Wednesday, 11 April 2012

IBU


Pronunciation: EYE-bue-PROE-fen
Generic Name: Ibuprofen
Brand Name: Examples include IBU and Motrin

IBU is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take IBU for a long time. Do not use IBU right before or after bypass heart surgery.


IBU may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.





IBU is used for:

Treating rheumatoid arthritis, osteoarthritis, menstrual cramps, or mild to moderate pain. It may also be used for other conditions as determined by your doctor.


IBU is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.


Do NOT use IBU if:


  • you are allergic to any ingredient in IBU

  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)

  • you have recently had or will be having bypass heart surgery

  • you are in the last 3 months of pregnancy

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



Before using IBU:


Some medical conditions may interact with IBU. 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 product, or dietary supplement

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

  • if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

  • if you have a history of swelling or fluid buildup, lupus, asthma, or growths in the nose (nasal polyps), or mouth inflammation

  • if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

  • if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

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


  • Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

  • Probenecid because it may increase the risk of IBU's side effects

  • Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by IBU

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by IBU

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


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


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

  • Take IBU by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

  • Take IBU with a full glass of water (8 oz/240 mL) as directed by your doctor.

  • If you miss a dose of IBU and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 the proper use of IBU.



Important safety information:


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

  • Serious stomach ulcers or bleeding can occur with the use of IBU. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking IBU with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

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

  • Do not take aspirin while you are using IBU unless your doctor tells you to.

  • Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be done to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use IBU with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.

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

  • PREGNANCY and BREAST-FEEDING: IBU may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking IBU while you are pregnant. It is not known if IBU is found in breast milk. Do not breast-feed while taking IBU.


Possible side effects of IBU:


All medicines can 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:



Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset.



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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .


See also: IBU 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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.


Proper storage of IBU:

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


General information:


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

  • IBU 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 IBU. 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 IBU resources


  • IBU Side Effects (in more detail)
  • IBU Dosage
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  • IBU Drug Interactions
  • 0 Reviews for IBU - Add your own review/rating


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  • Caldolor Consumer Overview

  • Caldolor Prescribing Information (FDA)

  • Caldolor Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ibutilide Fumarate Monograph (AHFS DI)

  • Motrin Prescribing Information (FDA)

  • Motrin Consumer Overview

  • Motrin IB Prescribing Information (FDA)

  • NeoProfen Prescribing Information (FDA)



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Monday, 9 April 2012

Chlorothiazide Suspension


Pronunciation: klor-oh-THYE-a-zide
Generic Name: Chlorothiazide
Brand Name: Diuril


Chlorothiazide Suspension is used for:

Treating excess fluid buildup in the body caused by certain conditions or medicines. It may also be used to treat high blood pressure or other conditions as determined by your doctor.


Chlorothiazide Suspension is a thiazide diuretic. It works by helping the kidneys eliminate fluid from your body. Exactly how Chlorothiazide Suspension works to treat high blood pressure is unknown.


Do NOT use Chlorothiazide Suspension if:


  • you are allergic to any ingredient in Chlorothiazide Suspension or to any other sulfonamide medicine (eg sulfamethoxazole, glyburide, acetazolamide)

  • you are unable to urinate

  • you are taking dofetilide or ketanserin

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



Before using Chlorothiazide Suspension:


Some medical conditions may interact with Chlorothiazide Suspension. 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 gout, kidney or liver problems, lupus, diabetes, asthma, parathyroid problems, high blood cholesterol or lipid levels, or low blood pressure

  • if you have low blood sodium, chloride, potassium, or magnesium levels; or high blood calcium levels

  • if you have recently had nerve surgery

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


  • Nonsteroidal anti-inflammatory medicines (NSAIDs) (eg, ibuprofen) because they decrease the effectiveness of Chlorothiazide Suspension

  • Barbiturates (eg, phenobarbital), narcotic pain medicines (eg, codeine, morphine, fentanyl), or medicines for high blood pressure because side effects of Chlorothiazide Suspension may be increased

  • Diazoxide or nondepolarizing muscle relaxants (eg, tubocurarine) because side effects may be increased by Chlorothiazide Suspension

  • Lithium because risk of toxicity may be increased by Chlorothiazide Suspension

  • Digoxin, dofetilide, or ketanserin because risk of irregular heartbeat may be increased by Chlorothiazide Suspension

  • Diabetes medicines (eg, glipizide, metformin) or insulin because their effectiveness may be decreased by Chlorothiazide Suspension

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


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


  • Chlorothiazide Suspension may be taken with or without food.

