Glucovance

glyburide and metformin hydrochloride

Dosage Form: tablet, film coated
Glucovance®

(Glyburide and Metformin HCl) Tablets

1.25 mg/250 mg

2.5 mg/500 mg

5 mg/500 mg

Glucovance Description

Glucovance® (Glyburide and Metformin HCl) Tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.

Glyburide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide is a white to off-white crystalline compound with a molecular formula of C23H28ClN3O5S and a molecular weight of 494.01. The glyburide used in Glucovance has a particle size distribution of 25% undersize value not more than 6 µm, 50% undersize value not more than 7 to 10 µm, and 75% undersize value not more than 21 µm. The structural formula is represented below.

Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:

Glucovance is available for oral administration in tablets containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5 mg glyburide with 500 mg metformin hydrochloride, and 5 mg glyburide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, povidone, croscarmellose sodium, and magnesium stearate. The tablets are film coated, which provides color differentiation.

Glucovance - Clinical Pharmacology

Mechanism of Action

Glucovance combines glyburide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes.

Glyburide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which glyburide lowers blood glucose during long-term administration has not been clearly established. With chronic administration in patients with type 2 diabetes, the blood glucose-lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects may be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs.

Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Pharmacokinetics

Absorption and Bioavailability

Glucovance

In bioavailability studies of Glucovance 2.5 mg/500 mg and 5 mg/500 mg, the mean area under the plasma concentration versus time curve (AUC) for the glyburide component was 18% and 7%, respectively, greater than that of the Micronase® brand of glyburide coadministered with metformin. The glyburide component of Glucovance, therefore, is not bioequivalent to Micronase®. The metformin component of Glucovance is bioequivalent to metformin coadministered with glyburide.

Following administration of a single Glucovance 5 mg/500 mg tablet with either a 20% glucose solution or a 20% glucose solution with food, there was no effect of food on the Cmax and a relatively small effect of food on the AUC of the glyburide component. The Tmax for the glyburide component was shortened from 7.5 hours to 2.75 hours with food compared to the same tablet strength administered fasting with a 20% glucose solution. The clinical significance of an earlier Tmax for glyburide after food is not known. The effect of food on the pharmacokinetics of the metformin component was indeterminate.

Glyburide

Single-dose studies with Micronase® tablets in normal subjects demonstrate significant absorption of glyburide within 1 hour, peak drug levels at about 4 hours, and low but detectable levels at 24 hours. Mean serum levels of glyburide, as reflected by areas under the serum concentration-time curve, increase in proportion to corresponding increases in dose. Bioequivalence has not been established between Glucovance and single-ingredient glyburide products.

Metformin Hydrochloride

The absolute bioavailability of a 500 mg metformin hydrochloride tablet given under fasting conditions is approximately 50% to 60%. Studies using single oral doses of metformin tablets of 500 mg and 1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination. Food decreases the extent of and slightly delays the absorption of metformin, as shown by approximately a 40% lower peak concentration and a 25% lower AUC in plasma and a 35-minute prolongation of time to peak plasma concentration following administration of a single 850 mg tablet of metformin with food, compared to the same tablet strength administered fasting. The clinical relevance of these decreases is unknown.

Distribution

Glyburide

Sulfonylurea drugs are extensively bound to serum proteins. Displacement from protein binding sites by other drugs may lead to enhanced hypoglycemic action. In vitro, the protein binding exhibited by glyburide is predominantly non-ionic, whereas that of other sulfonylureas (chlorpropamide, tolbutamide, tolazamide) is predominantly ionic. Acidic drugs, such as phenylbutazone, warfarin, and salicylates, displace the ionic-binding sulfonylureas from serum proteins to a far greater extent than the non-ionic binding glyburide. It has not been shown that this difference in protein binding results in fewer drug-drug interactions with glyburide tablets in clinical use.

Metformin Hydrochloride

The apparent volume of distribution (V/F) of metformin following single oral doses of 850 mg averaged 654±358 L. Metformin is negligibly bound to plasma proteins. Metformin partitions into erythrocytes, most likely as a function of time. At usual clinical doses and dosing schedules of metformin, steady state plasma concentrations of metformin are reached within 24 to 48 hours and are generally <1 µg/mL. During controlled clinical trials, maximum metformin plasma levels did not exceed 5 µg/mL, even at maximum doses.

