Cefalexin (Flynn)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefalexin monohydrate 26.295 mg/mL equivalent to cefalexin 25mg/mL;  

Available from:

Max Health Limited

Dosage:

125 mg/5mL

Pharmaceutical form:

Granules for oral suspension

Composition:

Active: Cefalexin monohydrate 26.295 mg/mL equivalent to cefalexin 25mg/mL   Excipient: Allura red AC Dimeticone Imitation guarana flavour 051880 TP0551 Methylcellulose Pregelatinised maize starch Sodium laurilsulfate Sucrose Xanthan gum

Prescription type:

Prescription

Therapeutic indications:

Cefalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: - bacterial sinusitis caused by streptococci, S. pneumoniae, and Staphylococcus aureus (methicillin -sensitive only); - respiratory tract infections caused by S. pneumoniae and S. pyogenes (penicillin is the usual medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever - cefalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available at present); - otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis; - skin and skin-structure infections caused by staphylococci and/or streptococci; - bone infections caused by staphylococci and/or P. mirabilis; - genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and Klebsiella pneumoniae; - dental infections caused by staphylococci and/or streptococci. Note - Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with child safety cap in outer carton - 100 mL - 24 months from date of manufacture stored at or below 25°C 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2020-06-26

Patient Information leaflet

New Zealand Consumer Medicine Information
CEFALEXIN
_Cephalexin Monohydrate _
_ _
_Oral suspension_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Cefalexin.
It does not contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cefalexin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEFALEXIN IS USED
FOR
The name of your medicine is
Cefalexin. It contains the active
ingredient cefalexin monohydrate.
Cefalexin is an antibiotic used to
treat infections in different parts of
the body caused by bacteria.
Cefalexin belongs to a group of
antibiotics called cephalosporins.
These antibiotics work by killing the
bacteria that are causing your
infection.
Cefalexin can be used to treat
infections of the:
•
respiratory tract (throat,
tonsils, chest and lungs)
•
nose (sinusitis)
•
ears (otitis media)
•
skin and soft tissue
•
kidneys and bladder
(genitourinary tract).
Your doctor may have prescribed
Cefalexin for another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CEFALEXIN HAS BEEN PRESCRIBED
FOR YOU.
Cefalexin is available only with a
doctor’s prescription. It is not
addictive.
BEFORE YOU TAKE
CEFALEXIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CEFALEXIN IF:
1.
YOU HAVE AN ALLERGY TO
CEFALEXIN MONOHYDRATE,
OTHER CEPHALOSPORINS OR ANY
OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
asthma, wheezing, shortness
of breath; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or
breathing; skin rash, itching or
hives.
2.
YOU HAVE HAD A SERIOUS
ALLERGIC REACTION TO ANY
PENICILLINS.
You may be more likely to have
an allergic reaction to Cefalexin
if you are aller

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Cefalexin 125 mg/5 mL Granules for oral suspension
Cefalexin 250 mg/5 mL Granules for oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefalexin 125 mg/5 mL Granules for oral suspension:
When prepared as directed, each 5 mL of reconstituted suspension
contains (as the active
ingredient) cefalexin monohydrate equivalent to 125 mg of cefalexin
base.
Excipients with known effect: contains 3.119 g of sucrose per 5 mL
after reconstitution.
Cefalexin 250 mg/5 mL Granules for oral suspension:
When prepared as directed, each 5 mL of reconstituted suspension
contains as the active
ingredient, cefalexin monohydrate equivalent to 250 mg of cefalexin
base.
Excipients with known effect: contains 2.972 g of sucrose per 5 mL
after reconstitution.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Granules for oral suspension.
White granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefalexin is indicated for the treatment of the following infections
when caused by
susceptible strains of the designated microorganisms:
•
bacterial sinusitis caused by streptococci, S. pneumoniae, and
Staphylococcus aureus
(methicillin-sensitive only);
•
respiratory tract infections caused by S. pneumoniae and S. pyogenes
(penicillin is the
usual medicine of choice in the treatment and prevention of
streptococcal infections,
including the prophylaxis of rheumatic fever - cefalexin is generally
effective in the
eradication of streptococci from the nasopharynx; however, substantial
data establishing
the efficacy of cefalexin in the subsequent prevention of either
rheumatic fever or
bacterial endocarditis are not available at present);
•
otitis media due to S. pneumoniae, H. influenzae, staphylococci,
streptococci, and M.
catarrhalis;
•
skin and skin-structure infections caused by staphylococci and/or
streptococci;
•
bone infections caused by staphylococci and/or P. mirabilis;
•
genitourinary tract infections, including acute prostatitis, caused by
E. coli, P. m