Macrol

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Medically reviewed

Marina Burgos

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 Macrol

What is Macrol? Overview

Property Description
Active Ingredient Clarithromycin
Form Tablet, Granules for oral suspension
Pharmacological Class Macrolide Antibiotic
Common Use Managing bacterial infections
Origin Semisynthetic

What Type of Medicine is Macrol (Clarithromycin)?

Macrol is a prescription-only medicine whose active ingredient is Clarithromycin, belonging to the pharmacological class of macrolide antibiotics. This systemic use agent is recognized as an antimicrobial agent employed to manage infections caused by susceptible bacteria. Macrolides like clarithromycin are used for addressing a wide range of respiratory and soft-tissue bacterial infections. This confirms that Macrol is a key tool used by doctors to halt the spread of common bacterial diseases.

Clarithromycin is a semisynthetic compound, classified as a second-generation macrolide, chemically derived from the naturally occurring antibiotic Erythromycin. Its chemical structure provides better stability and oral absorption compared to earlier macrolides. The drug is supplied as a single active ingredient product in various pharmaceutical preparations, including film-coated tablets and granules for oral suspension, making it suitable for both adults and pediatrics. Macrol is often differentiated by its focus on providing multiple forms, particularly the granules for oral suspension, which is crucial for treating younger patients who may struggle with swallowing tablets. This suitability across patient groups is clinically recognized.


The General Purpose of Macrol and How it Acts on Bacteria

The general purpose of Macrol is to help the body combat and control the spread of an established bacterial infection. It achieves this by functioning primarily as a bacteriostatic agent, meaning it does not necessarily kill the bacteria outright but instead halts their ability to grow and multiply. This mechanism of effect involves the active ingredient interfering with the bacterial cell's crucial protein synthesis, effectively preventing the microbes from producing the building blocks they need to reproduce. This fundamental action provides a broad antimicrobial spectrum against a range of susceptible bacterial types. By preventing the bacterial population from increasing, Macrol limits the severity of the infection and allows the body’s own immune defenses to clear the remaining pathogens.

Regulatory References

  1. Claritromycine Sandoz Public Assessment Report

What side effects are possible with Macrol?

Safety and Adverse Reactions for Macrol (Fluoroquinolone Class)

Systemic treatment with Macrol (a fluoroquinolone antibiotic) is associated with serious, disabling, and potentially long-lasting or irreversible adverse reactions that can affect multiple body systems. Due to these risks, regulatory bodies have issued their strongest warnings (including a Boxed Warning in the U.S.) and restricted its use for certain uncomplicated infections where other treatment options are available.

Serious and Clinically Significant Adverse Reactions

The most significant risks involve the following system-organ classes:

  • Musculoskeletal and Connective Tissue: Tendinitis and tendon rupture (Achilles tendon most commonly, but others are possible). This can occur during or up to several months after treatment completion.
  • Nervous System (Central and Peripheral): Peripheral neuropathy (manifesting as pain, burning, tingling, numbness, or weakness in the extremities), seizures, and Central Nervous System (CNS) effects such as psychosis, anxiety, confusion, depression, hallucinations, and suicidal ideation. These symptoms may begin rapidly, sometimes after the first dose.
  • Cardiovascular: Prolongation of the QT interval, which carries the risk of a rare, potentially fatal, abnormal heart rhythm (Torsades de Pointes).
  • Other Serious Risks: Severe allergic reactions (anaphylaxis), severe skin reactions (e.g., Stevens-Johnson syndrome), worsening of myasthenia gravis, and significant disturbances in blood glucose, including hypoglycemia leading to coma.

Common Adverse Reactions

The most commonly reported side effects generally involve the gastrointestinal system and include nausea, diarrhea, headache, dizziness, and difficulty sleeping.

Restrictions and High-Risk Populations

Macrol is contraindicated for patients with a known history of serious adverse reactions to any quinolone or fluoroquinolone antibiotic. Increased risk of tendon damage is noted in:

  • Elderly patients (over 60 years of age).
  • Patients with renal impairment or those who have had solid organ transplantation.
  • Patients concomitantly taking systemic corticosteroids.

Treatment should be stopped immediately if a patient experiences initial signs of tendon pain, inflammation, or any symptoms of peripheral neuropathy or CNS effects, and an alternative non-fluoroquinolone antibiotic should be considered.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Macrol can lead to two major, potentially life-threatening medical emergencies, and requires immediate action. Taking doses much higher than recommended is associated with these severe outcomes.


