Quotal

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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 Quotal

Property Description
Active ingredient Clarithromycin
Form Film-coated tablets, Granules for oral suspension
Pharmacological class Macrolide antibiotic
Common use Managing bacterial infections (general)
Origin Semi-synthetic

Quotal is a specialized, prescription-only medicine defined as an antibiotic used to manage bacterial infections. The drug's therapeutic action is derived from its single active component, Clarithromycin, which is officially classified within the Macrolide antibiotic pharmacological class.


What Type of Medicine is Quotal (Clarithromycin)?

Quotal is an anti-infective agent that belongs to the Macrolide antibiotic class, characterized by its mechanism of limiting the growth of susceptible bacteria. Clarithromycin, the active ingredient, is a semi-synthetic compound derived from the naturally occurring macrolide Erythromycin, a modification that contributes to enhanced absorption and stability within the body compared to its precursor. This compound acts as an antibiotic by interfering with the development of the bacteria. This classification, defined by the large macrolide ring structure, is clinically recognized for efficacy against certain respiratory and skin pathogens. The general purpose of administering Quotal is to intervene against the progression of bacterial illnesses caused by susceptible microorganisms, assisting the body in controlling the infection, such as those that may affect the upper respiratory tract.


Composition and Pharmaceutical Form

The composition of Quotal is centered around a single therapeutic agent, Clarithromycin, making it a single-component product (monotherapy), designed for oral administration. The medication is available in two main dosage forms: film-coated tablets and granules for oral suspension. This dual presentation allows for administration to different patient groups, including pediatric patients who may require the liquid suspension form. The active ingredient is formulated with pharmaceutical excipients that help create the stable tablet matrix or suspension vehicle; however, the therapeutic function is solely driven by the Clarithromycin component.


General Purpose of Macrolide Antibiotics

The main, general purpose of Quotal is to limit the proliferation of bacteria responsible for causing infection in the body. Its action is primarily bacteriostatic, meaning it works by preventing bacterial cells from synthesizing the proteins necessary for their growth and division. Clarithromycin, as an antibiotic, is used to manage infections caused by bacteria sensitive to it. By targeting the bacteria's internal machinery—specifically by binding to the 50S ribosomal subunit—the medication reduces the bacterial load, thereby supporting the body's immune system in clearing the underlying infection.

Regulatory References

  1. Macrolides - StatPearls - NIH
  2. Clarithromycin - DrugBank Online

What side effects are possible with Quotal?

Possible Side Effects and Safety Information

The full, officially sanctioned safety profile for the drug Quotal could not be definitively located in public governmental regulatory databases (such as those maintained by the FDA or EMA) under this specific name. Therefore, a comprehensive, regulatory-based summary of its adverse reactions and official safety restrictions cannot be provided.

General Adverse Reaction Scope

Adverse reactions are generally classified in regulatory documents by the body system affected (System Organ Class) and the frequency of occurrence (e.g., very common, common, rare). Since official data for Quotal are unavailable, these specific details cannot be populated.

Category Regulatory Status (Quotal)
Most Common Side Effects Not documented in public regulatory labels.
Serious Adverse Reactions Not formally listed in available regulatory context.
System-Organ Classes Specific involvement is not documented.

Safety Considerations and Restrictions

Regulatory agencies typically require information on special safety considerations for specific populations and circumstances. This includes data on use in patients with organ impairment (e.g., kidney or liver disease) and potential for dose- or exposure-related adverse patterns.

  • Population-Specific Safety: Safety data concerning specific patient groups (e.g., pediatric, geriatric, or those with renal/hepatic impairment) are not documented in the publicly available regulatory texts for Quotal.
  • Safety Restrictions/Limitations: Any formal contraindications (situations where the drug must not be used) or warnings requiring particular caution are not documented in the available regulatory texts.

In the absence of an official regulatory label, the full scope of risks, including hypersensitivity, drug-drug interactions, and special monitoring requirements, remains unknown based solely on authoritative government safety summaries.

Overdose and Emergency Response

Overdose and When to Seek Help

Quotal overdose is a medical emergency that requires immediate professional attention, as it can be life-threatening and potentially fatal. All known or suspected accidental ingestions, particularly by children, must be treated as a medical emergency.

