Benzoate

What it is used for

MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks.

MAXALT is not indicated for use in the management of hemiplegic or basilar migraine. MAXALT is not indicated for the prevention of migraine attacks. Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age Limitations of Use: Use only after clear diagnosis of migraine has been established Not indicated for the prophylactic therapy of migraine Not indicated for the treatment of cluster headache

The most important thing to know

Alogliptin and pioglitazone tablets can cause serious side effects, including: 1. Heart failure: Alogliptin and pioglitazone tablets can cause heart failure and cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.

Heart failure means your heart does not pump blood well enough. Before you start taking alogliptin and pioglitazone tablets: Tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Call your healthcare provider right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down an unusually fast increase in weight swelling or fluid retention, especially in the feet, ankles, or legs unusual tiredness These may be symptoms of heart failure.

2. Inflammation of the pancreas (pancreatitis): Alogliptin, one of the medicines in alogliptin and pioglitazone tablets, may cause pancreatitis, which may be severe. Certain medical conditions make you more likely to get pancreatitis. Before you start taking alogliptin and pioglitazone tablets: Tell your healthcare provider if you have ever had: pancreatitis high blood triglyceride levels kidney problems stones in your gallbladder (gall stones) liver problems a history of alcoholism Stop taking alogliptin and pioglitazone tablets and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away.

The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. What are alogliptin and pioglitazone tablets? Alogliptin and pioglitazone tablets are a prescription medicine that contain 2 diabetes medicines, alogliptin (NESINA) and pioglitazone (ACTOS).

Alogliptin and pioglitazone tablets are used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Alogliptin and pioglitazone tablets are not for people with type 1 diabetes. It is not known if alogliptin and pioglitazone tablets are safe and effective in children under the age of 18.

Alogliptin and pioglitazone tablets are not recommended for use in children.

How to take it

Take alogliptin and pioglitazone tablets exactly as your healthcare provider tells you to take it. Take alogliptin and pioglitazone tablets 1 time each day with or without food. Do not break or cut alogliptin and pioglitazone tablets before swallowing. Your healthcare provider may need to change your dose of alogliptin and pioglitazone tablets to control your blood glucose.

Do not change your dose unless told to do so by your healthcare provider. If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of alogliptin and pioglitazone tablets at the same time.

If you take too much alogliptin and pioglitazone tablets, call your healthcare provider or the Poison Help Line right away at 1-800-222-1222. If your body is under stress, such as from fever, infection, accident or surgery, the dose of your diabetes medicines may need to be changed. Call your healthcare provider right away.

Stay on your diet and exercise programs and check your blood sugar as your healthcare provider tells you to. Your healthcare provider may do certain blood tests before you start alogliptin and pioglitazone tablets and during treatment as needed. Your healthcare provider may change your dose of alogliptin and pioglitazone tablets based on the results of your blood tests due to how well your kidneys are working.

Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C. Your healthcare provider should check your eyes regularly while you take alogliptin and pioglitazone tablets.

Side effects, and when to stop

Alogliptin and pioglitazone tablets can cause serious side effects, including: Serious allergic (hypersensitivity) reactions, such as: swelling of your face, lips, throat and other areas on your skin raised, red areas on your skin (hives) difficulty swallowing or breathing skin rash, itching, flaking or peeling If you have these symptoms, stop taking alogliptin and pioglitazone tablets and contact your healthcare provider right away or go to the nearest hospital emergency room Liver problems.

Call your healthcare provider right away or go to the nearest hospital emergency room if you have unexplained symptoms such as: nausea or vomiting loss of appetite stomach pain dark urine unusual or unexplained tiredness yellowing of your skin or the whites of your eyes Broken bones (fractures). Usually in the hand, upper arm or foot in women.

Talk to your healthcare provider for advice on how to keep your bones healthy. Bladder tumors. There may be an increased chance of having bladder cancer when you take alogliptin and pioglitazone tablets. You should not take alogliptin and pioglitazone tablets if you are receiving treatment for bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms of bladder cancer: blood or a red color in your urine an increased need to urinate pain while you urinate Low blood sugar (hypoglycemia).

If you take alogliptin and pioglitazone tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take alogliptin and pioglitazone tablets. Signs and symptoms of low blood sugar may include: shaking or feeling jittery change in vision change in mood sweating headache confusion fast heartbeat hunger dizziness Diabetic eye disease with swelling in the back of the eye (macular edema).

Tell your healthcare provider right away if you have any changes in your vision. Your healthcare provider should check your eyes regularly. Release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take alogliptin and pioglitazone tablets.

This can increase your chance of getting pregnant. Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in alogliptin and pioglitazone tablets, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain. Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in alogliptin and pioglitazone tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital.

Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking alogliptin and pioglitazone tablets. The most common side effects of alogliptin and pioglitazone tablets include stuffy or runny nose and sore throat, back pain, cold-like symptoms (upper respiratory tract infection).

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of alogliptin and pioglitazone tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take alogliptin and pioglitazone tablets if you: have severe heart failure are allergic to alogliptin (NESINA), pioglitazone (ACTOS) or any ingredient in alogliptin and pioglitazone tablets or have had a serious allergic (hypersensitivity) reaction to alogliptin or pioglitazone. See the end of this Medication Guide for a complete list of the ingredients in alogliptin and pioglitazone tablets.

Symptoms of a serious allergic reaction to alogliptin and pioglitazone tablets may include: swelling of your face, lips, throat and other areas on your skin raised, red areas on your skin (hives) difficulty with swallowing or breathing skin rash, itching, flaking or peeling If you have these symptoms, stop taking alogliptin and pioglitazone tablets and contact your healthcare provider or go to the nearest hospital emergency room right away.

What to say before you start

Before you start taking alogliptin and pioglitazone tablets, tell your healthcare provider if you: have heart failure have a type of diabetic eye disease that causes swelling of the back of the eye (macular edema) have kidney or liver problems have or have had inflammation of the pancreas (pancreatitis) have or have had cancer of the bladder are pregnant or plan to become pregnant.

It is not known if alogliptin and pioglitazone tablets can harm your unborn baby. Talk to your healthcare provider about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant. are a premenopausal woman who does not have periods regularly or at all. Alogliptin and pioglitazone tablets may increase your chance of becoming pregnant.

Talk to your healthcare provider about birth control choices while taking alogliptin and pioglitazone tablets. Tell your healthcare provider right away if you become pregnant while taking alogliptin and pioglitazone tablets. are breastfeeding or plan to breastfeed. It is not known if alogliptin and pioglitazone tablets passes into your breast milk and if it can harm your baby.

Talk with your healthcare provider about the best way to control your blood glucose levels while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them and show it to your healthcare provider before you start a new medicine.

Alogliptin and pioglitazone tablets may affect the way other medicines work, and other medicines may affect how alogliptin and pioglitazone tablets works. Contact your healthcare provider before you start or stop other types of medicines.

Storing it

Store alogliptin and pioglitazone tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep container tightly closed and protect from moisture and humidity. Keep alogliptin and pioglitazone tablets and all medicines out of the reach of children.