Saxagliptin usage in T2DM: Update on newer insights from SAVOR

Approval ID: 408417.022, Not to be used after July 2016

Disclaimer: This presentation contains information on the topic based on recent published literature & international guidelines. The user/presenter of this
presentation at his discretion, may modify the contents as may be required. However, the modified version of the presentation shall be reviewed by AstraZeneca
Medical Team, before it can be presented in AstraZeneca driven CMEs. For product information, kindly refer to the full prescribing information.

Content
1. Sustainable Glycemic efficacy: has saxagliptin any
advantage over other drugs?
2. Diabetes and CKD: what is the effect of Saxagliptin on
Proteinuria and other markers?

CKD: Chronic Kidney Disease

RCTs: Randomised clinical trial

Now we have choices - What next?

GLP1

DPP4

SU
SGLT2
Insulin
Glucosidase
Inhibitor
Orlistat
TZD

SU: Sulphonylureas; DPP4i: Depeptidyl peptidase

SGLT2: Sodium glucose transporter; GLP: Glucagon like peptide

Network Meta-analysis Comparing Antihyperglycemic Drugs as Add-on to Metformin:

Results Compared to Placebo
Change in A1C (%)

Change in Body
Weight (kg)

Overall
Hypoglycemia

Mean
Diff.

Mean
Diff.

OR

Sulfonylureas

-0.82*

2.17*

8.86*

Meglitinides

-0.71*

1.40*

10.51*

TZDs

-0.82*

2.46*

0.45

AGIs

-0.66*

-1.01*

0.40

DPP-4 Inhibitors

-0.69*

0.23

1.13

GLP-1R agonists

-1.02*

-1.66*

0.92

Basal insulin

-0.88*

1.38*

4.77*

Premixed insulin

-1.07*

3.41*

17.78*

* significant vs PBO
Liu, Sung-Chen et al. Diab Obes & Metab 2012; 14:810-820.

Network Meta-analysis Comparing Antihyperglycemic Drugs as Add-on to Metformin:

Results Compared to Placebo
Change in A1C (%)

Change in Body
Weight (kg)

Overall
Hypoglycemia

Mean
Diff.

Mean
Diff.

OR

Sulfonylureas

-0.82*

2.17*

8.86*

Meglitinides

-0.71*

1.40*

10.51*

TZDs

-0.82*

2.46*

0.45

AGIs

-0.66*

-1.01*

0.40

DPP-4 Inhibitors

-0.69*

0.23

1.13

GLP-1R agonists

-1.02*

-1.66*

0.92

Basal insulin

-0.88*

1.38*

4.77*

Premixed insulin

-1.07*

3.41*

17.78*

* significant vs PBO
Liu, Sung-Chen et al. Diab Obes & Metab 2012; 14:810-820.

Network Meta-analysis Comparing Antihyperglycemic Drugs as Add-on to Metformin:

Results Compared to Placebo
Change in A1C (%)

Change in Body
Weight (kg)

Overall
Hypoglycemia

Mean
Diff.

Mean
Diff.

OR

Sulfonylureas

-0.82*

2.17*

8.86*

Meglitinides

-0.71*

1.40*

10.51*

TZDs

-0.82*

2.46*

0.45

AGIs

-0.66*

-1.01*

0.40

DPP-4 Inhibitors

-0.69*

0.23

1.13

GLP-1R agonists

-1.02*

-1.66*

0.92

Basal insulin

-0.88*

1.38*

4.77*

Premixed insulin

-1.07*

3.41*

17.78*

* significant vs PBO
Liu, Sung-Chen et al. Diab Obes & Metab 2012; 14:810-820.

DPP-4 INHIBITORS

Key Attributes of DPP-4i

Key features of DPP4-i/Gliptins1

Administration:

Orally

GLP-1 concentrations:

Physiologic

HbA1c reduction:

-0.8% to -1.8%

Insulin secretion:

Glucagon suppression:

++

Gastric emptying:

+/-

Weight:

Neutral effect

Nausea and vomiting:

No

Potential immunogenicity:

No

Risk of hypoglycemia:

Minimal

DPP4i: dipeptidyl peptidase-4 inhibitors, GLP: Glucagon-like polypeptide, HbA1c: glycosylated hemoglobin
8

Cornell S. Adv Stud Pharm. 2009;6(6):180-184.

