and must be administered during or immediately after a feeding.

These instructions establish the standardized method for administering the medicine, defining the appropriate route, the required dose ranges, the frequency, and the procedural handling necessary for safe and correct use.

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Recent Clinical Evidence

Research Evidence for Cardiovascular Uses

Research has been conducted on this medicine for several areas concerning the heart and circulatory system. For Hypertension (High Blood Pressure), studies examined specific measurements of blood pressure and heart rate, where findings describe patterns observed in the studies where blood pressure readings registered a change compared to control groups. Trials monitoring Angina Pectoris and Cardiac Arrhythmias described patterns of change when assessing the heart's activity and rate during rest and exercise. Comparative research provided context on how this medicine was assessed against other drug classes.

Evidence for Post-Myocardial Infarction Prophylaxis

Following an acute heart attack, the medicine was evaluated in multi-year, controlled trials that examined critical outcomes, including overall survival and the rates of subsequent cardiac events. Research explored patterns observed over extended follow-up periods and reported measurements related to event occurrence. However, these landmark studies were often conducted before modern protocols for cardiac care were established, meaning results apply only to the populations studied under those conditions.

Research Evidence for Neurological and Prophylactic Uses

The medicine was studied for conditions characterized by fluctuating manifestations like Migraine Headaches and Essential Tremor. In migraine research, studies monitored the frequency and duration of episodes and reported observations related to changes in these metrics. For tremor, trials examined functional activity and reported findings related to amplitude scores in the upper limbs, although results described variable measurements for axial tremor. It was also observed in specialized research examining the risk of gastrointestinal bleeding in patients with Portal Hypertension.

Evidence Gaps and Areas of Research Uncertainty

The current evidence landscape suggests several areas where certainty remains low. The research examined conditions such as migraine, but the related study mechanism is not fully established. Additionally, long-term effects are not fully established for all indications, and research into special patient populations, such as pediatric groups and those with specific heart function metrics, remains ongoing and limited.

Key Studies & References

  1. Controlled trial of propranolol in hypertension
  2. Systematic review with meta-analysis: the haemodynamic effects of carvedilol compared with propranolol for portal hypertension in cirrhosis
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Frequently Asked Questions (FAQ)

Common questions about Propranolol Sintofarm (FAQ)


Q: What conditions is Propranolol Sintofarm officially approved to treat?

Regulatory documents indicate that propranolol is approved for managing several conditions. These include high blood pressure (hypertension), chest pain due to heart disease (angina pectoris), and certain irregular heart rhythms (atrial fibrillation). It is also approved for preventative uses, such as after a heart attack, for migraine prophylaxis, and to treat essential tremor.


Q: How quickly does Propranolol Sintofarm typically start to work for its main uses?

The time it takes to notice effects can vary based on the specific condition being managed and the form of the medicine used. For some acute uses, effects may begin within a few hours. For preventative uses, such as migraine, official information suggests it may take several weeks to achieve the full benefit.


Q: Is Propranolol Sintofarm taken every day or only as needed?

For chronic conditions like high blood pressure or migraine prevention, the medicine is typically prescribed for daily use as maintenance therapy. However, for certain other approved situations, the medicine may be prescribed for use for a limited duration or only as required.


Q: What is the difference between Propranolol Sintofarm and other propranolol brands?

Propranolol Sintofarm contains the active ingredient propranolol hydrochloride. When a medicine is approved as a generic equivalent, regulatory bodies require that the active ingredient, strength, and dosage form are regulated to be the same as the original product. This standardization is intended to provide a comparable pharmacological effect across brands.


Q: Does Propranolol Sintofarm cause weight gain?

Official safety information documents various possible adverse effects. Some regulatory sources note that weight gain has been reported in patients taking propranolol, although it is not typically listed among the most frequently reported adverse reactions.


Q: Does Propranolol Sintofarm affect blood sugar levels?

Yes, regulatory documents state that propranolol can affect the body's response to low blood sugar (hypoglycemia). It is specifically documented that the medicine may mask certain physical signs of low blood sugar, such as a faster heart rate.


Q: Is Propranolol Sintofarm safe to stop suddenly?

Official safety warnings explicitly state that stopping propranolol suddenly is not recommended. Regulatory documents describe that if treatment must be discontinued, official guidance emphasizes that the dosage is typically reduced gradually over a period of time. Abrupt cessation may lead to the risk of symptoms becoming worse.


Q: Are there any specific foods to avoid while taking Propranolol Sintofarm?

Official regulatory documents specifically state that propranolol is contraindicated and should not be used during states of prolonged fasting. This is due to a recognized, increased risk of low blood sugar.


Q: Is Propranolol Sintofarm described as appropriate for children?

