Friday, September 30, 2016

Pen-V Lannacher




Pen-V Lannacher may be available in the countries listed below.


Ingredient matches for Pen-V Lannacher



Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Pen-V Lannacher in the following countries:


  • Austria

International Drug Name Search

Histade


Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion


What is Histade (chlorpheniramine and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


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


The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.


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


What is the most important information I should know about Histade (chlorpheniramine and pseudoephedrine)?


There are many brands and forms of this medication available and not all brands are listed on this leaflet.


Do not use chlorpheniramine and pseudoephedrine 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. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.


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 chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. 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.

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.


What should I discuss with my healthcare provider before taking Histade (chlorpheniramine and pseudoephedrine)?


Do not use chlorpheniramine and pseudoephedrine 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. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

  • severe or uncontrolled high blood pressure;




  • severe coronary artery disease;




  • narrow angle glaucoma;




  • a stomach ulcer;




  • if you are unable to urinate; or




  • if you are having an asthma attack.



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


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • circulation problems;




  • heart disease or high blood pressure;




  • overactive thyroid;




  • a seizure disorder such as epilepsy;




  • asthma, emphysema or chronic bronchitis; or




  • urination problems or an enlarged prostate.




FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid 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 Histade (chlorpheniramine 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. 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.

The chewable tablet must be chewed before swallowing.


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.


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.


This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


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


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold medicine is taken as 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 some of the serious side effects listed in this medication guide.


What should I avoid while taking Histade (chlorpheniramine 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 chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine 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 an antihistamine or decongestant.

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.


Histade (chlorpheniramine and pseudoephedrine) 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 this medication and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;




  • confusion, hallucinations, unusual thoughts or behavior;




  • severe dizziness, anxiety, restless feeling, nervousness;




  • urinating less than usual or not at all;




  • easy bruising or bleeding, unusual weakness; or




  • seizure (black-out or convulsions).



Less serious side effects may include:



  • blurred vision;




  • dry nose or mouth;




  • nausea, stomach pain, constipation, loss of appetite;




  • dizziness, drowsiness;




  • problems with memory or concentration;




  • ringing in your ears; or




  • feeling restless or excited (especially in children).



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 Histade (chlorpheniramine and pseudoephedrine)?


Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

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



  • mecamylamine (Inversine);




  • methyldopa (Aldomet);




  • reserpine;




  • 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;




  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or




  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.



This list is not complete and other drugs may interact with chlorpheniramine 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 Histade resources


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


Compare Histade with other medications


  • Hay Fever
  • Sinusitis


Where can I get more information?


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

See also: Histade side effects (in more detail)


Fluoxetine



Pronunciation: floo-OX-e-teen
Generic Name: Fluoxetine
Brand Name: Sarafem

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Fluoxetine outweigh the risks.


Family and caregivers must closely watch patients who take Fluoxetine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.





Fluoxetine is used for:

Treating premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome. It may also be used for other conditions as determined by your doctor.


Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve mood.


Do NOT use Fluoxetine if:


  • you are allergic to any ingredient in Fluoxetine

  • you are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days

  • you are taking a fenfluramine derivative (eg, dexfenfluramine), an H1 antagonist (eg, astemizole, terfenadine), nefazodone, pimozide, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg, paroxetine), sibutramine, thioridazine, or tryptophan

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



Video: Treatment for Depression







Treatments for depression are getting better everyday and there are things you can start doing right away.






Before using Fluoxetine:


Some medical conditions may interact with Fluoxetine. 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 or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse

  • if you have a history of seizures, heart problems, liver problems, severe kidney problems, stomach or bowel bleeding, diabetes, or metabolism problems

  • if you have a certain type of glaucoma (narrow-angle glaucoma) or are at risk of this condition

  • if you are dehydrated, have low blood sodium levels, or drink alcohol

  • if you will be having electroconvulsive therapy (ECT)

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


  • Anorexiants (eg, phentermine), fenfluramine derivatives (eg, dexfenfluramine), linezolid, MAOIs (eg, phenelzine), methylene blue, metoclopramide, nefazodone, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine ), St. John's wort, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur

  • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased

  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased

  • Tramadol because the risk of seizures may be increased

  • Cyclobenzaprine or H1 antagonists (eg, astemizole, terfenadine) because severe heart problems, including irregular heartbeat, may occur

  • HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Fluoxetine's side effects

  • Cyproheptadine because it may decrease Fluoxetine's effectiveness

  • Aripiprazole, benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), carbamazepine, clozapine, dextromethorphan, digoxin, flecainide, haloperidol, hydantoins (eg, phenytoin), lithium, norepinephrine reuptake inhibitors (eg, atomoxetine), phenothiazines (eg, chlorpromazine, thioridazine), pimozide, propafenone, risperidone, tricyclic antidepressants (eg, amitriptyline), or vinblastine because the risk of their side effects may be increased by Fluoxetine

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


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


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

  • Take Fluoxetine by mouth with or without food.