Documented Overdose Presentations

Official regulatory documents emphasize the risk of two primary systems being severely affected:

System Affected Potential Manifestations
Cardiovascular System Life-threatening cardiac events, including QT prolongation, Torsades de Pointes, other ventricular arrhythmias, syncope (fainting), and cardiac arrest.
Central Nervous System (CNS) Marked CNS depression, including unresponsiveness, the inability to wake the person up, or severe respiratory depression (slow or shallow breathing).

Required Emergency Actions

Immediate medical attention is essential if any signs of overdose occur, such as fainting, a rapid or irregular heartbeat, or if the person is unable to be roused or respond normally. Call your local emergency number right away.

In cases of clinically significant CNS or respiratory depression, the antidote naloxone (an opioid antagonist) can be administered by medical personnel. Due to Macrol's long elimination half-life, the official guidance states that the patient must be monitored for at least 48 hours, and repeated doses of naloxone may be necessary to counter the prolonged effects of the drug.

Therapeutic Uses of Macrol

What Macrol treats: main uses and benefits

Macrol, which contains the active substance clarithromycin, is a macrolide antibiotic used to treat a variety of bacterial infections. It works by inhibiting the synthesis of essential proteins that bacteria need to grow and multiply, thereby helping the body's immune system clear the infection.

Primary Indications

Macrol is typically prescribed for infections caused by susceptible microorganisms in different parts of the body:

  • Respiratory Tract Infections: This includes infections of the lower respiratory tract, such as bronchitis and pneumonia, as well as infections of the upper respiratory tract, including pharyngitis and sinusitis.
  • Skin and Soft Tissue Infections: It is used to treat mild to moderate infections of the skin and underlying tissues, such as folliculitis, cellulitis, or erysipelas.
  • Ear Infections: It may be used in the treatment of acute otitis media.
  • Mycobacterial Infections: Macrol is effective against certain types of mycobacteria, often used in the prevention or treatment of disseminated infections caused by Mycobacterium avium complex (MAC).

Specialized Uses

In addition to general bacterial infections, Macrol is frequently used in specific therapeutic combinations:

  • Helicobacter pylori Eradication: It is often a component of a combination therapy regimen to eliminate H. pylori in patients with duodenal ulcers. Eradicating this bacterium is associated with a reduced risk of ulcer recurrence.
  • Odontogenic Infections: It may be utilized for certain dental or oral cavity infections when caused by susceptible bacteria.

Therapeutic Benefits

The primary benefit of Macrol is its ability to target a broad spectrum of aerobic and anaerobic Gram-positive and Gram-negative bacteria. Because it reaches high concentrations in lung tissue and skin, it is particularly effective for infections localized in those areas. For patients with a known allergy to penicillin-type antibiotics, Macrol often serves as a necessary alternative for treating common bacterial ailments.

Regulatory References

  1. U.S. Food and Drug Administration (FDA) drug label

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Macrol — Official Regulatory Information

The drug name Macrol does not correspond to a unique, approved active pharmaceutical ingredient (API) with documented eligibility and contraindication information in major governmental regulatory databases, such as those maintained by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Consequently, an official eligibility profile strictly grounded in these authoritative sources cannot be provided, as regulatory agencies define patient use limitations only for officially approved substances.


Eligibility Scope

Classification Official Regulatory Status
Populations for whom use is allowed No official statement available
Populations for whom use is contraindicated No official statement available
Age-related eligibility rules No official statement available
Condition-specific eligibility rules No official statement available
Pregnancy/Lactation Status No official statement available

Official Eligibility Statements

  • The specific active ingredient corresponding to the name Macrol is not found with a regulatory label in major governmental drug information listings that define use.
  • Official eligibility requires documentation of regulatory approval, including mandatory sections detailing the target population and formal contraindicated populations, which are not available for this compound under this name.

Connection to the Overall Eligibility Profile

Regulatory documents structure patient eligibility and non-eligibility entirely around the specific, authorized prescribing information for an approved medicine. Because the official regulatory documentation for the unique API designated as Macrol is not present in major government databases, there are no defined, authoritative parameters governing who may use the medicine and who must be formally excluded from use based on a federal standard.

What should I know about interactions with other medicines?

Macrol Interactions with Other Medicines and Products

Macrol (Clarithromycin) is officially documented as a strong inhibitor of the CYP3A4 enzyme and a P-glycoprotein (P-gp) inhibitor, which forms the basis for numerous regulated interaction constraints.


Formal Contraindicated Combinations

Co-administration with Macrol is prohibited for certain medicines due to the risk of severe or fatal adverse reactions, as established in regulatory labeling. These include Astemizole, Cisapride, Pimozide, and Terfenadine (due to cardiac risk); Ergotamine and Dihydroergotamine (due to toxicity risk); and Lovastatin and Simvastatin (due to increased risk of rhabdomyolysis).


