October 11, 2019By pharmacyonlinehere
Galvus Met Tablet 50/500 50/850 50/1000 Uses Dosage Details
Galvus Met Tablet contains Metromin and vildagliptin in it. Metformin (HCL) is an oral biguanide antidiabetic agent introduced in 1950s. It reduces elevated blood glucose concentration in diabetic patients on the other hand it does not increase insulin secretion. On the other hand Vildagliptin is a dipeptidyl peptidase-4 (DDP-4 inhibitor. It works and improves the patients condition by increasing the amount of two in cretin hormones found in the body.
Galvus Met Tablet Indications
Mostly it indicated in patients with type 2 diabetes mellitus (T2DM:)
Galvus met Tablets mainly used as an adjunct to diet. and exercise to improve glycemic control but only in patients whose diabetes not adequately controlled on metformin hydrochloride or vildagliptin alone. Or in the patients who already treated with the combination of vildagliptin and metformin hydrochloride, as separate tab in the disease. However for exact use you may required and contact your doctor because he may understand the condition of one’s health condition.
GalvusMet Tablet Dosage And Administration
The use of antihyperglycemic therapy in the management of type 2 diabetes should individualized on the basis of effectiveness and tolerability. So most importantly when using Galvus Met Tablets do not exceed the maximum daily dose of vildagliptin (100 mg)
Therefore the recommend starting Galvus Met Tablets Dose should based on the patient’s current regimen of vildagliptin and /or metformin hydrochloride.
Starting Dose For Patients During Inadequately Controlled On Vildagliptin Monotherapy
Based on the usual starting doses of metformin hydrochloride (500 mg twice daily or 850 mg once daily). The tab may also started at the 50 mg/500 mg tablet used twice daily. And gradually titrated after assessing adequacy of therapeutic response.
Starting Dose For Patients Inadequately Controlled On Monotherapy
Based on the patient’s current dose of the tab may be initiated at either the 50 mg/500mg, 50 mg/850mg or 50 mg/1000 mg tab strength twice daily.
Starting Dose For Patients Switching From Combination Therapy Of Vilagliptin Plus As Separate Tab
Galvus Met may initiated with either the 50mg/500mg, 50mg/850mg, or 50mg,/1000 mg capsule strength based on the dose of vildagliptin or metformin already being taken.
GalvusMet Tablet Special Populations
Galvus Met Tablet Dosage adjustment may required in renally impaired patients with creatinine clearance. This can estimated from serum creatinine levels by using the croft-Gault formula between 60 and 90 ml/min. On the other hand itis contraindicated in patients with creatinine clearance <60 ml/min.
It is not recommended in patients with clinical or laboratory evidence of hepatic impairment. Including patients with a pre-treatment ALT or AST > 2.5X the upper limit of normal.
Safety and effectiveness of the medicationin pediatric patients have not been established. Therefore, Galvus Met Tablet not recommended for use in children who are below 18 years of age.
As metformin excreted via the kidney and elderly patients tend to decreased renal function. So, Elderly patients who using the medicationshould have their renal function monitored regularly. Therefore, the dosage of Eucreas for elderly patients should adjusted based on renal function.
Method Of Administration
Glavus Met should give with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride. If a dose of the capsulesmissed, it should taken as soon as the patient remembers. A double dose should not taken on the same day.
GalvusMet Tablet Contraindications
This product is contraindicated in patients with known hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients.
Glavus Met is contraindicated in patients with creatinine clearance <60ml/min.
Congestive Heart Failure
Similarly it is contraindicated in patients with congestive heart failure requiring pharmacologic treatment.
it Is contraindicated in patients with acute or chronic metabolic acidosis, including diabetic metoacidosis with or without coma. Diabetic ketoacidosis should treat with insulin.
Galvus Met Warnings And Precautions
Generally it did not administered as for insulin in insulin-requiring patients. Therefore, It should not used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Vildagliptin not recommended in patients with hepatic impairment. On the other hand, also in patients with a pre-treatment ALT or AST > 2.5X the upper limit of normal levels.
Liver Enzyme Monitoring
Rare cases of hepatic dysfunction (including hepatitis) have reported with vildagliptin. Therefore, in these cases the patients generally asymptomatic without clinical sequelae. And liver function tests (LFTs) come back to normal after discontinuation of this medicine treatment. LFTs should performed prior to the initiation of treatment with it. LFTs should monitored during GalvusMet treatment at three month intervals during the first year and periodically thereafter. However, Patients who develop increased transaminase levels should monitored with a second liver function evaluation to confirm the finding. And followed thereafter with frequent liver function tests until the abnormality return to normal.
