Saturday, 31 March 2012

Amlexanox


Pronunciation: am-LEX-an-ox
Generic Name: Amlexanox
Brand Name: Aphthasol


Amlexanox is used for:

Treating canker sores.


Amlexanox is an anti-inflammatory agent. How amlexanox works is not fully known. It appears to stop inflammatory reactions (eg, pain, redness, swelling) and allow sores to heal.


Do NOT use Amlexanox if:


  • you are allergic to any ingredient in Amlexanox

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



Before using Amlexanox:


Some medical conditions may interact with Amlexanox. 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 weakened immune system

Some MEDICINES MAY INTERACT with Amlexanox. Because little, if any, of Amlexanox is absorbed into the blood, the risk of it interacting with another medicine is low.


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


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


  • Apply Amlexanox after oral hygiene after breakfast, lunch, dinner, and at bedtime unless otherwise directed by your doctor.

  • Apply the paste as soon as possible after noticing the symptoms of canker sores.

  • Dry the ulcers by gently patting with a soft, clean cloth.

  • Wash your hands before and immediately after applying Amlexanox.

  • Moisten the tip of your index finger. Squeeze a dab of paste approximately one-fourth of an inch onto your fingertip. Dab paste onto each ulcer in the mouth using gentle pressure.

  • Use the paste until the ulcer heals. If significant healing or pain reduction has not occurred within 10 days, consult your dentist or doctor.

  • If you miss a dose of Amlexanox, use 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 use 2 doses at once.

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



Important safety information:


  • Avoid getting Amlexanox in your eyes. Wash eyes promptly if paste gets into eyes.

  • Use Amlexanox with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Amlexanox, discuss with your doctor the benefits and risks of using Amlexanox during pregnancy. It is unknown if Amlexanox is excreted in breast milk. If you are or will be breast feeding while you are using Amlexanox, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Amlexanox:


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:



Short-term pain, stinging, or burning at the application site.



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); inflammation of the lining of the mouth.



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: Amlexanox side effects (in more detail)


If OVERDOSE is suspected:


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


Proper storage of Amlexanox:

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


General information:


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

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

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

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

This information is a summary only. It does not contain all information about Amlexanox. 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 Amlexanox resources


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


Compare Amlexanox with other medications


  • Aphthous Stomatitis, Recurrent

Ipproton




Ipproton may be available in the countries listed below.


Ingredient matches for Ipproton



Omeprazole

Omeprazole is reported as an ingredient of Ipproton in the following countries:


  • Tunisia

International Drug Name Search

Fortum for Injection






Fortum for Injection 3 g, 2 g, 1 g, 500 mg and 250 mg



ceftazidime pentahydrate powder for injection


This leaflet contains information about Fortum. Please read it carefully. Keep it safe as you may want to read it again. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.




What Fortum for Injection contains


Each vial contains:


The active ingredient - ceftazidime 3 grams, 2 grams, 1 gram, 500 mg or 250 mg (as pentahydrate) powder for injection.


Other ingredient - sodium carbonate. The sodium content of each vial strength is 156 mg, 104 mg, 52 mg, 26 mg and 13 mg respectively.


Fortum for Injection is supplied as a single dose vial of ceftazidime 3 grams, 2 grams, 1 gram, 500 mg or 250 mg.




Product licence holder and manufacturer



Product Licence held by



GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT




Manufactured by



GlaxoSmithKline S.p.A.

Verona

Italy





What Fortum does


Fortum contains ceftazidime which is an antibiotic belonging to the cephalosporin class.


Antibiotics are used to kill the bacteria or “germs” that cause infections.


Fortum is used to treat infections caused by one germ, a mixture of germs and also severe infections in general. The types of infection that can be treated by Fortum include the following: Infections of the chest, ear, nose, throat, urinary systems, gut, abdomen, gall bladder, bones, joints, brain (meningitis), flesh and skin. It can also be used to treat infections that may occur after dialysis or to prevent infections that may occur after some surgical operations.


Your doctor has decided to give you Fortum because he has found you have an infection or to protect you from infection before an operation. Sometimes Fortum may be used at the same time as other antibiotics to help treat or prevent infection.




Before having Fortum


This medicine suits most people but there are some people who should not take it. Ask yourself these questions to check whether Fortum is right for you.


  • Have you previously experienced an allergic reaction to Fortum, ceftazidime, or any other antibiotics (e.g. penicillin)?

  • Do you think you may be pregnant?

  • Are you breast-feeding?

  • Do you have kidney disease?

  • Are you taking a diuretic (water tablet) such as frusemide?