Metabolism and Elimination

Glyburide

The decrease of glyburide in the serum of normal healthy individuals is biphasic; the terminal half-life is about 10 hours. The major metabolite of glyburide is the 4-trans-hydroxy derivative. A second metabolite, the 3-cis-hydroxy derivative, also occurs. These metabolites probably contribute no significant hypoglycemic action in humans since they are only weakly active (1/400 and 1/40 as active, respectively, as glyburide) in rabbits. Glyburide is excreted as metabolites in the bile and urine, approximately 50% by each route. This dual excretory pathway is qualitatively different from that of other sulfonylureas, which are excreted primarily in the urine.

Metformin Hydrochloride

Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Renal clearance (see Table 1) is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution.

Special Populations

Patients With Type 2 Diabetes

Multiple-dose studies with glyburide in patients with type 2 diabetes demonstrate drug level concentration-time curves similar to single-dose studies, indicating no buildup of drug in tissue depots.

In the presence of normal renal function, there are no differences between single- or multiple-dose pharmacokinetics of metformin between patients with type 2 diabetes and normal subjects (see Table 1), nor is there any accumulation of metformin in either group at usual clinical doses.

Hepatic Insufficiency

No pharmacokinetic studies have been conducted in patients with hepatic insufficiency for either glyburide or metformin.

Renal Insufficiency

No information is available on the pharmacokinetics of glyburide in patients with renal insufficiency.

In patients with decreased renal function (based on creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance (see Table 1; also, see WARNINGS).

Geriatrics

There is no information on the pharmacokinetics of glyburide in elderly patients.

Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance is decreased, the half-life is prolonged, and Cmax is increased, when compared to healthy young subjects. From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function (see Table 1). Metformin treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced.

Table 1: Select Mean (±SD) Metformin Pharmacokinetic Parameters Following Single or Multiple Oral Doses of Metformin

Subject Groups: Metformin Dosea (number of subjects)	Cmaxb (µg/mL)	Tmaxc (hrs)	Renal Clearance (mL/min)
a All doses given fasting except the first 18 doses of the multiple-dose studies
b Peak plasma concentration
c Time to peak plasma concentration
d SD=single dose
e Combined results (average means) of 5 studies: mean age 32 years (range 23-59 years)
f  Kinetic study done following dose 19, given fasting
g Elderly subjects, mean age 71 years (range 65-81 years)
h CLcr=creatinine clearance normalized to body surface area of 1.73 m2
Healthy, nondiabetic adults:
500 mg SDd (24)	1.03 (±0.33)	2.75 (±0.81)	600 (±132)
850 mg SD (74)e	1.60 (±0.38)	2.64 (±0.82)	552 (±139)
850 mg t.i.d. for 19 dosesf (9)	2.01 (±0.42)	1.79 (±0.94)	642 (±173)
Adults with type 2 diabetes:
850 mg SD (23)	1.48 (±0.5)	3.32 (±1.08)	491 (±138)
850 mg t.i.d. for 19 dosesf (9)	1.90 (±0.62)	2.01 (±1.22)	550 (±160)
Elderlyg, healthy nondiabetic adults:
850 mg SD (12)	2.45 (±0.70)	2.71 (±1.05)	412 (±98)
Renal-impaired adults: 850 mg SD
Mild (CLcrh 61-90 mL/min) (5)	1.86 (±0.52)	3.20 (±0.45)	384 (±122)
Moderate (CLcr 31-60 mL/min) (4)	4.12 (±1.83)	3.75 (±0.50)	108 (±57)
Severe (CLcr 10-30 mL/min) (6)	3.93 (±0.92)	4.01 (±1.10)	130 (±90)

Pediatrics

After administration of a single oral GLUCOPHAGE® (metformin hydrochloride) 500 mg tablet with food, geometric mean metformin Cmax and AUC differed <5% between pediatric type 2 diabetic patients (12-16 years of age) and gender- and weight-matched healthy adults (20-45 years of age), all with normal renal function.

After administration of a single oral Glucovance tablet with food, dose-normalized geometric mean glyburide Cmax and AUC in pediatric patients with type 2 diabetes (11-16 years of age, n=28, mean body weight of 97 kg) differed <6% from historical values in healthy adults.

Gender

There is no information on the effect of gender on the pharmacokinetics of glyburide.

Metformin pharmacokinetic parameters did not differ significantly in subjects with or without type 2 diabetes when analyzed according to gender (males=19, females=16). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of metformin was comparable in males and females.

