Piozer Plus 15mg+850mg Tablet 7 ‘S

Description

About

{{Product}} is a combination of two oral antidiabetic agents, Metformin and Pioglitazone. Both work as effective drugs for glycemic control in people with type 2 diabetes. The active agent “Pioglitazone” belongs to the class, “thiazolidinedione” of drugs that act as a blood glucose-lowering agent by making the tissues sensitive to insulin. It is prescribed when other conventional monotherapies fail to control blood sugar. Metformin, on the other hand, is a “biguanide” that decreases the production of glucose in liver cells, lowers the absorption of glucose, and renders the body make effective use of insulin. 

{{Product}} is also used alone or as part of the combination therapy (you may need to take it with other medications) with a recommended diet and exercise. {{Product}} is not supposed to be consumed by a person with type 1 diabetes, having a history of heart failure, or having diabetic ketoacidosis (when diabetes reaches a complication where the body has high levels of ketones or blood acids) due to serious adverse effects. 

Indications

{{Product}} is prescribed as an adjunct to exercise and diet to control high blood sugar in people with type 2 diabetes, who did not respond with pioglitazone or metformin alone or for those who initially responded to pioglitazone but need additional control of blood glucose. 

How Does Piozer Plus 15mg+850mg Tablet 7 ‘S Work?

{[Product}} is a combination of two antidiabetic drugs:

• Pioglitazone
• Metformin 

These two agents cause glycemic control by different mechanisms that are discussed below:

Pioglitazone 

Pioglitazone is responsible for causing insulin tissue sensitivity (insulin-sensitizing agent). Adipose tissue, skeletal muscles, and liver are the target sites for insulin’s action. These sites have Peroxisome proliferator-activated receptor gamma (PPARγ) that is involved in the insulin response.

These insulin-responsive genes are involved in controlling the production, transport, and utilization of lipids and glucose. This way, the active ingredient – pioglitazone increases tissue sensitivity and decreases hepatic production of glucose. This improves type 2 diabetes-associated insulin resistance without abnormal insulin secretion by the beta cells of the pancreas. 

Metformin

Metformin is a potent antidiabetic agent that decreases blood glucose levels by improving glucose tolerance. It does not stimulate insulin secretion, so hypoglycemia is not a risk factor. Metformin acts by three mechanisms:

• Reduces the production of glucose in liver cells by inhibiting gluconeogenesis and by blocking its breakdown in the muscles (glycogenolysis).
• Enhances tissue sensitivity to insulin.
• Decreases the absorption of glucose by the intestinal cells by increasing peripheral uptake and utilization of glucose. 

These effects of metformin cause a decrease in blood glucose thereby managing type II diabetes by efficient glycemic control. 

How To Use Piozer Plus 15mg+850mg Tablet 7 ‘S?

{{Product}} is administered daily in divided doses with meals so that metformin-associated gastrointestinal side effects are avoided. Swallow the tablet with water, do not crush or chew. This may affect the bioavailability of the active ingredients. 

Dosage

The active agents are available in film-coated tablet form as: 

• Pioglitazone 15 mg + Metformin HCl 500 mg
• Pioglitazone 15 mg + Metformin HCl 850 mg 

Adult Dose

The combination of Pioglitazone and Metformin can be started as a once-daily dose or twice-daily dose in 15mg + 500mg or 15mg + 850mg, depending on the past responses to antidiabetic monotherapies to any of the agents. The doses are gradually increased, based on clinical monitoring and therapeutic response. 

Individual drug monitoring should be made based on efficacy while the maximum daily dose of each of the active ingredients should not be exceeded, which is 45mg for pioglitazone and 2250 mg for Metformin. 

Pediatric Dose

Safety and efficacy are not established in children under 18 years of age. 

Pregnancy And Lactation

Significant studies are not established on taking use in pregnant women. However, Piozer Plus 15mg+850mg Tablet 7 ‘S should only be used in pregnancy if the potential benefit justifies the possible risk to the unborn. {{Product}} can cause side effects for the nursing infant, so either nursing or intake of Piozer Plus 15mg+850mg Tablet 7 ‘S should be discontinued.

