Friday, 29 June 2012

ampicillin



Generic Name: ampicillin (am pi SIL in)

Brand names: Principen, Totacillin, Omnipen, Omnipen-N, Totacillin-N


What is ampicillin?

Ampicillin is an antibiotic in the penicillin group of drugs. It fights bacteria in your body.


Ampicillin is used to treat many different types of infections caused by bacteria, such as ear infections, bladder infections, pneumonia, gonorrhea, and E. coli or salmonella infection.


Ampicillin may also be used for purposes not listed in this medication guide.


What is the most important information I should know about ampicillin?


Do not use this medication if you are allergic to ampicillin or to any other penicillin antibiotic, such as amoxicillin (Amoxil), carbenicillin (Geocillin), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Before using ampicillin, tell your doctor if you are allergic to cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others, or if you have asthma, kidney disease, a bleeding or blood clotting disorder, mononucleosis (also called "mono"), or a history of any type of allergy.


Ampicillin can make birth control pills less effective, which may result in pregnancy. Before taking ampicillin, tell your doctor if you use birth control pills. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Ampicillin will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ampicillin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


What should I discuss with my healthcare provider before taking ampicillin?


Do not use this medication if you are allergic to ampicillin or to any other penicillin antibiotic, such as:

  • amoxicillin (Amoxil, Amoxicot, Biomox, Dispermox, Trimox);




  • carbenicillin (Geocillin);




  • dicloxacillin (Dycill, Dynapen);




  • oxacillin (Bactocill); or




  • penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others).



To make sure you can safely take ampicillin, tell your doctor if you are allergic to any drugs (especially cephalosporins such as Omnicef, Cefzil, Ceftin, Keflex, and others), or if you have:



  • asthma;




  • kidney disease;




  • a bleeding or blood clotting disorder;




  • mononucleosis (also called "mono");




  • a history of diarrhea caused by taking antibiotics; or




  • a history of any type of allergy.




FDA pregnancy category B. Ampicillin is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ampicillin can make birth control pills less effective, which may result in pregnancy. Before taking ampicillin, tell your doctor if you use birth control pills. Ampicillin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking ampicillin.

How should I take ampicillin?


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.


Take the medicine with a full glass of water. Ampicillin should be taken on an empty stomach, at least 1 hour before or 2 hours after eating a meal.

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.


If you are being treated for gonorrhea, your doctor may also have you tested for syphilis, another sexually transmitted disease.


Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Ampicillin will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

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


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 confusion, behavior changes, a severe skin rash, urinating less than usual, or seizure (black-out or convulsions).


What should I avoid while taking ampicillin?


Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ampicillin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


Ampicillin 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. Call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;




  • diarrhea that is watery or bloody;




  • fever, chills, body aches, flu symptoms;




  • easy bruising or bleeding, unusual weakness;




  • urinating less than usual or not at all;




  • agitation, confusion, unusual thoughts or behavior; or




  • seizure (black-out or convulsions).



Less serious side effects may include



  • nausea, vomiting, stomach pain;




  • vaginal itching or discharge;




  • headache;




  • swollen, black, or "hairy" tongue; or




  • thrush (white patches or inside your mouth or throat).



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.


Ampicillin Dosing Information


Usual Adult Dose for Bacterial Endocarditis Prophylaxis:

Low to moderate risk: 2 g IV or IM 30 minutes before procedure.

High risk: Ampicillin 2 g plus gentamicin 1.5 mg/kg IV or IM 30 minutes before procedure. Follow with ampicillin 1 g IV or IM, or amoxicillin 1 g orally, 6 hours after initial dose.

Usual Adult Dose for Bronchitis:

Bacterial exacerbations of chronic bronchitis:
250 to 500 mg orally every 6 hours for 5 to 10 days, depending on the nature and severity of the infection.

Usual Adult Dose for Endocarditis:

Enterococcal:
Ampicillin 2 g IV every 4 hours plus gentamicin 1 mg/kg IV every 8 hours for 4 to 6 weeks.

Usual Adult Dose for Gastroenteritis:

250 to 500 mg orally every 6 hours.

Usual Adult Dose for Intraabdominal Infection:

1 to 2 g IV every 4 to 6 hours in combination with other antibiotics, depending on the nature and severity of the infection.

Duration: 10-14 days.

Usual Adult Dose for Leptospirosis:

Moderate to severe: 0.5 to 1 g intravenously every 6 hours.
Mild: 500 to 750 mg orally every 6 hours.

Usual Adult Dose for Meningitis:

IV:
200 mg/kg/day (up to 12 g/day) IV in equally divided doses every 4 hours, in combination with other parenteral antibiotics.

Intrathecal or intraventricular:
10 to 50 mg/day in addition to IV antibiotics.

Usual Adult Dose for Peritonitis:

CAPD-associated peritonitis: 250 to 500 mg orally twice daily and/or 100 to 125 mg/L exchange intraperitoneally, with or without other antibiotics depending on the nature and severity of the infection.

Secondary: 1 to 2 g IV every 4 to 6 hours in combination with other antibiotics, depending on the nature and severity of the infection.

Duration: 10 to 14 days.

Usual Adult Dose for Pneumonia:

Beta-lactamase negative, penicillin-susceptible: 1 to 2 g IV every 4 to 6 hours, in combination with other antibiotic(s) depending on the nature and severity of the infection.

Usual Adult Dose for Prevention of Perinatal Group B Streptococcal Disease:

As an alternative to penicillin G: 2 g IV as a loading dose, followed by 1 g every 4 hours until delivery.

