Sunday, 8 July 2012

Fleet Enema


Pronunciation: SOE-dee-um FOS-fates
Generic Name: Sodium Phosphates
Brand Name: Fleet


Fleet Enema is used for:

Treating constipation or cleansing the bowel before certain medical procedures. It may also be used for other conditions as determined by your doctor.


Fleet Enema is a saline laxative enema. It works by pulling water from the body into the bowel, which helps to soften the stool and cause a bowel movement.


Do NOT use Fleet Enema if:


  • you are allergic to any ingredient in Fleet Enema

  • you have a blockage of the bowel or other severe bowel problems, congestive heart failure, kidney failure, or too much phosphate in the blood

Contact your doctor or health care provider right away if any of these apply to you.



Before using Fleet Enema:


Some medical conditions may interact with Fleet Enema. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you are on a sodium-restricted diet or have a history of stomach or bowel problems

  • if you have appendicitis, liver or kidney problems, high blood pressure, low parathyroid function, bone problems (eg, osteomalacia), muscle problems (eg, rhabdomyolysis), pancreas problems, a kidney or bladder infection, kidney stones, electrolyte problems (eg, low blood calcium), a colostomy, nausea, vomiting, stomach pain, or a sudden change in bowel movements lasting longer than 2 weeks

  • if you have already used a laxative for more than 1 week

Some MEDICINES MAY INTERACT with Fleet Enema. However, no specific interactions with Fleet Enema are known at this time.


Ask your health care provider if Fleet Enema may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Fleet Enema:


Use Fleet Enema as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Remove the protective shield from the enema tip before inserting.

  • With steady pressure, gently insert the enema tip into the rectum with a slight side-to-side movement, with the tip pointing toward the navel. Insertion may be easier if you bear down, as if having a bowel movement. This helps relax the muscles around the anus.

  • Do not force the enema tip into the rectum. This can cause injury.

  • Squeeze the bottle until nearly all the liquid is gone. It is not necessary to empty the bottle completely. It contains more liquid than needed.

  • Remove the tip from the rectum and maintain the position until the urge to evacuate is strong (usually 2 to 5 minutes).

  • Do not use more than 1 enema in 24 hours.

  • If you miss a dose of Fleet Enema, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Fleet Enema.



Important safety information:


  • Stop using Fleet Enema and contact your doctor if you have rectal bleeding or fail to have a bowel movement after using Fleet Enema. These symptoms may indicate a serious condition.

  • Fleet Enema should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fleet Enema while you are pregnant. It is not known if Fleet Enema is found in breast milk. If you are or will be breast-feeding while you use Fleet Enema, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Fleet Enema:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Anal irritation; diarrhea; gas; nausea; stomach cramps.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; continued constipation; dizziness; vomiting; weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Fleet Enema:

Store Fleet Enema at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Fleet Enema out of the reach of children and away from pets.


General information:


  • If you have any questions about Fleet Enema, please talk with your doctor, pharmacist, or other health care provider.

  • Fleet Enema is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fleet Enema. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fleet resources


  • Fleet Use in Pregnancy & Breastfeeding
  • Fleet Drug Interactions
  • Fleet Support Group
  • 14 Reviews for Fleet - Add your own review/rating


Compare Fleet with other medications


  • Bowel Preparation
  • Constipation

guaifenesin and pseudoephedrine


Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)

Brand names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA, ...show all 149 brand names.


What is guaifenesin and pseudoephedrine?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.


Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about guaifenesin and pseudoephedrine?


Do not give this medication to a child younger than 4 years old. Alwayss ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

What should I discuss with my healthcare provider before taking guaifenesin and pseudoephedrine?


You should not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:



  • heart disease or high blood pressure;




  • diabetes; or




  • a thyroid disorder.




It is not known whether guaifenesin and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take guaifenesin and pseudoephedrine?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take with food if this medicine upsets your stomach. Do not take guaifenesin and pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.


Store at room temperature away from moisture, heat, and light.

See also: Guaifenesin and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?


Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.


What should I avoid while taking guaifenesin and pseudoephedrine?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

Guaifenesin and pseudoephedrine side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;




  • severe dizziness, anxiety, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).



