Alogliptin and pioglitazone (oral route)

Brand Name

US Brand Name

Oseni

Description

Alogliptin and pioglitazone combination is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Alogliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much of it in the blood. Pioglitazone works by helping your body use insulin better. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

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

This product is available in the following dosage forms:

Tablet

Before Using

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 alogliptin and pioglitazone combination in the pediatric population. Safety and efficacy have not been established. This medicine is not recommended for use in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alogliptin and pioglitazone combination in the elderly.

Breastfeeding

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

Colchicine
Ranolazine

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.

Abiraterone Acetate
Abiraterone Acetate, Micronized
Acarbose
Carbamazepine
Cariprazine
Chloroquine
Chlorothiazide
Chlorpropamide
Chlorthalidone
Ciprofloxacin
Clomipramine
Cyclosporine
Dabigatran Etexilate
Delafloxacin
Doxorubicin
Doxorubicin Hydrochloride Liposome
Enoxacin
Ensartinib
Furosemide
Gatifloxacin
Gemfibrozil
Gemifloxacin
Glimepiride
Glipizide
Glyburide
Grepafloxacin
Haloperidol
Hydrochlorothiazide
Hydroflumethiazide
Hydroxychloroquine
Ifosfamide
Indapamide
Insulin
Insulin Aspart, Recombinant
Insulin Bovine
Insulin Degludec
Insulin Detemir
Insulin Glargine, Recombinant
Insulin Glulisine
Insulin Lispro, Recombinant

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
Atenolol
Atorvastatin
Betaxolol
Bisoprolol
Bitter Melon
Carteolol
Carvedilol
Celiprolol
Clopidogrel
Esmolol
Fenugreek
Glecaprevir
Glucomannan
Guar Gum
Ketoconazole
Labetalol
Levobunolol
Metipranolol
Metoprolol
Nadolol
Nebivolol
Nilotinib
Oxprenolol
Penbutolol
Pibrentasvir
Pindolol
Practolol
Propranolol
Psyllium
Sotalol
Timolol

Other Interactions

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.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.

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

You may take this medicine with or without food.

Swallow the tablet whole. Do not split, crush, break, or chew it.

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:
  - Adults—Starting dose is based on the current alogliptin or pioglitazone you are already taking. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 25 milligrams (mg) of alogliptin and 45 mg of pioglitazone once a day.
    - Patients not treated with either alogliptin or pioglitazone—At first, 25 mg of alogliptin and 15 mg of pioglitazone or 25 mg of alogliptin and 30 mg of pioglitazone once a day.
    - Patients already treated with alogliptin—At first, 25 mg of alogliptin and 15 mg of pioglitazone or 25 mg of alogliptin and 30 mg of pioglitazone once a day.
    - Patients already treated with pioglitazone—At first, 25 mg of alogliptin and 15 mg of pioglitazone, 25 mg of alogliptin and 30 mg of pioglitazone, or 25 mg of alogliptin and 45 mg of pioglitazone once a day.
    - Patients already treated with alogliptin and pioglitazone—At first, your dose will be as close as possible to the current alogliptin and pioglitazone you are already taking.
  - Children—Use is not recommended.

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

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.

If you are rapidly gaining weight, having trouble breathing, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor right away. These may be symptoms of heart problems or fluid retention (too much water in the body).

Pancreatitis (swelling or inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or serious skin reactions (eg, Stevens-Johnson syndrome), which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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

Using this medicine for a long time may increase your risk for bladder cancer. Tell your doctor right away if you have blood in the urine, a frequent, strong, or increased urge to urinate, painful urination, or pain in the back, lower abdomen, or stomach.

Check with your doctor right away if blurred vision, decreased vision, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar must be treated before it causes you to pass out (unconsciousness).. People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

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 help with side effects if they occur. Also, patients with diabetes may need special counseling about the changes in the dosing of their diabetes medicine 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.

This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Anxiety
blurred vision
chest pain or tightness
chills
cold sweats
confusion
cool, pale skin
decreased urine output
depression
dilated neck veins
dizziness
extreme tiredness or weakness
fast heartbeat
headache
increased hunger
irregular breathing
irregular heartbeat
nausea
nightmares
seizures
shakiness
slurred speech
swelling of the face, fingers, feet, or lower legs
trouble breathing
unusual tiredness or weakness
weight gain

Rare

Blistering, peeling, or loosening of the skin
bloating
blood in the urine
constipation
cough
darkened urine
diarrhea
difficulty with swallowing
feeling of discomfort
fever
frequent, strong, or increased urge to urinate
hives, itching, or rash
indigestion
inflammation of the joints
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
muscle aches
pain in the back, lower abdomen, or stomach
painful urination
pains in the stomach, side, or abdomen, possibly radiating to the back
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
sore throat
sores, ulcers, or white spots in the mouth or on the lips
swollen lymph glands
vomiting
yellow eyes or skin

Incidence not known

Change in vision
general feeling of tiredness or weakness
light-colored stools
severe joint pain
stomach pain, continuing

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:

Less common

Back pain
body aches or pain
ear congestion
loss of voice
sneezing
stuffy or 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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