  • Shake well before using.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • When you first start taking Chlorothiazide Suspension, it may cause an increase in urine or in frequency of urination. To prevent this from affecting sleep, try not to take any dose later than 6 pm.

  • Continue to use Chlorothiazide Suspension even if you feel well. Do not miss any doses.

  • If you miss a dose of Chlorothiazide Suspension, 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 Chlorothiazide Suspension.



Important safety information:


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

  • Chlorothiazide Suspension may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

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

  • Chlorothiazide Suspension may cause high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor). If these symptoms occur, tell your doctor immediately.

  • Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.

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

  • Patients being treated for high blood pressure often feel tired or run down for a few weeks after beginning therapy. Continue taking your medication even though you may not feel quite "normal." Contact your doctor or pharmacist about any new symptoms.

  • LAB TESTS, including kidney function, blood pressure, and blood electrolyte levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Chlorothiazide Suspension with caution in the ELDERLY because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Chlorothiazide Suspension during pregnancy. Chlorothiazide Suspension is excreted in breast milk. Do not breast-feed while taking Chlorothiazide Suspension.


Possible side effects of Chlorothiazide Suspension:


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



Blurred vision; dizziness; headache; lightheadedness, especially when sitting up or standing; numbness or tingling of skin.



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); confusion; decrease in amount of urine; drowsiness; gout; inability to keep an erection; inflammation of the pancreas; muscle pain or cramps; rapid or irregular heartbeat; red, swollen, blistered, or peeling skin; restlessness; seizures; shortness of breath; unusual thirst; unusual tiredness or weakness; unusually dry mouth; vomiting.



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: Chlorothiazide 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 dry mouth; excessive urination followed by a decrease in amount of urine; muscle cramps; severe lightheadedness, especially upon standing; weak or irregular heartbeat.


Proper storage of Chlorothiazide Suspension:

Store Chlorothiazide Suspension 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 Chlorothiazide Suspension out of the reach of children and away from pets.


General information:


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

  • Chlorothiazide Suspension 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 Chlorothiazide Suspension. 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 Chlorothiazide resources


  • Chlorothiazide Side Effects (in more detail)
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  • 1 Review for Chlorothiazide - Add your own review/rating


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Saturday, 7 April 2012

Loprazolam 1mg tablets





1. Name Of The Medicinal Product



Loprazolam 1mg Tablets



Dormonoct


2. Qualitative And Quantitative Composition



Each tablet contains loprazolam mesylate equivalent to 1mg loprazolam.



3. Pharmaceutical Form



Light yellow, biconvex, round tablets, 7mm in diameter marked with an 'A' and '026' separated by a score line on one side. The other side is blank.



4. Clinical Particulars



4.1 Therapeutic Indications



Loprazolam is indicated for the short-term treatment of insomnia including difficulty in falling asleep and/or frequent nocturnal awakenings. Benzodiazepines should be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme distress. An underlying cause of insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.



4.2 Posology And Method Of Administration



Adults: The recommended dose is 1mg at bedtime. This may be increased to 1.5mg or 2mg if necessary.



Elderly: Dosage in the elderly should be limited to 1mg at bedtime.



Frail, debilitated or aged patients: A starting dose of a half tablet may be appropriate. Dosage should not exceed 1mg.



Treatment should if possible be intermittent.



The lowest dose to control symptoms should be used. Treatment should not normally be continued beyond 4 weeks.



Long term chronic use is not recommended.



Treatment should always be tapered off gradually.



Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.



Children: There is insufficient evidence to recommend the use of Loprazolam in children.



