Galvus Met 保胰健加 Uses

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Galvus Met 保胰健加 indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Patients with Type 2 Diabetes Mellitus (T2DM): Adjunct to diet and exercise to improve glycemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride or Vildagliptin (Galvus Met 保胰健加) alone or who are already treated with the combination of Vildagliptin (Galvus Met 保胰健加) and metformin hydrochloride, as separate tablets.

In combination with a sulphonylurea (SU) (ie, triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and SU.

Add-on to insulin as an adjunct to diet and exercise to improve glycemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycemic control; initial therapy in patients with T2DM whose diabetes is not adequately controlled by diet and exercise alone.

Galvus Met 保胰健加 description

Each 50 mg/500 mg, 50 mg/850 mg and 50 mg/1,000 mg tablet contains Vildagliptin (Galvus Met 保胰健加) 50 mg and metformin hydrochloride 500 mg, 850 mg and 1,000 mg, respectively.

It also contains the following excipients: Red ferric oxide, yellow ferric oxide, hypromellose, hydroxypropylcellulose, magnesium stearate, polyethylene glycol and talc. The chemical name of Vildagliptin (Galvus Met 保胰健加) is (S)-1-[2-(3-Hydroxy-adamantan-1-ylamino) acetyl] pyrrolidine-2-carbonitrile and metformin hydrochloride is Imidodicarbinimidic, N,N-dimethyl-, monohydrochloride.

Galvus Met 保胰健加 dosage

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Antidiabetic treatment should be individualized on the basis of effectiveness and tolerability. When using Galvus Met, do not exceed the maximum recommended daily dose of 100 mg Vildagliptin (Galvus Met 保胰健加).

The recommended starting dose of Galvus Met should be based on the current regimen of Vildagliptin (Galvus Met 保胰健加) and/or metformin.

Adults: Starting Dose for Patients Inadequately Controlled on Vildagliptin (Galvus Met 保胰健加) Monotherapy: Based on the usual starting dose of metformin (Daily Dose: 500-1000 mg), Galvus Met should be initiated at the 50 mg/500 mg or 50 mg/850 mg tablet strength twice daily, with the dose of metformin being gradually titrated based on an assessment of the therapeutic response.

Starting Dose for Patients Inadequately Controlled on Metformin Monotherapy: Based on the current dose of metformin, Galvus Met should be initiated at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily.

Starting Dose for Patients Switching to Galvus Met from the Free Combination of Metformin and Vildagliptin (Galvus Met 保胰健加): Based on the current dose of metformin or Vildagliptin (Galvus Met 保胰健加), Galvus Met should be initiated at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength.

Use in Combination with Insulin or Sulphonylurea: Based on the current dose of metformin, Galvus Met should be taken at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily. When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.

Renal Impairment: Galvus Met should not be used in patients with renal failure or renal dysfunction [creatinine clearance (≤60 mL/minute)].

Hepatic Impairment: Galvus Met is not recommended for use in patients with hepatic dysfunction, including patients with pre-treatment AST or ALT >2.5 × ULN.

Elderly: Metformin is excreted via the kidneys, and elderly patients have a tendency to decreased renal function. Therefore, elderly patients taking Galvus Met should have their renal function monitored regularly. Galvus Met should only be used in elderly patients with normal renal function.

Children and Adolescents: The safety and efficacy of Galvus Met have not been established in patients <18 years. Galvus Met is therefore, not recommended for use in paediatric patients.

Missed Dose: If a dose of Galvus Met is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Administration: For oral use. Galvus Met should be given with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride.

Galvus Met 保胰健加 interactions

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No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (Galvus Met 保胰健加) (100 mg once daily) was co-administered with metformin hydrochloride (1,000 mg once daily). Drug interactions for each component have been extensively studied. However, the concomitant use of the active substances in patients in clinical studies and in widespread clinical use has not resulted in any unexpected interactions. The following statements reflect the information available on the individual active substances (Vildagliptin (Galvus Met 保胰健加) and metformin).

Vildagliptin (Galvus Met 保胰健加): Has a low potential for drug interactions. Since Vildagliptin (Galvus Met 保胰健加) is not a CYP450 enzyme substrate nor does it inhibit nor induces CYP450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes.

Furthermore, Vildagliptin (Galvus Met 保胰健加) does not affect metabolic clearance of co-medications metabolized by CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4/5. Drug-drug interaction studies were conducted with commonly co-prescribed medications for patients with type 2 diabetes or medications with a narrow therapeutic window. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with Vildagliptin (Galvus Met 保胰健加).

