Uniklar

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Uniklar

Quick Facts

Property Description
Active ingredient Clarithromycin
Form Tablet (immediate and extended-release), Oral suspension
Pharmacological class Macrolide antibiotic, Antimicrobial agent
Route of administration Oral (Systemic effect)
Origin Semi-synthetic (derivative of Erythromycin)

What Type of Medicine is Uniklar?

Uniklar is a prescription-only medicinal product containing the active ingredient Clarithromycin, which is formally classified as a macrolide antibiotic and an antimicrobial agent. It is intended for systemic use, signifying that the active substance is absorbed into the bloodstream to reach infection sites throughout the body. Clarithromycin itself is a single-ingredient product and is a semi-synthetic derivative of Erythromycin, a chemical distinction that provides enhanced stability compared to its precursor. Pharmacological studies confirm that this modified structure contributes to a reliable absorption profile when the drug is taken by mouth.


Composition, Origin, and Available Forms

The core composition utilizes Clarithromycin formulated for oral administration using pharmaceutical excipients. Uniklar is commonly available in several dosage forms, including a standard film-coated tablet and granules for oral suspension, which is reconstituted into a liquid for swallowing.

The specialized availability of extended-release tablets is a feature that differentiates it from immediate-release preparations. This extended-release form is designed to regulate the delivery of the active ingredient into the system over time, which may allow for less frequent dosing while maintaining therapeutic antimicrobial action against susceptible bacteria.


General Purpose and High-Level Action

The general purpose of Uniklar is to address a range of infections by facilitating the inhibition of growth and subsequent eradication of susceptible bacteria. The drug achieves its effect through a highly specific biological mechanism: Clarithromycin works as a protein synthesis inhibitor by binding specifically to the 50S ribosomal subunit inside the bacterial cell. This binding action prevents the bacteria from assembling the proteins necessary for survival and division. By halting microbial proliferation, Uniklar provides a necessary therapeutic advantage to the body’s natural defense mechanisms.

Regulatory References

  1. Macrolides Mechanism of Action

What side effects are possible with Uniklar?

Possible Side Effects and Safety Information for Uniklar

This section summarizes the official safety profile for Uniklar (active ingredient umbralisib) as documented by governmental regulatory authorities. Note that official approval for this medication was withdrawn due to safety concerns.

Adverse Reaction Scope

The safety profile was characterized by the risk of severe and clinically significant adverse reactions. The most frequent and notable events included:

  • Serious Infections: Infections, including pneumonia and sepsis, were a prominent risk, with some cases being fatal. Grade 3 or higher infections occurred in a substantial percentage of patients.
  • Hepatotoxicity: Liver injury, indicated by significant elevations in transaminases (ALT and AST), was common and required proactive hepatic function monitoring.
  • Gastrointestinal Issues: Diarrhea and non-infectious colitis were frequent and could be serious, necessitating treatment interruption or dose reduction.
  • Hematologic Effects: Blood count abnormalities, specifically neutropenia (low neutrophil count) and thrombocytopenia (low platelet count), were commonly reported.

Frequency and Severity

Clinical trial data indicated several events occurring in 15% or more of patients, including increased creatinine, diarrhea-colitis, fatigue, nausea, transaminase elevation, musculoskeletal pain, and anemia. Discontinuation due to adverse reactions was required in a meaningful subset of patients.

Population-Specific Safety Considerations

Safety warnings addressed risks in specific populations, notably Embryo-Fetal Toxicity. Based on animal findings, the medicine was determined to potentially cause harm to an unborn fetus, requiring effective contraception during and shortly after treatment for patients of reproductive potential. The formulation also contained the inactive ingredient FD&C Yellow No. 5 (tartrazine), which may cause allergic reactions in susceptible individuals.

Regulatory Summary

Regulatory agencies concluded that the risks of treatment with the active ingredient outweighed its benefits, leading to the withdrawal of its approval for the previously authorized uses.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information describes that an overdosage with Uniklar (Clarithromycin) is typically associated with the potential for gastrointestinal symptoms and other physiological disturbances. Documented overdose presentations often include abdominal pain, vomiting, and nausea, which may be severe or persistent.

In addition to the gastrointestinal effects, overdosage may lead to serious outcomes like altered mental status, paranoid behavior, hypokalemia (low potassium), and hypoxemia (low oxygen in the blood). The potential for extended QT interval, a critical cardiac manifestation, has also been reported in regulatory literature and should be monitored.

Overdose Manifestations Serious Outcomes
Nausea, vomiting, abdominal pain Acute paranoid behavior/psychosis
Gastrointestinal upset Hypokalemia or Hypoxemia
Altered Mental Status Prolonged QT interval (Cardiac Risk)

When to Seek Immediate Medical Help:

Immediate emergency medical attention must be sought in all cases of suspected overdose. The official instruction states that patients should be admitted to a healthcare facility, and any unabsorbed drug should be removed. Management is generally supportive, focused on careful observation, electrolyte monitoring, and monitoring of cardiac function (ECG). Hemodialysis or peritoneal dialysis are not effective for removing this medicine from the body. Immediate contact with a poison control center is required.