4.3 Contraindications



Sensitivity to benzodiazepines, acute pulmonary insufficiency, severe respiratory insufficiency, myasthenia gravis, phobic or obsessional states and sleep apnoea syndrome. Monotherapy in depression or anxiety associated with depression and chronic psychosis and alcohol intake.



4.4 Special Warnings And Precautions For Use



Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients who are depressed and who exhibit aggressive behaviour towards self and others. Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.



In general, the dependence potential of benzodiazepines is low but this increases when high doses are attained, especially when given over long periods and particularly in patients with a history of alcoholism or drug abuse. However, withdrawal symptoms occur even with normal therapeutic doses given for short periods of time. Withdrawal from benzodiazepines may be associated with physiological and psychological symptoms of withdrawal including depression, anxiety, tension, restlessness, confusion, irritability and headaches. Patients receiving benzodiazepines should be regularly monitored.



Rebound insomnia may also occur. It may be accompanied by other reactions such as changes in mood, anxiety, sleep disturbances and restlessness.



Loprazolam should be used with caution in chronic pulmonary insufficiency, cerebrovascular disease and chronic renal or hepatic impairment.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Loprazolam may be potentiated by alcohol or other drugs acting on the CNS or with Cisapride. Additive synergy has been observed with neuromuscular depressants (curare-like drugs and muscle relaxants).



Combination with CNS depressants e.g. antipsychotics, hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines, causes enhancement of the central depressive effects of Loprazolam.



Concommitant intake with alcohol is not recommended. The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machinery.



The risk of a withdrawal syndrome occurring is increased when loprazolam is combined with other benzodiazepines prescribed as anxiolytics or hypnotics.



4.6 Pregnancy And Lactation



If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.



If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression can be expected due to the pharmacological action of the compound.



Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependency and may be at some risk for developing withdrawal symptoms in the postnatal period.



Since benzodiazepines are found in the breast milk, they should not be given to breast feeding mothers.



4.7 Effects On Ability To Drive And Use Machines



Attention should be drawn to the risk of drowsiness, sedation, amnesia, impaired concentration and muscular weakness, especially in drivers of vehicles and operators of machines, when taking the product (see also “Interactions”).



4.8 Undesirable Effects



In general, Loprazolam is very well tolerated. However, the common side effects of benzodiazepines, including headaches, nausea, drowsiness, hypotonia, blurring of vision, dizziness and ataxia may occur on the following day, particularly in unusually sensitive patients or when dosage has been excessive.



Rare behavioural adverse effects of benzodiazepines include paradoxical aggressive outbursts, excitement, confusion and the uncovering of depression with suicidal tendencies. If these reactions should occur, use of the drug should be discontinued. Even more rare side effects reported with some benzodiazepines have been hypotension, gastro-intestinal and visual disturbances, skin rashes, urinary retention, changes in libido, blood dyscrasias and jaundice.



Benzodiazepines may induce anterograde amnesia. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.



4.9 Overdose



As with other benzodiazepines, overdosage does not usually present a threat to life. Treatment is symptomatic and gastric lavage may be of use if performed shortly after ingestion. Use of a specific antidote such as flumazenil in association with symptomatic treatment in hospital should be considered.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Benzodiazepines have a widespread action as a result of their enhancing the release of gamma-aminobutyric acid (GABA). They are effective as anti-convulsants, muscle relaxants, anti-anxiety agents, pre-medications and sedative hypnotics.



5.2 Pharmacokinetic Properties



The pharmacokinetics of oral Loprazolam given in a single dose or in repeated doses on 7 consecutive nights were studied in a balanced cross-over trial in six healthy male subjects aged 22-37 years. The subjects were allocated randomly to the treatment phases which were separated by 2-week drug-free intervals. Loprazolam was administered as 1mg tablets.