Usual Adult Dose for Pyelonephritis:

500 mg to 2 g IV or IM every 4 to 6 hours with or without other antibiotics, depending on the nature and severity of the infection.
Duration: 2 to 3 weeks.

Usual Adult Dose for Septicemia:

1 to 2 g IV every 3 to 4 hours, in combination with other antibiotics.

Usual Adult Dose for Shigellosis:

500 mg orally every 6 hours for 5 days

Usual Adult Dose for Skin or Soft Tissue Infection:

250 to 500 mg orally every 6 hours or 1 to 2 g IV every 4 to 6 hours, depending on the nature and severity of the infection.

Usual Adult Dose for Surgical Prophylaxis:

Liver transplant: Ampicillin 1 g plus cefotaxime 1 g IV at induction, then every 6 hours for 48 hours after closure.

Usual Adult Dose for Typhoid Fever:

Severe, fully susceptible: 25 mg/kg IV or IM every 6 hours for 10 to 14 days.
Carrier state: 1.5 g orally or IV with probenecid 500 mg every 6 hours for 6 weeks.
Fluoroquinolones or amoxicillin are considered the drugs of choice.

Usual Adult Dose for Otitis Media:

500 mg orally or 1 to 2 g IV or IM every 6 hours, depending on the nature and severity of the infection.

Usual Adult Dose for Pharyngitis:

500 mg orally or 1 to 2 g IV or IM every 6 hours, depending on the nature and severity of the infection.

Usual Adult Dose for Sinusitis:

500 mg orally or 1 to 2 g IV or IM every 6 hours, depending on the nature and severity of the infection.

Usual Adult Dose for Upper Respiratory Tract Infection:

500 mg orally or 1 to 2 g IV or IM every 6 hours, depending on the nature and severity of the infection.

Usual Adult Dose for Urinary Tract Infection:

Mild, uncomplicated: 250 to 500 mg orally every 6 hours
Severe, complicated: 500 mg to 2 g IV every 4 to 6 hours with or without other antibiotics, depending on the nature and severity of the infection.

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis:

Low to moderate risk: 50 mg/kg IV or IM 30 minutes before procedure.

High risk: 50 mg/kg plus gentamicin 1.5 mg/kg, both intramuscularly or IV 30 minutes before procedure. Follow with ampicillin 25 mg/kg IV or IM, or amoxicillin 25 mg/kg orally, 6 hours after initial dose.

Usual Pediatric Dose for Meningitis:

Neonates:
2000 g: 50 mg/kg IV every 8 hours.
> 7 days, birthweight > 7 days, birthweight 1200 to 2000 g: 50 mg/kg IV every 8 hours.
> 7 days, birthweight > 2000 g: 50 mg/kg IV every 6 hours.

Infants and children:
50 to 100 mg/kg IV every 6 hours. Maximum dose 12 g/day.

Ampicillin should be given in combination with another antibiotic, depending on the nature of the infection.

Usual Pediatric Dose for Skin or Soft Tissue Infection:

IV: 6.25 to 12.5 mg/kg every 6 hours (maximum 12 g/day).

Oral: 6.25 to 12.5 mg/kg every 6 hours (maximum 2 to 3 g/day).

Usual Pediatric Dose for Upper Respiratory Tract Infection:

IV: 6.25 to 12.5 mg/kg every 6 hours (maximum 12 g/day).

Oral: 6.25 to 12.5 mg/kg every 6 hours (maximum 2 to 3 g/day).

Usual Pediatric Dose for Surgical Prophylaxis:

Liver transplant: Ampicillin 50 mg/kg plus cefotaxime 50 mg/kg at induction and every 6 hours for 48 hours after closure.


What other drugs will affect ampicillin?


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



  • allopurinol (Zyloprim);




  • methotrexate (Rheumatrex, Trexall);




  • probenecid (Benemid);




  • a sulfa drug (such as Bactrim or Septra); or




  • a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).



This list is not complete and there may be other drugs that can interact with ampicillin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More ampicillin resources


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


  • Ampicillin Prescribing Information (FDA)

  • Ampicillin Professional Patient Advice (Wolters Kluwer)

  • Ampicillin Monograph (AHFS DI)

  • Ampicillin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ampicillin Sodium and Sulbactam Sodium Monograph (AHFS DI)

  • Principen Advanced Consumer (Micromedex) - Includes Dosage Information



Compare ampicillin with other medications


  • Bacterial Endocarditis Prevention
  • Bronchitis
  • Endocarditis
  • Gastroenteritis
  • Intraabdominal Infection
  • Kidney Infections
  • Leptospirosis
  • Meningitis
  • Otitis Media
  • Peritonitis
  • Pharyngitis
  • Pneumonia
  • Prevention of Perinatal Group B Streptococcal Disease
  • Septicemia
  • Shigellosis
  • Sinusitis
  • Skin Infection
  • Surgical Prophylaxis
  • Typhoid Fever
  • Upper Respiratory Tract Infection
  • Urinary Tract Infection


Where can I get more information?


  • Your pharmacist can provide more information about ampicillin.

See also: ampicillin side effects (in more detail)


Thursday, 28 June 2012

Mycophenolate Mofetil


Pronunciation: MYE-koe-FEN-oh-late MOE-fe-til
Generic Name: Mycophenolate Mofetil
Brand Name: CellCept

Mycophenolate Mofetil weakens your immune system, which may decrease your ability to fight illness or infection. It may also increase the risk of certain types of cancer (eg, lymphoma). Use Mycophenolate Mofetil only under close medical supervision.


Mycophenolate Mofetil may cause birth defects or fetal death if taken during pregnancy. Women who may become pregnant must use an effective form of birth control while they are taking Mycophenolate Mofetil.





