Qurazit 250 Capsules

Qurazit 250 Capsules

COMPOSITION:

EACH CAPSULE CONTAINS:

Azithromycin Dihydrate USP
Equivalent to Azithromycin(anhydrous)
250 mg
PRESENTATION:

Quarzit 250 Capsule: 6 capsules packed in a blister and such 1 blister packed in a unit carton with insert .

INDICATIONS:

Qurazit 250 Capsule is indicated for the treatment of Upper respiratory tract infections: Pharyngitis, tonsillitis, acute bacterial sinusitis and acute otitis media; Lower respiratory tract infections: Community acquired pneumonia, bronchitis, acute bacterial exacerbation of chronic obstructive pulmonary diseases; Uncomplicated skin and soft tissue infections erythema migrans (the first stage of Lyme disease), erysipelas, impetigo and secondary pyoderma; Sexually transmitted diseases: Non gonococcal & gonococcal urethritis and cervicitis, genital ulcer diseases (chancroid); Gastric and duodenal infections caused by Helicobacter pylori.

DESCRIPTION:

Qurazit 250 Capsules contain Azithromycin, a macrolide antibiotic, which belongs to the azalide group. The mechanism of action of Azithromycin is based upon the suppression of bacterial protein synthesis by binding to the ribosomal 50S sub-unit and thus inhibiting the translocation of peptides.

AZITHROMYCIN IS ACTIVE AGAINST A BROAD RANGE OF GRAM POSITIVE AND GRAM NEGATIVE BACTERIA:

GRAM-POSITIVE COCCUSStreptococcus pneumoniae, Streptococcus pyogenes (β- haemolytic Streptococcus group A), Staphylococcus aureus and Staphylococcus epidermidisGRAM-POSITIVE BACILLUSClostridium perfringens (Erythromycin); Corynebacterium diptheriae; Listeria monocytogenes; Bacillus anthracis, Propionibacterium acnes and Nocardia spp. (certain strains).

GRAM-NEGATIVE MICROORGANISMSLegionella pneumophila, Campylobacter jejuni and Bordetella pertussis, Haemophilus influenzae (Erythromycin and Clarithromycin), Haemophilus ducrei, Neisseria gonorrhoeae, Neisseria meningitides, Pasteurella multocida, Borrelia spp., some strains of Brucella sppAnd Flavobacterium spp.

Most strains of Escherichia coli, species of Salmonella spp. (S. enterica), Shigella spp. and Aeromonas spp. And Bacteroides fragilis.

MYCOPLASMA: Mycoplasma pneumoniae hominis, Ureaplasma urealyticumchlamydia trachomatis and C. pneumoniae spirochetes (Treponema pallidum).

GRAM-NEGATIVE ANAEROBES: Some strains of Actinomyces spp. Mycobacterium scrofulaceum and M. kansasii.

Most resistant to Erythromycin strains of Staphylococcus, Enterococcus and Streptococcus strains of S. aureus, methicillin-resistant and resistant to Azithromycin. Pseudomonas aeruginosa, some species Klebsiella spp., Enterobacter spp., Citrobacter spp., Proteus spp., Providencia spp., Morganella spp., Serracia spp. resistant to Azithromycin.

Azithromycin, orally administered is absorbed rapidly and widely distributed throughout the body. Peak plasma drug concentration of approximately 0.4µg/ml is achieved in 2 to 3 hours. Rapid distribution of Azithromycin into tissues and high concentration within cells result in significantly higher concentrations in tissues than in plasma or serum. Small amounts are metabolized in the liver by demethylation, the metabolites being excreted in the bile. Biliary excretion of Azithromycin, predominantly as unchanged drug, is a major route of elimination. A small amount of the drug is excreted unchanged in the urine (12% of the dose). The terminal elimination half-life is about 68 hours.

CONTRAINDICATIONS:

Qurazit 250 Capsules are contra-indicated in patients with a known hypersensitivity to Azithromycin or any of the macrolide or ketolide antibiotics or to any excipients.

SIDE EFFECTS:

Diarrhea, nausea, abdominal pain, loose stool, cramping, vaginitis, dyspepsia, vomiting, malaise, anorexia, pruritus, rash.

PRECAUTIONS:

Qurazit 250 Capsule must be taken at least one hour before or two hours after a meal. Concurrent administration of Aluminium and Magnesium containing Antacids and Azithromycin is not recommended. Azithromycin is eliminated via liver; therefore, caution should be taken when Azithromycin is administered to patients with impaired hepatic function.

DOSAGE:

ADULTS:

Infection Recommended Dose/Duration of Therapy
Acute bacterial bronchitis,

acute exacerbation of chronic obstructive pulmonary disease (mild to moderate)

500 mg as a single dose for three days
Community acquired pneumonia, pharyngitis, tonsillitis, bronchitis and uncomplicated skin and skin structure infection 500 mg as a single dose on day 1, followed by 250 mg once daily from day 2 to day 5
Acute bacterial sinusitis 500 mg as a single dose for three days
Genital ulcer disease (chancroid) 1 g as a single dose
Non-gonococcal urethritis and cervicitis 1 g as a single dose
Gonococcal urethritis and cervicitis 1 g as a single dose
STORAGE:

Store in a dark and dry place below 25°C/ 30°C. Keep out of reach of children.

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