Saxagliptin efficacious across patient types

0

% HbA1c Drop from baseline

Mono
-0.1
-0.2
-0.3
-0.4
-0.5
-0.6
-0.7
-0.8
-0.9

plus Met

plus SU

plus TZD

plus INS

Saxagliptin efficacious across HbA1c

levels
*

% HbA1c Drop from baseline

A1c<8%

A1c 8-9%

A1c 9-10%

A1c >10%

-0.5

-1

-1.5

-2

-2.5

-3

-3.5

* When Saxagliptin in used with metformin as initial combination

Adapted from: Jadzinsky M et al. Diabetes Obes Metab. 2009; 11: 611 - 22

A1C:

DPP-4 Inhibitors vs Sulfonylureas (Added to Metformin)

Linagliptin vs SU

Adjusted Mean Change

in A1C (%) in PPS

(104 weeks) BL 7.5%

0.00
-0.25
-0.50
-0.75
-1.00
-1.25
-1.50

Linagliptin
+ MET (n = 477)
-0.35

Glimepiride
+ MET (n =458)
-0.53

Saxagliptin vs SU

Sitagliptin vs SU

(52 weeks) BL 7.7%

Saxagliptin
+ MET (n = 293)

-0.74

(52 weeks) BL 7.5%

Glipizide
+ MET (n = 293)

-0.80

LINA Non-inferior to GLIM

SAXA Non-inferior to GPZ

(GLIM mean dose 3 mg)

(GPZ mean dose 14.7 mg)

Sitagliptin
Glipizide
+ MET (n = 382) + MET (n = 411)
-0.67

-0.67

SITA Non-inferior to GPZ

(GPZ mean dose 10.3 mg)

* Significant vs comparator
11

* Significant vs comparator

PPS=Per Protocol Set

PPS = Per-protocol set

Gallwitz B et al. Lancet 2012;380:475-483.. Goke B et al. Int J Clin Pract 2010;64:1619-31. Nauck M et al. Diab Obes Metab 2007;9:194-205.

Impact of treatment with

saxagliptin on glycemic
stability and -cell function in
the SAVOR-TIMI-53 study

126-LB

G Leibowitz,1 O Mosenzon,1 DL Bhatt,2 B Hirshberg,3 C

Wei,3 A Cahn,1 G Jermendy,4 W H-H Sheu,5
JL
Sendon,6 BM Scirica,2 I Raz1

1Hadassah

University Hospital, Jerusalem, Israel; 2TIMI Study Group, Brigham and

Womens Hospital, Harvard Medical School, Boston, MA, USA; 3AstraZeneca Research and
Development, Wilmington, DE, USA; 4Bajcsy-Zsilinszky Hospital, Budapest, Hungry;
5Taichung Veterans General Hospital, Taiwan; 6Hospital Universitario La Paz, Bolivia
Presented at the 74th Scientific Sessions of the American Diabetes Association (ADA), San
Francisco, CA, USA, June 1317, 2014; doi: 10.1111/dom.12445

Glycemic instability Definition

1. HbA1C increase 0.5% post-randomization,
2. Initiation of new anti-diabetic medications for 3 months, or
3. Increase in dose of oral anti-diabetic medication or 25% increase in
insulin dose for 3 months.

-Cell function was assessed by calculating fasting HOMA-2 at baseline and at

year 2 in patients not treated with insulin

Leibowitz G et al. Diabetes obesity and Metabolism. 2015

Change in Additional Antidiabetic Therapies

35

Addition/increase in
antihyperglycemic medication

Initiation of insulin therapy

for >3 months

Patients Changing Therapy (%)

P<0.001
29.3

30

25

23.7

20

15

P<0.001

10

7.8
5.5

Saxagliptin
Scirica BM, et al. N Engl J Med. 2013.10.1056/NEJMoa1307684.

