Klarithran

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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 Klarithran

What is Klarithran? Defining the Semisynthetic Macrolide

Property Description
Active ingredient Clarithromycin
Form Tablet, Extended-Release Tablet, Oral Suspension
Pharmacological class Macrolide Antibiotic / Anti-infective agent
General purpose Suppressing the growth of susceptible bacterial infections
Origin Semisynthetic

Klarithran is a prescription-only medicine containing the active compound Clarithromycin, which is classified as a macrolide antibiotic. This medicine belongs to the broader group of anti-infective agents and functions primarily by disrupting the growth of susceptible bacterial pathogens. Clarithromycin is a semisynthetic analogue of Erythromycin, distinguished by a methyl group addition that results in improved acid stability and superior bioavailability compared to the older macrolide. This structural enhancement is associated with promoting better gastrointestinal tolerance in patients.


Clarithromycin: Composition, Forms, and General Purpose

The medication is a single-ingredient product designed exclusively for oral administration, utilizing solid or liquid pharmaceutical excipients. The active ingredient, Clarithromycin, is available in several dosage forms, including standard film-coated tablets, extended-release tablets (ER), and granules for oral suspension which are reconstituted into a liquid, enabling different delivery methods for various patient needs. The extended-release option allows for less frequent dosing, a key differentiating factor that supports patient adherence.

Clarithromycin's general therapeutic purpose is intrinsically linked to its mechanism of action: it acts as a bacteriostatic agent by inhibiting bacterial protein synthesis. This is achieved through the drug's specific binding to the 50S ribosomal subunit within the bacterial cell, thereby preventing the bacteria from producing the essential proteins required for their growth and replication. By successfully suppressing the proliferation of the infectious agent, the medicine directly aids the patient's immune system in stabilizing and clearing a wide range of bacterial illnesses, such as respiratory tract infections.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Klarithran?

Possible Side Effects and Safety Information

Klarithran contains Clarithromycin, a medicine whose safety profile is strictly documented by government regulatory agencies (e.g., FDA, EMA). All documented adverse reactions and safety statements are derived from official regulatory labeling.


Adverse Reaction Classifications

Adverse reactions are classified by frequency and grouped by System-Organ Class (SOC) in regulatory documents.

Classification Common Adverse Reactions (e.g., geq 1/100)
Gastrointestinal Diarrhoea, Nausea, Vomiting, Abdominal pain
Nervous System Dysgeusia (taste perversion), Headache
Psychiatric Insomnia

Uncommon reactions may include leukopenia, hypersensitivity, dizziness, palpitations, and elevated liver enzymes.


Serious Safety Risks and Contraindications

Official labeling highlights several serious risks and restrictions for use:

  • Cardiac Events: The drug is contraindicated in patients with a history of QT interval prolongation or ventricular cardiac arrhythmia (including Torsades de pointes). The risk of these events is also increased in patients with uncorrected hypokalemia or hypomagnesemia.
  • Hepatotoxicity: Reports include hepatic dysfunction and, rarely, fatal hepatic failure. The drug is contraindicated in patients with severe hepatic failure combined with renal impairment.
  • Gastrointestinal: The development of severe diarrhea, potentially progressing to Clostridioides difficile-associated diarrhea (CDAD) or acute pancreatitis, is a documented serious risk.
  • Severe Skin Reactions: Rare but life-threatening skin conditions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and DRESS, have been reported.

Population and Duration Notes

  • Elderly Patients: The official label notes that this population may be at increased risk for drug-associated QT interval prolongation and Torsades de pointes.
  • Pregnancy: Klarithran is generally contraindicated in pregnant women unless the need is deemed critical, based on observed fetal toxicity in animal studies.
  • Long-Term Pattern: Observational studies have suggested a rare, long-term risk of cardiovascular mortality that may persist one year or more after treatment has stopped.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosage of Klarithran (Clarithromycin) can lead to serious adverse effects and necessitates prompt medical intervention. The official regulatory profile documents that ingestion of large amounts can result in severe gastrointestinal disturbances, including significant abdominal pain, nausea, vomiting, and diarrhea. Neurological events, such as confusion and hallucinations, have also been noted in rare reported cases.