Contraindications

{{Product}} is contraindicated in the following cases:

• Hypersensitivity to any of the active agents or excipients
• In people with symptomatic heart failure or having a history of heart failure
• In people who have compromised liver function or have active liver disease
• Recent heart attack or shock
• Acute alcohol intoxication
• Kidney failure or compromised kidney function
• Diabetic ketoacidosis (high levels of ketones/ blood acids in the body) 
• Bladder cancer or a history
• Hematuria (blood in urine)
• Individuals, more than 80 years of age (may develop lactic acidosis) 

Precautions

Following measures should be taken before starting the treatment with Piozer Plus 15mg+850mg Tablet 7 ‘S:

• {{Product}} promotes ovulation. You may need to use potent birth control because taking this medication may lead to unwanted pregnancy.
• One of the active agents, pioglitazone, is known to interact with oral contraceptives containing Ethinyl estradiol or norethindrone. Pioglitazone renders oral contraceptives less effective by decreasing their plasma concentration. So, to avoid loss of contraception, an effective contraceptive should be used, and concomitant administration should be avoided.
• Stop taking Piozer Plus 15mg+850mg Tablet 7 ‘S if your x-ray procedure is around the corner. Administration of Piozer Plus 15mg+850mg Tablet 7 ‘S with x-ray contrast affects kidneys and causes lactic acidosis (high metabolic levels of acid in the body). So, Piozer Plus 15mg+850mg Tablet 7 ‘S should be temporarily stopped in patients who need to go through radiologic exams using iodinated contrast media.
• The active agent, Pioglitazone, is associated with a serious side effect of exacerbating heart failure in vulnerable populations. The patient should be closely observed for the symptoms of heart failure, such as rapid weight gain, edema, shortness of breath, etc. Dose reduction or discontinuation of therapy with Piozer Plus 15mg+850mg Tablet 7 ‘S should be considered if these symptoms are visible.
• Diabetic individuals with metabolic acidosis in which ketoacidosis is not confirmed should be suspected of lactic acidosis which is a medical emergency. 

Interactions With Other Medications

Concomitant administration of the following drugs with Piozer Plus 15mg+850mg Tablet 7 ‘S can result in unwanted effects: 

• Baricitinib 
• Iodinated contrast media (discontinue treatment 48 hours before imaging study)
• Eluxadoline
• Alcohol
• Ethanol 
• Ioversol
• Methylene blue 
• Topiramate 
• Acetazolamide
• Cimetidine
• Gemfibrozil
• Rifampin 
• Oral contraceptives (Ethinyl estradiol, norethindrone)
• Calcium channel blockers (e.g., Nifedipine)
• Furosemide
• Thiazide diuretics 
• Amiloride
• Vancomycin
• Trimethoprim

Adverse Effects

Common Side Effects 

• Anemia 
• Visual disturbances 
• Headache
• Hematuria
• Arthralgia (pain in the joints) 
• Weight gain
• Diarrhea 
• Upper respiratory tract infections

Less Common Adverse Effects 

• Flatulence
• Urinary tract infection
• Dizziness 
• Nausea 
• Edema

Rare Adverse Effects

• Hepatitis 
• Elevation of the hepatic enzymes

How To Cope with Some Of The Adverse Effects

• Upper Respiratory Tract Infections – Use nasal decongestant if you have difficulty in breathing, steam inhalation, or gargling with saltwater aid in clearing the airways. Take antibiotics upon your doctor’s suggestion for subsiding the infection.
• Weight gain – Weight gain can be controlled by lowering the dose of medicine, eating in little portions, avoiding high calories alcoholic beverages, increasing physical activity such as walking & exercise, and increasing protein intake. Protein will make you feel fuller for a long time. You can also limit weight gain by limiting salt intake i.e., consumption of fewer than 2000 mg of salt per day.
• Anemia – Pale skin, fatigue, weakness, and disturbed appetite are signs of anemia. Eat iron-rich food such as beef, salmon, cereals, liver, dry fruits, and leafy vegetables. Take a good night’s sleep, take rest when needed to avoid fainting, and light exercise daily improves blood flow.
• Diarrhea – Drink lots of water to stay hydrated and take light and healthy meals.  Avoid medications that may increase gastric motility. Intake Oral Rehydration Salt (ORS) gets the electrolytes levels back to normal. 

