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Haginat 500
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Haginat 500





COMPOSITION:

Cefuroxime.......................................................................................................... 500 mg

Excipients q.s...................................................................................................... 1 tablet

(Aerosil, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, ludipress, HPMC, PEG 6000, titanium dioxide).

DOSAGE FORM: Film coated tablets.

PRESENTATION: Box of 2 blisters x 5 film coated tablets.

PHARMACODYNAMICS: Haginat contains the main active ingredient - Cefuroxime which is a second-generation cephalosporin antibiotic. The antibacterial activity results from inhibition of bacterial cell wall synthesis. Cefuroxime is effective and specific bactericidal agent on a wide range of common pathogens including beta-lactamase- / cephalosporinase-producing species of Gram-positive and Gram-negative bacteria. Particularly, Cefuroxime is stable to beta-lactamase enzymes of Gram-negative bacteria.

Susceptible bacteria includes:

Gram-negative aerobic bacteria:  Escherichia   coli, Haemophilus   influenzae (including beta-lactamase-producing species), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including beta-lactamase-producing species), Proteus mirabilis, Proteus rettgeri, Providencia sp, Neisseria gonorrhoeae (including beta-lactamase-producing species).

Gram-positive aerobic bacteria: Staphylococcus aureus (including beta-lactamase-producing species), Staphylococcus epidermidis (including penicillinase-producing species, but except methicillin-resistant species), Streptococcus pyogenes and beta-haemolytic Streptococci, Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae).

Anaerobic bacteria: Gram-positive bacillus (Clostridium sp) and Gram-negative bacilli (Bacteroides and Fusobacterium spp.), Propionibacterium sp, Gram-positive and Gram-negative cocci (including Peptococcus and Peptostreptococcus spp.).

Nonsusceptible bacteria: Clostridium difficile, Pseudomonas sp, Campylobacter sp, Morganella morganii, Acinetobacter calcoacetinus, methicillin-resistant species of Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus faecalis, Proteus vulgaris, Enterobacter sp, Citrobacter sp, Serratia sp, Bacteroides fragilis.

PHARMACOKINETICS: Cefuroxime is given as the prodrug cefuroxime axetil. After oral administration, Cefuroxime axetil is quickly absorbed and hydrolyzed in the intestinal mucosa and blood to active cefuroxime and is distributed in the extracellular fluid. Cefuroxime is well absorbed when taken immediately after meals.

INDICATIONS: For the treatment of: Upper and lower respiratory tract infections including otitis media, sinusitis, stomatological infections, tonsillitis, pharyngitis, pneumonia, acute bronchitis, and acute course of chronic bronchitis.

Genitourinary tract infections: cystitis, pyelonephritis, urethritis, and gonorrhoea.

Skin and soft tissue infections: furuncle, pyoderma, and impetigo.

CONTRAINDICATIONS: Hypersensitivity to cephalosporin antibiotics.

WARNINGS: Use with caution is noticed for pregnant women and breast-feeding mothers (Cefuroxime is excreted in breast milk). Use of cefuroxime in newborn babies (under 3 months of age) is inexperienced. Prolonged use of cefuroxime may result in bacterial drug-fast superinfection. Special care should be given to patients who have experienced allergic reactions to penicillins and suffered from a history of colitis.

INTERACTIONS: The interval between Haginat and antacids or H2 inhibitors should be at least 2 hours because these drugs increase the gastric pH and reduce the bioavailability of cefuroxime axetil. Concurrent administration of cefuroxime and aminoglycoside or diuretics can lead to nephrotoxicity; Probenecid competes for renal tubular excretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime.  

ADVERSE EFFECTS:

Adverse effects caused by cefuroxime are generally mild and transient in nature: gastrointestinal disturbances (mild diarrhoea, nausea, vomiting).

Rarely: pseudomembranous colitis, Stevens-Johnson syndrome, Lyell syndrome, allergic reactions (prurigo, fever, urticaria, erythema), thrombocytopenia, hypoleukemia, jaundice, hemolytic anemia, acidophilic polynucleosis, headache.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

Acute overdose: Generally, the drug only causes nausea, vomiting, and diarrhoea. However, it can cause reaction of increased neuromuscular irritation and convulsive attacks, particularly in patients with renal impairment.

Treatment of overdosage: Protect the patient’s airway and support ventilation and perfusion. For patients developing convulsive attacks, the drug should be immediately discontinued; the anti-convulsive therapy can be used in case of clinical indication. Serum levels of cefuroxime can be reduced by haemodialysis; but mostly the treatment is supportive or settles the symptoms.

DOSAGE & ADMINISTRATION:

Note: Haginat should be given immediately after meals. Course of therapy is from 5 to 10 days, usually 7 days

Adults take 250 mg twice a day in most cases.

In severe infections (bronchitis, pneumonia), the dosage of 500 mg twice a day may be given.

Uncomplicated gonorrhoea: a 1-g single dose is recommended.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 300C.

Specifications: Manufacturer's.






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