Less serious side effects may include:



  • dizziness or headache;




  • feeling restless or excited;




  • sleep problems (insomnia);




  • mild nausea, vomiting, or stomach upset;




  • mild loss of appetite;




  • warmth, redness, or tingly feeling under your skin; or




  • skin rash or itching.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Guaifenesin and pseudoephedrine Dosing Information


Usual Adult Dose for Cough and Nasal Congestion:

Immediate release tablets: 1 tablet (30 mg to 45 mg pseudoephedrine) orally up to 4 times a day.
Immediate release syrup: 10 mL (30 mg to 90 mg pseudoephedrine) orally up to 4 times a day.
Immediate release capsule: 1 or 2 capsules (30 mg to 60 mg pseudoephedrine) every 4 to 6 hours, not to exceed 4 capsules in 24 hours.
Extended release tablets or capsules: 1 tablet or capsule (30 mg to 120 mg pseudoephedrine) orally every 12 hours.

Maximum is 240 mg pseudoephedrine or 2.4 g of guaifenesin/day.

Usual Pediatric Dose for Cough and Nasal Congestion:

3 years or older:
Immediate release tablet, capsule or syrup (15 mg to 60 mg pseudoephedrine) orally up to every 4 hours, not to exceed 4 mg/kg pseudoephedrine HCl or 12 mg/kg of guaifenesin/day.

13 years or older:
1 extended release tablet or capsule (30 mg to 120 mg pseudoephedrine) every 12 hours, not to exceed 4 mg/kg pseudoephedrine HCl or 12 mg/kg of guaifenesin/day.

guaifenesin-pseudoephedrine 150 mg-30 mg oral capsule:
12 years or older: 1 or 2 capsules every 4 to 6 hours, not to exceed 8 capsules in 24 hours.
6 years to 11 years: 1 capsule every 4 to 6 hours, not to exceed 4 capsules in 24 hours.


What other drugs will affect guaifenesin and pseudoephedrine?


Tell your doctor about all other medicines you use, especially:



  • methyldopa (Aldomet);




  • blood pressure medications;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More guaifenesin and pseudoephedrine resources


  • Guaifenesin and pseudoephedrine Side Effects (in more detail)
  • Guaifenesin and pseudoephedrine Dosage
  • Guaifenesin and pseudoephedrine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Guaifenesin and pseudoephedrine Drug Interactions
  • Guaifenesin and pseudoephedrine Support Group
  • 58 Reviews for Guaifenesin and pseudoephedrine - Add your own review/rating


Compare guaifenesin and pseudoephedrine with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: guaifenesin and pseudoephedrine side effects (in more detail)


Friday, 6 July 2012

Vimovo



Generic Name: esomeprazole and naproxen (ee soe MEP ra zole and na PROX en)

Brand Names: Vimovo


What is esomeprazole and naproxen?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever.


Esomeprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.


The combination of esomeprazole and naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The esomeprazole in this medication helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.


Esomeprazole and naproxen may also be used for purposes not listed in this medication guide.


What is the most important information I should know about esomeprazole and naproxen?


The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).


Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking esomeprazole and naproxen, especially in older adults.


Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take esomeprazole and naproxen during pregnancy unless your doctor has told you to.

What should I discuss with my healthcare provider before taking esomeprazole and naproxen?


You should not use this medication if you are allergic to esomeprazole (Nexium) or naproxen (Aleve, Anaprox, Naprosyn, and others), or if you have ever had a severe allergic reaction to aspirin or other NSAIDs. Do not use esomeprazole and naproxen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.


Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking esomeprazole and naproxen, especially in older adults.


To make sure you can safely take esomeprazole and naproxen, tell your doctor if you have any of these other conditions:


  • liver or kidney disease;


  • heart disease, high blood pressure, fluid retention, or a history of stroke, heart attack, or congestive heart failure;




  • low levels of magnesium in your blood;




  • a bleeding or blood clotting disorder, such as hemophilia;




  • a history of stomach ulcer, stomach bleeding, or intestinal disorder (Crohn's disease, ulcerative colitis);




  • asthma, or a history of allergic reaction to aspirin, especially aspirin triad syndrome; or




  • if you smoke.