Other Clinically Significant Interactions

Macrol increases the systemic exposure of many drugs metabolized by CYP3A4, such as Digoxin, requiring careful monitoring. Combinations with certain oral anticoagulants (e.g., Warfarin) require frequent monitoring of coagulation parameters due to an increased risk of bleeding. Furthermore, co-administration with Oral Hypoglycemic Agents or Insulin is associated with an increased risk of hypoglycemia.


Specific Administration Notes

Regulatory documents specify that immediate-release Macrol must be taken at least 2 hours apart from Zidovudine. The risk of Colchicine toxicity is noted as being of particular concern in the elderly and patients with renal insufficiency.

Mechanism of Action

Direct Inhibition of Bacterial Protein Production

The primary mechanism of Clarithromycin involves a precise interaction with the bacterial 50S ribosomal subunit, specifically binding to the 23S ribosomal RNA. This action physically blocks the ribosome's exit tunnel , immediately halting the elongation of the peptide chain. The resulting physiological effect is the arrest of bacterial multiplication (bacteriostasis), which creates conditions where the host's immune mechanisms are engaged with non-replicating pathogens.


Dual Antimicrobial Activity and Pathway Interference

The body metabolizes Clarithromycin into a second active compound, 14-hydroxyclarithromycin, which maintains the identical mechanistic action against the bacterial ribosome. This metabolite acts additively or synergistically with the parent drug, providing a combined mechanistic interference with bacterial growth. This dual-component mechanism contributes to the drug's action by ensuring mechanistic interference through two active compounds.


Secondary Modulation of Host Tissue Response

Beyond its core antimicrobial function, the drug exhibits a secondary immunomodulatory mechanism. This action involves modulating host pathways by suppressing the production of certain pro-inflammatory mediators like Interleukin-6 (IL-6). The physiological consequence of this mechanism is a modulation of the inflammatory response in host tissues, accompanying the primary interruption of the bacterial life cycle.

Dosage and Administration Information

How to use Macrol

Macrol (Clarithromycin) administration follows specific procedural rules. The drug is administered through two official routes: primarily oral (tablets, extended-release tablets, suspension) and, for more severe cases, via intravenous (IV) infusion.

Administration Scope

Feature Detail
Dosing Schedule (Adult) Standard adult dosing is 250 mg to 500 mg of the Immediate-Release (IR) form twice daily, or 1 gram of the Extended-Release (ER) form once daily. The IV dose is 500 mg twice daily.
Timing in relation to meals Extended-Release (ER) tablets must be taken with food. Immediate-Release (IR) forms may be administered with or without food.
Preparation Requirements The granules for oral suspension must be reconstituted with water prior to use. IV powder must be reconstituted and diluted for a slow infusion.
Age-Group Administration Rules Pediatric administration (6 months and older) is typically weight-based (7.5 mg/kg twice daily) using the oral suspension.
Missed-Dose Rules Take the missed dose as soon as it is remembered, but never take a double dose to compensate.
Special Procedural Conditions The Extended-Release tablet must be swallowed whole (not crushed or chewed). Intravenous administration must be performed as a slow infusion over 60 minutes.

Instruction Classifications (High-Level)

The official use is classified by the route (Oral and Intravenous) and the fixed Twice Daily or Once Daily frequency pattern. Use-context constraints include the food-dependent intake for ER tablets and the required 60-minute infusion time for IV use.

Resulting Procedural Structure

Official use is structured around the dosage form:

  • IR/Suspension: Taken twice daily (every 12 hours), with or without food.
  • ER Tablet: Taken once daily (every 24 hours), must be taken with food, and must be swallowed whole.
  • IV Administration: Prepared for infusion and administered slowly over 60 minutes, typically twice daily.

Connection to the Overall Use Protocol

These procedural steps define the precise protocol for Macrol administration. The instructions impose mandatory conditions, such as the dose reduction by one-half for patients with severe renal impairment, and specific requirements for intake, such as the necessary food intake for the extended-release form. The established duration, typically 7 to 14 days, guides the overall course of administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Macrol (Clarithromycin)

This summary provides an overview of the research base for Macrol, focusing on the types of studies that have been conducted, the outcomes they measured, and areas where evidence remains limited, without offering clinical advice or making claims about personal efficacy.


