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Riomet
Overview
What is Riomet?
RIOMET (metformin hydrochloride oral solution) is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride, USP (,-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:
Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of CHN•HCl and a molecular weight of 165.62. Metformin hydrochloride, USP 2.0 g is soluble in 20 mL of water. The pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. It is freely soluble in water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride.
RIOMET (Cherry Flavor) contains 500 mg of metformin hydrochloride, USP per 5 mL and the following inactive ingredients: Artificial cherry flavor, hydrochloric acid, potassium bicarbonate, purified water, saccharin calcium, and xylitol.
RIOMET (Strawberry Flavor) contains 500 mg of metformin hydrochloride, USP per 5 mL and the following inactive ingredients: Hydrochloric acid, N&A strawberry flavor (propylene glycol and glycerin), potassium bicarbonate, purified water, sucralose, and xylitol.
What does Riomet look like?
What are the available doses of Riomet?
Sorry No records found.
What should I talk to my health care provider before I take Riomet?
Sorry No records found
How should I use Riomet?
RIOMET (metformin hydrochloride oral solution) is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with RIOMET or any other pharmacologic agent. Dosage of RIOMET must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of RIOMET is 2550 mg (25.5 mL) in adults and 2000 mg (20 mL) in pediatric patients (10 to 16 years of age).
RIOMET should be given in divided doses with meals. RIOMET should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see ), fasting plasma glucose should be used to determine the therapeutic response to RIOMET and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months.
Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of RIOMET may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
What interacts with Riomet?
RIOMET is contraindicated in patients with:
1. Severe renal impairment (eGFR below 30 mL/min/1.73 m) (see and ).
2. Known hypersensitivity to metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
What are the warnings of Riomet?
Sorry No Records found
What are the precautions of Riomet?
General
Lactic Acidosis
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of RIOMET. In RIOMET treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue RIOMET and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
PRECAUTIONS: Laboratory Tests
Certain individuals (those with inadequate Vitamin B or calcium intake or absorption) appear to be predisposed to developing subnormal Vitamin B levels. In these patients, routine serum Vitamin B measurements at two- to three-year intervals may be useful.
Hypoglycemia
Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs.
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with RIOMET or any other oral anti-diabetic drug.
Information for Patients
Patients should be informed of the potential risks and benefits of RIOMET and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters.
The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the and sections, should be explained to patients. Patients should be advised to discontinue RIOMET immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of RIOMET, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving RIOMET.
Metformin alone does not usually cause hypoglycemia, although it may occur when metformin is used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.
Laboratory Tests
Response to all diabetic therapies should be monitored by periodic measurements of fasting blood glucose and glycosylated hemoglobin levels, with a goal of decreasing these levels toward the normal range. During initial dose titration, fasting glucose can be used to determine the therapeutic response. Thereafter, both glucose and glycosylated hemoglobin should be monitored. Measurements of glycosylated hemoglobin may be especially useful for evaluating long-term control (see also ).
Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. While megaloblastic anemia has rarely been seen with metformin therapy, if this is suspected, Vitamin B deficiency should be excluded.
Instruct patients to inform their doctor that they are taking RIOMET prior to any surgical or radiological procedure, as temporary discontinuation of RIOMET may be required until renal function has been confirmed to be normal (see Precautions).
Drug Interactions (Clinical Evaluation of Drug Interactions Conducted with Metformin)
Glyburide —
DOSAGE AND ADMINISTRATION: Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients
Furosemide —
Nifedipine —
Drugs that reduce metformin clearance—
In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when co-administered in single-dose interaction studies.
Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Other —
Carbonic Anhydrase Inhibitors ---
Alcohol ---
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks), at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively.
These doses are both approximately four times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice.
Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
There was no evidence of a mutagenic potential of metformin in the following tests: Ames test (), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the mouse micronucleus test were also negative.
Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Pregnancy
Teratogenic Effects: Pregnancy Category B
Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Because animal reproduction studies are not always predictive of human response, RIOMET should not be used during pregnancy unless clearly needed.
There are no adequate and well-controlled studies in pregnant women with metformin. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about two and six times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Nursing Mothers
Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If RIOMET is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
Pediatric Use
The safety and effectiveness of metformin for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of metformin in this age group is supported by evidence from adequate and well-controlled studies of metformin in adults with additional data from a controlled clinical study in pediatric patients ages 10 to 16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults. (See .) In this study, adverse effects were similar to those described in adults. (See .) A maximum daily dose of 2000 mg is recommended. (See .)
Geriatric Use
Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patient (see also and ).
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What are the side effects of Riomet?
