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Sitagliptin phosphate tablets (genovir)

Monotherapy This product combines diet control and exercise to improve blood glucose control in patients with type 2 diabetes. Combined with metformin When metformin is used alone, glucose control is not good, it can be combined with metformin hydrochloride to improve blood glucose control in type 2 diabetes patients on the basis of diet and exercise. The recommended dose for single drug or combined treatment with metformin is 100 mg once a day. This product can be taken with or without food. Patients with renal insufficiency Patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml / min, corresponding serum creatinine level is about male ≤ 1.7 mg / dl and female ≤ 1.5 mg / dl) do not need to adjust the dose when taking this product. (see the inner package manual for details) More role
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Common name:
Sitagliptin phosphate tablets
Product No.:
C14202012039
Approval No.:
Gyzz j20140095 (inquired by the State Drug Administration)
Jianke price:
¥139.69
Product specification:
100mg * 28 tablets 100mg * 7S * 2 plate 100mg*7s
Manufacturer:
Merck Sharp & Dohme Italia SPA
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Product name Sitagliptin phosphate tablets (genovir)
Main raw materials Sitagliptin phosphate.
Main role Monotherapy This product combines diet control and exercise to improve blood glucose control in patients with type 2 diabetes. Combined with metformin When metformin is used alone, glucose control is not good, it can be combined with metformin hydrochloride to improve blood glucose control in type 2 diabetes patients on the basis of diet and exercise. The recommended dose for single drug or combined treatment with metformin is 100 mg once a day. This product can be taken with or without food. Patients with renal insufficiency Patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml / min, corresponding serum creatinine level is about male ≤ 1.7 mg / dl and female ≤ 1.5 mg / dl) do not need to adjust the dose when taking this product. (see the inner package manual for details)
Product specification 100mg * 7S * 2 plate
Usage and dosage The recommended dose for single drug treatment of this product is 100 mg once a day. This product can be taken with or without food. Patients with renal insufficiency Patients with mild renal insufficiency (creatinine clearance [CrCl] & Ge; 50 ml / min, corresponding serum creatinine level is about male & le; 1.7 mg / dl and female & le; 1.5 mg / dl) do not need to adjust the dose when taking this product. In patients with moderate renal insufficiency (creatinine clearance [CrCl] & Ge; 30 to & lt; 50 ml / min, corresponding serum creatinine levels of about & gt; 1.7 to & le; 3.0 mg / dl for men and & gt; 1.5 to & le; 2.5 mg / dl for women), the dose is adjusted to 50 mg once a day. For patients with severe renal insufficiency (creatinine clearance [CrCl] & lt; 30 ml / min, corresponding serum creatinine level is about male & gt; 3.0 mg / dl and female & gt; 2.5 mg / dl) or patients with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose is adjusted to 25 mg once a day. Taking this product does not need to consider the time of hemodialysis. Since the dose needs to be adjusted according to the patient's renal function, it is recommended to evaluate the patient's renal function before starting the treatment, and then regularly. (see the inner package manual for details)
manufacturing enterprise Merck Sharp & Dohme Italia SPA
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[drug name] Sitagliptin phosphate tablets (genovir)

[common name] Sitagliptin phosphate tablets

[specification and model] 100mg * 7S * 2 plate

[manufacturer] Merck Sharp & Dohme Italia SPA

[drug type] Western medicine

[approval No.] Gyzz j20140095

[validity period] 24 months

[functional indications] Monotherapy This product combines diet control and exercise to improve blood glucose control in patients with type 2 diabetes. Combined with metformin When metformin is used alone, glucose control is not good, it can be combined with metformin hydrochloride to improve blood glucose control in type 2 diabetes patients on the basis of diet and exercise. The recommended dose for single drug or combined treatment with metformin is 100 mg once a day. This product can be taken with or without food. Patients with renal insufficiency Patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml / min, corresponding serum creatinine level is about male ≤ 1.7 mg / dl and female ≤ 1.5 mg / dl) do not need to adjust the dose when taking this product. (see the inner package manual for details)

[usage and dosage] The recommended dose for single drug treatment of this product is 100 mg once a day. This product can be taken with or without food. Patients with renal insufficiency Patients with mild renal insufficiency (creatinine clearance [CrCl] & Ge; 50 ml / min, corresponding serum creatinine level is about male & le; 1.7 mg / dl and female & le; 1.5 mg / dl) do not need to adjust the dose when taking this product. In patients with moderate renal insufficiency (creatinine clearance [CrCl] & Ge; 30 to & lt; 50 ml / min, corresponding serum creatinine levels of about & gt; 1.7 to & le; 3.0 mg / dl for men and & gt; 1.5 to & le; 2.5 mg / dl for women), the dose is adjusted to 50 mg once a day. For patients with severe renal insufficiency (creatinine clearance [CrCl] & lt; 30 ml / min, corresponding serum creatinine level is about male & gt; 3.0 mg / dl and female & gt; 2.5 mg / dl) or patients with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose is adjusted to 25 mg once a day. Taking this product does not need to consider the time of hemodialysis. Since the dose needs to be adjusted according to the patient's renal function, it is recommended to evaluate the patient's renal function before starting the treatment, and then regularly. (see the inner package manual for details)