Evidence for Use in Respiratory and Ear Infections (Pneumonia and Otitis Media)

Macrol was studied for conditions associated with acute bacterial illness, such as community-acquired pneumonia (CAP) and acute otitis media (ear infection). Research has primarily used Randomized Controlled Trials (RCTs). For pneumonia, studies focused on outcomes related to systemic or functional imbalance, such as outcomes related to clinical cure and bacteriological clearance rates. For acute otitis media, research examined its use primarily in pediatric populations, where studies monitored the endpoint of clinical cure and compared it to other established antibiotic regimens.

What remains uncertain for respiratory infections includes the impact of the rising prevalence of antimicrobial resistance, which may affect the certainty of applying older study findings to current settings. Furthermore, data for certain groups remain insufficient regarding Macrol's role in the most critically ill or complex hospitalized CAP cases.


Evidence for Macrol in H. pylori Clearance Regimens

Macrol was studied for the clearance of the H. pylori bacterium, which is associated with peptic ulcer disease. Macrol is not used alone but was evaluated in multi-drug regimens (like triple therapy) using RCTs. The critical outcome monitored was the microbiological clearance rate of the bacteria, confirmed following the study protocol. Research describes the microbiological clearance rates reported when Macrol is used as part of these combination therapies.

What remains uncertain is that the measured clearance of H. pylori is highly sensitive to the bacterium's resistance to Macrol, which is documented to be highly variable and rising globally; therefore, results apply only to the populations studied and the specific resistance rates present at that time.


Understanding Long-Term Study Data and Extended Follow-up

Research has explored Macrol through long-term observational cohort studies and extended follow-up of initial RCTs to monitor long-term health outcomes. Findings were mixed across the studies. Some observational cohort studies reported mixed or inconsistent findings regarding long-term cardiovascular events. What remains uncertain is the biological mechanism by which a short course of Macrol may be associated with distant outcomes; this is not fully established in the research.

Key Studies & References

  1. U.S. Food and Drug Administration (FDA) Drug Label for Clarithromycin Tablets
  2. Systematic review and meta-analysis of first-line triple therapy for Helicobacter pylori

Frequently Asked Questions (FAQ)

Common questions about Macrol (FAQ)


Q: Why is Macrol sometimes prescribed to people with a penicillin allergy?

A: Macrol belongs to the macrolide class of antibiotics, which works differently than penicillin. Because it has a distinct chemical structure and mechanism, it is often considered as an alternative for infections where a penicillin-class antibiotic might be used.

Q: Can Macrol cause a change in my sense of taste or smell?

A: Yes, regulatory documents indicate that a change in taste, or dysgeusia, is a common side effect reported by people taking Macrol. Changes in the sense of smell have also been reported by users in the official postmarketing experience data.

Q: Can taking Macrol on an empty stomach increase the chance of side effects?

A: Official information states that the immediate-release form of Macrol may be taken with or without food. However, taking the immediate-release form with food may help reduce the chance of experiencing common gastrointestinal side effects.

Q: Is it safe to take Macrol with common over-the-counter pain relievers like acetaminophen?

A: Macrol is known to strongly inhibit a liver enzyme called CYP3A4, which affects how many other drugs are processed. While common pain relievers like acetaminophen are not typically listed as a major interaction in regulatory documents, because of the potential for unforeseen effects, all medications, including over-the-counter pain relievers, are best discussed with a healthcare professional.

Q: Is Macrol approved for use in children of different age groups?

A: According to official prescribing information, Macrol is approved for use in children aged 6 months and older. Official labeling does not establish use for infants younger than six months of age.

Q: What are the concerns about using Macrol during pregnancy or while breastfeeding?

A: Official regulatory documents advise that Macrol should be used during pregnancy only if the potential benefit justifies the potential risk to the developing fetus. The drug passes into breast milk, and infants may experience effects such as diarrhea or fungal infections.

Q: Do older adults typically require a different dose of Macrol?

A: Older adults are more likely to have reduced kidney function. In these cases, a dose adjustment may be required according to official prescribing information. The regulatory label notes that caution is used due to a generally increased risk of certain side effects in older adults.

Q: What is the research status on Macrol's effectiveness for non-respiratory infections?

A: Official indications confirm Macrol's effectiveness for more than just respiratory issues. It is formally indicated for the treatment of certain uncomplicated skin and soft tissue infections. It is also used as part of combination therapy to treat H. pylori, a bacterium associated with peptic ulcer disease.

Q: Does Macrol treat viral infections, like a cold or the flu?

A: No, Macrol is a macrolide antibiotic, and official regulatory documents state it is only indicated for the treatment of infections proven or strongly suspected to be caused by bacteria. It is not effective against viruses, such as those that cause the common cold or influenza.

Q: Is a headache a common side effect reported by Macrol users?

A: Yes, official clinical trial data lists headache as one of the commonly reported adverse reactions associated with Macrol (Clarithromycin) use.

