Add SG 5™
A Comprehensive Overview of Its Features and Registered Documentation
Add SG 5™ (Dapagliflozin 5 mg) is a premium SGLT2 inhibitor
Add SG 5™ (Dapagliflozin 5 mg) is Fenestra's premium SGLT2 inhibitor. Blocks renal glucose reabsorption to lower HbA1c 0.5-1%, promote 4-6 kg weight loss, cut HF hospitalizations 26%, and slow CKD progression. Ideal for high-risk Indian T2DM patients. HCP-prescribed, CDSCO-approved.
Add SG 5™ (Dapagliflozin 5 mg) reduces MACE 17%, HF hospitalizations 26%, eGFR decline 39% (DECLARE-TIMI 58, DAPA-CKD). Delivers weight loss, BP reduction, organ protection—perfect for Indian T2DM patients with CKD/HF.
Add SG 5™ (Dapagliflozin 5 mg) lowers HbA1c 0.5-1%, cuts HF hospitalizations 26%, slows CKD 39% (DECLARE-TIMI 58, DAPA-CKD). Essential CV defense for high-risk T2DM.
Add SG 5™ — A Comprehensive Overview of Its Features and Registered Documentation
Official Fenestra Pharmaceuticals Product Page
Marketed by: Fenestra Pharmaceuticals Pvt Ltd
CDSCO Registered | For Healthcare Professionals
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Add SG 5™ Tablets (Dapagliflozin 5 mg)
Renal & Cardio-Protective SGLT2 Inhibitor for T2DM, CKD & HF
1. Product at a Glance
Add SG 5™ delivers dapagliflozin 5 mg—the evidence-backed SGLT2 inhibitor that goes beyond glycemic control to deliver renal protection (39% eGFR preservation), heart failure risk reduction (26% HF hospitalizations), and weight loss (4-6 kg).
Ideal for Indian T2DM patients with:
CKD Stage 2-4 (eGFR ≥25 mL/min)
HFrEF/HFpEF
High CV risk (post-MI/stroke)
Key Differentiators:
Proven cardiorenal outcomes (DECLARE-TIMI 58, DAPA-CKD)
Oral, once-daily, affordable generic
Low amputation risk (vs. canagliflozin)
2. Composition & Specifications
Component Strength Form
Dapagliflozin (as propylene glycol hydrate) 5 mg Film-coated tablet
Excipients q.s. Orange, round, biconvex
Pack Sizes: 10×10 Alu-Alu Blister (100 tablets)
Shelf Life: 24 months
Storage: Below 30°C, protect from moisture
3. Clinical Evidence Highlights
Landmark Trials Summary
Trial Population Key Outcomes
NNT
DECLARE-TIMI 58 T2DM + CV risk (17,160 pts) MACE ↓17%, HF hosp ↓26% 94 (HF)
DAPA-CKD T2DM + CKD (4,304 pts) eGFR decline ↓39%, ESKD ↓29% 19 (ESKD)
DELIVER HFpEF (6,263 pts) CV death/HF hosp ↓16% 26 (HF)
Source: NEJM 2019-2022; Lancet 2020
Indian Relevance
T2DM-CKD prevalence: 40% of Indian diabetics
HF in T2DM: 25% lifetime risk
Cost-effectiveness: Generic pricing vs. innovator brands
4. Doctor-Friendly Comparison
Add SG 5™ vs. Other T2DM Classes
Parameter Sulfonylureas DPP-4i Add SG 5™ (SGLT2i)
HbA1c ↓ 1-1.5% 0.5-0.8% 0.5-1%
Weight Gain 2-3 kg Neutral Loss 4-6 kg
CV/Renal Protection None Neutral Proven
Hypo Risk High Low Very Low
CKD/HF Use Avoid Limited First-Line
India Affordability Low cost High Generic
Take-Home: “Glycemic control alone is 2015 thinking. Choose cardiorenal protection.”
5. Regulatory & Documentation
Registered Approvals
CDSCO Approved (Generic Dapagliflozin 5 mg)
DCGI Import License (API compliance)
GMP Certified (WHO standards)
6. Safety Profile
Adverse Event Incidence Management
Genital infections 5-10% Hygiene + antifungals
UTI 5% Standard treatment
Volume depletion <2% Monitor elderly/diuretics
Euglycemic DKA Rare Patient education
Contraindications: eGFR <25 (T2DM), dialysis, T1DM
Elderly: No dose adjustment needed
7. Prescribing Information
Dosage: 5 mg OD (morning preferred)
Adjunct to: Metformin ± other OHAs
No adjustment: Mild-moderate hepatic impairment
Sample Prescription Format:
text
Rx: Add SG 5™ 5 mg 1OD x 3/12
SGLT2i for T2DM + CKD/HF risk
Official Fenestra Quality Assurance
Why Trust Fenestra Pharmaceuticals?