Race

No information is available on race differences in the pharmacokinetics of glyburide.

No studies of metformin pharmacokinetic parameters according to race have been performed. In controlled clinical studies of metformin in patients with type 2 diabetes, the antihyperglycemic effect was comparable in whites (n=249), blacks (n=51), and Hispanics (n=24).

Clinical Studies

Patients with Inadequate Glycemic Control on Diet and Exercise Alone

In a 20-week, double-blind, multicenter U.S. clinical trial, a total of 806 drug-naive patients with type 2 diabetes, whose hyperglycemia was not adequately controlled with diet and exercise alone (baseline fasting plasma glucose [FPG] <240 mg/dL, baseline hemoglobin A1c [HbA1c] between 7% and 11%), were randomized to receive initial therapy with placebo, 2.5 mg glyburide, 500 mg metformin, Glucovance 1.25 mg/250 mg, or Glucovance 2.5 mg/500 mg. After 4 weeks, the dose was progressively increased (up to the 8-week visit) to a maximum of 4 tablets daily as needed to reach a target FPG of 126 mg/dL. Trial data at 20 weeks are summarized in Table 2.

Table 2: Placebo- and Active-Controlled Trial of Glucovance in Patients with Inadequate Glycemic Control on Diet and Exercise Alone: Summary of Trial Data at 20 Weeks

	Placebo	Glyburide 2.5 mg tablets	Metformin 500 mg tablets	Glucovance 1.25 mg/250 mg tablets	Glucovance 2.5 mg/500 mg tablets
a p<0.001
b p<0.05
c p=NS
Mean Final Dose	0 mg	5.3 mg	1317 mg	2.78 mg/557 mg	4.1 mg/824 mg
Hemoglobin A1c	N=147	N=142	N=141	N=149	N=152
Baseline Mean (%)	8.14	8.14	8.23	8.22	8.20
Mean Change from Baseline	−0.21	−1.24	−1.03	−1.48	−1.53
Difference from Placebo		−1.02	−0.82	−1.26a	−1.31a
Difference from Glyburide				−0.24b	−0.29b
Difference from Metformin				−0.44b	−0.49b
Fasting Plasma Glucose	N=159	N=158	N=156	N=153	N=154
Baseline Mean FPG (mg/dL)	177.2	178.9	175.1	178	176.6
Mean Change from Baseline	4.6	−35.7	−21.2	−41.5	−40.1
Difference from Placebo		−40.3	−25.8	−46.1a	−44.7a
Difference from Glyburide				−5.8c	−4.5c
Difference from Metformin				−20.3c	−18.9c
Body Weight Mean Change from Baseline	−0.7 kg	+1.7 kg	−0.6 kg	+1.4 kg	+1.9 kg
Final HbA1c Distribution (%)	N=147	N=142	N=141	N=149	N=152
<7%	19.7%	59.9%	50.4%	66.4%	71.7%
≥7% and <8%	37.4%	26.1%	29.8%	25.5%	19.1%
≥8%	42.9%	14.1%	19.9%	8.1%	9.2%

Treatment with Glucovance resulted in significantly greater reduction in HbA1c and postprandial plasma glucose (PPG) compared to glyburide, metformin, or placebo. Also, Glucovance therapy resulted in greater reduction in FPG compared to glyburide, metformin, or placebo, but the differences from glyburide and metformin did not reach statistical significance.

Changes in the lipid profile associated with Glucovance treatment were similar to those seen with glyburide, metformin, and placebo.

The double-blind, placebo-controlled trial described above restricted enrollment to patients with HbA1c <11% or FPG <240 mg/dL. Screened patients ineligible for the first trial because of HbA1c and/or FPG exceeding these limits were treated directly with Glucovance 2.5 mg/500 mg in an open-label, uncontrolled protocol. In this study, 3 out of 173 patients (1.7%) discontinued because of inadequate therapeutic response. Across the group of 144 patients who completed 26 weeks of treatment, mean HbA1c was reduced from a baseline of 10.6% to 7.1%. The mean baseline FPG was 283 mg/dL and reduced to 164 and 161 mg/dL after 2 and 26 weeks, respectively. The mean final titrated dose of Glucovance was 7.85 mg/1569 mg (equivalent to approximately 3 Glucovance 2.5 mg/500 mg tablets per day).

