Aciphin IV Injection

Aciphin IV is a sterile, semisynthetic, broad-spectrum, 3rd generation cephalosporin antibiotic for intravenous or intramuscular administration. The bactericidal activity of Aciphin IV results from inhibition of cell wall synthesis. Aciphin IV has a high degree of stability in the presence of beta-lactamases both penicillinases and cephalosporinases of gram-negative and gram- positive bacteria.

Uses

Aciphin IV is used for the treatment of the following infections when caused by susceptible organisms:

Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, E. coli, Enterobacter aerogenes, Proteus mirabilis, Serratia marcescens.

Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), Moraxella catarrhalis (including beta-lactamase producing strains).

Skin and Skin Structure Infections caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, E. coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis, Peptostreptococcus species.

Urinary Tract Infections (complicated and uncomplicated) caused by E. coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Klebsiella pneumoniae.

Uncomplicated Gonorrhea (cervical, urethral, pharyngial and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae.

Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae.

Bacterial Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E. coli, Haemophilus influenzae, Klebsiella pneumoniae.

Bone and Joint Infections caused by Staphylococcus aureus, Streptococcus pneumoniae, E. coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species.

Intra-abdominal Infections caused by E. coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species, Peptostreptococcus species.

Meningitis caused by Haemophilus influenzae, Neisseria meningitidis, Streptococcus pneumoniae. Aciphin IV has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and E. coli.

Surgical Prophylaxis: The preoperative administration of a single 1 gm dose of Aciphin IV may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated.

Aciphin IV is also used to associated treatment for these conditions: Arthritis gonococcal, Bacterial Endocarditis, Bacterial Infections, Bacterial Sepsis, Bacterial Sinusitis, Bone and Joint Infections, Brain abscess, Chancroid, Community Acquired Pneumonia (CAP), Conjunctivitis gonococcal neonatal, Epididymitis, Epiglottitis, Gonococcal infection of pharynx, Gonococcal pelvic inflammatory disease, Intra-Abdominal Infections, Lower respiratory tract infection bacterial, Lyme Neuroborreliosis, Meningitis, Bacterial, Ophthalmia neonatorum due to gonococcus, Postoperative Infections, Prosthetic Joint Infection, Salmonella Typhi Infection, Septic Arthritis, Shigellosis, Skin and Subcutaneous Tissue Bacterial Infections, Syphilis, Vulvovaginitis gonococcal, Whipple Disease, Bacterial otitis media, Complicated Bacterial Urinary Tract Infections, Susceptible Bacterial Infections, Uncomplicated Gonorrhea, Uncomplicated Urinary tract infection bacterial

Trade Name Aciphin IV
Generic Ceftriaxone
Other Names Ceftriaxona, Ceftriaxone, Ceftriaxonum, Rocephin
Weight 250mg/vial, 500mg/vial, 1 gm/vial, 2gm/vial
Type Injection
Formula C18H18N8O7S3
Weight Average: 554.58
Monoisotopic: 554.04605704
Protein binding

Ceftriaxone is 95% protein bound.

Therapeutic Class Third generation Cephalosporins
Manufacturer ACI Limited
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:18 am

Dosage

Aciphin IV dosage

Generally, Aciphin IV should be taken once or equally devided twice a day for 4-14 days. Aciphin IV therapy should be continued for at least 2 days after the sign and symptoms of infection have disappeared.

The usual duration of therapy is 4 to 14 days; in complicated infections longer therapy may be required. No dosage adjustment is required for patients with renal or hepatic impairment.

Use the solution immediately after reconstitution of powder.

Side Effects

Generally Aciphin IV is well tolerated. However, few side effects including nausea, vomiting, diarrhea, dizziness and fever may occur.

Precaution

Aciphin IV should be administered with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Interaction

May increase nephrotoxicity of aminoglycosides. May diminish therapeutic effect of BCG, typhoid vaccine, Na picosulfate. May increase anticoagulant effect of vit K antagonists (e.g. warfarin). May increase serum level with probenecid.

Food Interaction

No interactions found.

Volume of Distribution

The apparent volume of distribution of an intravenous or intramuscular dose in healthy patients is 5.78 to 13.5 L. The volume of distribution of an intravenous or intramuscular dose in septic patients is 6.48 to 35.2 L. Aciphin IV has good enough CSF penetration to be used as an effective treatment of bacterial meningitis.

Half Life

The elimination half-life of ceftriaxone is 5.8-8.7 hours. The half-life of ceftriaxone in the middle ear fluid has been estimated to be 25 hours.

Clearance

The plasma clearance of ceftriaxone in healthy adults receiving a 0.15-3g dose is 0.58 to 1.45 L/hour. The renal clearance of ceftriaxone is 0.32 to 0.73 L/hour. In intensive care unit patients, ceftriaxone's total drug clearance was 0.96L/h (0.55-1.28 L/h), and unbound drug clearance was 1.91 L/h (1.46-6.20 L/h).

Pregnancy & Breastfeeding use

Pregnancy: The safety of Aciphin IV in the treatment of infections during pregnancy has not been established. Aciphin IV should only be used during pregnancy if the likely benefit outweighs the potential risk to the fetus and/or the mother.

Lactation: Aciphin IV is excreted in breast milk at low concentrations. Therefore, caution should be exercised when Aciphin IV is administered to a nursing mother.

Contraindication

Aciphin IV should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics. It is contraindicated in premature infants during the first 6 weeks of life. Its safety in human pregnancy has not been established. Aciphin IV is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium.

Acute Overdose

There is no specific antidote. Treatment of over dosage should be symptomatic.

Storage Condition

Store below 25°C, protected from light & moisture. Use reconstituted solutions immediately. 

Reconstituted solutions are stable for 6 hours at room temperature and for 24 hours at 2°-8°C. It should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride injection BP (for IM injection only).

Aciphin IV contains Ceftriaxone see full prescribing information from innovator Monograph