Wednesday, 28 September 2016

Germentin




Germentin may be available in the countries listed below.


Ingredient matches for Germentin



Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Germentin in the following countries:


  • Ireland

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Germentin in the following countries:


  • Ireland

International Drug Name Search

Tuesday, 27 September 2016

Aridex Drops


Pronunciation: car-beta-PEN-tane/kar-bi-NOX-a-meen/fen-ill-EF-rin
Generic Name: Carbetapentane/Carbinoxamine/Phenylephrine
Brand Name: Aridex


Aridex Drops are used for:

Relieving symptoms (eg, sinus congestion, runny nose, sneezing, cough) due to colds, allergies, hay fever, sinus congestion, flu, bronchitis, and other respiratory illnesses. It may also be used for other conditions as determined by your doctor.


Aridex Drops are a cough suppressant, antihistamine, and decongestant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by narrowing blood vessels and reducing swelling in the nasal passages.


Do NOT use Aridex Drops if:


  • you are allergic to any ingredient in Aridex Drops

  • you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

  • you are taking sodium oxybate (GHB) or droxidopa, or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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



Before using Aridex Drops:


Some medical conditions may interact with Aridex Drops. 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 a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, slow or irregular heartbeat); blood vessel problems; high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; trouble sleeping; or increased pressure in the eye

  • if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

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


  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Aridex Drops's side effects

  • Benzodiazepines (eg, diazepam), bromocriptine, hydantoins (eg, phenytoin), or sodium oxybate (GHB) because the risk of their side effects may be increased by Aridex Drops

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Aridex Drops

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


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


  • Aridex Drops may be taken with or without food.

  • Use the dropper that comes with Aridex Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Aridex Drops, 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 Aridex Drops.



Important safety information:


  • Aridex Drops may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Aridex Drops. Using Aridex Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Aridex Drops. Aridex Drops will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

  • Do not use Aridex Drops for persistent or chronic cough, such as a cough that occurs with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus, unless directed by your doctor.

  • Do not take diet or appetite control medicines while you are taking Aridex Drops without checking with your doctor.

  • Aridex Drops contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Aridex Drops for longer than prescribed without checking with your doctor.

  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

  • Aridex Drops may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Aridex Drops. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

  • If you are scheduled for allergy skin testing, do not take Aridex Drops for several days before the test because it may decrease your response to the skin tests.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Aridex Drops.

  • Use Aridex Drops with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion, seizures, hallucinations, or stroke.

  • Caution is advised when using Aridex Drops in CHILDREN because they may be more sensitive to its effects.

  • Use Aridex Drops with extreme caution in CHILDREN younger than 3 months of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not take Aridex Drops if you are pregnant. If you think you may be pregnant, contact your doctor immediately. It is unknown if Aridex Drops are excreted in breast milk. Do not breast-feed while taking Aridex Drops.


Possible side effects of Aridex Drops:


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:



Dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; restlessness; trouble sleeping; upset stomach; vomiting; weakness.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; overexcitement; pale skin; seizures; severe dizziness, lightheadedness, headache, or restlessness; tremor; vision changes.



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: Aridex 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; difficulty urinating; fast, slow, or irregular heartbeat; flushing; increased reflexes; one-sided weakness; severe or persistent diarrhea, dizziness, headache, irritability, restlessness, or trouble sleeping; stomach cramps; tremor; vision or speech changes.


Proper storage of Aridex Drops:

Store Aridex Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aridex Drops out of the reach of children and away from pets.


General information:


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

  • Aridex Drops are 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 Aridex Drops. 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 Aridex resources


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


Compare Aridex with other medications


  • Nasal Congestion

AlleRx DF Dose Pack


Generic Name: chlorpheniramine and methscopolamine (klor fen EER uh meen and meth sko POL uh meen)

Brand Names: aeroHist, AlleRx DF Dose Pack, Ryneze


What is AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

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.


Methscopolamine reduces the secretions of certain organs in the body.


