Metformin Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- METFORMIN HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- INDICATIONS & USAGE
- METFORMIN HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- METFORMIN HYDROCHLORIDE ADVERSE REACTIONS
- METFORMIN HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL PATIENT PACKAGE INSERT
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
METFORMIN HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of ActionPRECAUTIONS
PHARMACOKINETICS
Absorption and BioavailabilityDistribution
Metabolism and Elimination
Special Populations
Renal Insufficiency
WARNINGS
Hepatic Insufficiency
Geriatrics
WARNINGSDOSAGE AND ADMINISTRATION
Subject Groups: MetforminCmax(Tmax(hrs)Renal ClearanceHydrochloride Tablet dose*(mL/min)(number of subjects)Healthy, nondiabetic adults:Adults with type 2 diabetes:Elderly#, healthy nondiabetic adults:Renal-impaired adults:850 mg single dose*
#
Pediatrics
Gender
Race
Clinical Studies
Metformin hydrochloride tablets
Metformin Hydrochloride TabletsPlacebop-Value(n = 141)(n = 145)FPG (mg/dL)Hemoglobin Alc (%)Body Weight (lbs)
CombGlybMetGlybp-values(n = 213)(n = 209)(n = 210)CombMet vsMet vsCombGlybFasting Plasma Glucose (mg/dL)Hemoglobin Alc (%)Body Weight (lbs)
Metformin HClCombined MetforminTablets (n = 141)Hydrochloride Tablets/Glyburide vs MonotherapyMetforminPlac- Metformin HydrochlorideMetforminGlyb-HydrochlorideeboTablets (n = 210)HydrochlorideurideTablets (n = 141)(n=Tablets/ Glyburide(n =145)(n = 213)209)TotalCholesterol(mg/dL)TotalTriglycerides(mg/dL)LDLCholesterol(mg/dL)HDL-Cholesterol(mg/dL)
Metformin Hydrochloride Placebo / InsulinTreatment DifferenceTablets / Insulinn = 28MeanSEn = 26Hemoglobin Alc (%)*Insulin Dose (U/day)*
Metformin hydrochloride extended-release tablets
DOSAGE AND ADMINISTRATION
*
Metformin Hydrochloride Metformin Hydrochloride ExtendedTablets 500 mg Twice- release TabletsDaily1000 mg Once Daily1500 mgOnce DailyHemoglobinA1c (%)(n= 67)(n= 72)(n=66)FPG (mg/dL)(n = 69)(n = 72)(n = 70)Body Weight(n = 71)(n = 74)(n = 71)(lbs)*
DOSAGE AND ADMINISTRATION
*
Metformin Hydrochloride Extended-Placebo-release Tablets500 mg Once Daily1000150020001000mgmgmgmgOnceOnceOnceTwiceDailyDailyDailyDailyTotal Cholesterol(n=120)(n=(n=(n=(n=(n=(mg/dL)113)110)126)117)110)Total Triglycerides(n=120)(n=(n=(n=(n=(n=(mg/ dL)113)110)126)117)110)LDL- Cholesterol(n=119)(n=(n=(n=(n=(n=(mg/ dL)113)109)126)117)107)HDLCholesterol(n=120)(n=(n=(n=(n=(n=(mg/dL)108)108)125)117)108)*
*
MetforminMetformin Hydrochloride ExtendedHydrochloride-release TabletsTablets500 mg1000 mg1500 mgTwice DailyOnce DailyOnce DailyTotal Cholesterol (n=68)(n=70)(n=66)(mg/dL)Total Triglycerides (n = 68)(n=70)(n=66)(mg/dL)LDL- Cholesterol (n=68)(n=70)(n=66)(mg/dL)HDL -Cholesterol(n=68)(n=70)(n=65)(mg/dL)*
Pediatric Clinical Studies
Metformin Hydrochloride TabletsPlacebop- ValueFPG (mg/dL)(n=37)(n=36)Body Weight (lbs)(n=39)(n=38)
INDICATIONS & USAGE
METFORMIN HYDROCHLORIDE CONTRAINDICATIONS
WARNINGSPRECAUTIONS
PRECAUTIONS
WARNINGS
BOXED WARNINGPRECAUTIONS
PRECAUTIONS
PRECAUTIONS
CONTRAINDICATIONSPRECAUTIONS
PRECAUTIONS
GeneralWARNINGSDOSAGE AND ADMINISTRATION
PRECAUTIONS
CONTRAINDICATIONS
PRECAUTIONSLaboratory Tests
WARNINGS
INFORMATION FOR PATIENTS
Information for PatientsWARNINGSPRECAUTIONS
Patient Information
LABORATORY TESTS
Laboratory TestsDOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis, Mutagenesis, Impairment of FertilityPREGNANCY
Teratogenic Effects: Pregnancy Category BNURSING MOTHERS
PEDIATRIC USE
Pediatric UseCLINICAL PHARMACOLOGYADVERSE REACTIONSDOSAGE AND ADMINISTRATION
METFORMIN HYDROCHLORIDE ADVERSE REACTIONS
Geriatric UseCONTRAINDICATIONSWARNINGSCLINICAL PHARMACOLOGYWARNINGSDOSAGE AND ADMINISTRATION
METFORMIN HYDROCHLORIDE ADVERSE REACTIONS
ADVERSE REACTIONS*