  • Are you taking any other antibiotic e.g. chloramphenicol or aminoglycoside antibiotics?

  • Are you on a low sodium diet?

If you answer “yes” to any of these questions, inform your doctor before having Fortum. If you are unsure ask your doctor or pharmacist for advice.




How Fortum is given


Fortum will usually be given by a doctor or nurse either directly into a vein (intravenously) or into a muscle (intramuscularly). In some cases, it may be given as a “drip” (intravenous infusion).


Fortum is supplied as a powder, so before it can be given it must be diluted and made into a solution.


This is normally done by your doctor or nurse.


The usual adult dose is 1 g three times a day or 2 g twice a day. Doses may be less or more than this and given more often depending on the severity and type of infection, your weight, age and kidney function.


The duration of treatment depends on the type of infection.


For prevention of an infection after surgery, 1 g is given before the operation and a second dose after the operation.


For infants and children, the dose is based on body weight.


Children aged over 2 months: 30 mg to 100 mg per kilo daily divided into 2 or 3 separate doses.


Severely ill children may receive up to 150 mg per kilo daily (to a maximum of 6 g daily), divided into 3 separate doses.


New-born and children aged under 2 months: 25 mg to 60 mg per kilo daily divided into 2 or 3 separate doses.


For elderly patients the total daily dose should normally not be more than 3 g, especially in those over 80 years of age.


For patients with moderate to severe kidney problems the dose of Fortum will be reduced.


For patients with renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration the dose is 1 g daily in divided doses.


For patients who have haemodialysis courses, the appropriate dose should be repeated after each haemodialysis period. This is because some of the Fortum may be removed from the body during this type of dialysis and so needs to be topped up.


Fortum can be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). It can be given intravenously or can be incorporated into the dialysis fluid (usually 125-250 mg for 2L of dialysis fluid).


For the treatment of lung infections in patients with cystic fibrosis with normal kidney function, high doses of 100 mg to 150 mg per kilogram of body weight per day (up to 9 grams a day in adults or 6 grams a day in children), given in 3 divided doses should be used. In some cases, the parent of a cystic fibrosis child or an adult patient with cystic fibrosis may be specially instructed on how to give Fortum at home.


Your medication will usually be given to you by a health professional - if you think you may have missed a dose
or have received too much medicine please tell your doctor or nurse.


If, in a rare situation, you have been instructed by your doctor to give yourself Fortum and you think you have given too much, don’t delay, ask your doctor what to do or contact your nearest hospital emergency department. If you have missed a dose, give another as soon as you remember and then carry on as before.


As with all antibiotics it is important that you are given Fortum regularly and the full course is completed.




Side effects


Along with its needed effects, a medicine may cause unwanted effects. Most people given this medicine find it causes no problems. As with other antibiotics, some people find they have an allergy to it.


Tell your doctor immediately if any of the following rare severe allergy symptoms occur:


  • Sudden wheeziness and tightness of chest

  • Swelling of eyelids, face or lips

  • Skin lumps or hives

  • Skin rash (red spots), itchiness, fever

  • Collapse

Check with your doctor as soon as possible if any of the following side effects occur:




Uncommon


  • Pain or inflammation at the site of injection

  • Headache, dizziness, "pins and needles" and a bad taste in the mouth

  • Feeling sick (nausea) or being sick (vomiting), stomach pain

  • Diarrhoea




Rare


  • Thrush in the mouth or vagina

  • Severe diarrhoea from colitis (inflamed lower end of the bowel)

  • Skin reaction where the skin appears to look scalded.

If you think you are getting this rare reaction contact your doctor immediately, especially if the reaction is widespread and affects other parts of your body including mouth, eyes, vagina or anus.





Very rare


Jaundice; if you notice your skin or eyes becoming yellow coloured tell your doctor.


Fortum can cause changes to the body’s normal blood levels of certain cells or chemicals or lead to other blood abnormalities. If you are having a blood test for any reason, tell the person who is taking your blood sample that you are having Fortum, as it may affect your result.


If your urine is being tested for sugar, Fortum may cause a false positive result.


When too much is given, especially in people whose kidneys are not working properly, it can cause trembling, fits and, in a few cases, coma.


If you feel unwell or have any unusual discomfort you don't understand, tell the doctor as soon as possible.





Where to keep your injections


As with all medicines, keep Fortum vials safely away from children.


Store any unopened vials at room temperature below 25°C (77°F). Made up injections are best used straight away. If this is not possible, store them in a fridge at 2-8°C (36°F to 46°F) for no longer than 24 hours.


Protect from light by keeping the vials in their cartons.



