CEPHALEXIN MAX cefalexin monohydrate 250 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin, Quantity: 250 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

cefalexin

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: microcrystalline cellulose; patent blue V; sunset yellow FCF; Gelatin; quinoline yellow; purified water; titanium dioxide; sodium lauryl sulfate; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

20 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Respiratory tract infections caused by S. pneumoniae and group A beta-haemolytic streptococci (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. CEPHALEXIN MAX Capsule is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin Capsule in the subsequent prevention of rheumatic fever are not available at present). Bacterial sinusitis caused by streptococci, S. pneumoniae and S. aureus (methicillin sensitive only). Otitis media. due to S. pneumoniae, Staphylococci. Skin and soft tissue infections. Caused by staphylococci and/or streptococci. Genitourinary tract infections, including acute prostatitis caused by E. coli, P. mirabilis and Klebsiella sp. The effectiveness of CEPHALEXIN MAX Capsule in the treatment of bacterial infections of the brain and spinal column has not been established and CEPHALEXIN MAX capsule is not indicated in these conditions. Note: Appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to CEPHALEXIN MAX Capsule. Renal function studies should be performed when indicated.

Product summary:

Visual Identification: Size '2' capsules with dark green cap imprinted with "250" in black ink and white body without imprint; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-05-07

Summary of Product characteristics

PRODUCT INFORMATION
CEPHALEXIN - MAX
CEPHALEXIN (AS CEPHALEXIN MONOHYDRATE)
NAME OF THE MEDICINE
CEPHALEXIN-MAX (
cephalexin monohydrate) is a semisynthetic cephalosporin antibiotic
for oral
administration. It is
7-(D-α-amino-α-phenyl-acetamido)-3-methyl-3-cephem-4-carboxylic
acid,
monohydrate Cephalexin monohydrate has the following structural
formula.
O
H
NH
2
NH
O
N
S
H
H
CH
3
CO
2
H
H
2
O
Molecular formula: C
16
H
17
N
3
O
4
S. H
2
O
Molecular weight: 365.4
CAS number: [23325-78-2]
DESCRIPTION
The nucleus of cephalexin is related to that of other cephalosporin
antibiotics. The compound is a
zwitterion; ie. the molecule contains both a basic and an acidic
group. The isoelectric point of
cephalexin in water is approximately 4.5 to 5.
The crystalline form of cephalexin which is available is a
monohydrate. It is a white crystalline solid
having a bitter taste. Solubility in water is low at room temperature;
1or 2 mg/mL may be dissolved
readily, but higher concentrations are obtained with increasing
difficulty.
The cephalosporins differ from penicillins in the structure of the
bicyclic ring system. Cephalexin
has a D-phenylglycyl group as substituent at the 7-amino position and
an unsubstituted methyl
group at the 3-position.
Product Information
Cephalexin-Max capsules
Lupin Australia Pty Ltd
Version 3 22 March 2011
Page 2 of 13
Cephalexin-Max capsules contains cephalexin monohydrate equivalent to
250 mg or 500 mg of
anhydrous cephalexin. They also contain microcrystalline cellulose and
magnesium stearate. The
capsules are of gelatin, sodium lauryl sulphate, and are coloured with
sunset yellow (E110),
quinoline yellow (E104), titanium dioxide (E171), patent blue (E131)
and black ink (SW 9008).
PHARMACOLOGY
PHARMACOKINETICS
The following mean pharmacokinetic parameters have been reported for
the oral administration of
cephalexin capsules. Pharmacokinetic parameters obtained for
Cephalexin-Max capsules (250 mg
and 500 mg) have shown a linear relationship to known values for both
strengths.
_ _
Drug
Bioavailability