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


Chlorpheniramine and methscopolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?


Do not use chlorpheniramine and methscopolamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and methscopolamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, 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 can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine and methscopolamine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.


Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and methscopolamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety), or medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the side effects of chlorpheniramine and methscopolamine.


What should I discuss with my healthcare provider before taking AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?


Do not use chlorpheniramine and methscopolamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and methscopolamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, 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.



Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • heart disease, high blood pressure, or circulation problems;




  • overactive thyroid;




  • a seizure disorder such as epilepsy;




  • asthma, emphysema or chronic bronchitis; or




  • urination problems or an enlarged prostate.



If you have any of these conditions, you may not be able to use chlorpheniramine and methscopolamine, or you may need a dosage adjustment or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine and methscopolamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 6 years old.

How should I take AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.


Take this medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.


Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.


This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using chlorpheniramine and methscopolamine. You may need to stop using the medication for a short time before having a medical test.


Store chlorpheniramine and methscopolamine 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. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a chlorpheniramine and methscopolamine overdose may include nausea, vomiting, severe drowsiness, shallow breathing, ringing in your ears, problems with balance or coordination, hallucinations (seeing things), sleep problems (insomnia), feeling restless or excited, blurred vision, tremors, flushed face, and seizure (convulsions).


What should I avoid while taking AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine and methscopolamine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.


Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and methscopolamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety), or medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the side effects of chlorpheniramine and methscopolamine.


AlleRx DF Dose Pack (chlorpheniramine and methscopolamine) 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 chlorpheniramine and methscopolamine and call your doctor at once if you have any of these serious side effects:

  • problems with balance or coordination;




  • severe drowsiness, feeling light-headed, fainting;




  • extreme thirst and hot, dry skin;




  • breathing problems;




  • easy bruising or bleeding, unusual weakness;




  • fever, chills, body aches, flu symptoms;




  • fast or uneven heart beats;




  • tight feeling in your chest;




  • seizure (convulsions);




  • hallucinations (seeing things that are not there); or




  • tremors.



Continue using this medication and talk with your doctor if you have any of these less serious side effects:



  • dry mouth, stomach pain, changes in appetite;




  • drowsiness, dizziness, weakness, headache;




  • dry eyes, blurred vision;




  • painful or difficult urination;




  • increased sweating;




  • skin rash; or




  • feeling nervous or excited (especially in children).



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?


Before taking this medication, tell your doctor if you are using any of the following drugs:



  • antacids;




  • medicine to treat diarrhea (such as Immodium, Kaopectate, Pepto-Bismol);




  • atropine (Donnatal, and others);




  • belladonna;




  • clidinium (Quarzan);




  • dicyclomine (Bentyl);




  • glycopyrrolate (Robinul);




  • hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);




  • mepenzolate (Cantil);




  • methantheline (Provocholine);




  • methscopolamine (Pamine);




  • propantheline (Pro-Banthine); or




  • scopolamine (Transderm-Scop).




  • a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren);




  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or




  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).



If you are using any of these drugs, you may not be able to use chlorpheniramine and methscopolamine, or you may need dosage adjustments or special tests during treatment.


There may be other drugs not listed that can affect chlorpheniramine and methscopolamine. 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 AlleRx DF Dose Pack resources


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


  • Allergy DN II Prescribing Information (FDA)

  • Dexodryl Chewable Tablet MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ryneze 12-Hour Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare AlleRx DF Dose Pack with other medications


  • Rhinitis


Where can I get more information?


  • Your pharmacist has additional information about chlorpheniramine and methscopolamine written for health professionals that you may read.

See also: AlleRx DF Dose Pack side effects (in more detail)


Friday, 23 September 2016

Aralast


Generic Name: alpha-1 proteinase inhibitor human (Intravenous route)


AL-fa 1 PRO-teen-aze in-HIB-i-ter HUE-man


Commonly used brand name(s)

In the U.S.