Taking esomeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether esomeprazole is the actual cause of an increased risk of fracture. Tell your doctor if you have osteoporosis or osteopenia (low bone mineral density). FDA pregnancy category D. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take esomeprazole and naproxen during pregnancy unless your doctor has told you to. Naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking esomeprazole and naproxen.

How should I take esomeprazole and naproxen?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Esomeprazole and naproxen is usually taken 2 times each day, at least 30 minutes before a meal. Follow your doctor's instructions.


Take this medication with a full glass of water. Do not crush, chew, or break an enteric coated pill. Swallow it whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your blood pressure and kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision. Visit your doctor regularly.


This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using esomeprazole and naproxen.


Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling weak or tired, nausea, vomiting, stomach pain or discomfort, severe dizziness or drowsiness, bleeding, uncontrolled muscle movements, weak or shallow breathing, or loss of coordination.


What should I avoid while taking esomeprazole and naproxen?


Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains naproxen or another NSAID.

Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these drugs with an NSAID may increase your risk of stomach bleeding.


Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Esomeprazole and naproxen side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using esomeprazole and naproxen and call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising, unusual bleeding, or any bleeding that will not stop;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, problems with vision, speech, or balance;




  • pain, swelling, warmth, or redness in one or both legs;




  • low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);




  • urinating less than usual or not at all;




  • swelling, rapid weight gain, feeling short of breath (even with mild exertion);




  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or




  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.



Less serious side effects may include:



  • constipation, diarrhea; or




  • mild stomach pain.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect esomeprazole and naproxen?


Tell your doctor about all other medicines you use, especially:



  • cholestyramine (Prevalite, Questran);




  • digoxin (digitalis, Lanoxin);




  • lithium (Eskalith, Lithobid, others);




  • methotrexate (Rheumatrex, Trexall);




  • probenecid (Benemid);




  • St. John's wort;




  • tacrolimus (Prograf);




  • an iron supplement;




  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • steroids (prednisone and others);




  • medication used to prevent blood clots, such as clopidogrel (Plavix), ticlopidine (Ticlid), and others;




  • a diuretic (water pill) such as furosemide (Lasix);




  • antifungal medication such as ketoconazole (Nizoral) or voriconazole (Vfend);




  • HIV medication such as atazanavir (Reyataz) or nelfinavir (Viracept);




  • aspirin or other NSAIDs such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others;




  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), or ramipril (Altace); or




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), or sotalol (Betapace).



This list is not complete and other drugs may interact with esomeprazole and naproxen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Vimovo resources


  • Vimovo Side Effects (in more detail)
  • Vimovo Use in Pregnancy & Breastfeeding
  • Vimovo Drug Interactions
  • Vimovo Support Group
  • 6 Reviews for Vimovo - Add your own review/rating


  • Vimovo Prescribing Information (FDA)

  • Vimovo Advanced Consumer (Micromedex) - Includes Dosage Information

  • Vimovo Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vimovo Consumer Overview



Compare Vimovo with other medications


  • Ankylosing Spondylitis
  • NSAID-Induced Ulcer Prophylaxis
  • Osteoarthritis
  • Rheumatoid Arthritis


Where can I get more information?


  • Your pharmacist can provide more information about esomeprazole and naproxen.

See also: Vimovo side effects (in more detail)


Thursday, 5 July 2012

perflubron


per-FLOO-bron


Uses For perflubron

Perflubron is a contrast agent. Contrast agents are used to help provide a clear picture during magnetic resonance imaging (MRI). MRI is a special kind of diagnostic procedure. It uses magnets and computers to create images or "pictures'' of certain areas inside the body. Unlike x-rays, it does not involve radiation.


Perflubron is taken by mouth before MRI to darken bowel (intestines) images, which may help the doctor diagnose problems or diseases of the bowel.


Perflubron is to be used only by or under the supervision of a doctor.


Before Using perflubron


In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to perflubron 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


Although there is no specific information comparing use of perflubron in children with use in other age groups, this agent is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


perflubron has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.


Interactions with Medicines


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


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.