FAQs

Q. HOW LONG DOES IT TAKE {{PRODUCT}} TO PRODUCE ITS EFFECTS?

It takes a few weeks to lower the blood sugar levels. {{Product}} helps maintain a stable sugar level and this way, it prevents developing diabetes-associated problems in the future. 

Q. WILL I EXPERIENCE HYPOGLYCEMIA AS A SIDE EFFECT OF {{PRODUCT}}?

{{Product}} if taken alone, does not tend to cause hypoglycemia. However, low blood sugar can occur because of combination therapy. The dose of any of the combined insulin sensitizers is reduced if there is hypoglycemia. 

Q. DOES THE USE OF {{PRODUCT}} PUT ME AT A RISK OF HEART FAILURE?

{{Product}} has the potential to put a person at risk of heart failure but in those who are above 65 years of age. Also, the tendency of this side effect increases if administered with insulin. You should not take Piozer Plus 15mg+850mg Tablet 7 ‘S if you had gone through any type of heart failure in the past.  Also, watch yourself for shortness of breath, edema, and swollen legs. These symptoms suspect heart failure. 

Q. CAN {{PRODUCT}} BE TAKEN BEFORE SURGERY?

Tell your doctor if you are taking Piozer Plus 15mg+850mg Tablet 7 ‘S along with other antidiabetic agents or with insulin. Because, if there is hypoglycemia, it will be difficult to distinguish between anesthesia and hypoglycemia after surgery. Your doctor might reduce your insulin dose before surgery. 

Q. DO LIFESTYLE CHANGES AID IN MANAGING DIABETES?

You can maintain your body for glycemic controls by taking a balanced & healthy diet, doing regular exercise, quitting smoking, and refraining from alcohol. {{Product}} is usually prescribed along with a suggested diet and exercise when these two factors alone are not enough to control high blood sugar. 

Q. IS THERE ANY FOOD I NEED TO AVOID?

Since you need to avoid food with high sugar content, you can check the nutrition labels on the products to see if they suit you. You should avoid fizzy drinks, sweets, chocolates, and cakes. Along with that, you need to keep fast-acting carbohydrates with you such as fruit juices, and sugar cubes for aid if your blood sugar level drops. 

Q. CAN I GO ON A RIDE AFTER TAKING {{PRODUCT}}?

It depends on the glycemic control of your body. You can drive a vehicle and lift heavy machinery if your blood sugar levels are stable with the use of Piozer Plus 15mg+850mg Tablet 7 ‘S. But if you are taking other antidiabetic medications, this puts you at risk of getting hypoglycemic episodes. Monitor your blood glucose frequently and then decide to go on a ride. 

Q. CAN A PREGNANT OR NURSING MOTHER TAKE {{PRODUCT}}?

Significant studies are not established on safe use in pregnant women. However, Piozer Plus 15mg+850mg Tablet 7 ‘S should only be used in pregnancy if the potential benefit justifies the possible risk to the unborn. {{Product}} can cause side effects in the nursing infant, so either nursing or intake of Piozer Plus 15mg+850mg Tablet 7 ‘S should be discontinued. 

Q. WHAT ARE THE STORAGE CONDITIONS OF {{PRODUCT}}?

Store Piozer Plus 15mg+850mg Tablet 7 ‘S at room temperature, between 25°C to 30°C and protect it from moisture and direct sunlight. Traveling is permitted between 15°C-30°C.