Therapeutic Uses of Uniklar

Uniklar is considered relevant in situations where a susceptible bacterial infection is associated with the illness. This medication is commonly applied in addressing conditions presenting with acute episodes such as certain types of pneumonia, acute flare-ups of bronchitis and sinusitis, infections of the ears (otitis media) and throat (pharyngitis), uncomplicated bacterial skin infections, and is relevant for the management of the H. pylori bacteria associated with peptic ulcers and disseminated Mycobacterium avium complex (MAC) infection.

It helps address symptom clusters that may become intense or disruptive, including fever, persistent cough, and localized pain. This supportive use may help patients cope more steadily with symptom fluctuations and contributes to easing the overall symptom load during acute phases of infection. The benefit of this supportive use is that:

“it helps maintain a sense of stability when symptoms are more noticeable.”


Quick Fact Block

Property Description
Therapeutic Scope Applied in addressing bacterial infections in the respiratory tract, skin, and GI system.
Relief Focus Symptoms related to inflammatory or irritative states (e.g., fever, localized pain, persistent cough).
Context of Use Applied in settings marked by temporary physiological imbalance due to acute or episodic infection.
Patient Benefit Provides support that helps ease the overall symptom burden and supports digestive comfort.

Regulatory References

  1. NIH MedlinePlus overview on Clarithromycin

Eligibility and Restrictions for Use

Uniklar (clarithromycin) is an antibiotic prescribed to treat various bacterial infections. Its suitability for use depends on the patient's medical history and current medications.

Patients Who Can Typically Use Uniklar

Patient Group Indication
Adults and Children Various susceptible bacterial infections, including respiratory tract, skin, and H. pylori (in combination therapy).

Patients Who Should NOT Use Uniklar

Uniklar is generally contraindicated (should not be used) in patients with the following conditions or drug interactions:

  • Hypersensitivity: Known allergy or hypersensitivity to clarithromycin, erythromycin, or any macrolide antibiotics.
  • Cardiac Conditions: A history of QT prolongation (congenital or acquired) or certain ventricular cardiac arrhythmias, including Torsades de Pointes.
  • Liver/Kidney Impairment: Severe liver failure when combined with kidney impairment.
  • Drug Interactions: Concomitant use with certain medications, including HMG-CoA reductase inhibitors (statins), ergot alkaloids (e.g., ergotamine, dihydroergotamine), and specific drugs that may prolong the QT interval (e.g., astemizole, cisapride, pimozide, terfenadine).

Individuals with pre-existing conditions like coronary artery disease, severe cardiac insufficiency, or clinically relevant bradycardia may need careful consideration and monitoring if prescribed Uniklar.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The way a medicine works, or its effectiveness and safety profile, can be altered when it is taken with other medicines, supplements, or certain foods. This is known as a drug interaction. When taking Uniklar, it is important to understand the known or potential interactions to ensure appropriate and safe use.

Key Interaction Categories

Many clinically significant interactions are often rooted in the medicine's effect on liver enzymes, specifically the cytochrome P450 system (e.g., CYP3A4). A medicine that inhibits these enzymes can cause the levels of other medicines that are metabolized by the same enzyme to build up in the body, potentially leading to increased side effects or toxicity.

Interacting Product Category Mechanism of Interaction (Typical) Potential Result of Co-administration
Statins (e.g., simvastatin, lovastatin) Inhibition of metabolism (CYP3A4) Increased risk of muscle toxicity, including rhabdomyolysis.
Anticoagulants (e.g., warfarin, DOACs) Altered metabolism or bleeding risk Increased risk of bleeding; dose adjustments and monitoring may be necessary.
Antiarrhythmics / QT Prolonging Drugs Pharmacodynamic interaction Increased risk of serious cardiac arrhythmias, such as Torsades de Pointes.

Combinations with medicines that are highly dependent on the CYP3A4 enzyme for their clearance are often contraindicated or require strict medical supervision and dose adjustment. Patients should inform their healthcare provider of all prescription drugs, over-the-counter products, and herbal supplements currently being taken to properly manage the risk of interaction, particularly with agents affecting heart rhythm, blood clotting, or cholesterol levels.

Mechanism of Action

Targeted Inhibition of Microbial Protein Synthesis

Uniklar (Clarithromycin) primarily acts as a highly selective inhibitor by binding to the 50S ribosomal subunit of susceptible bacteria, specifically obstructing the nascent polypeptide exit tunnel. This molecular blockage halts the bacteria's ability to assemble essential proteins, causing the cessation of microbial proliferation and resulting in the ultimate clearance of the microbial population.


Modulation of Host Inflammatory Responses

Beyond its direct antimicrobial action, the drug engages a secondary mechanism that modulates the function of host immune cells through non-ribosomal pathways. This effect dampens excessive physiological reactions by decreasing the production of certain pro-inflammatory mediators and reducing the migration of inflammatory cells. This action contributes to a reduction in the signaling of targeted pathways, which mitigates the impact of excessive host inflammatory responses on local tissue.


Mechanism Constraints and Molecular Evasion

The functional applicability of the mechanism is fundamentally constrained when bacteria acquire molecular resistance mechanisms. These limitations occur through the modification of the 50S ribosomal target site (e.g., via methylation) or through the action of efflux pumps that actively expel the drug. When these evasion mechanisms are engaged, the core inhibitory mechanism cannot be established, and the physiological effect of halting microbial growth fails to occur.

Dosage and Administration Information

Official Administration Guidelines for Uniklar

Uniklar (clarithromycin) is administered via the oral route, typically as a tablet or a suspension. The medicine may be taken with or without food. The specific procedural requirements and dose depend on the treatment regimen prescribed.

Administration Scope Standard Rules (Adults/Adolescents)
Route of Administration Oral
Dosing Frequency Usually twice daily (every 12 hours).
Timing with Meals May be taken without regard to food. Extended-release forms must be taken with food.
Preparation Tablets should be swallowed whole; extended-release forms must not be split, crushed, or chewed. Oral suspensions must be shaken well before each use.

Dosing Rules and Special Conditions

  • Standard Dosing: For most adult regimens, the dose ranges from 250 mg to 500 mg every 12 hours for a duration of 7 to 14 days.
  • Combination Therapy: For specific combination treatments, such as for H. pylori eradication, the dose is 500 mg either every 8 hours or every 12 hours, and is administered in conjunction with other specific agents for 10 to 14 days.
  • Renal Impairment: For patients diagnosed with severe renal impairment (creatinine clearance < 30 mL/min), the total daily dose is typically reduced by 50%. Treatment duration in these patients should not exceed 14 days.

Missed Dose Instructions

If a dose is missed, the patient should take the missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped entirely, and the regular dosing schedule should be resumed. A double dose should never be taken to compensate for a forgotten one. Adherence to the prescribed regimen is critical for effective treatment.

Recent Clinical Evidence

Research Overview: Understanding the Studies for Uniklar

This introductory section will provide context on the types of clinical studies, such as Randomized Controlled Trials ( RCTs), that form the evidence base for Clarithromycin ( Uniklar) and how researchers assess outcomes for bacterial infections. Research on Clarithromycin has been conducted and includes a range of clinical study designs, from controlled trials to observational settings, relevant in trials assessing short-term or episodic symptom patterns. Studies observe how outcomes related to physiological strain or stress are measured, and findings describe group patterns rather than personal outcomes.


Evidence for Use in Respiratory and Ear/Throat Infections

This section will summarize the structure of the research available for treating certain types of pneumonia, acute flare-ups of bronchitis, sinusitis, otitis media (ear infections), and pharyngitis (throat infections), focusing on the types of trials conducted and the clinical endpoints measured for these conditions.

Study Structure for Pneumonia and Bronchitis

Clarithromycin was studied for specific types of pneumonia and acute flare-ups of bronchitis. Research includes RCTs, Observational Studies, and Meta-analyses exploring short-term symptom changes in adults and children. Studies monitored patient-reported outcomes over defined time intervals, usually concluding around the end of the treatment course. These trials were relevant in evidence describing how symptoms are measured, focusing on outcomes related to systemic or functional imbalance, such as fever and persistent cough, and monitoring changes in bacterial count.

Studies contribute to understanding symptom patterns, and findings described patterns related to measurements of clinical status at study endpoints and symptom change. However, follow-up durations were limited, meaning there is limited information for long-term outcomes or recurrence rates in the months following the initial treatment for these conditions.

Frequently Asked Questions (FAQ)

Common questions about Uniklar (FAQ)

Q: Does this medication make you sleepy?

Official product information states that somnolence (sleepiness) and dizziness are commonly reported side effects. Regulatory documents also include a warning that this medication may impair an individual’s ability to drive or safely operate machinery.

Q: Is it safe for long-term use?

Official regulatory information discusses the use of Uniklar in chronic treatment. It is noted that when stopping the medication, the dose should be reduced gradually, as rapid discontinuation may increase the risk of certain adverse effects. Swelling of the face, lips, tongue, or throat (angioedema) has been reported during both initial treatment and chronic use.

Q: Is it safe for children 2 years old?

According to official product information, Uniklar is indicated as adjunctive therapy for partial-onset seizures in pediatric patients 1 month of age and older. This indication covers pediatric patients starting from 1 month of age. Specific dosing recommendations are provided in the regulatory documents for different weight groups, such as children weighing less than 30 kg.

How should Uniklar be stored and disposed of?

How to Store and Dispose of Uniklar?

The storage and disposal requirements for Uniklar (clarithromycin) are strictly defined by regulatory documents to maintain its quality and ensure safety. These rules apply to both tablet and oral suspension forms.

Official Storage Requirements

Storage Category Requirement
Temperature & Environment Store at room temperature, protected from light, excess heat, and moisture.
Prohibited Environments Do not refrigerate or freeze the mixed liquid suspension.
Child Safety Keep this medication out of the sight and reach of children.

Form-Specific Stability and Disposal

The medication must be kept in its original, tightly closed container. The reconstituted oral suspension has a limited stability and must be discarded after 14 days. For disposing of any unused or expired medicine, patients are officially instructed to ask a healthcare professional (a doctor or pharmacist) for guidance on proper, safe disposal.

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

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