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GALVUS (VILDAGLIPTIN): ADVERSE REACTIONS

Summary of the safety profile

Safety data were obtained from a total of 3,784 patients exposed to vildagliptin at a daily dose of 50 mg (once daily) or 100 mg (50 mg twice daily or 100 mg once daily) in controlled trials of at least 12 weeks duration. Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product. 2,682 patients were treated with vildagliptin 100 mg daily (either 50 mg twice daily or 100 mg once daily) and 1,102 patients were treated with vildagliptin 50 mg once daily.

The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations. No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose.

Rare cases of hepatic dysfunction (including hepatitis) have been reported. In these cases, the patients were generally asymptomatic without clinical sequelae and liver function returned to normal after discontinuation of treatment. In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations >= 3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively. These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.

Rare cases of angioedema have been reported on vildagliptin at a similar rate to controls. A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor). The majority of events were mild in severity and resolved with ongoing vildagliptin treatment.

Tabulated list of adverse reactions

Adverse reactions reported in patients who received Galvus in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency. Frequencies are defined as very common (>= 1/10), common (>= 1/100 to < 1/10), uncommon (>= 1/1,000 to < 1/100), rare (>= 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Combination with metformin

Metabolism and nutrition disorders

Common: hypoglycaemia

Nervous system disorders

Common: headache, tremor, dizziness
Uncommon: fatigue

Gastrointestinal disorders

Common: nausea

Description of selected adverse reactions

In controlled clinical trials with the combination of vildagliptin 100 mg daily + metformin, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + metformin or the placebo + metformin treatment groups.

In clinical trials, the incidence of hypoglycaemia was common in patients receiving Vildagliptin (Galvus) 100 mg daily in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%). No severe hypoglycaemic events were reported in the vildagliptin arms.

In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and - 1.0 kg for vildagliptin and placebo, respectively). Clinical trials of up to more than 2 years' duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin.

Combination with a sulphonylurea

Infections and infestations

Very rare: nasopharyngitis

Metabolism and nutrition disorders

Common: hypoglycaemia

Nervous system disorders

Common: headache, dizziness, tremor, asthenia

Gastrointestinal disorders

Uncommon: constipation

Description of selected adverse reactions

In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the Vildagliptin (Galvus) 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group. In clinical trials, the incidence of hypoglycaemia when vildagliptin 50 mg once daily was added to glimepiride was 1.2% versus 0.6% for placebo + glimepiride. No severe hypoglycaemic events were reported in the vildagliptin arms.

In clinical trials, weight did not change from baseline when vildagliptin 50 mg daily was added to glimepiride (-0.1 kg and -0.4 kg for vildagliptin and placebo, respectively).

Combination with a thiazolidinedione

Metabolism and nutrition disorders

Common: weight increase
Uncommon: hypoglycaemia

Nervous system disorders

Uncommon: headache, asthenia

Vascular disorders

Common: oedema peripheral

Description of selected adverse reactions

In controlled clinical trials with the combination of vildagliptin 100 mg daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups.

In clinical trials, the incidence of hypoglycaemia was uncommon in patients receiving vildagliptin + pioglitazone (0.6%) but common in patients receiving placebo + pioglitazone (1.9%). No severe hypoglycaemic events were reported in the vildagliptin arms.

In the pioglitazone add-on study, the absolute weight increases with placebo, Galvus (Vildagliptin) 100 mg daily were 1.4 and 2.7 kg, respectively.

The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.

Monotherapy

Infections and infestations

Very rare: upper respiratory tract infection, nasopharyngitis

Metabolism and nutrition disorders

Uncommon: hypoglycaemia

Nervous system disorders

Common: dizziness
Uncommon: headache

Vascular disorders

Uncommon: oedema peripheral

Gastrointestinal disorders

Uncommon: constipation

Musculoskeletal and connective tissue disorders

Uncommon: arthralgia

Description of selected adverse reactions

In addition, in controlled monotherapy trials with Vildagliptin (Galvus) the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).

In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.

In clinical trials, weight did not change from baseline when Vildagliptin (Galvus) 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).

Clinical trials of up to 2 years' duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy.

Combination with metformin and a sulphonylurea

Metabolism and nutritional disorders

Common: hypoglycaemia

Nervous system disorders

Common: tremor, dizziness

Skin and subcutaneous tissue disorders

Common: hyperhidrosis

General disorders and administration site conditions

Common: asthenia

Description of selected adverse reactions

There were no withdrawals due to adverse reactions reported in the vildagliptin + metformin + glimepiride treatment group versus 0.6% in the placebo + metformin + glimepiride treatment group.

The incidence of hypoglycaemia was common in both treatment groups (5.1% for the vildagliptin + metformin + glimepiride group versus 1.9% for the placebo + metformin + glimepiride group). One severe hypoglycaemic event was reported in the vildagliptin group.

At the end of the study, effect on mean body weight was neutral (+0.6 kg in the vildagliptin group and -0.1 kg in the placebo group).

Combination with insulin

Metabolism and nutrition disorders

Common: decreased blood glucose

Nervous system disorders

Common: headache, chills

Gastrointestinal disorders

Common: nausea, gastro-oesophageal reflux disease
Uncommon: diarrhoea, flatulence

Description of selected adverse reactions

In controlled clinical trials using vildagliptin 50 mg twice daily in combination with insulin, with or without concomitant metformin, the overall incidence of withdrawals due to adverse reactions was 0.3% in the vildagliptin treatment group and there were no withdrawals in the placebo group.

The incidence of hypoglycaemia was similar in both treatment groups (14.0% in the Vildagliptin (Galvus) group vs 16.4% in the placebo group). Two patients reported severe hypoglycaemic events in the Galvus (Vildagliptin) group, and 6 patients in the placebo group.

At the end of the study, effect on mean body weight was neutral (+0.6 kg change from baseline in the vildagliptin group and no weight change in the placebo group).

Post-marketing experience

Gastrointestinal disorders

Not known: pancreatitis

Hepatobiliary disorders

Not known: hepatitis (reversible upon discontinuation of the medicinal product); abnormal liver function tests (reversible upon discontinuation of the medicinal product)

Musculoskeletal and connective tissue disorders

Not known: myalgia

Skin and subcutaneous tissue disorders

Not known: urticaria, bullous or exfoliative skin lesions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.


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