Patients with Inadequate Glycemic Control on Sulfonylurea Alone

In a 16-week, double-blind, active-controlled U.S. clinical trial, a total of 639 patients with type 2 diabetes not adequately controlled (mean baseline HbA1c 9.5%, mean baseline FPG 213 mg/dL) while being treated with at least one-half the maximum dose of a sulfonylurea (eg, glyburide 10 mg, glipizide 20 mg) were randomized to receive glyburide (fixed dose, 20 mg), metformin (500 mg), Glucovance 2.5 mg/500 mg, or Glucovance 5 mg/500 mg. The doses of metformin and Glucovance were titrated to a maximum of 4 tablets daily as needed to achieve FPG <140 mg/dL. Trial data at 16 weeks are summarized in Table 3.

Table 3: Glucovance in Patients with Inadequate Glycemic Control on Sulfonylurea Alone: Summary of Trial Data at 16 Weeks

	Glyburide 5 mg tablets	Metformin 500 mg tablets	Glucovance 2.5 mg/500 mg tablets	Glucovance 5 mg/500 mg tablets
a p<0.001
Mean Final Dose	20 mg	1840 mg	8.8 mg/1760 mg	17 mg/1740 mg
Hemoglobin A1c	N=158	N=142	N=154	N=159
Baseline Mean (%)	9.63	9.51	9.43	9.44
Final Mean	9.61	9.82	7.92	7.91
Difference from Glyburide			−1.69a	−1.70a
Difference from Metformin			−1.90a	−1.91a
Fasting Plasma Glucose	N=163	N=152	N=160	N=160
Baseline Mean (mg/dL)	218.4	213.4	212.2	210.2
Final Mean	221.0	233.8	169.6	161.1
Difference from Glyburide			−51.3a	−59.9a
Difference from Metformin			−64.2a	−72.7a
Body Weight Mean Change from Baseline	+0.43 kg	−2.76 kg	+0.75 kg	+0.47 kg
Final HbA1c Distribution (%)	N=158	N=142	N=154	N=159
<7%	2.5%	2.8%	24.7%	22.6%
≥7% and <8%	9.5%	11.3%	33.1%	37.1%
≥8%	88%	85.9%	42.2%	40.3%

After 16 weeks, there was no significant change in the mean HbA1c in patients randomized to glyburide or metformin therapy. Treatment with Glucovance at doses up to 20 mg/2000 mg per day resulted in significant lowering of HbA1c, FPG, and PPG from baseline compared to glyburide or metformin alone.

Addition of Thiazolidinediones to Glucovance Therapy

In a 24-week, double-blind, multicenter U.S. clinical trial, patients with type 2 diabetes not adequately controlled on current oral antihyperglycemic therapy (either monotherapy or combination therapy) were first switched to open label Glucovance 2.5 mg/500 mg tablets and titrated to a maximum daily dose of 10 mg/2000 mg. A total of 365 patients inadequately controlled (HbA1c >7.0% and ≤10%) after 10 to 12 weeks of a daily Glucovance dose of at least 7.5 mg/1500 mg were randomized to receive add-on therapy with rosiglitazone 4 mg or placebo once daily. After 8 weeks, the rosiglitazone dose was increased to a maximum of 8 mg daily as needed to reach a target mean daily glucose of 126 mg/dL or HbA1c <7%. Trial data at 24 weeks or the last prior visit are summarized in Table 4.

Table 4: Effects of Adding Rosiglitazone or Placebo in Patients Treated with Glucovance in a 24-Week Trial

	Placebo + Glucovance	Rosiglitazone + Glucovance
a Adjusted for the baseline mean difference
b p<0.001
Mean Final Dose   Glucovance   Rosiglitazone	10 mg/1992 mg 0 mg	9.6 mg/1914 mg 7.4 mg
Hemoglobin A1c	N=178	N=177
Baseline Mean (%)	8.09	8.14
Final Mean	8.21	7.23
Difference from Placeboa		−1.02b
Fasting Plasma Glucose	N=181	N=176
Baseline Mean (mg/dL)	173.1	178.4
Final Mean	181.4	136.3
Difference from Placeboa		−48.5b
Body Weight Mean Change from Baseline	+0.03 kg	+3.03 kg
Final HbA1c Distribution (%)	N=178	N=177
<7%	13.5%	42.4%
≥7% and <8%	32.0%	38.4%
≥8%	54.5%	19.2%

For patients who did not achieve adequate glycemic control on Glucovance, the addition of rosiglitazone, compared to placebo, resulted in significant lowering of HbA1c and FPG.

