Klaz

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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 Klaz

Klaz is a prescription-only medication whose active component is Clarithromycin (INN), a single-ingredient product used systemically to manage infections. The drug is classified as a macrolide antibiotic, positioning it as a potent anti-infective agent. The Clarithromycin compound is a semi-synthetic substance derived from the structure of Erythromycin A, an attribute that is clinically recognized for enhancing its stability in the digestive system compared to its predecessors.

Property Description
Active Ingredient Clarithromycin
Form Tablet, Oral Suspension, Extended-Release Tablet
Pharmacological Class Macrolide Antibiotic / Anti-infective Agent
General Purpose To arrest the growth and multiplication of susceptible bacteria
RX Status Prescription Drug (Rx)

Composition, Origin, and Available Forms

As a semi-synthetic substance, Clarithromycin is the sole active ingredient in Klaz. The drug is designed for systemic administration and is manufactured in several dosage forms to suit diverse patient groups. These include standard immediate-release tablets, film-coated tablets, and granules for oral suspension, often used for liquid dosing. The availability of an extended-release tablet formulation (often marketed as Klaz OD) is a distinguishing feature, designed to sustain the therapeutic effect over a longer duration.

General Purpose: Why Clarithromycin is Used

The overarching purpose of Klaz is to manage the progression of microbial illnesses by limiting the ability of bacterial entities to multiply. This anti-infective agent operates primarily as a bacteriostatic agent by targeting the process of bacterial protein synthesis. The Clarithromycin molecule binds to the 50S ribosomal subunit inside the bacterial cell, thereby halting the production of proteins essential for the bacteria's growth and replication. By arresting the microbial life cycle, Klaz provides a clear therapeutic advantage to the host immune system in clearing the underlying bacterial infections.

Regulatory References

  1. NIH StatPearls: Macrolides

What side effects are possible with Klaz?

Possible side effects and safety information

The official safety profile of Klaz (Clarithromycin) is categorized by the frequency and physiological system affected, based on regulatory documentation from authorities like the EMA and FDA. The most frequently observed adverse reactions affect the gastrointestinal system and sensory perception.

Frequency Classification of Adverse Reactions

Classification Representative Adverse Effects
Very Common Dysgeusia (taste perversion)
Common Diarrhea, Nausea, Vomiting, Abdominal pain, Headache, Insomnia, Rash
Uncommon Leukopenia, Hypersensitivity, Vertigo, Palpitations, Hepatitis, Myalgia
Not Known Pseudomembranous colitis, Anaphylactic reaction, Hepatic failure, Stevens-Johnson syndrome, Torsades de pointes

Serious Adverse Reactions and Safety Constraints

The regulatory label documents risks to the cardiac system, including QT interval prolongation and potentially fatal Ventricular Arrhythmias (e.g., Torsades de pointes). The potential for severe Hepatotoxicity is also noted, including rare cases of Fatal Hepatic Failure. Severe skin reactions, such as Stevens-Johnson syndrome (SJS), are listed as serious adverse events.

Safety constraints apply to specific populations. Use is restricted in individuals with known pre-existing QT prolongation or a history of certain ventricular arrhythmias. Furthermore, the label includes specific safety notes for patients with severe renal impairment and those with pre-existing coronary heart disease, due to a documented long-term cardiovascular risk observed years after treatment completion in that specific population.

Overdose and Emergency Response

Overdose and When to Seek Help

Documented Overdose Manifestations

Overdose of Klaz (Clarithromycin) is formally documented as presenting primarily with gastrointestinal symptoms, including abdominal pain, vomiting, nausea, and diarrhea. Regulatory data also reports that ingestion of large amounts has been associated with more severe systemic and neurobehavioral manifestations such as altered mental status, paranoid behavior, and specific laboratory findings like hypokalemia and hypoxemia.


Severe Outcomes and Emergency Response

Official regulatory documents classify the potential for serious outcomes, including the risk of QT interval prolongation and severe ventricular cardiac arrhythmias (Torsades de pointes), as well as significant hepatic dysfunction, which may progress to hepatic failure. Given these risks, any individual experiencing severe adverse reactions, especially those indicative of cardiac or hepatic issues, must seek immediate medical attention. Management guidance mandates the prompt elimination of unabsorbed drug and the provision of symptomatic and supportive treatment.


Management Limitations and Specific Considerations

No specific antidote is known for Klaz. Regulatory statements note that common clearance procedures, such as hemodialysis and peritoneal dialysis, are not expected to be effective in appreciably affecting serum levels. Special consideration is advised for patients with existing severe renal or hepatic impairment, who may be at increased risk of systemic toxicity due as the drug is primarily eliminated via these pathways.

