ProEthic Pharmaceuticals Announces Launch Of Ibudone For Acute Pain

ProEthic Pharmaceuticals, Inc. announced launch of Ibudone™ ( hydrocodone bitartrate and ibuprofen tablets ) , a new prescription fixed combination of hydrocodone and ibuprofen for short-term ( generally less than 10 days ) management of acute pain.

Ibudone provides highest hydrocodone/ibuprofen dosage available - 10 mg of hydrocodone/ 200 mg of ibuprofen - in each tablet. Peak plasma levels are achieved in less than two hours. Ibudone is also available with 5 mg hydrocodone/ 200 mg of ibuprofen.

Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, " By combining 10 mg of hydrocodone with gold standard NSAID, ibuprofen, Ibudone offers a powerful new option for relieving acute pain. It's important to note that Ibudone doesn't have the risk of acetaminophen liver toxicity, a leading cause of acute liver failure in United States. In addition, Ibudone also offers physicians Schedule III prescribing convenience, a key issue with today's busy practices. "

ProEthic acquired the exclusive marketing, sales and distribution rights to Ibudone from Vintage Pharmaceuticals ( Huntsville, Alabama ) . To learn more about Ibudone, visit http: //www. ibudone. com.

Important Information about Ibudone

Ibudone ( hydrocodone bitartrate and ibuprofen tablets ) is indicated for short-term ( generally less than 10 days ) management of acute pain. Ibudone tablets aren't indicated for treatment of such conditions as osteoarthritis or rheumatoid arthritis. Ibudone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs ( NSAIDs ) . Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration and perforation of stomach, small intestine, or large intestine, with or without warning symptoms, can occur in patients taking NSAIDs. NSAIDs have been associated with an increase in cardiovascular adverse events. The most commonly reported side effects with Ibudone include headache, nausea, dizziness, dyspepsia, somnolence, and constipation. Hydrocodone may impair mental and/or physical abilities when ingested with alcohol and other CNS depressants. Ibudone tablets should be used with caution in elderly or debilitated patients, and in those patients with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.

Please see full Prescribing Information for more on Warnings, Precautions and additional Adverse Reactions that may occur.

About ProEthic Pharmaceuticals, Inc.

ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in areas of pain and migraine. Founded in 2001, privately held company focuses its efforts on acquisition, development, licensing, and marketing of pharmaceutical products.

ProEthic Pharmaceuticals

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Quinapril? For what?

Quinapril: uses Quinapril belongs to a group of medications called ACE inhibitors. It's used to treat high blood pressure ( hypertension ) . It works by relaxing blood vessels, causing them to widen. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

Quinapril is also used with other drugs ( e. g. , " water pills " /diuretics, digoxin ) to treat congestive heart failure.

Quinapril: how to use Take Quinapril by mouth, usually once or twice a day; or as directed by your doctor. Quinapril is best taken on an empty stomach ( 1 hour before or 2 hours after a meal ) , or with a light meal. High-fat meals may decrease the absorption of the medicine into your bloodstream.

Quinapril contains magnesium which can interfere with absorption of certain antibiotics. If we are taking a tetracycline antibiotic, take it at least 2 hours apart from this medicine. If we are taking a quinolone antibiotic ( e. g. , ciprofloxacin, levofloxacin ) , consult your pharmacist for proper times to take it.

Use Quinapril regularly in order to get most benefit from it. Remember to use it at same time ( s ) each day.

Don't take potassium supplements or salt substitutes containing potassium without talking to your doctor or pharmacist first. This medicine can raise your potassium levels, which rarely can cause serious side effects such as muscle weakness or very slow heartbeats. Tell your doctor immediately if these effects occur.

The dosage is based on your medical condition and response to therapy. For the treatment of high blood pressure, it may take 1 to 2 weeks before the full benefit of Quinapril occurs or several weeks to months when used for congestive heart failure.

It's important to continue taking Quinapril even if we feel well. Most people with high blood pressure do not feel sick.

Quinapril: side effects We may experience dizziness, light-headedness, fatigue, nausea, vomiting, back pain, dry cough or blurred vision as your body adjusts to medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Quinapril because he or she has judged that the benefit to we is greater than risk of side effects. Many people using Quinapril do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

Quinapril may rarely cause serious ( possibly fatal ) liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention:

A serious allergic reaction to Quinapril is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

Quinapril: precautions Before taking Quinapril, tell your doctor or pharmacist if we are allergic to it; or to other ACE inhibitors ( e. g. , benazepril, captopril ) ; or if you have any other allergies ( including an allergic reaction after exposure to certain membranes used for blood filtering ) .

Quinapril shouldn't be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if we have:

Before using Quinapril, tell your doctor or pharmacist your medical history, especially of:

Quinapril may make we dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

To minimize dizziness and light-headedness due to lowering of your blood pressure, get up slowly when rising from a seated or lying position. Serious loss of body fluids can also lower your blood pressure and worsen dizziness. Drink adequate fluids to prevent from becoming dehydrated. If we are on restricted fluid intake, consult your doctor for further instructions. Be careful not to become too overheated during exercise which can lead to excessive sweating. Consult your doctor if we experience severe vomiting or diarrhea.

Before having surgery, tell your doctor or dentist that we are taking Quinapril.

Caution is advised when using Quinapril in elderly because they may be more sensitive to its effects, especially dizziness.

Quinapril isn't recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. ( See also Warning section. )

Quinapril passes into breast milk. Breast-feeding isn't recommended due to potential harm to nursing infant. Consult your doctor before breast-feeding.

Quinapril: interactions Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change dosage of any medicine before checking with them first.

See also How To Use section.

Before using Quinapril, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of:

A very serious reaction may occur while use Quinapril if you're getting injections for bee/wasp sting allergy ( desensitization ) and are also taking Quinapril. Make sure all your doctors know which medicines we are using.

Check labels on all your medicines ( e. g. , cough-and-cold products, diet aids ) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about safe use of those products.

This document doesn't contain all possible interactions. Therefore, before using Quinapril, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Quinapril: overdose If overdose of Quinapril is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unusually fast or slow heartbeat, severe dizziness, or fainting.

Quinapril: notes Do not share Quinapril with others. Lifestyle changes such as stress reduction programs, exercise and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests ( e. g. , kidney function, potassium blood level ) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication, especially when you first start Quinapril or when your dose is changed. Learn how to monitor your own blood pressure at home, and share results with your doctor.

Quinapril: missed dose If we miss a dose Quinapril, use it as soon as we remember. If it's near the time of next dose, skip missed dose and resume your usual dosing schedule. Don't double the dose of Quinapril to catch up.

Quinapril: storage Store Quinapril at room temperature between 59-86 degrees F ( 15-30 degrees C ) away from light and moisture. Don't store Quinapril in bathroom. Keep all medicines away from children and pets.

Properly discard Quinapril when it's expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Quinapril: warning Quinapril can cause serious ( possibly fatal ) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking Quinapril. Consult your doctor for more details and to discuss use of reliable forms of birth control while taking this medication. If you're planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.

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