Indications and Usage for Glucovance

Glucovance (Glyburide and Metformin HCl) Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Contraindications

Glucovance is contraindicated in patients with:

1. Renal disease or renal dysfunction (eg, as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).


2. Known hypersensitivity to metformin hydrochloride or glyburide.


3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Glucovance 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. (See also PRECAUTIONS.)

Warnings

Metformin Hydrochloride

Lactic acidosis:

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Glucovance (Glyburide and Metformin HCl) Tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 µg/mL are generally found.

The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Glucovance treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, Glucovance should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, Glucovance should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking Glucovance, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, Glucovance should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).

The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS). Glucovance should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of Glucovance, gastrointestinal symptoms, which are common during initiation of therapy with metformin, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking Glucovance do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling. (See also PRECAUTIONS.)

Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).

Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking Glucovance, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery. (See also CONTRAINDICATIONS and PRECAUTIONS.)

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study inv

GlutaSolve

Generic Name: glutamine (GLOO ta meen)

Brand Names: GlutaSolve, NutreStore, SYMPT-X G.I., SYMPT-X Glutamine

What is GlutaSolve (glutamine)?

Glutamine is an amino acid that affect the processes of growth and function of cells in the stomach and intestines.

Glutamine is a medical food product that is used to supplement dietary sources of glutamine, to treat a glutamine deficiency, or to treat a loss of glutamine caused by injury or illness.

Glutamine is also used in combination with human growth hormone to treat short bowel syndrome.

Glutamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about GlutaSolve (glutamine)?

Before you take glutamine, tell your doctor if you have liver or kidney disease.

The number of times per day you take glutamine depends on the reason you are using it. Always follow your doctor's instructions.

Take glutamine oral powder with a meal or snack unless directed otherwise. Take glutamine tablets on an empty stomach, at least 1 hour before or 2 hours after a meal.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using glutamine.

Do not pour dry glutamine powder directly into a tube feeding formula. Always mix the powder with water and infuse it directly into the feeding tube using a syringe.

Glutamine may be only part of a complete program of treatment that may also include a special diet, tube feedings, and IV fluids. It is very important to follow the diet and medication plan created for you by your doctor or nutrition counselor.

What should I discuss with my health care provider before taking GlutaSolve (glutamine)?

Before you take glutamine, tell your doctor if you have liver or kidney disease. You may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. It is not known whether glutamine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether glutamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take GlutaSolve (glutamine)?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

When treating short bowel syndrome, you may need to take glutamine 6 times per day for up to 16 weeks.

The number of times per day you take glutamine depends on the reason you are using it. Always follow your doctor's instructions.

Take glutamine oral powder with a meal or snack unless directed otherwise. Take glutamine tablets on an empty stomach, at least 1 hour before or 2 hours after a meal. Dissolve your dose of glutamine oral powder in at least 8 ounces of hot or cold liquid. You may also mix the powder with a soft food such as pudding, applesauce, or yogurt. Stir this mixture and use all of it right away. Do not pour dry glutamine powder directly into a tube feeding formula. Always mix the powder with water and infuse it directly into the feeding tube using a syringe.

To be sure this medication is not causing harmful effects, your kidney and liver function may need to be checked with blood or urine tests on a regular basis. Do not miss any scheduled appointments.

Glutamine may be only part of a complete program of treatment that may also include a special diet, tube feedings, and IV fluids. It is very important to follow the diet and medication plan created for you by your doctor or nutrition counselor.

Store glutamine at room temperature away from moisture and heat. Keep each dose of the oral powder in its packet until you are ready to use the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of glutamine is not expected to produce life-threatening symptoms.

What should I avoid while taking GlutaSolve (glutamine)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using glutamine.

GlutaSolve (glutamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain;

  
  


• 
  

  hearing problems; or

  
  


• 
  

  signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, unusual weakness.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, stomach pain, gas;

  
  


• 
  

  dry mouth, runny nose;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  muscle or joint pain, back pain;

  
  


• 
  

  headache, dizziness, tired feeling;

  
  


• 
  

  mild skin rash or itching; or

  
  


• 
  

  increased sweating.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect GlutaSolve (glutamine)?

