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Drugs reference index «Actoplus Met»

Actoplus Met


Actoplus Met

Generic Name: pioglitazone and metformin (Oral route)

met-FOR-min hye-droe-KLOR-ide, Pioglitazone Hydrochloride

Oral routeTablet

Warning: Congestive Heart Failure

Thiazolidinediones, including pioglitazone hydrochloride cause or exacerbate congestive heart failure in some patients. After initiation of metformin hydrochloride/pioglitazone hydrochloride, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of metformin hydrochloride/pioglitazone hydrochloride must be considered.

Metformin hydrochloride/pioglitazone hydrochloride is not recommended in patients with symptomatic heart failure. Initiation of metformin hydrochloride/pioglitazone hydrochloride in patients with established NYHA Class III or IV heart failure is contraindicated .

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with pioglitazone hydrochloride and metformin hydrochloride 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 (greater than 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 greater than 5 mcg/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. Metformin treatment should not be initiated in patients greater than or equal to 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, metformin 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, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, wither acute or chronic, when taking metformin, since alcohol potentiated the effects of metformin hydrochloride on lactate metabolism. In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure.

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 patients should be instructed to notify the physician immediately if they occur. Metformin 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 patients is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, 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 metformin 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.

Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis backing 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 metformin, 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 .

May cause or worsen congestive heart failure, is not recommended in patients with symptomatic heart failure, and is contraindicated in patients with established NYHA Class III or IV heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases and if heart failure occurs, consider dose reduction or discontinuing metformin/pioglitazone and manage according to current standards of care.

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin/pioglitazone; when it occurs, it is fatal in approximately 50% of cases. The risk of lactic acidosis increases with renal impairment, increased age, diabetes mellitus, congestive heart failure, hepatic insufficiency, and other conditions whenever there is significant tissue hypoperfusion and hypoxemia. Treatment with metformin/pioglitazone should not be initiated in patients 80 years of age or older unless measurement of creatinine clearance demonstrates that renal function is normal. Therapy should temporarily be discontinued prior to any intravascular radiocontrast study or surgical procedure. Avoid excessive alcohol use since alcohol potentiates the effects of metformin on lactate metabolism. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .

Commonly used brand name(s):

In the U.S.

  • Actoplus Met

Available Dosage Forms:

  • Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

Uses For Actoplus Met

Metformin and pioglitazone is a combination medicine used to treat a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using metformin and pioglitazone will help to lower blood sugar when it is too high and help restore the way you use food to make energy.

Many people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of metformin and pioglitazone combination you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.

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

Before Using Actoplus Met

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 metformin and pioglitazone combination 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 metformin and pioglitazone combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving metformin and pioglitazone combination.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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

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.

  • Acetrizoic Acid
  • Diatrizoate
  • Ethiodized Oil
  • Iobenzamic Acid
  • Iobitridol
  • Iocarmic Acid
  • Iocetamic Acid
  • Iodamide
  • Iodipamide
  • Iodixanol
  • Iodohippuric Acid
  • Iodopyracet
  • Iodoxamic Acid
  • Ioglicic Acid
  • Ioglycamic Acid
  • Iohexol
  • Iomeprol
  • Iopamidol
  • Iopanoic Acid
  • Iopentol
  • Iophendylate
  • Iopromide
  • Iopronic Acid
  • Ioseric Acid
  • Iosimide
  • Iotasul
  • Iothalamate
  • Iotrolan
  • Iotroxic Acid
  • Ioversol
  • Ioxaglate
  • Ioxitalamic Acid
  • Ipodate
  • Metrizamide
  • Metrizoic Acid
  • Tyropanoate Sodium

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.

  • Alatrofloxacin
  • Balofloxacin
  • Cimetidine
  • Ciprofloxacin
  • Clinafloxacin
  • Dofetilide
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Levofloxacin
  • Lomefloxacin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin
  • Temafloxacin
  • Tolvaptan
  • 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
  • Alprenolol
  • Atenolol
  • Atorvastatin
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bitter Melon
  • Bucindolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cephalexin
  • Clorgyline
  • Dilevalol
  • Enalaprilat
  • Enalapril Maleate
  • Esmolol
  • Ethinyl Estradiol
  • Fenugreek
  • Gemfibrozil
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Ketoconazole
  • Labetalol
  • Levobunolol
  • Levonorgestrel
  • Mepindolol
  • Mestranol
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Norethindrone
  • Norgestrel
  • Oxprenolol
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Rifampin
  • Selegiline
  • Sotalol
  • St John's Wort
  • Talinolol
  • Tertatolol
  • Timolol
  • Toloxatone
  • Topiramate
  • Tranylcypromine

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.