Adverse ReactionMetformin Hydrochloride TabletsPlaceboMonotherapy n = 141n = 145% of Patients*
*
Adverse ReactionMetformin Hydrochloride Extended-Placebo- release Tablets n = 781n = 195% of Patients*
Pediatric Patients
OVERDOSAGE
WARNINGSDOSAGE & ADMINISTRATION
Patient Information
Recommended Dosing Schedule
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
Specific Patient Populations
WARNINGS
HOW SUPPLIED
STORAGE AND HANDLING
SPL PATIENT PACKAGE INSERT
What are metformin hydrochloride tablets and metformin hydrochloride extended-release tablets?
Who should not take metformin hydrochloride tablets and metformin hydrochloride extended-release tablets?
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● have kidney problems
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● have liver problems
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● have heart failure that is treated with medicines, such as Lanoxin(digoxin) or Lasix(furosemide)
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● drink a lot of alcohol. This means you binge drink for short periods or drink all the time
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● are seriously dehydrated (have lost a lot of water from your body)
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● are going to have an x-ray procedure with injection of dyes (contrast agents)
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● are going to have surgery
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● develop a serious condition, such as heart attack, severe infection, or a stroke
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● are 80 years or older and you have NOT had your kidney function tested
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● Tell your doctor if you are pregnant or plan to become pregnant. Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.
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How should I take metformin hydrochloride tablets or metformin hydrochloride extended-release tablets?
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● start to take other medicines or change how you take a medicine. Metformin hydrochloride tablets or metformin hydrochloride extended-release tablets canaffect how well other drugs work, and some drugs can affect how well metformin hydrochloride tablets or metformin hydrochloride extended-release tablets work. Some medicines may cause high blood sugar.
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What are the side effects of metformin hydrochloride tablets and metformin hydrochloride extended-release tablets?
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● trouble breathing
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● unusual or unexpected stomach discomfort
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● feeling cold
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● feeling dizzy or lightheaded
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● suddenly developing a slow or irregular heartbeat
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● If your medical condition suddenly changes, stop taking metformin hydrochloride tablets or metformin hydrochloride extended-release tablets and call your doctor right away. This may be a sign of lactic acidosis or another serious side effect.
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● Other Side Effects. Common side effects of metformin hydrochloride tablets and metformin hydrochloride extended-release tablets include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.
INACTIVE INGREDIENT
INACTIVE INGREDIENTSHYPROMELLOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLP
OVIDONE
CELLULOSE, MICROCRYSTALLINE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Metformin HydrochlorideMetformin Hydrochloride TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