There may be other drugs that can interact with glutamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More GlutaSolve resources

• GlutaSolve Side Effects (in more detail)
• GlutaSolve Use in Pregnancy & Breastfeeding
• GlutaSolve Support Group
• 0 Reviews for GlutaSolve - Add your own review/rating

• glutamine Advanced Consumer (Micromedex) - Includes Dosage Information


• Nutrestore Prescribing Information (FDA)

Compare GlutaSolve with other medications

• Anemia, Sickle Cell
• Dietary Supplementation
• Short Bowel Syndrome

Where can I get more information?

• Your pharmacist can provide more information about glutamine.

See also: GlutaSolve side effects (in more detail)

Glynase Pres-Tab

Generic Name: glyburide (Oral route)

GLYE-bure-ide

Commonly used brand name(s)

In the U.S.

• Diabeta


• Glycron


• Glynase Pres-Tab


• Micronase

In Canada

• Euglucon

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 2nd Generation Sulfonylurea

Uses For Glynase Pres-Tab

Glyburide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glyburide belongs to a class of medicines called sulfonylureas. It causes your pancreas to release more insulin into the blood stream. This medicine may be used alone or with another oral medicine such as metformin.

This medicine is available only with your doctor's prescription.

Before Using Glynase Pres-Tab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glyburide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glyburide in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving glyburide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bosentan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Disopyramide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Alprenolol


• Apazone


• Aspirin


• Atenolol


• Benoxaprofen


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bromfenac


• Bucindolol


• Bufexamac


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Clarithromycin


• Clometacin


• Clonixin


• Clorgyline


• Colesevelam


• Cyclosporine


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dilevalol


• Dipyrone


• Droxicam


• Esmolol


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Fenugreek


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gemfibrozil


• Glucomannan


• Ibuprofen


• Indomethacin


• Indoprofen


• Iproniazid


• Isocarboxazid


• Isoxicam


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nialamide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Pargyline


• Penbutolol


• Phenelzine


• Phenylbutazone


• Pindolol


• Pirazolac


• Piroxicam


• Pirprofen


• Procarbazine


• Propranolol


• Propyphenazone


• Proquazone


• Psyllium


• Rifampin


• Rifapentine


• Selegiline


• Sotalol


• Sulfamethoxazole


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Toloxatone


• Tranylcypromine


• Voriconazole


• Warfarin


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol intoxication or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glyburide.

• Diabetic ketoacidosis (ketones in the blood) or


• Type I diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (a blood disorder) in patients with this condition.

• Heart disease—Use with caution. May make this condition worse.

• Kidney disease or


• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of glyburide

This section provides information on the proper use of a number of products that contain glyburide. It may not be specific to Glynase Pres-Tab. Please read with care.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 2.5 to 5 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (micronized tablets):
    
    • Adults—At first, 1.5 to 3 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. The dose is usually not more than 12 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Glynase Pres-Tab

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack.

Too much glyburide can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Do not take this medicine if you are also using bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.

Glynase Pres-Tab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Rare

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• diarrhea


• fever


• headache


• light-colored stools


• loss of appetite


• nausea and vomiting


• rash


• unpleasant breath odor


• upper right abdominal pain


• vomiting of blood


• yellow eyes and skin

Incidence not known

• Agitation


• back, leg, or stomach pains


• bleeding gums


• blood in the urine or stools


• bloody, black, or tarry stools


• blurred vision


• change in near or distance vision


• chest pain


• coma


• confusion


• convulsions


• cough or hoarseness


• decreased urine output


• depression


• difficulty in focusing eyes


• difficulty with breathing


• fast or irregular heartbeat


• fluid-filled skin blisters


• general body swelling


• high fever


• hostility


• increased thirst


• irritability


• itching of the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• lower back or side pain


• muscle pain or cramps


• muscle twitching


• nosebleeds


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• rapid weight gain


• seizures


• sensitivity to the sun


• skin thinness


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stupor


• swelling of the face, ankles, or hands


• swollen or painful glands


• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety


• cold sweats


• cool, pale skin


• increased hunger


• nervousness


• nightmares


• shakiness


• slurred speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Indigestion


• passing of gas

Incidence not known

• Difficulty with moving


• itching


• joint pain


• redness or other discoloration of the skin


• severe sunburn


• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Glynase Pres-Tab side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Glynase Pres-Tab resources

• Glynase Pres-Tab Side Effects (in more detail)
• Glynase Pres-Tab Use in Pregnancy & Breastfeeding
• Drug Images
• Glynase Pres-Tab Drug Interactions
• Glynase Pres-Tab Support Group
• 0 Reviews for Glynase Pres-Tab - Add your own review/rating

Compare Glynase Pres-Tab with other medications

• Diabetes, Type 2

Goniosoft

Generic Name: hypromellose (Ophthalmic route)

hye-PROE-me-lose

Commonly used brand name(s)

In the U.S.

