Surlid

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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.

Overview of Surlid

Surlid

Surlid, with the active ingredient Roxithromycin, is a prescription-only antimicrobial agent belonging to the macrolide class of antibiotics. Its primary role is to suppress the growth of pathogenic bacteria responsible for systemic bacterial infections.

Property Description
Active Ingredient Roxithromycin
Form Film-coated Tablet; Oral Suspension
Pharmacological Class Macrolide Antibiotic; Antibacterial agent
Origin Semi-synthetic (derived from Erythromycin)

What is the Macrolide Antibiotic Roxithromycin?

Roxithromycin is specifically identified as a semi-synthetic macrolide antibiotic, meaning its chemical framework is derived from the natural substance Erythromycin but chemically refined to enhance its properties. The Macrolide classification defines the mechanism by which the drug interferes with the life cycle of pathogenic bacteria. Roxithromycin is recognized for its effectiveness against organisms commonly causing infections in the respiratory tract and skin. Unlike the original Erythromycin, this semi-synthetic version offers improved oral absorption and longer action, properties established for its clinical application.

Composition and How the Drug is Presented

The pharmaceutical preparation Surlid is a single-ingredient product, containing only Roxithromycin as the active substance. It is primarily supplied for the oral route of administration in common dosage forms such as a film-coated tablet or an oral suspension. The use of a film-coated tablet is a design feature intended to protect the compound from the acidic environment of the stomach and ensure effective systemic delivery of the active ingredient throughout the body.

General Therapeutic Purpose and Core Action

The fundamental therapeutic purpose of Surlid is the management of systemic bacterial infections by controlling microbial growth. The drug functions as a protein synthesis inhibitor, disrupting the necessary processes of pathogenic bacteria. Roxithromycin is utilized for treating certain infections where macrolide therapy is indicated. This interference results in bacteriostatic activity, halting bacterial multiplication and allowing the body's immune defenses to overcome the infection, such as when resolving a typical community-acquired infection.

Regulatory References

  1. oral absorption data (Medsafe SmPC)
  2. product composition (Medsafe SmPC)
  3. oral route (Medsafe SmPC)
  4. film-coated tablet form (Medsafe SmPC)
  5. mechanism of action (Medsafe SmPC)
  6. bacteriostatic properties (Medsafe SmPC)

What side effects are possible with Surlid?

Possible Side Effects and Safety Information

The safety profile of Surlid, containing Roxithromycin, is officially classified by government regulatory documents based on the affected System-Organ Classes (SOCs) and the frequency of adverse reactions.

Frequency-Classified Adverse Reactions

The most common adverse reactions reported in regulatory sources primarily involve Gastrointestinal Disorders, including nausea, vomiting, diarrhea, epigastric pain, and flatulence. Reactions classified as uncommon include hypersensitivity reactions like rash and pruritus (itching).

Reactions categorized as Frequency Unknown are also documented, encompassing events observed during post-marketing use where an exact incidence cannot be reliably estimated. These include more significant effects in the Nervous System (e.g., headache, dizziness, confusion), Hepatobiliary Disorders (hepatitis, elevated liver enzymes), and Cardiac Disorders.

Serious Adverse Reactions and Safety Constraints

Official labeling highlights the potential for several serious adverse reactions. These include significant events impacting the heart, such as QT interval prolongation and ventricular arrhythmias (Torsades de Pointes). Other serious documented reactions are Severe Cutaneous Adverse Reactions (SCARs) like Stevens-Johnson Syndrome (SJS), and Pseudomembranous Colitis.

Population-Specific Safety Constraints are mandated for certain groups. The medication is officially contraindicated in patients with severe hepatic impairment. Furthermore, caution is required in patients with pre-existing renal impairment or those taking specific medications, as the drug is contraindicated for concomitant use with vasoconstrictive ergot alkaloids (e.g., ergotamine). Long-term treatment (exceeding two weeks) requires official monitoring of liver function, renal function, and blood count. The risk of superinfection by non-susceptible organisms, such as candidiasis, is associated with prolonged use.