Immediate Action Mandated by Regulators:

Contact emergency medical services or call the Poison Help line immediately if a suspected overdose has occurred. Urgent medical treatment is required for severe manifestations such as an irregular or faster heartbeat, or severe and persistent abdominal pain. Furthermore, patients must stop the medication at once and seek help if signs of acute hepatic toxicity emerge, such as jaundice, dark urine, or pruritus.

Management is strictly symptomatic and supportive, as official data confirms that Clarithromycin levels are not expected to be significantly reduced by hemodialysis or peritoneal dialysis, meaning no specific antidote is available.

Critical Regulatory Risks in Overdose
Cardiovascular Risk: QT interval prolongation and life-threatening ventricular arrhythmias (e.g., Torsades de pointes).
Hepatic Risk: Severe hepatic dysfunction, with reports of fatal outcomes.
Population Risk: Elderly patients are noted to have increased susceptibility to drug-associated cardiac effects.

Therapeutic Uses of Klarithran

Klarithran is generally applied across therapeutic domains where additional symptomatic support is needed in contexts marked by increased discomfort. The medication may assist with easing the patient's experience and supports general well-being during symptomatic phases.

The medication is considered relevant within the therapeutic scope for conditions such as chest infections, ear and sinus infections, and bacterial skin problems.

Symptom Management and Patient Support

Klarithran is used for managing symptoms that interfere with daily comfort, such as those related to systemic imbalance (like fever) and localized physical discomfort (like pain and pressure). It addresses symptom clusters that may become intense or disruptive, often applied when symptoms create noticeable physiological strain, especially during acute flare-ups.

This supportive role contributes to managing the overall symptom load and helps with stability during difficult episodes.


Quick Fact: Relief for Acute Discomfort Klarithran is commonly used when short-term symptomatic assistance is needed during phases of increased distress or discomfort associated with acute bacterial episodes.

Eligibility and Restrictions for Use

Klarithran (Clarithromycin) eligibility is strictly defined by regulatory documents based on patient population and pre-existing conditions.

Contraindicated Populations

The medicine is contraindicated and must not be used in the following populations:

  • Patients with a known hypersensitivity to any macrolide antibacterial drug.
  • Patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior Clarithromycin use.
  • Patients with a history of QT prolongation or ventricular arrhythmias, including Torsades de pointes.
  • Individuals with severe hepatic failure combined with renal impairment or pre-existing electrolyte disturbances (hypokalaemia/hypomagnesaemia).

Eligibility Rules and Restrictions

Use is established for adults and adolescents 12 years and older, but children from 6 months to 12 years must use the oral suspension formulation; use is not established for infants under six months. Patients with severe renal impairment (Ccr < 30 mL/min) require a 50% dosage reduction, and treatment duration must not exceed 14 days. Caution is advised for patients with impaired hepatic function and certain cardiovascular conditions. The medicine is not recommended for use during pregnancy, and nursing must be discontinued during treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Klarithran's official interaction profile is defined by its documented effect on metabolic and transporter pathways. The drug is classified as a strong inhibitor of Cytochrome P450 3A4 (CYP3A4) and an inhibitor of the transport protein P-glycoprotein (P-gp). This classification leads to decreased clearance and increased plasma concentration (exposure) of many co-administered medicines that are substrates for these systems.

Regulatory documents formally identify multiple contraindicated combinations that must not be co-administered. These include agents such as Pimozide, Cisapride, Ergot Alkaloids (Ergotamine, Dihydroergotamine), and the statins Lovastatin and Simvastatin, due to the risk of severe toxicity or life-threatening events. The combination with other QT-prolonging drugs increases the risk of serious cardiac rhythm disturbances.

For other interacting medicinal products, such as Warfarin and Digoxin, official regulatory constraints require close monitoring of patient metrics (e.g., International Normalized Ratio for Warfarin) due to the documented risk of increased exposure. Furthermore, the extended-release formulation of Klarithran has a specific timing-based administration rule: it must be taken with food to ensure the appropriate drug exposure is achieved. The interaction with Colchicine is explicitly contraindicated in patients with pre-existing hepatic or renal impairment.