Placebo
14

Saxagliptin reduces need for other agents or dose

increases
Reduction Compared to Usual Care
Insulin Initiation

OAD Up Titration

Insulin Up Titration

0
-5
-10
-15
-20
-25
-30

P<0.0001

-35
Leibowitz G et al. Diabetes obesity and Metabolism. 2015

Saxagliptin reduces glucose instability compare to standard

anti-diabetic therapy
Risk reduction compare to Placebo
0
Glycemic Instability

A1c worsening

-5

-10

-15

-20

-25

-30

-35

P<0.0001

-40

Leibowitz G et al. Diabetes obesity and Metabolism. 2015

Saxagliptin effects on fasting HOMA-2

Changes in HOMA
2

0
Standard Care

P<0.0001

Saxagliptin

-1

-2

-3

-4

-5

Leibowitz G et al. Diabetes obesity and Metabolism. 2015

Sustainable - Saxagliptin added to metformin

102 Weeks: HbA1c mean change from baseline
SAXA 5mg + MET

HbA1c (%) Mean From BLSE

0.4

Baseline HbA1c: 8.0 - 8.1%

Diabetes duration: 6.3 - 6.7 years

0.2
0.0
-0.2
-0.4
-0.6

BL 4 8 12
Patients:
SAXA 5mg + MET
PBO + MET

PBO + MET

20

30

37

50

63

76

89

102

89
52

70
33

58
25

25
15

Weeks
191
179

146
111

116
72

99
60

DeFronzo RA, et al. Diabetes. 2009; 58 (suppl 1):A147, Abstract 547

Take Home
Compared to placebo, treatment with saxagliptin improved glycemic
indices and attenuated glycemic instability over time, irrespective of
baseline anti-hyperglycemic regimens.
Saxagliptin minimized the deterioration of -cell function observed
in placebo-treated patients; in patients not taking any oral anti-diabetic
drugs or when added to other oral anti-diabetic drugs.
These findings suggest that inhibition of DPP-4 with saxagliptin may
slow the natural progression of T2D, as reflected by a slower decline
in -cell function.

19

 What about Renal effects?

What is Renal safety?

1. Renal Safety: Drug which will not
harm kidney i.e. increasing S.Cr. or
reducing eGFR
2. Dose Flexibility: Drug which is
excreted by Kidney, dose needs to be
adjusted. Drug excreted via non-renal
route dose adjustment is not
required. No correlation to renal
safety
3. Reno-Protection: Drug which protect
Kidney by improving renal
parameters i.e. reducing proteinuria,
improving ACR or eGFR etc.

Prognosis of CKD by GFR AND ALBUMINURIA

GFR categories (ml/min/1.73 m2)

Description and range

Persistent albuminuria categories

Description and range

G1

Normal or High

G2

Mildly decreased

60-89

G3a

Mildly to moderately
decreased

45-59

G3b

Moderately to severely
decreased

30-44

G4

Severely decreased

15-29

G5

Kidney failure

Low risk (if no other markers of kidney disease, no CKD

A1

A2

A3

Normal to mildly
increased

Moderately
increased

Severely increased

<30 mg/g
<3 mg/mmol

30-300 mg/g
3-30 mg/mmol

>300 mg/g
>30 mg/mmol

90

<15

Moderately increased risk

High risk

Very high risk

GFR: Glomerular Filtration rate

Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney inter., Suppl. 2013; 3: 1150.

22

Is Albuminuria Preventable?

IRMA-2

Normoalbuminuria

Microalbuminuria

UAE (g/min) <20

Ruggenenti P, et al. N Engl J Med 2004; 351: 1941-51.

ADA. Diabetes Care 2004; 27(Suppl. 1): S79-S83.

