Uniklar Suspension Hazirlamak Icin Kuru Powder 125 250 Mg/5Ml

Uniklar Suspension (Hazirlamak Icin Kuru Powder) is an antibiotic medication containing Clarithromycin, widely used to treat various bacterial infections. This comprehensive article examines its composition, therapeutic applications, dosage recommendations, and important safety information for healthcare providers and patients.

Composition and Formulation

Uniklar Suspension is available as a dry powder that requires reconstitution with water before administration. The active pharmaceutical ingredient is Clarithromycin, a semi-synthetic macrolide antibiotic. The medication is available in two strengths: 125 mg/5ml and 250 mg/5ml suspensions. Once reconstituted, the suspension forms a white to off-white liquid with a characteristic taste.

The formulation contains several excipients, including sucrose as a sweetening agent. Each 5 ml of the 125 mg/5ml suspension contains approximately 2.4 g of sucrose, which is an important consideration for patients with diabetes or those following specific dietary restriction. The suspension also contains potassium sorbate as a preservative.

Therapeutic Indications

Respiratory‌ Tract Infections

Uniklar Suspension is indicated for the treatment of both upper and lower respiratory tract infections. For upper respiratory tract infections, it is effective against pharyngitis, tonsillitis, and acute maxillary sinusitis caused by susceptible organisms including Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. In lower respiratory tract infections, it treats community-acquired pneumonia and chronic bronchitis.

Ear Infections

The suspension is particularly useful for treating acute otitis media in children, where it demonstrates efficacy against common pathogens responsible for ear infections.

Skin and Soft Tissue Infections

Uniklar is indicated for uncomplicated skin and soft tissue infections such as impetigo, folliculitis, cellulitis, erysipelas, and abscesses, particularly those caused by Staphylococcus aureus and Streptococcus pyogenes.

Helicobacter Pylori Eradication

In adults, Clarithromycin plays a crucial role in combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcers. It is typically administered with other antibiotics and proton pump inhibitors for this indication.

Mechanism of Action

Clarithromycin belongs to the macrolide class of antibiotics. It exerts its antibacterial effect by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. This mechanism effectively prevents bacterial growth (bacteriostatic) and at higher concentrations can be bactericidal against certain organisms. Clarithromycin is effective against a wide range of gram-positive and gram-negative bacteria, as well as atypical pathogens including Mycoplasma pneumoniae and Chlamydophila pneumoniae.

Dosage and Administration

Preparation of the Suspension

The supplied Clarithromycin granules must be reconstituted with water before administration:

1. Add half the required volume of water to the bottle containing the Clarithromycin granules

2. Shake the bottle vigorously

3. Add the remaining water and shake again

4. The reconstituted suspension should be shaken well before each use

After reconstitution, the suspension should be stored at 15° to 30°C (59° to 86°F) and used within 14 days. Refrigeration is not recommended.

Pediatric Dosing

For children under 12 years, the recommended dosage is based on weight, following an approximate 7.5 mg/kg twice daily regimen. The doses should be administered at 12-hour intervals.

Pediatric dosing for Clarithromycin 250 mg/5 ml suspension by weight:

• 8-11 kg: 62.5 mg (1.25 ml) twice daily

• 12-19 kg: 125 mg (2.5 ml) twice daily

• 20-29 kg: 187.5 mg (3.75 ml) twice daily

• 30-40 kg: 250 mg (5.0 ml) twice daily

Children weighing less than 8 kg should receive a dose calculated at approximately 7.5 mg/kg twice daily.

Adult Dosing

The standard adult dose is 250 mg twice daily. For severe infections, the dose may be increased to 500 mg twice daily. For H. pylori eradication, clarithromycin is typically administered at 500 mg twice daily in combination with other medications for 7-14 days.

Duration of Treatment

The typical duration of treatment ranges from 5 to 10 days depending on the pathogen involved and the severity of the infection. For streptococcal infections, treatment should continue for at least 10 days to prevent rheumatic fever.

Contraindications

Uniklar Suspension is contraindicated in the following situations:

1. Hypersensitivity to macrolide antibiotics or any component of the formulation

2. Concurrent use with ergot alkaloids (ergotamine or dihydroergotamine)

3. Concurrent administration of oral midazolam

4. Co-administration with astemizole, cisapride, pimozide, or terfenadine due to risk of QT prolongation and cardiac arrhythmias

5. History of QT prolongation or ventricular cardiac arrhythmias

Special Warnings and Precautions

Cardiac Considerations

Clarithromycin has been associated with QT interval prolongation and increased risk of ventricular arrhythmias. Caution is advised in patients with coronary artery disease, as studies indicate an increased risk of adverse cardiac events and mortality in these patients. Particularly concerning is evidence suggesting that clarithromycin may cause heart attack or stroke years after treatment in patients with heart problems.

Liver Function

Hepatic dysfunction, including increased liver enzymes and hepatocellular/cholestatic hepatitis with or without jaundice, has been reported with clarithromycin. Monitoring of liver function may be necessary, especially during prolonged treatment.

Renal Impairment

Dosage adjustment is necessary for patients with moderate to severe renal impairment. The dose should be reduced by 50% in patients with creatinine clearance less than 30 ml/min.

Clostridium difficile-Associated Diarrhea

As with nearly all antibacterial agents, clarithromycin treatment has been associated with Clostridium difficile-associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis.

Side Effects

Common Side Effects

The most frequently reported adverse reactions include:

• Gastrointestinal disturbances (stomach pain, nausea, vomiting)

• Diarrhea

• Unusual or unpleasant taste in the mouth

Serious Side Effects

More serious adverse effects requiring immediate medical attention include:

• Severe allergic reactions (hives, difficulty breathing, swelling of face/lips/tongue/throat)

• Severe skin reactions with fever and blistering

• Severe stomach pain or bloody diarrhea

• Liver problems (loss of appetite, upper stomach pain, dark urine, jaundice)

• Kidney problems (little or no urination, swelling in feet/ankles)

• Heart rhythm problems (fast/pounding heartbeats, fluttering, shortness of breath, dizziness)

Drug Interactions

Clarithromycin interacts with numerous medications due to its inhibitory effect on the cytochrome P450 enzyme system. Some notable interactions include:

• Ergot alkaloids: Increased risk of ergot toxicity

• QT-prolonging drugs (astemizole, cisapride, pimozide, terfenadine): Increased risk of cardiac arrhythmias

• Statins: Increased risk of myopathy and rhabdomyolysis

• Oral anticoagulants: Enhanced anticoagulant effects

• Oral hypoglycemic agents: Increased risk of hypoglycemia

• Theophylline: Increased serum concentrations and potential toxicity

Use During Pregnancy and Lactation

The safety of clarithromycin during pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted into human breast milk and caution should be exercised when administering it to nursing women.

Storage and Handling

The unconstituted powder should be stored at room temperature in a tightly closed container. Once reconstituted, the suspension should be stored at 15° to 30°C (59° to 86°F) and used within 14 days. The suspension should not be refrigerated.

Key Information Table

Conclusion

Uniklar Suspension (Clarithromycin) is a versatile antibiotic effective against a wide range of bacterial infections affecting the respiratory tract, ears, skin, and soft tissues. Its availability as a suspension makes it particularly suitable for pediatric patients and those who have difficulty swallowing tablets. However, like all medications, it carries risks of side effects and drug interactions that necessitate careful consideration.

Healthcare providers should weigh the benefits against potential risks when prescribing this medication, especially for patients with pre-existing cardiac or hepatic conditions. Patients should strictly adhere to the prescribed dosage and duration to ensure optimal therapeutic outcomes while minimizing adverse effects.