Klaricid 250mg Tablets (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Abbott Healthcare Products Limited |
|---|---|
| Διεύθυνση | Mansbridge Road, West End, Southampton, SO18 3JD |
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Contraindications
Klaricid 250mg Tablets are contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs or to any of its excipients Concomitant administration of clarithromycin and ergotamine ...
Name of the medicinal product
Klaricid or Clarithromycin 250 mg Tablets.
Interaction with other medicinal products and other forms of interaction
The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects Cisapride, pimozide, astemizole and terfenadine Elevated cisapride levels have been reported ...
Undesirable effects
a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and peadiatric populations are abdominal pain, diarrhoea, nausea, vomiting ...
Special warnings and precautions for use
The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6). Caution ...
Overdose
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin ...
Therapeutic indications
Consideration should be given to official guidance on the appropriate use of antibacterial agents. Klaricid 250mg Tablets are indicated in adults and children 12 years and older. Clarithromycin is indicated ...
Pharmaceutical form
A yellow, ovaloid film-coated tablet containing 250 mg of clarithromycin.
Posology and method of administration
Patients with respiratory tract/skin and soft tissue infections Adults: The usual dose is 250 mg twice daily although this may be increased to 500mg twice daily in severe infections. The usual duration ...
Effects on ability to drive and use machines
There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should ...
Pregnancy and lactation
The safety of clarithromycin during pregnancy and breast feeding of infants has not been established. Based on variable results obtained from studies in mice, rats, rabbits and monkeys, the possibility ...
Pharmacodynamic properties
ATC classification Pharmacotherapeutic group: Anti-infectious ATC code: J01FA09 Mode of Action Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding ...
Qualitative and quantitative composition
250 mg/tablet. Active: Clarithromycin.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Abbott Laboratories Limited Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UK
Pharmacokinetic properties
H. pylori is associated with acid peptic disease including duodenal ulcer and gastric ulcer in which about 95% and 80% of patients respectively are infected with the agent. H. pylori is also implicated ...
Marketing authorization number(s)
PL 0037/0211
Nature and contents of container
2/14/56 tablets in a blister original pack. The blisters are packaged in a carton with a pack insert.
Incompatibilities
None known.
Special precautions for storage
Protect from light. Store in a dry place.
Date of revision of the text
03 November 2011
List of excipients
Croscarmellose sodium Starch pregelatinised Cellulose microcrystalline Silica gel Povidone Stearic acid Magnesium stearate Talc Hypromellose Hydroxypropylcellulose Propylene glycol Sorbitan monooleate ...
Preclinical safety data
In acute mouse and rat studies, the median lethal dose was greater than the highest feasible dose for administration (5g/kg). In repeated dose studies, toxicity was related to dose, duration of treatment ...
Shelf life
The recommended shelf life is 24 months.
Date of first authorization / renewal of the authorization
09/04/91