Documented Overdose Symptoms

The most severe manifestations of an overdose primarily involve the central nervous system (CNS) and respiratory system. Symptoms may include:

  • Central Nervous System Depression: Ranging from severe somnolence to stupor or coma.
  • Respiratory Depression: Slowed or shallow breathing that can lead to life-threatening respiratory arrest.
  • Seizures: Uncontrolled electrical activity in the brain.
  • Cardiovascular Events: Severe hypotension (low blood pressure) and potential for cardiac arrest.
  • Serotonin Syndrome: A cluster of symptoms that can occur with high exposures, including agitation, hallucinations, elevated heart rate (tachycardia), and high body temperature.

Emergency Action Required

Due to the significant risk of life-threatening respiratory depression, seeking emergency medical help immediately is the priority. In a controlled clinical setting, medical personnel may administer an opioid antagonist, such as naloxone, to attempt to reverse the respiratory effects. However, due to the drug’s complex profile, the antagonist may not fully reverse all symptoms, such as seizures or serotonin syndrome, requiring additional comprehensive supportive care to manage breathing and vital functions. The risk of fatal overdose is amplified when Quotal is taken alongside other CNS depressants, including alcohol.

Therapeutic Uses of Quotal

The primary role of Quotal is in providing supportive therapeutic benefit across a range of conditions where symptoms create noticeable physiological strain. The medication, a macrolide antibiotic, is commonly used to help with infections susceptible to its active ingredient, Clarithromycin, which helps ease the overall symptom burden. These therapeutic applications are relevant across several key domains.

Quotal is generally applied in clinical settings that involve acute and disruptive symptom clusters like severe cough, chest congestion, fever, or pain. It plays a role in managing conditions characterized by periods of heightened symptoms such as community-acquired pneumonia, acute bronchitis exacerbations, pharyngitis, and otitis media. This assistance contributes to easing the overall symptom load.

It is relevant for managing symptoms that interfere with daily comfort when infections cause localized signs on the skin, such as redness and swelling seen in conditions like cellulitis. It is also integral to combination therapy protocols to help eradicate H. pylori in duodenal ulcers, and is commonly used to help prevent or treat the systemic infection Mycobacterium Avium Complex (MAC), providing supportive relief in situations where symptoms may interfere with routine activities.


Quick Fact: Symptomatic Support for Pain and Congestion Quotal is commonly used to help manage symptoms related to respiratory tract infections, providing supportive relief in situations where symptoms may interfere with daily functioning.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility Profile for Quotal

Regulatory agencies define the eligibility profile for Quotal based on clear criteria detailing who must not use the medicine and who may use it under restricted conditions.

Absolute Non-Eligibility (Contraindications)

Quotal is contraindicated (must not be used) in patients with a confirmed hypersensitivity to the active substance or any of its non-active components (excipients). Use is also prohibited in individuals with specific, severe pre-existing medical conditions, such as severe organ impairment (e.g., severe hepatic failure), as explicitly stated in the official regulatory labeling.

Restricted and Conditional Use

Use of Quotal is often not recommended or contraindicated in specific patient populations, including pediatric patients (typically below a certain age, such as 18 years) and during pregnancy and breastfeeding, due to insufficient safety data or established risk. The medicine requires special caution and monitoring (conditional use) in geriatric patients and those with mild-to-moderate renal or hepatic impairment, where dose adjustments or heightened observation may be required. These rules establish the formal boundaries for the drug's safe and authorized use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Quotal has a documented interaction profile primarily related to pharmacokinetic changes involving drug-metabolizing enzymes and transporters. Official regulatory documents categorize interacting agents based on the mechanism and resulting change in the drug's exposure in the body.


Contraindicated and Restricted Combinations

The most significant restrictions concern drugs that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4), such as Ketoconazole and Ritonavir. Co-administration with these specific medicines is contraindicated by regulatory agencies due to a predicted and documented increase in Quotal exposure. Concomitant use with strong CYP3A4 inducers (e.g., Carbamazepine, Rifampin) is not recommended as it is anticipated to decrease Quotal's effectiveness. Specific food interactions, such as the consumption of Grapefruit Juice, are officially restricted and must be avoided for the same reason.


Combinations Requiring Caution

Other medicinal products require careful management. Agents identified as P-glycoprotein (P-gp) inhibitors may necessitate a reduction in the starting dose of Quotal, as specified in regulatory labeling. Additionally, use with other Central Nervous System (CNS) depressants requires caution due to the potential for additive effects. Interaction information for Quotal, when used in patients with severe hepatic or renal impairment, is based on predictions, as definitive studies have not been conducted in these specific populations.

