For the use only of Registered Medical Practitioner or a Hospital or a Laboratory only
UDAPA* GOLD 1
UDAPA*GOLD 2
Dapagliflozin, Glimepiride and Metformin Hydrochloride (Extended Release) Tablets
Composition:
Each film coated bilayered tablet contains:Dapagliflozin Propanediol USP Eq. to Dapagliflozin 10 mg, Glimepiride IP 1mg, Metformin Hydrochloride IP (As Extended release) 500 mg
Each film coated bipalayered tablet contains:Dapagliflozin Propanediol USP Eq. to Dapagliflozin 10 mg, Glimepiride IP 2mg, Metformin Hydrochloride IP (As Extended release) 500 mg
Indication: As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 Diabetes Mellitus(T2DM).
Recommended Dosage: As directed by the Physician
Method of Administration: Oral
Warnings and Precautions: Dapagliflozin, Metformin and Glimepiride should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.Lactic acidosis- Lactic acidosis, a rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis. Hypotension -Dapagliflozin causes intravascular volume contraction. Symptomatic hypotension can occur after initiating dapagliflozin particularly in patients with impaired renal function (eGFR less than 60 ml/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating dapagliflozin in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms of hypotension after initiating therapy. Genital Mycotic Infections – Dapagliflozin increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections. Monitor and treat appropriately. Hypoglycemia- Patients receiving Insulin and insulin secretagogues (e.g., sulfonylurea) may be at risk for hypoglycemia. Therefore, a reduction in the dose of the sulphonylurea or insulin may be necessary
Precautions for use:
Pregnancy
Limited data on Dapagliflozin, Glimepiride & Metformin Tablets use during pregnancy. Advise patients to inform their healthcare provider if pregnant or planning pregnancy before initiating treatment.
Nursing Mothers
Udapa Gold is not recommended in breastfeeding. Hence, if you are breastfeeding, inform your doctor if you are breastfeeding or planning to breastfeed.
Pediatric Use
The safety and effectiveness of Udapa Gold in pediatric patients under 18 years of age have not been established.
Renal Impairment
Dapagliflozin- Use of dapagliflozin is not recommended when eGFR is less than 45 mL/min/1.73 m2
Glimepiride- To minimize the risk of hypoglycemia, the recommended starting dose of glimepiride is 1 mg daily for all patients with type 2 diabetes and renal impairment.
Contraindications: Udapa Gold is contraindicated in patients with:
Severe renal impairment (eGFR below 30 mL/min/1.73 m2), end stage renal disease or patients on dialysis; History of a serious hypersensitivity reaction to any of the excipients of this Tablet. dapagliflozin, such as anaphylactic reactions or angioedema, or hypersensitivity to metformin HCl, Sulfonamide derivatives, such as glimepiride, other sulfonylureas, other sulfonamides; Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin ; Hepatic insufficiency; Acute alcohol intoxication, alcoholism; Lactation.
For Additional Information/full prescribing information, please write to us:
USV Private Limited, Arvind Vithal Gandhi Chowk, B.S.D Marg, Govandi, Mumbai – 400088
Updated on 29th March 2024