  • Taking Fluoxetine at the same time each day will help you remember to take it.

  • Continue to take Fluoxetine even if you feel well. Do not miss any doses.

  • Do not suddenly stop taking Fluoxetine without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Fluoxetine and whenever a change in dose is made.

  • If you miss a dose of Fluoxetine, 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 Fluoxetine.



Important safety information:


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

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Fluoxetine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or take Fluoxetine for longer than prescribed without checking with your doctor.

  • Children and teenagers who take Fluoxetine may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Fluoxetine closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

  • Diabetes patients - Fluoxetine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Serotonin syndrome is a possibly fatal syndrome that can be caused by Fluoxetine. Your risk may be greater if you take Fluoxetine with certain other medicines (eg, MAOIs, SSRIs, "triptans"). Symptoms may include agitation; coma; confusion; excessive sweating; fast or irregular heartbeat; fever; hallucinations; nausea, vomiting, or diarrhea; tremor. Contact your doctor at once if you have any of these symptoms.

  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Fluoxetine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.

  • If your doctor tells you to stop taking Fluoxetine, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Fluoxetine.

  • Fluoxetine may cause decreased sexual desire or ability. This has occasionally been reported to continue after treatment has been stopped. Discuss any questions or concerns with your doctor.

  • Fluoxetine may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.

  • Fluoxetine contains some of the same ingredients as Prozac, a medicine used to treat depression and other mental problems, and Symbyax, a medicine used to treat depression in patients with bipolar disorder. Do not take Fluoxetine if you are also taking Prozac or Symbyax. Discuss any questions or concerns with your doctor.

  • Use Fluoxetine with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.

  • Fluoxetine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • Fluoxetine may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Fluoxetine.

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


Possible side effects of Fluoxetine:


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; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms (eg, fever, chills, muscle aches); increased sweating; loss of appetite; nausea; nervousness; runny nose; sore throat; stomach upset; trouble sleeping; weakness.



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; unusual hoarseness); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; increased hunger, thirst, or urination; joint or wrist aches or pain; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety, trouble sleeping, or weakness; severe or persistent nausea, vomiting, diarrhea, or headache; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating; unusual bruising or bleeding; unusual hoarseness; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes; worsening of depression.



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: Fluoxetine 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 coma; confusion; delirium; difficult breathing; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting; tremor.


Proper storage of Fluoxetine:

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


General information:


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

  • Fluoxetine 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 summary only. It does not contain all information about Fluoxetine. 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 Fluoxetine resources


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


Compare Fluoxetine with other medications


  • Anxiety and Stress
  • Body Dysmorphic Disorder
  • Bulimia
  • Depression
  • Dysautonomia
  • Dysthymia
  • Fibromyalgia
  • Hot Flashes
  • Obsessive Compulsive Disorder
  • Panic Disorder
  • Postpartum Depression
  • Premature Ejaculation
  • Premenstrual Dysphoric Disorder
  • Schizoaffective Disorder
  • Trichotillomania
  • Vulvodynia

Naxen



Generic Name: naproxen (Oral route)

na-PROX-en

Oral route(Tablet;Tablet, Enteric Coated;Suspension)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .



Commonly used brand name(s)

In the U.S.


  • Aflaxen

  • Aleve

  • Aleve Arthritis

  • Anaprox

  • Anaprox DS

  • EC Naprosyn

  • Naprelan

  • Naprelan 500

  • Naprelan Dose Card

  • Naprosyn

In Canada


  • Naxen

Available Dosage Forms:


  • Tablet

  • Suspension

  • Tablet, Enteric Coated

  • Tablet, Extended Release

Therapeutic Class: Analgesic


Pharmacologic Class: NSAID


Chemical Class: Propionic Acid (class)


Uses For Naxen


Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.


This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.


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


Before Using Naxen


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.


Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Ketorolac

  • Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abciximab

  • Ardeparin

  • Argatroban

  • Aspirin

  • Beclamide

  • Beta Glucan

  • Bivalirudin

  • Caramiphen

  • Carbamazepine

  • Certoparin

  • Chlormethiazole

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Diazepam

  • Dipyridamole

  • Enoxaparin

  • Escitalopram

  • Ethotoin

  • Felbamate

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Fosphenytoin

  • Gabapentin

  • Ginkgo

  • Heparin

  • Lacosamide

  • Lepirudin

  • Mephenytoin

  • Mephobarbital

  • Methotrexate

  • Nadroparin

  • Nefazodone

  • Oxcarbazepine

  • Paraldehyde

  • Paramethadione

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Phenacemide

  • Phenobarbital

  • Phenytoin

  • Piracetam

  • Pregabalin

  • Protein C

  • Reviparin

  • Rivaroxaban

  • Rufinamide

  • Sertraline

  • Sibutramine

  • Stiripentol

  • Tacrolimus

  • Tiagabine

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Topiramate

  • Trimethadione

  • Valproic Acid

  • Vigabatrin

  • Vilazodone

  • Warfarin

  • Zimeldine

  • Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acebutolol

  • Acetohexamide

  • Alacepril

  • Alprenolol

  • Amiloride

  • Arotinolol

  • Atenolol

  • Azilsartan Medoxomil

  • Azosemide

  • Befunolol

  • Bemetizide

  • Benazepril

  • Bendroflumethiazide

  • Benzthiazide

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bopindolol

  • Bucindolol

  • Bumetanide

  • Bupranolol

  • Buthiazide

  • Candesartan Cilexetil

  • Canrenoate

  • Captopril

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chlorothiazide

  • Chlorpropamide

  • Chlorthalidone

  • Cilazapril

  • Clopamide

  • Cyclopenthiazide

  • Cyclosporine

  • Delapril

  • Desvenlafaxine

  • Dilevalol

  • Duloxetine

  • Enalaprilat

  • Enalapril Maleate

  • Eprosartan

  • Esmolol

  • Ethacrynic Acid

  • Fosinopril

  • Furosemide

  • Gliclazide

  • Glimepiride

  • Glipizide

  • Gliquidone

  • Glyburide

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Imidapril

  • Indapamide

  • Irbesartan

  • Labetalol

  • Landiolol

  • Levobetaxolol

  • Levobunolol

  • Lisinopril

  • Lithium

  • Losartan

  • Mepindolol

  • Methyclothiazide

  • Metipranolol

  • Metolazone

  • Metoprolol

  • Milnacipran

  • Moexipril

  • Nadolol

  • Nebivolol

  • Nipradilol

  • Olmesartan Medoxomil

  • Oxprenolol

  • Penbutolol

  • Pentopril

  • Perindopril

  • Pindolol

  • Piretanide

  • Polythiazide

  • Propranolol

  • Quinapril

  • Ramipril

  • Sotalol

  • Spirapril

  • Spironolactone

  • Talinolol

  • Tasosartan

  • Telmisartan

  • Temocapril

  • Tertatolol

  • Timolol

  • Tolazamide

  • Tolbutamide

  • Torsemide

  • Trandolapril

  • Triamterene

  • Trichlormethiazide

  • Valsartan

  • Venlafaxine

  • Xipamide

  • Zofenopril

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Bleeding problems or

  • Blood clots or

  • Edema (fluid retention or body swelling) or

  • Heart attack, history of or

  • Heart disease (e.g., congestive heart failure) or

  • Hypertension (high blood pressure) or

  • Kidney disease or

  • Liver disease (e.g., hepatitis) or

  • Stomach or intestinal ulcers or bleeding, history of or

  • Stroke, history of—Use with caution. May make these conditions worse.

  • Aspirin-sensitive asthma or

  • Aspirin sensitivity, history of—Should not be used in patients with these conditions.

  • Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of naproxen

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


For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.


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


When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.


Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.


Swallow the delayed-release tablet whole. Do not crush, break, or chew it.


If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day.

      • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day.

      • Children younger than 2 years of age—Use and dose must be determined by your doctor.


    • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
      • Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed.

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


    • For acute gout:
      • Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved.

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



  • For naproxen controlled-release tablet (e.g., Naprelan®) dosage form:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day.

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


    • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
      • Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day.

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


    • For acute gout:
      • Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved.

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



  • For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.

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



  • For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.

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


    • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
      • Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day.

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


    • For acute gout:
      • Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved.

      • 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


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Naxen


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


This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.


This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).


Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.


Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.


This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.


Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.


Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.


This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .


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


Naxen Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Belching

  • bruising

  • difficult or labored breathing

  • feeling of indigestion

  • headache

  • itching skin

  • large, flat, blue, or purplish patches in the skin

  • pain in the chest below the breastbone

  • shortness of breath

  • skin eruptions

  • stomach pain

  • swelling

  • tightness in the chest

  • wheezing

Less common
  • Bloating

  • bloody or black, tarry stools

  • blurred or loss of vision

  • burning upper abdominal or stomach pain

  • cloudy urine

  • constipation

  • decrease in urine output or decrease in urine-concentrating ability

  • disturbed color perception

  • double vision

  • fast, irregular, pounding, or racing heartbeat or pulse

  • halos around lights

  • indigestion

  • loss of appetite

  • nausea or vomiting

  • night blindness

  • overbright appearance of lights

  • pale skin

  • pinpoint red or purple spots on the skin

  • severe and continuing nausea

  • severe stomach burning, cramping, or pain

  • skin rash

  • swelling or inflammation of the mouth

  • troubled breathing with exertion

  • tunnel vision

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting of material that looks like coffee grounds