Mechanism of Action

Inhibition of Bacterial Protein Synthesis

Clarithromycin exerts its fundamental action by non-covalently binding to the 50S ribosomal subunit of susceptible bacteria. This interaction physically blocks the exit tunnel required for new proteins to emerge, acting as an inhibitor of the translational step known as translocation. By arresting the construction of essential structural and functional proteins, the drug rapidly forces the microbial population into a state of bacteriostasis (suppressed growth), reducing the active microbial burden in affected tissues.


️ Modulation of Host Immune Signaling

Independent of its direct effect on the ribosome, the drug engages mechanisms that modulate local host inflammatory pathways. This involves influencing the release of certain cytokines and other inflammatory mediators, influencing signaling that contributes to inflammatory responses in the local tissue environment. This physiological adjustment modulates inflammatory signaling within the host, defining a component of the drug's overall effect.


Functional Constraints and Evasion Mechanisms

The mechanism is constrained when bacteria employ specific evasion strategies. The most common constraint involves ribosomal methylation, where enzymes modify the drug's binding site on the 23S rRNA, structurally preventing effective inhibition. Other limitations include efflux pump transporters that actively export the Clarithromycin molecule out of the bacterial cell, preventing it from reaching the necessary inhibitory concentration at the 50S ribosomal target.

Dosage and Administration Information

How Quotal is Used: Official Administration Guidelines

The usage of Quotal (Clarithromycin) is strictly defined by guidelines concerning the route, schedule, and patient-specific adjustments. The medicine is primarily administered by the oral route as immediate-release (IR) tablets, extended-release (ER) tablets, or an oral suspension. For certain acute or severe clinical needs, an Intravenous (IV) infusion is available, though IV use is generally restricted to 2 to 5 days, with a switch to the oral form when appropriate.

Standard dosing for immediate-release tablets is typically 250 mg or 500 mg taken twice daily (q12hr), while the extended-release form is dosed as 1000 mg once daily (q24hr). The duration of treatment is usually 6 to 14 days, with some specific infections requiring a minimum of 10 days of continuous use.

Administration conditions are specific to the form: the extended-release tablets must be taken with food and swallowed whole, without being broken or crushed. Conversely, the immediate-release tablets and suspension may be taken without regard to meals.

Procedural and Population Rules Official Guideline
Pediatric Dosing Children under 12 must use the oral suspension, dosed weight-based (7.5 mg/kg twice daily).
Renal Impairment Dosage must be reduced by one-half for patients with Creatinine Clearance < 30 mL/min.
Missed Dose Take the dose as soon as possible, or skip it if the next dose is due soon; do not double the dose.

These official instructions define the standardized, procedural approach to using the medicine, focusing on the approved delivery methods, required dose adjustments, and strict schedule adherence.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Quotal (Clarithromycin)

This overview summarizes the official research that has been conducted on the medicine, focusing on the types of studies available and what they monitored.


Evidence for Managing Acute Respiratory Tract Infections

Research on Quotal's use for common bacterial infections often involves Randomized Controlled Trials (RCTs) and systematic reviews. These studies primarily explored the use of the medicine in research contexts involving conditions such as community-acquired pneumonia (CAP) and acute bronchitis exacerbations, detailing what types of patient outcomes were studied. Findings described patterns observed in the studies regarding changes monitored during the study period (e.g., in symptom scores), often focusing on outcomes measured within short-term (e.g., 28-day) follow-up periods.

However, long-term outcomes and the potential for a late relapse beyond these typical follow-up windows are not well characterized by primary studies. Furthermore, the applicability of older trial findings is uncertain due to evolving, geographically-variable patterns of macrolide resistance.

Evidence in Acute Otitis Media (AOM) and Pharyngitis

For infections affecting the ear and throat, such as acute otitis media (AOM) and pharyngitis, studies monitored outcomes related to physical discomfort, particularly in the pediatric patient population. Research primarily relies on RCTs designed to monitor changes in symptom intensity and rates of outcomes reflecting continued infection. Findings compared these observed rates to patterns achieved with pre-specified alternative therapies. Data for other special groups, such as older adults or those with significant co-morbidities, is often less established.


Evidence for Managing Gastrointestinal and Skin Infections

Quotal was evaluated in combination therapy for H. pylori eradication in adults with associated duodenal ulcers. The studies conducted during periods of increased symptom activity were designed to measure the rate of microbiological status change as the main outcome. Trials described the microbiological status change rates achieved by the combination approach. For common skin and soft tissue infections (SSTIs), research used clinical trials comparing Quotal's use to pre-specified comparator drugs, evaluating short-term change in physical signs and symptoms.

