Nixaven

Nixaven

cefixime

Manufacturer:

Novell Pharma
Full Prescribing Info
Contents
Cefixime trihydrate.
Action
Pharmacology: Inhibition of wall synthesis sets. Cefixime has a high affinity for penicillin-binding protein (PBP) 1 (la, 1 b, 1c) and 3, on the side which affects several organism activities.
Microbiology: Antibacterial activity: Cefixime has a wide spectrum against gram-positive and gram-negative microorganisms. When compared with other cephalosporins, cefixime has potent activity against gram-positive organisms such as Streptococcus spp, Streptococcus pneumonias and gram negatives such as Branhamella catarrhalis, Eschericia coli, Proteus spp, Haemophilus influenzae. This substance acts as bactericidal. Cefixime is very stable against n-lactamase-producing organisms.
Indications/Uses
Treatment of the following infections when caused by susceptible strains of the designated microorganisms: Uncomplicated urinary tract infections caused by E. coli and P. mirabilis; otitis media caused by H. influenza (β-lactamase positive and -negative strains), Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive) and Streptococcus pyogenesis; acute bronchitis and acute exacerbations of chronic bronchitis causes by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase positive and -negative strains). Uncomplicated gonorrhoeae (cervical/urethral) caused by Neisseria gonorrhoeae (penicilinase-and non-penicilinase-producing strains). Sinusitis caused by susceptible organism to cefixime.
Dosage/Direction for Use
Susp: Children: Daily dose: 1.5 - 3 mg/kg twice daily, given by oral. Dose must be adjusted to the patient's condition. Dose can be increased to 6 mg/kg twice daily for patients with severe condition. This suspension preparation is given as a cure to otitis media in children.
Patients with renal disorder: Crcl 21-60 mL/min or patients who are receiving hemodialysis treatment: 300 mg daily.
Crcl <20 mL/min or patients who are receiving peritoneal dialysis outpatient care: 200 mg daily.
Reconstitution: Add 20 mL of water, by adding 10 mL of water and shake until homogeneous. After homogenizing add 10 mL of water, shake again until a homogeneous suspension is formed.
Overdosage
In cases of overdose, gastric lavage can be done; if there is no specific antidote. Cefixime is not removed in significant amounts from circulating hemodialysis or peritoneal dialysis.
Contraindications
Patients who have a history of shock or hypersensitivity to the components of Nixaven products.
Special Precautions
General: Cefixime administration must be monitored closely because cefixime should not be used in patients who receive other antibiotic treatment. Cefixime must be given with special attention in the following patients: Patients who have hypersensitive to penicillin. Patients who have any hereditary problems, such as bronchial asthma, reddish skin and urticaria. Patients who have serious kidney dysfunction. Patients who lack nutritional intake orally. Patients who receive parenteral nutrition, elderly, or debilitated patients. These patients must be monitored closely as the symptoms of vitamin K deficiency might occur. Be cautious of some hypersensitivity events, because shock reactions may occur. Pregnancy & Lactation.
Shock: Immediately stop use if there is dysphoria, discomfort in the digestive cavity, stridor, headache, abnormal desire for defecation, tinnitus or diaphoresis.
Adverse Reactions
Hypersensitivity.
Hematological: Granulocytopenia or eosinophilia, thrombocytopenia.
Hepatic: an increase in SGOT, SGPT or alkaline phosphatase can occur.
Kidney: renal insufficiency may occur.
Digestion: Severe colitis, such as pseudomembranous colitis can occur, which is indicated by the presence of blood in the stool. Abdominal pain or diarrhea rarely occurs vomiting, diarrhea, abdominal pain, abdominal discomfort, heartburn or anorexia, nausea, satiety or constipation.
Respiratory: interstitial pneumonia or PIE syndrome, fever, cough, dyspnea, abnormal chest x-ray or eosinophilia.
Changes in bacterial flora: Stomatitis or candidiasis.
Vitamin deficiency: Vitamin K deficiencies such as hypoprothrombinemia or bleeding tendencies or vitamin B group deficiencies (such as glossitis, stomatitis, anorexia, or neuritis).
Others: Headaches or dizziness.
Storage
After reconstitution, suspension could be stored in the temperature 30°C or below until 7 days or stored in refrigerator (2°-8°C) for 14 days maximum. Stored in a tight close container. Discard the remaining suspension after 7 days.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Dry syr (bottle) 100 mg/5 mL x 30 mL x 1's.
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