  • weight loss

Rare
  • Anxiety

  • back or leg pains

  • bleeding gums

  • blindness

  • blistering, peeling, or loosening of the skin

  • blood in the urine or stools

  • blue lips and fingernails

  • canker sores

  • change in the ability to see colors, especially blue or yellow

  • chest pain or discomfort

  • clay-colored stools

  • cold sweats

  • coma

  • confusion

  • cool, pale skin

  • cough or hoarseness

  • coughing that sometimes produces a pink frothy sputum

  • cracks in the skin

  • darkened urine

  • decreased vision

  • depression

  • diarrhea

  • difficult, burning, or painful urination

  • difficult, fast, or noisy breathing

  • difficulty with swallowing

  • dilated neck veins

  • dizziness

  • dry cough

  • dry mouth

  • early appearance of redness, or swelling of the skin

  • excess air or gas in the stomach

  • extreme fatigue

  • eye pain

  • fainting

  • fever with or without chills

  • fluid-filled skin blisters

  • flushed, dry skin

  • frequent urination

  • fruit-like breath odor

  • greatly decreased frequency of urination or amount of urine

  • hair loss

  • high fever

  • hives

  • increased hunger

  • increased sensitivity of the skin to sunlight

  • increased sweating

  • increased thirst

  • increased urination

  • increased volume of pale, dilute urine

  • irregular breathing

  • joint or muscle pain

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas

  • light-colored stools

  • lightheadedness

  • loss of heat from the body

  • lower back or side pain

  • nervousness

  • nightmares

  • no blood pressure

  • no breathing

  • no pulse

  • nosebleeds

  • numbness or tingling in the hands, feet, or lips

  • pain in the ankles or knees

  • pain or burning in the throat

  • pain or discomfort in the arms, jaw, back, or neck

  • painful, red lumps under the skin, mostly on the legs

  • pains in the stomach, side, or abdomen, possibly radiating to the back

  • pale or blue lips, fingernails, or skin

  • pounding in the ears

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • rapid, shallow breathing

  • red, irritated eyes

  • red skin lesions, often with a purple center

  • red-green color blindness

  • redness or other discoloration of the skin

  • redness, swelling, or soreness of the tongue

  • scaly skin

  • seizures

  • severe sunburn

  • shakiness

  • skin thinness

  • slurred speech

  • sneezing

  • sore throat

  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

  • sores, welting, or blisters

  • spots on your skin resembling a blister or pimple

  • stiff neck or back

  • stomach cramps or tenderness

  • stomach upset

  • swelling in the legs and ankles

  • swelling of the face, fingers, feet, or lower legs

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • tiny bumps on the inner lining of the eyelid

  • unexplained weight loss

  • unpleasant breath odor

  • watery or bloody diarrhea

  • weakness or heaviness of the legs

  • weight gain

  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Bleeding under the skin

  • confusion about identity, place, and time

  • muscle tremors

  • restlessness

  • sleepiness

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
  • Continuing ringing or buzzing or other unexplained noise in the ears

  • hearing loss

Less common
  • Acid or sour stomach

  • change in hearing

  • feeling of constant movement of self or surroundings

  • passing gas

  • sensation of spinning

  • stomach soreness or discomfort

Rare
  • Appetite changes

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • burning, dry, or itching eyes

  • difficulty with moving

  • discharge, excessive tearing

  • general feeling of discomfort or illness

  • lack or loss of strength

  • menstrual changes

  • muscle aching, cramping, stiffness, or weakness

  • not able to concentrate

  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

  • seeing, hearing, or feeling things that are not there

  • shakiness in the legs, arms, hands, or feet

  • sleeplessness

  • swollen joints

  • trembling or shaking of the hands or feet

  • trouble getting pregnant

  • trouble performing routine tasks

  • trouble sleeping

  • unable to sleep

  • unusual drowsiness, dullness, or feeling of sluggishness

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: Naxen 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.


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More Naxen resources


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


Compare Naxen with other medications


  • Ankylosing Spondylitis
  • Aseptic Necrosis
  • Back Pain
  • Bursitis
  • Costochondritis
  • Diffuse Idiopathic Skeletal Hyperostosis
  • Dysautonomia
  • Fever
  • Frozen Shoulder
  • Gout, Acute
  • Headache
  • Juvenile Rheumatoid Arthritis
  • Muscle Pain
  • Osteoarthritis
  • Pain
  • Period Pain
  • Rheumatoid Arthritis
  • Sciatica
  • Spondylolisthesis
  • Tendonitis

Thursday, September 29, 2016

Riluzole


Class: Central Nervous System Agents, Miscellaneous
VA Class: CN900
Chemical Name: 6-(Trifluoromethoxy)-2-benzothiazolamine
Molecular Formula: C8H5F3N2OS
CAS Number: 1744-22-5
Brands: Rilutek