Should an increase in AST or ALT or 3X upper limit of normal or greater persist, withdrawal of therapy with this productrecommended. Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue this and contact their physician immediately. Following withdrawal of treatment with GlavusMet and LFTs normalization. Itshould not reinitiated, and also not recommended in patients with hepatic impairment.
A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I-III showed that treatment with vildagliptin not associated with a change in left ventricular function. Or gone more bad of pre-existing congestive heart failure (CHF) versus placebo. Clinical experience in patients with NYHA functional class III treated with this still limited and results inconclusive.
Yet there is no study available of vildagliptin use in clinical trials in patients with NYHA functional class IV. Therefore use not recommended in such patients.
Lactic acidosis a very rare but serious metabolic complication that can occur due to metformin accumulation. Reported cases of lactic in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and reduced by also assessing other associated risk factors. Like poorly controlled diabets, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia.
Diagnosis Of Lactic Acidosis
Lactic acidosis characterized by acidotic dyspnea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory findings decreased blood pH, plasma lactate levels above 5 mmol/l. And an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis suspected, treatment with the medicinal product should discontinued and the patient hospitalized immediately.
Monitoring Of Renal Function
Metformin hydrochloride known to substantially excreted by the kidney, and the risk of metformin hydrochloride accumulation and lactic acidosis increases with the degree of renal function impairment. Since advancing age associated with reduced renal function. GlavusMet should carefully titrated in the elderly to rederly to establish the minimum dose for adequate glycemic effect. And on the other hand renal function monitored regularly. Also, special caution should exercise where renal function may become impaired. For example when initiating antihypertensive or diuretic therapy or when starting treatment with an NSAID. Renal function should assessed before the initiation of Glavus Met. Then at lest once a year in patients with normal renal function and at least two to four times a years in patients with creatinine clearance at the lower limit of normal clearance and in elderly subjects. Additionally, patients in whom renal dysfunction anticipated, should have their renal function assessed more frequently.
Concomitant Medications That May Affect Renal Function
Concomitant medications that may affect renal function, result in significant hemodyamic change or interfere with the disposition of metformin hydrochloride. Like cationic drugs that eliminated by renal tubular secretion should used with caution.
Administration Of Intravascular Iodinated Contrast Materals
Glavus Met should temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Because use of medicines like these result in acute alteration of renal function. And on the other hand it increase the risk of lactic acidosis. In patients undergoing such studies. Glavus met should temporarily discontinued at the time of or prior to the procrdure. Therefore, withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has re-evaluted and found to normal.
Cardiovascular collapse (shock), acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemi have associated with lactic acidosis. And may also cause prerenal azotmeia. However, if such events occur in patients receiving it therapy the medication should promptly discontinued.
Galvus Met Use should temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids). And should not restarted until the patient’s oral intake has resumed and renal function has evaluated as normal.
Alcohol known to potentiate the effect of metformin hydrochloride on lactic metabolism. Patients should warned against excessive alcohol intake while receiving GlavusMet.
Impaired Hepatic Function
Since impaired hepatic function has associated with some cases of lactic acidosis, a risk associated with netformin hydrochloride. Galvus Met Tablets should generally avoided in patients with clinical or laboratory evidence of hepatic disease.
Vitamin B/12 Levels
The metformin component of the medicine has associated with a decrease in serum vitamin B/12 levels without clinical manifestations but In approximately 7% of patients. Such decrease only happen some times with anemia and appears to rapidly reversible with discontinuation of this product and vitamin B/12 supplementation. Measurement of hematological parameters on at least an annual basis advised for patients receiving the product and any apparent abnormalities should appropriately investigated and managed. Certain individuals Like. those with inadequate vitamin B/12 or calcium intake or absorption, appear to predisposed to developing subnormal vitamin B/12 levels. In these patients, routine serum vitamin B/12 measurements at minimally two-to-three-year-intervals may useful.
Change In Clinical Status Of Patients With Previously Controlled Type 2 Diabetes
A patients with type 2 diabetes previously well-controlled on Galvus Met who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should promptly evaluated for ketoacidosis and/or lactic acidosis. IF acidosis of either form occurs,GlavusMet must stopped immediately and appropriate measures initiated.
