Excipients q.s ........................................................................................... 1 sachet
(ß-cyclodextrine, refined sugar, pregelatinized starch, mannitol, aspartame, aerosil,
anhydrous citric acid, sodium citrate, sodium benzoate, strawberry-flavored powder).
DOSAGE FORM: Powder for oral suspension.
PRESENTATION: Box of 10 sachets x 3.5 g.
PHARMACODYNAMICS: Haginat contains Cefuroxime which is a second-generation cephalosporin broad-spectrum semi-synthetic antibiotic. The antibacterial activity results from inhibition of bacterial cell wall synthesis by binding essential target proteins. Cefuroxime is an effectively and specifically 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 resistant to beta-lactamase enzymes of Gram-negative bacteria.
PHARMACOKINETICS: After oral administration, Cefuroxime axetil is absorbed from the gastrointestinal tract and quickly hydrolyzed in the intestinal mucosa and blood to release cefuroxime in the circulation. 50% cefuroxime in the circulation is bound to plasma proteins. The plasma half-life of cefuroxime is about 70 minutes and is prolonged in patients with renal impairment and in neonates.
Cefuroxime is widely distributed in the body, including in the pleural fluid, sputum, bone, synovial fluid, and aqueous humour. The apparent distribution volume in healthy adults is between 9.3 and 15.8 liters/1.73m2. 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.
INDICATIONS: For the treatment of: Upper and lower respiratory tract infections including ear-nose-throat: otitis media, sinusitis, stomatological infections, tonsillitis, pharyngitis, pneumonia, acute bronchitis and acute course of chronic bronchitis. Genitourinary tract infections e.g. cystitis, pyelonephritis, urethritis. Skin and soft tissue infections: furuncle, pyoderma, impetigo.
CONTRAINDICATIONS: Hypersensitivity to cephalosporin antibiotics.
PRECAUTIONS: Use with caution is warned for pregnant women and breast-feeding mothers. Use of cefuroxime for infants aged < 3 months has not been studied. Prolonged use of cefuroxime may result in drug-fast bacterial superinfection. Caution should be given to patients who have experienced allergic reactions to penicillins, a history of colitis.
INTERACTIONS: Ranitidine and sodium bicarbonate reduce the bioavailability of cefuroxime. The interval between cefuroxime and antacids or H2 inhibitors should be at least 2 hours because these drugs increase the gastric pH. High-dose probenecid reduces the renal cefuroxime clearance, makes cefuroxime plasma concentration higher and more prolonged. Aminoglycoside increases the renal intoxication. A positive Coombs' test can be found in patients treated with cefuroxime. The administration of Cefuroxime may be result in a false-positive reaction for glucose in the blood using Clinitest, Benedict's solution, Fehling's solution. It is recommended that either the glucose oxidase or hexokinase method should be used to determine the blood plasma glucose levels in patients receiving cefuroxime.
ADVERSE EFFECTS: Adverse reactions to cefuroxime have been generally mild and transient in nature. Gastrointestinal disturbances: mild diarrhoea, nausea, vomiting.
Rarely: eosinophilia, hypoleukemia, positive Coombs' test, urticaria, pruritus.
Inform your physician about any adverse effects occur during treatment.
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 supportive measures and treatment of symptoms should be instituted.
DOSAGE & ADMINISTRATION:
Notes: Haginat 125 should be orally taken after meals.
Course of therapy is from 5 to 10 days, usually 7 days.
* Children: Recommended dose is 1 sachet or 10 mg/kg body-weight twice daily; maximum dose is 250 mg daily.
Children > 2 years of age suffered from otitis media or other severe infections should be orally given 2 sachets or 15 mg / kg body-weight twice daily; maximum dose is 500 mg daily.
* Use of cefuroxime for infants aged < 3 months has not been studied.
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.