Mycophenolate Mofetil is used for:

Preventing organ rejection following kidney, liver, or heart transplants. Mycophenolate Mofetil is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Mycophenolate Mofetil is an immunosuppressant. It works by decreasing the activity of certain cells that make up part of the immune system to help reduce the risk of organ transplant rejection.


Do NOT use Mycophenolate Mofetil if:


  • you are allergic to any ingredient in Mycophenolate Mofetil or to mycophenolic acid

  • you are taking azathioprine, cholestyramine, colestipol, or another medicine that contains mycophenolate or mycophenolic acid

  • you are taking norfloxacin and metronidazole together

  • you have a rare hereditary deficiency of hypoxanthine guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome

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



Before using Mycophenolate Mofetil:


Some medical conditions may interact with Mycophenolate Mofetil. 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 have immune system problems or have been taking another medicine that may suppress your immune system

  • if you have stomach or intestinal problems (eg, ulcers), or kidney problems

  • if you have a personal or family history of skin cancer, blood cancer (eg, lymphoma), or other blood problems

  • if you are scheduled for a vaccination

  • if you will be in close contact with a person who has shingles, another type of herpes infection, or cytomegalovirus (CMV) infection

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


  • Acyclovir, azathioprine, ganciclovir, mycophenolic acid, or probenecid because they may increase the risk of Mycophenolate Mofetil's side effects

  • Cholestyramine, colestipol, cyclosporine, norfloxacin along with metronidazole, or rifampin because they may decrease Mycophenolate Mofetil's effectiveness

  • Live vaccines or oral contraceptives because their effectiveness may be decreased by Mycophenolate Mofetil

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mycophenolate Mofetil 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 Mycophenolate Mofetil:


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


  • Mycophenolate Mofetil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mycophenolate Mofetil refilled.

  • Take Mycophenolate Mofetil by mouth on an empty stomach at least 1 hour before or 2 hours after eating unless your doctor tells you otherwise.

  • Swallow Mycophenolate Mofetil whole. Do not break, crush, or chew before swallowing.

  • Do not take an antacid that has aluminum or magnesium in it within 3 hours of taking Mycophenolate Mofetil.

  • If you take a calcium-free phosphate binder (eg, sevelamer), take it 2 hours after taking Mycophenolate Mofetil.

  • If you miss a dose of Mycophenolate Mofetil, 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 Mycophenolate Mofetil.



Important safety information:


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

  • Women who may become pregnant must have a negative pregnancy test within 1 week before starting Mycophenolate Mofetil.

  • Women who may become pregnant must use 2 effective forms of birth control for 4 weeks before they start Mycophenolate Mofetil, during treatment, and for 6 weeks after they stop Mycophenolate Mofetil. Check with your doctor if you have any questions about effective birth control.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are taking Mycophenolate Mofetil. Discuss any questions or concerns with your doctor.

  • Mycophenolate Mofetil may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Avoid the sun, sunlamps, or tanning booths while you take Mycophenolate Mofetil. Use a sunscreen and wear protective clothing if you must be outside for more than a short time. Tell your doctor right away if you notice a change in the size or color of a mole or if you develop any new or unusual skin growths.

  • Mycophenolate Mofetil may lower the ability of your body to fight infection and may increase the risk of severe or fatal infections. Avoid contact with people who have colds, shingles, other herpes infections, cytomegalovirus (CMV), or other infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.

  • Some patients treated with Mycophenolate Mofetil have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. Discuss any questions or concerns with your doctor.

  • Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination).

  • Tell your doctor right away if you notice symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Discuss any questions or concerns with your doctor.

  • Some patients treated with Mycophenolate Mofetil have developed a type of anemia called pure red cell aplasia (PRCA). Contact your doctor right away if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin.

  • Mycophenolate Mofetil may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Diarrhea may occur with Mycophenolate Mofetil. If you develop diarrhea, check with your doctor or pharmacist about ways to lessen this effect. Do not stop Mycophenolate Mofetil without talking with your doctor.

  • Do not change brands or doseforms (eg, tablets, suspension, injection) of Mycophenolate Mofetil without talking with your doctor.

  • Do not receive a live vaccine (eg, measles, mumps) while you are using Mycophenolate Mofetil. Talk with your doctor before you receive any vaccine.

  • Lab tests, including complete blood cell counts and kidney function, may be performed while you use Mycophenolate Mofetil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Mycophenolate Mofetil with caution in the ELDERLY; they may be more sensitive to its effects, especially infection, stomach or intestinal bleeding, and trouble breathing.

  • Caution is advised when using Mycophenolate Mofetil in CHILDREN; they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: Mycophenolate Mofetil may cause birth defects or fetal death if you take it while you are pregnant. Do not become pregnant while you are taking Mycophenolate Mofetil. If you think you may be pregnant, contact your doctor right away. It is not known if Mycophenolate Mofetil is found in breast milk. Do not breast-feed while taking Mycophenolate Mofetil.


Possible side effects of Mycophenolate Mofetil:


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:



Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; 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); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, blood in the urine; difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.



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: Mycophenolate Mofetil 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 diarrhea; nausea; vomiting.


Proper storage of Mycophenolate Mofetil:

Store Mycophenolate Mofetil at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mycophenolate Mofetil out of the reach of children and away from pets.


