HAGINAT 500

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COMPOSITION:
Cefuroxime axetil ....................................... equivalent to 500 mg of cefuroxime
Excipients q.s .................................................................................... 1 caplet
(Aerosil, sodium lauryl sulfate, polyplasdone XL, sodium starch glycolate, kollidon VA64, talc, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide).
DOSAGE FORM: Film coated caplet.
PRESENTATION: Box of 2 blisters x 5 film coated caplets.
PHARMACODYNAMICS: Haginat contains cefuroxime which is a second-generation cephalosporin antibiotic, used as a precursor of cefuroxime axetil. The bactericidal activity results from inhibition of bacterial cell-wall synthesis. Cefuroxime has very effective and specific activity against a wide range of common pathogens, including beta-lactamase-/cephalosporinase-producing strains of Gram-positive and Gram-negative organisms. Cefuroxime is highly stable in the presence of beta-lactamases of certain Gram-negative bacteria. Cefuroxime is active against aerobic and anaerobic Gram-positive and Gram-negative cocci, including most strains of penicillinase-producing Staphylococci, and against intestinal Gram-positive bacteria. Cefuroxime has high vitality; therefore, the minimum inhibitory concentration (MIC) is low for Streptococcus strains (group A, B, C, and G), strains of Gonococcus and Meningococcus. At first the MIC of cefuroxime is also low for the strains of Gonococcus, Moraxella catarrhalis, Haemophilus influenzae and beta-lactamase-producing Klebsiella spp. However, many bacteria was presently resistant to cefuroxime in Vietnam, the MIC for these strains also changed. The strains of Enterobacter, Bacteroides fragilis and positive Proteus indol reduced the sensitivity to cefuroxime. Some strains of Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Legionella spp. is not sensitive to cefuroxime. Strains of methicillin-resistant Staphylococcus aureus, Staphylococcus epidermidis are resistant to cefuroxime. Listeria monocytogenes and most of Enterococcus strains are also resistant to cefuroxime.
PHARMACOKINETICS: After oral administration, cefuroxime axetil is quickly absorbed and hydrolyzed in the intestinal mucosa to active cefuroxime, and is distributed in the extracellular fluid. Cefuroxime is readily absorbed right after meals. Cefuroxime is widely distributed in the body, including in the pleural fluid, sputum, bone, synovial fluid, and aqueous humour. It crosses the blood-brain barrier when meninges are inflamed. It crosses the placenta and has been detected in breast-milk. Cefuroxime is not metabolized and is excreted unchanged and approximately 50% by glomerular filtration and 50% by renal tubular secretion, and high concentrations are achieved in the urine. Small amounts of cefuroxime are excreted in bile.
INDICATIONS: For the treatment of infections caused by susceptible bacteria in following cases: 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, gonorrhoea.
Skin and soft tissue infections: furuncle, pyoderma, impetigo.
CONTRAINDICATIONS: Hypersensitivity to cephalosporin antibiotics.
PRECAUTIONS:
The drug should be given cautiously to penicillin-allergic-sensitive patients.
Cefuroxime rarely altered renal function, checking renal function should be done during cefuroxime therapy, especially in patients with severely impaired renal function receiving the maximum dose. Cefuroxime should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.
Pseudomembranous colitis has been reported in patients who present with severe diarrhea subsequent to administration of antibiotics.
The drug should be given with caution to patients having a history of colitis.
Use of cefuroxime in pediatric patients below 3 months of age has not been established.
PREGNANCY AND LACTATION: The drug should be used in caution in these subjects because it crosses placenta and is excreted in breast-milk.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effect of this drug on the ability to drive and operate machinery is rarely reported.
INTERACTIONS: The interval between oral doses of cefuroxime and antacid drugs or H2-inhibitors should be at least 2 hours because these drugs may enhance the gastric pH, reduce the bioavailability of cefuroxime. Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics or potent diuretics and cefuroxime. The concomitant oral administration of probenecid with cefuroxime slows renal secretion resulting in higher and more prolonged plasma concentration of cefuroxime.
ADVERSE EFFECTS: Adverse reactions to cefuroxime have been generally mild and transient in nature.
Frequently observed: Diarrhea. Rash.
Infrequently observed: anaphylactic reaction, candidiasis. Eosinophilia, leucopenia, neutropenia, positive Coombs' test. Nausea, vomiting. Urticaria, pruritus. Elevations in serum creatinine.
Rarely observed: Fever. Hemolytic anemia. Pseudomembranous colitis. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Cholestatic jaundice, rise in AST and ALT hepatic enzymes. Kidney toxicity associated with temporary elevations in serum creatinine and blood urea, interstitial nephritis. Convulsions (in case of high doses and renal impairment), headache, irritation. Arthralgia.
Inform your physician about any adverse effects occur during treatment.
OVERDOSAGE: Acute overdose: Generally, the drug only causes nausea, vomiting, and diarrhoea. However, reactions of increased neuromuscular irritation and convulsive attacks, particularly in patients with renal impairment may have been reported.
Treatment of overdosage: Protect the patient’s airway and support ventilation and perfusion. For patients developing convulsive attacks, discontinue the drug immediately; the anti-convulsive therapy can be used in case of clinical indication. Serum levels of cefuroxime can be reduced by haemodialysis; but the treatment is mostly to support or reduce symptoms.
DOSAGE & ADMINISTRATION:
Adults: oral dose of 250 mg twice daily.
Severe infections (bronchitis, pneumonia): The recommended dose is 500 mg twice daily.
Uncomplicated gonorrhea: A single dose of 1 g is recommended.
Note: The drug should be taken immediately after meals.
       The course of therapy must be from 5 to 10 days, usually for 7 days.
       No special cautions are necessary in patients with renal impairment, renal dialysis or in elderly patients if the daily dosage does not exceed 1 g.
Or as prescribed 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 30oC, protect from light.
Specifications: Vietnamese Pharmacopoeia IV.

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