Consumer medicine information

1. Why am I taking KALIXOCIN?

KALIXOCIN contains the active ingredient clarithromycin. KALIXOCIN is used to treat certain bacterial infections including respiratory tract infections, ear infections, skin infections and peptic ulcer. KALIXOCIN is also used to prevent a specific bacterial infection associated with HIV infection. For more information, see Section 1. Why am I taking KALIXOCIN? in the full CMI.

2. What should I know before I take KALIXOCIN?

Do not take if you have ever had an allergic reaction to clarithromycin, other antibiotics from the macrolide family 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 take KALIXOCIN? in the full CMI.

3. What if I am taking other medicines?

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

4. How do I take KALIXOCIN?

Your doctor will tell you how much to take and when to take it. Take KALIXOCIN exactly as directed by your doctor. More instructions can be found in Section 4. How do I take KALIXOCIN? in the full CMI.

5. What should I know while taking KALIXOCIN?

6. Are there any side effects?

Tell your doctor if you experience any of the following: stomach cramps and pains, nausea, vomiting and diarrhoea, oral thrush or vaginal thrush, change in taste sensation, headache, asthma, shortness of breath, muscle weakness, pain or spasms, conjunctivitis, chills, fatigue, eructation (belching), stomach distension or flatulence. Tell your doctor immediately if you notice any of the following as you may need urgent medical care: yellowing of the eyes or skin, feeling generally unwell and having poor appetite, hearing disturbances, chest pain, dizziness, confusion, hallucinations, convulsions, fainting, irregular heartbeat, any type of skin rash, itching, hives, severe diarrhoea, especially if bloody or severe upper stomach pain, with nausea and vomiting. Stop taking KALIXOCIN and call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects: swelling to the face, lips, mouth, throat or neck which may cause difficulty in swallowing or breathing or sudden collapse.
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

Clarithromycin.

2 Qualitative and Quantitative Composition

Kalixocin (clarithromycin) is a semi-synthetic macrolide antibiotic. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol and acetonitrile and practically insoluble in water.
Kalixocin tablets contain sorbates. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The Kalixocin 250 mg tablet is yellow, ovaloid and film-coated, containing 250 mg clarithromycin.

4 Clinical Particulars

4.9 Overdose

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce pronounced gastrointestinal symptoms. Severe liver toxicity, including cholestatic jaundice, may occur. One patient who had a history of bipolar disorder ingested eight grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalaemia and hypoxemia.
There is no known antidote. Treatment consists of prompt elimination of the unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
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

Hepatotoxicity, atrophy of lymphatic tissues (lymph, thymus) and adverse reproductive toxicity were seen in several species at exposures less than those which might be expected clinically at proposed doses. The clinical significance of these observations is not known.
Genotoxicity. Clarithromycin gave negative results in a battery of mutagenicity studies with the exception of a positive result in an in vitro chromosome aberration assay.
Carcinogenicity. Long-term studies in animals have not been performed to assess carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemically, it is 6-0-Methyl Erythromycin A.
The molecular formula is C₃₈H₆₉NO₁₃, the molecular weight is 747.96 and the structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCLARIT.gif CAS number. 81103-11-9.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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