  • Aralast

  • Aralast NP

  • Glassia

  • Prolastin

  • Prolastin-C

  • Zemaira

Available Dosage Forms:


  • Powder for Solution

  • Solution

Therapeutic Class: Blood Modifier Agent


Uses For Aralast


Alpha-1 proteinase inhibitor injection, also called alpha 1-PI, is used to treat a certain type of emphysema (a lung condition). The emphysema is caused by the lack of a protein called alpha 1-antitrypsin (AAT) in the body. This medicine replaces the protein when the body does not produce enough.


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


Before Using Aralast


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 alpha-1 proteinase inhibitor 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 alpha-1 proteinase inhibitor in the geriatric population. Safety and efficacy have not been established.


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


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


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


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


  • IgA deficiency with antibodies against IgA—Should not be used in patients with this condition.

Proper Use of alpha-1 proteinase inhibitor human

This section provides information on the proper use of a number of products that contain alpha-1 proteinase inhibitor human. It may not be specific to Aralast. Please read with care.


A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.


This medicine is usually given once a week on a regular schedule. If you have any questions about this, check with your doctor.


Precautions While Using Aralast


It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.


This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.


Alpha 1-PI is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from alpha 1-PI is very low and has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns. Your doctor may give you a hepatitis B vaccine before receiving this medicine.


Aralast 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
  • Bladder pain

  • bloody or cloudy urine

  • body aches or pain

  • chills

  • cough

  • difficult, burning, or painful urination

  • difficulty with breathing

  • ear congestion

  • fever

  • frequent urge to urinate

  • headache

  • loss of voice

  • lower back or side pain

  • nasal congestion

  • runny nose

  • sneezing

  • sore throat

  • unusual tiredness or weakness

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

  • blurred vision

  • chest pain

  • cough producing mucus

  • diarrhea

  • difficult or labored breathing

  • dizziness

  • feeling faint, dizzy, or lightheadedness

  • flushing or redness of the skin, especially on the face and neck

  • general feeling of discomfort or illness

  • joint pain

  • loss of appetite

  • muscle aches and pains

  • nausea

  • nervousness

  • noisy breathing

  • pounding in the ears

  • rapid weight gain

  • shivering

  • shortness of breath

  • slow or fast heartbeat

  • stuffy nose

  • sweating

  • tightness in the chest

  • tingling of the hands or feet

  • trouble sleeping

  • unusual weight gain or loss

  • vomiting

  • wheezing

Incidence not known
  • Confusion

  • difficulty with swallowing

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fast, pounding, or irregular heartbeat or pulse

  • hives

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

  • skin rash

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
  • Feeling of warmth

  • itching skin

  • muscle or bone pain

  • pain or tenderness around the eyes and cheekbones

  • redness of the face, neck, arms, and occasionally, upper chest

  • sudden sweating

Rare
  • Back pain

  • bloating

  • change in taste

  • changes in vision

  • fever

  • hives or welts

  • loss of taste

  • pain

  • redness of the skin

  • sleepiness or unusual drowsiness

  • swelling of the joints

  • unusual drowsiness, dullness, tiredness, weakness, 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: Aralast side effects (in more detail)



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


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


More Aralast resources


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


  • Aralast NP Prescribing Information (FDA)

  • Aralast NP MedFacts Consumer Leaflet (Wolters Kluwer)

  • Glassia Prescribing Information (FDA)

  • Glassia Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Glassia Consumer Overview

  • Prolastin-C Prescribing Information (FDA)

  • Zemaira Prescribing Information (FDA)

  • Zemaira Consumer Overview



Compare Aralast with other medications


  • Alpha-1 Proteinase Inhibitor Deficiency

Plaquenil


Generic Name: Hydroxychloroquine Sulfate
Class: Antimalarials
VA Class: AP101
CAS Number: 747-36-4