Mechanism of Action

Core Mechanism: Ribosomal Inhibition and Bacteriostasis

Klarithran (Clarithromycin) acts by targeting the machinery responsible for life within susceptible bacteria. The molecule is a high-affinity inhibitor that binds specifically to the 50S ribosomal subunit . This molecular interaction physically blocks the passage of the growing protein chain, immediately halting bacterial protein synthesis. The resulting bacteriostasis is a physiological effect that suppresses the pathogen’s proliferation, which facilitates the action of the host's immune system.


️ Secondary Effect: Modulation of Host Inflammation and Virulence

Beyond the direct anti-infective action, Clarithran engages secondary mechanistic domains involving the host and the pathogen's behavior. The drug modulates host immune pathways by influencing the production of pro-inflammatory cytokines. Concurrently, it interferes with the bacteria's quorum sensing system, limiting the expression of harmful virulence factors. This dual mechanism alters the physiological environment by decreasing tissue-level inflammatory mediator concentration and lowering the pathogenic potential of the suppressed bacteria.


Mechanistic Limitations: Target Defense Pathways

The effectiveness of this mechanism is constrained by bacterial defense pathways. The drug's affinity for the 50S subunit can be compromised if bacteria acquire mechanisms like target site methylation or activate efflux pumps. These defenses either structurally modify the target, preventing drug binding, or actively expel the molecule from the cell, leading to failure in achieving the inhibitory concentration required for bacteriostasis.

Dosage and Administration Information

How to Use Klarithran: Official Administration Guidelines

Klarithran (Clarithromycin) is used according to established guidelines that define its administration route, dosage, and timing. The medicine is primarily available for oral use as film-coated tablets, extended-release (ER) tablets, or granules for oral suspension. It is also available for intravenous (IV) infusion when parenteral administration is necessary.


Standard Dosing and Frequency

Standard adult regimens require specific frequency patterns. Immediate-Release (IR) oral tablets are typically administered twice daily (every 12 hours) in 250 mg or 500 mg doses. In contrast, the Extended-Release tablets are administered once daily in a 1000 mg dose. The IV formulation is also administered twice daily, typically 500 mg every 12 hours, with IV therapy generally limited to an initial 2 to 5 days before switching to the oral form. The full treatment course usually lasts 6 to 14 days.


Administration Conditions and Constraints

Usage depends on the specific formulation. ER tablets must be taken with food to ensure proper absorption and release. IR tablets and the oral suspension may be administered independently of meals. For the ER formulation, tablets must be swallowed whole and must not be chewed, broken, or crushed to maintain the correct drug release profile. For patients with severe kidney impairment (creatinine clearance < 30 mL/ min), the labeled dosage is reduced by 50%.


Pediatric and Procedural Use

For children aged 6 months to 12 years, the oral suspension is used, with dosing calculated at 7.5 mg/ kg administered twice daily. The IV infusion is a highly procedural administration: the diluted solution is infused over a 60-minute period and is prohibited from being given as a bolus or intramuscular injection. If a dose is missed, it is typically taken promptly unless it is near the time for the next scheduled dose, in which case the missed dose is skipped.

Recent Clinical Evidence

Research evidence / Overview of studies for Klarithran

Evidence for Use in Respiratory Tract Infections

Klarithran was studied for its approved indications, which include acute bacterial infections affecting the upper and lower respiratory tracts. Researchers have used short-term Randomized Controlled Trials (RCTs) and comprehensive meta-analyses to examine its use in infections such as pneumonia, acute bronchitis, and certain sinus or throat infections. These studies monitored outcomes related to systemic or functional imbalance, such as the change in acute symptoms and measurements of the specific bacteria causing the infection (bacteriological eradication).

Research examined how Klarithran was evaluated in settings for many common respiratory pathogens, including comparisons against other standard antibacterial treatments. Findings describing patterns observed in the studies were often evaluated alongside those reported for other standard treatments. The available research provides insight into short-term changes but often offers limited information for long-term outcomes or the risk of infection recurrence.

Evidence for Use in Helicobacter pylori Eradication Regimens

Research examined Klarithran as a critical component of combination therapy regimens designed to address Helicobacter pylori infection, which was studied for its association with certain peptic ulcers. The primary endpoint evaluated was the H. pylori eradication rate, confirmed by specific diagnostic tests conducted after a defined treatment interval.

Findings indicate that eradication rates were observed to be associated with the specific combination of medicine used and, critically, the baseline level of clarithromycin resistance in the local bacterial strains. Research describes that in geographic regions with lower resistance levels, the regimens were observed in studies to have attained specific eradication rates. Conversely, findings were mixed in areas where resistance was high, and different eradication rates were reported.

What Research Gaps and Uncertainties Remain

A primary limitation noted in regulatory summaries is the global variability of antibiotic resistance. Findings were mixed in regions where macrolide resistance is high, and the evidence quality may vary across studies depending on the regional context. Additionally, while short-term cure rates were observed in many studies, the certainty remains low regarding sustained long-term efficacy and the durability of the initial clinical success. Comparative evidence is lacking for certain rare or complicated infections.

Key Studies & References 2024 American College of Gastroenterology (ACG) Clinical Guideline: Treatment of Helicobacter pylori Infection

Frequently Asked Questions (FAQ)

Common questions about Klarithran (FAQ)


Q: Does Klarithran cure the infection, or just stop it from growing?

A: Klarithran works by targeting the bacteria’s internal machinery to stop them from producing the proteins they need to grow and multiply. This effect is known as bacteriostasis (suppressing bacterial growth). By suppressing the infection, the medicine is intended to aid the body’s own immune system in clearing the infection fully.

Q: What should I do if I forget to take my Klarithran dose?

A: General guidance suggests taking a missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, regulatory guidance indicates that the missed dose should be skipped and the regular schedule resumed. Official guidance indicates that double dosing to compensate for a missed dose is not advised.

Q: Can Klarithran cause a metallic taste in the mouth?

A: Yes, regulatory documents list dysgeusia (taste perversion) as a common adverse reaction reported with Klarithran. Patients commonly report that this taste change manifests as a metallic or unpleasant sour taste.

Q: Can Klarithran be crushed or chewed if someone has trouble swallowing pills?

A: Official product information strictly states that the Extended-Release (ER) tablets must be swallowed whole. These must not be chewed, broken, or crushed to maintain the correct drug release mechanism. If difficulties swallowing tablets occur, a consultation with a healthcare professional is appropriate, as alternative formulations may be an option.

Q: Is it better to take Klarithran with food or on an empty stomach?

A: This depends on the specific formulation being used. The Extended-Release (ER) tablets must be taken with food to ensure the medicine is absorbed correctly. In contrast, the immediate-release (IR) tablets and the oral suspension may be administered independently of meals.

Q: Why do some people say Klarithran gave them diarrhea?

A: Diarrhea is a common side effect of Klarithran, as documented in regulatory safety information. Antibacterial agents, in general, have the potential to disrupt the normal balance of gut bacteria. If severe or persistent diarrhea occurs, contact with a healthcare provider is noted as important, as this can be associated with a serious complication.

Q: Does Klarithran interact with birth control pills?

A: Official information indicates Klarithran may alter the blood levels of certain hormonal contraceptives. This potential interaction may increase the risk of breakthrough bleeding and could possibly reduce contraceptive effectiveness. Patients are generally advised to discuss all medications, including hormonal contraceptives, with a healthcare professional.

Q: Can taking Klarithran affect my sleep?

A: Yes, official safety information indicates that insomnia, or difficulty sleeping, is listed as a common adverse reaction reported with the use of Klarithran.

Q: Is Klarithran safe to take during pregnancy (general information)?

A: Klarithran is generally not recommended for use during pregnancy. This caution is based on animal studies which showed evidence of potential harm to the developing fetus. Use during pregnancy is determined by a healthcare professional, balancing the potential risks and benefits in each circumstance.

Q: What are the serious but rare side effects of Klarithran?

A: Regulatory labeling highlights several serious risks, including rare, life-threatening Severe Skin Reactions (e.g., SJS or TEN), Hepatotoxicity (severe liver damage), and serious heart rhythm changes (like QT prolongation). Detailed safety information is available through regulatory labeling and patient information leaflets.

Q: Does Klarithran cause yeast infections in some people?

A: Yes, official documents and post-marketing reports indicate that fungal infection (candidiasis), commonly known as a yeast infection, has been reported as an uncommon side effect associated with the use of Klarithran.

Q: Does Klarithran interact with any vitamins or herbal supplements?

A: Klarithran can inhibit certain liver enzymes that are responsible for processing many substances in the body. It is generally recommended that patients inform their healthcare provider about all products, including vitamins and herbal supplements, to assess potential interaction risks.

Q: Can children take Klarithran, and is the dosage different?

A: Yes, Klarithran can be prescribed to children who are 6 months of age and older. For this population, it is typically given as an oral suspension. Dosage for children is determined by a doctor and is typically calculated based on the child's body weight.

Q: Is a rash from Klarithran always a sign of a severe allergy?

A: No, a rash is not always a severe allergy, but any new rash or change in skin condition should be brought to the attention of a healthcare professional. Regulatory warnings highlight the risk of rare, severe skin reactions. Assessment by a healthcare professional is necessary to determine if a rash is a mild reaction or potentially a sign of a more serious condition.

Q: What happens if Klarithran is taken too close to another medicine?

A: Klarithran is known to block the action of certain liver enzymes. Taking it close to other medicines that rely on these same enzymes for processing can lead to a significant increase in the blood concentration of those other medicines, potentially raising the risk of toxicity.

Q: What is the research evidence supporting the use of Klarithran?

A: Studies reviewed by regulatory bodies confirm the drug's effectiveness for its approved indications. This evidence supports its use in treating various respiratory tract infections and as a component of specific combination regimens to address H. pylori bacteria.

Q: Does Klarithran affect blood sugar levels?

A: Yes, the safety information notes that hypoglycemia (low blood sugar) has been reported with Klarithran. This side effect may be of particular concern for patients who are also receiving treatment for diabetes.

Q: Can Klarithran cause dizziness or lightheadedness?

A: Yes, official safety documentation lists both dizziness and lightheadedness as potential side effects associated with Klarithran.

Q: Is there a liquid form of Klarithran for people who can't swallow tablets?

A: Yes, Klarithran is available in the form of granules for oral suspension. These are mixed with water to create a liquid medicine. This form is used when difficulty in swallowing tablets or precise dosing (as in children) is a factor.

Q: What is the shelf life of Klarithran once the bottle is opened?

A: For the liquid form, once the oral suspension is mixed, any unused portion must be discarded after 14 days. For tablets, the medication should be stored in its original, closed container, protected from excess heat, light, and moisture, until the stated expiration date.

Q: Does taking Klarithran make you more sensitive to the sun?

A: While not listed as a common side effect, some patients have reported photophobia (an abnormal sensitivity to light) in post-marketing reports. Any observed unusual reaction to sunlight can be discussed with a healthcare professional.

Q: Are there different brand names for the medicine Klarithran?

A: Yes, Klarithran is a brand name for the active ingredient clarithromycin. This medicine is also sold under other brand names (for instance, Biaxin) and is widely available in generic form.

How should Klarithran be stored and disposed of?

Official Storage and Disposal Requirements

Storage Conditions

  • Tablets: Store at controlled room temperature, typically 68 F to 77 F (20 C to 25 C). The tablets must be protected from excess heat, light, and moisture.
  • Oral Suspension (Mixed): Store between 59 F and 86 F (15 C and 30 C). Do not refrigerate.

Handling and Stability

  • Keep the medication in its original container, and keep the container tightly closed to protect the contents from moisture.
  • Shake the oral suspension well before each use.
  • Any unused portion of the mixed (reconstituted) oral suspension must be discarded after 14 days.
  • Keep all forms of Klarithran out of the reach and sight of children.

Disposal

  • Dispose of any expired or no-longer-needed Klarithran by following official guidelines for medication disposal, such as using drug take-back programs.
  • Do not flush the medication down a toilet or pour it down a sink unless specifically instructed by a regulatory authority.

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

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