Hypoglycemia doses not usually occur in patients receiving italone, but could occur when caloric supplementation. Or ethanol use, when strenuous exercise not compensated by caloric supplementation, or ethanol use. On the other hand elderly, Debilitated or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication susceptible to hypoglycemic effects. Hypoglycemia may difficult to recognize in the elderly and in people taking beta-adrenergic blocking drugs.
Loss of Control Of Blood Glucose
When a patient stabilized on any diabetic regimen exposed to stress such as fever, trauma, infection, surgery, etc. Therefore, A temporary loss of glycemic control may occur. At such times, it may necessary to withhold it and temporarily administer insulin. Galvus met may re instituted after the acute episode resolved.
Galvus Met 50/500 50/850 50/1000 Tablets Side Effects
However, its a well tolrated medicine but like all the other medical products the data available here about the administration of vildagliptin and metformin as a free or fixed dose combination.
Rare cases of angioedema have reported when vildagliptin at a similar rate to controls a greater proportion of cases reported. Therefore, Vildagliptin administered in combination with an angiotensin converting enzyme (ACE-Inhibitor). So, The majority of events mild in severity and resolved with ongoing vildagliptin treatment. However, in Rare cases of hepatic dysfunction (including hepatitis) have reported with vildagliptin. In these cases, the patients generally asymptomatic without clinical sequelae. And liver function tests (LFTs) returned to normal after discontinuation of the Galvus Met medicine treatment. In data from controlled monotherapy and add-on therapy trials up to 24 weeks in duration.
In clinical trials with the combination of vildagliptin + metformin, 0.4% of patients withdrew due to adverse reactions in the 50 mg once daily + metformin treatment groups. Most importantly In clinical trials, the incidence of hypoglycemia was uncommon in patients receiving 50 mg once daily in combination with metformin (0.9%). On the other hand patients receiving 50 mg twice daily in combination with this medication (0.5%). And in patients receiving placebo and this (0.4%). No severe hypoglycemic events reported in the medicine arms.
Therefore, Long term clinical trials of up to more than 2 years did not show any additional safety signal.
Adverse reactions for vildagliptin component from monotherapy double blind studies presented in table 2.
Table 2: Adverse reactions reported in patients who received vildagliptin 50 mg once daily (n=409) or 50 mg twice daily (n=1,373) as monotherapy in double-blid studies
Nervous System Disorders
General Disorders And Administration Site Condition
Most importantly, None of the adverse reactions reported for this medicationmonotherapy observed at clinically significant higher rates. In other words when it administered concomitantly with metformin.
The overall incidence of withdrawals from montherapy trials due to adverse reactions no greater for patients treated with this at a dose of 50 mg once daily (0.2%). Or at a dose of 50 mg twice daily (0.1%) than for placebo (0.6%) or comparators (0.5%).
In monotherapy studies, hypoglycemia uncommon, reported in 0.5% (2 of 409) of patients treated with 50 mg twice once daily. And 0.3% (4 of 1,373)of patients treated with 50 mg twice 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. Therefore, the weight neutral when administered as monotherapy. On the other hand Long term clinical trials of up to 2 years did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy.
Adverse drug Reactions From Spontaneous Reports And Literature Cases-Post-Marketing Experience (Frequency Not Known)
As a result following adverse drug reactions have derived from post-marketing experience with the medicine via spontaneous case reports and literature cases. Therefore these reactions reported voluntarily from a population of uncertain size. So, Not possible to reliably estimate their frequency which therefore categorized as not known.
- Hepatitis, reversible upon drug discontinuation.
- Urticaria, pancreatitis, bullous and exfoliative skin lesions.
Arthralgia, sometimes severe.
Known adverse reactions for metformin component summarized in table 3.
Table 3: Known adverse reactions for metformin
|Metabolism And Nutrition Disorders|
|Very Common||Decreased Appetite|
Nervous System Disorders
|Very Common||Flatulence, Nausea, Vomiting, Diarrhea, Abdominal Pain|
Skin And Subcutaneous Tissue Disorders
|Very Rare||Skin Reactions Such As Erythema, pruritus, urticaria|
|Very Rare||Decrease of vitamin B12, Liver function test abnormal|
Galvus Met Drug Interactions Information
No clinically relevant pharmacokinetic interaction observed when vildagliptin (100 mg once daily) co-administered with the medicine (1,000 mg once daily). 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. Moreover, The following statements reflect the information available on the individual active substances (vildagiptin and metformin).
Firstly, Vildagliptin has a very low potential of drug interactions with some other medicine. So, vildagliptin not a cytochrome p (CYP) 450 enzyme substrate nor doses. Therefore, it inhibit nor induce CYP 450 enzymes. So, not likely to interact with co-medications that substrates, inhibitors or inducers of these enzymes.
