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MetFORMIN

Pronunciation

Pronunciation

(met FOR min)

Index Terms

  • Metformin HCl
  • Metformin Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Combination:

D-Care DM2: Extended release tablet, as hydrochloride: 500 mg

Solution, Oral, as hydrochloride:

Riomet: 500 mg/5 mL (118 mL, 473 mL) [contains propylene glycol; strawberry flavor]

Riomet: 500 mg/5 mL (118 mL, 473 mL) [contains saccharin calcium; cherry flavor]

Tablet, Oral, as hydrochloride:

Glucophage: 500 mg, 850 mg

Glucophage: 1000 mg [scored]

Generic: 500 mg, 850 mg, 1000 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride:

Fortamet: 500 mg, 1000 mg

Glucophage XR: 500 mg, 750 mg

Glumetza: 500 mg, 1000 mg

Generic: 500 mg, 750 mg, 1000 mg

Brand Names: U.S.

  • D-Care DM2
  • Fortamet
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Riomet

Pharmacologic Category

  • Antidiabetic Agent, Biguanide

Pharmacology

Decreases hepatic glucose production, decreasing intestinal absorption of glucose and improves insulin sensitivity (increases peripheral glucose uptake and utilization)

Distribution

Vd: 654 ± 358 L; partitions into erythrocytes; concentrates in liver, kidney, and GI tract

Metabolism

Not metabolized by the liver

Excretion

Urine (90% as unchanged drug; active secretion)

Onset of Action

Within days; maximum effects up to 2 weeks

Time to Peak

Immediate release: 2 to 3 hours; Extended release: 7 hours (range: 4 to 8 hours)

Half-Life Elimination

Plasma: 4 to 9 hours; Blood ~17.6 hours

Protein Binding

Negligible

Special Populations: Renal Function Impairment

Peak and systemic exposure is increased and oral and renal Cl is decreased.

Special Populations: Elderly

Total plasma Cl is decreased, half-life is prolonged, and Cmax is increased.

Use: Labeled Indications

Diabetes mellitus, type 2: Management of type 2 diabetes mellitus (noninsulin dependent, NIDDM) when hyperglycemia cannot be managed with diet and exercise alone.

Note: If not contraindicated and if tolerated, metformin is the preferred initial pharmacologic agent for type 2 diabetes management (ADA 2016a).

Contraindications

US labeling: Hypersensitivity to metformin or any component of the formulation; severe renal dysfunction (eGFR <30 mL/minute/1.73 m2); acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).

Canadian labeling: Hypersensitivity to metformin or any component of the formulation; renal function unknown, renal impairment, and serum creatinine levels above the upper limit of normal range; renal disease or renal dysfunction (serum creatinine ≥136 micromol/L in males or ≥124 micromol/L in females or abnormal creatinine clearance <60 mL/minute) which may result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia; unstable and/or insulin-dependent (type I) diabetes mellitus; acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, history of ketoacidosis with or without coma; history of lactic acidosis (regardless of precipitating factors); excessive alcohol intake (acute or chronic); severe hepatic dysfunction or clinical or laboratory evidence of hepatic disease; cardiovascular collapse and disease states associated with hypoxemia including cardiorespiratory insufficiency, which are often associated with hyperlactacidemia; stress conditions (eg, severe infection, trauma, surgery and postoperative recovery phase); severe dehydration; pregnancy; breast-feeding

Dosing: Adult

Diabetes mellitus, type 2: Oral: Note: Allow 1 to 2 weeks between dose titrations: Clinically significant responses may not be seen at doses <1,500 mg daily; however, a lower recommended starting dose and gradual increased dosage is recommended to minimize gastrointestinal symptoms.

Immediate-release tablet or solution: Adults ≥17 years: Initial: 500 mg twice daily or 850 mg once daily; titrate in increments of 500 mg weekly or 850 mg every other week; may also titrate from 500 mg twice a day to 850 mg twice a day after 2 weeks

If a dose >2,000 mg/day is required, it may be better tolerated in 3 divided doses. Maximum recommended dose: 2,550 mg/day.

