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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. PIOGLITAZONE/GLIMEPIRIDE - ORAL (PYE-oh-GLI-ta-zone/glih-MEH-pih-ride) COMMON BRAND NAME(S): Duetact WARNING: This medication may infrequently cause or worsen a certain heart problem (congestive heart failure). Tell your doctor immediately if you notice any symptoms of heart failure, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, or unusual tiredness.
USES: This medication is a combination of 2 drugs, pioglitazone and glimepiride. It is used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Pioglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones." It works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar. Talk to your doctor about the risks and benefits of using pioglitazone-containing products. Glimepiride belongs to a class of drugs known as sulfonylureas. It works by causing the release of your body's natural insulin.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth, usually once daily with the first main meal of the day or as directed by your doctor. The dosage is based on your medical condition and response to treatment. Do not take more than 45 milligrams of pioglitazone a day. Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Monitor your blood sugar levels on a regular basis, and share the results with your doctor. It may take up to 2 to 3 months before you get the full benefit of this drug. When switching from individual diabetes drugs to this combination product, your doctor may ask you to check your blood sugar more often to make sure you do not have a sudden attack of low blood sugar (hypoglycemic reaction) when starting this product. (See also Side Effects section.) Follow your doctor's directions carefully.
SIDE EFFECTS: See also Warning section. Headache, dizziness, diarrhea, nausea, muscle pain, sore throat, or tooth problems may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: new/worsening vision problems (e.g., color or night vision problems), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating. Tell your doctor immediately if any of these rare but very serious side effects occur: loss of appetite, yellowing eyes/skin, dark urine, mental/mood changes (e.g., hallucinations, confusion), seizures, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat). This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or glimepiride; or to other "glitazones" (e.g., rosiglitazone); or to other sulfonylureas (e.g., glipizide, tolbutamide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: type 1 diabetes (insulin-dependent diabetes), very high blood sugar levels (diabetic ketoacidosis), newly diagnosed or worsening heart failure (acute congestive heart failure), active liver disease, active bladder cancer. Before taking this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., chronic congestive heart failure), fluid in your lungs, swelling (edema, fluid retention), liver problems, kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), mineral imbalance (hyponatremia), anemia, eye (retina) problems, bladder cancer. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar (hypoglycemia). It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). In these cases, consult your doctor because you may require a change in your treatment plan, medications, or blood sugar testing. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. This medication may increase the risk of bone fracture (e.g., upper arm, hand, foot, ankle) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be at greater risk for low blood sugar while using this drug. This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems. Women of child-bearing age should use a reliable form of birth control while taking this medication. Consult your doctor for more details. This medication is not recommended for use during pregnancy. Your doctor may direct you to switch to insulin treatment during your pregnancy. Use of pioglitazone/glimepiride close to the expected delivery date may increase the risk of low blood sugar in your newborn. Consult your doctor for more details, and follow all instructions carefully. It is unknown if this medication passes into breast milk, and it may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of pioglitazone from your body, which may affect how pioglitazone works. Examples include gemfibrozil, rifamycins including rifampin, among others. Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.
NOTES: Do not share this medication with others. You should attend a diabetes education program to learn more about diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye/foot/medical exams. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if you need to take calcium/vitamin D supplements and discuss lifestyle changes that might benefit you. Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to check for side effects and monitor your response to treatment. Check your blood sugar levels regularly as directed.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.
Prescription Return Policy
We are prevented by law from accepting returns for any prescription medication. If you need to dispose of any medication, please follow the steps below...
FDA Guidelines on Proper Methods of Disposing of Unused Medicine
For guidelines on proper methods of disposing of unused medicines, consult the following FDA link: www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm
As a general rule of thumb, do not flush prescription drugs down the toilet or drain unless the label or accompanying patient information specifically instructs you to do so. For information on drugs that should be flushed visit the FDA’s website.
To dispose of prescription drugs not labeled to be flushed, you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events, that collect drugs at a central location for proper disposal. Call your city or county government’s household trash and recycling service and ask if a drug take-back program is available in your community.
If a drug take-back or collection program is not available:
1. Take your prescription drugs out of their original containers.
2. Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.
3. Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag.
4. Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off.
5. Place the sealed container with the mixture, and the empty drug containers, in the trash.
Shipping Policy
Although we strive to fill your medication as quickly as possible, we are not an urgent facility. Please obtain a local fill of your medication if you have an emergency or urgent needs to ensure no disruption with your medical therapy.
All orders ship from Titusville, FL. We offer 100% FREE shipping on all orders. We ship orders Monday through Friday. We only ship to valid street addresses within the state of Florida. No Post Office boxes.
For all orders, you can expect the following shipping times: 1-2 business days.
Please note that prescription items cannot be shipped until a valid, verified prescription is on file. In addition to the shipping times stated above, please add up to 1-2 business days of processing time to all orders.
Offer to Counsel
If you have any questions regarding this prescription or any other medication, please feel free to contact us at info@atyourdoorpharmacy.com or during store counseling hours (Mon-Fri, 9am-6pm, Eastern) at (407) 476-1721.
