Dapaveldactin PLUS 5/850 MG

Dapaveldactin PLUS 5/850 mg

Description:

Dapaveldactin PLUS 5/850 mg 28 f.c. tabs is an oral prescription antidiabetic medicine combining dapagliflozin and metformin for the management of type 2 diabetes mellitus in adults. It belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors plus biguanides and is used as part of a comprehensive diabetes care plan that includes diet and exercise. By reducing glucose reabsorption in the kidneys and improving insulin sensitivity, Dapaveldactin PLUS helps lower blood glucose levels and supports long-term glycemic control, contributing to the prevention of diabetes-related complications.

Indications:

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• May be used in patients insufficiently controlled on metformin alone or already treated with the combination of dapagliflozin and metformin as separate tablets (as directed by a physician).
• Helps reduce elevated fasting and postprandial blood glucose levels.
• Supports reduction of HbA1c in patients with type 2 diabetes (when used as prescribed and combined with lifestyle measures).
• May assist in weight reduction and mild blood pressure lowering as part of overall metabolic management (class-related effects of SGLT2 inhibitors), where appropriate and under medical supervision.

Active Ingredients / Key Components:

• Dapagliflozin – 5 mg per film-coated tablet.
• Metformin hydrochloride – 850 mg per film-coated tablet.
• Other excipients: Film-coating and tablet core excipients (full excipient list is not available in the provided information; refer to the official package leaflet for complete details).

Dosage & Administration / How to Use:

• Use only as prescribed by a physician experienced in the management of diabetes.
• Typical adult dose: One film-coated tablet containing dapagliflozin 5 mg and metformin 850 mg taken orally once or twice daily, as directed by the doctor. The exact dose and frequency depend on the patient’s current therapy, renal function, and glycemic control goals.
• Tablets should be swallowed whole with water; do not crush or chew.
• It is generally recommended to take metformin-containing products with meals to reduce gastrointestinal side effects. Follow your doctor’s specific instructions regarding timing with food.
• If a dose is missed, take it as soon as you remember unless it is almost time for the next dose. Do not double the dose to make up for a missed dose.
• Regular monitoring of blood glucose and HbA1c is recommended to assess treatment response.
• Renal function should be assessed before initiation and periodically thereafter, as both dapagliflozin and metformin require adequate kidney function.
• Do not adjust or stop the medication without consulting your healthcare provider.

Clinical Benefits:

• Improves glycemic control in adults with type 2 diabetes by combining two complementary mechanisms of action (SGLT2 inhibition and biguanide effect).
• Dapagliflozin promotes urinary glucose excretion by inhibiting SGLT2 in the kidney, helping reduce blood glucose levels independently of insulin.
• Metformin decreases hepatic glucose production and improves peripheral insulin sensitivity, helping the body use insulin more effectively.
• Combination therapy has been shown in clinical trials to significantly reduce HbA1c when added to metformin compared with placebo.
• May support modest weight loss and reduction in blood pressure in some patients, due to the osmotic diuresis and caloric loss associated with SGLT2 inhibition (class effect, individual results vary).
• Convenient fixed-dose combination helps reduce pill burden and may improve adherence compared with taking separate tablets.

Warnings & Contraindications:

• Contraindicated in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
• Contraindicated in patients with severe renal impairment, end-stage renal disease, or on dialysis. Metformin is contraindicated in significant renal dysfunction due to risk of lactic acidosis.
• Not recommended in patients with severe hepatic impairment or conditions associated with tissue hypoxia (e.g., acute heart failure, recent myocardial infarction, severe infection) due to increased risk of lactic acidosis from metformin.
• Dapagliflozin may increase the risk of genital mycotic infections and urinary tract infections; use with caution in patients with a history of such infections.
• Risk of volume depletion, hypotension, and dehydration, especially in elderly patients, those on diuretics, or with low blood pressure. Ensure adequate fluid intake.
• Cases of diabetic ketoacidosis (often with only moderately elevated blood glucose) have been reported with SGLT2 inhibitors; seek urgent medical attention if symptoms such as nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing, confusion, or unusual fatigue occur.
• Discontinue temporarily in situations that may predispose to renal impairment, dehydration, or hypoxia (e.g., major surgery, severe infection, contrast imaging procedures) as advised by your doctor.
• Use with caution in elderly patients and those with cardiovascular disease; close monitoring is recommended.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. Use during pregnancy or lactation is generally not recommended unless clearly needed and prescribed.
• Use with caution if taking other medications that affect kidney function, blood pressure, or blood glucose (e.g., diuretics, insulin, sulfonylureas, ACE inhibitors). Dose adjustments of concomitant antidiabetics may be required to reduce risk of hypoglycemia.
• Not intended to diagnose, treat, cure, or prevent any disease without medical supervision; it is a prescription medicine that must be used under a healthcare provider’s guidance.
• Keep out of reach of children.

Side Effects:

• Common side effects may include genital yeast infections (vulvovaginal candidiasis in women, balanitis in men), urinary tract infections, increased urination, thirst, and mild volume depletion symptoms (dizziness, low blood pressure).
• Metformin-related gastrointestinal side effects such as nausea, vomiting, diarrhea, abdominal discomfort, and loss of appetite may occur, especially at treatment initiation; taking with food may help reduce these effects.
• Headache, back pain, and dyslipidemia changes have been reported in some patients.
• Hypoglycemia is more likely when used in combination with insulin or insulin secretagogues (e.g., sulfonylureas); dose adjustment of these agents may be required.
• Rare but serious side effects include lactic acidosis (a medical emergency characterized by rapid breathing, abdominal pain, severe weakness, and drowsiness) associated with metformin, and diabetic ketoacidosis associated with SGLT2 inhibitors.
• Allergic reactions such as rash, itching, or swelling may occur; discontinue and seek medical attention if signs of hypersensitivity appear.
• If you experience severe or persistent side effects, signs of infection, difficulty breathing, chest pain, or any unusual symptoms, seek immediate medical attention.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children.

Specifications:

• Product type: Oral antidiabetic prescription medicine.
• Form: Film-coated tablet.
• Strength: Dapagliflozin 5 mg + Metformin hydrochloride 850 mg per tablet.
• Pack size: 28 film-coated tablets per pack.
• Intended use: Adult patients with type 2 diabetes mellitus, as prescribed by a healthcare professional.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.