Introduction

Antimalarial; 4-aminoquinoline derivative.a


Uses for Plaquenil


Malaria


Prevention (prophylaxis) of malaria caused by Plasmodium malariae, P. ovale, P. vivax, or susceptible strains of P. falciparum.105 109 CDC and others recommend chloroquine for prevention of malaria caused by Plasmodium susceptible to 4-aminoquinoline derivatives;105 110 hydroxychloroquine is as effective and may be better tolerated105 and may be used when chloroquine is unavailable.105 110


Treatment of uncomplicated malaria caused by P. malariae, P. ovale, P. vivax, or susceptible strains of P. falciparum.109 110


Active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure; primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.105 109


Detailed recommendations regarding prevention of malaria available from CDC 24 hours a day from the voice information service (877-394-8747), fax information service (888-232-3299), or Internet at .105


Assistance with diagnosis or treatment of malaria available from CDC Malaria Epidemiology Branch by contacting CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.118


Rheumatoid Arthritis


Treatment of rheumatoid arthritis in patients whose symptoms progress despite an adequate regimen of nonsteroidal anti-inflammatory agents (NSAIAs).103 104 109


One of several disease-modifying antirheumatic drugs (DMARDs) that can be used when DMARD therapy is appropriate.103 104 If used for prolonged periods in treatment of rheumatoid arthritis, the risk of severe and sometimes irreversible toxicity should be considered.109 (See Cautions.)


Lupus Erythematosus


Treatment of discoid lupus erythematosus and systemic lupus erythematosus.109 Used as an adjunct to corticosteroids and/or other appropriate therapy.a


If used for prolonged periods in treatment of lupus erythematosus, the risk of serious and sometimes irreversible toxicity should be considered. (See Cautions.)


Q Fever


Treatment of Q fever endocarditis caused by Coxiella burnetii; used in conjunction with doxycycline.111 112 113


CDC recommends a 2- to 3-week regimen of doxycycline for treatment of acute Q fever, a 1-year regimen of doxycycline and hydroxychloroquine for treatment of acute Q fever in patients with preexisting valvular heart disease (to prevent progression of acute disease to endocarditis), and a 1.5- to 3-year regimen of doxycycline and hydroxychloroquine for treatment of chronic Q fever.113


Porphyria Cutanea Tarda and Polymorphous Light Eruptions


Has been used in treatment of porphyria cutanea tarda.115 116 117 (See Patients with Psoriasis or Porphyria under Cautions.)


Has been effective in some cases when used in the treatment of polymorphous light eruptions.


Plaquenil Dosage and Administration


Administration


Oral Administration


Administer orally.109


When used in treatment of rheumatoid arthritis, administer with a meal or a glass of milk.109


Dosage


Available as hydroxychloroquine sulfate; dosage usually expressed as hydroxychloroquine.109


Each 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg of hydroxychloroquine.109


Pediatric Patients


Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

5 mg/kg (6.5 mg/kg of hydroxychloroquine sulfate) once weekly on the same day each week.105 109


Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.105 114 CDC states it may be advisable to initiate prophylaxis 3–4 weeks prior to travel to ensure that the drug or combination of drugs (in individuals receiving other drugs) is well tolerated and to allow ample time if a switch to another antimalarial agent is required.105


If not initiated prior to entering a malarious area, manufacturer recommends a loading dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) given in 2 equally divided doses 6 hours apart followed by the usual dosage.109


Treatment of Uncomplicated Chloroquine-susceptible Malaria

Oral

An initial dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) followed by 5-mg/kg doses (6.5 mg/kg of hydroxychloroquine sulfate) given at 6, 24, and 48 hours after the initial dose.109


Adults


Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

310 mg (400 mg of hydroxychloroquine sulfate) once weekly on the same day each week.105 109


Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.105 114 CDC states it may be advisable to initiate prophylaxis 3–4 weeks prior to travel to ensure that the drug or combination of drugs (in individuals receiving other drugs) is well tolerated and to allow ample time if a switch to another antimalarial agent is required.105


If not initiated prior to entering a malarious area, the manufacturer recommends a loading dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by the usual dosage regimen.109