Health Insurance Portability & Accountability Act
At Your Door is committed to protecting your privacy. As a healthcare provider, we know that your trust in us is of central importance. This policy discloses our information use and policies and procedures in detail. Please read it to learn more about the ways we protect the information we collect and to find out how you can limit the information about you that is shared. If At Your Door should change its information practices, we will provide you notice of any material changes.
Strict Security Measures
At Your Door takes the security of information very seriously and has established security standards and procedures to prevent unauthorized access to patient information. We maintain physical, electronic, and procedural safeguards to comply with federal standards to guard patient information.
The following are ways AtYourDoorPharmacy.com will use and disclosure your Personal Health Information (PHI). Every allowable use or disclosure may not be listed:
For Treatment AtYourDoorPharmacy.com will use and disclose PHI to coordinate and manage your healthcare in order to dispense your prescription medication.
For Payment AtYourDoorPharmacy.com will use and disclose PHI to receive payment for our services. We may disclose your PHI to other HIPAA covered entities or business associates who may need it for their processing of your healthcare payments.
For Healthcare Operations AtYourDoorPharmacy.com will use and disclose PHI for administrative purposes to evaluate and improve the quality of care we provide you.
We may also use or disclose PHI for the following purposes
Business associates AtYourDoorPharmacy.com may provide some services through contracts with HIPAA compliant business associates. The business associates must enter into a confidentiality agreement to protect your PHI from unauthorized use and disclosure.
Communication with individuals involved in your care If you do not object, AtYourDoorPharmacy.com may disclose PHI to a friend or family member who is involved in your care.
Parents or legal guardians If you are a minor, we may release your PHI to your parents or legal guardians when we are permitted or required to do so under federal and applicable state law.
Health related communications AtYourDoorPharmacy.com may contact you to provide refill reminders or other health-related services that may be of interest to you as permitted by law.
As required by law We may disclose PHI when required to do so by federal, state or local law.
Law enforcement We may disclose PHI for law enforcement purposes, in response to a subpoena or other legal process.
Public Health As required by law, we may disclose PHI about you to public health authorities to prevent or control a serious threat to the health and safety of another person. We may also disclose PHI for the purpose of reporting adverse events and product recalls
Health Oversight Activities We may disclose PHI to an oversight agency for activities authorized by law. These activities would include pharmacy investigations, audits, credentialing and inspections required for our licensure. These are governmental agencies who monitor the health care system who are subject to government regulation and civil right laws.
Judicial and administrative proceedings We may disclose your PHI in response to a subpoena, court or administrative order, or other lawful process, but only if efforts were made to notify you about the request or to obtain an order protecting the requested PHI as required by law.
Coroners, medical examiners, and funeral directors We may disclose PHI to a coroner or medical examiner. This may be necessary to identify a deceased person or determine the cause of death. We may also disclose PHI to funeral directors as necessary with applicable laws so they may carry out their duties.
Organ, eye and tissue donation We may disclose PHI, consistent with applicable law to organizations who engage in organ procurement or transplant to facilitate the donation.
Research Under certain circumstances, we may disclose PHI for research purposes. Before disclosing PHI we would either remove information that personally identifies you or obtain your written authorization.
Military and Veterans Under certain circumstances, we may disclose to military authorities PHI or armed forces personnel.
National Security We may disclose PHI to authorized federal officials for intelligence, counterintelligence, and other national security activities authorized by law.
Correctional Institution We may disclose PHI of an inmate to the institution when necessary for your health or the health and safety of others.
Workers’ compensation We may disclose your PHI to comply with Workers’ Compensation Laws or other similar programs.
Individual Rights
In most cases, you have the right to look at or get a copy of health information about you that we use to make decisions about your care. You also have the right to receive a list of instances where we have disclosed health information about you for reasons other than treatment, payment, or related administrative purposes. If you believe that information in your record is incorrect or if important information is missing, you have the right to request that we correct or add the missing information. We will take precautions to prevent inappropriate or non-essential use or distribution of patient information when transmitted via the Internet and while the pharmacy possesses such information. You may request in writing that we not use or disclose your information for treatment payment and administrative purposes except when specifically authorized by you, when required by law, or in emergencies. We will consider your request but are not legally required to accept it.
Other Uses and Disclosures of your PHI
We are required by law to protect the privacy of your information, provide this notice of our information practices, and follow the information practices described in this notice. AtYourDoorPharmacy.com will request written authorization from you before using or disclosing your PHI for purposes not included in this document or as otherwise permitted or required by law. If you provide authorization and want to revoke this authorization at any time, or have any questions or complaints, this can be done in writing at any time by sending a written request to:
Atyourdoorpharmacy.com
Attn: Privacy Officer
100 E. Pine St.Suite 110
Orlando, FL
You may also call if you have any questions or complaints, please contact AtYourDoorPharmacy.com at (407) 476-1727
This revocation will not affect any use or disclosure of your PHI allowed by your authorization while it was in effect.