Medicine Overview of Glycema 5mg Tablet
Glycema 5 is used alone or in combination with other medicines to treat type 2 diabetes mellitus. It helps control the high blood sugar levels seen in diabetes. This reduces the chances of serious complications of diabetes and also helps prevent heart disease.
Glycema 5 can be taken with or without food at any time of day but you should try to take it at the same time every day. The dose will be decided by your doctor. Do not stop taking it without asking your doctor. If you do, your blood sugar levels may increase and put you at risk of serious complications like kidney damage and blindness. This medicine is only part of a treatment program that should include a healthy diet, regular exercise and weight reduction as advised by your doctor.
The most common side effects of this medicine include nausea, frequent urge to urinate, increased thirst, urinary tract infections, hypoglycemia (low blood sugar levels) and genital tract infection. It may cause the body to lose too much water. Drinking plenty of fluids to prevent dehydration. Some people may develop fungal infections in the genital area. Maintaining good hygiene can help prevent this.
Before taking this medicine, inform your doctor if you have any kidney or liver problems or a urinary tract infection or if you are on water pills (diuretics). Pregnant or breastfeeding women should also consult their doctor before taking it. Avoid excessive alcohol intake while taking it as this may increase the risk of developing some side effects. Monitor your blood sugar levels regularly while taking this medicine.
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- Type 2 diabetes mellitus
- Nausea
- Frequent urge to urinate
- Genital fungal infection
- Increased thirst
- Urinary tract infection
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Glycema 5 is used alone or together with other diabetes medicines to control blood sugar and avoid long-term complications.
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It may cause your body to lose too much fluid (dehydration) or you may urinate more often. Drink plenty of water and stay hydrated.
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It may cause hypoglycemia (low blood sugar level) when used with other antidiabetic medicines, alcohol or if you delay or miss a meal.
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Always carry some sugary food or fruit juice with you in case you experience hypoglycemia symptoms such as cold sweats, cool pale skin, tremor and anxiety.
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It can cause genital fungal and/or urinary tract infections (UTIs) in both females and males, so practice good hygiene.
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Monitor your blood sugar regularly while taking this medicine.
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Inform your doctor immediately if you experience constant dizziness, joint pain, cold-like symptoms or unexplained nausea/vomiting.
Diabetes Mellitus Type 2
Selective sodium-glucose transporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus
Initial: 5 mg PO qDay; take in am with or without food
May increase to 10 mg qDay in patients tolerating 5 mg/day who have an eGFR ?60 mL/min/1.73 m² and require additional glycemic control
Indicated as monotherapy, as initial therapy with metformin, or as an add-on to other oral glucose-lowering agents, including metformin, glimepiride, sitagliptin, and insulin
Hepatic impairment
Mild or moderate: No dosage adjustment required
Severe: Not studied
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Renal impairment
eGFR ?60 mL/min/1.73 m²: No dosage adjustment required
eGFR <60 mL/min/1.73 m²: Do not initiate
Not recommended with eGFR that declines persistently between 30 to <60 mL/min/1.73 m²
eGFR <30 mL/min/1.73 m²: Contraindicated
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Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
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CV disease; history of hypotension. Monitor vol status & electrolytes. UTI. Childn. Elderly.
Lactation: Unknown whether distributed in human breast milk; breast feeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
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>10%
Renal impairment
1-10%
Female genital mycotic infections (6.9-8.4%),Urinary tract infection (4.3-5.7%),Increased urination (2.9-3.8%),Male genital mycotic infections (2.7-2.8%),Dyslipidemia (2.1-2.5%),Constipation (1.9-2.2%),Discomfort with urination (2.6-2.1%),Extremity pain (1.7-2%),Volume depletion
<1%
Hypersensitivity (0.3%)
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Pregnancy
Based on animal data showing adverse renal effects drug is not recommended during second and third trimesters of pregnancy
Limited data in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when administered during a period of renal development corresponding to late second and third trimesters of human pregnancy, at all doses tested
Clinical considerations
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
Lactation
There is no information regarding presence of dapagliflozin in human milk, effects on breastfed infant, or on milk production; drug is present in milk of lactating rats; however, due to species-specific differences in lactation physiology, clinical relevance of these data are not clear
Since human kidney maturation occurs in utero and during first 2 years of life when lactational exposure may occur, there may be risk to developing human kidney; because of potential for serious adverse reactions in breastfed infants, advise women that therapy is not recommended while breastfeeding
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Hypoglycemia may occur w/ concomitant use w/ insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC w/ rifampin. Increase in Cmax & AUC w/ mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
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