Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Nicotine Transdermal Anti-smoking May 1995
therapeutic system
2.Nicotine Polacrilex Lozenges 18-02-2009
2mg/4mg
To reduce withdrawal symptoms including nicotine craving, associated
with Quitting the Smoking and Quitting Chewed tobacco and Gutka
containg Tobacco
3.Nicotine Polacrilex Gum 03-02-2009
2mg/4mg
Addl.Indcn.
To reduce the withdrawal symptoms, including Nicotine craving,
associated with quitting the smoking and Quitting Chewed Tobacco
and Gutka Containg Tobacco
4.Nicotinic Acid and Lapropirant 26-03-2010
Modified Release tablets-
Nicotinic Acid 1000mg
Lapropirant 20mg LDL
i. For the Treatment of Dyslipidaemia, particularly in patients with
Combined mixed Dyslipidemia (Charatcterised by elevated levels
of cholesterol and triglycerides and Low HDL Cholesterol) and in
patients with primary Hypercholesterolemia (Heterozygous Familial
and Non-Familal )
ii. In combination with HMG-COA Reductase inhibtors (Statins),
when Cholesterol Lowering effect of HNG-COA Reductase Inhibitor
therapy is inadequate .
It can be used as a monotherapy only in patients in whom
HMG-COA Reductase inhibitors are considered inadequate or
not tolerated.
Diet or other Non-pharmacological treatments (eg.Excercise ,
weight reduction) should be continued during therapy
Smoking cessation
Dosages/ Overdosage Etc:
Indication-
Smoking cessation
Dosage-
usual dosage - week 1 to 6 - 1 piece of gum evey 1 to 2 hours
week 7 to 9 - 1 piece of gum every 2 to 4 hours
weeks 10 to 12 - 1 piece of gum every 4 to 8 hours
Patients who smoke less than 25 cigarette per day- start with 2mg nicotine gum
25 cigaretes or more a day- start with 4mg nicotine gum
Dosage adjustment - if there is a strong and frequent craving use a second piece within 1 hour
Usual dosage-
If a patient smokes his/her first cigareette more than 30 minutes of waking up
-use 2mg nicotine lozenges
If a patient smokes his/her first cigarette within 30 minutes of waking up
-use 4mg nicotine lozenges
week 1 to 6 - 1 lozenge every 1 to 2 hours
week 7 to 9- 1 lozenge every 2 to 4 hours
week 10 - 12 - i lozenge every 4 to 8 hours
Maximum dose - do not use use more than 5 lozenges in 6 hours.
Do not use more than 20 lozenges/day
Manufacturer Details