What to do with any unused Fortum


If you are at home and your doctor stops your treatment, return any unused Fortum to a pharmacist for disposal. Only keep your medication if your doctor tells you to. Do not use the unopened vials after the expiry date on the label or carton.




Remember


This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.





Further information


This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.


You may be able to find out more about prescribed medicines from books in public libraries.


Leaflet updated March 2003


The information provided applies only to Fortum for Injection


Fortum is a registered trademark of the GlaxoSmithKline group of companies


© 2003 GlaxoSmithKline group of companies



10000000004061






Friday, 30 March 2012

Boots Nasal Spray






Boots Nasal Spray



(Oxymetazoline Hydrochloride)



Clears nasal congestion



22 ml e



Read all of this carton for full instructions.




What this medicine is for


This medicine contains a decongestant, which acts to relieve nasal congestion. It can be used for fast relief of stuffy noses due to head colds and hayfever.




Before you use this medicine



Do not use:



  • If you are allergic to any of the ingredients


  • If you have heart or blood vessel disease


  • If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days


  • If you have an overactive thyroid


  • If you have glaucoma


  • If you are a man with prostate problems



Talk to your pharmacist or doctor:


  • If you are pregnant or breastfeeding

Methyl hydroxybenzoate (E218) may cause allergic reactions (possibly delayed).





How to use this medicine


Check the seal is not broken before first use. If it is, do not use the medicine.



Adults and children of 12 years and over


One or two sprays in each nostril


Every 6 to 8 hours.



For use in the nose only.


Do not use for children under 12 years.


Do not use more than the amount recommended above.


Do not use this medicine for more than 7 days unless your doctor tells you to.


If symptoms do not go away talk to your doctor.



If you use too much: Talk to a doctor.




Possible side effects


Most people will not have problems, but some may get some of these:


  • Irritation to the nose

  • Dry mouth and throat

  • Return of your symptoms if used for a long time


If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.




How to store this medicine


Do not store above 25°C.



Keep all medicines out of the sight and reach of children.


Use by the date on the side panel.




Active ingredient


This spray contains Oxymetazoline Hydrochloride 0.05% w/v.


Also contains: purified water, disodium phosphate, monosodium phosphate, ethanol, methyl hydroxybenzoate (E218), cetrimide, levomenthol, camphor racemic, eucalyptol.


PL 00014/0292


Text prepared 3/09


Manufactured by the Marketing Authorisation holder



The Boots Company PLC

Nottingham

NG2 3AA


If you need more advice ask your pharmacist.


BTC43708 vC 07/04/09






Tuesday, 27 March 2012

Prednisone



Pronunciation: PRED-ni-sone
Generic Name: Prednisone
Brand Name: Generic only. No brands available.


Prednisone is used for:

Treating severe allergies, arthritis, asthma, multiple sclerosis, and skin conditions. It may also be used for other conditions as determined by your doctor.


Prednisone is a corticosteroid. It works by decreasing or preventing tissues from responding to inflammation. It also modifies the body's response to certain immune stimulation.


Do NOT use Prednisone if:


  • you are allergic to any ingredient in Prednisone

  • you have a systemic fungal infection

  • you are currently taking mifepristone

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



Before using Prednisone:


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


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

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

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

  • if you are scheduled for a vaccination with a live virus vaccine (eg, smallpox)

  • if you have an underactive thyroid, liver or kidney problems, diabetes, or ulcerative colitis

  • if you have heart problems, esophagitis, gastritis, stomach obstruction or perforation, or an ulcer

  • if you have a history of mental problems, such as depression

  • if you have a herpes infection in your eye or any other type of infection (bacterial, fungal, or viral); have or recently had tuberculosis (TB) or tested positive for TB, measles, or chickenpox

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


  • Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because the effectiveness of Prednisone may be decreased

  • Clarithromycin azole antifungals (eg, ketoconazole), steroidal contraceptives (eg, desogestrel), or troleandomycin because side effects, such as weakness, confusion, muscle aches, joint pain, or low blood sugar, may occur

  • Methotrexate or ritodrine because the actions and side effects of these medicines may be increased

  • Hydantoins (eg, phenytoin), mifepristone, or live vaccines because the effectiveness of these medicines may be decreased

  • Anticoagulants (eg, warfarin) or aspirin because the actions and side effects of these medicines may be increased or decreased

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


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


  • Take Prednisone by mouth with food.

  • Prednisone comes as a dose pack with specific instructions as to when to take the medicine or how much to take each time. It is very important to follow these instructions as closely as possible. Do not miss any doses.

  • If you miss a dose of Prednisone, 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 Prednisone.



