Linaxone

Ingredients

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For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.

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Composition:

Each Vial Contains :

Sterile Ceftriaxone Sodium - USP

Eq. to Anhydrous Ceftriaxone - 500mg

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PHARMACEUTICAL FORM

Dry powder injection

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THERAPEUTIC INDICATIONS

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Infections caused by pathogens sensitive to Ceftriaxone Injection, e.g.:

•Sepsis;

- Meningitis:

Abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts):

- Infections of the bones, joints, soft tissue, skin and of wounds;

- Respiratory tract infections, particularly pneumonia, and ear, nose and throat infections;

Genital infections, including gonorrhoea.

Perioperative prophylaxis of infections.

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Dosage and Administration

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Injection may be administered either by the Intravenous route or Intramuscularly.

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Adults

The usual adult daily dose in terms of Ceftriaxone is 1-2 grams given once a day (or in equally divided doses

Dosage regimen for Cetriaxone Should be adusted in patents with marked decrease in tenal functon

(creatinine clearance of <30mL/min).

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Paediatric patients

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For treatment of Skin and Soft tissue infections the recommended total dailydose (in terms of Ceftriaxone) is 50 75ma/ka given once a day or in equally divided doses twice a dav). The total daily dose should not exceed 11 For treatment of acute bacterial ottis media: A single intramuscular dose of 50mg/kg (not to exceed 1gram) is recommended.

For treatment of serious infections other than meningitis: Recommended total daily dose in terms of Ceftriaxone is 50-75 mg/kg given in divided doses every 12 hours The total daily dose (in terms of Ceftriaxone) should not exceed more than 2 grams.

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CONTRAINDICATIONS

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Ceftriaxone For Injection is contraindicated in patients with known allergy to Cephalosporin group of antibiotics.

Hypersensitivity to penicillin may pre-dispose the patient to the possibility or allergic cross-reactions.

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SPECIAL WARNINGS AND PRECAUTIONS

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• Superinfections with non-susceptible microorganisms may occur.

• Since pseudo-membranous colitis has been reported to occur with ceftriaxone, it is important to consider this

diagnosis in patients who present with diarrhea subsequent to the administration of Cettriaxone For Injection

• Ceftriaxone, if given at higher than standard doses, may get precipitated as its calcium salt in the gall bladder, the shadows of which seen under sonography, could be mistaken for gallstones. However, it is largely

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of therapy. Even in the case of symptomatic cases surgical interventions are not required, and they may be treated conservatively.

• Discontinuation of treatment in symptomatic cases is at the discretion of the clinician.

• Like other cephalosporins, ceftriaxone is known to displace bilirubin from serum albumin. Hence caution needs

to be exercised when considering centraxone For Injection tor the treatment or neonates with nyper bilirubinemia. In order to avoid the risk of development of bilirubin encephalopathy, use of Ceftriaxone For Injection is best avoided in neonates in general and prematures in particular.

• During prolonged treatment with Ceftriaxone For Injection, blood profile should be checked at regular intervals.

• Dosage adjustments are not necessary in hepatic Tailure. However, in patients with hepatic dystunction ana significant renal malfunction, Ceftriaxone For Injection doses should not exceed an equivalent of 2g/day of

• Extreme caution needs to be exercised in penicillin-sensitive patients. In case of serious hypersensivity reactions, se administration of epinephrine and other emergency measures are recommended.
• The allergic reaction is the indication for the interruption of Ceftriaxone For Injection therapy.

•Centriaxone For Injection snoula not be administered to neonates in general, nyperbilirubinemic neonates in particular, and to premature babies.

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DRUG INTERACTIONS

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• No impairment or renal function has been observed alter concurrent administration or large doses or Ceftriaxone and potent diurectics
• There is no evidence to suggest that Ceftriaxone increases renal toxicity of aminoglycosides
• The elimination of Ceftriaxone is not altered by probenecid.

     lviO SualeS.

• In cases of concomitant severe renal and hepatic dysfunction, the plasma concentrations of ceftriaxone should be determined at regular intervals.

• Coombs test may show false-positive results during Ceftriaxone therapy.

• Non-enzymatic urinary glucose estimation methods may give false-positive results.

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PREGNANCY AND LACTATION

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Pregnancy

Reproductive studies have been performed in mice and rats at doses upto 20 times the usual human dose and

no evidence of emoryo toxicity, fetotxicity or teratogenicity. In primates no teratogenicity or embryogenicity was demonstrated at a dose approximately 3 times the human dose. There are however no well-controlled studies in pregnant women because animal reproductive studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

Breastfeeding

Low concentrations of Ceftriaxone are excreted in human milk. No risk to nursing infants have been reported but caution should be exercised when ceftriaxone is administered to nursing women.

Ceftriaxone has been associated with dizziness, which may affect the ability to drive or operate machinery.

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UNDESIRABLE EFFECTS

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Diarrhoea, Nausea, Vomiting (less frequent) Stomatitis, Glossitis, Elevations of SGOT/SGPT, Eosinophilia, Thrombocytopenia, Leukopenia, Granulocytopenia, Hematoma, Exanthema, Allergic central tract, Oliguria, Fever.

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OVERDOSAGE

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Limited information is available on the acute toxicity of Cetriaxone For Injection. No specific antidote is available for the treatment of overdose. Hemodialysis does not remove the drug from system effectively. Hence, the treatment of Ceftriaxone for injection overdose is essentially supportive and symptomatic.

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PHARMACODYNAMIC PROPERTIES 

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Ceftriaxone is a cephalosporin/cephamycin beta-lactam antibiotic used in the treatment of bacterial infections caused by susceptible, usually gram-positive organisms. Ceftriaxone works by inhibiting the mucopeptide synthesis and gram-negative aerobic and anaerobic bacteria.

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PHARMACOKINETIC PROPERTIES

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Absorption

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Following intramuscular administration, peak serum concentrations of Ceftriaxone is seen between 15 minutes

protein by about 83-90%.

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Distribution

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The volume of distribution of Ceftriaxone sodium is 7-12 L. Ceftriaxone sodium penetrates well into the extravascular spaces, tissue fluid and the synovial fluid of inflamed joints. Ceftriaxone crosses placenta and is distributed in the amniotic fluid. It is also disctributed in the milk.

Ceftriaxone is not metabolised in the body and is eliminated unchanged via two pathways, urine and bile

40-5eto of parenterally administered dose is excreted into the urine within 48 hours as active drug. Thus, high concentrations are attained in urine, whatever's not excreted via kidney is excreted through bile.

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STORAGE

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Store Protected from Light at a Temperature not Exceeding 30°C.

500 mg injection is available in a vial and 5 ml ampoule containing Sterile Water For Injection (WFI) packed in mono carton with pack insert.

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Marketed and Distributed bv:

Lin Care

LINCARE LTD.

10 York Avenlie " incoln.

LN1 1LL, United Kingdom.

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