Friday 24 December 2010

Glipizid LPH




Glipizid LPH may be available in the countries listed below.


Ingredient matches for Glipizid LPH



Glipizide

Glipizide is reported as an ingredient of Glipizid LPH in the following countries:


  • Romania

International Drug Name Search

Thursday 23 December 2010

Bromodel




Bromodel may be available in the countries listed below.


Ingredient matches for Bromodel



Bromocriptine

Bromocriptine mesilate (a derivative of Bromocriptine) is reported as an ingredient of Bromodel in the following countries:


  • Bangladesh

International Drug Name Search

Friday 17 December 2010

Nidazole




Nidazole may be available in the countries listed below.


Ingredient matches for Nidazole



Metronidazole

Metronidazole is reported as an ingredient of Nidazole in the following countries:


  • Bahrain

  • Indonesia

  • Iraq

  • Jordan

  • Oman

  • Saudi Arabia

  • Syria

  • United Arab Emirates

  • Yemen

International Drug Name Search

Thursday 16 December 2010

Colchicine-Odan




Colchicine-Odan may be available in the countries listed below.


Ingredient matches for Colchicine-Odan



Colchicine

Colchicine is reported as an ingredient of Colchicine-Odan in the following countries:


  • Canada

International Drug Name Search

Tuesday 14 December 2010

Nodescrón




Nodescrón may be available in the countries listed below.


Ingredient matches for Nodescrón



Vecuronium

Vecuronium Bromide is reported as an ingredient of Nodescrón in the following countries:


  • Mexico

International Drug Name Search

Tuesday 7 December 2010

Avandamet


Avandamet is a brand name of metformin/rosiglitazone, approved by the FDA in the following formulation(s):


AVANDAMET (metformin hydrochloride; rosiglitazone maleate - tablet; oral)



  • Manufacturer: SB PHARMCO

    Approval date: October 10, 2002

    Strength(s): 500MG;EQ 2MG BASE, 500MG;EQ 4MG BASE


  • Manufacturer: SB PHARMCO

    Approval date: August 25, 2003

    Strength(s): 1GM;EQ 2MG BASE, 1GM;EQ 4MG BASE [RLD]

Has a generic version of Avandamet been approved?


No. There is currently no therapeutically equivalent version of Avandamet available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Avandamet. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Novel compounds
    Patent 5,002,953
    Issued: March 26, 1991
    Inventor(s): Hindley; Richard M.
    Assignee(s): Beecham Group p.l.c.
    Compounds of formula (I): ##STR1## or a tautomeric form thereof, or a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable solvate thereof, wherein: A.sup.1 represents a substituted or unsubstituted aromatic heterocyclyl group; R.sup.1 represents a hydrogen atom, an alkyl group, an acyl group, an aralkyl group, wherein the aryl moiety may be substituted or unsubstituted, or a substituted or unsubstituted aryl group; R.sup.2 and R.sup.3 each represent hydrogen, or R.sup.2 and R.sup.3 together represent a bond; A.sup.2 represents a benzene ring having in total up to five substituents; and n represents an integer in the range of from 2 to 6; pharmaceutical compositions containing such compounds and the use of such compounds and compositions in medicine.
    Patent expiration dates:

    • September 17, 2011
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • September 17, 2011
      ✓ 
      Patent use: FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • September 17, 2011
      ✓ 
      Patent use: TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • September 17, 2011
      ✓ 
      Patent use: USE AS A MONOTHERAPY, IN COMBINATION WITH A SULFONYLUREA, METFORMIN OR INSULIN OR IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • March 17, 2012
      ✓ 
      Pediatric exclusivity




  • Substituted thiazolidinedionle derivatives
    Patent 5,741,803
    Issued: April 21, 1998
    Inventor(s): Pool; Colin Ripley & Tremper; Alan William & Brightwell; Malcolm David & Roman; Robin Sherwood
    Assignee(s): SmithKline Beecham plc
    ##STR1## A compound of formula (I) or a tautomeric form therof and/or a pharmaceutically acceptable solvate thereof, wherein R1,A1,A2,M are as defined in the, specification. A process for preparing such a compound, a pharmaceutical composition containin such a compound and the use of such a compound for treating hyperglycemia.
    Patent expiration dates:

