Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Chlorhexidine Gluconate gel 0.2% 30-12-2009
For the prevention of plaque and treatment of gingivitis
2. Chlorhexidine Gluconate Mouth wash 0.1% 30-12-2009
For the prevention of plaque and treatment of gingivitis
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Chlorhexidine gluconate IP 1%w/v+ 29-12-2010
Ethyl alcohol IP 61% w/v solution
Surgical hand scrub and healthcare personnel hand wash
2.Chlorhexidine gluconate IP 1%w/v + 29-12-2010
Ethyl alcohol IP 61% w/v syrup
For treatment of allergic rhinitis in adults only
Gingivitis
General antisepsis.
dressing changes
wounds and and burns
Gingivitis
General antisepsis. dressing changes wounds and and burns
Other Information:
EVIDENCE BASED MEDICINE (MIMS April 2003)
Treatment of Aphthous Ulcers
Comparative effectiveness of various interventions for mouth ulcers
Likely to be beneficial
1. Chlorhexidine (but no effect on recurrence rates)
Unknown effectivenes
1. Topical corticostreroids
Unlikely to beneficial
1. Hexidine
KEY POINTS
1. Nine small randomised clincal trials (RCTs) have found no consistent effect of topical corticosteroids on the incidence of new ulcers compared to control preparations. Weak evidence was found that topical corticosteroids may reduce duration of ulcers and hasten pain relief without adverse local or systemic effects.
2. RCTs found that chlorhexidine gluconate rinsers may reduce the duration and severity of episodes of ulceration. No evidence of effect on incidence of recurrent ulceration was found.
3. Single RCTs provide no evidence of benefit from hexidine mouth wash or from proprietary antiseptic mouth wash compared with controls
Patient Information:
Chlorhexidine - Dental
1.Allergies-
Tell your doctor if you are have ever had any unusual or allergic reaction to
this medicine or to skin disinfectants containg chloehexidine. Also tell your
dentist or medical healthcare care professional if you are allergic to any
other substances such as foods. preservatives or dyes.
2.Pregnancy-
Chlohexidine has not been studied in pregnant women.However, chlohexidine
has not shown to cause birth defects or other problems in studies to cause
birth defects or other problems in animal studies.
3. Breast-feeding-
It is not known whether chlorhexidine passes into breast milk. Although most
medicines pass into breast milk in small amounts,many of them may be used
safely while breast-feeding. Mothers who are taking this medicine and who
wish to breast feed should discuss this with their dentist or their doctor.
4.Children-
Studies of this medicine has been done only in adult patients and there is no
specific information comparing use of chlorhexidine in children with use in
other age groups.
5.Older adults-
Many medicines have not been studied specifically in older people.
Therefore, it may not be known whether they work exactly the same way
they do in younger adults, or if they cause different side effects or problems
in older people. There is no specific information comparing use of chlohexidine
in the elderly with use in other age groups
6. Other medicines-
Although certain medicines should not be used together at all, in other cases two
different medicines may be used together even if an interaction might occur.
In such cases your dentist or your doctor may want to change the dose, or other
precautions may be necessary.
Tell your dentist or your doctor if you are using any other prescription or
non-prescription (Over-the counter) OTC medicine.
7. Other medical problems-
The presence of other medical problems may affect the use of chlohexidine..
Make sure you tell your dentist or your doctor if you have any other medical
problems especially-
Front tooth fillings (especially those having rough surfaces) chlorhexidine
may cause staining that, in some cases it may be impossible to remove
and may requirement of replacement of filling
Gum problems- use of chlorhexidine may make other gum problems, such
as peritodentistis worse.