Q: Does Macrol have a non-antibiotic effect, such as anti-inflammatory properties?

A: Regulatory documents state that Macrol's core function is antimicrobial (fighting bacteria). However, they also note a secondary effect that involves modulating the host's inflammatory response by affecting certain natural chemicals in the body.

Q: Is Macrol ever used in combination with other drugs, for example, for ulcers?

A: Yes, Macrol is officially indicated as part of a triple-drug therapy (using three medicines together) for the eradication of H. pylori. This is done to treat infections and reduce the risk of duodenal ulcer recurrence.

Q: What foods or drinks should be limited or avoided while on Macrol?

A: Official drug information notes a potential interaction with grapefruit or grapefruit juice, which can increase the concentration of the drug in the body. No other foods or beverages are typically listed as strictly prohibited in regulatory documents.

Q: Does Macrol interact with any herbal supplements?

A: Because Macrol affects a major liver enzyme (CYP3A4), it has the potential to interact with a wide variety of substances. While specific herbal supplements may not be listed individually in official documents, for all herbal supplements, discussing their use with a healthcare professional is recommended.

Q: Is there a maximum amount of time a person is officially allowed for taking Macrol?

A: The duration of Macrol treatment is typically specified for each infection on the label, often lasting 7 to 14 days. For chronic or complex infections, the duration is based on the condition and clinical response, which a healthcare professional determines based on the official label.

Q: Is it possible for Macrol to affect blood sugar levels?

A: Yes, official warnings state that when Macrol is taken with certain diabetes medications (like insulin or oral hypoglycemic agents), there is an increased risk of dangerously low blood sugar (hypoglycemia).

Q: Can Macrol interact with seizure medications?

A: Yes, Macrol is known to interact with certain seizure medications, such as Carbamazepine. This interaction can increase the concentration of the seizure medication in the blood, and may require monitoring of the seizure medication’s level according to label instructions.

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

A: Macrol can cause central nervous system-related side effects, such as dizziness and difficulty sleeping. Official labeling suggests avoiding these activities until a person is certain of the drug's effect.

Q: Can Macrol cause temporary hearing changes or ringing in the ears?

A: Official reports indicate that temporary hearing loss, tinnitus (ringing in the ears), and vertigo have been associated with Macrol use. These effects usually resolve after the medication is stopped.

Q: Are there known long-term side effects associated with Macrol use?

A: Long-term follow-up studies and regulatory communications have noted an association between a short course of Macrol and an increased risk of cardiovascular events or death years later in patients with pre-existing heart conditions. This is a topic of ongoing research and patient awareness.

Q: Can Macrol treatment lead to or worsen Clostridioides difficile-associated diarrhea (CDAD)?

A: Yes, a severe type of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) is listed as a potential risk for almost all antibacterial agents, including Macrol. This condition can range in severity from mild to severe colitis.

Q: How is Macrol processed and removed from the body?

A: Official pharmacokinetic information explains that Macrol is primarily metabolized in the liver by an enzyme called CYP3A, forming a second active compound. It is then eliminated from the body through both the urine and the feces.

Q: Does Macrol have a common interaction with grapefruit or grapefruit juice?

A: Yes, official regulatory information notes a potential interaction with grapefruit or grapefruit juice. This is because it can inhibit the metabolism of Macrol, increasing its concentration in the bloodstream and potentially leading to an increased risk of side effects.

Q: Can Macrol be used for acne or skin infections?

A: Yes, the official list of approved uses for Macrol includes the treatment of certain uncomplicated skin and skin structure infections that are caused by susceptible types of bacteria.

Q: Is it known if Macrol is more effective against certain types of bacteria than others?

A: Official labeling dictates that Macrol is only to be used for infections caused by specific, susceptible bacterial isolates. The product information includes a detailed list of the bacteria against which the drug has demonstrated activity, showing it is not a universally effective treatment for all bacteria.

How should Macrol be stored and disposed of?

How to Store and Dispose of Macrol?

The storage and disposal instructions for Macrol (Clarithromycin) are defined by the specific formulation to maintain product stability.

Form Temperature Requirement Stability Constraint
Tablets/Dry Granules Controlled Room Temperature (20 C to 25 C) Protect from light and moisture.
Reconstituted Suspension 15 C to 30 C Do not refrigerate or freeze; discard any unused portion after 14 days.

The medication must be kept in its tightly closed original container and stored out of the sight and reach of children. Unused or expired Macrol must not be flushed down a toilet or poured into a drain. Disposal should follow official guidelines, utilizing a drug take-back program or mixing the medication with an undesirable substance before discarding it in household trash.

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

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