20-199

RENAAL
IDNT

Macroalbuminuria

>_200

ESRD

SAVOR patient as per GFR categories

16492
Total population

GFR>50
N= 13916

GFR 3050ml/min
N= 2240

GFR<30 ml/min
N= 336

GFR: Glomerular filtration rate

Udell JA et al. Diabetes Care; DOI: 10.2337/dc14-1850

Does Saxagliptin improve renal outcome in

CKD patients? Results from SAVOR study
eGFR >50 mL/min/1.73 m2 (n= 10,621)
6000

Frequency of progressive
microalbuminuria by completion of
follow-up according to renal function
(n=12,360)

5380

5241

5000

p <0.0001
4139

4000
3000
2000
1000

559

Total

Improved

120
775

p =0.037

758

547

519

Worsened

Placebo

96

p= 0.61 (NS)
76

80

600

72

60

500
400

40

300
200

94

100
0

110

100

700

No Change

eGFR <30mL/min/1.73 m2 (n= 206)

eGFR 30-50 mL/min/1.73 m2 (n= 1,533)

800

790

682

448

Saxagliptin

900

4008

134

73

166

0
Total

Improved
Saxagliptin

No Change
Placebo

Worsened

17

20

Total

17

11

Improved
Saxagliptin

No Change

13

Worsened

Placebo

Jacob A. Udell et al; Saxagliptin in DM Patients and Renal Impairment; Diabetes Care, DOI: 10.2337/dc14-1850,
published online January 12, 2015

Changes in Microalbuminuria

14
12
10

11.4

12.4

13.3

6
4
2

Year 1

Year 2

End of treatment

Saxagliptin
Placebo

14

10

9.4

Improved* microalbuminuria

16

12

18

Patients With Improved Microalbuminuria (%)

Patients With Worsening Microalbuminuria (%)

Worsening* microalbuminuria
15.9
16

14.2
18

11.8

11.1

9.6

10.7
9.2

8.7

8
6
4
2
0

Year 1

Year 2

End of treatment

*Treatment difference in the number and proportion of patients with albumin/creatinine ratios that worsened, did
not change, or improved is defined as a shift from baseline category (<3.4, 3.4 to 33.9, or >33.9 mg/mmol).
P<0.001 vs placebo; P = 0.0058 vs placebo.
Scirica BM, et al. N Engl J Med. 2013.10.1056/NEJMoa1307684.

26

Saxagliptin reverses Micro-albuminurea to

normal
Reversing Microalbuminuria to normal
32

P<0.0001
30

28

26

24

22

20
Saxa

Placebo

Standard antidiabetic
drug

28

Set area descriptor | Sub level 1

Author | 00 Month Year

Clinical implications of SAVOR Study: renal

impairment subgroup observations
1. Largest cohort in prospective study with any diabetic medicine studied to
evaluate safety and efficacy
2. Saxagliptin is a CV safe drug and did not increased chances of AE in
moderately or severly decreased GFR patients
3. Study shows sign of nephroprotective effect of saxagliptin by reversing
microalbuminuria in about one third of study population
4. These data needs to be further validated in future clinical trials.

Summary
DPP4i have sustainable glycemic efficacy equal to other OADs. SAVOR study has
demonstrated positive effect on beta cell function in largest RCT.
This can result in reduced requirement to up-titrate existing medications in long standing
T2DM
These benefits are in addition to weight neutral effects and low risk of hypoglycemia with
DPP4i class of drugs
Reversal of Proteinuria and positive effect on ACR with saxagliptin in SAVOR study
suggests this molecule may have some benefit in halting CKD progression in T2DM
patients

API: Onglyza
For the use of a registered medical practitioner or a hospital or laboratory only
BRIEF SUMMARY OF PRESCRIBING INFORMATION
ONGLYZA
(Saxagliptin) film-coated tablets 2.5 mg & 5 mg
INDICATIONS AND USAGE:
Monotherapy and Combination Therapy
ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes.
Important Limitations of Use
ONGLYZA should not be used in patients with type 1 diabetes or for the treatment of
diabetic ketoacidosis, as it would not be effective in these settings.
ONGLYZA has not been studied in patients with a history of pancreatitis. It is unknown
whether patients with a history of pancreatitis are at an increased risk for the development of
pancreatitis while using ONGLYZA.
DOSAGE AND ADMINISTRATION:
Recommended Dosing
The recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of
meals.
Patients with Renal Impairment
No dosage adjustment for ONGLYZA is recommended for patients with mild renal
impairment (creatinine clearance [CrCl] >50 mL/min.
The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal
impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (CrCl50
mL/min, approximately corresponding to serum creatinine levels of 1.7 mg/dL in men and
1.5 mg/dL in women).
Strong CYP3A4/5 Inhibitors
The dose of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome
P450 3A4/5 (CYP3A4/5) inhibitors.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea)
or with insulin, a lower dose of the insulin secretagogue or insulin may be required to
minimize the risk of hypoglycemia. [See Warnings and Precautions]
CONTRAINDICATIONS:
History of a serious hypersensitivity reaction to ONGLYZA, such as anaphylaxis,
angioedema, or exfoliative skin conditions.
WARNINGS & PRECAUTION:
Pancreatitis
There have been postmarketing reports of acute pancreatitis in patients taking ONGLYZA. If
pancreatitis is suspected, ONGLYZA should promptly be discontinued and appropriate
management should be initiated.
Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions (including
anaphylaxis, angioedema, and exfoliative skin conditions) in patients treated with
ONGLYZA. If a serious hypersensitivity reaction is suspected, discontinue ONGLYZA,
assess for other potential causes for the event, and institute alternative treatment for diabetes.

