Gentamycin Sulfate Injection Small Volume Parenteral Antibiotics 40mg/2ml 80mg/2ml

Gentamycin Sulfate Injection Small Volume Parenteral Antibiotics 40mg/2ml 80mg/2ml

Product name : Gentamycin Sulfate Injection

Dosage and strength : Injection, 80mg:2ml, 40mg:2ml

Packaging : 10 x 10 amps/box, 10 amps/box

Standard : BP/USP

Dossier : Ready to submit

Description :

This product is clarity, or almost colorless clarity liquid.

Indications and Dosages

➤➤To treat serious bacterial infections caused by aerobic gram-negative organisms and some gram-positive organisms, including Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus species, Pseudomonas aeruginosa, Serratia species, Staphylococcus aureus, and many strains of Streptococcus species

I.V. INFUSION, I.M. INJECTION

Adults and adolescents. 1 to 1.7 mg/kg every 8 hr or 4-7 mg/kg every 24 hours.

Children. 2 to 2.5 mg/kg every 8 hr.

Infants. 2.5 mg/kg every 8 to 16 hr.

Premature or full-term neonates up to age

1 week. 2.5 mg/kg every 12 to 24 hr.

INTRATHECAL (INTRALUMBAR OR INTRAVENTRICULAR) INJECTION

Adults and adolescents. 4 to 8 mg daily.

Infants and children age 3 months and over. 1 to 2 mg daily.

➤➤To treat uncomplicated UTI

I.V. INFUSION, I.M. INJECTION

Adults and adolescents weighing more than 60 kg (132 lb). 160 mg once daily or

80 mg every 12 hr.

Adults and adolescents weighing less than 60 kg. 3 mg/kg once daily or 1.5 mg/kg

every 12 hr.

DOSAGE ADJUSTMENT Supplemental dose of 1 to 1.7 mg/kg (2 to 2.5 mg/kg for children) given by I.M. injection or I.V. infusion after hemodialysis, based on infection severity.

Mechanism of Action

Binds to negatively charged sites on the outer cell membrane of bacteria, thereby disrupting the membrane’s integrity. Gentamicin also binds to bacterial ribosomal subunits and inhibits protein synthesis. Both actions lead to cell death.

Incompatibilities

Don’t administer gentamicin through same I.V. line as other drugs, especially betalactam

antibiotics (penicillins and cephalosporins), because substantial mutual inactivation may occur. Give drugs through separate sites.

Contraindications

Hypersensitivity or serious toxic reaction to other aminoglycosides, hypersensitivity to gentamicin or its components

Interaction

DRUGS

aminoglycosides (concurrent use of two or more): Decreased bacterial uptake of each drug, increased risk of ototoxicity and nephrotoxicity

cephalosporins, enflurane, methoxyflurane, vancomycin: Increased risk of nephrotoxicity loop diuretics: Increased risk of ototoxicity and nephrotoxicity

neuromuscular blockers: Prolonged respiratory depression, increased neuromuscular blockade

penicillins: Inactivation of gentamicin by certain penicillins, increased risk of nephrotoxicity

Adverse Reactions

CNS: Acute organic mental syndrome, confusion, depression, fever, headache, increased protein in cerebrospinal fluid lethargy, myasthenia gravis–like syndrome, neurotoxicity (dizziness, hearing loss, tinnitus, vertigo), peripheral neuropathy or encephalopathy (muscle twitching, numbness, seizures, skin tingling), pseudotumor cerebri

CV: Hypertension, hypotension, palpitations

EENT: Blurred vision, increased salivation, laryngeal edema, ototoxicity, stomatitis,

vision changes

GI: Anorexia, nausea, splenomegaly, transient hepatomegaly, vomiting

GU: Nephrotoxicity

HEME: Anemia, eosinophilia, granulocytopenia, increased or decreased reticulocyte count, leukopenia, thrombocytopenia

MS: Arthralgia, leg cramps

RESP: Pulmonary fibrosis, respiratory depression

SKIN: Alopecia, generalized burning sensation, pruritus, purpura, rash, urticaria

Other: Anaphylaxis, injection-site pain, superinfection, weight loss

Pharmacodynamics

Gentamicin is a broad spectrum aminoglycoside antibiotic. Aminoglycosides work by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Aminoglycosides are useful primarily in infections involving aerobic, Gram-negative bacteria, such as Pseudomonas, Acinetobacter, and Enterobacter. In addition, some mycobacteria, including the bacteria that cause tuberculosis, are susceptible to aminoglycosides. Infections caused by Gram-positive bacteria can also be treated with aminoglycosides, but other types of antibiotics are more potent and less damaging to the host. In the past the aminoglycosides have been used in conjunction with penicillin-related antibiotics in streptococcal infections for their synergistic effects, particularly in endocarditis. Aminoglycosides are mostly ineffective against anaerobic bacteria, fungi and viruses.