Important safety information:


  • Patients on long-term steroid therapy should carry an ID card at all times that says they take Prednisone.

  • Prednisone makes you more susceptible to illnesses, especially if you take it for an extended period of time. Prevent infection by avoiding contact with people who have colds or other infections. If you are exposed to chickenpox, measles, or TB while taking Prednisone or within 12 months after stopping Prednisone, call your doctor. Report any injuries or signs of an infection (fever, sore throat, pain during urination, or muscle aches) that occur during treatment and within 12 months after stopping Prednisone. Your dose may need to be adjusted or you may need to start taking Prednisone again.

  • Tell your doctor or dentist that you take Prednisone before you receive any medical or dental care, emergency care, or surgery.

  • Prednisone may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement.

  • Prednisone can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements.

  • Do not receive a live vaccine, especially smallpox, while you are taking Prednisone.

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

  • Lab tests may be performed while you use Prednisone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Infants and CHILDREN on long-term therapy must be closely monitored by a health care provider.

  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisone.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisone while you are pregnant. Prednisone is found in breast milk. If you are or will be breast-feeding while you use Prednisone, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Prednisone:


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:



Difficulty sleeping; feeling of a whirling motion; increased appetite; increased sweating; indigestion; mood changes; nervousness.



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); appetite loss; black, tarry stools; changes in menstrual periods; convulsions; depression; diarrhea; dizziness; exaggerated sense of well-being; fever; general body discomfort; headache; increased pressure in the eye; joint or muscle pain; mood swings; muscle weakness; personality changes; prolonged sore throat, cold, or fever; puffing of the face; severe nausea or vomiting; swelling of feet or legs; unusual weight gain; vomiting material that looks like coffee grounds; weakness; weight loss.



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: Prednisone 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.


Proper storage of Prednisone:

Store Prednisone 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 Prednisone out of the reach of children and away from pets.


General information:


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

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

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

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

This information is a summary only. It does not contain all information about Prednisone. 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 Prednisone resources


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


Compare Prednisone with other medications


  • Acute Lymphocytic Leukemia
  • Adrenocortical Insufficiency
  • Adrenogenital Syndrome
  • Allergic Reactions
  • Ankylosing Spondylitis
  • Aspiration Pneumonia
  • Asthma
  • Atopic Dermatitis
  • Autoimmune Hemolytic Anemia
  • Berylliosis
  • Bullous Pemphigoid
  • Bursitis
  • Chorioretinitis
  • Cluster Headaches
  • Cogan's Syndrome
  • Conjunctivitis, Allergic
  • Corneal Ulcer
  • Dermatitis Herpetiformis
  • Dermatomyositis
  • Eczema
  • Epicondylitis, Tennis Elbow
  • Erythroblastopenia
  • Fibromyalgia
  • Gouty Arthritis
  • Graft-versus-host disease
  • Hay Fever
  • Herpes Zoster
  • Herpes Zoster Iridocyclitis
  • Hypercalcemia of Malignancy
  • Idiopathic Thrombocytopenic Purpura
  • Immunosuppression
  • Inflammatory Bowel Disease
  • Inflammatory Conditions
  • Iridocyclitis
  • Iritis
  • Juvenile Rheumatoid Arthritis
  • Keratitis
  • Leukemia
  • Lichen Planus
  • Lichen Sclerosus
  • Loeffler's Syndrome
  • Lymphoma
  • Multiple Sclerosis
  • Mycosis Fungoides
  • Nephrotic Syndrome
  • Neurosarcoidosis
  • Osteoarthritis
  • Pemphigoid
  • Pemphigus
  • Pharyngitis
  • Polymyositis/Dermatomyositis
  • Psoriasis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Sarcoidosis
  • Seborrheic Dermatitis
  • Sinusitis
  • Skin Rash
  • Synovitis
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • Thrombocytopenia
  • Toxic Epidermal Necrolysis
  • Tuberculosis, Extrapulmonary
  • Tuberculous Meningitis
  • Ulcerative Colitis
  • Uveitis, Posterior

Tuesday, 20 March 2012

Meclofenamate Sodium


Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
CAS Number: 6385-02-0


  • Cardiovascular Risk


  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).146 147 Risk may increase with duration of use.146 147 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.146 (See Cardiovascular Effects under Cautions.)




  • Contraindicated for the treatment of pain in the setting of CABG surgery.146



  • GI Risk


  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).100 108 109 117 145 146 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.100 108 109 117 146 Geriatric individuals are at greater risk for serious GI events.100 146 (See GI Effects under Cautions.)




