Consumer medicine information

1. Why am I using KEFLEX?

KEFLEX contains the active ingredient cefalexin monohydrate. KEFLEX is used to treat infections caused by bacteria in different parts of the body, including infections of the respiratory tract (throat, tonsils, chest and lungs), nose (sinusitis), ears (otitis media), skin and soft tissue, kidneys and bladder (genitourinary tract).
For more information, see Section 1. Why am I using KEFLEX? in the full CMI.

2. What should I know before I use KEFLEX?

Do not use if you have ever had an allergic reaction to cefalexin monohydrate, penicillin, other cephalosporins or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use KEFLEX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with KEFLEX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use KEFLEX?

• Follow all directions given to you by your doctor or pharmacist.

• You doctor will tell you how much and how often you should take KEFLEX.

5. What should I know while using KEFLEX?

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Cefalexin monohydrate.

2 Qualitative and Quantitative Composition

Keflex capsules contain the active cefalexin monohydrate equivalent to 250 mg or 500 mg of cefalexin.
Keflex powder for oral liquid in bottles contains the active cefalexin monohydrate equivalent to 125 mg or 250 mg of cefalexin per 5 mL upon reconstitution.
Excipient with known effect. Sucrose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Keflex is available in hard gelatin capsules and powder for oral liquid in bottles.
Keflex capsules. 250 mg. An opaque dark green and white size 1 capsule marked with "GP1" on the cap and body containing 250 mg cefalexin.
500 mg. An opaque dark green and light green size 0 capsule marked with "GP2" on the cap and body containing 500 mg cefalexin.
Keflex powder for oral liquid. 125 mg/5 mL. A white free flowing powder before reconstitution and a red suspension after reconstitution containing 125 mg cefalexin per 5 mL.
250 mg/5 mL. A white free flowing powder before reconstitution and a red suspension after reconstitution containing 250 mg cefalexin per 5 mL.

4 Clinical Particulars

4.9 Overdose

There is no definite experience of poisoning or severe overdosage with cefalexin. However, clinical features of overdosage may be similar to those seen with other cephalosporins and penicillins, i.e. convulsions, hallucinations, hyper-reflexia, electrolyte imbalance, gastrointestinal disturbances and haematuria.
In the event of severe overdosage, general supportive care is recommended including close clinical and laboratory monitoring of haematological, renal, hepatic functions and coagulation status until the patient is stable.
Forced diuresis, peritoneal dialysis, haemodialysis or charcoal haemoperfusion have not been established as beneficial for an overdose of cefalexin.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Keflex (cefalexin 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.
The nucleus of cefalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e. the molecule contains both a basic and an acidic group. The isoelectric point of cefalexin in water is approximately 4.5 to 5.
The crystalline form of cefalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 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. Cefalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.
Cefalexin monohydrate has the following structural formula.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFAMO.gif CAS number. 15686-71-2.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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