Introduction

An antiglutamate agent that acts in the CNS;1 2 3 4 5 6 7 10 11 12 13 a synthetic aryl-substituted benzothiazolamine.1 2 3 4 5 6 7 8 9


Uses for Riluzole


Amyotrophic Lateral Sclerosis


Used in the management of amyotrophic lateral sclerosis (ALS, Lou Gehrig disease, Dejerine-type Charcot syndrome) to extend survival and/or time to tracheostomy;1 7 8 11 15 22 24 designated an orphan drug by FDA for this use.26


Riluzole Dosage and Administration


General



  • Measure serum aminotransferases, including ALT levels, before and during riluzole therapy.8 (See Hepatic Effects under Cautions.)



Administration


Oral Administration


Administer orally, usually in 2 equally divided doses daily, 1 hour before or 2 hours after meals.1 8 22 24 (See Food under Pharmacokinetics.)


Dosage


Adults


Amyotrophic Lateral Sclerosis

Oral

50 mg every 12 hours.8


Prescribing Limits


Adults


Amyotrophic Lateral Sclerosis

Oral

Maximum 50 mg every 12 hours; higher daily dosages provide no additional benefit but may increase the risk of adverse effects.8 22 24


Special Populations


Hepatic Impairment


Use with caution; however, no specific dosage recommendations.a


Discontinue therapy if ALT is >10 times ULN or if jaundice develops.a


Manufacturer states that there is no experience with reinitiating therapy in patients whose therapy was discontinued for ALT >5 times ULN.a


Renal Impairment


Use with caution; however, no specific dosage recommendations.a


Geriatric Patients


Use with caution; however, no specific dosage recommendations.a


Cautions for Riluzole


Contraindications


History of severe hypersensitivity reactions to riluzole or any ingredient in the formulation.8


Warnings/Precautions


Warnings


Hepatic Effects

Associated with increases in serum aminotransferase (ALT) concentrations.a Maximum increases usually occur within 3 months of initiating therapy and are usually transient when <5 times ULN.8


Rarely, jaundice has been reported.a


Use not recommended in patients with baseline elevations of liver function tests (especially increased bilirubin).a Use with caution in patients with current or a history of abnormal liver function (i.e., significant abnormalities in serum transaminase [ALT; AST], bilirubin, and/or gamma-glutamate transferase [GGT] levels).a


Determine serum aminotransferase (ALT) concentrations prior to initiating therapy, once monthly during the first 3 months, every 3 months during the first year, and periodically thereafter; determine more frequently if increases in ALT concentrations develop.a


Manufacturer states there is no experience of continuing treatment in patients whose ALT is >5 times ULN and if a decision is made to continue therapy, at least weekly monitoring of liver function tests is recommended.a


Hematologic Effects

Neutropenia (ANC <500/mm3) reported rarely within the first 2 months of therapy.8 Monitor WBC counts if febrile illness occurs.8


Specific Populations


Pregnancy

Category C. 8


Lactation

Distributed into milk in rats; not known whether distributed into human milk.a Discontinue nursing because of potential risk to nursing infants.8


Pediatric Use

Safety and efficacy not established in children <18 years of age.8 22


Geriatric Use

Possible increased incidence of hepatic dysfunction compared with younger adults.8 Use with caution due to greater frequency of decreased hepatic and/or renal function observed in the elderly.8 Adverse effects similar to those in younger adults.8


Hepatic Impairment

Use with caution;8 increased AUC in patients with mild or moderate hepatic impairment.8 Pharmacokinetics not studied in patients with severe hepatic impairment.8


Manufacturer states there is no experience with continuing treatment in patients once ALT >5 times ULN and if a decision is made to continue therapy, frequent monitoring (at least weekly) of liver function tests is recommended.a


Renal Impairment

Use with caution.8 There is no significant difference in pharmacokinetic parameters between patients with moderate or severe renal insufficiency and healthy volunteers. 8 Pharmacokinetics not studied in patients undergoing hemodialysis.8


Common Adverse Effects


Asthenia, nausea, dizziness, decreased lung function, diarrhea, abdominal pain, pneumonia, vomiting, vertigo, circumoral paresthesia, anorexia, somnolence.8


Interactions for Riluzole


Appears to be metabolized principally by CYP1A2; pharmacokinetic interactions with substrates of CYP1A2 are likely.8 CYP2D6, 2C19, 3A4, and 2E1 not significantly involved in metabolism.a


Not known whether riluzole has potential for enzyme induction in humans.8


Protein-bound Drugs


Potential pharmacokinetic interactions (displacement of riluzole or other protein-bound drugs).8


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors of CYP1A2: potential pharmacokinetic interaction (decreased rate of riluzole elimination).8


Inducers of CYP1A2: potential pharmacokinetic interaction (increased rate of riluzole elimination).8


