Consumer medicine information

1. Why am I using CECLOR?

CECLOR contains the active ingredient cefaclor. CECLOR is used to treat infections caused by bacteria in different parts of the body. For more information, see Section 1. Why am I using CECLOR? in the full CMI.

2. What should I know before I use CECLOR?

Do not use if you have ever had an allergic reaction to CECLOR 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 CECLOR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CECLOR 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 CECLOR?

• Your doctor will tell you how much CECLOR you need to take.

• This will depend on the type of infection you have.

5. What should I know while using CECLOR?

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following and they worry you: diarrhoea; itchy rash; oral thrush - white, furry, sore tongue or mouth; vaginal thrush - sore and itchy vagina and/or abnormal discharge. Tell your doctor as soon as possible if you notice any of the following: nausea; vomiting; drowsiness; headache; hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations; severe muscle stiffness; swelling of the joints with or without fever; pain in the joints with or without fever; itching or swelling of the skin; yellowing of the skin or eyes; frequent infections such as fever, severe chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal; difficulty in swallowing or breathing.
This is not a complete list of all possible 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

Cefaclor (as monohydrate).

2 Qualitative and Quantitative Composition

Each 5 mL of Ceclor powder for oral liquid upon reconstitution contains 125 mg or 250 mg of cefaclor (as monohydrate) as the active ingredient.
Excipients of known effect. Sugars.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ceclor 125 mg/5 mL and 250 mg/5 mL powder for oral liquids are pink free-flowing dry powders. After constitution, a red coloured suspension with a characteristic strawberry odour is formed.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. The toxic symptoms following an overdose of Ceclor may include nausea, vomiting, epigastric distress and diarrhoea. The severity of the epigastric distress and the diarrhoea are dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication.
Treatment. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in the patient.
Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing charcoal.
Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of cefaclor.
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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFMON.gif Chemical name: 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate.
Molecular formula: C₁₅H₁₆ClN₃O₅S.
Molecular weight: 385.8.
Ceclor (cefaclor monohydrate) is a semisynthetic cephalosporin antibiotic for oral administration.
Cefaclor monohydrate is a white to off white crystalline powder, slightly soluble in water, but is insoluble in alcohol and chloroform.
CAS number. 70356-03-5.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CECLORST.gif