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SKY-ZONE 500mg / 250mg and 1gm Injection


SKY-ZONE
INJECTION

(Cefriaxone Sodium)
250mg, 500mg, 1gm
3rd Generation Cephalosporin – Antibiotic

Action Arid Clinical Pharmacology: in vitro studies indicate that the bactericidal action of  Cefriaxone results from the inhibition of cell-wall synthesis.

Indication And Clinical Uses:  The treatment of the following infections when caused by susceptible strains of the designated microorganisms.

Lower Respiratory tract infections: caused by E. Coli, H. influenza, K. pneumonia and species, S. aureus, S. pneumonia and species (excluding enterococcl).

Urinary Tract Infections (complicated and uncomplicated ): caused by E. coli. Klebsiella species , P. mirabilis and P. vulgaris.

Bacterial Septicemia: caused by e, coli, H. influenza, K. pneumonia, S. aureus and S.  pneumonia, (excluding  enterococcl).

Skin care skin structure infections: caused by K. pneumonia and species, P. mirabilis, S. aureus, S. epidermidis and streptococcus species (excluding enterococcl).

Bone and joint infections: caused by . aureus, S.  pneumonia, and streptococcus species (excluding enterococcl).

Intra-Abdominal Infections:  caused by e, coli, and K. pneumonia.

Meningitis : caused by H. influenza, N meningitides, and , S.  pneumonia.  Cefriaxone should not be used for the treatment of meningitis caused by L. monocytogenes.

Uncomplicated gonorrhea (cewical/urethral, and rectal): caused by N. gonorrhea (penicillinase and nonpenicillinase producing strains).

Prophylaxis: the preoperative administration of a singal 1g dose of Cefriaxone may reduce the incidence of postoperative infections in patients undergoing vaginal or abdominal lhysterectomy, coronary artery bypass surgery, or in patients at risk of infection undergoing biliary tract surgery. If signs of post surgical infection should appear, specimens for culture should be obtained for identification of the causactive organism (s) so that the appropriate therapy may be instituted.

Contra-indications:  known allergy to Cefriaxone, other cephalosporins or penicilins.

Warnings in clinical states: before therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to ceftriaone, other cephalosporins penicilins or other allergens. Cefriaxone should only be administered with caution to any patient who has demonstrated any form of allergy particularly to drugs. Serious, and occasionally fatal hypersensitivity (anaphylactoid ) reactions have been reported in patients receiving  cephalosporins. The reactions are more likely to occur in person with a history of sensitivity to multiple allergens. Cefriaxoneshould be administered withcaution to patients with type 1 hypersensitivity reaction to penicillin. If an allergic recation occurs, the  administration of Cefriaxone should be discontinued and appropriate therapy instituted.
Psedomembranous colitis has been reported with the use of Cefriaxone (and with broad-spectrum and other antibiotics). Therefore, it is important to consider its diagnosis in patients who develop diarrhea. Treatment with board-spectrum antibiotics, including  Cefriaxone, alters the normal flora of the colon and may permit overgrowth of clostridia, studies indicate that a toxin produced by C. diffcile  is one primary cause of antibiotic associated colitis. Mild cases of colitis may respond to drug discontinuation alone. Moderate to sever cases should be managed with fluid, electrolyte, and protein supplementation as indicated. When the colitis is not relieved by discontinuation of Cefriaxone administration or when it is severs, consideration should be given to the administration of vancornycin or other suitable therapy. Other possible causes of the colitis should also be considered.

There have been reports of sonographic abnormalities in the gallbladder of patients treated with Cefriaxone, some of these patients also had symptoms of gallbladder disease. These abnormalities appear on sonography as an echo without acoustical shadowing or as an echo with acoustical shadowing suggesting material has been determined to be predominarity a Cefriaxone calcium salt. The condition appears to be transient and reversible upon discontinuation of Cefriaxone and institution of conservative management. Therefore Cefriaxone should be discontinues in patient who develop sign and symptoms suggestive of gallbladder disease and/or sonographic findings described above. The effect of pre-existing gallbladder disease is not known.