Specific Drugs and Food




























































Drug



Interaction



Comments



Alcohol



Possible additive adverse hepatic effects8



Allopurinol



Possible additive adverse hepatic effects8



Safety of concomitant administration not established; use caution8



Amitriptyline



Possible decreased rate of riluzole eliminationa



Caffeine



Possible decreased rate of riluzole eliminationa



Charcoal-broiled food



Possible increased rate of riluzole eliminationa



Cigarette smoke



Possible increased rate of riluzole eliminationa



Digoxin



No effect on riluzole protein binding in vitroa



Imipramine



No effect on riluzole protein binding in vitroa



Methyldopa



Possible additive adverse hepatic effects8



Safety of concomitant administration not established; use caution8



Omeprazole



Possible increased rate of riluzole elimination



Phenacetin



Possible decreased rate of riluzole elimination



Quinine



No effect on riluzole protein binding in vitroa



Quinolones



Possible decreased rate of riluzole eliminationa



Rifampin



Possible increased rate of riluzole elimination



Sulfasalazine



Possible additive adverse hepatic effects8



Safety of concomitant administration not established; use caution8



Tacrine



Potential pharmacokinetic interaction (altered metabolism) with concurrent use of other drugs metabolized by CYP1A2a



Theophylline



Possible decreased rate of riluzole elimination



Warfarin



No effect on riluzole or warfarin protein binding in vitroa


Riluzole Pharmacokinetics


Absorption


Bioavailability


Well-absorbed (approximately 90%); average absolute oral bioavailability approximately 60%.8


With multiple-dose administration, riluzole accumulates in plasma by about twofold; steady-state is reached in <5 days.8


Food


High fat meal decreases absorption, reducing AUC by about 20% and peak blood levels by about 45%.8


Special Populations


Increased AUC in patients with mild or moderate hepatic impairment.8 Pharmacokinetics not studied in patients with severe hepatic impairment.8


Distribution


Plasma Protein Binding


96% (mainly to albumin and lipoproteins).8


Elimination


Metabolism


Extensively metabolized in the liver to 6 major and a number of minor metabolites, principally via CYP1A2-dependent hydroxylation and glucuronidation.


Elimination Route


Excreted in urine (90%) mainly as metabolites and in feces (5%).8


Half-life


Averages 12 hours after repeated doses.8


Stability


Storage


Oral


Tablets

20°–25°C; protect from bright light.8


Actions and SpectrumActions



  • Precise mechanism of action has not been fully elucidated but appears to involve interference with the effects mediated by excitatory amino acids (EAAs) in the CNS, possibly through inhibition of glutamic acid release,1 2 3 4 5 6 8 9 11 12 15 17 18 blockade or inactivation of voltage-dependent sodium channels,1 4 5 6 7 8 15 17 18 19 and/or activation of a G-protein-dependent signal transduction pathway.1 6 17




  • May act via noncompetitive blockade of EAA receptors;5 14 however, does not appear to bind to any known glutamate receptor.2 4 6




  • Exhibits neuroprotective properties in vitro and in vivo in animals, including inhibition of neuronal toxicity associated with exposure to EAAs 7 8 or cerebrospinal fluid from ALS patients,6 7 and inhibits neuronal toxicity associated with anoxia4 7 8 9 or focal or global ischemia.2 3 4 6 7 9




  • Prolonged survival in a study in a transgenic mouse model of ALS but did not delay onset of the disease.8 21 22



Advice to Patients



  • Importance of patients informing clinician of any febrile illness.8




  • Importance of taking riluzole on a regular basis and at the same time of the day (e.g., in the morning and evening) each day.8 Importance of taking every 12 hours on an empty stomach, 1 hour before or 2 hours after meals.1 8 22 24




  • If a dose is missed, importance of patient taking only the next scheduled dose.8




  • Risk of dizziness, vertigo, or somnolence: avoid driving or operating machinery until effects on individual are known.8




  • Alcohol may increase the risk of serious hepatotoxicity; drinking excessive amounts of alcohol should be discouraged.8




  • Importance of keeping riluzole out of the reach of children.8




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.8




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.8




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



Preparations


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













Riluzole

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



50 mg



Rilutek



Aventis


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.