    • April 21, 2015
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted


    • April 21, 2015
      ✓ 
      Patent use: FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted


    • October 21, 2015
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical composition
    Patent 5,965,584
    Issued: October 12, 1999
    Inventor(s): Ikeda; Hitoshi & Sohda; Takashi & Odaka; Hiroyuki
    Assignee(s): Takeda Chemical Industries, Ltd.
    Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
    Patent expiration dates:

    • June 19, 2016
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
      ✓ 
      Sponsor has requested patent be delisted




  • Pharmaceutical composition
    Patent 6,166,042
    Issued: December 26, 2000
    Inventor(s): Ikeda; Hitoshi & Sohda; Takashi & Odaka; Hiroyuki
    Assignee(s): Takeda Chemical Industries, Ltd.
    Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
    Patent expiration dates:

    • June 19, 2016
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
      ✓ 
      Sponsor has requested patent be delisted




  • Compounds
    Patent 6,288,095
    Issued: September 11, 2001
    Inventor(s): Hindley; Richard Mark & Cawthorne; Michael Antony
    Assignee(s): Beecham Group p.l.c.
    A method is provided for the treatment and/or prophylaxis of cardiovascular diseases or eating disorders in a human or non-human mammal, which comprises administering to a human or non-human mammal in need thereof, an effective, non-toxic amount of a compound of formula (I): ##STR1## or a tautomeric form thereof and/or a pharmaceuticlaly acceptable salt thereof and/or a pharmaceutically acceptable solvate thereof, in which A.sup.1 represents a substituted or unsubstituted aromatic heterocyclyl group; R.sup.1 represents a hydrogen atom, an alkyl group, an acyl group, an aralkyl group, wherein the aryl moiety may be substituted or unsubstituted, or a substituted or unsubstituted aryl group; R.sup.2 and R.sup.3 each represent hydrogen, or R.sup.2 and R.sup.3 together represent a bond; A.sup.2 represents a benzene ring having in total up to five substituents; and n represents an integer in the range of from 2 to 6.
    Patent expiration dates:

    • February 11, 2017
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
      ✓ 
      Sponsor has requested patent be delisted


    • August 11, 2017
      ✓ 
      Pediatric exclusivity




  • Thiazolidinedione derivative and its use as antidiabetic
    Patent 7,358,366
    Issued: April 15, 2008
    Inventor(s): Blackler; Paul David James & Giles; Robert Gordon & Moore; Stephen & Sasse; Michael John
    Assignee(s): SmithKline Beecham p.l.c.
    A polymorphic form of 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione, maleic acid salt (the “Polymorph”) characterised in that it provides: (i) an infra red spectrum containing peaks at 1752, 1546, 1154, 621, and 602 cm−1; and/or (ii) a Raman spectrum containing peaks at 1751, 1243 and 602 cm−1; and/or (iii) a solid-state nuclear magnetic resonance spectrum containing peaks at 111.9, 114.8, 119.6, 129.2, 134.0, 138.0, 144.7, 153.2, 157.1, 170.7, 172.0, and 175.0 ppm; and/or (iv) an X-ray powder diffraction (XRPD) pattern which gives calculated lattice spacings of 6.46, 5.39, 4.83, 4.68, 3.71, 3.63, 3.58, and 3.48 Angstroms; a process for preparing such a compound, a pharmaceutical composition containing such a compound and the use of such a compound in medicine.
    Patent expiration dates:

    • April 19, 2020
      ✓ 
      Drug substance


    • October 19, 2020
      ✓ 
      Pediatric exclusivity



See also...

  • Avandamet Consumer Information (Drugs.com)
  • Avandamet Consumer Information (Wolters Kluwer)
  • Avandamet Consumer Information (Cerner Multum)
  • Avandamet Advanced Consumer Information (Micromedex)
  • Rosiglitazone/Metformin Consumer Information (Wolters Kluwer)
  • Metformin and rosiglitazone Consumer Information (Cerner Multum)
  • Metformin and rosiglitazone Advanced Consumer Information (Micromedex)
  • Rosiglitazone and metformin Advanced Consumer Information (Micromedex)

Saturday 27 November 2010

Expeck




Expeck may be available in the countries listed below.