On the night of administration of the single dose and the seventh repeated dose, venous blood samples were taken before and at intervals after treatment. Serum Loprazolam concentrations were measured using both a radioimmunoassay (RIA) and the more specific high pressure liquid chromatography and gas chromatography (HPLC/GC) technique. Maximum serum levels (Cmax) and the time taken to achieve them (Tmax) were measured, and the half-life (t1/2) was calculated. The area under the serum concentration-time curve (AUC) was determined using the trapezoidal rule. The ratios of AUC and Cmax after repeated doses to AUC and Cmax after single doses were used to assess possible accumulation of Loprazolam.







































 


MEAN (SD)


 


SINGLE DOSES




RIA data




HPLC/GC data




Cmax (mcg/litre)




4.0 (1.2)




4.1 (2.2)




tmax (hours)




4.0 (2.1)




5.0 (3.6)




t1/2 (hours)




11.7 (4.7)




8.0 (3.4)*




AUC (mcg/litre hour)




60.0 (20.9)




35.5 (22.2)



 
  


REPEATED DOSES




RIA data




HPLC/GC data




Cmax (mcg/litre)




5.1 (1.2)




4.6 (2.1)




tmax (hours)




5.3 (3.7)




5.5 (2.7)




t1/2 (hours)




12.8 (4.9)




3.5 (0.2)**




AUC (mcg/litre hour)




75.6 (21.1)




50.0 (26.9)



n = 6 subjects, except for *n = 5, **n = 3.



5.3 Preclinical Safety Data



No additional data of relevance to the prescriber.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Povidone, Lactose, Colloidal silicon dioxide, Maize starch, Microcrystalline cellulose and Magnesium stearate.



6.2 Incompatibilities



None.



6.3 Shelf Life



24 months.



6.4 Special Precautions For Storage



Store below 25oC in a dry place. Protect from light.



6.5 Nature And Contents Of Container



UPVC/aluminium foil blisters, packaged in cartons of 10, 28 or 30 tablets.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



Winthrop Pharmaceuticals UK Limited



One Onslow Street



Guildford



Surrey



GU1 4YS



UK



Trading as: Winthrop Pharmaceuticals, P.O. Box 611, Guildford GU1 4YS.



8. Marketing Authorisation Number(S)



PL 17780/0306



9. Date Of First Authorisation/Renewal Of The Authorisation



17th March 2009



10. Date Of Revision Of The Text



15 July 2010



LEGAL CLASSIFICATION


POM




Friday, 6 April 2012

HIV Infection Medications


Definition of HIV Infection: HIV infection is a viral infection caused by the human immunodeficiency virus (HIV) that gradually destroys the immune system, resulting in infections that are hard for the body to fight.

Drugs associated with HIV Infection

The following drugs and medications are in some way related to, or used in the treatment of HIV Infection. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about HIV Infection





Drug List:

Wednesday, 4 April 2012

Integrilin


Pronunciation: ep-ti-FIB-ih-tide
Generic Name: Eptifibatide
Brand Name: Integrilin


Integrilin is used for:

Treating unstable angina (chest pain) or certain types of heart attacks. It may also be used to treat patients undergoing a certain type of procedure (percutaneous coronary intervention [PCI]). It may also be used to treat certain conditions as determined by your doctor that may not be listed in the professional package insert.


Integrilin is a platelet aggregation inhibitor. It works by preventing blood platelets from sticking together and forming blood clots.


Do NOT use Integrilin if:


  • you are allergic to any ingredient in Integrilin

  • you have a history of bleeding problems, active bleeding within the past 30 days, stroke or bleeding in the brain, or major surgery or severe injury within the past 6 weeks

  • you have uncontrolled severe high blood pressure or if you must have kidney dialysis

  • you are or will be taking another medicine similar to this one

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



Before using Integrilin:


Some medical conditions may interact with Integrilin. 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 kidney problems or high serum creatinine levels, high blood pressure, or low blood platelet levels (eg, thrombocytopenia)

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


  • Anticoagulants (eg, warfarin, heparin), aspirin, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or thrombolytics (eg, alteplase) because risk of bleeding may be increased

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


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


  • Integrilin will be administered as an injection at a hospital. Ask your doctor any questions that you may have about Integrilin.

  • If you miss a dose of Integrilin, contact your doctor right away.

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



Important safety information:


  • Integrilin may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark tarry stools to your doctor.