Extended-release tablet: Note: If glycemic control is not achieved at maximum dose, may divide dose and administer twice daily.

Initial: 500 to 1000 mg once daily; dosage may be increased by 500 mg weekly up to a maximum of 2,000 mg/day (Glucophage XR, Glumetza) or 2,500 mg/day (Fortamet)

Conversion from immediate-release to extended-release tablets: Patients receiving metformin immediate release may be switched to metformin ER once daily at the same total daily dose, up to 2,000 mg once daily (2,500 mg for Fortamet)

Transfer from other antidiabetic agents: No transition period is generally necessary except when transferring from chlorpropamide. When transferring from chlorpropamide, care should be exercised during the first 2 weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant use with insulin or insulin secretagogues: Reduced dose of insulin or insulin secretagogues (eg, sulfonylureas) may be needed.

Diabetes mellitus, type 2, prevention (off-label use): Immediate-release tablet or solution: Oral: Initial: 850 mg once daily; Target: 850 mg twice daily (Knowler 2002)

Polycystic ovary syndrome with anovulatory infertility (off-label use): Females: Oral:

Immediate release: 1,500 to 2,000 mg/day in 2 or 3 divided doses (Johnson 2010; Moll 2006; Morin-Papunen 2012)

Extended release: 1,000 mg twice daily (Legro 2007)

Note: Metformin should be initiated at lower doses (500 mg daily) and increased gradually over 1 to 2 weeks to the target dose to minimize adverse effects (eg, GI intolerance) (Johnson 2010; Legro 2007; Moll 2006; Morin-Papunen 2012)

Polycystic ovary syndrome with menstrual irregularities (off-label use): Females: Oral: Immediate release: 500 mg 2 or 3 times daily, up to 1,000 mg twice daily (Costello 2007; Morin-Papunen 2003; Meyer 2007; Moghetti 2000). The dose of metformin should be increased gradually to minimize GI adverse effects (Meyer 2007)

Note: When metformin is used, cyclic progestin therapy may be added for the first 6 months of metformin treatment, until regular cycles are established.

Prevention of ovarian hyperstimulation syndrome with polycystic ovary syndrome (off-label use): Females: Oral: Immediate release: 1,000 mg to 2,550 mg per day as 500 mg 2 or 3 times per day or 850 mg 2 or 3 times per day (Palomba 2013; Palomba 2011; Tang 2006; Tso 2014). The dose of metformin should be increased gradually to minimize GI adverse effects.

Note: Pretreatment with metformin may be started as early as 16 weeks prior (but typically 4 to 5 weeks prior) to as late as the first day of gonadotropin-releasing hormone (GnRH) agonist administration; some studies continued metformin therapy during gonadotropin ovarian stimulation (Tso 2014).

Dosing: Geriatric

Refer to adult dosing. The initial and maintenance dosing should be conservative, due to the potential for decreased renal function (monitor).

Dosing: Pediatric

Diabetes mellitus, type 2: Oral: Note: Allow 1 to 2 weeks between dose titrations: Clinically significant responses may not be seen at doses <1,500 mg daily; however, a lower recommended starting dose and gradual increased dosage is recommended to minimize gastrointestinal symptoms.

Immediate-release tablet or solution:

Children ≥10 years and Adolescents ≤16 years: Initial: 500 mg twice daily; increases in daily dosage should be made in increments of 500 mg at weekly intervals, given in divided doses, up to a maximum of 2,000 mg daily

Adolescents ≥17 years: Refer to adult dosing.

Extended-release tablet: Adolescents ≥17 years: Fortamet, Glucophage XR: Refer to adult dosing.

