Aciphin^®

Aciphin is a preparation of Ceftriaxone Sodium which is bactericidal, long-acting, broad spectrum, parenteral cephalosporin preparation, active against a wide range of gram positive and gram negative susceptible microorganisms. Aciphin acts by inhibition of bacterial cell wall synthesis. Aciphin has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

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Aciphin is indicated for the treatment of:

• Lower respiratory tract infections
• Renal and urinary tract infections (complicated and uncomplicated)
• Uncomplicated gonorrhoeae
• Pelvic inflammatory disease
• Septicaemia
• Skin, soft tissue, bone and joint infections
• Intra-abdominal infections
• Bacterial meningitis
• Surgical prophylaxis
• Prevention of post operative infections
• Typhoid fever
• ENT infections
• Acute bacterial otitis media
• Bacterial endocarditis
• Infections in cancer patients, neutropenic and immunosuppressed

Route of administration: Aciphin® should be administered in intramuscular (IM) and intravenous (IV) route. Aciphin should be taken once or equally divided twice a day for 4-14 days. Aciphin therapy should be continued for at least 2-3 days after the signs and symptoms of infection have disappeared Aciphin® IV injection should be administered slowly for 5 minute.

Adults and children over 12 years: The usual dosage is 1-2 g of Aciphin® once daily (every 24 hours); 2-4 g daily in severe infections; intramuscular doses over 1 g divided between more than one site; single intravenous doses above 1 g by intravenous infusion only.

Children up to 12 years, infants and neonates: The following dosage schedules are recommended for once daily administration:

Infants and children (15 days to 12 years): By deep intramuscular injection, or by intravenous injection for 5 minutes, or by intravenous infusion, 20-50 mg/kg once daily; up to 80 mg/kg once daily in severe infections; doses of 50 mg/kg and over by intravenous infusion over at least 30 minutes.

Neonates (up to 14 days): By intravenous infusion over 60 minutes, 20-50 mg/kg body weight once daily. The daily dose should not exceed 50 mg/kg.
For children with body weights of 50 kg or more: The usual adult dosage should be used.

Special dosage instructions

Endocarditis: caused by Haemophilus, Actinobacillus, Cardiobacterium, Eikenella, and Kingella species, by intravenous infusion, 2-4 g daily.
Uncomplicated gonorrhoea: By deep intramuscular injection, 250 mg as a single dose.
Surgical prophylaxis: By deep intramuscular injection or by intravenous injection over at least for 5 minutes, 1 g at induction; colorectal surgery, by deep intramuscular injection or by intravenous infusion, 2 g at induction; intramuscular doses over 1 g divided between more than one site.

Meningitis: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/kg (up to a maximum of 4 g) once daily.

Combination therapy: Simultaneous administration of Aciphin® with diuretics or aminoglycosides in human subject have shown no impairment of renal functions or increased nephrotoxicity.
Reconstitution and preparation for injection
The use of freshly prepared solution is recommended. The reconstituted solution maintain their physical and chemical stability at least 6 hours at room temperature and 24 hours at 5ºC.

Intramuscular injection: 250 mg or 500 mg of Aciphin® should be dissolved in 2 ml of xylone‚ 1% injection (lidocaine hydrochloride USP 1%) and 1 g in 3.5 ml of xylone‚ 1% injection (lidocaine hydrochloride USP 1%) solution provided in the accompanying solvent ampoule and administered by deep intragluteal injection. Dosage greater than 1 g should be divided and injected at more than one site. For intramuscular administration, use of xylone‚ 1% injection (lidocaine hydrochloride USP 1%) is must to avoid the pain. Aciphin® in xylone‚ 1% injection (lidocaine hydrochloride USP 1%) should not be administrated intravenously.

Intravenous injection: 250 mg or 500 mg of Aciphin® should be dissolved in 5 ml, 1 g in 10 ml and 2 g in 20 ml of water for injection BP and then administered intravenously for 5 minutes. Due to possible incompatibility with other solutions or anti-microbial drugs, ceftriaxone should be used with above listed infusion solutions.

Elderly patients: The dosages recommended for adults require no modification in elderly patients.

Patients with hepatic impairment: In patient with impaired hepatic function, there is no need to reduce the dose of Aciphin®. In patient with liver damage, dose reduction is not required if renal function is intact.

Patients with renal impairment: In case of preterminal renal failure (creatinine clearance < 10 ml/min), the daily dose must not exceed 2 g.

Pregnancy: The safety of ceftriaxone in the treatment of infections during pregnancy has not been established. So it should not be given in pregnancy (particularly in the first trimester), unless absolutely indicated.