Precautions:  hypoprothrombinemia and alterations in prothrombin time have occurred rarely. Patients with impaired vitamin K synthesis or low vitamin K stores (e.g. chronic hepatic disease and mainutrition) may require monitoring of hematology and coagulation parameters during treatment.
Vitamin K administration (10 mg. weekly) may be necessary if the prothrombin time is prolonged before or during treatment. Cefriaxone should be administrated with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Renal and Hepatic impairment: Although  transient elevation of BUN and serum creatinine have been abserved in clinical studies, there is no other evidence the Cefriaxone, when administrated alone, is nephrotoxic. In severe renal impairment ( creatinine clearance of less than 10 ml/min).periodicmonitoring of serum Cefriaxone concentrations is recommended. The maximum daily dose should not exceed 2 g. In severe renal impairment associated with clinically significant hepatic impairment, close monitoring of serum Cefriaxone concentration of accumulation dosage should be decreased accorgingly.

Drug Interactions: interaction between Cefriaxone and other drugs have not been evaluated.

Pregnancy: safety in the treatment of infection during pregnancy has not been established. Cefriaxone should only be used during pregnancy if the likely benefit outweighs the potential risk to the fetus and/or the monitor.

Lactation: Cefriaxone is excreted in human milk at low concentration, (e.g. the peak concentration of total drug in milk ranged between 0.45 to 0.65 ug/ml approximately  5 hours after the administration of 1 g i.v. or i.m.). the clinical significance of this in inknown, therefore , caution should be exercised.

Neonates: safety in neoates (birth to 1 month of age) has not been established. In vitro studies have shown that  Cefriaxone can displace billirubin from serum slbumin. Caution should be exercised when considering Cefriaxone treatment for hyperbillirubienemic neonates especially if premature.

Geriatrics: the elimination of Cefriaxone may be reduced in elderly patients possibly due to impairment of both renal and hepatic function.

Clinical Advese Experiences:
Dermatological  rash (13%) exanthema, allergic dermatitis and purities (0.1 to 1.0 %) urticaria. Isolated cases of severe cutaneous adverse reactions (erythema multiform, Stevens Johnson syndrome or lyell`s syndrome/toxic epidermal necrolysis) have also been reported.

Hematological:
Anemia (0.1 to 1.0%) auto-immune hemolytic anemia and serum sickness (<0. 1%) granulocytopenia (postmarketing reports) Isolated cases ofagranulocytosis (<500/mm have boon reported, most of them after 10 days of treatment and following total doses of 20 g or more.

Hepatic:
Jaundice, reports. (in asymptomatic patients) of ultrasonograpbic shadows suggesting precipitations in the gallbladder and reports of gallbladder sludge (<0.1%)
Urogenital: Moniliasis and vaginitis (0.1 to 1.0%); oliguria and nephrolithiasis. 
Gastroinntestinal: Diarrhea (3.3%); nausea,  vomiting and gastric pain (0.1 to 1.0%) abdominal pain, colitis, flatulence, dyspepsia, pseudomembranous colitis and stomatitis (<0.1%); glossitis.
Neurological: Dizziness and headache (0.1 to 1.0%) ataxia and paresthesia (<0.1%).
Misccellaneous:  Fever, chills, diaphoresis, malaise, butning tongue, flushing edema and anaphylactic shock (0.1 to 1.0%; btonchospasm, palpitations and epistaxis (<0.1%); glottis/laryngeal edema.
Local Reactions at Injection Site: Pain (9.4%) Indurations and tenderness (1. To 2%); phlebitis reactions (0.1 to 1.0%). Thrombophlebitis (0.1%).
Hepatic: Increase in AST (4.0%) ALT (4.8%) increase in alkaline phosphatase (1.0%); increase in BUN (1.1%)increase in creatinine, erythrocyturia, proteinuria, proteinuria and presence. Of casts in urine 0.1 to 1.0%); glycosuria (<0.1%)phosphatase (1.0%); increase in bilirubin (0.1 to 1.0%). Urinary: Increase in BUN (1 1%) increase in creatinine, erythrocyturia, proteinuria and presence of casts in urine (0.1 to 1.0%); glycosuria (<0.1%)

Symptoms and Treatment; Ultrasonographic shadows suggesting precipitations in the kidneys accompanied by calcium ceftiaxone precipitate in the urine was observed in 1 patient dosed at 10 g/day (2.5 times the maximum recommended dose). No other case of overdosage has been reported to data. Excessive serum concentration of treatment is available. Excessive serum concentration of ceftriaxone cannot be reduced by hemodialysis or peritoneal dialysis. Treatment should be symptomatic.