Ingredient matches for Expeck



Teprenone

Teprenone is reported as an ingredient of Expeck in the following countries:


  • Japan

International Drug Name Search

Monday 22 November 2010

Bupropion Hydrochloride



Class: Antidepressants, Miscellaneous
VA Class: CN609
Chemical Name: ±-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone Hydrochloride
Molecular Formula: C13H18ClNO•ClH
CAS Number: 31677-93-7
Brands: Wellbutrin, Zyban


  • Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders


  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 142 143 161 162 168 Bupropion is not approved for use in pediatric patients.1 142 143 168 (See Pediatric Use under Cautions.)




  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.161 162




  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.161 162 167




  • Appropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 142 143 162 161 167 168 (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders under Cautions.)



  • Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment


  • Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving bupropion for smoking cessation.182 183 184 185 186 187 (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment under Cautions.)




  • Symptoms have occurred in patients with and without preexisting psychiatric disease; some patients experienced worsening of their psychiatric illness.182 183 184 185




  • Depressed mood may be a symptom of nicotine withdrawal;182 183 184 185 186 however, some symptoms occurred in bupropion-treated patients who continued to smoke.182 183 184 185 186 187




  • Most symptoms occurred during bupropion therapy, but some were reported following discontinuance of drug.182 183 184 185




  • Monitor all patients receiving bupropion for smoking cessation for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).182 183 184 185




  • Patients should discontinue bupropion and immediately contact their clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.182 183 184 185




  • Symptoms resolved upon drug discontinuance in many cases, but persisted in a few cases.182 183 184 185 186 187 Provide ongoing monitoring and supportive care until symptoms resolve.182 183 184 185




  • Weigh risks of bupropion for smoking cessation against benefits.182 183 184 185 186 187 Bupropion shown to increase likelihood of abstinence from smoking for up to 6 months compared with placebo.182 183 184 185 186 187 Health benefits of quitting smoking are immediate and substantial.182 183 184 185 186 187



REMS:


FDA approved a REMS for bupropion to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of bupropion and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Antidepressant and smoking deterrent; aminoketone derivative.1 43 142 143 168


Uses for Bupropion Hydrochloride


Major Depressive Disorder


Treatment of major depressive disorder.1 127 128 129 131 132 142 168 179 180


May be useful (alone or in combination with other antidepressants) in patients with refractory depression.179 180


Seasonal Affective Disorder


Prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD; also referred to as winter depression).168 169 170 171


Smoking Cessation


Adjunct in the cessation of smoking (alone or in combination with nicotine replacement therapy).143 145 146 147 152 (See Cardiovascular Effects under Cautions and see also Smoking Cessation and Specific Drugs under Interactions.)


Depression Associated with Bipolar Disorder


Treatment of patients with bipolar depression (bipolar disorder, depressive episode).2 77 78 85 86 102 154


American Psychiatric Association (APA) considers bupropion one of several second-line agents for use when first-line agents are ineffective or not tolerated.154


Attention Deficit Hyperactivity Disorder (ADHD)


Used in a limited number of children2 44 79 80 134 156 157 158 and adults in the management of ADHD.2 44 76 126


Panic Disorder


Ineffective in the treatment of panic disorder and concomitant phobic disorder,2 44 99 134 but may improve symptoms of panic and depression in patients with major depression who have superimposed panic symptoms.44


Bulimia Nervosa


Not recommended by APA for bulimia nervosa because associated with seizures in purging bulimic patients.153


Bupropion Hydrochloride Dosage and Administration


General



  • Appropriately monitor and closely observe all patients receiving bupropion for any indication for clinical worsening, suicidality, or unusual changes in behavior, particularly during initial therapy or following any change (increase or decrease) in dosage.161 162 167 182 183 184 (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders in Boxed Warning and also under Cautions.)




  • Monitor all patients receiving bupropion for smoking cessation for serious neuropsychiatric symptoms or worsening of preexisting psychiatric illness.182 183 184 185 186 187 (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment in Boxed Warning and also under Cautions.)



Major Depressive Disorder



  • Increase dosages gradually to minimize the risk of seizures and other adverse effects; do not exceed recommended maximum individual doses or daily dosages.1 142 168 (See Prescribing Limits and see Seizures under Warnings.)




