APHTHAOL*
Manufacturer Details
DISCUS DENTAL INC
Discus Dental Inc.
Compositions:
Amlexanox 5% oral paste in benzyl alcohol,
mineral oil,
petrolatum ,
5g,
|
Strength
|
Rate
|
Packing Style
|
|
5%
|
0.00
|
5g oral paste
|
List of Related Indications:
List Of Drugs:
- Amlexanox - Mouth and throat disorders- (May 2007)
Indication Type Description:
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 68
Name of the Drug- Amlexanox Oral Paste (5%) Pharmacological Classification- For apthous ulcers in people with normal
immune system
Date of Approval- 16-05-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Aphthous ulcers
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Amlexanox oral paste 5% 16-05-2007
For apthous ulcers in people with normal immune system
Adverse Reaction:
Adverse reactions-
Transcient pain, stinging or burning at the site of application ( 1 to 2%)
Others- nausea, and diarrhea
Contra-Indications:
Hypersensitivity to the drug
Special Precautions-
Local irritation- wash hands immediately after applying amlexanox paste to ulcers
with the finger tips. If contact mucositis occurs , discontinue use
Pregnancy- the drug should be used during pregnancy only if clearly needed
Lactation- caution should be excercised when administering amlexanox oral paste
to nursing women.
Children- safety and efficacy have not been established
Elderly- caution should be excercised in elderly patients starting with a low end of dosing
range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and
of concomittant disease or other drug therapy.
Dosages/ Overdosage Etc:
Indication-
Aphthous ulcers
Dosage-
The paste should be applied as soon as possible after noting the symptoms and should be
used 4 times daily preferably following oral hygiene after breakfast, lunch, dinner and
at bed time.
Sqeeze a dab of the paste approx 1/2 inch onto a finger tip . With little pressure dab the
onto each ulcer in the mouth. Use should be continued until the ulcer heals.
If significant healing of pain reduction has not occured in 10 days consult your dentist
or your physician
Pregnancy and lactation:
Pregnancy-
The drug should be used during pregnancy only if clearly needed
Lactation-
Caution should be excercised when administering amlexanox oral paste
to nursing women.
Children-
Safety and efficacy have not been established
Elderly-
Caution should be excercised in elderly patients starting with a low end of dosing
range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and
of concomittant disease or other drug therapy.
