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Roxone
Ceftriaxone Sodium for Inj. 1gm
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ROXONE
Ceftriaxone Sodium for Inj. 1gm
COMPOSITION :
Each vial contains :
Sterille Ceftriaxone Sodium USP
Equivalent to Anhydrous Ceftriaxone 1gm.
DESCRIPTION :
Ceftriaxone is a sterile, semisynthetic, broad spectrum third Generation cephalosporin
antibiotic for intravenous or intramuscular injection.
It is a slight yellow white crystalline power which is readily soluble in water.
ANTIBACTERIAL ACTIVITY :
Ceftriaxone has a broad spectrum activity in vitro includes gram positive and gram
negative, aerobioc and some anaerobic bacteria. It has a high degree of stability
in presence of Betalactamase. Both penicilinase and cephalosporinases of gram positive
and gram negative bacteria.
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INDICATION :
Ceftriaxone is indicated for the treatment of a wide variety of infections.
- Lower respiratory tract infections
- Skin and skin structure infections
- Urinary tract infection
- Gonorrhea
- Bone & joint infections
- Meningitis
- Pelvic inflammatory diseases
- Prophylaxis-A single dose of Ceftriaxone preoperatively may
may reduce chances of postoperative infections
CONTRA-INDICATIONS:
Ceftriaxone is contraindicated in patients with know allergy to ceftriaxone should be Avoided in jaundiced neonates.
WARNINGS :
Cephalosporin antibiotics should be given cautiously to patients with any Kind of allergy particularly to drugs. Serious hypersensitivity reactions may require use of Subcutaneous epinephrine and other emergency measures. Pseudomembranous colitis has been reported with the use of Cephalosporins and other spectrum antibiotics. Therefore it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use. Treatment with broad apectrum antibiotics can alter normal flora of colon and promote growth of clostridia.
PRECAUTIONS :
In renal impairment with a creatinine clearance of less than 10 mi.
Min-1 the daily dose must not exceed 2 g.
In patients with liver damage dose reduction is not required if renal function is intact.
In severe renal impairment with hepatic insufficiency the plasma concentration of ceftriaxone should be measured regularly to ensure it is in excess of the MIC of the causative organism, and the dosage of ceftriaxone adjusted to prevent accumulation.
DOSAGE :
Adults : 1-2 gm once a day or twice a day, total dose should not exceed 4 gm.
In infants and young children : 20 to 80 mg/kg/day. Premature babies/neonates :
Less then 50mg/kg/day
In Gonnorhoeae : A single Intramuscular dose of 250 mg is recommended.
Ceftriaxone for intramuscular injection may be given in 1% lignocaine and administered by a deep intragluteal injection pain. For the treatment of serious infections in children other than meningitis the recommended total daily dose is 50-75 mg/kg/body weight given in two divided doses.
ADMINISTRATION:
For IM Injection: Dissolve the contents of the vial in 4 ml of water for injection and shake well until dissolved. Then withdraw the entire contents of the syringe and use immediately in the deep gluteus muscle.
For IV injection : Dissolve the contents in 10 ml of Water for injection and the reconstituted solution should be administered slowly over a period of 3-5 minutes.
Ceftriaxone may be sdministered by Intravenous infusion by dissolving 1-2gm in 40-100 ml of water for injection or in the infusion fluid mentioned as under :
Ceftriaxone is compatible with the following commonly used intravenous infusion :
Sodium Chloride Injection, 5% Dextrose Injection, Dextrose and Sodium Chloride Injection. The prepared solution should be administered over a period of 20-60 minutes.
Ceftriaxone is not compatible with calcium containing solution such as Hartman’s solution or Ringer Lactate Injection.
Discard any unused solution after 24 hours.
STORAGE :
Ceftriaxone should be stored at 25°C or below and protected from light.Reconstituted Ceftriaxone is stable for 24 hours at 25°C and for 3 days if refrigerated at 4°C. Frozen solution should be thawed at room temperature before use. Do not freeze.
PRESENTATION : Ceftriaxone 1 gm vial with 10 ml sterile water for injection in a carton.
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