  • Maximum antidepressant effects of therapy may not be evident until ≥4 weeks of treatment.1 142 168




  • Sustained therapy may be required; monitor periodically for need for continued therapy.1 142 168



Administration


Oral Administration


Conventional Tablets

Initially, administer orally twice daily in the morning and evening, then increase to 3 times daily, preferably with 6 or more hours separating doses (e.g., in the morning, at midday, and in the evening).1 23 24 141


Dosages ≥300 mg should be administered as divided doses that do not exceed 150 mg per dose.1 If components of a larger dosage include 4 whole tablets of 100 mg each, administer the divided doses 4 times daily separated by 4 or more hours so that no individual dose exceeds 150 mg.1


Avoid bedtime administration of evening dose to decrease incidence of insomnia.1 142 152


Extended-release Tablets

Extended-release, film-coated tablets (e.g., Wellbutrin SR): Initially, administer orally once daily in the morning, then increase to twice daily, in the morning and evening.142 Dosages >150 mg should be administered as divided doses twice daily, preferably with 8 or more hours separating the doses.142 143 Avoid bedtime administration of evening dose to decrease incidence of insomnia.183


Extended-release, film-coated tablets (e.g., Zyban): Administer orally once daily for the first 3 days, then usually increase to twice daily administration with 8 or more hours separating the doses.143 Avoid bedtime administration of evening dose to decrease incidence of insomnia.182


Extended-release tablets (Wellbutrin XL): Administer orally once daily in the morning, with an interval of 24 hours separating the doses.168


Do not chew, divide, or crush the extended-release tablets (e.g., Zyban, Wellbutrin SR, Wellbutrin XL); tablets should be swallowed whole.142 143 168


The shell of the extended-release tablet (Wellbutrin XL) does not dissolve and may be passed in the stool.168


Dosage


Available as bupropion hydrochloride; dosage expressed in terms of the salt.1


Pediatric Patients


ADHD

Oral

Children weighing ≥20 kg: Initially, 1 mg/kg daily in 2–3 divided doses.156 After 3 days, titrate up to 3 mg/kg daily in 2–3 divided doses by day 7, then up to 6 mg/kg daily in 2–3 divided doses or 300 mg (whichever is smaller) by third week of therapy.156


Alternatively, may give initial dose of 37.5 or 50 mg twice daily with titration over 2 weeks up to a maximum of 250 mg daily (300–400 mg daily in adolescents).157


Pediatric dosage for ADHD generally has ranged from 50–100 mg 3 times daily for conventional tablets or 100–150 mg twice daily for extended-release tablets.158


Adults


Major Depression

Therapy with Conventional Tablets

Oral

Initially, 100 mg twice daily.1 Alternatively, dosage may be initiated at 75 mg 3 times daily.23 24 141


If clinical improvement not apparent after >3 days, may increase to 100 mg 3 times daily.1 23 24 141 142


Dosages >300 mg should not be considered until completion of several weeks of therapy; if no improvement is apparent, then the dosage may be increased to 150 mg 3 times daily.1 142 Dosage should not be increased by more than 100 mg every 3 days.1 23 24 141 142


If no improvement after appropriate trial at 450 mg daily, the drug should be discontinued.1 23 24 141


Therapy with Extended-release Tablets

Oral

Extended-release, film-coated tablets (e.g., Wellbutrin SR): Initially, 150 mg once daily in the morning.142 If tolerated, may increase to 150 mg twice daily as early as fourth day of therapy.142 Dosages >300 mg daily should not be considered until completion of several weeks of therapy; then, if no apparent improvement, may increase dosage to 200 mg twice daily.1 142


Extended-release tablets (Wellbutrin XL): Initially, 150 mg once daily.168 If tolerated, may increase to 300 mg once daily as early as fourth day of therapy.168 Dosages >300 mg should not be considered until completion of several weeks of therapy; then, if no apparent improvement, may increase dosage to 450 mg once daily.168


When switching from conventional or extended-release, film-coated tablets (e.g., Wellbutrin SR) to extended-release tablets (Wellbutrin XL), administer same total daily dose when possible.168


Seasonal Affective Disorder

Therapy with Extended-release Tablets

Oral

Extended-release tablets (Wellbutrin XL): Initiate therapy in autumn prior to onset of depressive symptoms; continue treatment through the winter and taper and discontinue in early spring.168 169 Individualize timing of initiation and duration of therapy based on patient’s historical pattern of seasonal depressive episodes.168