Lactation: Ceftriaxone is secreted in breast milk at low concentration, hence to be administered with caution in nursing mothers.

Use in children and adolescents
In vitro studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Ceftriaxone should not be administered to hyperbilirubinemic neonates, especially prematures.

Anaphylactic shock is to be borne in mind and the shock reuqires immediate counter measure such as intravenous epinephrine followed by glucocorticoid. In-vitro studies have shown that ceftriaxone, like other cephalosporins may displace billirubin from serum-albumin. Ceftriaxone should therefore not be given to neonates. In severe renal impairment with hepatic insufficiency, ceftriaxone should be administered with caution. Perform screening test with a test dose prior to administer into the patient. It should also be given with caution to patients with history of GI diseases, especially colitis. Prolonged use may also cause hyperinfection.

Ceftriaxone is generally well tolerated, the adverse reactions being relatively infrequent, usually mild and transient, which were reversible either spontaneously or after withdrawal of the drug. However, few side effects includes risk of convulsions, involuntary movements, nausea, vomiting, diarrhoea, dizziness and fever may occur; rarely prolongation of prothombin time and pancreatitis.

Ceftriaxone is contraindicated in patients with a known hypersensitivity to ceftriaxone or any components of this product. It is also contraindicated in premature infants.

Drug interaction with medication: No impairment of renal function or increased nephrotoxicity has been observed after simultaneous administration of ceftriaxone with diuretics e.g. frusemide or with aminoglycosides.

Drug interaction with food and others: Not applicable.

In the case of overdose, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.

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Keep in a cool and dry place, below 30◦C.

Aciphin 250 mg Dry Powder for injection: Each vial contains Ceftriaxone Sodium USP equivalent to 250 mg Ceftriaxone for both IV & IM administration.

Aciphin 500 mg Dry Powder for injection: Each vial contains Ceftriaxone Sodium USP equivalent to 500 mg Ceftriaxone for both IV & IM administration.

Aciphin 1 g Dry Powder for injection: Each vial contains Ceftriaxone Sodium USP equivalent to 1 g Ceftriaxone for both IV & IM administration.

Aciphin 2 g Dry Powder for injection: Each vial contains Ceftriaxone Sodium USP equivalent to 2 g Ceftriaxone for IV administration.

Storage
Store in a cool dry place protected from light. Keep away from the reach of children.

Packing

Aciphin 250 mg IM injection: Box containing 1 vial of dry powder equivalent to 250 mg Ceftriaxone, 1 ampoule of 2 ml Xylone‚ 1% injection (Lidocaine Hydrochloride USP 1%), 1 disposable syringe (5 ml/cc), 1 baby needle, 1 first aid bandage, and 1 alcohol pad.

Aciphin 250 mg IV injection: Box containing 1 vial of dry powder equivalent to 250 mg Ceftriaxone, 1 ampoule of 5 ml Water for injection BP, 1 disposable syringe (5 ml/cc), 1 baby needle, 1 first aid bandage, and 1 alcohol pad.

Aciphin 500 mg IM injection: Box containing 1 vial of dry powder equivalent to 500 mg Ceftriaxone, 1 ampoule of 2 ml Xylone‚ 1% injection (Lidocaine Hydrochloride USP 1%), 1 disposable syringe (5 ml/cc), 1 baby needle, 1 first aid bandage, and 1 alcohol pad.

Aciphin 500 mg IV injection: Box containing 1 vial of dry powder equivalent to 500 mg Ceftriaxone, 1 ampoule of 5 ml Water for injection BP, 1 disposable syringe (5 ml/cc), 1 baby needle, 1 first aid bandage, and 1 alcohol pad.

Aciphin 1 g IM injection: Box containing 1 vial of dry powder equivalent to 1 g Ceftriaxone, 1 ampoule of 3.5 ml Xylone‚ 1% injection (Lidocaine Hydrochloride USP 1%), 1 disposable syringe (5 ml/cc), 1 first aid bandage, and 1 alcohol pad.

Aciphin 1 g IV injection: Box containing 1 vial of dry powder equivalent to 1 g Ceftriaxone, 1 ampoule of 10 ml Water for injection BP, 1 disposable syringe (10 ml/cc), 1 butterfly needle, 1 first aid bandage, and 1 alcohol pad.

Aciphin 2 g IV injection: Box containing 1 vial of dry powder equivalent to 2 g Ceftriaxone, 2 ampoules of 10 ml Water for injection BP, 1 disposable syringe (20 ml/cc), 1 butterfly needle, 1 first aid bandage, and 1 alcohol pad.