Use with Medications Known to Cause Hypoglycemia

Insulin or Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a
lower dose of the insulin or insulin secretagogue may be required to reduce the risk of
hypoglycemia when used in combination with ONGLYZA.
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk
reduction with ONGLYZA or any other antidiabetic drug.
USE IN SPECIAL POPULATION
Pregnancy (Category B):
There are no adequate and well-controlled studies in pregnant women. Because animal
reproduction studies are not always predictive of human response, ONGLYZA should be
used during pregnancy only if clearly needed.
Nursing mothers
Saxagliptin is secreted in the milk of lactating rats. It is not known whether saxagliptin is
secreted in human milk. Because many drugs are secreted in human milk, caution should be
exercised when ONGLYZA is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of ONGLYZA in pediatric patients have not been established.
Geriatric Use
Because elderly patients are more likely to have decreased renal function, care should be
taken in dose selection in the elderly based on renal function.
ADVERSE REACTIONS:
The more common adverse reactions reported in patients treated with ONGLYZA 5 mg were
upper respiratory tract infection, urinary tract infection, nasopharyngitis & headache.
The less common adverse reactions that were reported in patients treated with ONGLYZA
2.5 mg or 5 mg included the following: sinusitis, abdominal pain, gastroenteritis, vomiting,
hypersensitivity reactions, and dose-related mean decrease in absolute lymphocyte count,
which was clinically irrelevant. Hypoglycemia was seen in patients on insulin, insulin
secretagogues such as sulphonylureas, and in renally impaired patients.
Vital signs- No clinically meaningful changes in vital signs have been observed in patients
treated with ONGLYZA.
OVERDOSE:
In a controlled clinical trial, once-daily, orally-administered ONGLYZA in healthy subjects
at doses up to 400 mg daily for 2 weeks (80 times the MRHD) had no dose-related clinical
adverse reactions and no clinically meaningful effect on QTc interval or heart rate.
In the event of an overdose, appropriate supportive treatment should be initiated as dictated by
the patients clinical status. Saxagliptin and its active metabolite are removed by hemodialysis
(23% of dose over 4 hours).
STORAGE: Store below 30C.
MARKETED BY
AstraZeneca Pharma India Ltd., Bangalore 560 024, India
For further information, please contact
AstraZeneca Pharma India Ltd.
Manyatha Tech Park
PLEASE REFER TO THE PACKAGE INSERT FOR COMPLETE PRECRIBING
INFORMATION.
Based on package insert Version-7, dated 18th December 2012.
Issued: January 2013