Treatment of Uncomplicated Chloroquine-susceptible Malaria

Oral

An initial dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by 310-mg doses (400 mg of hydroxychloroquine sulfate) given 6–8 hours, 24, and 48 hours after the initial dose.109 This represents a total hydroxychloroquine dose of 1.55 g (2 g of hydroxychloroquine sulfate) in 3 days.109 Alternatively, adults may receive a single 620-mg dose (800 mg of hydroxychloroquine sulfate).109


Rheumatoid Arthritis

Oral

Initiate treatment with 310–465 mg (400–600 mg of hydroxychloroquine sulfate) daily.109 If adverse effects occur, dosage may be temporarily reduced; after 5–10 days, increase dosage gradually until an optimum response occurs without recurrence of adverse effects.109


A response may not occur until after 4–12 weeks and several months of therapy may be required to attain optimum response.109 When a good response is obtained, decrease dosage by 50% and continue treatment with a maintenance dosage of 155–310 mg (200–400 mg of hydroxychloroquine sulfate) daily.109


If relapse occurs after hydroxychloroquine is discontinued, the drug can be reinitiated or continued on an intermittent schedule if there is no evidence of adverse ocular effects.109


If objective improvement of rheumatoid arthritis (e.g., reduced joint swelling, increased mobility) does not occur within 6 months, hydroxychloroquine should be discontinued.109


Lupus Erythematosus

Oral

310 mg (400 mg of hydroxychloroquine sulfate) once or twice daily for several weeks or months depending on response of the patient.109 For prolonged maintenance therapy, 155–310 mg (200–400 mg of hydroxychloroquine sulfate) daily may be adequate.109


Q Fever

Acute Q Fever in Patients with Preexisting Valvular Heart Disease

Oral

CDC recommends 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1 year.113 Adjust hydroxychloroquine dosage to maintain plasma hydroxychloroquine concentrations at 1 ± 0.2 mcg/mL.113


Chronic Q Fever

Oral

CDC recommends 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1.5–3 years.113


Prescribing Limits


Pediatric Patients


Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

Maximum of 310 mg (400 mg of hydroxychloroquine sulfate) daily, regardless of weight.105


Cautions for Plaquenil


Contraindications



  • Hypersensitivity to 4-aminoquinoline derivatives.109




  • Retinal or visual field changes attributable to 4-aminoquinoline derivatives or to any other etiology.109




  • Long-term use in children.109



Warnings/Precautions


Warnings


Chloroquine-resistant Plasmodium

Hydroxychloroquine is not effective against chloroquine-resistant P. falciparum.105 109 For prevention of malaria, use only in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.105


For prevention or treatment of malaria, consider that chloroquine-resistant P. falciparum have been reported in all areas where malaria occurs, except the Dominican Republic, Haiti, Mexico and Central America west of the former Panama Canal zone, Paraguay, northern Argentina, Egypt, most of the Middle East (chloroquine resistance has been reported in Iran, Oman, Saudi Arabia, and Yemen), and most of China (chloroquine resistance has been reported in Hainin and Yunnan provinces).105 110 114


Ocular Effects

Dose-related retinopathy reported, which may progress even after the drug is discontinued.109 Irreversible retinal damage has occurred in some patients who received long-term or high-dosage 4-aminoquinoline therapy for treatment of discoid and systemic lupus erythematosus or rheumatoid arthritis.109


Whenever long-term therapy is contemplated, perform initial (base line) and periodic (every 3 months) ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests.109


Discontinue drug immediately and closely observe patient for possible progression if there is any indication of abnormalities in visual acuity or visual field, abnormalities in the retinal macular area (such as pigmentary changes or loss of foveal reflex), or if any other visual symptoms (e.g., light flashes and streaks) occur which are not fully explainable by difficulties of accommodation or corneal opacities.109


Neuromuscular Effects

Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy reported.109 May lead to progressive weakness and atrophy of proximal muscle groups and may be associated with mild sensory changes, depression of tendon reflexes, and abnormal nerve conduction.109