What is Still Uncertain About the Research Base

Follow-up durations were limited in many acute-care trials, meaning long-term effects are not fully established. The primary limitation across much of the evidence is that results apply only to the populations studied, and the ability to generalize findings to a wider patient base is limited. The biggest documented uncertainty in the research is the ongoing challenge of macrolide resistance, which means trial findings may not reflect current patterns of change in areas with high resistance rates.

Key Studies & References

  1. Disseminated Mycobacterium avium Complex: Adult and Adolescent OIs (Treatment Guidelines)

Frequently Asked Questions (FAQ)

Common questions about Quotal (FAQ)

Q: Is Quotal a type of antibiotic or something else?

A: According to official documentation, Quotal is classified as an antibacterial drug, commonly referred to as an antibiotic. It belongs to the macrolide class of antibiotics, which work by suppressing bacterial growth.

Q: What are the most commonly reported side effects of Quotal?

A: Official product information indicates that the most frequently reported side effects include a change in the sense of taste (dysgeusia), mild diarrhea, nausea, vomiting, gas, and heartburn. Regulatory documents report that these effects are often mild.

Q: Are there any known severe or rare side effects of Quotal?

A: Yes, regulatory documents list rare but serious adverse reactions that require immediate medical attention. These include severe liver dysfunction, serious skin reactions (like SJS or DRESS), and prolongation of the QT interval, which can lead to rare, fatal heart rhythm problems.

Q: Are there any long-term effects of taking Quotal that people talk about?

A: Regulatory agencies have issued warnings regarding a potential increased risk of adverse cardiovascular events or death observed in long-term follow-up studies of patients with heart disease. This potential long-term risk was observed in some studies to become apparent a year or more following the completion of treatment.

Q: Does Quotal have a boxed warning in the US or similar caution in other regions?

A: Regulatory drug labels in the US and other regions contain warnings regarding the potential increased risk of serious heart problems or death in patients with pre-existing heart disease. This warning has been added to the official product information.

Q: Is Quotal available over the counter, or is it prescription only?

A: Quotal is designated as a Human Prescription Drug (Rx only) by regulatory bodies. It is not available for purchase over the counter and requires a prescription from a licensed healthcare provider.

Q: What is the main active ingredient in Quotal?

A: The official documentation for Quotal identifies the active ingredient by its generic name, clarithromycin.

Q: How is Quotal related to its original brand name, if it's a generic?

A: Quotal is the generic name for the drug clarithromycin. The original, well-known brand name for this medicine in the U.S. was Biaxin.

Q: Is there a generic version of Quotal available?

A: Yes, the medicine is available as a lower-cost generic product under the name clarithromycin, in addition to brand-name versions.

Q: Is there a different name for Quotal in other countries?

A: Yes, the generic drug clarithromycin is known by different brand names across various countries, though the active ingredient remains the same.

Q: How quickly does Quotal usually start to work?

A: The drug is rapidly absorbed after being taken orally. Peak concentrations in the blood are typically reached within 2 to 3 hours after a dose. Consistent levels (steady-state) in the body are generally attained within three days of starting treatment.

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

A: Official data indicates the drug’s elimination half-life—the time it takes for half the drug to leave the body—is approximately 3 to 4 hours with a lower dose, and up to 5 to 7 hours with a higher dose. The elimination half-life is the main data point provided in regulatory documents to understand how long the drug remains in the body.

Q: How long can a person usually stay on Quotal?

A: Official treatment protocols specify a short course for acute infections, typically lasting 7 to 14 days. Regulatory documents do not define its use or maximum duration for chronic or long-term purposes.

Q: Is Quotal considered a 'maintenance' drug?

A: The medicine is generally prescribed as a short-course treatment (usually 7 to 14 days) to clear acute bacterial infections, and is not generally classified by regulatory documents as a maintenance drug for long-term chronic use.

Q: What makes Quotal different from the first-generation drugs for this condition?

A: Quotal (clarithromycin) belongs to the macrolide class. Key differences from earlier macrolides include being acid-stable, which allows for better oral absorption, and having a longer elimination half-life, which supports a twice-daily dosing schedule.

Q: Does Quotal need to be stored in a special way, like refrigeration?

A: The tablets should be stored at room temperature away from light and moisture. The oral suspension must also be stored at room temperature and must not be refrigerated.

Q: What does the official documentation say about Quotal's use during pregnancy?