API: KombiglyzeTM
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.
BRIEF SUMMARY OF PRESCRIBING INFORMATION KOMBIGLYZETM XR (Saxagliptin / Metformin
HCl
extended-release) tablets. COMPOSITION: KombiglyzeTM XR is available as lm-coated tablets in the
dosage strengths 5 mg/500 mg, 5 mg/1000 mg, 2.5 mg/1000 mg for oral administration. INDICATIONS
AND USAGE: KombiglyzeTM XR is indicated as an adjunct to diet and exercise to improve glycaemic
control
in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.
IMPORTANT LIMITATIONS OF USE: KombiglyzeTM XR should not be used for the treatment of type 1
diabetes mellitus or diabetic ketoacidosis; it has not been studied in patients with a history of pancreatitis.
DOSAGE AND ADMINISTRATION: Generally should be administered once daily with the evening meal,
with
gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The
recommended starting dose in patients who need 5 mg of saxagliptin and who are not currently treated
with metformin is 5 mg saxagliptin/500 mg metformin extended-release. In patients treated with
metformin, the dose should provide metformin at the dose already being taken, or the nearest
therapeutically appropriate dose. Patients who need 2.5 mg saxagliptin in combination with metformin
extended-release may be treated with KombiglyzeTM XR 2.5 mg/1000 mg. The maximum daily
recommended dose is 5 mg for saxagliptin and 2000 mg for metformin extended-release. When
coadministered with strong CYP3A4/5 inhibitors, limit the dose to 2.5 mg/1000 mg once daily. When
KOMBIGLYZETM XR is used in combination with an insulin secretagogue (e.g. sulphonylurea) or with
insulin,
a lower dose of the insulin secretagogue or insulin may be required to minimise the risk of hypoglycaemia.
CONTRAINDICATIONS: Renal impairment, hypersensitivity to metformin hydrochloride, acute or chronic
metabolic acidosis (including diabetic ketoacidosis), history of a serious hypersensitivity reaction to
KombiglyzeTM XR or saxagliptin (such as anaphylaxis, angioedema, or exfoliative skin conditions).
WARNINGS AND PRECAUTIONS FOR USE: Lactic acidosis - It is a rare, but serious complication that
can
occur due to metformin accumulation during treatment with KombiglyzeTM XR. If acidosis is suspected,
KombiglyzeTM XR should be discontinued and the patient hospitalised immediately. Pancreatitis - There
have been postmarketing reports of acute pancreatitis in patients taking saxagliptin. If pancreatitis is
suspected, KombiglyzeTM XR should promptly be discontinued and appropriate management should be
initiated. KombiglyzeTM XR is contraindicated in patients with renal impairment and not recommended in

patients with hepatic impairment. Use with Medications Known to Cause Hypoglycemia - Insulin or
insulin secretagogues, such as sulphonylureas, cause hypoglycaemia. Therefore, when used in
combination with saxagliptin, a lower dose of the insulin or insulin secretagogue may be required to
reduce the risk of hypoglycaemia. Hypersensitivity Reactions - There have been postmarketing
reports of serious hypersensitivity reactions in patients treated with saxagliptin which include
anaphylaxis, angioedema, and exfoliative skin conditions. If a serious hypersensitivity reaction is
suspected, discontinue KombiglyzeTM XR, assess for other potential causes for the event, and institute
alternative treatment for diabetes. ADVERSE REACTIONS: Diarrhoea, nausea/vomiting, upper
respiratory tract infection, urinary tract infection, headache, nasopharyngitis, hypersensitivity
reactions, infections, dose-related mean decrease in absolute lymphocyte count, acute pancreatitis.
Hypoglycaemia was seen in patients on insulin, insulin secretagogues such as sulphonylureas, and in
renally impaired patients.
USE IN SPECIAL POPULATIONS: Pregnancy Category B: KombiglyzeTM XR, like other
antidiabetic medications, should be used during pregnancy only if clearly needed. Nursing Mothers:
Because many drugs are secreted in human milk, caution should be exercised when KombiglyzeTM
XR is administered to a nursing woman.
Paediatric Use: Safety and effectiveness of KombiglyzeTM XR in paediatric patients have not been
established. Geriatric Use: Because metformin is contraindicated in patients with renal impairment,
carefully monitor renal function in the elderly and use KombiglyzeTM XR with caution as age
increases.
PRESENTATION: Each carton contains 4 blister cards of 7 lm-coated tablets in Alu/Alu blisters.
STORAGE: Store below 30C. MARKETED BY: AstraZeneca Pharma India Ltd., Manyatha Tech
Park, Nagavara- Bangalore-24
PLEASE REFER TO THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION.
API issued on: January 2013 (Based on package insert version 6 dated 18 December 2012).