Metformin Hydrochloride: The following is known for metformin component: Furosemide: Furosemide increased Cmax and blood AUC of metformin with no change in renal clearance of metformin. Metformin decreased Cmax, blood AUC of furosemide, with no change in renal clearance of furosemide.

Nifedipine: Nifedipine increased absorption, Cmax and AUC of metformin, and increased excretion of metformin in urine. Metformin had minimal effects on nifedipine.

Glyburide: Glyburide produced no changes in metformin pharmacokinetics/pharmacodynamic parameters. Decreases in Cmax, blood AUC of glyburide were observed, but were highly variable. Therefore, the clinical significance of this finding was unclear.

Cationic Drugs: Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Thus, with cimetidine increases in metformin plasma/blood concentration and AUC were observed to be 60% and 40%, respectively. Metformin had no effect on cimetidine pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful monitoring of patients and doses of metformin and such medications are recommended.

Other: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and isoniazid. Close monitoring of glycemic control and metformin dose adjustments are recommended when such drugs are administered or withdrawn for these patients. There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance. Avoid consumption of alcohol and medicinal products containing alcohol.

Incompatibilities: Not applicable.

Galvus Met 保胰健加 side effects

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Galvus Met: The data presented here relate to co-administration of Vildagliptin (Galvus Met 保胰健加) and metformin as a free or fixed-dose combination.

Rare cases of angioedema have been reported with Vildagliptin (Galvus Met 保胰健加) at a rate similar to that in the control group. A greater number of cases were reported when Vildagliptin (Galvus Met 保胰健加) was administered in combination with an ACE inhibitor. The majority of events were mild in severity and resolved with ongoing Vildagliptin (Galvus Met 保胰健加) treatment.

Rare cases of hepatic dysfunction (including hepatitis) have been reported with Vildagliptin (Galvus Met 保胰健加). In these cases, the patients were generally asymptomatic, without clinical sequelae and hepatic function returned to normal after discontinuation of treatment. In controlled monotherapy and add-on therapy studies of up to 24 weeks duration, the incidence of ALT or AST elevations ≥3 × ULN (detected at no fewer than 2 consecutive measurements or at the final on-treatment visit) was 0.2% for Vildagliptin (Galvus Met 保胰健加) 50 mg once daily, 0.3% for Vildagliptin (Galvus Met 保胰健加) 50 mg twice daily and 0.2% for all comparators. These increases in transaminases were generally asymptomatic, not progressive and not associated with cholestasis or jaundice.

In controlled studies, hypoglycaemia was uncommon in patients receiving Vildagliptin (Galvus Met 保胰健加) in combination with metformin and in patients receiving placebo and metformin. No severe cases of hypoglycaemia occurred in the Vildagliptin (Galvus Met 保胰健加) group.

Gastrointestinal adverse effects, including diarrhoea and nausea, occur very commonly during the introduction of metformin.

Overall, gastrointestinal symptoms were reported in 12.9% of patients treated with the combination of Vildagliptin (Galvus Met 保胰健加) and metformin, compared with 18.1% of patients treated with metformin alone.

In comparative controlled monotherapy studies, hypoglycaemia was uncommon.

Adverse effects reported in patients who received Vildagliptin (Galvus Met 保胰健加) in double-blind studies as monotherapy and add-on therapy are listed below by system organ class and absolute frequency.

Frequencies are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse effects are ranked in order of decreasing seriousness.

Infections and Infestations: Very rare: Upper respiratory tract infections, nasopharyngitis.

Endocrine Disorders: Not known: Pancreatitis.

Nervous System Disorders: Common: Dizziness, tremor. Uncommon: Headache.

Vascular Disorders: Uncommon: Peripheral oedema.

Gastrointestinal Disorders: Common: Nausea. Uncommon: Diarrhoea, constipation.

Hepatic Disorders: Rare: Elevated transaminase levels.

Musculoskeletal Disorders: Uncommon: Arthralgia.

Metabolism Disorders: Uncommon: Hypoglycaemia, weight gain.

General Disorders: Uncommon: Asthenia.

None of the adverse effects reported with Vildagliptin (Galvus Met 保胰健加) monotherapy were observed at clinically significantly higher rates when Vildagliptin (Galvus Met 保胰健加) was administered concomitantly with metformin.

Post-marketing Experience: The following additional adverse drug reaction has been reported during the post-marketing period: Rare cases of hepatitis that resolved following discontinuation of Galvus Met.