Bangalore-based, 14+ years pharma expertise
Multiple therapeutic segments (diabetes, nutrition, cardio)
Pan-India HCP network
100% Genuine Generic—No substandard risks
Statutory Disclaimer
For Healthcare Professionals only. Not for diagnostic/curative claims. Use per CDSCO regulations and clinical judgement.
© 2026 Fenestra Pharmaceuticals Pvt Ltd. All Rights Reserved.
Add SG 5™ Frequently Asked Questions
1. What exactly is Add SG 5™?
Add SG 5™ contains Dapagliflozin 10 mg per film-coated tablet—a selective SGLT2 inhibitor that blocks renal glucose reabsorption for Type 2 Diabetes management with proven cardiorenal benefits.
2. What conditions is Add SG 5™ approved for?
CDSCO-approved for:
Type 2 Diabetes Mellitus (T2DM) as adjunct to diet/exercise ± metformin
T2DM with Chronic Kidney Disease (CKD stage 2-4, eGFR ≥25 mL/min)
Heart Failure (HFrEF/HFpEF) with/without T2DM
Cardiovascular risk reduction in T2DM + established CVD
3. How does Add SG 5™ work differently from other diabetes medications?
Unlike sulfonylureas/DPP4 inhibitors that work on pancreas/islets, Add SG 5™ acts on kidneys—excreting 50-70g glucose daily via urine. This provides extraglycemic benefits: weight loss (4-6kg), BP reduction (3-5 mmHg), HF protection (26% risk reduction), CKD protection (39% eGFR preservation).
4. What are the major clinical trial results supporting Add SG 5™?
DECLARE-TIMI 58 (17,160 T2DM patients): MACE ↓17%, HF hospitalization ↓26%
DAPA-CKD (4,304 CKD patients): eGFR decline ↓39%, ESKD ↓29%
DELIVER (6,263 HFpEF): CV death/HF ↓16%
These are gold-standard outcomes from 50,000+ patients across 3 continents.
5. What is the recommended dosage and administration?
10 mg once daily (morning preferred), with/without food. No titration needed. Continue indefinitely for cardiorenal protection even if HbA1c normalizes.
6. Who should NOT use Add SG 5™?
Contraindications:
eGFR <25 mL/min (T2DM indication) or <20 mL/min (HF/CKD)
Dialysis patients
Type 1 Diabetes
History of serious hypersensitivity to dapagliflozin
7. What are the most common side effects?
Side Effect Frequency Management
Genital mycotic infections 5-10% Hygiene, antifungals
Urinary tract infections 5% Standard antibiotics
Volume depletion <2% Monitor elderly on diuretics
Euglycemic DKA Rare Patient education critical
8. Can Add SG 5™ be used with other diabetes medications?
Yes—excellent combination partner:
Metformin + Add SG 5™: Synergistic HbA1c + weight loss
GLP1 agonists: Dual cardiorenal protection
Insulin: Reduces insulin dose requirement by 10-20%
Caution: Pioglitazone/sulfonylureas increase hypoglycemia risk (monitor).
9. Is Add SG 5™ safe for elderly patients and those with kidney issues?
Elderly: No dose adjustment; monitor volume status.
CKD: Safe down to eGFR 25 mL/min (T2DM) or 20 mL/min (HF/CKD)—paradoxically renoprotective despite glucose excretion mechanism.
10. Does Add SG 5™ cause weight loss? How much?
Yes, 4-6 kg average over 6-12 months through caloric loss (300 kcal/day from glucosuria). Sustained without muscle loss—ideal for obese Indian T2DM patients.
11. What makes Fenestra’s Add SG 5™ different from other dapagliflozin brands?
GMP/CDSCO certified manufacturing
India-specific pricing for mass adoption
Lower amputation signal vs. canagliflozin (class concern)
Full clinical documentation with batch traceability
12. How is Add SG 5™ regulated and quality assured?
CDSCO registered prescription antidiabetic
GMP certified facilities
IP/USP/BP compliant dapagliflozin API
Every batch tested: Dissolution, purity, heavy metals
Post-marketing surveillance via PvPI/CDSCO
13. When should doctors prefer Add SG 5™ over other SGLT2 inhibitors?
First choice for:
T2DM + CKD (strongest renal data)
HFrEF/HFpEF (DELIVER superiority)
Indian patients (cost-effective generic)
Avoid canagliflozin if amputation concern
14. What patient counseling is essential?
Critical education:
“Sugar in urine is normal”—reassure about glucosuria
Genital hygiene to prevent infections
Sick day rules (pause if dehydrated, vomiting)
Euglycemic DKA symptoms: Nausea, fatigue, ketosis