  • After using Integrilin, your doctor may prescribe other medicines to continue your treatment at home. If so, be sure to fill your prescriptions promptly.

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

  • LAB TESTS, including platelet counts, blood cell counts, and serum creatinine levels, will be performed to monitor your progress. Be sure to keep all doctor and lab appointments.

  • Use Integrilin with caution in the ELDERLY because they may be more sensitive to its effects, especially the risk of bleeding.

  • Integrilin is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.

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


Possible side effects of Integrilin:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding from gums when brushing or flossing teeth; coughing up blood; excessive bleeding from cuts; increased menstrual bleeding; major bleeding episodes; nosebleeds; one-sided weakness; red urine; redness or pain after an injection; severe headache; stomach pain or swelling; unexplained vaginal bleeding; unusual bruising; vision or speech changes; vomiting blood or material that looks like coffee grounds.



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: Integrilin 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 Integrilin:

Vials should be stored refrigerated at 36 to 46 degrees F (2 to 8 degrees C). Protect from light until time of use. Vials may be stored at room temperature between 59 and 86 degrees F (15 and 30 degrees C) for a period of 2 months or less. Do not use past the expiration date. Discard any unused portion left in the vial. Keep Integrilin out of the reach of children and away from pets.


General information:


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

  • Integrilin 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 Integrilin. 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 Integrilin resources


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


  • Integrilin Prescribing Information (FDA)

  • Integrilin Consumer Overview

  • Integrilin Monograph (AHFS DI)

  • Integrilin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Eptifibatide Professional Patient Advice (Wolters Kluwer)



Compare Integrilin with other medications


  • Acute Coronary Syndrome
  • Angina
  • Heart Attack
  • Percutaneous Coronary Intervention

Tuesday, 3 April 2012

Nagase America Corp.


Address


Nagase America Corp.,
546 5th Avenue 16F, New York, NY 10036

Contact Details

Phone: (212) 703-1340
Website: http://www.nagase.com/

Sunday, 1 April 2012

lamotrigine


la-MOE-tri-jeen


Oral route(Tablet;Tablet, Chewable;Tablet, Disintegrating;Tablet, Extended Release)

Serious, life-threatening rashes requiring hospitalization and discontinuation of treatment have been caused by lamotrigine in adults and children. The rate of serious rash is greater in pediatric patients than in adults. The risk of rash may also be increased by coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Nearly all cases of life-threatening rashes associated with lamotrigine have occurred within 2 to 8 weeks of treatment initiation. Benign rashes also occur; however, it is not possible to predict which rashes prove to be serious or life-threatening. Lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related .



Commonly used brand name(s)

In the U.S.


  • Lamictal

  • Lamictal CD

  • Lamictal XR

Available Dosage Forms:


  • Tablet, Extended Release

  • Tablet

  • Tablet, Chewable

Therapeutic Class: Anticonvulsant


Chemical Class: Phenyltriazine


Uses For lamotrigine


Lamotrigine is used alone or together with other medicines to help control certain types of seizures (e.g., partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. lamotrigine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It can also be used in the treatment of bipolar disorder (manic-depressive illness) in adults older than 18 years of age.


lamotrigine is available only with your doctor's prescription.


Before Using lamotrigine


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 lamotrigine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to lamotrigine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lamotrigine chewable tablets, disintegrating tablets, or tablets in children with certain types of seizures older than 2 years of age. However, safety and efficacy have not been established in children less than 2 years of age.


Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine extended-release tablets in children with partial seizures younger than 13 years of age. Safety and efficacy have not been established.


Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine chewable tablets, disintegrating tablets, or tablets in children with bipolar disorder. Safety and efficacy have not been established.


Geriatric


Although appropriate studies on the relationship of age to the effects of lamotrigine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of lamotrigine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving lamotrigine.


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


  • Ezogabine

  • Valproic Acid

Using lamotrigine 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.