Overdose and Emergency Response

The regulatory overdose profile for Surlid (Roxithromycin) is defined by mandated emergency actions and specific documented clinical signs. Official labeling indicates that overdose may primarily present with gastrointestinal disturbances, including nausea, vomiting, and diarrhoea. Other manifestations noted are headache and dizziness. Although clinical experience is limited and the acute toxicity is often described as low, the macrolide class association with cardiac risk (potential for QT prolongation) requires vigilant intervention.

Immediate medical attention is required upon suspicion of overdose. Regulatory guidance explicitly mandates contacting a poison control center or immediately presenting to an Emergency Department for necessary care. Management is focused on symptomatic treatment and supportive care, as no specific antidote exists. Depending on the exposure timing, procedures such as gastric lavage or administration of activated charcoal may be utilized. Continuous clinical and ECG monitoring is a requirement during observation due to the potential for cardiac effects.

Therapeutic Uses of Surlid

What Surlid Treats: Main Uses and Benefits

Surlid (Roxithromycin) is relevant in contexts where supportive symptom management is appropriate for conditions characterized by periods of heightened symptoms caused by susceptible bacteria.

This medication is commonly used to address bacterial infections throughout the upper and lower respiratory tract, including conditions like acute pharyngitis, tonsillitis, sinusitis, and bronchitis. The use is applied in addressing symptoms related to the bacterial cause in these areas, as well as in skin and soft tissue infections such as cellulitis and impetigo, and specific urogenital tract infections.

“The medication is generally applied in clinical settings that involve acute or unstable symptom patterns and is relevant for easing symptoms related to physical discomfort.”

Its use is associated with symptomatic relief in conditions caused by susceptible bacteria, and is used for managing symptoms that interfere with daily comfort, such as fever, persistent cough, and localized pain. This intervention contributes to easing the overall symptom load and supports general well-being during symptomatic phases.

Quick Fact: Relief for Symptoms related to physical discomfort

Eligibility and Restrictions for Use

Surlid (Roxithromycin) is subject to strict eligibility rules defined by regulatory agencies, which determine the populations who may or may not use the medicine.

Contraindicated Populations

Use is absolutely contraindicated if a patient has a known hypersensitivity to Roxithromycin or any other macrolide antibiotic. It must also not be used in patients diagnosed with severe hepatic insufficiency (severe liver disease). Furthermore, the medicine is prohibited in patients with a history of congenital or acquired QT interval prolongation. Co-administration with certain medications, including vasoconstrictive ergot alkaloids (like Ergotamine) and specific QT-prolonging agents (like Cisapride, Astemizole, or Terfenadine), is also formally contraindicated.

Age and Physiological Restrictions

Regulatory labeling restricts use based on age, prohibiting administration to infants under six months of age. Use is formally not recommended during pregnancy, and it requires caution during breastfeeding as the substance passes into breast milk. Although standard use is permitted for adults and older adults, caution is required for individuals with mild to moderate hepatic impairment or certain proarrhythmic conditions, as officially documented in the product label.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Surlid (Roxithromycin) has a documented interaction profile categorized by regulatory authorities, with specific combinations being formally prohibited or requiring close monitoring.

Formal Regulatory Prohibitions

Certain combinations are contraindicated due to the risk of severe or life-threatening adverse events:

  • Vasoconstrictive Ergot Alkaloids (e.g., Ergotamine, Dihydroergotamine): Co-administration is prohibited due to the risk of severe vasoconstriction, known as ergotism, and potential necrosis.
  • QT-prolonging Agents: Concomitant use with agents such as Cisapride, Astemizole, Terfenadine, and Pimozide is contraindicated due to the potential for QT interval prolongation and severe cardiac arrhythmias.

