1. Name Of The Medicinal Product
Clove Oil BP.
2. Qualitative And Quantitative Composition
Clove Oil BP 100% v/v.
3. Pharmaceutical Form
Dental Solution
4. Clinical Particulars
4.1 Therapeutic Indications
For the temporary relief of toothache.
4.2 Posology And Method Of Administration
Local.
Adults, the elderly and children:
Apply on cotton wool to the tooth cavity as required.
4.3 Contraindications
Contra-indicated in patients hypersensitive to clove oil or eugenol.
4.4 Special Warnings And Precautions For Use
Use with caution in the mouth or if sensitive to clove oil.
Avoid contact with the skin.
Repeated use may cause gum damage.
Seek dental attention as soon as possible.
Use with caution in children under 2 years.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
May enhance inhibition of platelet activity in patients receiving anti-coagulant therapy.
4.6 Pregnancy And Lactation
As for all medicines, use only with caution during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Contact with skin or soft tissue may cause transient irritation, contact dermatitis, inflammation of the lips, and inflammation or ulceration of the mouth.
Patients may become sensitive to clove oil.
4.9 Overdose
Accidental oral ingestion of clove oil may lead to CNS depression, urinary abnormalities, anion-gap acidosis, deterioration of liver function, coma, seizure and low blood glucose levels.
Treatment should be supportive and symptomatic; there have been reports in the literature that N-acetylcysteine has been successfully used as an antidote.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Clove Oil has local anaesthetic, antiseptic and antihistaminic properties, and is used as an anodyne in toothache.
5.2 Pharmacokinetic Properties
Clove Oil acts at the site of application.
No data exists on the human pharmacokinetics of Eugenol the principle ingredient of Clove Oil.
In the rat 20-30% of Eugenol is metabolised to homovanillic acid and 4-hydroxy-3-methoxymandelic acid.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
None.
6.2 Incompatibilities
None known.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Store below 25°C.
Keep container tightly closed and protect from light.
6.5 Nature And Contents Of Container
10ml & 50ml: amber glass bottle with plastic cap or white plastic child resistant cap with EPE/Saranex liner or white 28mm polypropylene cap with Tamper Evident band and EPE/ Saranex liner.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH
England.
8. Marketing Authorisation Number(S)
PL: 12965/0006
9. Date Of First Authorisation/Renewal Of The Authorisation
25.08.93 / 11.11.98/
10. Date Of Revision Of The Text
10.11.2008
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
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