Initially, 150 mg once daily in the morning.168 If tolerated, may increase dosage after 1 week to 300 mg once daily.168 If this dosage is not tolerated, reduce dosage to 150 mg once daily.168


Usual target dosage: 300 mg once daily in the morning.168


For patients receiving 300 mg once daily during the autumn-winter period, taper dosage to 150 mg once daily for 2 weeks prior to discontinuance.168


Smoking Cessation

Therapy with Extended-release, Film-coated Tablets

Oral

Initially, 150 mg daily for the first 3 days of therapy.143 145 152 Initiate 1–2 weeks prior to discontinuance of cigarette smoking.143 145 152


Maintenance, 150 mg twice daily.143 145 Continue therapy for 7–12 weeks; evaluate need for prolonged therapy after that period based on individual patient assessment.143 152


Cessation of smoking is unlikely in patients who do not show substantial progress toward abstinence after 7 weeks of therapy, so such therapy should be discontinued at that time in these patients.143


Combination Therapy with Extended-release Tablets and Transdermal Nicotine Patches

Oral

Initially, 150 mg daily, and after 3 days increase to 150 mg twice daily while still smoking.143


After about 1 week of therapy, when the patient is scheduled to stop smoking, initiate transdermal nicotine therapy at a dosage of 21 mg/24 hours.143


Taper transdermal nicotine to 14, then to 7 mg/24 hours during the eighth and ninth weeks of therapy, respectively.143


Depression Associated With Bipolar Disorder

Oral

Dosages generally range from 75–400 mg in conjunction with a mood-stabilizing agent (e.g., carbamazepine, lithium, valproate).2


ADHD

Therapy with Conventional Tablets

Oral

Initially, 150 mg daily.2 May be titrated up to 450 mg daily.2


Prescribing Limits


Adults


Major Depression

Oral

Conventional tablets: Maximum 450 mg daily (not >150 mg per dose).1


Extended-release, film-coated tablets (e.g., Wellbutrin SR): Maximum 400 mg daily (not >200 mg per dose).142


Extended-release tablets (Wellbutrin XL): Maximum 450 mg daily.168


Seasonal Affective Disorder

Oral

Extended-release tablets (e.g., Wellbutrin XL): Dosages >300 mg daily have not been studied.168


Smoking Cessation

Oral

Extended-release, film-coated tablets (e.g., Zyban): 300 mg daily (not >150 mg per dose).143


Special Populations


Hepatic Impairment











Maximum Dosage for Major Depression and Seasonal Affective Disorder in Severe Hepatic Cirrhosis1142168

Dosage Form



Maximum Dosage



Conventional tablets



75 mg once daily1



Extended-release, film-coated tablets (e.g., Wellbutrin SR)



100 mg once daily or 150 mg every other day142



Extended-release tablets (Wellbutrin XL)



150 mg every other day168


Smoking cessation in patients with severe hepatic cirrhosis: Maximum 150 mg every other day as extended-release, film-coated tablets (e.g., Zyban).143


Major depression, seasonal affective disorder, or smoking cessation in patients with mild to moderate hepatic impairment (e.g., mild to moderate hepatic cirrhosis): Reduce dosage and/or frequency of administration as required.1 142 143 168 (See Hepatic Impairment under Cautions.)


Renal Impairment


Active metabolites may accumulate; reduce dosage and/or frequency of administration as required.1 142 143 168 177 (See Renal Impairment under Cautions.)


Smoking cessation in patients undergoing hemodialysis: Some clinicians recommend a dosage of 150 mg every 3 days as extended-release, film-coated tablets (e.g., Zyban).177


Cautions for Bupropion Hydrochloride


Contraindications



  • Seizure disorders.1 142 143 152 168




  • Current or past diagnosis of anorexia nervosa or bulimia.1 21 22 24 39 142 143 152 168




  • Contraindicated in patients receiving any other bupropion formulation (e.g., for smoking cessation, antidepressant use) because risk of seizures is dose-dependent.1 142 143 168




  • Patients undergoing abrupt discontinuance of alcohol or sedatives (including benzodiazepines).1 142 143 168




  • Patients currently receiving, or having recently received (i.e., within 2 weeks), MAO inhibitor therapy.1 142 152 168




  • Hypersensitivity to the drug or any ingredient in the formulation.1 142 168



Warnings/Precautions


Warnings


Seizures

Seizures reported;1 6 19 20 24 52 142 143 168 risk of seizures may be higher with sudden and large increases in dosage.1 8 (See Dosage and Administration.)