Other Medical Problems


The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blockage or perforation of the bowel—Either of these conditions may allow perflubron to be absorbed into the body and possibly increase the risk of side effects

Proper Use of perflubron


Dosing


The dose of perflubron 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 perflubron. 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.


Precautions While Using perflubron


This agent may cause some leakage from the rectum. The use of absorbent pads may be necessary to prevent soiling of clothing and embarrassment.


perflubron Side Effects


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:


More common
  • Abdominal or stomach fullness

  • diarrhea

  • loss of control of bowels

  • nausea and vomiting

  • oily taste in mouth

Less common
  • Abdominal or stomach pain

  • rectal gas

  • rectal leakage of the solution of perflubron

Rare
  • Chills

  • dizziness

  • flushing or redness of skin

  • headache

  • numb mouth

  • trembling

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.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Tuesday, 3 July 2012

Phentolamine





Dosage Form: injection, powder, for solution
Phentolamine MESYLATE

FOR INJECTION, USP

Rx ONLY.



Phentolamine Description


Phentolamine Mesylate for Injection USP, is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains Phentolamine mesylate USP, 5 mg and mannitol USP, 25 mg in sterile, lyophilized form.


Phentolamine mesylate is m-[N-(2-Imidazolin-2-ylmethyl)-p-toluidino]phenol monomethanesulfonate (salt), and its structural formula is:



Molecular Formula - C17H19N3O•CH4O3S                                  M.W. - 377.47


Phentolamine mesylate USP is a white or off-white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in alcohol, and slightly soluble in chloroform. It melts at about 178°C.



Phentolamine - Clinical Pharmacology


Phentolamine mesylate produces an alpha-adrenergic block of relatively short duration. It also has direct, but less marked, positive inotropic and chronotropic effects on cardiac muscle and vasodilator effects on vascular smooth muscle.


Phentolamine has a half-life in the blood of 19 minutes following intravenous administration. Approximately 13% of a single intravenous dose appears in the urine as unchanged drug.



Indications and Usage for Phentolamine


Phentolamine Mesylate for Injection is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision.


Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.


Phentolamine Mesylate for Injection is also indicated for the diagnosis of pheochromocytoma by the Phentolamine blocking test.



Contraindications


Myocardial infarction, history of myocardial infarction, coronary insufficiency, angina, or other evidence suggestive of coronary artery disease; hypersensitivity to Phentolamine or related compounds.



Warnings


Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the administration of Phentolamine, usually in association with marked hypotensive episodes.


For screening tests in patients with hypertension, the generally available urinary assay of catecholamines or other biochemical assays have largely replaced the Phentolamine and other pharmacological tests for reasons of accuracy and safety. None of the chemical or pharmacological tests is infallible in the diagnosis of pheochromocytoma. The Phentolamine blocking test is not the procedure of choice and should be reserved for cases in which additional confirmatory evidence is necessary and the relative risks involved in conducting the test have been considered.



Precautions



General


Tachycardia and cardiac arrhythmias may occur with the use of Phentolamine or other alpha-adrenergic blocking agents. When possible, administration of cardiac glycosides should be deferred until cardiac rhythm returns to normal.



Drug Interactions


See DOSAGE AND ADMINISTRATION. Diagnosis of pheochromocytoma, Preparation.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term carcinogenicity studies, mutagenicity studies, and fertility studies have not been conducted with Phentolamine.



Pregnancy


Teratogenic Effects-Pregnancy Category C

Administration of Phentolamine to pregnant rats and mice at oral doses 24 to 30 times the usual daily human dose (based on a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral doses 60 times the usual daily human dose (based on a 60 kg human), a slightly lower rate of implantation was found in the rat. Phentolamine did not affect embryonic or fetal development in the rabbit at oral doses 20 times the usual daily human dose (based on a 60 kg human). No teratogenic or embryotoxic effects were observed in the rat, mouse, or rabbit studies.


There are no adequate and well-controlled studies in pregnant women. Phentolamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Phentolamine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


See DOSAGE AND ADMINISTRATION.



Adverse Reactions


Acute and prolonged hypotensive episodes, tachycardia, and cardiac arrhythmias have been reported. In addition, weakness, dizziness, flushing, orthostatic hypotension, nasal stuffiness, nausea, vomiting, and diarrhea may occur.