Dosing: Renal Impairment

eGFR >45 mL/minute/1.73 m2: No dosage adjustment necessary; monitor renal function at least annually. More frequent monitoring (every 3 to 6 months) has been recommended for patients with eGFR >45 to <60 mL/minute/1.73 m2 (Lipska 2011).

eGFR 30 to 45 mL/minute/1.73 m2: Use is not recommended for initiation of therapy; if eGFR falls to <45 mL/minute/1.73 m2 during therapy, consider benefits/risks of continuing therapy. Alternatively, may consider dosage reduction (eg, 50% reduction or 50% of maximal dose), monitor renal function every 3 months (Lipska 2011).

eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dosing: Hepatic Impairment

The manufacturer recommends avoiding metformin since liver disease is considered a risk factor for the development of lactic acidosis during metformin therapy. However, continued use of metformin in diabetics with liver dysfunction, including cirrhosis, has been used successfully and may be associated with a survival benefit in carefully selected patients; use cautiously in patients at risk for lactic acidosis (eg, renal impairment, alcohol use) (Brackett 2010; Zhang 2014).

Administration

Oral: Administer with a meal (to decrease GI upset).

Extended release: Swallow whole; do not crush, break, or chew. Administer once daily doses with the evening meal. Fortamet should also be administered with a full glass of water.

Dietary Considerations

Drug may cause GI upset; take with food (to decrease GI upset). Take at the same time(s) each day. Dietary modification based on ADA recommendations is a part of therapy. Monitor for signs and symptoms of vitamin B12 and/or folic acid deficiency; supplementation may be required.

Storage

Oral solution: Store at 15°C to 30°C (59°F to 86°F).

Tablets: Store at 20°C to 25°C (68°F to 77°F); excursion permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Drug Interactions

Alcohol (Ethyl): May enhance the adverse/toxic effect of MetFORMIN. Specifically, alcohol may potentiate the risk of lactic acidosis Avoid combination

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

BuPROPion: May increase the serum concentration of OCT2 Substrates. Monitor therapy

Carbonic Anhydrase Inhibitors: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk of developing lactic acidosis may be increased. Exceptions: Brinzolamide; Dorzolamide. Monitor therapy

Cephalexin: May increase the serum concentration of MetFORMIN. Monitor therapy

Cimetidine: May increase the serum concentration of MetFORMIN. Management: Consider alternatives to cimetidine in patients receiving metformin due to a potential for increased metformin concentrations and toxicity (including lactic acidosis). Consider therapy modification

Dalfampridine: MetFORMIN may increase the serum concentration of Dalfampridine. Dalfampridine may increase the serum concentration of MetFORMIN. Monitor therapy

Dofetilide: MetFORMIN may increase the serum concentration of Dofetilide. Monitor therapy

Dolutegravir: May increase the serum concentration of MetFORMIN. Management: Limit the daily metformin dose to 1,000 mg when used together with dolutegravir. Metformin dose adjustments may also be needed upon discontinuation of dolutegravir. Monitor patient response to metformin closely. Consider therapy modification

Glycopyrrolate (Systemic): May increase the serum concentration of MetFORMIN. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Iodinated Contrast Agents: May enhance the adverse/toxic effect of MetFORMIN. Renal dysfunction that may be caused by iodinated contrast agents may lead to metformin-associated lactic acidosis. Management: Management advice varies. Refer to the full drug interaction monograph content for details. Exceptions: Diatrizoate Meglumine; Ethiodized Oil. Consider therapy modification

Isavuconazonium Sulfate: May increase the serum concentration of MetFORMIN. Monitor therapy

LamoTRIgine: May increase the serum concentration of MetFORMIN. Management: The lamotrigine Canadian product monograph states that coadministration of these drugs is not recommended. Monitor therapy

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Ombitasvir, Paritaprevir, and Ritonavir: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. Monitor therapy

Ondansetron: May increase the serum concentration of MetFORMIN. Monitor therapy

Patiromer: May decrease the serum concentration of MetFORMIN. Management: Administer metformin at least 3 hours before or 3 hours after patiromer. Consider therapy modification

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Ranolazine: May increase the serum concentration of MetFORMIN. Management: Limit the metformin dose to a maximum of 1700 mg/day when used together with ranolazine 1000 mg twice daily. Consider therapy modification