  • Carbamazepine

  • Desogestrel

  • Dienogest

  • Drospirenone

  • Escitalopram

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Ginkgo

  • Levonorgestrel

  • Lopinavir

  • Medroxyprogesterone Acetate

  • Mestranol

  • Methsuximide

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Oxcarbazepine

  • Phenobarbital

  • Primidone

  • Rifampin

  • Risperidone

  • Ritonavir

  • Rufinamide

  • Sertraline

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


  • Blood or bone marrow problems or

  • Depression—May make these conditions worse.

  • Heart disease—It is not clear if patients who have problems with heart rhythms will have increased problems while taking lamotrigine.

  • Kidney disease or

  • Liver disease—Higher blood levels of lamotrigine may occur, which may increase the chance of unwanted effects; your doctor may need to change your dose.

  • Thalassemia—Lamotrigine may cause your body to stop making or to make fewer red blood cells.

Proper Use of lamotrigine


Take lamotrigine only as directed by your doctor to help your condition as much as possible and to decrease the chance of unwanted effects. 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.


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


Lamotrigine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.


If you are taking the chewable dispersible tablets, they may be swallowed whole, chewed, and swallowed, or dispersed in a small amount of liquid and swallowed. If the tablets are chewed, they should be followed with a small amount of water or diluted fruit juice to aid in swallowing. To break up these tablets, add the tablets in enough water or diluted fruit juice to cover the tablets (about a teaspoonful), wait until the tablets are completely dispersed (about 1 minute), then swirl the solution and swallow it immediately.


If you are taking the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet into your tongue and moved around in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.


Swallow the extended-release tablets whole. Do not break, crush, or chew it.


Use only the brand of lamotrigine that your doctor prescribed. Different brands and dosage forms may not work the same way.


lamotrigine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.


Dosing


The dose of lamotrigine 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 lamotrigine. 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 oral dosage forms (chewable dispersible tablets, disintegrating tablets, or tablets):
    • For treatment of bipolar disorder:
      • Adults not taking valproic acid (Depakote®) and not taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 milligrams (mg) of lamotrigine once a day for two weeks, then a total of 50 mg divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.

      • Adults taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 100 mg a day.

      • Adults not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 50 mg of lamotrigine once a day for two weeks, then a total of 100 mg divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.

      • Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—Dose will be determined by your doctor.

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


    • For treatment of epilepsy:
      • Adults and teenagers not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for two weeks, then a total of 100 mg divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 500 mg a day.

      • Adults and teenagers not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for two weeks, then 50 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 375 mg a day.

      • Adults and teenagers taking valproic acid (Depakote®) and also taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.

      • Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—Dose will be determined by your doctor.

      • Children 2 to 12 years of age:
        • Children not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)— At first, 0.6 milligrams (mg) per kilogram (kg) (0.27 mg per pound) of body weight of lamotrigine once a day for two weeks, then 1.2 mg/kg (0.54 mg per pound) of body weight divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.

        • Children not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)— At first, 0.3 milligrams (mg) per kilogram (kg) (0.14 mg per pound) of body weight of lamotrigine once a day for two weeks, then 0.6 mg/kg (0.27 mg per pound) of body weight divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 300 mg a day.

        • Children taking valproic acid (Depakote®) and also taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)— At first, 0.15 mg per kg (0.07 mg per pound) of body weight of lamotrigine given in one dose or two smaller doses each day for two weeks, then 0.3 mg/kg (0.136 mg per pound) of body weight given in one dose or two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.


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



  • For oral dosage form (extended-release tablet):
    • For seizures:
      • Adults and teenagers older than 13 years of age not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for two weeks, then 100 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 600 mg a day.

      • Adults and teenagers older than 13 years of age not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for two weeks, then 50 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.

      • Adults and teenagers older than 13 years of age taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 250 mg a day.

      • Children younger than 13 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of lamotrigine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using lamotrigine


It is important that your doctor check the progress of you or your child at regular visits, especially during the first few months of your treatment with lamotrigine. This will allow your doctor to change your dose, if necessary, and will help reduce any unwanted effects.


It is important to tell your doctor if you become pregnant while using lamotrigine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.


You should not start or stop using birth control pills or other female hormonal products while you are taking lamotrigine until you have consulted your doctor.