Dosage and Administration: Ceftriaxone may be administered i.v.or i.m. after reconstitution. Dosage and reute of administration should be determined by the severity of infection, susceptibility of the causative organisms, and condition of the patient. The i.v. route is preferable for patients with septicemia or other severe or life-threatening infections. Ceftriaxone is administered over 2 to 4 minutes, by inten-nitent intravenous infusion over at least 30 minutes, or by deep intramuscular injection. If more than 1g is to be injected intramuscularly then the dose should be divided between more than one site, It is usually given to adults in a dose of Ito 2g as a single dose or in two divided doses: in severe infections up to 4g daily may be -given. Suggested doses for infants and children am 20 to 50mg per kg body weight once daily; for severe infections up to 80mg per kg daily may be given. In neonates, the maximum dose should not exceed 50mg per kg; intravenous doses in neonates should be given over 60 minutes, Doses above 50mg per kg should be administered by intrvenous infusion only A single intramuscular dose of 250mg is recommended for the tteatment of uncomplicated gonorrhoea in adults, For surgical infection prophylaxis in adults, a single dose of 1g may be administered 0.5 to 2 hours prior to surgery; a 2g dose is suggested before colorectal surgery. For the prevention of secondary cases of meningococcal meningitis a single intramuscular dose of 250mg has been suggested for adults and 125mg for children. A reduction in dosage may be necessary in patients with severe renal impairment and hepatic function. Plasma concentrations should be monitored in such patients.

Impairment of Renal and/or Hepatic Function: In patients with mild to moderate renal impairment, changes in the dosage regimen are not required, provided liver function is intact. In cases of preterminal renal failure (creatinine clearance less than 10 ml/min), periodic monitoring of serum ceftriaxone concentrations is recommended. The daily dosage should be limited to 2 g or less. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is intact. In cases of coexistent renal and clinically significant hepatic insufficiency, close monitoring of serum ceftriaxone concentrations, at regular intervals, is recommended. If there is evidence of accumulation, dosage should be decreased accordingly.

I.M.: The reconstituted solution should be administered by deep intragluteal injection< It is recommended that not more than 1 g be injected at a single site. Pain on i.m. injection is usually mild and less frequent when ceftriaxone is administered in sterile 1% Ligno-Ans. injected at a single site. Pain on i.m. injection is usually mild and less frequent when ceftriaxone is administered in sterile 1% Ligno-Ans.

Short I.V. infusion: The further diluted i.v. solution shoule be given over a period of 10 to15 minutes in infants and children and 20 to 30 minutes in adults.

Stability and Storage: I.M.: Solutions should be reconstituted immediately before use. If storage is required, these solutions may be stored under refrigeration and should be used within 48 hours. I.V. Infusion: Further diluted reconstituted solutions should be administered within 24 hours when stored at room temperature.

Warning: As with all parenteral drug products, i.v. admixtures should be visually inspected prior to administration, whenever solution and container permit. Solutions showing any evidence of haziness or cloudiness, particulate matter, precipitation, discoloration or leakage should not be used.

Incompatibility: Ceftriaxone should not be physically mixed with other antimicrobial agents, vancomycin, amsacrine, or fluconazole. Ceftriaxone should not be added to blood products, protein hydrolysates or amino acids. Ceftriaxone should not be added to solutions containing calcium.

Presentation:
1. Sky-Zone 250mg Injection I.M
Each vial Contains:
Caftriaxone 250mg as Caftriaxone Sodium USP with 02m1 Ligno-Ans Injection as solvent.

2. Sky-Zone 500mg Injection I.M
Each vial Contains:
Ceftriaxone 500mg as Ceftriaxone Sodium USP with 02m1 Ligno-Ans Injection as solvent.

3. Sky-Zone 1gm Injection I.M
Each vial Contains:
Ceftriaxone 1gm as Ceftriaxone Sodium USP with 2 x 2 ml Ligno-Ans Injection as solvent.

4. Sky-Zone 250 mg Injection I.V.
Each vial Contains:
Ceftriaxone 250mg as Ceftriaxone Sodium USP with 5m1 ampoule of water for Injection as solvent.

5. Sky-Zone 500mg Injection I.V.
Each vial Contains:
Ceftriaxone 500mg as Ceftriaxone Sodium USP with 5m1 ampoule of water for Injection as solvent.

6. Sky-Zone 1gm Injection I.V.
Each vial Contains:
Ceftriaxone 1gm as Ceftriaxone Sodium USP with 2 x 5 ml ampoules of water for Injection as solvent.

Storage: Store in cool, dry place. Keep out of reach of children. Protect from direct sun light.