Overdosage



Acute Toxicity


No deaths due to acute poisoning with Phentolamine have been reported.


Oral LD50’s (mg/kg): mice, 1000; rats, 1250.



Signs and Symptoms


Overdosage with Phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock. In addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances; nausea, vomiting, diarrhea; hypoglycemia.



Treatment


There is no specific antidote.


A decrease in blood pressure to dangerous levels or other evidence of shocklike conditions should be treated vigorously and promptly. The patient’s legs should be kept raised and a plasma expander should be administered. If necessary, intravenous infusion or norepi-nephrine, titrated to maintain blood pressure at the normotensive level, and all available supportive measures should be included. Epinephrine should not be used, since it may cause a paradoxical reduction in blood pressure.



Phentolamine Dosage and Administration


The reconstituted solution should be used upon preparation and should not be stored.


  1. Prevention or control of hypertensive episodes in the patient with pheochromo-cytoma. For preoperative reduction of elevated blood pressure, 5 mg of Phentolamine mesylate (1 mg for children) is injected intravenously or intramuscularly 1 or 2 hours before surgery, and repeated if necessary.

    During surgery, Phentolamine mesylate (5 mg for adults, 1 mg for children) is administered intravenously as indicated, to help prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of epinephrine intoxication. (Postoperatively, norepinephrine may be given to control the hypotension that commonly follows complete removal of a pheochromocytoma.)

  2. Prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.

    For Prevention: 10 mg of Phentolamine mesylate is added to each liter of solution containing norepinephrine. The pressor effect of norepinephrine is not affected.

    For Treatment: 5 to 10 mg of Phentolamine mesylate in 10 mL of saline is injected into the area of extravasation within 12 hours.

  3. Diagnosis of pheochromocytoma - Phentolamine blocking test.

    The test is most reliable in detecting pheochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False-positive tests may occur in patients with hypertension without pheochromocytoma.


a. Intravenous


Preparation

The CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections should be reviewed. Sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to 72 hours, prior to the test. Antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. This test is not preformed on a patient who is normotensive.


Procedure

The patient is kept at rest in a supine position throughout the test, preferably in a quiet, darkened room. Injection of Phentolamine is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes.


Five milligrams of Phentolamine mesylate is dissolved in 1 mL of Sterile Water for Injection. The dose for adults is 5 mg; for children, 1 mg.


The syringe needle is inserted into the vein, and injection is delayed until pressor response to venipuncture has subsided.


Phentolamine is injected rapidly. Blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes.


Interpretation

A positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mm Hg systolic and 25 mm Hg diastolic. A typical positive response is a reduction in pressure of 60 mm Hg systolic and 25 mm Hg diastolic. Usually, maximal effect is evident within 2 minutes after injection. A return to preinjection pressure commonly occurs within 15 to 30 minutes but may occur more rapidly.


If blood pressure decreases to a dangerous level, the patient should be treated as outlined under OVERDOSAGE.


A positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites.


A negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mm Hg systolic and 25 mm Hg diastolic after injection of Phentolamine. A negative response to this test does not exclude the diagnosis of pheo-chromocytoma, especially in patients with paroxysmal hypertension in whom the incidence of false-negative responses is high.



b. Intramuscular


If the intramuscular test for pheochromocytoma is preferred, preparation is the same as for the intravenous test. Five milligrams of Phentolamine mesylate is then dissolved in 1 mL of Sterile Water for Injection. The dose for adults is 5 mg intramuscularly; for children, 3 mg. Blood pressure is recorded every 5 minutes for 30 to 45 minutes following injection. A positive response is indicated when the blood pressure is reduced 35 mm Hg systolic and 25 mm Hg diastolic, or more, within 20 minutes following injection.


Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.



How is Phentolamine Supplied


Phentolamine Mesylate for Injection USP, 5 mg, for intramuscular or intravenous use, is supplied in a 2mL vial and individually boxed. NDC 55390-113-01.


The reconstituted solution should be used upon preparation and should not be stored.


Store at controlled room temperature, 15° to 30°C (59° to 86°F).