General information:


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

  • Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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 Mycophenolate Mofetil resources


  • Mycophenolate Mofetil Side Effects (in more detail)
  • Mycophenolate Mofetil Dosage
  • Mycophenolate Mofetil Use in Pregnancy & Breastfeeding
  • Drug Images
  • Mycophenolate Mofetil Drug Interactions
  • Mycophenolate Mofetil Support Group
  • 27 Reviews for Mycophenolate Mofetil - Add your own review/rating


  • Mycophenolate Mofetil Prescribing Information (FDA)

  • mycophenolate mofetil Advanced Consumer (Micromedex) - Includes Dosage Information

  • CellCept Prescribing Information (FDA)

  • Cellcept Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cellcept Consumer Overview



Compare Mycophenolate Mofetil with other medications


  • Autoimmune Hepatitis
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  • Inflammatory Bowel Disease
  • Multiple Sclerosis
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  • Nephrotic Syndrome
  • Organ Transplant, Rejection Prophylaxis
  • Pemphigoid
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Mefenamic Acid


Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Chemical Name: N-(2,3-xylyl)anthranilic acid
Molecular Formula: C15H15NO2
CAS Number: 61-68-7
Brands: Ponstel


  • Cardiovascular Risk


  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).125 b Risk may increase with duration of use.125 b Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.125 b (See Cardiovascular Effects under Cautions.)




  • Contraindicated for the treatment of pain in the setting of CABG surgery.125 b



  • GI Risk


  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).100 104 125 b Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.100 101 104 125 b Geriatric individuals are at greater risk for serious GI events.125 b (See GI Effects under Cautions.)




Introduction

Prototypical NSAIA; anthranilic acid derivative (fenamate); structurally and pharmacologically related to meclofenamate sodium.125 a


Uses for Mefenamic Acid


Consider potential benefits and risks of mefenamic acid therapy as well as alternative therapies before initiating therapy with the drug.125 b Use lowest possible effective dosage and shortest duration of therapy consistent with patient’s treatment goals.125 b


Pain


Relief of mild to moderate pain in patients ≥14 years of age when the duration of therapy ≤1 week.125 b


Dysmenorrhea


Treatment of primary dysmenorrhea.125 b


Fever


Has been used for reduction of fever† associated with infection in children; routine use as an antipyretic not recommended because of potential adverse effects.a


Mefenamic Acid Dosage and Administration


General



  • Consider potential benefits and risks of mefenamic acid therapy as well as alternative therapies before initiating therapy with the drug.125 b



Administration


Oral Administration


Administer orally.125 May be administered in divided doses up to 4 times daily.125


Dosage


To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.125 b Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.125 b


Pediatric Patients


Pain

Oral

Adolescents ≥14 years of age should receive dosage recommended for adults.125 (See Adult Dosage.)


Adults


Pain

Oral

For mild to moderate pain in adults, 500 mg initially followed by 250 mg every 6 hours as necessary.125


Dysmenorrhea

Oral

For relief of primary dysmenorrhea in adults, 500 mg initially followed by 250 mg every 6 hours as necessary.125 Initiate at onset of bleeding and associated symptoms; treatment should not be necessary for >2–3 days.125


Prescribing Limits


Pediatric Patients


Pain

Oral

Duration of therapy usually should not exceed 1 week.125


Adults


Pain

Oral

Duration of therapy usually should not exceed 1 week.125


Dysmenorrhea

Oral

Therapy should not be necessary for more than 2–3 days.125


Special Populations


Hepatic Impairment


Dosage reduction may be required.125


Renal Impairment


Dosage reduction may be required if used in patients with renal impairment.125


Use not recommended in patients with preexisting renal disease or substantial renal impairment.125


Geriatric Patients


Select dosage carefully since may be more likely to have decreased renal function.125 b


Cautions for Mefenamic Acid


Contraindications



  • Known hypersensitivity to mefenamic acid or any ingredient in the formulation.125 b




  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.125 b




  • Treatment of perioperative pain in the setting of CABG surgery.125 b




  • Active ulceration or chronic inflammation of upper or lower GI tract.125




  • Preexisting renal disease.125



Warnings/Precautions


Warnings


Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.125 129 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.125 133 134 135 Information not available on risk associated with mefenamic acid at this time.133 134 135 136


Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events) and at the lowest effective dosage for the shortest duration necessary.125 b


Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).125 b


No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.125 b (See Specific Drugs under Interactions.)


Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.125 b Use with caution in patients with hypertension; monitor BP.125 b Impaired response to certain diuretics may occur.125 b (See Specific Drugs under Interactions.)


Fluid retention and edema reported.125 b Caution in patients with fluid retention or heart failure.125 b


GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.100 104 124 125 126 b


For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;124 127 h i alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)124 h i or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).125 h


Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.125 b


Potential for overt renal decompensation.125 b Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.125 128 b (See Renal Impairment under Cautions.)


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylactoid reactions reported.125 b


Immediate medical intervention and discontinuance for anaphylaxis.125 b


Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.125 b


Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.125 b Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).125 b


General Precautions


Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.125 b


Elevations of serum ALT or AST reported.125 b


Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.125 b Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.125 b


Hematologic Effects

Anemia reported rarely.125 b Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.125 b


May inhibit platelet aggregation and prolong bleeding time.125 b


Ocular Effects

Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.125 a


Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.125 b


May mask certain signs of infection.125 b


Obtain CBC and chemistry profile periodically during long-term use.125 b


Specific Populations


Pregnancy

Category C.125 b Avoid use in third trimester because of possible premature closure of the ductus arteriosus.125 b


Lactation

Distributed into milk.125 c Discontinue nursing or the drug.125


Pediatric Use

Safety and efficacy not established in children <14 years of age.125


Geriatric Use

Use with caution in patients ≥65 years of age.125 b Geriatric adults appear to tolerate therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.125 b Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.125 b


Substantially eliminated by kidneys; periodic monitoring of renal function may be useful since geriatric patients are more likely to have decreased renal function.125 (See Geriatric Patients under Dosage and Administration and Renal Impairment under Cautions.)


