Farxiga (Dapagliflozin Propanediol Monohydrate)
(℞) Prescription required. Can not be split. Product of UK/EU. Shipped from United Kingdom. Farxiga is also marketed internationally under the name Forxiga.
(℞) Prescription required. Can not be split. Product of Australia. Shipped from Australia. Farxiga is also marketed internationally under the name Forxiga.
To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. read more
Dapagliflozin Propanediol Monohydrate Information
(dap'' a gli floe' zin)[Posted 08/29/2018] AUDIENCE: Patient, Endocrinology, Health Professional, Pharmacy ISSUE: FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier's gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. BACKGROUND: SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. RECOMMENDATION: To read all of the recommendations see the Drug Safety Communication, available at: http://bit.ly/2wNOpdK. Patients should:
- Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.
- Read the patient Medication Guide every time you receive a prescription for an SGLT2 inhibitor because there may be new or important additional information about your drug. The Medication Guide explains the benefits and risks associated with the medicine
- Assess patients for Fournier's gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary.
- Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
Before taking dapagliflozin,
- tell your doctor and pharmacist if you are allergic to dapagliflozin, any other medications, or any of the ingredients in dapagliflozin tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon, in Prestalia), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARB) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); diabetes medications such as glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase), repaglinide (Prandin, in Prandimet), and tolbutamide; diuretics ('water pills'); and insulin.
- tell your doctor if you are on dialysis and if you have or have ever had kidney disease. Your doctor may tell you not to take dapagliflozin.
- tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking) or if you are on a low sodium diet. Also tell your doctor if you have or have ever had heart failure, pancreatic disease including pancreatitis (swelling of the pancreas) or have had surgery on your pancreas, urinary tract infections or problems urinating, low blood pressure, bladder cancer, yeast infections in the genital area, or liver disease. If you are male, tell your doctor if you have never been circumcised. Also tell your doctor, if you eating less due to illness, surgery or a change in your diet, or have recently had diarrhea, vomiting, not been drinking enough fluids, been in the sun too long, or have been sweating a lot, which may cause dehydration (loss of a large amount of body fluids).
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking dapagliflozin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dapagliflozin.
- alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking dapagliflozin.
- you should know that dapagliflozin may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. If you have this problem, call your doctor. This problem is more common when you first start taking dapagliflozin. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of dapagliflozin you may need.
- urinating a lot, including at night
- increased thirst
- frequent, urgent, burning, or painful urination
- urine that is cloudy, red, pink, or brown
- strong smelling urine
- decrease in amount of urine
- pelvic or rectal pain
- (in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
- (in men) redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
- swelling of the legs or feet
- difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, mouth, or eyes
- stomach-area pain
- difficulty breathing