Pioglitazone/metformin 15-850mg Tb
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Establish a routine by taking your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store the tablets in their original container at room temperature. Keep the container tightly closed and protect it from light. Store the medication in a dry place, avoiding areas like the bathroom where moisture may be present.
What to Do If You Miss a Dose
If you forget to take a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a healthy diet plan as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Monitor your blood sugar levels regularly as instructed.
- Do not drink excessive amounts of alcohol, as it can increase the risk of a serious side effect called lactic acidosis.
- Inform your doctor if you are scheduled for any X-ray procedures involving dye or any surgery, as you may need to temporarily stop this medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Bone pain
Changes in eyesight
Pain when passing urine or blood in urine
Frequent urination
Swelling
Stomach Problems and Lactic Acidosis
It's common to experience stomach problems like upset stomach, vomiting, or diarrhea when starting this medication. However, if you develop stomach problems later during treatment, contact your doctor right away, as this may be a sign of lactic acidosis, a serious condition.
Low Blood Sugar
Low blood sugar can occur, especially when this medication is used with other diabetes medications. Be aware of the following symptoms:
Dizziness
Headache
Feeling sleepy or weak
Shaking
Fast heartbeat
Confusion
Hunger
Sweating
If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Liver Problems
Severe and potentially life-threatening liver problems have been reported with this medication. Seek medical help immediately if you notice any of the following symptoms:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach or vomiting
Gas
Headache
Signs of a common cold
Weight gain
Feeling tired or weak
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of lactic acidosis: unusual muscle pain, trouble breathing, stomach pain, dizziness, lightheadedness, feeling cold, or very tired/weak.
- Signs of heart failure: unusual or rapid weight gain, swelling in your hands or feet, or shortness of breath.
- Signs of low blood sugar (hypoglycemia): sweating, shaking, fast heartbeat, hunger, confusion, or dizziness. Carry a source of sugar (e.g., glucose tablets, juice) for emergencies.
- Signs of liver problems: unusual tiredness, dark urine, yellowing of skin or eyes (jaundice), nausea, vomiting, or stomach pain.
- Signs of bladder cancer: blood in urine, painful urination, or urgent need to urinate.
- Signs of bone fracture: new or unusual pain in bones, especially in arms or legs.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Acidic blood problems
+ Bladder cancer
+ Type 1 diabetes (note: this medication is not intended to treat type 1 diabetes)
+ Kidney disease
+ Liver disease
+ Recent heart attack or stroke
If you have any issues with eating or drinking normally, such as before undergoing a procedure or surgery
If you are scheduled to have an exam or test that involves contrast or have had one within the past 48 hours
* If you are a child, as this medication is not suitable for pediatric use
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
If you experience low blood sugar, avoid driving, as it increases the risk of accidents. Monitor your blood sugar levels as directed by your doctor. Additionally, follow your doctor's instructions for regular blood work and other laboratory tests.
Adhere to the diet and exercise plan recommended by your doctor. Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control. Changes in physical activity, exercise, or diet can also impact blood sugar levels.
Long-term treatment with metformin may lead to decreased vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration.
There is a potential increased risk of bladder cancer associated with this medication. Discuss this risk with your doctor. Furthermore, this drug may increase the risk of fractures, particularly in females. Most fractures occurred in the upper arm, hand, or foot after one year of treatment. Consult your doctor about maintaining bone health and addressing any concerns.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age who have not been ovulating may experience a renewed risk of pregnancy. To avoid pregnancy, use birth control while taking this medication.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (dizziness, confusion, seizures, loss of consciousness)
- Lactic acidosis (severe abdominal pain, rapid breathing, muscle pain, weakness, hypothermia, hypotension)
- Fluid retention, edema
What to Do:
Seek immediate medical attention or call 911. For suspected overdose, contact a poison control center (1-800-222-1222). Management is supportive, including correction of hypoglycemia and treatment of lactic acidosis (e.g., hemodialysis for metformin).