Exposure Modification and Monitoring

Specific medicines may experience altered plasma concentrations when co-administered, leading to official requirements for monitoring:

  • Anticoagulants: Co-administration with Vitamin K Antagonists (e.g., Warfarin) is associated with an official increase in the International Normalized Ratio (INR), mandating strict INR monitoring.
  • Cardiac Glycosides (e.g., Digoxin): Roxithromycin may increase the absorption and subsequent serum levels of these agents, requiring mandatory ECG and serum level monitoring.
  • Theophylline and Cyclosporine: Roxithromycin may slightly increase the plasma concentrations of these medicines.

Administration and Substance Constraints

  • Food: Taking Roxithromycin with food results in decreased absorption. Official sources advise taking the medicine on an empty stomach (e.g., 15 minutes before a meal).
  • Antacids: A separation time of 2 hours is advised between Roxithromycin and antacid medicines containing aluminum or magnesium to prevent reduced absorption.
  • Alcohol: Avoidance is advised by some regulatory bodies as alcohol may worsen associated effects.

Population-Specific Note

  • Severe Hepatic Function Impairment: Caution is required, as the Roxithromycin serum half-life is increased in patients with severe hepatic failure, which is a factor in managing interaction risk.

Mechanism of Action

Blocking Bacterial Protein Synthesis (Bacteriostasis)

The primary mechanism involves the targeted inhibition of microbial growth by binding to the 50S ribosomal subunit within susceptible bacteria. Roxithromycin, the active ingredient, interacts with the 23S ribosomal RNA component, creating a steric hindrance that physically blocks the exit tunnel used for protein assembly. This molecular interaction prevents the essential elongation of new peptide chains. This effect leads to the physiological outcome of bacteriostasis—the halting of bacterial multiplication—and the resulting reduction in microbial multiplication changes the pathogen-to-host balance.


Modulating Host Inflammatory Responses

The mechanism extends beyond the microbe to include the modulation of host immune signaling pathways. The drug influences intracellular processes, such as those governed by Nuclear Factor kappa B (NF-κB), which are critical for activating inflammatory responses. This engagement with host pathways leads to the downregulation of local inflammatory signaling and the release of inflammatory mediators at the site of action.


Mechanistic Constraints and Resistance

The functional mechanism is physiologically limited by the emergence of bacterial defense systems that directly counteract the drug's intended action. The inhibition is constrained when bacteria either develop efflux pumps to actively expel the drug or genetically modify the ribosomal target site, preventing the necessary binding.

Dosage and Administration Information

How to Use Surlid: Official Administration Guidelines

Surlid, which contains the active ingredient Roxithromycin, is intended strictly for the oral route of administration. Standard guidelines outline two main daily dosing regimens for adults, totaling 300 mg per day: either 300 mg taken once daily or 150 mg taken twice daily in divided doses.


Administration Conditions and Timing

To ensure proper systemic absorption, Surlid must be administered on an empty stomach. This condition requires taking the film-coated tablet at least 15 minutes before a meal or waiting more than three hours after a meal. The tablets must be swallowed whole with water and should not be crushed, broken, or chewed.

Course Duration and Dose Management

The typical treatment course usually runs for 5 to 10 days, although therapy for specific conditions, such as streptococcal tonsillitis, requires a minimum of 10 days of continuous administration. If a scheduled dose is missed, established instructions state that the dose should be skipped entirely, and the patient should return to the normal schedule; a double dose must not be taken to compensate.

Population-Specific Adjustments

Dosage requires specific adjustment only for patients with impaired liver function. In cases of severe hepatic insufficiency, the dose must be reduced by half to 150 mg once daily. Conversely, no change in dosage is necessary for patients with renal impairment or for older adults. Children weighing 40 kg or more are typically administered the adult dose of 150 mg twice daily.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Surlid

This section provides a factual overview of the clinical research conducted on the active ingredient Roxithromycin, including the types of studies performed, the populations examined, and what remains uncertain in the evidence landscape.