Introduction

Prototypical NSAIA;100 a anthranilic acid derivative;100 a structurally related to diclofenac and mefenamic acid.100 a


Uses for Meclofenamate Sodium


Consider potential benefits and risks of meclofenamate sodium therapy as well as alternative therapies before initiating therapy with the drug.100 146 Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.100 146


Inflammatory Diseases


Symptomatic treatment of acute and chronic osteoarthritis and rheumatoid arthritis.100 a


Has been used with some success in a limited number of adults with ankylosing spondylitisa b or acute gouty arthritis.a c


Has been used in a limited number of patients with psoriatic arthritis.a


Pain


Relief of mild to moderate pain in adults.a 100 101 102 103 104 105 106


Dysmenorrhea and Menorrhagia


Treatment of primary dysmenorrhea.100 107 a


Treatment of idiopathic menorrhagia.100 112 a Use only for heavy menstrual flow that is idiopathic (i.e., no underlying pathophysiologic cause can be identified);100 112 do not use for the management of spotting or bleeding that occurs between menstrual cycles.100


Use for primary dysmenorrhea or idiopathic menorrhagia only when the potential benefits justify the possible risks.100


Meclofenamate Sodium Dosage and Administration


General



  • Consider potential benefits and risks of meclofenamate sodium therapy as well as alternative therapies before initiating therapy with the drug.100 146



Administration


Oral Administration


Administer orally.100 a


Administration with meal, milk, or antacids may minimize adverse GI effects.100 146 a


Dosage


Available as meclofenamate sodium; dosage expressed in terms of meclofenamic acid.100 a


To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.100 146 a Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.100 146 a


Adults


Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

200–400 mg daily in 3 or 4 equally divided doses.100 a Initiate at lower dosage and adjust dose and frequency as necessary based on severity of symptoms and clinical response (maximum 400 mg daily).100 146 a


Pain

Oral

50 mg every 4–6 hours.a 100 101 103 104 105 106 Some patients may require 100-mg doses for optimal pain relief (maximum 400 mg daily).a 100 101 102 103 104 105 106


Dysmenorrhea and Menorrhagia

Oral

100 mg 3 times daily.a 100 107 112 Initiated at onset of menses and continue ≤ 6 days or until cessation of menses.100 112 a


Prescribing Limits


Adults


Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Maximum 400 mg daily.100 a


Pain

Oral

For mild to moderate pain, maximum 400 mg daily.100 101


Dysmenorrhea and Menorrhagia

Oral

Maximum 300 mg daily.100


Special Populations


Renal Impairment


Dosage reduction recommended in patients with renal impairment; monitor renal function.100 a


Use not recommended in patients with advanced renal disease.146


Geriatric Patients


Consider reduced initial dosage; monitor carefully.a 100


Cautions for Meclofenamate Sodium


Contraindications



  • Known hypersensitivity to meclofenamate sodium or any ingredient in the formulation.100 146 a




  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.100 146 a




  • Treatment of perioperative pain in the setting of CABG surgery.146



Warnings/Precautions


Warnings


Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.147 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.150 151 152 Information not available on risk associated with meclofenamate sodium at this time.150 151 152


Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.146


Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).146


No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.146 147 (See Specific Drugs under Interactions.)


Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.146 Use with caution in patients with hypertension; monitor BP.146 Impaired response to certain diuretics may occur.146 (See Specific Drugs under Interactions.)


Fluid retention and edema reported.146 Use with caution in patients with fluid retention or heart failure.146


GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;100 108 109 117 146 increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.100 146 a


For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;111 120 134 135 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).111 120 134


Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.100 146


Potential for overt renal decompensation.100 146 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.100 146 149 a (See Renal Impairment under Cautions.)


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylactoid reactions reported.146


Immediate medical intervention and discontinuance for anaphylaxis.146


Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.100 146


Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported;100 146 can occur without warning.146 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).146


General Precautions


Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.100 146 a


Elevations of serum ALT, AST, or alkaline phosphatase reported.100 146


Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.100 146 a Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.100 146 a


Hematologic Effects

Anemia reported.100 146 a Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.100 146 a


Leukopenia, thrombocytopenic purpura, neutropenia, and agranulocytosis reported rarely.100 a Decreased WBC counts usually transient and return to normal despite continued meclofenamate sodium therapy.100 a Further clinical evaluations are necessary if leukopenia, granulocytopenia, or thrombocytopenia persists; discontinuance of meclofenamate sodium therapy may be necessary.100 a


May inhibit platelet aggregation and prolong bleeding time.a 146


Ocular Effects

Ocular toxicity reported in patients receiving NSAIA therapy.100 a If visual difficulties develop during therapy, discontinue the drug and perform complete ophthalmologic examination.100 a