Tell your doctor right away if you have unusual changes in your menstrual cycle such as breakthrough bleeding while taking lamotrigine and birth control pills or other female hormonal products.


lamotrigine may increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; ; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using lamotrigine.


Lamotrigine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, or drowsiness. Make sure you know how you react to lamotrigine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to see well. If these reactions are especially bothersome, check with your doctor.


Skin rash may be a sign of a serious unwanted effect. Check with your doctor immediately if you or your child develop a rash, fever, flu-like symptoms, or swollen glands, or if your seizures becomes worse.


Lamotrigine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark urine, headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellow eyes or skin.


lamotrigine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.


Check with your doctor right away if you or your child start to have a stiff neck, confusion, drowsiness, fever, chills, headache, nausea or vomiting, rash, or sensitivity to light. These could be symptoms of a rare and serious condition called aseptic meningitis.


Do not stop taking lamotrigine without first checking with your doctor. Stopping lamotrigine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.


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


lamotrigine Side Effects


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


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


More common
  • Blurred vision

  • changes in vision

  • clumsiness or unsteadiness

  • double vision

  • poor coordination

  • skin rash

Less common
  • Anxiety

  • chest pain

  • confusion

  • continuous, uncontrolled back and forth or rolling eye movements

  • depression

  • increase in seizures

  • infection

  • irritability

Rare
  • Blistering, peeling, or loosening of the skin

  • chills

  • dark-colored urine

  • fever

  • flu-like symptoms

  • itching

  • memory loss

  • muscle cramps, pain, or weakness

  • red or irritated eyes

  • small red or purple spots on the skin

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • swelling of the face, mouth, hands, or feet

  • swollen lymph nodes

  • trouble with breathing

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • yellow eyes or skin

Incidence not known
  • Back, leg, or stomach pains

  • bleeding gums

  • bloating

  • blood in the urine

  • bloody, black or tarry stools

  • bluish lips or skin

  • bruising

  • constipation

  • cough or hoarseness

  • coughing or vomiting blood

  • difficulty with breathing

  • difficulty with swallowing

  • fainting

  • fast heartbeat

  • general body swelling

  • general feeling of discomfort or illness

  • general feeling of tiredness or weakness

  • heartburn

  • high fever

  • lightheadedness

  • loss of appetite

  • loss of balance control

  • lower back or side pain

  • mask-like face

  • muscle spasms

  • nosebleeds

  • not breathing

  • pain or burning in the throat

  • painful or difficult urination

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

  • pale skin

  • persistent bleeding or oozing from puncture sites, mouth, or nose

  • rapid, shallow breathing

  • redness, soreness, or itching skin

  • shortness of breath

  • shuffling walk

  • slowed movement

  • slurred speech

  • sores, welting, or blisters

  • stiffness of the arms and legs

  • swollen or painful glands

  • tic-like (jerky) movements

  • tightness in the chest

  • unexplained bleeding or bruising

  • wheezing

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


Symptoms of overdose
  • Clumsiness or unsteadiness (severe)

  • coma

  • continuous, uncontrolled back and forth or rolling eye movements (severe)

  • dizziness (severe)

  • drowsiness (severe)

  • dryness of the mouth (severe)

  • headache (severe)

  • increased heart rate

  • slurred speech (severe)

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
  • Dizziness

  • drowsiness

  • headache

  • nausea

  • vomiting

Less common
  • Diarrhea

  • indigestion

  • loss of strength

  • menstrual pain

  • pain

  • runny nose

  • trembling or shaking

  • trouble with sleeping

  • unusual weight loss

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: lamotrigine side effects (in more detail)



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More lamotrigine resources


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


  • Lamictal Consumer Overview

  • Lamictal Prescribing Information (FDA)

  • Lamictal ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lamictal XR Prescribing Information (FDA)

  • Lamictal XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lamotrigine Prescribing Information (FDA)

  • Lamotrigine Monograph (AHFS DI)

  • Lamotrigine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lamotrigine Professional Patient Advice (Wolters Kluwer)



Compare lamotrigine with other medications


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