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Metformin Hydrochloride Tablets, USP


DESCRIPTION


CLINICAL PHARMACOLOGY


Mechanism of Action


Pharmacokinetics


Absorption and Bioavailability


Distribution


Metabolism and Elimination


Special Populations


Patients with Type 2 Diabetes


Renal Insufficiency


Hepatic Insufficiency


Geriatrics

 Healthy, nondiabetic adults:   500 mg single dose (24)   850 mg single dose (74)d   850 mg three times daily for 19 dosese (9)   1.03 (±0.33)1.6 (±0.38)2.01 (±0.42)   2.75 (±0.81)      2.64 (±0.82)      1.79 (±0.94)      600 (±132)      552 (±139)      642 (±173)   
 Adults with type 2 diabetes:   850 mg single dose (23)   850 mg three times daily for 19 dosese (9)  1.48 (±0.5)1.9 (±0.62)   3.32 (±1.08)      2.01 (±1.22)      491 (±138)      550 (±160)   
 Elderlyf, healthy nondiabetic adults:   850 mg single dose (12)2.45 (±0.7)   2.71 (±1.05)      412 (±98)   
 Renal-impaired adults:  850 mg single dose    Mild (CLcrg 61 to 90 mL/min) (5)    Moderate (CLcr 31 to 60 mL/min) (4)    Severe (CLcr 10 to 30 mL/min) (6) 1.86 (±0.52)4.12 (±1.83)3.93 (±0.92)    3.2 (±0.45)      3.75 (±0.5)      4.01 (±1.1)       384 (±122)      108 (±57)      130 (±90)   

Pediatrics


Gender


Race


Clinical Studies

 FPG (mg/dL)    Baseline    Change at FINAL VISIT241.5-53237.76.3NS**0.001
 Hemoglobin A1c (%)    Baseline    Change at FINAL VISIT8.4-1.48.20.4 NS**0.001
 Body Weight (lbs)    Baseline    Change at FINAL VISIT   201-1.4206-2.4NS **NS **
 Fasting Plasma Glucose (mg/dL)   Baseline   Change at FINAL VISIT 250.5-63.5 247.513.7 253.9-0.9 NS**0.001 NS**0.001 NS**0.025
 Hemoglobin A1c (%)   Baseline   Change at FINAL VISIT8.8-1.78.50.28.9-0.4NS**0.001  NS**  0.0010.0070.001
 Body Weight (lbs)   Baseline   Change at FINAL VISIT   202.20.9203-0.7204-8.4NS**0.011NS**0.001NS**0.001
 Total Cholesterol (mg/dL)   Baseline   Mean % Change at FINAL VISIT   211 -5% 212.3 1% 213.1 -2% 215.6 -4% 219.6 1%
 Total Triglycerides (mg/dL)   Baseline   Mean % Change at FINAL VISIT   236.1 -16% 203.5 1% 242.5 -3% 215 -8% 266.1 4%
 LDL-Cholesterol (mg/dL)   Baseline   Mean % Change at FINAL VISIT 135.4 -8% 138.5 1% 134.3 -4% 136 -6%137.5 3%
      
 HDL Cholesterol (mg/dL)   Baseline   Mean % Change at FINAL VISIT 39 2% 40.5 -1% 37.2 5% 39 3% 37 1%
 Hemoglobin A1c (%)   Baseline   Change at FINAL VISIT8.95-2.19.32-1.56-0.54 ± 0.43a
 Insulin Dose (U/day)   Baseline   Change at FINAL VISIT93.12-0.1594.6415.93-16.08 ± 7.77b

Pediatric Clinical Studies

  FPG (mg/dL)    Baseline    Change at FINAL VISIT   (n=37)162.4-42.9(n=36)192.321.4 <0.001
  Body Weight (lbs)    Baseline    Change at FINAL VISIT   (n=39)205.3-3.3(n=38)189-2 NS**

INDICATIONS AND USAGE


CONTRAINDICATIONS

Metformin 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.)

  • Renal disease or renal dysfunction (e.g., 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.)
  • Known hypersensitivity to metformin hydrochloride.
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.  

WARNINGS


Lactic Acidosis


PRECAUTIONS


General


Information for Patients


Laboratory Tests


Drug Interactions (Clinical Evaluation of Drug Interactions Conducted With Metformin Hydrochloride Tablets)


Carcinogenesis, Mutagenesis, Impairment of Fertility


Pregnancy


Teratogenic effects


Nursing Mothers


Pediatric Use


Geriatric Use


ADVERSE REACTIONS

 Diarrhea53.211.7
 Nausea/Vomiting25.58.3
 Flatulence12.15.5
 Asthenia9.25.5
 Indigestion7.14.1
 Abdominal Discomfort6.44.8
 Headache5.74.8

Pediatric Patients


OVERDOSAGE


DOSAGE AND ADMINISTRATION


Recommended Dosing Schedule


Transfer From Other Antidiabetic Therapy


Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients


Concomitant Metformin and Insulin Therapy in Adult Patients


Specific Patient Populations


HOW SUPPLIED

They are supplied by State of Florida DOH Central Pharmacy as follows:

53808-0459-1850 mg30 Tablets in a Blister PackWHITE65862-009

Patient Information


Metformin Hydrochloride Tablets, USP


What is metformin?


Who should not take metformin?

 

  • have kidney problems
  • have liver problems
  • have heart failure that is treated with medicines, such as Lanoxin® (digoxin) or Lasix® (furosemide)
  • drink a lot of alcohol. This means you binge drink for short periods or drink all the time
  • are seriously dehydrated (have lost a lot of water from your body)
  • are going to have an x-ray procedure with injection of dyes (contrast agents)
  • are going to have surgery
  • develop a serious condition, such as heart attack, severe infection, or a stroke
  • are 80 years or older and you have NOT had your kidney function tested

Can metformin hydrochloride tablets be used in children?


How should I take metformin hydrochloride tablets?

 

  • have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking metformin for a short time.
  • plan to have surgery or an x-ray procedure with injection of dye (contrast agent). You may need to stop taking metformin hydrochloride tablets for a short time.
  • start to take other medicines or change how you take a medicine. Metformin can affect how well other drugs work, and some drugs can affect how well metformin work. Some medicines may cause high blood sugar.

What should I avoid while taking metformin hydrochloride tablets?


What are the side effects of metformin?

 

 

  • feeling very weak, tired, or uncomfortable
  • unusual muscle pain
  • trouble breathing
  • unusual or unexpected stomach discomfort
  • feeling cold
  • feeling dizzy or lightheaded
  • suddenly developing a slow or irregular heartbeat

General advice about prescription medicines

This Product was Repackaged By:

State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States