Therapeutic Uses of Klaz

Quick Facts: Uses of Klaz

  • Respiratory Support: Can be used to address infections of the lower respiratory tract, including certain types of pneumonia and bronchitis.
  • Upper Respiratory and Ear Issues: May be prescribed for issues such as tonsillitis, pharyngitis, and acute otitis media (middle ear infection).
  • Skin: Used in the management of uncomplicated skin and soft tissue infections.
  • H. pylori: Indicated for use in combination with other therapeutic agents to manage Helicobacter pylori infection in patients with duodenal ulcers.
  • Mycobacterial Health: Employed to address certain disseminated or localized mycobacterial infections.

Klaz (clarithromycin) is a prescription medication utilized to address a variety of bacterial infections caused by susceptible microorganisms. This medication is primarily indicated for managing conditions affecting the upper and lower respiratory tracts, such as pharyngitis, tonsillitis, and specific cases of bronchitis or community-acquired pneumonia. The therapeutic domains also include the management of acute maxillary sinusitis and otitis media.

In addition to respiratory applications, Klaz is used to manage uncomplicated infections of the skin and soft tissues. It also forms a component of combination therapy for patients with Helicobacter pylori infection, a bacterium associated with duodenal ulcers. Furthermore, it is included in regimens to address or prevent disseminated or localized mycobacterial infections in specific patient populations.

Eligibility and Restrictions for Use

Who can and cannot use Klaz? (Clarithromycin)

Official regulatory documents define strict population eligibility for Klaz, classifying groups for absolute prohibition (contraindications) and conditional use.

Contraindicated Populations (Absolute Non-Eligibility)

Klaz (clarithromycin) is contraindicated in patients with a known hypersensitivity to macrolide antibiotics or a history of cholestatic jaundice linked to prior clarithromycin use. Absolute non-eligibility applies to individuals with documented QT prolongation or ventricular arrhythmia, uncorrected hypokalemia or hypomagnesemia, and those with severe hepatic failure combined with renal impairment. The medicine is also strictly prohibited when co-administered with certain drugs, including lovastatin, simvastatin, ergot alkaloids, pimozide, and lurasidone.

Age and Conditional Use

Eligibility is dependent on age and organ function. Clarithromycin tablets are not suitable for children under 12 years; the oral suspension is the approved formulation for pediatric patients aged 6 months and older, with use not established in infants under 6 months. Caution is required for all patients with impaired hepatic function or severe renal impairment, as these conditions necessitate special regulatory consideration. Use during pregnancy is not recommended unless the therapeutic benefit is essential, while use during lactation is often considered acceptable with caution.

What should I know about interactions with other medicines?

Official Interaction Profile

Klaz (clarithromycin) is officially documented as a potent inhibitor of both the Cytochrome P450 3A4 (CYP3A4) enzyme and the P-glycoprotein (P-gp) transport protein. This dual inhibition significantly alters the systemic exposure of many co-administered medicinal products, which is the regulatory basis for numerous restrictions.

Interaction Type Examples of Affected Substances Constraint
Contraindicated Combinations Cisapride, Pimozide, Lovastatin, Simvastatin, Ergotamine, Dihydroergotamine, Lurasidone, Lomitapide, Ranolazine, Oral Midazolam Co-administration is prohibited due to the risk of dangerously increased drug exposure and associated severe toxicity (e.g., cardiotoxicity, rhabdomyolysis, ergotism).
Exposure-Altering Digoxin, Benzodiazepines, Calcium Channel Blockers, Sildenafil, Warfarin Increased plasma concentrations of these drugs are expected, often necessitating regulatory-recommended monitoring or dose adjustments.
Pharmacodynamic Other QT-prolonging drugs, Colchicine (in certain populations) Additive risks are documented, such as the potential for increased QT prolongation or toxicity.

Required Constraints

The contraindication for Colchicine is conditional: co-administration is strictly prohibited in patients with pre-existing renal or hepatic impairment. Furthermore, to mitigate the reduction of Zidovudine exposure, the administration of Klaz immediate-release tablets and Zidovudine must be separated by an interval of at least 4 hours, as stated in regulatory labeling. The Klaz extended-release formulation must be administered with food to ensure adequate absorption, a specific administration-timing rule.

Mechanism of Action

Inhibition of Bacterial Protein Translation

The primary mechanism of action for Klaz (Clarithromycin) is defined by its ability to act as a highly selective inhibitor of microbial replication. The molecule reversibly targets the 23S ribosomal RNA within the bacterial 50S ribosomal subunit. This binding blocks the translocation step of protein synthesis, preventing the elongation of polypeptide chains. This molecular interference leads directly to the core physiological consequence of cessation of microbial replication and growth.


Modulation of Host Signaling and Resistance

A secondary domain involves the drug acting as a modulator of specific host pathways. Klaz influences host inflammatory pathways by reducing the release of key mediators like IL-8, and affects epithelial fluid regulation through non-competitive inhibition of chloride ion channels. Mechanistically, the drug's effect is limited by bacterial resistance mechanisms, including mathbfribosomal methylation and active drug efflux, which physically interfere with the compound’s ribosomal binding or intracellular concentration.