Patients receiving prolonged therapy should be questioned and examined periodically for evidence of muscular weakness; knee and ankle reflexes should be tested.109


Discontinue hydroxychloroquine if muscular weakness occurs.109


Patients with Psoriasis or Porphyria

May exacerbate psoriasis and precipitate a severe attack in patients with the disease.109 Use in psoriasis patients only if potential benefits outweigh risks.109


May exacerbate porphyria.109 Use in patients with porphyria only if potential benefits outweigh risks.109


General Precautions


Dermatologic Effects

Dermatologic reactions may occur; use with caution in patients with tendency for dermatitis.109


Hematologic Effects

Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia (hemolysis in patients with G-6-PD deficiency) reported rarely.109


Periodically monitor CBCs in patients receiving prolonged treatment.109 Consider discontinuing hydroxychloroquine if any severe blood disorder occurs which is not attributable to the disease being treated.109


Use with caution in patients with G-6-PD deficiency.109


Specific Populations


Pregnancy

Category C.b


Avoid use during pregnancy unless the clinician determines that the benefits of prevention or treatment of malaria outweigh the risks.109 Chloroquine has been used for prophylaxis and treatment of malaria in pregnant women without evidence of adverse effects on the fetus,105 110 and CDC states that the benefits of chloroquine or hydroxychloroquine prophylaxis in pregnant women exposed to malaria outweigh potential risks to the fetus.105 110


Lactation

Distributed into milk.102 Amount of drug present in human milk does not appear to be harmful to nursing infants, but is insufficient to provide adequate protection against malaria in these infants.105 When chemoprophylaxis is necessary in such infants, they should receive recommended dosages of the appropriate antimalarial agent(s).105


Pediatric Use

Pediatric patients are especially sensitive to 4-aminoquinoline derivatives.109 Fatalities have been reported following accidental ingestion of relatively small doses.109


Prolonged therapy with hydroxychloroquine is contraindicated in children; safe use of the drug for treatment of juvenile arthritis has not been established.109


Hepatic Impairment

Hydroxychloroquine may concentrate in the liver;a use with caution in patients with hepatic disease or alcoholism and in patients receiving other hepatotoxic drugs.109


Common Adverse Effects


Ocular effects; skeletal muscle myopathy or neuromyopathy; GI effects (anorexia, diarrhea, nausea, abdominal cramps, vomiting); CNS effects (headache, dizziness); dermatologic effects.109


Plaquenil Pharmacokinetics


Distribution


Extent


Distributed into milk.102


Elimination


Metabolism


Partially metabolized; the major metabolites are desethylhydroxychloroquine and desethylchloroquine.100 Bisdesethylchloroquine, a carboxylic acid derivative, also is formed in small amounts.100


Elimination Route


Hydroxychloroquine and its metabolites are slowly excreted by the kidneys.100


Stability


Storage


Oral


Tablets

Room temperature ≤30°C in tight, light-resistant container.109


Actions and SpectrumActions



  • A blood schizonticidal agent active against asexual erythrocytic forms of most strains of Plasmodium malariae, P. ovale, P. vivax, and many strains of P. falciparum.a Not active against preerythrocytic or exoerythrocytic forms of plasmodia.a Gametocidal for P. malariae and P. vivax, but has no direct activity against the gametocytes of P. falciparum.a




  • Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine109 and may be cross-resistant to pyrimethamine or quinine.a




  • Has anti-inflammatory activity; mechanism(s) of action in the treatment of rheumatoid arthritis and lupus erythematosus has not been determined.a



Advice to Patients



  • Importance of keeping hydroxychloroquine out of reach of children since they are especially sensitive to 4-aminoquinoline derivatives.109




  • Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).105 110




  • Possibility of contracting malaria during travel, regardless of prophylactic regimen used.105 110




  • Importance of seeking medical attention as soon as possible if febrile illness develops during or after return from a malaria-endemic area and of informing clinician of possible malaria exposure.105 110




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




  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.109




  • Importance of advising 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.