Rilutek 50MG Tablets (SANOFI-AVENTIS U.S.): 60/$999.99 or 180/$2950.97



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 May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Bensimon G, Lacomblez L, Meininger V et al. A controlled trial of riluzole in amyotrophic lateral sclerosis. N Engl J Med. 1994; 330:585-91. [IDIS 326262] [PubMed 8302340]



2. Mantz J, Chéramy A, Thierry AM et al. Anesthetic properties of riluzole (54274 RP), a new inhibitor of glutamate neurotransmission. Anesthesiology. 1992; 76:844-8. [PubMed 1349464]



3. Mantz J, Laudenbach V, Lecharny JB et al. Riluzole, a novel antiglutamate, blocks GABA uptake by striatal synaptosomes. Eur J Pharmacol. 1994; 257:R7-8. [PubMed 8082687]



4. Martin D, Thompson MA, Nadler JV. The neuroprotective agent riluzole inhibits release of glutamate and aspartate from slices of hippocampal area CA1. Eur J Pharmacol. 1993; 250:473-6. [PubMed 8112408]



5. Hays SJ, Rice MJ, Ortwine DF et al. Substituted 2-benzothiazolamines as sodium flux inhibitors: quantitative structure–activity relationships and anticonvulsant activity. J Pharm Sci. 1994; 83:1425-32. [PubMed 7884664]



6. Couratier P, Sindou P, Esclaire F et al. Neuroprotective effects of riluzole in ALS CSF toxicity. Neuroreport. 1994; 5:1012-4. [PubMed 8061281]



7. Rabasseda X, Mealy N, Castaner J. Riluzole. Drugs Future. 1994; 19:920-2.



8. Aventis. Rilutek (riluzole) tablets prescribing information. Bridgewater, NJ; 2003 May.



9. Dessi F, Ben-Ari Y, Charriaut-Marlangue C. Riluzole prevents anoxic injury in cultured cerebellar granule neurons. Eur J Pharmacol. 1993; 250:325-8. [PubMed 8112389]



10. Rowland LP. Riluzole for the treatment of amyotrophic lateral sclerosis—too soon to tell? N Engl J Med. 1994; 330:636-7. Editorial. (IDIS 326266)



11. Orrell RW, Lane RJM, Guiloff RJ. Recent developments in the drug treatment of motor neurone disease. BMJ. 1994; 309:140-1. [IDIS 332937] [PubMed 8044087]



12. Rowland LP. Amyotrophic lateral sclerosis. Curr Opin Neurol. 1994; 7:310-5. [PubMed 7952238]



13. Benavides J, Camelin JC, Mitrani N et al. 2-amino-6-trifluoromethoxy benzothiazole, a possible antagonist of excitatory amino acid neurotransmission—II. Neuropharmacology. 1985; 24:1085-92. [PubMed 3001571]



14. Debono MW, Le Guern J, Canton T et al. Inhibition by riluzole of electrophysiological responses mediated by rat kainate and NMDA receptors expressed in Xenopus oocytes. Eur J Pharmacol. 1993; 235:283-9. [PubMed 7685290]



15. Anon. Riluzole for amyotrophic lateral sclerosis. Med Lett Drugs Ther. 1995; 37:113-4. [PubMed 7500908]



16. Meldrum B , Garthwaite J. Neurotoxicity and neurodegenerative disease. Trends Pharmacol Sci. 1990; 11:379-87. [PubMed 2238094]



17. Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. N Engl J Med. 1994; 330:613-22. [IDIS 326265] [PubMed 7905600]



18. Martin D, Thompson MA, Nadler JV. The neuroprotective agent riluzole inhibits release of glutamate and aspartate from slices of hippocampal area CA1. Eur J Pharmacol. 1993; 250:473-6. [PubMed 8112408]



19. Hubert JP, Delumeau JC, Glowinski J et al. Antagonism by riluzole of entry of calcium evoked by NMDA and veratridine in rat cultured granule cells: evidence for a dual mechanism of action. Br J Pharmacol. 1994; 113:261-7. [PubMed 7812619]



20. McKee P, Fuller GN, Stevens DL. Riluzole in amyotrophic lateral sclerosis. N Engl J Med. 1994; 331:272. [IDIS 332877] [PubMed 8068095]



21. Gurney ME, Cutting FB, Zhai P et al. Benefit of vitamin E, riluzole, and gabapentin in a transgenic model of familial amyotrophic lateral sclerosis. Ann Neurol. 1996; 39:147- 57. [PubMed 8967745]



22. Rhone-Poulenc Rorer, Collegeville, PA: Personal communication.



24. Lacomblez L, Bensimon G, Leigh PN et al. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Lancet. 1996; 347:1425-31. [IDIS 365047] [PubMed 8676624]



25. MacRae KD. Riluzole in amyotrophic lateral sclerosis. N Engl J Med. 1994; 331:272-3.



26. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.



a. Aventis. Rilutek (riluzole) tablets prescribing information. Bridgewater, NJ; 2004 September.