Sodium Content and Electrolyte Imbalance

100-mg meclofenamate sodium capsules each contain 0.34 mEq of sodium.a


Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.146 a


May mask certain signs of infection or other conditions.146 a


Obtain CBC and chemistry profile periodically during long-term therapy.146 a


Specific Populations


Pregnancy

No FDA category rating.100 Safety not established; avoid use, particularly during first and third trimesters.100 146 a Avoid use in third trimester because of possible premature closure of the ductus arteriosus.a


Lactation

Meclofenamic acid is distributed into milk.a 100 Discontinue nursing or the drug.100 146 a


Pediatric Use

Safety and efficacy not established in children <14 years of age.100 a


Geriatric Use

Use with caution in patients ≥65 years of age.100 146 a Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.a 100 146 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.a 100


Renal Impairment

Metabolites eliminated principally via the kidney.100 a


Use with caution and close monitoring in patients with substantial renal impairment.100 a Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.146


Common Adverse Effects


Diarrhea, nausea with or without vomiting, other GI disorders, abdominal pain, flatulence, pyrosis, dizziness, headache, rash.100 146 a


Interactions for Meclofenamate Sodium


Protein-bound Drugs


Possible pharmacokinetic interaction; observe for adverse effects if used with other protein-bound drugs.100 a


Specific Drugs







































Drug



Interaction



Comments



ACE inhibitors



Reduced BP response to ACE inhibitor possible146 153


Possible deterioration of renal function in individuals with renal impairment146



Angiotensin II receptor antagonists



Reduced BP response to angiotensin II receptor antagonist possible146 153


Possible deterioration of renal function in individuals with renal impairment146



Antacids (aluminum- and magnesium-containing)



No effect on meclofenamate sodium absorption100



Aspirin



May decrease plasma concentrations of meclofenamic acid100 a


Increased risk of GI ulceration and other complications100 137


No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs147



Concomitant use not recommended146



Diuretics (furosemide, thiazides)



Reduced natriuretic effects146



Monitor for diuretic efficacy and renal failure146



Lithium



Increased plasma lithium concentrations146



Monitor for lithium toxicity146



Methotrexate



Possible toxicity associated with increased plasma methotrexate concentrations146



Caution advised146



Propoxyphene



Pharmacokinetic interaction unlikely100



Warfarin



Possible bleeding complications and increases in PT100 146 a



Monitor PT, adjust warfarin dosage as needed, and observe for adverse effects100 146 a


Meclofenamate Sodium Pharmacokinetics


Absorption


Bioavailability


Rapidly and completely absorbed following oral administration.100 a Peak plasma concentrations usually attained within 0.5–2 hours following oral administration.2 100


Food


Food decreases rate27 100 and extent100 of absorption.


Distribution


Extent


Distribution into human body tissues and fluids not fully characterized.a In animals, the drug is distributed mainly into the plasma, liver, and kidneys, with lower concentrations being distributed into the heart, spleen, fat, skeletal muscle, and brain.a


Crosses the placenta.100 a Meclofenamic acid is distributed into milk.100 a


Plasma Protein Binding


>99% (mainly albumin).2 100 114 a


Elimination


Elimination Route


Excreted in urine (70%), mainly as glucuronide conjugates of the metabolites,2 27 100 114 and in feces (20–30%).2 27 100


Half-life


40 minutes–5.3 hours.2 100 114


Stability


Storage


Oral


Capsules

Tight, light-resistant containers at 15–30°C.100 a


ActionsActions



  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.127 128 129 130 131 132




  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.100 a



Advice to Patients



  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.146




  • Risk of serious cardiovascular events with long-term use.146 150 151 152 154 Importance of notifying a clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.146




  • Risk of GI bleeding and ulceration.100 108 109 146 Importance of notifying a clinician if signs and symptoms of serious adverse GI effects occur.146




  • Risk of serious skin reactions.146 Importance of discontinuing meclofenamate sodium and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.146




  • Risk of anaphylactoid and other sensitivity reactions.146 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.146




  • Risk of hepatotoxicity.100 146 a Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.146




  • Importance of notifying clinician if signs or symptoms of edema or unexplained weight gain develop.100 146




  • Risk of dizziness and potential for drug to impair mental alertness; use caution when driving or operating machinery until effects on individual are known.a




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.146 Importance of avoiding meclofenamate sodium in pregnancy, particularly during early and late pregnancy (first and third trimesters).100 146 a




  • Importance of advising women receiving meclofenamate sodium for menorrhagia to notify clinician if spotting or bleeding between menstrual cycles or worsening of menstrual blood flow occurs.100 a




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.100




  • Importance of informing patients of other important precautionary information.100 (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


















Meclofenamate Sodium

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



50 mg (of meclofenamic acid)*



Meclofenamate Sodium Capsules



Mylan



100 mg (of meclofenamic acid)*



Meclofenamate Sodium Capsules



Mylan


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.