Evidence for Use in Acute Respiratory and Skin Infections

Research exploring Surlid's application in acute infections, such as those in the upper and lower respiratory tract (URTIs/LRTIs), typically involves short-term Randomized Controlled Trials (RCTs) and aggregated meta-analyses. These trials usually enroll adults and are designed to compare outcomes in treatment groups against a control or comparator group.

Studies primarily monitored two main types of outcomes: measures of symptom evolution and change, which refers to changes in visible signs and self-reported symptoms (like cough and fever) over a short, defined period; and bacteriological status after treatment, which measures the presence or absence of susceptible bacteria after the treatment course. Findings describe patterns observed in these studies, where clinical measurements were tracked in populations presenting with conditions associated with acute or disruptive episodes.

Evidence for Use in Other Specific Acute Infections

Surlid was studied for its relevance in research settings in certain other acute infections, including skin and soft tissue infections and some urogenital tract infections. For skin conditions, studies generally monitored outcomes related to physical discomfort and objective signs like the resolution of swelling and lesions. Findings contribute to the broader evidence landscape by describing how patients reported their experience and how symptoms evolved in the observed populations during the short study period.

In the case of urogenital infections, research focused on specific susceptible atypical pathogens. Studies examined outcomes related to physical discomfort and the measurements of bacteriological eradication (clearing the targeted bacteria). Data show patterns related to short-term changes in these outcomes. However, the evidence quality varies across studies.

Long-Term Studies and Extended Follow-up

For most acute infections, research has focused on short-term outcomes, and follow-up durations were limited to the immediate post-treatment period (typically 7 to 28 days). Consequently, there is limited information for long-term outcomes, such as sustained symptom patterns or the durability of the treatment effect over many months.

Research has explored the use of the macrolide class in a long-term context for certain chronic respiratory conditions, such as bronchiectasis. These studies often involved placebo-controlled pilot trials lasting several months. In this setting, studies examined outcomes related to functional balance and patient-reported measures, such as changes in Quality of Life (QoL) scores and the frequency of exacerbations (periods of heightened symptoms). While research provides insight into short-term changes in self-reported symptom scores, data are still emerging.

Research Gaps and Areas of Uncertainty

A review of the evidence highlights several remaining areas of uncertainty. While numerous studies were conducted for acute respiratory infections, the evidence quality varies across studies due to methodological differences. For the exploratory use in chronic conditions, sample sizes were modest in the pilot trials, and long-term effects are not fully established, particularly the sustained clinical relevance of the anti-inflammatory properties observed in some studies.

Key Studies & References

  1. Clinical efficacy of roxithromycin in the treatment of adults with upper and lower respiratory tract infection due to Haemophilus influenzae
  2. ROXITHROMYCIN - FDA Verification Portal (National Regulatory Label Example)

Frequently Asked Questions (FAQ)

Common questions about Surlid (FAQ)

Q: How does Surlid differ from amoxicillin or other common antibiotics?

Surlid is classified as a macrolide antibiotic, while drugs like amoxicillin belong to the penicillin class. This difference means they use distinct mechanisms to fight bacteria.

Official information states that macrolides like Surlid work by targeting and blocking the protein-making machinery (the 50S ribosomal subunit) within susceptible bacteria, which halts their growth.


Q: What conditions or infections is Surlid officially approved to treat?

Regulatory documents generally list Surlid (Roxithromycin) as being authorized for treating infections caused by specific susceptible microorganisms.

These commonly include infections in the respiratory tract (like certain types of pneumonia and pharyngotonsillitis), acute otitis media (middle ear infection), and certain skin and soft tissue infections.


Q: Can Surlid cause dizziness or affect my ability to drive?

