CEFIXIME FOR SUSPENSION

cefixime for suspension 100mg/5ml, 30ml

  • Product No.: AMC16036-03
  • Specification: 100mg/5ml, 30ml
  • Trademark: Shinepharm
  • Support OEM/ODM: Yes
  • Mini. Order: 20000 Boxes
  • Delivery Time: 30~60 Days
  • Trade Term: FOB,CIF
  • Payment Term: T/T,L/C
  • Standard Available: CP,BP
  • Documents: GMP,COPP,CTD

Indications

Gram-positive Organisms; Streptococcus pneumoniae; Streptococcus pyogenes; Gram-negative Organisms; Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive), Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase- and non-penicillinase-producing strains).

Dosage and Administration

Usage: Oral

Adults: The recommended dose of the suspension is 400 mg daily. Children: The recommended dose is 8 mg/kg/day of the suspension.

Precautions & Warning:

1.Hypersensitivity reactions including shock and fatalities have been reported with cefixime. Discontinue use if a reaction occurs.

2. Clostridium difficile associated diarrhea: Evaluate if diarrhea occurs.

3.Risk in Patients with Phenylketonuria (PKU)

4.Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Contraindications:

Cefixime for suspension is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Adverse Reactions:

1. Gastrointestinal: Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting.

2. Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema.

3. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.

4. Hepatic: Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.

5. Renal: Transient elevations in BUN or creatinine, acute renal failure. Central Nervous System: Headaches, dizziness, seizures.

6. Hemic and Lymphatic Systems: Transient thrombocytopenia, leukopenia, neutropenia, and eosinophilia. Prolongation in prothrombin time was seen rarely.

7. Abnormal Laboratory Tests: Hyperbilirubinemia. Other: Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.

8. Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage,   and colitis.

9. Abnormal Laboratory Tests: Positive direct Coombs test, elevated LDH, pancytopenia, agranulocytosis.

Drug Interactions

1. Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

2. Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

Storage instructions:

Store drug at 20 - 25°C