Renal Impairment

Use not recommended in patients with preexisting renal disease or substantial renal impairment.125


Common Adverse Effects


Abdominal pain,125 constipation,125 diarrhea,125 dyspepsia,125 flatulence,125 gross bleeding/perforation,125 heartburn,125 nausea,125 GI ulcers (gastric/duodenal),125 vomiting,125 abnormal renal function,125 anemia,125 dizziness,125 edema,125 elevated liver enzymes,125 headaches,125 increased bleeding time,125 pruritus,125 rashes,125 tinnitus.125


Interactions for Mefenamic Acid


Protein-bound Drugs


Possible pharmacokinetic interaction; potential for mefenamic acid to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs (e.g., oral anticoagulants, hydantoins, salicylates, sulfonamides, and sulfonylureas).125 a f Observe for adverse effects if used with other protein-bound drugs.a


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors of CYP2C9: possible altered safety and efficacy of mefenamic acid.125


Specific Drugs

































Drug



Interaction



Comments



ACE inhibitors



Reduced BP response to ACE inhibitor possible 125 128 b


Possible deterioration of renal function in individuals with renal impairment128



Monitor BP128



Angiotensin II receptor antagonists



Reduced BP response to angiotensin II receptor antagonist possible128


Possible deterioration of renal function in individuals with renal impairment128



Monitor BP128



Antacids (magnesium-containing)



Increased peak plasma concentrations and AUC of mefenamic acid125 d



Anticoagulants (e.g., warfarin)



Possible bleeding complications125 128 a b e



Use with caution; frequent monitoring of PT advised125 128 a e



Aspirin



Increased risk of GI ulceration or other complications 125 128 b


No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs125 b



Concomitant use generally not recommended125 b



Diuretics (furosemide, thiazides)



Reduced natriuretic effects possible125 b



Monitor for diuretic efficacy and renal failure125 b



Lithium



Increased plasma lithium concentrations105 125 b



Monitor for lithium toxicity105 125 b



Methotrexate



Possible toxicity associated with increased plasma methotrexate concentrations during concomitant NSAIA use125 b



Caution advised125 b


Mefenamic Acid Pharmacokinetics


Absorption


Bioavailability


Rapidly absorbed following oral administration.125 a Peak plasma concentrations usually attained within 2–4 hours.125 a


Food


Effect of food on rate and extent of absorption not known.125


Distribution


Extent


Appears to cross the placenta.g


Distributed into milk in small amounts.125 c


Plasma Protein Binding


>90%.125


Elimination


Metabolism


Metabolized by CYP2C9 to 3′-hydroxymethyl mefenamic acid; further oxidation to 3′-carboxymefenamic acid may occur. 125 Mefenamic acid and its metabolites also are glucuronidated.125


Elimination Route


Excreted in urine (52%) primarily as glucuronic acid conjugates of the drug and its metabolites and in feces (<20%).125


Half-life


Mefenamic acid: approximately 2 hours.125 Half-lives of 3′-hydroxymethyl mefenamic acid and 3′-carboxymefenamic acid may be longer than parent compound.125


Special Populations


Half-life 5 times longer in preterm infants compared with adults.125


In patients with renal or hepatic impairment, clearance of metabolites may be decreased.125


Not substantially removed by hemodialysis.125 a


Stability


Storage


Oral


Capsules

20–25°C (may be exposed to 15–30°C).125 a


ActionsActions



  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.117 118 119 120 121 122




  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.125 a



Advice to Patients



  • Importance of reading the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.125 b




  • Risk of serious cardiovascular events with long-term use.125 133 134 135 136 b Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.125 b




  • Risk of GI bleeding and ulceration.100 104 125 b Importance of notifying a clinician if signs and symptoms of serious adverse GI effects occur.125 b




  • Importance of discontinuing mefenamic acid and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.125 b Importance of seeking immediate medical attention if an anaphylactic reaction occurs.125 b




  • Risk of hepatotoxicity.125 b Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.125 b




  • Importance of notifying clinician if signs and symptoms of unexplained weight gain or edema develop.125 b




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.125 Importance of avoiding mefenamic acid in late pregnancy (third trimester).125




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.125




  • Importance of informing patients of other important precautionary information.125 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name













Mefenamic Acid

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



250 mg*



Ponstel



First Horizon


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Ponstel 250MG Capsules (SHIONOGI PHARMA): 100/$1345.97 or 300/$3989.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



100. Palmer JF. Letter sent to Lents CE, of Parke Davis, Division of Warner-Lambert Company regarding labeling revisions about gastrointestinal adverse reactions to Ponstel (mefenamic acid). Rockville, MD: Food and Drug Administration, Division of Oncology and Radiopharmaceutical Drug Products. 1988 Sep.



101. Food and Drug Administration. Labeling revisions for NSAIDs. FDA Drug Bull. 1989; 19:3-4.



102. Searle. Cytotec (misoprostol) prescribing information. Skokie, IL; 1989 Jan.



104. Soll AH, Weinstein WM, Kurata J et al. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991; 114:307-19. [IDIS 277370] [PubMed 1987878]



105. Nonsteroidal anti-inflammatory drug interactions: Lithium. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:608-9.



106. Miller LG, Bowman RC, Bakht F. Sparing effect of sulindac on lithium levels. J Fam Prac. 1989; 28:592-3.



107. Corticosteroid interactions: nonsteroidal anti-inflammatory drugs (NSAIDs). In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:562.



108. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet. 1994; 343:769-72. [IDIS 328176] [PubMed 7907735]



109. Hollander D. Gastrointestinal complications of nonsteroidal anti-inflammatory drugs: prophylactic and therapeutic strategies. Am J Med. 1994; 96:274-81. [IDIS 328041] [PubMed 8154516]



110. Schubert TT, Bologna SD, Yawer N et al. Ulcer risk factors: interaction between Helicobacter pylori infection, nonsteroidal use, and age. Am J Med. 1993; 94:413-7. [IDIS 314155] [PubMed 8475935]



111. Bateman DN, Kennedy JG. Non-steroidal anti-inflammatory drugs and elderly patients: the medicine may be worse than the disease. BMJ. 1995; 310:817-8. [IDIS 345154] [PubMed 7711609]



112. Piper JM, Ray WA, Daugherty JR et al. Corticosteroid use and peptic ulcer disease: role of nonsteroidal anti-inflammatory drugs. Ann Intern Med. 1991; 114:735-40. [IDIS 280191] [PubMed 2012355]



113. Lithium interactions: diclofenac. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:607.



114. Ciba Geigy, Ardsley, NY: Personal communication on diclofenac 28:08.04.



115. Reviewers’ comments (personal observations) on diclofenac 28:08.04.



116. Searle. Cytotec (misoprostol) prescribing information. 1989 Jan.



117. Hawkey CJ. COX-2 inhibitors. Lancet. 1999; 353:307-14. [IDIS 418284] [PubMed 9929039]



118. Kurumbail RG, Stevens AM, Gierse JK et al. Structural basis for selective inhibition of cyclooxygenase-2 by anti-inflammatory agents. Nature. 1996; 384:644-8. [PubMed 8967954]



119. Riendeau D, Charleson S, Cromlish W et al. Comparison of the cyclooxygenase-1 inhibitory properties of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors, using sensitive microsomal and platelet assays. Can J Physiol Pharmaco. 1997; 75:1088-95.



120. DeWitt DL, Bhattacharyya D, Lecomte M et al. The differential susceptibility of prostaglandin endoperoxide H synthases-1 and -2 to nonsteroidal anti-inflammatory drugs: aspirin derivatives as selective inhibitors. Med Chem Res. 1995; 5:325-43.



121. Cryer B, Dubois A. The advent of highly selective inhibitors of cyclooxygenase—a review. Prostaglandins Other Lipid Mediators. 1998; 56:341-61. [PubMed 9990677]



122. Simon LS, Role and regulation of cyclooxygenase-2 during inflammation. Am J Med. 1999; 106(Suppl 5B):37-42S.



123. Morrison BW, Daniels SE, Kotey P et al. Rofecoxib, a specific cyclooxygenase-2 inhibitor, in primary dysmenorrhea: a randomized controlled study. Obstet Gynecol. 1999; 94:504-8. [IDIS 437014] [PubMed 10511349]



124. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999; 340:1888-99. [IDIS 426864] [PubMed 10369853]



125. First Horizon Pharmaceutical Corporation. Ponstel (mefenamic acid) capsules prescribing information. Alpharetta, GA; 2006 Jan.



126. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol. 1999; 26(suppl 56):18-24.



127. Lanza FL, and the Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. A guideline for the treatment and prevention of NSAID-induced ulcers. Am J Gastroenterol. 1998; 93:2037-46. [IDIS 417402] [PubMed 9820370]



128. Merck & Co., Inc. Clinoril (sulindac) tablets prescribing information. Whitehouse Station, NJ; 2007 Feb.



129. Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. 2005 Apr 6.



130. Cush JJ. The safety of COX-2 inhibitors: deliberations from the February 16-18, 2005, FDA meeting. From the American College of Rheumatology website (). Accessed 2005 Oct 12.



131. Novartis Pharmaceuticals. Diovan (valsartan) capsules prescribing information (dated 1997 Apr). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:2013-5.



132. Pharmacia. Daypro (oxaprozin) caplets prescribing information. Chicago, IL; 2002 May.



133. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006; 296: 1633-44. [PubMed 16968831]



134. Kearney PM, Baigent C, Godwin J et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006; 332: 1302-5. [PubMed 16740558]



135. Graham DJ. COX-2 inhibitors, other NSAIDs, and cardiovascular risk; the seduction of common sense. JAMA. 2006; 296:1653-6. [PubMed 16968830]



136. Chou R, Helfand M, Peterson K et al. Comparative effectiveness and safety of analgesics for osteoarthritis. Comparative effectiveness review no. 4. (Prepared by the Oregon evidence-based practice center under contract no. 290-02-0024.) . Rockville, MD: Agency for Healthcare Research and Quality. 2006 Sep. Available at: .



a. AHFS drug information 2007. McEvoy GK, ed. Mefenamic acid. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2096-9.



b. US Food and Drug Administration. Proposed NSAID Package Insert Labeling Template 1. From the FDA website (). Accessed 10 Oct 2005.



c. Buchanan RA, Eaton CJ, Koeff ST et al. The breast milk excretion of mefenamic acid. Curr Ther Res Clin Exp. 1968; 10: 592-7. [PubMed 4973976]



d. Neuvonen PJ, Kivistö KT. Enhancement of drug absorption by antacids: an unrecognized drug interaction. Clin Pharmacokinet. 1994; 27:120-8. [PubMed 7955775]



e. Chan TY. Adverse interactions between warfarin and nonsteroidal antinflammatory drugs: mechanisms, clinical significance, and avoidance. Ann Pharmacother. 1995; 29:1274-83. [PubMed 8672833]



f. Diana FJ, Veronich K, Kapoor AL. Binding of nonsteroidal anti-inflammatory agents and their effect on binding of racemic warfarin and its enantiomers to human serum albumin. J Pharm Sci. 1989; 78: 195-9. [PubMed 2724076]



g. MacKenzie IZ, Graf AK, Mitchell MD. Prostaglandins in the fetal circulation following maternal ingestion of a prostaglandin synthetase inhibitor during mid-pregnancy. Int J Gynaecol Obstet. 1985; 23: 455-8. [PubMed 2868938]



h. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis; 2002 update. Arthritis Rheum. 2002; 46:328-46. [IDIS 476480] [PubMed 11840435]



i. Anon. Drugs for rheumatoid arthritis. Med Lett Drugs Ther. 2000; 42:57-64. [PubMed 10887424]