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—These conditions could make you more sensitive to the effects of low blood sugar.
  • Blood poisoning or
  • Dehydration, severe or
  • Heart or blood vessel disorders or
  • Hypoxemia (low oxygen in the blood) or
  • Kidney disease or
  • Liver disease or
  • Shock (low blood pressure, blood circulation is poor)—Lactic acidosis can occur with these conditions and chances of it occurring are even greater with a medicine that contains metformin.
  • Diabetic ketoacidosis (ketones in the blood) or
  • Heart failure, severe or
  • Kidney disease, severe or
  • Metabolic acidosis (acid in the blood) or
  • Type I diabetes—Should not be used in patients with these conditions.
  • Edema (e.g., swelling or retaining fluid)—May cause this condition to become worse.
  • Fever or
  • Infection or
  • Surgery or
  • Trauma—May cause temporary problems with blood sugar control.
  • Kidney, heart, or other problems that require medical tests, or examinations that use certain medicines called contrast agents with x-ray exams or
  • Major surgery—Because this medicine contains metformin, your doctor should advise you to stop taking it before you have any medical exams, diagnostic tests, or major surgeries that might cause less urine output than usual; you may be advised to start taking the medicine again 48 hours after the exam or test if your kidney function is tested and found to be normal.
  • Liver disorder—Higher blood levels of this medicine may occur, which may cause serious problems.

Proper Use of Actoplus Met

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Carefully follow the special meal plan your doctor gave you. This is a very 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.

Metformin and pioglitazone combination should be taken with meals to help reduce the stomach or intestinal side effects that may occur during the first few weeks of treatment.

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 oral dosage form (tablets):
    • For type 2 diabetes:
      • For patients already taking metformin alone:
        • Adults—At first, 15 milligrams (mg) pioglitazone with 500 mg metformin or 15 mg pioglitazone with 850 mg metformin once per day or two times per day. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • For patients already taking pioglitazone alone:
        • Adults—At first, 15 milligrams (mg) pioglitazone with 500 mg metformin two times per day or 15 mg pioglitazone with 850 mg metformin once per day. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from a combination of metformin and pioglitazone as separate tablets:
        • Adults—At first, 15 milligrams (mg) pioglitazone with 500 mg metformin or 15 mg pioglitazone with 850 mg metformin, based on the doses of pioglitazone and metformin already being taken. Your doctor will tell you how often to take the tablet and may adjust your dose as needed.
        • 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 Actoplus Met

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood tests may be needed to check for unwanted effects.

Check with your doctor immediately if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase the risk of bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include: abdominal or stomach discomfort; decreased appetite; diarrhea; fast or shallow breathing; a general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should get immediate emergency medical help.

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

  • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
  • Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
  • 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 with lifestyle changes, such as changes in exercise or 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 a 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 that lists all of your medicines.

If you are rapidly gaining weight, or having shortness of breath, or excessive swelling of hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Tell your doctor right away if you have any of these symptoms: loss of appetite, nausea, vomiting, stomach pain, unusual tiredness or weakness, weight loss, or yellow eyes or skin. These may be symptoms of liver problems.

Metformin and pioglitazone combination can cause low blood sugar. However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take metformin or pioglitazone combination with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly.

Symptoms of hypoglycemia (low blood sugar) include: anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with 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 and needle, and know how to use it. The members of your household should also know how to use it.

Symptoms of hyperglycemia (high blood sugar) include: blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Actoplus Met 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:

More common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
  • swelling of the face, fingers, feet, or lower legs
  • weight gain
Less common
  • Pain or swelling in the arms or legs without any injury
  • pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Rare
  • Abdominal discomfort
  • anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool pale skin
  • decreased appetite
  • depression
  • diarrhea
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • general feeling of discomfort
  • headache
  • increased hunger
  • muscle pain or cramping
  • nausea
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • shortness of breath
  • sleepiness
  • 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:

More common
  • Body aches or pain
  • cough
  • difficulty with breathing
  • ear congestion
  • fever, sneezing, or sore throat
  • loss of voice
  • nasal congestion
  • runny nose

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.

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  • Actoplus Met Prescribing Information (FDA)
  • Actoplus Met MedFacts Consumer Leaflet (Wolters Kluwer)
  • Actoplus Met Consumer Overview

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