Drug Interactions
Contraindicated Interactions
- Iodinated contrast media (temporarily discontinue metformin at time of or prior to procedure)
- Severe heart failure (NYHA Class III or IV) (due to pioglitazone)
- Active liver disease or elevated ALT >2.5x ULN (due to pioglitazone)
- Metabolic acidosis, including diabetic ketoacidosis (due to metformin)
- Severe renal impairment (eGFR <30 mL/min/1.73m2) (due to metformin)
Major Interactions
- Alcohol (increases risk of lactic acidosis with metformin)
- Gemfibrozil (increases pioglitazone exposure, consider dose reduction of pioglitazone)
- Rifampin (decreases pioglitazone exposure, consider dose increase of pioglitazone)
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) (may increase risk of lactic acidosis with metformin)
- Cimetidine (increases metformin exposure)
- Drugs that affect renal function (e.g., NSAIDs, ACE inhibitors, ARBs, diuretics) (may increase risk of lactic acidosis with metformin)
Moderate Interactions
- Nifedipine (increases metformin absorption and Cmax)
- Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) (may compete for renal tubular transport with metformin)
- Corticosteroids, diuretics, thyroid products, phenothiazines, sympathomimetics, niacin, calcium channel blockers, isoniazid (may cause hyperglycemia, requiring dose adjustment of antidiabetic agents)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide initial therapy.
Timing: Prior to initiation
Rationale: Metformin is renally eliminated; risk of lactic acidosis increases with impaired renal function.
Timing: Prior to initiation
Rationale: Pioglitazone is contraindicated in active liver disease.
Timing: Prior to initiation
Rationale: Pioglitazone can cause or exacerbate congestive heart failure.
Timing: Prior to initiation
Rationale: Metformin can decrease vitamin B12 absorption.
Timing: Prior to initiation (consider if risk factors present)
Routine Monitoring
Frequency: Every 3-6 months
Target: <7% (individualized)
Action Threshold: >7% (consider dose adjustment or additional therapy)
Frequency: At least annually; more frequently (e.g., every 3-6 months) in elderly or those with risk factors for renal impairment.
Target: >60 mL/min/1.73m2 (for full dose metformin)
Action Threshold: <45 mL/min/1.73m2 (re-evaluate metformin dose/discontinue)
Frequency: At each visit
Target: Absence of symptoms
Action Threshold: Development or worsening of symptoms (discontinue pioglitazone)
Frequency: Periodically, or if symptoms suggestive of liver dysfunction develop.
Target: <2.5x ULN
Action Threshold: >3x ULN (discontinue pioglitazone)
Frequency: Periodically (e.g., every 2-3 years) or if anemia/neuropathy suspected.
Target: Normal range
Action Threshold: Low levels (consider supplementation)
Symptom Monitoring
- Signs of lactic acidosis (e.g., malaise, myalgia, respiratory distress, increased somnolence, abdominal distress)
- Signs of heart failure (e.g., unusual weight gain, swelling of ankles/feet, shortness of breath)
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger)
- Symptoms of bladder cancer (e.g., hematuria, dysuria, urinary urgency)
- Symptoms of bone fracture (e.g., new pain, swelling, deformity)
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy. Insulin is typically the preferred treatment for glycemic control in pregnant women with diabetes. Pioglitazone is Category C (animal studies show adverse effects, no adequate human studies). Metformin is Category B (animal studies show no risk, human data limited but generally reassuring). Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
Lactation
Metformin is excreted into breast milk in small amounts and is generally considered compatible with breastfeeding by many experts. Pioglitazone is also excreted into breast milk in small amounts, but data are limited, and potential effects on the infant are not well established. Use with caution, and monitor the infant for adverse effects. Consider alternative agents if possible.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
Use with caution in elderly patients due to increased risk of renal impairment (metformin), heart failure (pioglitazone), and bone fractures (pioglitazone). Start with lower doses and titrate slowly. Closely monitor renal function and for signs of heart failure.
Clinical Information
Clinical Pearls
- Pioglitazone/metformin is a fixed-dose combination, meaning dose adjustments for one component may be limited by the other. If individual dose adjustments are needed beyond the available combinations, separate medications should be considered.
- Patients should be educated on the signs and symptoms of lactic acidosis and heart failure, and instructed to seek immediate medical attention if these occur.
- Pioglitazone has been associated with an increased risk of bladder cancer; patients should be advised to report any hematuria or other urinary symptoms.
- Pioglitazone can cause dose-related fluid retention, which may lead to or exacerbate heart failure. Monitor for edema and weight gain.
- Metformin can cause vitamin B12 deficiency with long-term use; periodic monitoring of B12 levels should be considered, especially in patients with neuropathy or anemia.
- Risk of bone fractures (especially in the upper arm, hand, and foot) has been observed in female patients taking pioglitazone.
Alternative Therapies
- Other oral antidiabetic agents (e.g., sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors)
- Insulin therapy
- Lifestyle modifications (diet, exercise)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.