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  • Mefenamic Acid MedFacts Consumer Leaflet (Wolters Kluwer)

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  • mefenamic acid Concise Consumer Information (Cerner Multum)

  • mefenamic acid Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ponstel Prescribing Information (FDA)



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  • Pain
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Monday, 25 June 2012

Senna Plus


Pronunciation: DOCK-yoo-sate/SEN-oh-sides
Generic Name: Docusate/Sennosides
Brand Name: Examples include Senna Plus and Senokot S


Senna Plus is used for:

Relieving occasional constipation (irregularity).


Senna Plus is a stool softener and laxative combination. It works by softening the stool and increasing water content to allow easier passage of the stool.


Do NOT use Senna Plus if:


  • you are allergic to any ingredient in Senna Plus

  • you have appendicitis, fecal impaction, blood in the stool, or a blockage of your bowel, or you have recently had abdominal surgery

  • you are taking mineral oil or you have been using a laxative for longer than 1 week

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



Before using Senna Plus:


Some medical conditions may interact with Senna Plus. 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 have congestive heart failure, stomach pain, nausea, or vomiting, or if you notice a sudden change in bowel movements that continues for longer than 2 weeks

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


Ask your health care provider if Senna Plus 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 Senna Plus:


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


  • Take Senna Plus at bedtime unless directed otherwise by your health care provider.

  • If you miss taking a dose of Senna Plus for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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



Important safety information:


  • Do not use Senna Plus if the safety seal is broken or missing.

  • Stop using Senna Plus and contact your health care provider if you have rectal bleeding or fail to have a bowel movement after using Senna Plus. These may be signs of a serious condition.

  • Senna Plus should be used with extreme caution in CHILDREN younger than 6 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 Senna Plus while you are pregnant. It is not known if Senna Plus is found in breast milk. If you are or will be breast-feeding while you are using Senna Plus, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Senna Plus:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); black, tarry stools; severe stomach pain.



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: Senna Plus 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 abdominal cramps; diarrhea.


Proper storage of Senna Plus:

Store Senna Plus at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Senna Plus out of the reach of children and away from pets.


General information:


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

  • Senna Plus 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 Senna Plus. 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.

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Sunday, 24 June 2012

Trihexyphenidyl Hydrochloride


Class: Anticholinergic Agents
VA Class: AU350
CAS Number: 52-49-3

Introduction

Antimuscarinic antiparkinsonian agent.a b


Uses for Trihexyphenidyl Hydrochloride


Parkinsonian Syndrome


Adjunctive treatment of all forms of parkinsonian syndrome.a b


May reduce the frequency and duration of oculogyric crises, salivation, spastic contractions, and dyskinesia, and relieve mental inertia and depression characteristic of all forms of parkinsonian syndrome.b


Drug-Induced Extrapyramidal Reactions


Control of extrapyramidal reactions induced by antipsychotic agents (e.g., phenothiazines, thioxanthenes).a b


Trihexyphenidyl Hydrochloride Dosage and Administration


Administration


Oral Administration


Administer orally before or after meals, depending on patient reaction.a b Administer before meals in patients with excessive xerostomia.a Administer after meals if nausea occurs.a


May be administered 3 times daily; if a fourth dose is required, administer at bedtime.b


Mint candies, chewing gum, water, or administration of a saliva substitute (e.g., Xero-lube) may relieve xerostomia that may accompany administration after meals.a b


Dosage


Available as trihexyphenidyl hydrochloride; dosage expressed in terms of the salt.a


Adjust dosage carefully according to individual requirements and response.b


Adults


Parkinsonian Syndrome

Oral

Initially, 1 mg on first day.a Dosages may be increased in 2-mg increments at 3- to 5-day intervals up to a maximum of 6–10 mg daily.a b


Postencephalitic patients: 12–15 mg daily may be required.a b


When trihexylphenidyl is used as an adjunct to levodopa, consider reducing levodopa and trihexyphenidyl dosages.a Generally, 3–6 mg daily of trihexyphenidyl hydrochloride is adequate.a


If trihexyphenidyl is replacing another antiparkisonian agent, increase trihexyphenidyl dose as needed while decreasing other drug dose until complete replacement is achieved.b


Drug-Induced Extrapyramidal Reactions

Oral

Usual dosage: 5–15 mg total daily dosage.a b


Initially, 1 mg; if extrapyramidal reactions are not controlled within a few hours, progressively increase dosage until control is achieved. a b


Alternatively, to achieve a more rapid control, reduce dosage of the drug causing the reaction, then adjust the dosage of both drugs to attain the desired drug effect without extrapyramidal symptoms.b Once control of extrapyramidal reactions has been maintained for several days, dosage of trihexyphenidyl may be reduced or discontinued.b


Prescribing Limits


Adults


Parkinsonian Syndrome

Oral

Maximum of 6–10 mg daily in most patients; postencephalitic patients may require 12–15 mg daily.a b