More Riluzole resources


  • Riluzole Side Effects (in more detail)
  • Riluzole Dosage
  • Riluzole Use in Pregnancy & Breastfeeding
  • Riluzole Drug Interactions
  • Riluzole Support Group
  • 1 Review for Riluzole - Add your own review/rating


  • Riluzole Professional Patient Advice (Wolters Kluwer)

  • Riluzole MedFacts Consumer Leaflet (Wolters Kluwer)

  • riluzole Concise Consumer Information (Cerner Multum)

  • riluzole Advanced Consumer (Micromedex) - Includes Dosage Information

  • Rilutek Prescribing Information (FDA)



Compare Riluzole with other medications


  • Amyotrophic Lateral Sclerosis
  • Obsessive Compulsive Disorder

Alfa-Amylase Biogaran




Alfa-Amylase Biogaran may be available in the countries listed below.


Ingredient matches for Alfa-Amylase Biogaran



Amylase, Alpha-

Amylase, Alpha- is reported as an ingredient of Alfa-Amylase Biogaran in the following countries:


  • France

International Drug Name Search

Wednesday, September 28, 2016

Adcetris


Generic Name: brentuximab (Intravenous route)


bren-TUX-i-mab ve-DOE-tin


Intravenous route(Powder for Solution)

Progressive multifocal leukoencephalopathy and/or death may occur, as a result of JC virus infection, in patients receiving brentuximab therapy .



Commonly used brand name(s)

In the U.S.


  • Adcetris

Available Dosage Forms:


  • Powder for Solution

Pharmacologic Class: Mitotic Inhibitor


Uses For Adcetris


Brentuximab injection is used to treat a type of cancer called Hodgkin's lymphoma (HL). It is given to patients who have received an autologous stem cell transplant (ASCT) or other cancer treatments that did not work well.


Brentuximab injection is also used to treat patients with systemic anaplastic large cell lymphoma (sALCL). It is used after at least one other cancer medicine was given and did not work well.


Brentuximab interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by brentuximab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.


This medicine is to be administered only by or under the immediate supervision of your doctor.


Before Using Adcetris


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the geriatric population. Safety and efficacy have not been established.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Bleomycin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Atazanavir

  • Clarithromycin

  • Indinavir

  • Itraconazole

  • Ketoconazole

  • Nefazodone

  • Nelfinavir

  • Ritonavir

  • Saquinavir

  • Telithromycin

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood or bone marrow problems (e.g., neutropenia) or

  • Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.

  • Infection—May decrease your body's ability to fight infection.

Proper Use of Adcetris


Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.


You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.


This medicine must be given slowly, so the needle will remain in place for 30 minutes. It is usually given every 3 weeks until your condition improves. You may also receive medicines (e.g., acetaminophen, steroid medicines) to help prevent possible allergic reactions to the injection.


Precautions While Using Adcetris


It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.


Do not take this medicine together with bleomycin (Blenoxane®). Using these medicines together may cause serious side effects, such as cough, shortness of breath, troubled breathing, or wheezing


Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.


This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are receiving this medicine.


Check with your doctor if you notice any signs of fever, chills, sore throat, or painful urination. These could be symptoms of an infection resulting from low white blood cell counts.


This medicine may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.


Serious skin reactions can occur during treatment with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.


This medicine may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Talk to your doctor about the benefits of using this medicine and the risk of this infection. Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.


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


Adcetris 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 or nurse immediately if any of the following side effects occur:


More common
  • Black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • body aches or pain

  • burning, numbness, tingling, or painful sensations

  • chills

  • cough

  • difficult or labored breathing

  • difficulty with breathing

  • ear congestion

  • fever

  • headache

  • loss of voice

  • lower back or side pain

  • pain

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

  • shortness of breath

  • sneezing

  • sore throat

  • stuffy or runny nose

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • tightness in the chest

  • troubled breathing with exertion

  • ulcers, sores, or white spots in the mouth

  • unsteadiness or awkwardness

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • weakness in the arms, hands, legs, or feet

  • wheezing

Less common
  • Anxiety

  • back pain

  • bladder pain

  • blistering, peeling, or loosening of the skin

  • bloating or swelling of the face, arms, hands, lower legs, or feet

  • blurred vision

  • chest pain

  • cloudy urine

  • confusion

  • convulsions

  • diarrhea

  • dizziness or lightheadedness

  • drowsiness

  • fainting

  • fast heartbeat

  • frequent urge to urinate

  • general feeling of discomfort or illness

  • irregular heartbeat

  • itching

  • joint pain, stiffness, or swelling

  • muscle pain

  • rapid weight gain

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • severe pain in the chest

  • stomach pain

  • sudden onset of severe breathing difficulty

  • sudden shortness of breath or troubled breathing

  • thickening of bronchial secretions

  • troubled breathing

  • unusual weight gain or loss

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
  • Decreased appetite or weight

  • difficulty having a bowel movement (stool)

  • difficulty with moving

  • hair loss or thinning of the hair

  • muscle spasms

  • muscle stiffness

  • nausea

  • night sweats

  • pain in the arms or legs

  • rash

  • sleeplessness

  • trouble with sleeping

  • unable to sleep

  • vomiting

Less common
  • Dry skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



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