Cefaclor for Suspension

Cefaclor for Suspension

 

Generic name: Cefaclor for Suspension
Brand name: Zaike
Composition:
Cefaclor (6R,7R)-7-{[(2R)-2-amino-2-phenylacetyl]amino}- 3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene
- 2-carboxylic acid

Chemical structure:

 

Molecular formula: C15H14ClN3O4S
Molecular weight:367.808 g/mol

Description: Zaike is granular and powder; aromatic, sweet.
Strength:125mg

Indications:Cefaclor belongs to the family of antibiotics known as the cephalosporins (cefalosporins). The
cephalosporins are broad-spectrum antibiotics that are used for the treatment of septicaemia, pneumonia,
meningitis, biliary tract infections, peritonitis, and urinary tract infections. Pharmacology of the cephalosporins
is similar to that of the penicillins, excretion being principally renal. Cephalosporins penetrate  cerebrospinal
fluid poorly unless the meninges are inflamed; cefotaxime is a more suitable cephalosporin than cefaclor for
infections of the central nervous system, e.g. meningitis. Cefaclor is active against many bacteria, including
both Gram-negative and Gram-positive organisms

Dosage and Administration:

Taken orally.
For adults: 0.25g (2 packets) once, and three times daily. The dose can be doubled for the patient with serious
infection, but the daily dose should be no more than 4g (32 packets), or follow the doctor's advice.
For children: the daily dose is 20~40mg/kg based on patient weight, and administrated as 3 times daily , but
the daily dose should be no more than 1g (8 packets).

Side Effects
Gastrointestinal
If diarrhea occurs and it is unresponsive to discontinuation of the drug and/or standard therapy, pseudomem-
branous colitis should be considered.Gastrointestinal side effects have included diarrhea, nausea, vomiting,
and abdominal pain. Extended-release cefaclor has been associated with diarrhea (3.8%), nausea (3.4%),
and anorexia, constipation, dyspepsia, flatulence, gastritis, nausea and vomiting, and vomiting in 0.1% to 1%
of patients. Pseudomembranous colitis has been reported in patients treated with cephalosporins.

Hypersensitivity
Anaphylactic reactions are rare, but may occur, especially in patients with a history of penicillin allergy.

Serum-sickness-like reactions are more frequent in pediatric patients and following a second or subsequent
course of cefaclor and have been characterized by erythema multiforme, rash, arthritis, and/or arthralgia with
 or without fever.Hypersensitivity reactions have included rash, morbilliform eruptions (1%), pruritus, serum-
sickness-like reactions, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis,
anaphylactoid reaction, and angioedema
Nervous system
Nervous system side effects have rarely included reversible hyperactivity, agitation, nervousness, insomnia,
confusion, hypertonia, dizziness, hallucinations, and somnolence. Extended release cefaclor has been
associated with headache in 4.9% of patients, and dizziness, insomnia, nervousness, somnolence, and
tremor in 0.1% to 1% of patients, and paresthesia and vertigo. Some cephalosporins have been associated
with seizures, primarily when dosages were not reduced in renally impaired patients.

Clinical Pharmacology
Cefaclor is well-absorbed after oral administration to fasting subjects. Total absorption is the same whether
the drug is given with or without food; however, when it is taken with food, the peak concentration achieved
is 50% to 75% of that observed when the drug is administered to fasting subjects and generally appears from
three-fourths to 1 hour later. Following administration of 250 mg, 500 mg, and 1 g doses to fasting subjects,
average peak serum levels of approximately 7, 13, and 23 mcg/mL, respectively, were obtained within 30 to
60 minutes. Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the
greater portion being excreted within the first 2 hours. During this 8-hour period, peak urine concentrations
following the 250 mg, 500 mg and 1 g doses were approximately 600, 900 and 1,900 mcg/mL, respectively.
The serum half-life in normal subjects is 0.6 to 0.9 hour. In patients with reduced renal function, the serum
half-life of Cefaclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life
of the intact molecule is 2.3 to 2.8 hours. Excretion pathways in patients with markedly impaired renal function
have not been determined. Hemodialysis shortens the half-life by 25% to 30%.
Storage:Store below 25°C, protected from moisture.
After reconstitution the product must be stored at 2-8°C in a refrigerator. In order to maintain stability, the
prepared suspension must under no circumstances be stored outside the fridge.
Packs: 125mg /sachet,  6 sachets/Box
Shelf-life:24months