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Topiramate: May enhance the adverse/toxic effect of MetFORMIN. Monitor therapy

Trimethoprim: May increase the serum concentration of MetFORMIN. Monitor therapy

Trospium: MetFORMIN may decrease the serum concentration of Trospium. Monitor therapy

Vandetanib: May increase the serum concentration of MetFORMIN. Monitor therapy

Verapamil: May diminish the therapeutic effect of MetFORMIN. Monitor therapy

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (IR tablet: 53%; ER tablet: 10%), nausea and vomiting (IR tablet: 26%; ER tablet: 7%), flatulence (12%)

1% to 10%:

Cardiovascular: Chest discomfort (1% to 5%), flushing (1% to 5%), palpitations (1% to 5%)

Central nervous system: Headache (6%), chills (1% to 5%), dizziness (1% to 5%), taste disorder (1% to 5%)

Dermatologic: Diaphoresis (1% to 5%), nail disease (1% to 5%), skin rash (1% to 5%)

Endocrine & metabolic: Decreased vitamin B12 serum concentrate (7%), hypoglycemia (1% to 5%)

Gastrointestinal: Dyspepsia (≤1% to 7%), abdominal distress (6%), abdominal distention (1% to 5%), abdominal pain (1% to 5%), abnormal stools (1% to 5%), constipation (1% to 5%), heartburn (≤1% to 5%)

Neuromuscular & skeletal: Weakness (9%), myalgia (1% to 5%)

Respiratory: Dyspnea (1% to 5%), flu-like symptoms (1% to 5%), upper respiratory tract infection (1% to 5%)

<1% (Limited to important or life-threatening): Lactic acidosis, megaloblastic anemia

ALERT: U.S. Boxed Warning

Lactic acidosis

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), ≥65 years, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.

If metformin-associated lactic acidosis is suspected, immediately discontinue metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular mortality: Administration of oral antidiabetic drugs has been reported to be associated with increased cardiovascular mortality; metformin does not appear to share this risk.

• Lactic acidosis: [US Boxed Warning]: Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset is often subtle, accompanied by nonspecific symptoms (eg, malaise, myalgias, respiratory distress, somnolence, abdominal pain); elevated blood lactate levels (>5 mmol/L); anion gap acidosis (without evidence of ketonuria or ketonemia); increased lactate:pyruvate ratio; metformin plasma levels generally >5 mcg/mL. Risk factors for lactic acidosis include patients with renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), ≥65 years, having a radiologic study with contrast, surgery and other procedures, hypoxic states (eg, acute heart failure), excessive alcohol intake, and hepatic impairment. Discontinue immediately if lactic acidosis is suspected; prompt hemodialysis is recommended. Lactic acidosis should be suspected in any patient with diabetes receiving metformin with evidence of acidosis but without evidence of ketoacidosis. Discontinue use in patients with conditions associated with dehydration, hypoperfusion, sepsis, or hypoxemia. Temporarily discontinue therapy in patients with restricted food and fluid intake. The risk of accumulation and lactic acidosis increases with the degree of impairment of renal function.

• Vitamin B12 concentrations: May impair vitamin B12 absorption, particularly in those with inadequate vitamin B12 or calcium intake/absorption; very rarely associated with anemia. Rapid reversal of vitamin B12 deficiency may be observed with discontinuation of therapy or supplementation. Monitor vitamin B12 serum concentrations periodically with long-term therapy.

Disease-related concerns:

• Heart failure: Use caution in patients with congestive heart failure requiring pharmacologic management, particularly in patients with unstable or acute heart failure; risk of lactic acidosis may be increased secondary to hypoperfusion. In a scientific statement from the American Heart Association, metformin has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]).

• Hepatic impairment: Use with caution in patients with impaired liver function due to potential for lactic acidosis.