Official product information notes that Surlid can cause adverse effects such as dizziness or make a person feel drowsy. Because of these potential effects on the nervous system, regulatory information suggests that people who use the medication determine how it affects them before driving or operating machinery.


Q: What types of foods or drinks should be avoided while taking Surlid?

Surlid is typically administered on an empty stomach (at least 15 minutes before or 3 hours after a meal) because consuming food can decrease its absorption into the body.

Furthermore, some regulatory bodies include a statement about avoiding alcohol during treatment, as it may potentially worsen associated side effects.


Q: Is Surlid known by any other brand names in different countries?

Yes, the active ingredient in Surlid is Roxithromycin, and this active substance is marketed under various brand names in different countries.

Examples found in international regulatory databases include Rulide and Roxithromycin Sandoz.


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

Regulatory documents confirm that co-administration with certain blood thinning medicines, specifically Vitamin K Antagonists (like Warfarin), is associated with an increase in the International Normalized Ratio (INR).

Monitoring of this lab value is an officially required part of co-administration.


Q: Can Surlid affect the effectiveness of oral contraceptive pills?

Regulatory documents on drug interactions indicate that Roxithromycin, the active ingredient in Surlid, does not appear to interact with oral contraceptives (birth control pills).


Q: Is Surlid known to cause stomach upset more often than other antibiotics?

Official safety information classifies Gastrointestinal Disorders as the most common type of adverse reaction reported for Surlid (Roxithromycin).

These common effects include nausea, vomiting, diarrhea, and abdominal pain.


Q: What should a patient expect if they feel Surlid is not working for their infection?

Regulatory guidance suggests that if the symptoms of the infection do not improve within a few days of starting Surlid, or if the symptoms worsen, the need for consultation with a healthcare professional is suggested.

Regulatory documents describe the course as continuing for a few days after clinical signs of the infection have improved.


Q: How does the EMA or FDA classify the safety profile of Surlid?

Regulatory agencies, such as the TGA in Australia, use classification systems to describe a drug's safety status. For instance, Roxithromycin's use in pregnancy is classified under a category (e.g., B1).

Despite the use of these categories, the medication is generally not recommended for use during pregnancy.


Q: How long does Surlid typically stay in the body after the last dose is taken?

Regulatory pharmacokinetic data indicates that Surlid has a specific serum half-life, which is the time required for the amount of drug in the blood to decrease by half.

Official documents note that this half-life is increased in patients with severe hepatic (liver) failure, meaning the drug takes longer to clear the body in that population.


Q: Can Surlid cause changes in mood or anxiety?

Official safety documents do not specifically list mood changes or anxiety as adverse reactions. However, documented effects on the Nervous System include reactions like headache, dizziness, and confusion, which are listed as having an unknown frequency.


Q: Why is Surlid sometimes prescribed when first-line treatments haven't worked?

Official information on the drug's mechanism mentions that its ability to work is constrained by bacterial resistance, meaning some bacteria have developed ways to counteract it.

Surlid is used to target infections caused by specific types of bacteria that are known to be susceptible to this drug class.


Q: Is it normal to feel tired or fatigued while taking Surlid?

Official safety documents do not explicitly list fatigue. However, they do state that the drug may make a person feel drowsy or cause other Nervous System effects like dizziness, which may contribute to a feeling of being tired.

How should Surlid be stored and disposed of?

How to Store and Dispose of Surlid (Roxithromycin)

Official Storage Conditions

Surlid tablets must be stored at a temperature below 25°C in a cool, dry place. The medicine must be protected from light and moisture and kept away from direct sunlight. The tablets should remain in their original container or blister pack until the time of use to maintain stability.

Child-Safety and Disposal Requirements

It is a mandatory regulatory requirement to keep Surlid out of the sight and reach of children. Regarding disposal, any unused or expired Surlid must be returned to a pharmacist or an approved collection point for safe disposal. This prevents environmental contamination and misuse; do not discard the medicine in household waste or wastewater.

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

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