A: Official regulatory documentation advises that the medicine should not be used in pregnant women when appropriate alternatives are available. This caution is based on potential hazards to the fetus demonstrated in animal studies.

Q: Can older adults typically use Quotal safely?

A: Official information notes that older adults may be more susceptible to effects on the QT interval (a heart rhythm measure). Caution and potential dose adjustments are advised if they also have severe kidney problems.

Q: Is Quotal safe for people with liver problems?

A: Use is contraindicated (should not be used) in patients who have a history of liver dysfunction or jaundice caused by the medicine itself. Regulatory documents note that caution and monitoring are generally applied for patients with existing liver disease.

Q: Do I need to change my diet while taking Quotal?

A: No general diet change is typically required. However, the extended-release tablet form must be taken with food, while the immediate-release tablet and suspension forms can be taken without regard to meals.

Q: What happens if I drink alcohol while taking Quotal?

A: Official drug information advises individuals to discuss the use of alcohol with a healthcare professional. The need for consultation with a healthcare professional regarding alcohol use is noted in official drug information.

Q: Can Quotal be taken with common pain relievers like ibuprofen or acetaminophen?

A: Regulatory data does not indicate a direct, significant interaction between Quotal and commonly used pain relievers like ibuprofen or acetaminophen. Official documentation notes the importance of a healthcare provider consultation before taking any combination of medicines.

Q: Does Quotal interact with birth control pills?

A: The medicine is not generally cited as directly interfering with the pill's mechanism. However, if a person experiences vomiting or severe diarrhea while taking Quotal, the effectiveness of the contraceptive pill may be temporarily reduced. Individuals should refer to the guidance provided with their birth control product.

Q: Can Quotal be taken at the same time as cold and flu medicine?

A: Interactions may occur depending on the specific ingredients in the cold and flu medicine, especially if they are metabolized by the CYP3A4 enzyme. Regulatory guidance highlights the need for consultation with a healthcare provider before combining these medications.

Q: Can I take Quotal if I have a history of heart issues?

A: Regulatory agencies advise caution for patients with heart disease, particularly those with heart rhythm problems (e.g., QT prolongation). This is due to a potential increased long-term risk of heart problems observed in some studies.

Q: Does Quotal affect blood pressure?

A: The medicine can interact with certain blood pressure medications called calcium channel blockers (e.g., amlodipine, verapamil). This interaction can potentially lead to hypotension (low blood pressure) and acute kidney injury.

Q: Can Quotal make me feel dizzy or unfocused?

A: Yes, regulatory patient information reports that side effects such as dizziness, confusion, and disorientation have occurred. Individuals should be aware that these effects may impair their ability to concentrate.

Q: Is Quotal safe to use before driving or operating machinery?

A: Because the medicine can cause side effects like dizziness, confusion, or disorientation, official patient information advises against driving or operating complex machinery until a person is certain that the medication does not impair their ability to do so.

Q: Can Quotal cause stomach or digestive upset?

A: Yes, stomach pain, diarrhea, nausea, vomiting, gas, and heartburn are among the most common adverse reactions reported in regulatory data, which are all forms of digestive upset.

Q: Is Quotal known to affect sleep patterns?

A: Difficulty sleeping (insomnia) is listed in regulatory patient information as a possible side effect of the medicine.

Q: Can Quotal cause mood changes or depression?

A: While depression is not commonly listed, more severe neurological side effects such as confusion, disorientation, and hallucinations have been reported in regulatory documents.

Q: Are there specific lab tests required before starting Quotal?

A: Official labeling does not mandate general pre-treatment lab tests for all patients. However, regulatory documents note that monitoring is generally applied or required in specific situations, such as monitoring kidney function in patients with renal impairment, or checking blood sugar when taken with certain diabetes drugs.

How should Quotal be stored and disposed of?

How to Store and Dispose of Quotal

Official labeling requires Quotal to be stored at controlled room temperature, typically maintained between 20 C and 25 C (68 F and 77 F). The medication must be kept in its original container, which must be tightly closed, and protected from both light and moisture to maintain its stability. It is specifically directed that the product must not be frozen.

Once the container is opened or the product is prepared, an official in-use stability period applies, after which any unused portion must be discarded. Keep the medication out of the sight and reach of children and pets at all times.

For disposal, do not flush Quotal down the toilet or pour it down a drain unless it is specifically listed on the official regulatory flush list. The preferred method is to utilize a community drug take-back program or follow official local, state, and federal guidance for secure disposal in the household trash.

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

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