• Renal impairment: Metformin is substantially excreted by the kidney; assess renal function prior to initiation of therapy using estimated glomerular filtration rate (eGFR). Initiation of therapy is not recommended if eGFR is between 30 to 45 mL/minute/1.73 m2 and is contraindicated if eGFR <30 mL/minute/1.73 m2. Assess benefits/risks of continuing therapy in patients whose eGFR falls below 45 mL/minute/1.73 m2 during therapy. Use of concomitant medications that may affect renal function (ie, affect tubular secretion) may also affect metformin disposition. Metformin should be withheld in patients with dehydration and/or prerenal azotemia.

• Stress-related states: It may be necessary to discontinue metformin and administer insulin if the patient is exposed to stress (fever, trauma, infection, surgery).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution; risk of metformin associated lactic acidosis increases with age.

Dosage form specific issues:

• Extended release tablet: Insoluble tablet shell (Glumetza 1,000 mg tablet) may remain intact and be visible in the stool. Other extended released tablets (Fortamet, Glucophage XR, Glumetza 500 mg) may appear in the stool as a soft mass resembling the tablet.

Other warnings/precautions:

Appropriate use: Not indicated for use in patients with type 1 diabetes mellitus or with diabetic ketoacidosis (DKA).

• Ethanol use: Instruct patients to avoid excessive acute or chronic ethanol use; ethanol may potentiate metformin's effect on lactate metabolism.

• Iodinated contrast: Temporarily discontinue metformin at the time of or before iodinated contrast imaging procedures in patients with an eGFR 30 to 60 mL/minute/1.73 m2; or with a history of hepatic disease, alcoholism, or heart failure; or in patients who will receive intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after imaging procedure; restart if renal function is stable. Alternatively, the American College of Radiology (ACR) guidelines recommend that metformin may be used prior to or following administration of iodinated contrast media in patients with no evidence of acute kidney injury (AKI) and with an eGFR ≥30 mL/minute/1.73 m2; ACR guidelines recommend temporary discontinuation of metformin in patients with known AKI or severe chronic kidney disease ([stage IV or V [ie, eGFR <30 mL/minute/1.73 m2]) or who are undergoing arterial catheter studies (ACR 2015).

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

• Surgical procedures: Therapy should be suspended for any surgical procedures, excluding minor procedures not associated with restricted food and fluid intake. Restart only after normal oral intake resumed and normal renal function is verified.

Monitoring Parameters

Urine for glucose and ketones, fasting blood glucose, hemoglobin A1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2016c]). Initial and periodic monitoring of hematologic parameters (eg, hemoglobin/hematocrit and red blood cell indices); renal function (eGFR) prior to therapy initiation and at least annually (more often in patients at risk of developing renal impairment; every 3 to 6 months if eGFR 45 to <60 mL/minute/1.73 m2; every 3 months if eGFR 30 to <45 mL/minute/1.73 m2 [Lipska 2011]). Monitor vitamin B12 serum concentrations periodically with long-term therapy; folate (if megaloblastic anemia is suspected).

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Metformin has been found to cross the placenta in concentrations which may be comparable to those found in the maternal plasma. Pharmacokinetic studies suggest that clearance of metformin may increase during pregnancy and dosing may need adjusted in some women when used during the third trimester (Charles 2006; de Oliveira Baraldi 2011; Eyal 2010; Gardiner 2003; Hughes 2006; Vanky 2005).

An increased risk of birth defects or adverse fetal/neonatal outcomes has not been observed following maternal use of metformin for GDM or type 2 diabetes when glycemic control is maintained (Balani 2009; Coetzee 1979; Coetzee 1984; Ekpebegh 2007; Niromanesh 2012; Rowan 2008; Rowan 2010; Tertti 2008).

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2016e; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2016e; Blumer 2013; Kitzmiller 2008).

Metformin may be used to treat GDM when non-pharmacologic therapy is not effective in maintaining glucose control (ADA 2016e).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, flatulence, nausea, vomiting, or loss of strength and energy. Have patient report immediately to prescriber signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), pharyngitis, chills, or severe abdominal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer:Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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