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Sitavia-M 50/500
Sharif Pharmaceuticals Ltd.
Generic: Metformin Hydrochloride + Sitagliptin
Safety Advices
বাংলা
English
UNSAFE
It is unsafe to consume alcohol with Sitavia-M 50/500.
SAFE IF PRESCRIBED
Sitavia-M 50/500 is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Sitavia-M 50/500 is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
CAUTION
Your ability to drive may be affected if your blood sugar is too low or too high. Do not drive if these symptoms occur.
CAUTION
Sitavia-M 50/500 should be used with caution in patients with kidney disease. Dose adjustment of Sitavia-M 50/500 may be needed. Please consult your doctor.
Use of Sitavia-M 50/500 is, however, not recommended in patients with severe kidney disease. Regular monitoring of kidney function test is advisable while you are taking this medicine.
SAFE IF PRESCRIBED
Sitavia-M 50/500 is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of Sitavia-M 50/500 may not be needed in these patients. Please consult your doctor.
Medicine Overview of Sitavia-M 50/500mg+50mg Tablet
Introduction
Sitavia-M 50/500 is a combination of two medicines that control high blood sugar levels in people with type 2 diabetes mellitus. This helps prevent serious complications of diabetes such as kidney damage and blindness and may reduce your chance of having a heart attack or stroke. Sitavia-M 50/500 can be prescribed alone or together with other diabetes medications. All diabetes medicines work best when used along with a healthy diet and regular exercise. The dose you are given will depend on your condition, blood sugar levels and what other medicines you are taking. Taking it with meals helps to reduce...
... Show moreUses of Sitavia-M 50/500
- Type 2 diabetes mellitus
Side effects of Sitavia-M 50/500
Common
- Diarrhea
- Nausea
- Vomiting
- Upset stomach
- Headache
- Nasal congestion (stuffy nose)
- Sore throat
- Respiratory tract infection
- Hypoglycaemia (low blood sugar level) in combination with insulin or sulphonylurea
How to use Sitavia-M 50/500
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sitavia-M 50/500 is to be taken with food.
How Sitavia-M 50/500 works
Sitavia-M 50/500 is a combination of two antidiabetic medicines: Sitagliptin and Metformin. They help your pancreas produce more insulin, facilitate effective use of insulin by the body, and reduce excess sugar that your liver makes. Together, they provide better control of blood sugar.
Quick Tips
- Take it with food to lower your chance of having an upset stomach.
- Chances of weight gain and low blood sugar are lesser as compared to other diabetes medicines.
- Inform your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic.
- Tell your doctor immediately if you experience any deep or rapid breathing, persistent nausea, vomiting, and stomach pain as Janumet XR CP Tablet may cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood.
Brief Description
Indication
Type 2 DM
Administration
Should be taken with food.
Adult Dose
Oral Type 2 DM The recommended starting dose in patients not currently treated with Metformin Initially 50 mg/500 mg bd. The starting dose in patients already treated with Metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients taking Metformin 850 mg twice daily, the recommended starting dose of this combination is 50 mg Sitagliptin/1000 mg Metformin hydrochloride twice daily. May adjust the dosing based on effectiveness and tolerability. Max daily dose: Sitagliptin 100 mg/metformin 2000 mg. Extended Release Tablet: Initially: Sitagliptin 50 mg or...
... Show moreChild Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
Obtain eGFR before starting metformin
eGFR <30 mL/min/1.73 m²: Contraindicated
eGFR 30-45 mL/min/1.73 m²: Not recommended to initiate treatment
Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly)
If eGFR falls below 45mL/min/1.73 m² while taking metformin, risks and benefits of continuing therapy should be evaluated
If eGFR falls below 30 mL/min/1.73 m²: while taking metformin, discontinue the drug
Contraindication
Renal dysfunction, e.g., serum creatinine >1.5 mg/dL [males], >1.4 mg/dL [females] or abnormal creatinine clearance.
Metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction (e.g., anaphylaxis or angioedema) to Sitagliptin + Metformin or to one of its components.
Mode of Action
Sitagliptin: Dipeptidyl peptidase 4 (DPP-4) inhibitor, thereby increasing and prolonging incretin hormone activity which are inactivated by DPP-4 enzyme. Incretins increase insulin release and synthesis from pancreatic beta cells and reduce glucagon secretion pancreatic alpha cells.
Metformin: Biguanide; acts by decreasing endogenous hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; improves glucose tolerance and lowers both basal and postprandial plasma glucose .
Precaution
Not for use in type 1 DM or treatment of ketoacidosis. Discontinue use if pancreatitis is suspected. Renal & hepatic impairment. Sulfonylurea- or insulin-induced hypoglycemia, risk of lactic acidosis, hypoxic states, surgical procedures, alcohol intake, decreased vit B12 absorption, loss of glycemic control. Pregnancy. Elderly. Childn <18 yr.
Lactation: not known if crosses into breast milk, use caution
Pregnancy Categories
Side Effect
1-10%
Abdominal pain (2.2%),Diarrhea (2.4%),Hypoglycemia (2.1%),Nausea (1.3%),Vomiting (1.1%)
Frequency Not Defined
Exfoliative disorder of skin of scalp,Stevens-Johnson syndrome,Lactic acidosis (rare ),Anaphylaxis/hypersensitivity reaction,Rhabdomyolysis,Acute renal failure,Angioedema
Interaction
Additive effect w/ sulfonylureas. Thiazide diuretics, corticosteroids, phenothiazines, OC, sympathomimetics, niacin, Ca channel blockers and isoniazid may exacerbate loss of glycaemic control. ACE inhibitors may reduce fasting blood glucose concentrations. May increase serum level w/ cimetidine.
Potentially Fatal: Concurrent use w/ iodinated contrast agents may increase the risk of metformin-induced lactic acidosis.
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