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













Hydroxychloroquine Sulfate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



155 mg (of hydroxychloroquine)*



Plaquenil



Sanofi-Synthelabo


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.


Hydroxychloroquine Sulfate 200MG Tablets (WATSON LABS): 60/$35.99 or 180/$88.99


Plaquenil 200MG Tablets (SANOFI-AVENTIS U.S.): 60/$204.33 or 180/$587.44



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 August 2005. 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


Only references cited for selected revisions after 1984 are available electronically.



100. McChesney EW. Animal toxicity and pharmacokinetics of hydroxychloroquine sulfate. Am J Med. 1983; 75(Suppl. 1A):11-8. [IDIS 174380] [PubMed 6408923]



101. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Inter Med. 2000; 160:610-9.



102. American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 1989; 84:924-36. [IDIS 260411] [PubMed 2677964]



103. 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]



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



105. Centers for Disease Control and Prevention. Health information for international travel, 2003–2004. Atlanta, GA: US Department of Health and Human Services; 2003:13-39,99-116,136,138,175-7,227,231-5,240-2,249-50. Updates available from CDC website ().



106. Clark P, Casas E, Tugwell P et al. Hydroxychloroquine compared with placebo in rheumatoid arthritis: a randomized controlled trial. Ann Intern Med. 1993; 119:1067-71. [IDIS 322560] [PubMed 8239224]



107. Harris ED Jr. Hydroxychloroquine is safe and probably useful in rheumatoid arthritis. Ann Intern Med. 1993; 119:1146-7. [IDIS 322565] [PubMed 8239236]



108. Makin AJ, Wendon J, Fitt S. Fulminant hepatic failure secondary to hydroxychloroquine. Gut. 1994; 35:569-70. [IDIS 330037] [PubMed 8175002]



109. Sanofi-Synthelabo. Plaquenil (hydroxychloroquine sulfate) prescribing information. New York, NY; 2002 Apr.



110. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website (). Accessed 2005 Feb 2.



111. Raoult D, Houpikian P, Dupont HT et al. Treatment of Q fever endocarditis: comparison of 2 regimens containing doxycycline and ofloxacin or hydrochloroquine. Arch Intern Med. 1999; 159:167-73. [IDIS 418047] [PubMed 9927100]



112. Lupoglazoff JM, Brouqui P, Magnier S et al. Q fever tricuspid valve endocarditis. Arch Dis Child. 1997; 77:448-9. [IDIS 398559] [PubMed 9487972]



113. Centers for Disease Control and Prevention. Q fever—California, Georgia, Pennsylvania, and Tennessee, 2000-2001. MMWR Morb Mortal Wkly Rep. 2002; 51:924-5. [PubMed 12403408]



114. Anon. Advice for travelers. Med Lett Drugs Ther. 2004; 2:33-40.



115. Bruce AJ, Ahmed I. Childhood-onset porphyria cutanea tarda: successful therapy with low-dose hydroxychloroquine (Plaquenil). J Am Acad Dermatol. 1998; 38(5 pt 2):810-3. [IDIS 406218] [PubMed 9591792]



116. Wallace DJ. The use of chloroquine and hydroxychloroquine for non-infectious conditions other than rheumatoid arthritis or lupus: a critical review. Lupus. 1996; 5(Suppl 1):S59-64.



117. Petersen CS, Thomsen K. High-dose hydroxychloroquine treatment of porphyria cutanea tarda. J Am Acad Dermatol. 1992; 26:614-9. [PubMed 1597548]



118. Centers for Disease Control and Prevention. CDC treatment guidelines: Treatment of malaria (guidelines for clinicians). 2004 Jun 28. From the CDC website: (). Accessed 2004 Oct 25.



a. AHFS Drug Information 2004. McEvoy GK, ed. hydroxychloroquine Sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2004:827-8.



b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia; PA: Lippincott Wiliams & Wilkins; 2002:671-4.



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