• Genteal


• Genteal Mild


• Gonak


• Goniosoft


• Goniovisc


• Isopto Tears


• Nature's Tears


• Tearisol


• Tears Again Mc

Available Dosage Forms:

• Solution


• Gel/Jelly

Therapeutic Class: Surgical Aid, Ocular

Uses For Goniosoft

Hydroxypropyl methylcellulose belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. It helps prevent damage to the eye in certain eye diseases. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. In addition, it may be used in certain eye examinations.

Some of these preparations are available only with your doctor's prescription.

Before Using Goniosoft

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hydroxypropyl methylcellulose in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicine have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydroxypropyl methylcellulose in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hypromellose

This section provides information on the proper use of a number of products that contain hypromellose. It may not be specific to Goniosoft. Please read with care.

To use:

• First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients wearing hard contact lenses:

• Take care not to float the lens from your eye when applying this medicine. If you have any questions about this, check with your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For dry eyes:
  
  • For ophthalmic solution (eye drops) dosage form:
    
    • Adults and children—Use 1 drop three or four times a day.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Goniosoft

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Goniosoft Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Eye irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common - more common with 1% solution

• Blurred vision


• matting or stickiness of eyelashes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Glyquin

Generic Name: hydroquinone topical (HYE droe KWIN one)

Brand Names: Aclaro, Aclaro PD, Alera, Alphaquin HP, Alustra, Claripel, Eldopaque, Eldopaque Forte, Eldoquin, Eldoquin Forte, EpiQuin Micro, Esoterica, Esoterica with Sunscreen, Glyquin, Glyquin-XM, Hydroquinone and Sunscreen, Lustra, Lustra-AF, Lustra-Ultra, Melpaque HP, Melquin HP, Melquin-3, Nuquin HP, Solaquin, Solaquin Forte

What is Glyquin (hydroquinone topical)?

Hydroquinone decreases the formation of melanin in the skin. Melanin is the pigment in skin that gives it a brown color.

Hydroquinone topical is used to lighten areas of darkened skin such as freckles, age spots, chloasma, and melasma.

Hydroquinone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Glyquin (hydroquinone topical)?

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What should I discuss with my healthcare provider before using Glyquin (hydroquinone topical)?

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical.

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  liver disease; or

  
  


• 
  

  kidney disease.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydroquinone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Glyquin (hydroquinone topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Hydroquinone topical is for external use only. Wash your hands before and after applying this medication, unless you are treating a skin area on your hand.

Apply the medication to clean, dry skin. Apply just enough medication to cover the affected area. Avoid applying to the unaffected surrounding skin. Rub in the medication gently and completely.

Avoid getting this medication on your lips or inside your nose or mouth. Hydroquinone may cause numbness of these areas. If the medication does get on any of these areas, rinse with water.

It is important to use hydroquinone topical regularly to get the most benefit.

Store hydroquinone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of topically applied hydroquinone is not likely to cause life-threatening symptoms.

What should I avoid while using Glyquin (hydroquinone topical)?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use hydroquinone topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may cause a temporary staining of your skin. This staining can usually be removed with soap and water. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Glyquin (hydroquinone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hydroquinone topical and call your doctor if you have severe burning, stinging, or other irritation of your skin after apply the medication.

Less serious side effects may include mild burning, stinging, itching, redness, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Glyquin (hydroquinone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydroquinone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Glyquin resources

• Glyquin Side Effects (in more detail)
• Glyquin Use in Pregnancy & Breastfeeding
• Glyquin Support Group
• 0 Reviews for Glyquin - Add your own review/rating

• Alustra MedFacts Consumer Leaflet (Wolters Kluwer)


• Epiquin Micro Prescribing Information (FDA)


• Esoterica Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Solaquin Forte Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Glyquin with other medications

• Dermatological Disorders

Where can I get more information?

• Your pharmacist can provide more information about hydroquinone topical.

See also: Glyquin side effects (in more detail)