Dapaglin 5

Dapaglin 5

Dapaglin 5

Cardiovascular Drugs

Dapaglin® contains the active substance dapagliflozin. It belongs to a group of
  medicines called “sodium glucose co-transporter-2 (SGLT2) inhibitors”. They 
  work by blocking the SGLT2 protein in your kidney. By blocking this protein,
  blood sugar (glucose), salt (sodium) and water are removed from your body via 
  the urine.
- Dapagliflozin reduces both fasting and post-prandial plasma glucose levels by
  reducing renal glucose reabsorption leading to urinary glucose excretion.

Indecation

Dapaglin® is indicated in adults for the treatment of insufficiently controlled 
  type 2 diabetes mellitus as an adjunct to diet and exercise.
- as monotherapy when metformin is considered inappropriate due to intolerance.
- in addition to other medicinal products for the treatment of type 2 diabetes.
- Dapaglin® is indicated in adults for the treatment of insufficiently controlled 
   type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2,
   when insulin alone does not provide adequate glycaemic control despite optimal 
  insulin therapy.
- Dapaglin® can be used in adults along with other heart failure medicines when 
  your heart is unable to pump blood as well as normal to:
• reduce your risk of cardiovascular death,
• reduce your risk of hospitalization or urgent visits for heart failure.

Dosage & Administration

Dapaglin® can be used as:
Type 2 diabetes mellitus
- The recommended dose is 10 mg dapagliflozin once daily.
  When dapagliflozin is used in combination with insulin or an insulin
  secretagogue, such as asulphonylurea, a lower dose of insulin or insulin 
  secretagogue may be considered to reduce the risk of hypoglycaemia 
Type 1 diabetes mellitus
- The recommended dose is 5 mg once daily.
- Dapagliflozin must only be administered as an adjunct to insulin.
- Heart failure
- The recommended dose is 10 mg dapagliflozin once daily. 
Treatment of diabetes mellitus in patients with renal impairment
  As glycaemic efficacy is dependent on renal function, Dapaglin® should not be
  initiated to improve glycaemic control in patients with a glomerular filtration 
  rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below 
  45 mL/min .
  No dose adjustment is required based on renal function.
Treatment of heart failure in patients with renal impairment
  No dose adjustment is required based on renal function .
  There is limited experience with dapagliflozin for the treatment of heart failure 
  in patients with severe renal impairment (GFR < 30 mL/min).
- Hepatic impairment
  No dose adjustment is necessary for patients with mild or moderate hepatic
  impairment. In patients with severe hepatic impairment, a starting dose of 5 mg 
  is recommended. If well tolerated, the dose may be increased to 10 mg when
  indicated.
- Patients with type 1 diabetes mellitus
  Dapaglin® 10 mg is not recommended for the treatment of heart failure in  
  patients with type 1 diabetes mellitus .
- Elderly (≥ 65 years)
  No dose adjustment is recommended based on age.
- Paediatric population
  The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not 
  yet been established.No data are available.
  Dapaglin® can be taken orally once daily at any time of day with or without 
  food. Tablets are to be swallowed whole.

Overdose:
  Dapagliflozin did not show any toxicity in healthy subjects at single oral doses
  up to 500 mg (50 times the maximum recommended human dose).
  In the event of an overdose, appropriate supportive treatment should be initiated 
  as dictated by the patient’s clinical status. The removal of dapagliflozin by 
  haemodialysis has not been studied.

Each film coated tablet of Dapaglin® 5 contains: 
  Dapagliflozin (as dapagliflozin propanediol)                            5 mg
- Each film coated tablet of Dapaglin® 10 contains:   
  Dapagliflozin (as dapagliflozin propanediol)                          10 mg

Dapaglin® is contraindicated in:
- Hypersensitivity  to the active substance.
- Severe renal impairment, end-stage renal disease (ESRD), or patients on 
  dialysis.

Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and
  may increase the risk of dehydration and hypotension .
- Following coadministration of dapagliflozin with rifampicin (an inducer of 
  various active transporters and drug-metabolising enzymes) a 22% decrease in 
  dapagliflozin systemic exposure (AUC) was observed, but with no clinically 
  meaningful effect on 24-hour urinary glucose excretion. No dose adjustment is
  recommended.

Use during Pregnancy and Lactation:
- There are no data from the use of dapagliflozin in pregnant women. Studies in
   rats have shown toxicity to the developing kidney in the time period 
  corresponding to the second and third trimesters of human pregnancy. 
  Therefore, the use of dapagliflozin is not recommended during the second and 
  third trimesters of pregnancy.
- When pregnancy is detected, treatment with dapagliflozin should be  
  discontinued.
- It is unknown whether dapagliflozin and/or its metabolites are excreted in 
  human milk. A risk to the newborns/infants cannot be excluded. Dapagliflozin
  should not be used while breast-feeding.
Effects on ability to drive and use machines:
- Dapaglin® has no or negligible influence on the ability to drive and use 
  machines. Patients should be alerted to the risk of hypoglycaemia when 
  dapagliflozin is used in combination with a sulphonylurea or insulin.

Contact a doctor or the nearest hospital straight away if you have any of the 
  following side effects:
• Angioedema, seen very rarely (may affect up to 1 in 10,000 people)  
• Diabetic ketoacidosis - this is rare in patients with type 2 diabetes (may affect 
  up to 1 in 1,000 people).  
• Necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft 
   tissue infection of the genitals or the area between the genitals and the anus, 
   seen very rarely. 
- Stop taking Dapaglin® and see a doctor as soon as possible if you notice any of 
  the following serious side effects: 
• Urinary tract infection, seen commonly (may affect up to 1 in 10 people).
• Low blood sugar levels (hypoglycaemia), seen very commonly (may affect 
  more than 1 in 10 people) in patients with diabetes taking this medicine with a
   sulphonylurea or insulin.
Common side effect
- Genital infection (thrush) of your penis or vagina (signs may include irritation,
  itching, unusual discharge or odour)
- Back pain
- Passing more water (urine) than usual or needing to pass water more often
- Changes in the amount of cholesterol or fats in your blood (shown in tests)
- Increases in the amount of red blood cells in your blood (shown in tests)
- Decreases in creatinine renal clearance (shown in tests) in the beginning of 
  treatment.
- Dizziness.
- Rash.
Uncommon (may affect up to 1 in 100 people)
- Loss of too much fluid from your body (dehydration, signs may include very dry
  or sticky mouth, passing little or no urine or fast heartbeat).
- Thirst.
- Constipation.
- Awakening from sleep at night to pass urine.
- Dry mouth.
- Weight decreased.
- Increases in creatinine (shown in laboratory blood tests) in the beginning of 
  treatment.
- Increases in urea (shown in laboratory blood tests).

Monitor for signs and symptoms of hypotension after initiating therapy in
   patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), 
  elderly patients, or patients on loop diuretics.
- Renal function should be evaluated prior to initiation of Dapaglin® and
  monitored periodically thereafter especialy in Elderly patients and patients
  with impaired renal function.
- Dapaglin® 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.
- Increases in LDL-C occur with Dapaglin® . Monitor LDL-C and treat per 
  standard of care after initiating Dapaglin®.
- Dapaglin® should not be used in patients with active bladder cancer.In 
  patients with prior history of bladder cancer, the benefits of glycemic control
  versus unknown risks for cancer recurrence with Dapaglin® should be 
  considered. 

Dapaglin® 5 pack of 3 blisters, Blister of 10 tablets. 
- Dapaglin® 10 pack of 3 blisters, Blister of 10 tablets.

Store in a dry place at temperature below 25° C.