Meclofenamate Sodium 100MG Capsules (MYLAN): 30/$65.99 or 90/$175.9


Meclofenamate Sodium 50MG Capsules (MYLAN): 30/$42.99 or 90/$109.97



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


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




References



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27. Smith TC. Clinical pharmacology studies of sodium meclofenamate (Meclomen). Curr Ther Res. 1978; 23(Suppl):S42-50.



100. Mylan Pharmaceuticals Inc. Meclofenamate sodium capsules prescribing information. Morgantown, WV; 1998 Jun.



101. Markowitz NR, Young SK, Rohrer MD et al. Comparison of meclofenamate sodium with buffered aspirin and placebo in the treatment of postsurgical dental pain. J Oral Maxillofac Surg. 1985; 43:517-22. [IDIS 202502] [PubMed 3859595]



102. Rowe NH, Aseltine LF, Turner JL. Control of pain with meclofenamate sodium following removal of an impacted molar. Oral Surg Oral Med Oral Pathol. 1985; 59:446-8. [PubMed 3892406]



103. Kempf KK, Konzelman JL, Schultz RE et al. Comparison of meclofenamate sodium with buffered aspirin and placebo for the relief of postoperative dental pain. Clin Ther. 1987; 9:594-601. [PubMed 3326678]



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



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



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



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



129. Riendeau D, Charleson S, Cromlish W et al. Comparison of the cyclooxygenase-1 inhibitory properties of nonsteroidal anti-inflammatory drug (NSAIDs) and selective COX-2 inhibitors, using sensitive microsomal and platelet assays. Can J Physiol Pharmacol. 1997; 75:1088-95. [PubMed 9365818]



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



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



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



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



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



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



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b. Ebner W, Poal Ballarin JM, Boussina I. Meclofenamate sodium in the treatment of ankylosing spondylitis: report of a European double-blind controlled multicenter study. Arzneimittelforschung. 1983; 33(Suppl 4A):660-3. [PubMed 6349653]



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More Meclofenamate Sodium resources


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


  • Meclofenamate Prescribing Information (FDA)

  • meclofenamate Concise Consumer Information (Cerner Multum)

  • Meclofenamate MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Meclofenamate Sodium with other medications


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Plaquenil


Generic Name: hydroxychloroquine (Oral route)

hye-drox-ee-KLOR-oh-kwin

Oral route(Tablet)

Physicians should completely familiarize themselves with the contents of the leaflet before prescribing hydroxychloroquine .



Commonly used brand name(s)

In the U.S.


  • Plaquenil

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antimalarial


Chemical Class: Aminoquinoline


Uses For Plaquenil


Hydroxychloroquine belongs to the family of medicines called antiprotozoals. Protozoa are tiny, one-celled animals. Some are parasites that can cause many different kinds of infections in the body.


This medicine is used to prevent and to treat malaria and to treat some conditions such as liver disease caused by protozoa. It is also used in the treatment of arthritis to help relieve inflammation, swelling, stiffness, and joint pain and to help control the symptoms of lupus erythematosus (lupus; SLE).


This medicine may be given alone or with one or more other medicines. It may also be used for other conditions as determined by your doctor.


Hydroxychloroquine is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, hydroxychloroquine is used in certain patients with the following medical conditions:


  • Arthritis, juvenile

  • Hypercalcemia, sarcoid-associated

  • Polymorphous light eruption

  • Porphyria cutanea tarda

  • Urticaria, solar

  • Vasculitis, chronic cutaneous

Before Using Plaquenil


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


Children are especially sensitive to the effects of hydroxychloroquine. This may increase the chance of side effects during treatment. Overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-milligrams [mg] strength) of chloroquine has resulted in death in small children. Because hydroxychloroquine is so similar to chloroquine, it is probably just as toxic.


Geriatric


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


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.


  • Aurothioglucose

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.