Manufactured for:                                               Manufactured by:


Bedford Laboratories™                                       Ben Venue Laboratories™


Bedford, OH 44146                                             Bedford, OH 44146


May 1999                                                           PHT - P01



VIAL LABEL


Vial Label 5 mg




CARTON


Unit Carton 5 mg










Phentolamine MESYLATE 
Phentolamine mesylate  injection, powder, for solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)55390-113
Route of AdministrationINTRAMUSCULAR, INTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phentolamine MESYLATE (Phentolamine)Phentolamine MESYLATE5 mg  in 1 mL






Inactive Ingredients
Ingredient NameStrength
MANNITOL25 mg  in 1 mL


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
155390-113-011 VIAL In 1 BOXcontains a VIAL
11 mL In 1 VIALThis package is contained within the BOX (55390-113-01)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04023505/15/1998


Labeler - Bedford Laboratories (884528407)









Establishment
NameAddressID/FEIOperations
Ben Venue Laboratories, Inc.004327953MANUFACTURE
Revised: 03/2010Bedford Laboratories

More Phentolamine resources


  • Phentolamine Side Effects (in more detail)
  • Phentolamine Use in Pregnancy & Breastfeeding
  • Phentolamine Drug Interactions
  • Phentolamine Support Group
  • 0 Reviews for Phentolamine - Add your own review/rating


  • Phentolamine Professional Patient Advice (Wolters Kluwer)

  • phentolamine Injection Advanced Consumer (Micromedex) - Includes Dosage Information

  • OraVerse Consumer Overview

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  • Dermal Necrosis, Treatment
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Epifrin


Generic Name: epinephrine (Ophthalmic route)

ep-i-NEF-rin

Commonly used brand name(s)

In Canada


  • Epifrin

  • Glaucon

Available Dosage Forms:


  • Solution

Uses For Epifrin


Ophthalmic epinephrine is used to treat certain types of glaucoma. It may also be used in eye surgery.


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


Before Using Epifrin


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of this medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy


Ophthalmic epinephrine may be absorbed into the body. However, studies on effects in pregnancy have not been done in either humans or animals.


Breast Feeding


Ophthalmic epinephrine may be absorbed into the body. However, it is not known whether epinephrine passes into the breast milk.


Interactions with Medicines


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


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.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bronchial asthma or

  • Type 2 diabetes mellitus or

  • Eye disease (other) or

  • Heart or blood vessel disease or

  • High blood pressure or

  • Overactive thyroid—Epinephrine may make the condition worse.

  • Dental surgery on gums—Dental surgery may include the use of epinephrine in topical or injection form. Use of ophthalmic epinephrine during this time may increase blood levels of the medicine and increase the chance of side effects.

Proper Use of epinephrine

This section provides information on the proper use of a number of products that contain epinephrine. It may not be specific to Epifrin. Please read with care.


Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.


To use:


  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using epinephrine ophthalmic solution:


  • Do not use if the solution turns pinkish or brownish in color, or if it becomes cloudy.

For patients using epinephryl borate ophthalmic solution:


  • The color of this solution may vary from colorless to amber yellow. Do not use if the solution turns dark brown or becomes cloudy.

Dosing


The dose medicines in this class 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 these medicines. 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 epinephrine and epinephryl borate

  • For ophthalmic solution (eye drops) dosage forms:
    • For glaucoma:
      • Adults and teenagers—One drop one or two times a day.

      • Children—Use and dose must be determined by your doctor.



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


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Epifrin


Your doctor should check your eye pressure at regular visits.


This medicine may cause blurred vision or other vision problems for a short time after it is applied. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well.


Epifrin 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 as soon as possible if any of the following side effects occur:


Less common
  • Blurred or decreased vision

Symptoms of too much medicine being absorbed into the body
  • Fast, irregular, or pounding heartbeat

  • feeling faint

  • increased sweating

  • paleness

  • trembling

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:


More common
  • Headache or browache

  • stinging, burning, redness, or other eye irritation

  • watering of eyes

Less common
  • Eye pain or ache

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.