Dosage and Administration Information

Official Administration Guidelines for Klaz (Clarithromycin)

Klaz is a prescription anti-infective agent administered via two primary routes: oral (using immediate-release tablets, extended-release tablets, or oral suspension) and intravenous (using a powder for solution for infusion). The drug's usage is governed by precise, high-level instructions.

For most adult infections, the standard regimen for the immediate-release (IR) tablet is 250 mg taken twice daily (every 12 hours), while the dose may be increased to 500 mg twice daily for severe infections or as part of combination therapy. The extended-release (ER) tablet is generally administered as 1000 mg once daily.

Administration Condition Procedural Instruction
Timing in Relation to Meals IR Tablets and Suspension: May be taken without regard to food. ER Tablets: Must be taken with food.
Form Handling ER Tablets: Must be swallowed whole; the tablet must not be crushed, broken, or chewed. Suspension: Must be shaken well before use.
Course Duration The typical treatment course ranges from 7 to 14 days, with specific indications like pharyngitis often requiring a 10-day course.

Population-Specific Usage Rules

Official labeling specifies necessary dose modifications for certain populations. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the total daily dosage must be reduced by one-half. Furthermore, the extended-release tablet is not permitted for use in this specific population because the required dose adjustment cannot be achieved with the available strength. In the pediatric population, dosing for the oral suspension is calculated based on body weight, typically 15 mg/kg/day divided every 12 hours.

Recent Clinical Evidence

Research evidence / Overview of Studies for Klaz (Clarithromycin)

Evidence for use in Respiratory Infections (Pneumonia and Bronchitis)

Research on Klaz for lower respiratory tract infections, such as community-acquired pneumonia and acute exacerbations of chronic bronchitis, primarily involves short-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies have been used in research exploring how symptoms change over time in adult and pediatric patient populations. The research examined outcomes related to physical discomfort, including fever, cough, and difficulty breathing, as well as the clearance of the infecting bacteria from the body.

Studies conducted during periods of increased symptom activity monitored and reported that symptoms improved in the observed populations during the defined time intervals of treatment. In studies involving more severe pneumonia, Klaz was evaluated as a component of the multi-drug regimens used in the research. These findings help contextualize how patients reported their experience over the short term.

Evidence for use in H. pylori Eradication

Klaz was studied as a component of multi-drug combination therapy to manage Helicobacter pylori infection, particularly in patients with duodenal ulcers. Research explored short-term symptom changes, primarily by using comparative clinical trials where different regimens containing Klaz were evaluated against alternatives.

The main outcome measured in these research scenarios was the rate of confirmed eradication of the H. pylori bacterium. Findings describe patterns observed in the studies: observed eradication rates were associated with local rates of clarithromycin resistance in the bacterial strain. Where resistance is low, studies monitored and described patterns in the rate of microbiological clearance. Data show patterns related to a global increase in resistance, meaning that the success rate findings were mixed or lower in certain geographic areas.

Evidence in Special Populations and Uncertainties

Klaz was evaluated in studies across different age ranges, including extensive research in pediatric patients for common infections like acute otitis media. Research has also explored the use of Klaz in specific groups with underlying health issues. For example, studies monitored specific clinical parameters in patients with pre-existing heart conditions; data show patterns related to observed outcomes in some of these groups, and the results apply only to the populations studied.

The evidence landscape contains several acknowledged limitations. Long-term effects are not fully established for all populations or clinical situations, and comparative evidence is lacking in certain areas to definitively establish differentiating patterns of outcomes over first-line, non-macrolide alternatives. A primary factor introducing uncertainty into the research is the global rise in macrolide antibiotic resistance, which means that evidence from older trials may not accurately reflect current outcomes.

Key Studies & References

  1. Disseminated Mycobacterium avium Complex: Adult and Adolescent OIs | NIH - Clinical Info .HIV.gov (Guidelines)

How should Klaz be stored and disposed of?

How to Store and Dispose of Klaz?

Official regulatory labeling strictly defines the storage and disposal requirements for Klaz (clarithromycin), which vary by form.

Storage Conditions

Dosage Form Temperature Requirement Handling/Protection
Tablets (IR/ER) Controlled Room Temperature (20 C to 25 C) Protect from moisture and excess heat. Keep in original container.
Oral Suspension (Liquid) Room Temperature (15 C to 30 C) Do not refrigerate or freeze. Discard after 14 days.

All forms of Klaz must be kept out of the sight and reach of children. The medication must be stored in its tightly closed container and protected from direct light.

Disposal Instructions

To dispose of unused or expired Klaz, do not flush the medicine down a toilet or pour it into a drain due to environmental restrictions. Regulatory guidance advises using a drug take-back program or following the official household disposal procedure for unused medication.

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

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