Frequency Not Known: Urticaria, pancreatitis, bullous eruptions, localized exfoliation and blistering of the skin.

Metformin: The known adverse effects of metformin are summarized below.

Blood and Lymphatic System Disorders: Isolated cases of leukopenia, thrombocytopenia and haemolytic anaemia. Very Rare: Reduced vitamin B12 blood levels.

Metabolism and Nutrition Disorders: Very Rare: Lactic acidosis (Incidence: 3 cases per 100,000 patient-years; see Precautions).

Nervous System Disorders: Common: Metallic taste (3%). Uncommon: Fatigue.

Gastrointestinal Disorders: Common to Very Common: Gastrointestinal disorders (5-15%) eg, nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.

These symptoms usually occur at the start of treatment and resolve spontaneously in most cases.

Hepatobiliary Disorders: Isolated Cases: Abnormal results in hepatic function tests, eg, elevated transaminases or hepatitis (reversible after discontinuing metformin).

Skin and Subcutaneous Tissue Disorders: Very Rare: Skin reactions eg, erythema, pruritus, urticaria.

Combination of Vildagliptin (Galvus Met 保胰健加) with Insulin (with/without Metformin): The incidence of hypoglycaemia in the controlled clinical studies conducted was similar in both treatment groups (14% of patients on Vildagliptin (Galvus Met 保胰健加) vs 16.4% of patients on placebo). Severe hypoglycaemia occurred in n=2 patients on Vildagliptin (Galvus Met 保胰健加) versus n=6 on placebo. The overall effect on mean weight was small in both treatment groups (+0.6 kg on Vildagliptin (Galvus Met 保胰健加) vs ±0 kg on placebo).

The following adverse effects occurred with Vildagliptin (Galvus Met 保胰健加) in these studies.

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.

Discontinuations due to these adverse effects were rare overall.

Combination with a Sulphonylurea: Hypoglycaemia was common in both treatment groups (5.1% for Vildagliptin (Galvus Met 保胰健加)+metformin+glimepiride vs 1.9 % for placebo+metformin+glimepiride). One (1) severe hypoglycaemic event was reported in the Vildagliptin (Galvus Met 保胰健加) group. At the end of the study, the effect on mean body weight was small (+0.6 kg in the Vildagliptin (Galvus Met 保胰健加) group and 0.1 kg in the placebo group).

Adverse effects in patients who received Galvus 50 mg twice daily in combination with metformin and a sulphonylurea (n=157).

Metabolism and Nutrition Disorders: Common: Hypoglycaemia.

Nervous System Disorders: Common: Dizziness, tremor.

Skin Disorders: Common: Hyperhidrosis.

General Disorders: Common: Asthenia.

Galvus Met 保胰健加 contraindications

Known hypersensitivity to Vildagliptin (Galvus Met 保胰健加) or metformin hydrochloride or any of the excipients of Galvus Met 保胰健加.

Congestive Heart Failure (CHF): Contraindicated in patients with CHF requiring pharmacologic treatment.

Diabetic Ketoacidosis: Contraindicated in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Radiologic Studies: Treatment should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

Patients with Renal Impairment: Not recommended in patients with renal failure or renal dysfunction eg, serum creatinine levels ≥1.5 mg/dL (>135 micromole/L) in males and ≥1.4 mg/dL (>110 micromole/L) in females. Patients with renal disease or dysfunction (eg, as suggested by serum creatinine levels in males and females or abnormal creatinine clearance) which may also result from conditions eg, cardiovascular collapse shock, acute myocardial infarction and septicemia.



Active ingredient matches for Galvus Met 保胰健加:

Metformin HCl/Vildagliptin in Hongkong.


Unit description / dosage (Manufacturer)Price, USD
Galvus Met 50 mg/1, 000 mg film-coated tab 60's (Novartis)
Galvus Met 50 mg/500 mg film-coated tab 60's (Novartis)
Galvus Met 50 mg/850 mg film-coated tab 60's (Novartis)

List of Galvus Met 保胰健加 substitutes (brand and generic names):

ProglinMet 50 mg/1, 000 mg FC tab 30's (LR Imperial)$ 20.71
ProglinMet 50 mg/500 mg FC tab 30's (LR Imperial)$ 20.71
ProglinMet 50 mg/850 mg FC tab 30's (LR Imperial)$ 20.71

References

  1. PubChem. "Vildagliptin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. PubChem. "metformin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Vildagliptin". http://www.drugbank.ca/drugs/DB04876 (accessed September 17, 2018).

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