[adverse reactions] In the single drug treatment of this product and the controlled clinical study of this product combined with metformin or pioglitazone, the overall incidence of adverse reactions, hypoglycemia and withdrawal due to clinical adverse reactions were similar between the treatment group and the placebo treatment group. (see the inner package manual for details)

[precautions] This product should not be used for patients with type 1 diabetes or for treatment of diabetic ketoacidosis. Pancreatitis: in the post marketing experience, there are reports of acute pancreatitis in patients taking sitagliptin, including fatal and non fatal hemorrhagic or necrotizing pancreatitis (see adverse reactions, post marketing experience). Because these reports are submitted spontaneously and the number of people in whom they occur is uncertain, it is usually impossible to reliably estimate their frequency or determine their causal relationship with drug exposure. Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. It has been reported that the symptoms of pancreatitis disappeared after discontinuation of sitagliptin. If pancreatitis is suspected, stop using sitagliptin and other suspicious drugs. Medication for patients with renal insufficiency: This product can be excreted through the kidney. In order to make the plasma concentration of this product in patients with renal insufficiency similar to that in patients with normal renal function, it is recommended to reduce the dose of this product in patients with moderate and severe renal insufficiency and patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis (see usage and dosage, patients with renal insufficiency). Hypersensitivity reaction: the following severe hypersensitivity reactions were found during the treatment of patients after the product was put on the market. These reactions include allergic reactions, angioedema and exfoliative skin damage, including Stevens Johnson syndrome. Since these reactions come from spontaneous reports in an uncertain number of people, it is usually impossible to reliably estimate the incidence of these reactions or determine the causal relationship between these adverse reactions and drug exposure. These reactions occurred within the first 3 months of treatment with this product, and some reports occurred after the first administration. If hypersensitivity is suspected, discontinue the use of this product, assess whether there are other potential causes, and adopt other regimens to treat diabetes (see taboo and adverse reaction "post marketing experience"). Please read the instructions carefully and follow the doctor's advice.

[taboo] It is forbidden for those who are allergic to any ingredient in this product. (see precautions, hypersensitivity and adverse reactions, post marketing experience.)

[listing Permit Holder] MerckSharp&DohmeItaliaSPA

[packaging unit] box

[main ingredients] Sitagliptin phosphate.

[character] Light brown film coated tablets, white or off white after removing the coating.

[applicable population] adult

[medication for pregnant and lactating women] In the embryonic organ formation stage, rats and rabbits did not produce deformities when the oral dose of sitagliptin was as high as 250mg / kg and 125mg / kg respectively (32 times and 22 times of human exposure according to the daily recommended dose of 100mg for adults). A slight increase in the incidence of embryonic rib deformities (missing, hypoplastic and wavy ribs) was observed when the oral dose of rats was up to 1000mg / kg per day (about 100 times the human exposure according to the daily recommended dose of 100mg for adults). When the oral dose of rats reached 1000mg / kg per day, it was observed that the average body weight of male and female offspring decreased slightly before weaning, and the body weight of male offspring increased after weaning. However, the results of animal reproductive research can not always predict the human response. There are currently no adequate and well controlled studies in pregnant women; Therefore, the safety of this product in pregnant women is unknown. Like other oral anti hyperglycemic drugs, this product is not recommended for pregnant women. Sitagliptin can be secreted from the milk of lactating rats. It is unknown whether sitagliptin can be secreted in human milk. Therefore, this product is not suitable for lactating women. (see the inner package manual for details)

[medication for children] At present, the safety and efficacy of this product in children under the age of 18 have not been determined.

[medication for elderly patients] In clinical studies, the safety and efficacy of this product in elderly patients (≥ 65 years old) are equivalent to those in younger patients (< 65 years old). Dose adjustment based on age is not required. Since this product is not recommended for patients with moderate and severe renal insufficiency, it is recommended to regularly evaluate the patient's renal function before and during the use of this product. (see usage and dosage, "patients with renal insufficiency"). (see the inner package manual for details)

[storage] Store below 30 ℃.

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    Sitagliptin phosphate tablets (genovir)

    ¥139.69

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