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.a


Renal Impairment


No specific dosage recommendations at this time.a


Geriatric Patients


Patients ≥60 years of age: Initiate with low dosage; titrate dosage gradually.a


Cautions for Trihexyphenidyl Hydrochloride


Contraindications



  • Known hypersensitivity to trihexylphenidyl or any ingredient in the formulation.c



Warnings/Precautions


Warnings


Ophthalmic Effects

Possible increased ocular tension.a Possible precipitation of glaucoma in patients receiving prolonged therapy.a c


Use with caution in patients with glaucoma.a c


Periodic gonioscopic evaluation and intraocular pressure monitoring recommended.a b


General Precautions


Tardive Dyskinesia

Antiparkinsonian agents do not alleviate symptoms of tardive dyskinesia and may aggravate these symptoms.a


Cardiovascular Effects

Possible tachycardia;a use with caution and carefully monitor patients with cardiac disease or hypertension.a c


GU Effects

Possible urinary hesitancy and retention;a c use with caution and carefully monitor patients with prostatic hypertrophy or obstructive disease of the GU tract.a c


CNS Effects

Possible mental confusion, disorientation, agitation, hallucinations, and psychotic-like symptoms.a


GI Effects

Possible decreased intestinal mobility and paralytic ileus; use with caution in patients with obstructive diseases of the GI tract.a


Specific Populations


Pregnancy

Category C.d


Geriatric Use

Possibility exists of greater sensitivity to the drug in some geriatric individuals.a


Hepatic Impairment

Use with caution; careful monitoring recommended.a


Renal Impairment

Use with caution; careful monitoring recommended.a


Common Adverse Effects


Dry mouth, blurred vision, dizziness, nausea, nervousness.a


Interactions for Trihexyphenidyl Hydrochloride


Specific Drugs









Drug



Interaction



Anticholinergic agents



Increased risk of adverse anticholinergic effectsc


Trihexyphenidyl Hydrochloride Pharmacokinetics


Absorption


Rapidly absorbed from the GI tract following oral administration.b


Onset


Following oral adminstration, onset of action occurs within 1 hour.b


Duration


6–12 hours.b


Elimination


Elimination Route


Excreted principally in urine, probably as unchanged drug.b


Stability


Storage


Oral


Elixir

20–25°C.e Do not freeze.e


Tablets

20–25°C.a


ActionsActions



  • Exhibits atropine-like action and exerts antispasmodic effects on parasympathetic-innervated peripheral structures, including smooth muscle.a b




  • Exact mechanism of action in parkinsonian syndrome not understood; may result from blockade of efferent impulses and from central inhibition of cerebral motor centers.b




  • Competitively inhibits acetylcholine or other cholinergic stimuli at autonomic effectors innervated by postganglionic nerves.c




  • Exhibits weak mydriatic, antisialagogue, and cardiovagal blocking effects.b



Advice to Patients



  • Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.a




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of informing patients of other important precautionary information.a (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name























Trihexyphenidyl Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Elixir



2 mg/5 mL*



Trihexyphenidyl Hydrochloride Elixir



Mikart, Pharmaceutical Associates, Pharmaceutical Ventures



Tablets



2 mg*



Trihexyphenidyl Hydrochloride Tablets



URL, Vintage, Watson, West-Ward



5 mg*



Trihexyphenidyl Hydrochloride Tablets



URL, Vintage, Watson, West-Ward


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Trihexyphenidyl HCl 0.4MG/ML Elixir (PHARMACEUTICAL ASSOCIATES): 473/$30.99 or 1419/$79.97


Trihexyphenidyl HCl 2MG Tablets (WATSON LABS): 90/$22.99 or 180/$39.97


Trihexyphenidyl HCl 5MG Tablets (WEST-WARD): 180/$65.99 or 280/$95.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. Watson Laboratories Inc. trihexyphenidyl hydrochloride tablets, USP. prescribing information. Corona, CA; 2005 May.



b. AHFS drug information 2006. McEvoy GK, ed. Trihexyphenidyl. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1256.



c. AHFS drug information 2006. McEvoy GK, ed. Antimuscarinics/Antispasmodics General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1257-64].



d. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1628



e. Pharmaceutical Associates, Inc. Trihexyphenidyl HCl elixir prescribing information. Greenville, SC; 2002 May.



More Trihexyphenidyl Hydrochloride resources


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


  • Trihexyphenidyl MedFacts Consumer Leaflet (Wolters Kluwer)

  • Trihexyphenidyl Prescribing Information (FDA)

  • Artane Advanced Consumer (Micromedex) - Includes Dosage Information

  • Artane Concise Consumer Information (Cerner Multum)



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Jodthyrox




Jodthyrox may be available in the countries listed below.


Ingredient matches for Jodthyrox



Levothyroxine

Levothyroxine sodium salt (a derivative of Levothyroxine) is reported as an ingredient of Jodthyrox in the following countries:


  • Austria

  • Germany

Potassium Iodide

Potassium Iodide is reported as an ingredient of Jodthyrox in the following countries:


  • Austria

  • Germany

International Drug Name Search

Saturday, 23 June 2012

Bronchodilator combinations


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Bronchodilator combinations are generally inhalers or inhalation devices, which contain more than one bronchodilator, or a bronchodilator and a steroid.


Bronchodilator combinations with more than one bronchodilator usually consist of a short acting and a long acting bronchodilator. The bronchodilators may work by different mechanisms to dilate the air passages, and makes air flow easier.


Bronchodilator combinations with a steroid and bronchodilator act more like a preventative. Steroids block the body

See also

Medical conditions associated with bronchodilator combinations:

  • Asthma
  • Asthma, Maintenance
  • COPD
  • COPD, Maintenance

Drug List: