Sitro

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Sitro

Sitro is a prescription medicine used to combat specific bacterial infections. It is classified as an antibiotic within the macrolide family.

Property Description
Active ingredient Roxithromycin (INN)
Form Oral tablets (coated) or oral suspension
Pharmacological class Macrolide antibiotic
General purpose To control the growth of susceptible bacterial infections
Origin Semi-synthetic (derived from erythromycin)

What Type of Medicine is Sitro (Roxithromycin)?

Sitro is a pharmaceutical product containing the active substance Roxithromycin, which is a prescription-only antibiotic used to address specific bacterial infections. This medicine is formally classified as a macrolide antibiotic, a major class of antimicrobial agents used systemically for the management of infections. As an antimicrobial agent for systemic use, this classification underscores that the medicine is clinically recognized for its intended purpose against susceptible bacteria.

Roxithromycin is a semi-synthetic compound, meaning it is chemically synthesized but derived from the naturally occurring macrolide, erythromycin, placing it in the second-generation macrolide category. Unlike first-generation macrolides, this structural modification results in improved stability and absorption. Sitro is formulated as a single-ingredient product, containing only Roxithromycin alongside necessary pharmaceutical excipients. Its prescription-only status reinforces that its use must be medically guided.

Composition and General Purpose of Roxithromycin

Sitro is typically provided for oral administration as coated tablets or, for specific patient needs such as the treatment of pediatric patients, as an oral suspension. These forms are designed for the oral route, allowing the active ingredient to be absorbed into the bloodstream. Its general purpose is to halt the proliferation of susceptible bacteria. Macrolide antibiotics work by inhibiting bacterial protein synthesis. This means that the medicine functions by exerting a bacteriostatic effect, stopping bacteria from growing and multiplying, thereby aiding the body’s own defenses in clearing the infection. A typical neutral use scenario involves taking Sitro to manage a diagnosed respiratory tract infection caused by susceptible organisms.

Regulatory References

  1. Macrolides Mechanism of Action (NCBI/NIH)

What side effects are possible with Sitro?

Sitro's official safety profile, as documented in government regulatory sources, is defined by classifications of adverse reactions across several physiological systems. The most frequently documented events primarily affect the gastrointestinal system, including nausea, vomiting, diarrhoea, and abdominal pain. Less common reactions may involve the nervous system, such as headache, dizziness, and alteration in the senses of smell and taste, as well as dermatological events like skin rashes.

The prescribing information highlights several serious adverse reactions. These include severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Cardiovascular risks are also documented, specifically the prolongation of the QT interval, which is associated with potentially fatal ventricular arrhythmias, including Torsades de pointes. Furthermore, the medicine is associated with a risk of Clostridium difficile-associated diarrhoea (CDAD).

Population-specific safety considerations are noted in official labeling. Caution is advised for patients with impaired hepatic function, and a specific dose reduction is specified for those with severe hepatic insufficiency. For children, neutropenia has been observed. Safety-related restrictions include a contraindication for concurrent use with vasoconstrictive ergot alkaloids due to the risk of severe vasoconstriction (ergotism). Caution is also required for patients with pre-existing cardiac conditions.

Overdose and Emergency Response

The official regulatory profile for a Sitro (Roxithromycin) overdose emphasizes the need for immediate medical response due to potentially life-threatening outcomes. Documented manifestations of overdose primarily involve severe gastrointestinal disturbances, including nausea, vomiting, and diarrhea, along with reports of headache and dizziness.

The most critical concern documented in regulatory labeling is the risk of cardiotoxicity. Overdose may result in QT interval prolongation and subsequent severe Ventricular Arrhythmias, such as Torsades de Pointes. Due to this severe cardiac risk, regulatory authorities mandate that urgent medical attention or emergency services must be contacted immediately for any suspected overdose, even if no symptoms are present. If signs of cardiac arrhythmia occur, the medicine must be discontinued and ECG monitoring initiated.

Management for an overdose is strictly defined as symptomatic and supportive care, as no specific antidote is known. Procedures such as gastric lavage may be utilized as part of the management strategy. A note on population risk is included: patients with impaired hepatic function are at a heightened risk for increased toxicity because the drug's clearance is prolonged.

Therapeutic Uses of Sitro

What Sitro Treats: Main Uses and Benefits

Sitro is commonly used to help with conditions involving acute or disruptive symptom patterns. This may be part of symptomatic management in addressing conditions presenting with systemic or localized discomfort, which assists with easing the overall symptom load. It supports patients during episodes where discomfort is heightened and is relevant in clinical settings that involve acute or disruptive symptom patterns.

Sitro is commonly applied for managing conditions such as acute pharyngitis, acute bronchitis, community-acquired pneumonia, impetigo, cellulitis, erysipelas, and specific non-gonococcal urogenital infections. In these situations, it contributes to improved comfort by addressing symptom clusters involving fever, persistent cough, or localized pain and swelling. Furthermore, its use is commonly applied as an alternative option for patients with known hypersensitivities to other antibiotic classes, offering targeted symptomatic support.

“It helps address symptom clusters that may become intense or disruptive, supporting the patient during difficult episodes by easing distress.”


Quick Fact: Relief for Systemic Discomfort

Sitro is applied in scenarios where symptoms, such as fever or malaise, become more noticeable and are linked to active bacterial infection. This may assist with supportive relief.

Eligibility and Restrictions for Use

The eligibility profile for Sitro (Roxithromycin) is strictly defined by regulatory documents, establishing clear limitations on its use.

Absolute Contraindications

Use is contraindicated in patients with documented hypersensitivity to roxithromycin or any other macrolide antibiotic. The medicine must also not be used concomitantly with specific prohibited drugs, such as ergot alkaloids (e.g., ergotamine), cisapride, or pimozide, which pose a risk of serious cardiac events. Patients with a documented history of prolonged QT interval are likewise ineligible.

Restricted and Conditional Use

Use is not recommended for women who are pregnant due to insufficient clinical data. For lactating women, use is possible but restricted, as the substance is excreted into human milk. Patients with severe hepatic insufficiency have limited eligibility and require a mandatory dose reduction if administration is deemed essential. Caution is required in patients with Myasthenia Gravis and pro-arrhythmic conditions.

Age-Related Eligibility

Sitro is contraindicated in infants under 6 months of age. Furthermore, the tablet formulation is not established for pediatric patients under 6 years or weighing less than 40 kg. No dose adjustment is required for older adults based on age alone.

What should I know about interactions with other medicines?

Sitro (Roxithromycin) has formally documented interaction patterns with several medicinal products and substance classes that define specific co-administration restrictions.

The co-administration of Sitro with vasoconstrictive ergot alkaloids (such as Ergotamine and Dihydroergotamine) is formally contraindicated. This mandatory prohibition is due to the documented risk of severe vasoconstriction, potentially leading to ergotism. Use is also not recommended with certain medicines associated with QT interval prolongation, including Terfenadine, Astemizole, Cisapride, and Pimozide, due to the potential for increased serum concentrations and subsequent cardiac risk.

The co-administration of Sitro may result in an increase in plasma concentrations for several drugs. Specifically, concurrent use with Coumarin anticoagulants (e.g., Warfarin) is associated with an increase in the International Normalised Ratio (INR) and reports of bleeding. Roxithromycin may also increase the systemic exposure of Theophylline and Ciclosporin A, requiring monitoring. Furthermore, it may enhance and prolong the effect of Midazolam and increase the absorption of Digoxin. Caution is also required with Class IA and Class III Antiarrhythmic Agents due to a documented additive risk of QT interval prolongation. Official labeling notes that the serum half-life of Roxithromycin is increased in patients with hepatic failure. This alteration in clearance can heighten the relevance of potential drug interactions in this specific patient population.

Mechanism of Action

How Sitro Works

Sitro (Roxithromycin) functions by exerting a targeted, non-competitive inhibitory action on the core biological processes of susceptible bacteria, with its mechanism focused strictly on the cellular components of susceptible bacteria.


Blockade of the Bacterial Protein Synthesis Machinery

Sitro specifically targets the bacterial 50S ribosomal subunit, the site of essential protein synthesis. By binding reversibly to a site near the peptidyl transferase center, the drug acts as a steric hindrance that physically obstructs the exit tunnel for newly forming proteins.


Interruption of the Bacterial Growth Pathway

The physical obstruction halts the bacterial protein synthesis pathway, which is essential for the microbe to create the components needed for growth and division. This interruption prevents the bacteria from replicating, leading to a state of bacteriostasis (growth arrest). The mechanism induces bacteriostasis—the cessation of microbial growth—by limiting expansion. This bacteriostatic effect permits the host immune response to process the non-replicating bacterial load.


️ Understanding Mechanistic Limitations

The drug's action can be constrained when bacteria develop active resistance mechanisms. These include target site modification, where the ribosome is chemically altered to prevent binding, or the activation of drug efflux pumps that actively expel the Roxithromycin molecule from the bacterial cell. These constraints prevent the necessary molecular interaction from occurring.

Dosage and Administration Information

How to Use Sitro (Roxithromycin)

The usage of Sitro, a macrolide antibiotic, is governed by prescribing instructions that detail the required dosage, schedule, and administration conditions. The medicine is administered via the oral route, typically available as 150 mg and 300 mg film-coated tablets.


Standard Dosing and Schedule

The total standard adult dose is 300 mg per day. This dosage is administered using one of two common regimens: either 300 mg taken once daily or 150 mg taken twice daily (every 12 hours). The usual course of treatment is typically defined as lasting 5 to 10 days. However, specific conditions, such as streptococcal infections, require a minimum course duration of 10 days. If a dose is missed, the instruction is to skip the missed dose if it is almost time for the next scheduled dose, and not take a double dose.


Administration Requirements

Administration of Sitro is timed in relation to meals to optimize absorption. The medicine must be taken on an empty stomach, meaning at least 15 minutes before a meal or more than three hours after eating. Tablets must be swallowed whole with a glass of water, and are generally not suitable for children under six years of age.


Population-Specific Adjustments

For most adult groups, including older adults and those with renal impairment, no change to the standard 300 mg daily dose is specified. However, patients with severe hepatic insufficiency require a dose reduction, which is lowered to 150 mg taken once daily. For pediatric patients weighing under 40 kg, the use involves a weight-dependent dose of 5 to 8 mg/kg/day, divided into two daily administrations.

Recent Clinical Evidence

Research Evidence and Overview of Studies for Sitro (Roxithromycin)

This section summarizes the structure of clinical research, including randomized controlled trials and meta-analyses, which form the basis for the medicine's approved uses, while detailing the types of populations and outcomes studied.


Evidence Supporting Use in Respiratory Tract Infections

Clinical trials involving adults and older adults with respiratory tract infections have been conducted to understand how Sitro was studied against other standard antibiotics and, in some cases, placebo. These studies are typically short-term Randomized Controlled Trials (RCTs) that focused on clinical response (research exploring how symptoms change over time) and bacteriological eradication. Studies suggest that the medicine has been observed in research examining short-term clinical cure rates in populations with confirmed or suspected susceptible bacterial infections. The evidence supporting the study of short-term outcomes is broadly considered of High consistency and weight.


Research on Skin and Soft Tissue Infections

Clinical trials have examined Sitro in adult populations presenting with skin and soft tissue infections. These trials primarily monitored clinical response, such as the resolution of localized symptoms related to inflammatory or irritative states. Findings from these studies report patterns consistent with the research context involving fluctuating or unstable symptoms for a macrolide antibiotic. The evidence base for these indications is generally characterized as Moderate-level. Data are still emerging, and comparative evidence is lacking against some first-line therapeutic options.


Investigation of Non-Antimicrobial Properties in Chronic Conditions

Research has explored the potential long-term, non-antibiotic actions of Sitro in specific conditions characterized by fluctuating or episodic manifestations, such as stable non-cystic fibrosis bronchiectasis. These were often pilot RCTs administered for long periods (e.g., 8 weeks to 6 months). Researchers monitored patient-reported outcomes describing perceived discomfort and Quality of Life (QoL) metrics. Findings were mixed regarding objective measures like lung function tests. The evidence base for these applications is considered Low-level and heterogeneous.


Research Gaps and Remaining Uncertainties

Long-term data on recurrence rates and durability of the observed short-term changes are not well characterized. Evidence quality varies across studies due to the rising prevalence of macrolide resistance in common bacterial pathogens. Sample sizes were modest in many trials focused on specific subgroups or on the immunomodulatory effects, and results apply only to the populations studied in the research.

Key Studies & References

  1. Roxithromycin as Anti-Inflammatory Drug Improves Clinical Outcomes in Adult Patients with Bronchiectasis: A Double- Blinded Randomized, Placebo-Controlled Pilot Clinical Trial
  2. Is Roxithromycin Better than Amoxicillin in the Treatment of Acute Lower Respiratory Tract Infections in Primary Care?
  3. British Thoracic Society guideline for the use of long-term macrolides in adults with respiratory disease

Frequently Asked Questions (FAQ)

Common questions about Sitro (FAQ)


Q: What does the official information say about Sitro and liver health?

Official information indicates that patients with severe hepatic insufficiency (a serious form of liver impairment) require a dose reduction. Furthermore, for patients showing signs of liver dysfunction, hepatic function parameters must be controlled regularly by a healthcare professional. If those parameters worsen, discontinuation of therapy may be considered.


Q: Can Sitro affect my ability to drive or operate machinery?

Official product information includes a cautionary statement regarding driving and operating machinery. This is because side effects affecting the nervous system, such as dizziness, blurred vision, and headache, may be reported. Caution is noted regarding these activities if these effects occur.


Q: Are there known issues with Sitro during pregnancy or breastfeeding?

Official documents advise that Sitro should not be used during pregnancy unless clearly indicated by a healthcare professional. This is noted due to a lack of adequate data on the drug’s use in pregnant women. During lactation (breastfeeding), the substance is known to be excreted into human milk, and this finding is noted in the official guidance.


Q: Is Sitro the same type of medicine as [similar drug name]?

Sitro, which contains the active ingredient Roxithromycin, is formally classified as a semisynthetic macrolide antibiotic. This classification defines it as an antimicrobial agent used systemically to control the growth of susceptible bacteria. This information places it within a specific family of medicines.


Q: What happens if I stop taking Sitro suddenly?

Official documents advise against stopping the medicine unless directed by a healthcare professional. Discontinuation before completing the full prescribed course may result in the bacteria causing the infection not being fully killed. If bacteria continue to grow, the infection may not fully clear or could return.


Q: Is there a maximum time someone can take Sitro?

The usual course of treatment for the approved uses of Sitro is defined by official regulatory labels as typically lasting 5 to 10 days. Some specific conditions, such as streptococcal infections, require a minimum course duration of 10 days.


Q: Do I need any special monitoring while taking Sitro?

Special monitoring is noted for certain patient populations. Official labeling requires the regular control of hepatic function parameters for patients with signs of liver dysfunction. Furthermore, when co-administered with certain other medicines, such as Disopyramide, close monitoring of ECG and serum levels is noted.


Q: Can I use Sitro if I have a history of heart problems?

Official documents state that Sitro is contraindicated (not recommended for use) in patients with a history of prolonged QT interval or those with certain pro-arrhythmic conditions. Caution is broadly advised for patients with pre-existing cardiac conditions.


Q: Does Sitro interact with common allergy medications?

Official guidance indicates that specific allergy medicines, such as Terfenadine and Astemizole, have a potential for adverse interaction with Sitro. Co-administration with these specific medicines is not recommended due to documented cardiac risk.


Q: Why is Sitro sometimes prescribed to people without the 'main' condition?

In addition to its use as an antibiotic, official research has explored the non-antimicrobial properties of Sitro in chronic conditions. Official research has explored its use in specific cases of stable non-cystic fibrosis bronchiectasis to monitor patient-reported outcomes.


Q: Does Sitro make you feel drowsy?

Official labeling notes that side effects affecting the nervous system, such as dizziness and headache, may occur. Because of these possible effects, caution is officially advised when driving or operating machinery.


Q: What are the restrictions on who can prescribe Sitro?

Sitro is officially classified as a prescription-only medicine. This regulatory status means that its dispensing and use must be authorized by a licensed healthcare professional.

How should Sitro be stored and disposed of?

Official Storage and Disposal Requirements

Sitro (Roxithromycin) must be stored according to official regulatory specifications to preserve its stability. The product is to be kept in a cool, dry place where the temperature stays below 25 °C or 30 °C, depending on the formulation and region. The medicine must be protected from direct sunlight, heat, and excessive moisture, and should not be frozen.

The tablets should remain in their original packaging and the container must be kept tightly closed. For the oral suspension, any unused portion must be discarded after 14 days of reconstitution. Sitro must always be stored out of the sight and reach of children.

Unused or expired medicine should not be flushed or poured down a drain. Disposal should be via an official drug take-back program or by mixing the product with an undesirable substance before discarding it in the household trash, following established guidelines.

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

Available in countries:

Equivalent of Sitro found in:

A-Z Index: