Description
Uniklar Film Tablet 500 Mg is a pharmaceutical product containing clarithromycin as its active ingredient. This medication belongs to the macrolide antibiotic class and serves as a potent tool in combating various bacterial infections. This article provides a detailed analysis of Uniklar’s composition, applications, dosage guidelines, and safety considerations to facilitate informed medical decisions.
Composition and Physical Characteristics
Uniklar presents as smooth, yellow, elliptical biconvex tablets. Each film-coated tablet contains 500 mg of clarithromycin as the primary active ingredient. The formulation includes several excipients that contribute to the tablet’s stability, dissolution properties, and palatability.
These auxiliary components include croscarmellose sodium, pregelatinized starch, silicon dioxide, povidone, stearic acid, magnesium stearate, talc, microcrystalline cellulose, hydroxypropyl methylcellulose, propylene glycol, sorbitan monooleate, hydroxypropyl cellulose, titanium dioxide (E171), quinoline yellow (E104) lake, vanillin, and sorbic acid.
Pharmacological Properties
Mechanism of Action
Clarithromycin, a semi-synthetic macrolide antibiotic, exerts its antibacterial effect through a specific mechanism targeting bacterial protein synthesis. The compound binds to the 50S ribosomal subunit of susceptible bacteria, effectively inhibiting protein production essential for bacterial growth and reproduction. This bacteriostatic action allows the host’s immune system to more effectively eliminate the infection while preventing further bacterial proliferation.
Antimicrobial Spectrum
Uniklar demonstrates efficacy against numerous clinically significant pathogens. These include gram-positive bacteria such as Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pyogenes (Group A beta-hemolytic streptococci), alpha-hemolytic streptococci (viridans group), Streptococcus pneumoniae, Streptococcus agalactiae, and Listeria monocytogenes.
Additionally, the medication proves effective against various gram-negative bacteria, including Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Legionella pneumophila, and Bordetella pertussis. This broad-spectrum activity makes Uniklar a versatile option for treating diverse infectious conditions.
Therapeutic Applications
Upper Respiratory Tract Infections
Uniklar demonstrates pronounced efficacy in treating pharyngitis (throat inflammation), tonsillitis, and acute maxillary sinusitis. The medication effectively targets and eliminates causative pathogens in these conditions, providing symptomatic relief and resolving the underlying infection. Its effectiveness in community-acquired respiratory infections stems from its activity against common and atypical respiratory pathogens.
Lower Respiratory Tract Infections
For patients suffering from lower respiratory tract infections, including acute bacterial exacerbation of chronic bronchitis and pneumonia, Uniklar offers a reliable therapeutic option. The medication’s ability to achieve adequate tissue concentrations in pulmonary tissues contributes to its effectiveness in these conditions.
Skin and Soft Tissue Infections
Uniklar serves as an effective treatment for various uncomplicated skin and soft tissue infections caused by susceptible microorganisms. These include conditions such as folliculitis, cellulitis, and erysipelas of mild to moderate severity. The medication’s tissue penetration properties ensure delivery of therapeutic concentrations to the infection site.
Mycobacterial Infections
Beyond conventional bacterial infections, Uniklar demonstrates utility in addressing infections caused by mycobacteria. In particular, the medication plays a crucial role in the prevention of disseminated Mycobacterium avium complex (MAC) infections in HIV-infected patients with CD4 cell counts below 100/mm³.
Helicobacter pylori Eradication
In combination with acid-suppressing medications like omeprazole or lansoprazole, Uniklar contributes to the eradication of Helicobacter pylori in patients with duodenal ulcers. This approach helps reduce duodenal ulcer recurrence by eliminating the underlying causative bacterium.
Dental Infections
Uniklar also finds application in the management of dental infections, offering an effective solution for odontogenic infections that require systemic antibiotic therapy.
Dosage and Administration
Standard Dosage
For adults and children over 12 years of age, the standard dosage regimen for severe infections typically consists of one 500 mg tablet administered twice daily (every 12 hours). This dosing schedule ensures maintenance of therapeutic drug concentrations throughout the treatment period.
Treatment Duration
The duration of Uniklar therapy generally ranges from 5 to 14 days, depending on the specific infection being treated. Conditions such as pneumonia and sinusitis may require longer treatment periods to ensure complete eradication of the causative pathogens and prevent relapse or recurrence.
Special Considerations
Dosage adjustments may be necessary for patients with compromised renal function. The medication should be taken consistently, preferably at the same times each day, to maintain stable blood concentrations. Uniklar may be taken with or without food, although administration with food might help mitigate gastrointestinal side effects in sensitive individuals.
Safety Profile
Like all medications, Uniklar may cause various side effects, though not all patients will experience them. Common adverse reactions include gastrointestinal disturbances such as stomach pain, diarrhea, nausea, and vomiting. Headaches may also occur in some patients. These effects are generally mild to moderate in severity and often resolve spontaneously as treatment continues.
Drug Interactions
Clarithromycin interacts with several medications, necessitating careful consideration when prescribing. Concurrent use with cisapride, pimozide, lomitapide, lovastatin, simvastatin, ergotamine, or dihydroergotamine should be avoided due to potentially serious interactions. Patients should inform their healthcare provider about all medications they are taking to prevent adverse drug interactions.
Pregnancy Considerations
Clarithromycin carries a pregnancy category C designation, indicating that risk cannot be ruled out during pregnancy. The potential benefits of therapy should be weighed against possible risks to the fetus when considering use in pregnant women.
Patient Guidance
Storage Instructions
Uniklar tablets should be stored at room temperature, away from excessive heat, moisture, and direct light. The medication should be kept in its original packaging until ready for use and stored out of reach of children.
Missed Doses
If a dose is missed, patients should take it as soon as they remember. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Doubling doses to compensate for missed ones should be avoided.
Seeking Medical Attention
Patients should contact their healthcare provider immediately if they experience severe or persistent side effects, signs of allergic reaction (such as rash, itching, swelling, or difficulty breathing), or if their condition does not improve after several days of treatment.
Reference Table
Property | Information |
---|---|
Active Ingredient | Clarithromycin 500 mg |
Pharmaceutical Form | Film-coated tablet |
Appearance | Yellow, elliptical, biconvex tablets |
Therapeutic Class | Macrolide antibiotic |
Primary Indications | Upper and lower respiratory infections, skin/soft tissue infections, H. pylori eradication |
Standard Adult Dosage | 500 mg twice daily (every 12 hours) |
Treatment Duration | 5-14 days (infection-dependent) |
Common Side Effects | Stomach pain, diarrhea, nausea, vomiting, headache |
Serious Side Effects | Severe allergic reactions (rare), liver problems, severe skin reactions |
Contraindications | History of hypersensitivity to macrolide antibiotics |
Major Drug Interactions | Cisapride, pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine |
Pregnancy Category | C (risk cannot be ruled out) |
Patient Age Range | Adults and children over 12 years |
Storage Conditions | Room temperature, protected from moisture and light |
Packaging | Box containing 14 tablets |
Price (Turkey, 2024) | 288.00 TL |
Conclusion
Uniklar Film Tablet 500 Mg represents a valuable therapeutic option for various bacterial infections owing to its broad antimicrobial spectrum and favorable pharmacokinetic profile. Its efficacy against respiratory, skin, and other infections makes it a versatile choice in clinical practice. As with all antibiotics, appropriate patient selection, adherence to prescribed regimens, and monitoring for adverse effects are essential for optimal therapeutic outcomes.
Healthcare providers should carefully weigh the benefits against potential risks when prescribing this medication, considering patient-specific factors such as comorbidities, concomitant medications, and previous antibiotic experiences.
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