See also: Epifrin side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Epifrin resources


  • Epifrin Side Effects (in more detail)
  • Epifrin Use in Pregnancy & Breastfeeding
  • Epifrin Drug Interactions
  • Epifrin Support Group
  • 0 Reviews for Epifrin - Add your own review/rating


  • epinephrine ophthalmic Concise Consumer Information (Cerner Multum)



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  • Glaucoma, Open Angle

Sunday, 1 July 2012

Stagesic


Pronunciation: a-SEET-a-MIN-oh-fen/HYE-droe-KOE-done
Generic Name: Acetaminophen/Hydrocodone
Brand Name: Examples include Dolacet and Stagesic

Stagesic contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.





Stagesic is used for:

Treating moderate to moderately severe pain. It may also be used for other conditions as determined by your doctor.


Stagesic is an analgesic combination. Acetaminophen works by lowering a chemical in the brain that stimulates pain nerves. Hydrocodone, an opioid (narcotic) analgesic, works by binding to receptors in the brain and nervous system used by the body's natural "pain relievers." The combination may provide better pain relief than either medicine alone.


Do NOT use Stagesic if:


  • you are allergic to any ingredient in Stagesic

  • you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)

  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Stagesic:


Some medical conditions may interact with Stagesic. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you are allergic to other narcotic medicines (eg, medicines that contain codeine, morphine, oxycodone)

  • if you have or have ever had alcoholism, substance abuse, narcotic dependence, or if you consume more than 3 alcoholic drinks per day

  • if you have a history of suicidal thoughts or behavior

  • if you have a head injury, increased pressure in the head, a brain injury or tumor, epilepsy, or seizures

  • if you are having an asthma attack

  • if you have an acute stomach or intestinal problem, chronic inflammation and ulceration of the bowel, or you have had recent abdominal surgery

  • if you have adrenal gland problems; enlargement of the prostate gland; heart failure or lung disease, including shortness of breath; liver or kidney problems; thyroid disease; urinary blockage; or viral hepatitis

Some MEDICINES MAY INTERACT with Stagesic. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because serious side effects, such as increased sleepiness and decreased ability to breathe, may occur

  • Naltrexone because it may decrease the effectiveness of Stagesic and withdrawal symptoms may occur in patients who have become physically dependent on opioids

This may not be a complete list of all interactions that may occur. Ask your health care provider if Stagesic may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Stagesic:


Use Stagesic as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Stagesic by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • If you miss a dose of Stagesic, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Stagesic.



Important safety information:


  • Stagesic may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Stagesic with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Stagesic; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Stagesic may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

  • Stagesic has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Stagesic may harm your liver. Your risk may be greater if you drink alcohol while you are using Stagesic. Talk to your doctor before you take Stagesic or other fever reducers if you drink more than 3 drinks with alcohol per day.

  • Use Stagesic with caution in the ELDERLY; they may be more sensitive to its effects, especially possible decreased breathing and drowsiness.

  • Stagesic should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stagesic while you are pregnant. Stagesic is found in breast milk. Do not breast-feed while taking Stagesic.

When used for long periods of time or at high doses, Stagesic may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Stagesic stops working well. Do not take more than prescribed.


Some people who use Stagesic for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.


If you suddenly stop taking Stagesic, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.



Possible side effects of Stagesic:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Blurred vision; constipation; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in the amount of urine produced; fear; hearing change or loss; interrupted breathing; mental or mood changes; unusual tiredness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Stagesic side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure; stomach or intestinal pain.


Proper storage of Stagesic:

Store Stagesic at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not freeze. Dispense in a tight, light-resistant container. Do not store in the bathroom. Keep Stagesic out of the reach of children and away from pets.


General information:


  • If you have any questions about Stagesic, please talk with your doctor, pharmacist, or other health care provider.

  • Stagesic is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Stagesic. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Stagesic resources


  • Stagesic Side Effects (in more detail)
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  • Stagesic Support Group
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  • Vicodin Prescribing Information (FDA)

  • Vicodin ES Prescribing Information (FDA)

  • Vicodin HP Prescribing Information (FDA)

  • Xodol Prescribing Information (FDA)

  • Zolvit Prescribing Information (FDA)

  • Zydone Prescribing Information (FDA)



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  • Back Pain
  • Cough
  • Pain
  • Rheumatoid Arthritis