Xigduo 5/1000 mg 56 tablets

Xigduo 5/1000 mg 56 tablets

Composition:

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.

Description:

Drug used in diabetes, Combinations of oral brood glucose-lowering drugs.

Indications:

Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:

- in patients insufficiently controlled on their maximally tolerated dose of metformin alone

-in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products

-in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Dosage and Method of administration:

Adults with normal renal function:

The recommended dose is one tablet twice daily. 

Renal impairment

A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter. 

The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. 

Hepatic impairment

This medicinal product must not be used in patients with hepatic impairment.

Elderly (> 65 years)

Because metformin is eliminated in part by the kidney, and because elderly patients are more likely to have decreased renal function, this medicinal product should be used with caution as age increases.

Method of administration:

Xigduo should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.

Contraindications:

Xigduo is contraindicated in patients with:

-hypersensitivity to the active substances or to any of the excipients

-any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis):

-diabetic pre-coma;

-severe renal failure (GFR «< 30 mL/min);

-acute conditions with the potential to alter renal function such as:

dehydration, severe infection, shock.

-acute or chronic disease which may cause tissue hypoxia such as:

cardiac or respiratory failure, recent myocardial– infarction, shock;

-hepatic impairment;

-acute alcohol intoxication, alcoholism

Special warnings and precautions for use:

-Lactic acidosis

Mettormin accumulation occurs at acute worsening of renal function and increases in risk of lactic acidosis.

In case of dehydration (severe diarrhea or vomiting, fever or reduced fluid intake), Xigduo should be temporarily discontinued and contact with a neath care professional is recommended.

-Renal function

The glycaemic efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and is likely absent in patients with severe renal impairment. Xigduo should not be initiated in patients with FR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min.

Metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis.

-Diabetic ketoacidosis

The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.

-Treatment should be interrupted in patients who are hospitalized for major surgical procedures or acute serious medical illnesses. Momtong of ketones is recommended in these patients.

-Necrotising fasciitis of the perineum (Fourniers gangrene)

Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perianal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis. If Foumier's gangrene is suspected, Xigduo should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.

-Urinary tract infections

Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of treatment should be considered when treating pyelonephritis or urosepsis.

Elderly (≥ 65 years)

Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics.

Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-l and angiotensin ll type 1 receptor blockers (ARB). The same recommendations for renal function apply to elderly patients as to all patients.

-Urine laboratory assessments

Due to its mechanism of action, patients taking this medicinal product will test positive for glucose in their urine.

-Administration of iodinated contrast agents

Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis. Xigduo should be discontinued prior to, or at the time of, the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable.

-Surgery

Xigduo must be discontinued at the time of surgery with general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.

-Pregnancy:

When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.

-Breast-feeding:

A risk to the newborns/infants cannot be excluded.

This medicinal product should not be used white breast-feeding.

Side Effects:

The most frequently reported adverse reactions across the clinical studies were genital infections.

Very common: Hypoglycaemia (when used with SU or insulin), Gastro-intestinal symptoms.

Common: Vulvovaginitis, balanitis, Urinary tract infection, Fungal infection, Taste disturbance, Dizziness, Rash, Back pain, Dysuria, Polyuria, Haematocrit increased, Creatinine renal clearance decreased during initial treatment, Dyslipidaernial.

Uncommon: Fungal infection, Volume depletion, Thirst, Constipation

Dry mouth, Nocturia, Vuivovaginal pruritus, Pruritus genital, Blood creatinine increased during initial treatment, Blood urea increased, Weight decreased.

Storage Method:

Store in a temperature not exceeding 30C.

Keep out of reach of children.

Package:

A carton box contains blisters with tablets. Total 56 tablets and insert leaflet.