In a U.S. double-blind clinical study of metformin in patients with type 2 diabetes, a total of 141 patients received metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin patients, and that were more common in metformin-than placebo-treated patients, are listed in
Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin. Additionally, the following adverse reactions were reported in ≥ 1.0 to ≤ 5.0% of metformin patients and were more commonly reported with metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
| % of patients | ||
| Diarrhea | 53.2 | 11.7 |
| Nausea/ Vomiting | 25.5 | 8.3 |
| Flatulence | 12.1 | 5.5 |
| Asthenia | 9.2 | 5.5 |
| Indigestion | 7.1 | 4.1 |
| Abdominal Discomfort | 6.4 | 4.8 |
| Headache | 5.7 | 4.8 |
Pediatric Patients
In clinical trials with metformin in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
What should I look out for while using Riomet?
RIOMET is contraindicated in patients with:
1. Severe renal impairment (eGFR below 30 mL/min/1.73 m) (see and ).
2. Known hypersensitivity to metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
What might happen if I take too much Riomet?
Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no casual association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see S). Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
How should I store and handle Riomet?
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Keep bottles tightly closed.Dispense in a tight container.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Keep bottles tightly closed.Dispense in a tight container.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Keep bottles tightly closed.Dispense in a tight container.RIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USARIOMET (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.Cherry FlavorNDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)Strawberry FlavorSTORAGEStore at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].You may report side effects to FDA at .RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.Manufactured for:Ranbaxy Laboratories Inc.Jacksonville, FL 32257 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
Non-Clinical Toxicology
RIOMET is contraindicated in patients with:1. Severe renal impairment (eGFR below 30 mL/min/1.73 m) (see and ).
2. Known hypersensitivity to metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
General
Lactic Acidosis
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of RIOMET. In RIOMET treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue RIOMET and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
PRECAUTIONS: Laboratory Tests
Certain individuals (those with inadequate Vitamin B or calcium intake or absorption) appear to be predisposed to developing subnormal Vitamin B levels. In these patients, routine serum Vitamin B measurements at two- to three-year intervals may be useful.
Hypoglycemia
Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs.
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with RIOMET or any other oral anti-diabetic drug.
Information for Patients
Patients should be informed of the potential risks and benefits of RIOMET and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters.
The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the and sections, should be explained to patients. Patients should be advised to discontinue RIOMET immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of RIOMET, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving RIOMET.
Metformin alone does not usually cause hypoglycemia, although it may occur when metformin is used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.
Laboratory Tests
Response to all diabetic therapies should be monitored by periodic measurements of fasting blood glucose and glycosylated hemoglobin levels, with a goal of decreasing these levels toward the normal range. During initial dose titration, fasting glucose can be used to determine the therapeutic response. Thereafter, both glucose and glycosylated hemoglobin should be monitored. Measurements of glycosylated hemoglobin may be especially useful for evaluating long-term control (see also ).
Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. While megaloblastic anemia has rarely been seen with metformin therapy, if this is suspected, Vitamin B deficiency should be excluded.
Instruct patients to inform their doctor that they are taking RIOMET prior to any surgical or radiological procedure, as temporary discontinuation of RIOMET may be required until renal function has been confirmed to be normal (see Precautions).
Drug Interactions (Clinical Evaluation of Drug Interactions Conducted with Metformin)
Glyburide —
DOSAGE AND ADMINISTRATION: Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients
Furosemide —
Nifedipine —
Drugs that reduce metformin clearance—
In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when co-administered in single-dose interaction studies.
Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Other —
Carbonic Anhydrase Inhibitors ---
Alcohol ---
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks), at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively.
These doses are both approximately four times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice.
Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
There was no evidence of a mutagenic potential of metformin in the following tests: Ames test (), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the mouse micronucleus test were also negative.
Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Pregnancy
Teratogenic Effects: Pregnancy Category B
Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Because animal reproduction studies are not always predictive of human response, RIOMET should not be used during pregnancy unless clearly needed.
There are no adequate and well-controlled studies in pregnant women with metformin. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about two and six times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Nursing Mothers
Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If RIOMET is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
Pediatric Use
The safety and effectiveness of metformin for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of metformin in this age group is supported by evidence from adequate and well-controlled studies of metformin in adults with additional data from a controlled clinical study in pediatric patients ages 10 to 16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults. (See .) In this study, adverse effects were similar to those described in adults. (See .) A maximum daily dose of 2000 mg is recommended. (See .)
Geriatric Use
Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patient (see also and ).
In a U.S. double-blind clinical study of metformin in patients with type 2 diabetes, a total of 141 patients received metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin patients, and that were more common in metformin-than placebo-treated patients, are listed in
Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin. Additionally, the following adverse reactions were reported in ≥ 1.0 to ≤ 5.0% of metformin patients and were more commonly reported with metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).