  • Digoxin

  • Metoprolol

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 disease (severe)—Hydroxychloroquine may cause blood disorders

  • Eye or vision problems—Hydroxychloroquine may cause serious eye side effects, especially in high doses

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Hydroxychloroquine may cause serious blood side effects in patients with this deficiency

  • Kidney disease—There may be an increased chance of side effects in patients with kidney disease

  • Liver disease—May decrease the removal of hydroxychloroquine from the blood, increasing the chance of side effects

  • Nerve or brain disease (severe), including convulsions (seizures)—Hydroxychloroquine may cause muscle weakness and, in high doses, seizures

  • Porphyria—Hydroxychloroquine may worsen the symptoms of porphyria

  • Psoriasis—Hydroxychloroquine may bring on severe attacks of psoriasis

  • Stomach or intestinal disease (severe)—Hydroxychloroquine may cause stomach irritation

Proper Use of Plaquenil


Take this medicine with meals or milk to lessen possible stomach upset, unless otherwise directed by your doctor.


Keep this medicine out of the reach of children. Children are especially sensitive to the effects of hydroxychloroquine and overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-mg strength) of chloroquine has resulted in death in small children. Hydroxychloroquine is probably just as dangerous.


It is very important that you take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of serious side effects.


If you are taking this medicine to help keep you from getting malaria, keep taking it for the full time of treatment. If you already have malaria, you should still keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return.


Hydroxychloroquine works best when you take it on a regular schedule. For example, if you are to take it once a week to prevent malaria, it is best to take it on the same day each week. Or if you are to take 2 doses a day, 1 dose may be taken with breakfast and the other with the evening meal. Make sure that you do not miss any doses. If you have any questions about this, check with your health care professional.


For patients taking hydroxychloroquine to prevent malaria:


  • Your doctor may want you to start taking this medicine 1 to 2 weeks before you travel to an area where there is a chance of getting malaria. This will help you to see how you react to the medicine. Also, it will allow time for your doctor to change to another medicine if you have a reaction to this medicine.

  • Also, you should keep taking this medicine while you are in the area and for 4 to 6 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important to keep taking this medicine for the full time your doctor ordered. Also, if fever develops during your travels or within 2 months after you leave the area, check with your doctor immediately.

For patients taking hydroxychloroquine for arthritis or lupus:


  • This medicine must be taken regularly as ordered by your doctor in order for it to help you. It may take up to several weeks before you begin to feel better. It may take up to 6 months before you feel the full benefit of this medicine.

For patients unable to swallow hydroxychloroquine tablets:


  • Your pharmacist can crush the tablets and put each dose in a capsule. Contents of the capsules may then be mixed with a teaspoonful of jam, jelly, or jello. Be sure you take all the food in order to get the full dose of medicine.

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 tablets dosage form:
    • For prevention of malaria:
      • Adults—400 milligrams (mg) once every seven days.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.4 mg per kilogram (kg) (2.9 mg per pound) of body weight once every seven days.


    • For treatment of malaria:
      • Adults—800 mg as a single dose. This may sometimes be followed by a dose of 400 mg six to eight hours after the first dose, then 400 mg once a day on the second and third days.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 32 mg per kg (14.5 mg per pound) of body weight taken over a period of three days.


    • For treatment of arthritis:
      • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.5 mg per kg (2.9 mg per pound) of body weight per day.



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.


Precautions While Using Plaquenil


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


If your symptoms do not improve within a few days (or a few weeks or months for arthritis), or if they become worse, check with your doctor.


Hydroxychloroquine may cause blurred vision, difficulty in reading, or other change in vision. It may also cause some people to become dizzy or lightheaded. 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 dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.


Malaria is spread by mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:


  • If possible, sleep under mosquito netting to avoid being bitten by malaria-carrying mosquitoes.

  • Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.

  • Apply mosquito repellent to uncovered areas of the skin from dusk through dawn when mosquitoes are out.

Plaquenil 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. When this medicine is used for short periods of time, side effects usually are rare. However, when it is used for a long time and/or in high doses, side effects are more likely to occur and may be serious.


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


Less common
  • Blurred vision or any other change in vision—this side effect may also occur or get worse after you stop taking this medicine

Rare
  • Convulsions (seizures)

  • increased muscle weakness

  • mood or other mental changes

  • ringing or buzzing in ears or any loss of hearing

  • sore throat and fever

  • unusual bleeding or bruising

  • unusual tiredness

  • weakness

Symptoms of overdose
  • Drowsiness

  • headache

  • increased excitability

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
  • Diarrhea

  • difficulty in seeing to read

  • headache

  • itching (more common in black patients)

  • loss of appetite

  • nausea or vomiting

  • stomach cramps or pain

Less common
  • Bleaching of hair or increased hair loss

  • blue-black discoloration of skin, fingernails, or inside of mouth

  • dizziness or lightheadedness

  • nervousness or restlessness

  • skin rash

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: Plaquenil side effects (in more detail)



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