The medicine is generally approved for adults. Specific oral liquid formulations are approved for use in infants aged 5 weeks to 5 months for a limited, specific indication. Regulatory guidance states that use is generally not recommended for pediatric populations outside of this specific age window.


Q: What official information is available about taking Propranolol Sintofarm during pregnancy?

Official information notes that the medicine is used only if the potential benefit is assessed to justify the potential risk to the fetus. Studies conducted on animals have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies available in humans.


Q: What official information is available about taking Propranolol Sintofarm while breastfeeding?

Official information confirms the medicine is excreted into human milk. While the amounts passed to the infant are considered small, regulatory guidance emphasizes that monitoring of the infant for potential adverse effects is generally advised during lactation.


Q: How is Propranolol Sintofarm stored?

Official instructions specify that Propranolol tablets should be stored at Controlled Room Temperature, which is 20^circ to 25 C (68^circ to 77 F). Regulatory requirements state the medicine should be protected from light and moisture and typically kept in a light-resistant container.


Q: How should Propranolol Sintofarm be disposed of safely?

Expired or unused medicine should be disposed of in accordance with local environmental requirements. Official instructions generally describe that disposal should not be via household waste or wastewater, requiring adherence to local environmental protocols, which may include local drug take-back programs.


Q: Is Propranolol Sintofarm used for anxiety or performance issues?

Official regulatory documents for propranolol do not list anxiety or performance issues as an approved indication. The officially approved uses are specific to conditions like high blood pressure, angina, and migraine prophylaxis.


Q: Are there any differences in effect between immediate-release and extended-release Propranolol Sintofarm?

The primary difference lies in the release of the medicine. The immediate-release (IR) form is designed to be absorbed faster and typically requires dosing multiple times per day. The extended-release (ER) form is formulated for once-daily administration, providing sustained levels of the medicine throughout the day.


Q: How long does Propranolol Sintofarm stay in the system?

Pharmacokinetic data from regulatory documents indicate that the elimination half-life of propranolol is approximately 3 to 6 hours for the immediate-release form and around 8 hours for the extended-release form. The total time the medicine remains in the system can vary slightly by individual.


Q: Does Propranolol Sintofarm affect the ability to drive or operate machinery?

Official patient information generally advises caution when driving or operating machinery. This is because the medicine can cause side effects like dizziness and fatigue, which may affect a person's ability to perform these tasks safely until the effects of the medicine are understood.


Q: Can Propranolol Sintofarm cause cold hands or feet?

Yes, official safety information lists cold extremities (hands and feet) as a common adverse reaction associated with the use of propranolol. This is a recognized effect related to the medicine's activity on the circulatory system.


Q: Can Propranolol Sintofarm affect sleep patterns?

Official regulatory documents include reports of sleep disturbances as a possible side effect of the medicine. Patients should refer to the safety information for a complete listing of reported effects.


Q: Is it true that Propranolol Sintofarm can mask the signs of low blood sugar?

Yes, official safety warnings confirm that propranolol has the potential to mask the physical signs of low blood sugar (hypoglycemia). For example, it can hide symptoms like a rapid heart rate, which is a common physical indicator of low blood sugar.


Q: Does taking Propranolol Sintofarm at a certain time of day matter?

Official administration instructions emphasize that oral forms should be taken consistently, either always with or always without food. For some forms, such as the extended-release capsule, it is often recommended to be taken once daily at bedtime for optimal effect.


Q: Can Propranolol Sintofarm affect a person's mood?

Official regulatory documents list mood changes and other psychiatric disturbances, such as hallucinations or psychosis, as possible adverse reactions. These effects are generally categorized among the less common side effects.


Q: What are the official guidelines regarding maximum use duration for Propranolol Sintofarm?

For most approved chronic conditions, the medicine is intended for long-term maintenance use and requires periodic evaluation. For specific uses like migraine prophylaxis, the official label suggests that therapy be withdrawn if a satisfactory preventative response is not seen after a period of several weeks.


Q: Is Propranolol Sintofarm used to prevent a heart attack?

One of the official indications is for the prophylaxis (prevention) of subsequent heart events after a patient has already experienced a myocardial infarction (heart attack). It is intended to lower the risk of future cardiac events in this population.

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How should Propranolol Sintofarm be stored and disposed of?

Official Storage and Disposal Requirements

Propranolol tablets must be stored at Controlled Room Temperature, defined as 20^circ to 25 C (68^circ to 77 F), with permitted excursions to 15^circ to 30 C.

Requirement Specific Condition
Environmental Protection Protect from light and moisture.
Container Rules Must be dispensed in a well-closed, light-resistant container.
Child Safety Keep out of the sight and reach of children.
Stability Rule The oral solution must be discarded 90 days after first opening.

All unused or expired product must be disposed of in accordance with local requirements. Official instructions state that the medication should not be disposed of via household waste or wastewater, requiring adherence to proper environmental protocols.

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

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