Klacid 250 mg 14 tablets

Klacid 250 mg 14 tablets

Composition:

One tablet contains 250 mg clarithromycin.

Description:

Clarithromycin is an antibiotic belonging to the macrolide antibiotic group. 

Indications:

Clarithromycin is indicated for treatment of infection caused by susceptible organisms.

Indications include:

• Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.

• Upper respiratory tract infections for example, sinusitis and pharyngitis.

• Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atyploal respiratory pathogens as listed in the microbiology section.

• Skin and soft tissue Infections of mild to moderate severity, for example follicultis, cellulitis and erysipelas.

Dosage and Method of Administration:

Patients with respiratory tract/skin and soft tissue infections:

Adults: The usual dose is 250 mg twice daily although this may be increased to 500 mg twice daily in severe infections. The usual duration of treatment is 6 to 14 days.

Children older than 12 years: As for adults.

Children younger than 12 years:

Use of Klacid Tablets are not recommended for children younger than 12 years. 

Renal impairment:

In patients with renal Impairment with creatinine clearance less than 30 ml / min, the dosage of clarithromycin should be reduced by one-half, le 240 mg once dally, or 260 mg twice dally in more severe infections. Treatment should not be continued beyond 14 days in these patients.

Contraindications:

-Hypersensitivity to macrolide antibiotic drugs or to any of the excipients.

-Concomitant administration of clarithromycin and ergot alkaloids (e.g, ergotamine or dihydroergotamine) is contraindicated, as this may result in toxicity.

-Concomitant administration of clarithromycin and oral midazolam is contraindicated.

-Clarithromycin should not be given to patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, Including torsades de pointes.

-Concomitant administration with ticagrelor or ranolazine is contraindicated.

-Clarithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of Clarithromycin. 

-Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.

Precautions:

-Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. 

-Caution is advised regarding concomitant administration of clarithromycin and triazolobenzodiazepines, such as triazolam, and intravenous or oromucosal midazolam.

-Cardiovascular Events:

Prolongation of the QT interval, reflecting effects on cardiac repolarization imparting a risk of developing cardiac arrhythmia and torsades de ponlas, have been seen in patients treated with macrolides including clarithromycin.

-Furthermore, clarithromycin should be used with caution in the following patients;

• Patients with coronary artery disease, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia.

• Patients with hypomagnesaemia.

• Patients concomitantly taking other medicinal products associated with QT prolongation other than those which are contraindicated.

Pregnancy and lactation:

Pregnancy:

The safety of clarithromycin for use during pregnancy has not been established. Therefore, use during pregnancy is not advised without carefully weighing the benefits against risk.

Breast-feeding:

The safety of clarithromycin for use during breast-feeding of infants has not been established. Clarithromycin is excreted into human breast milk.

Side Effects:

The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and taste perversion.

These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrology antibiotics.

Some more reactions:

Psychiatric disorders: Insomnia (common)

Vascular disorders: Vasodilation (common)

Hepatobiliary disorders: Liver function  test abnormal (common)

Skin and subcutaneous tissue disorders: Rash, hyperhidrosis (common) 

Storage Method:

Store at a temperature not exceeding 30C.

Keep away of reach of children.

Package:

A carton box contains 2 blisters with 7 tablets each and an insert leaflet.