Furthermore, vildagliptin doses not affect metabolic clearance of co-medications metabolized by. CYP 1A2, CYP 2C8, CYP 2C9, CYP 2D6, CYP 2E1 and CYP 3A4/5. Drug-drug interaction studies with conducted or medications with a narrow therapeutic window. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamid, pioblitazone, metformin dydrochloride). Amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin observed after co-administration with vildagliptin.
The following known for metformin component:
Furosemide increased C/max and blood AUC of metformin with no change in renal clearance in renal clearance of furosemide.
Nifedipine increased absorption, C/max and AUC of metformin. And increased excretion of metformin in urine. Therefore, it had minimal effects on nifedipine.
Glyburide produced no changes in metformin PPPPK/Pd parameters. Decrease in C/max blood AUC of glyburide observed, But highly variable. Therefore the clinical significance of this finding was unclear.
Cationic drug (Like, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin). That eliminated by renal tubular secretion theoretically have the potential for interaction with netformin by competing for common renal tubular transport system. Therefore, with cimetidine increase in metformin plasma/blood concentration and ACU observed to 60 % and 40 % respectively. On the other hand it had no effect on cimetidine PK. Therefore, such interactions remain theoretical (except for cimetidine). Therefore careful monitoring of patients and doses and such medications recommended.
Certain drug tend to produce hyperglycemia and may lead to less of glycemic control. So, These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, theyoid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. Therefore, Close monitoring of glycemic control and dose adjustments recommended. When such drugs 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 active substance of this product. Most importantly, avoid consumption of alcohol and medicinal products containing alcohol.
Galvus Met Capsules Use During Pregnancy And Lactation
Embryo-fetal development (teratology) studies have conducted in rats and rabbits with combination of vildagliptin and metfromin hydrochloride in a 1:10 ratio and produced no evidence met in pregnant women. Therefore, the medicine should not used during pregnancy unless the potential benefit justifies the potential benefit justifies the potential risk to the fetus. Animal studies not always predictive of human response.
Galvus Met During Breast Feeding
No studies have conducted with the combined components of the medicine excreted into human breast milk. So, It not known whether vildagliptin excreted in human milk or not. Therefore it should not administered to breast-feeding women.
The studies have performed with vildagliptin in rats at doses producing exposure equivalent to up 200 times the doses. And have shown no proves of impaired fertility or early embryonic development due to vildagliptin. Therefore, Fertility of male or rats unaffected by this when administered at doses as high as 600 mg/kg/day. Which approximately three times the maximum recommended human daily doses bases on body surface area comparisons. As a result, No studies on about the effects on human fertility have yet conducted for Galvus Met Tablet.
Galvus Met 50/500, 50/850, 50/1000 Tablet Overdosage Symptoms & Treatment Guide
Signs And Symptoms
Meanwhile, in normal healthy patients (between 7 to 14 year of age), vildagliptin administered in once-daily doses of 25, 50, 100, 200, 400, and 600 mg for up to 10 consecutive days. Moreover Doses up to 200 mg well tolerated. Therefore, At 400 mg there cases of muscle pain, and individual cases of mild and transient paresthesia, fever, edema and transient increase in lipase levels (2x ULN). On the other hand 600 mg one subject experienced edema of the feet and hands. And an excessive increase in creatine phosphokinase (CPK)levels. In other words accompanied by elevations of aspartate aminotrandferase (AST), C-rective protein, and myoglobin. Therefore, Three additional subjects in this doses group presented with laboratory abnormalities resolved after study drug discontinuat.
Most Importantly, the thing to know that Vildagliptin not dialyzable. However the major hydrolysis metabolite (LAY151) can removed by hemodialysis.
Further, Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hyproglycemia reported in approximately 10 % of cases, but no causal association with this medication has established. Therefore, Lactic acidosis has reported in approximately 32% of metformin hydrochloride overdose cases. On the other hand it also dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may useful for removal of accumulated drug from patients in whom this medication overdosage suspected.
Therefore, In the event of overdosage, appropriate supportive treatment should initiated according to patient’s clinical signs and symptoms.
Galvus Met 50/500 And Other Medicine Storage Instuctions
Most importantly, keep all the medicine out of the reach of the children. Protect Galvus Met Drug from sunlight and heat. So, Also protect the medicine from moisture.
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Galvus Met (50 MG/500 MG, 50 MG/850 MG, 50 MG/ 1000 MG) Tablets