Risk factors include patient factors (e.g., history of head trauma or prior seizure, CNS tumor, presence of severe hepatic cirrhosis), clinical situations (excessive use of alcohol or sedatives [e.g., benzodiazepines], abrupt withdrawal from alcohol or other sedatives, addiction to opiates, cocaine, or stimulants, use of OTC stimulants and anorectics, diabetes treated with oral hypoglycemics or insulin), and concomitant drugs that lower seizure threshold.1 8 142 143 168 (See Interactions: Specific Drugs.)


If patients experience a seizure during therapy, discontinue drug and do not restart.1 142 143 168


Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.1 142 143 161 162 167 168 181 However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.161 162 167


Appropriately monitor and closely observe patients receiving bupropion for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.1 142 143 161 162 167 168 (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders in Boxed Warning and also see Pediatric Use under Cautions.)


Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.161 167 Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 142 143 161 162 167 168 (See General under Dosage and Administration.)


Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 142 143 168 161


Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.1 142 143 161 168


Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment

Serious neuropsychiatric symptoms, including mood changes (e.g., depression, mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic as well as suicidal ideation, suicide attempt, and completed suicide, reported in patients receiving bupropion for smoking cessation.182 183 184 185 186 187 (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment in Boxed Warning.)


Monitor all patients receiving bupropion for smoking cessation for such neuropsychiatric symptoms.182 183 184 185


Patients and caregivers that patients should stop taking bupropion and immediately contact their clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.182 183 184 185 Symptoms resolved upon drug discontinuance, in many cases but persisted in a few cases.182 183 184 185 186 187 Provide ongoing monitoring and supportive care until symptoms resolve.182 183 184 185 186


Weigh possible risk of serious adverse effects with bupropion against health benefits of smoking cessation (e.g., reduced risk of developing pulmonary disease, cardiovascular disease, and cancer).182 183 184 185 186 187


Bipolar Disorder

May unmask bipolar disorder.1 142 143 161 168 (See Activation of Mania or Psychosis under Cautions.) Bupropion is not approved for use in treating bipolar depression.1 142 143 168


Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 142 143 161 168


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylactoid reactions (e.g., pruritus, urticaria, angioedema, dyspnea) have been reported;1 142 143 168 however, causality has not been established.145 Postmarketing reports include erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock.1 142 143 168


Possible arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity.1 142 143 168


Major Toxicities


Hepatotoxicity

Abnormal hepatic function (e.g., jaundice, hepatitis) infrequently reported during postmarketing surveillance; causal relationship not established.1 40 142 143 168 However, increased incidence of hepatic hyperplastic nodules and hepatocellular hypertrophy observed in rats receiving large doses and various histologic changes and mild hepatocellular injury observed in dogs administered large doses of the drug.1 142 143 168


General Precautions


CNS Effects

Agitation,1 3 5 6 7 8 45 46 47 51 52 53 54 142 168 insomnia,1 3 5 7 45 46 47 51 52 53 142 143 152 168 and anxiety1 3 54 142 168 have been reported.1 Insomnia may be minimized by avoidance of bedtime administration or reduction of dosage.1 142 143 168


Neuropsychiatric manifestations, including confusion, delusions, hallucinations, psychosis, disturbances in concentration, and paranoia, reported in patients receiving bupropion in depression trials.182 183 184 185 Similar types of neuropsychiatric manifestations reported during postmarketing experience in patients receiving the drug for smoking cessation.182 183


Activation of Mania or Psychosis

Possible activation of mania or hypomania in bipolar disorder patients (see Bipolar Disorder under Cautions); activation of latent psychosis may occur in susceptible patients.1 142 143 168


Metabolic Effects

Possible anorexia and weight loss (exceeding 2.27 kg);1 19 29 30 52 caution in patients in whom weight loss is a presenting manifestation of depression.1 143 168


Cardiovascular Effects

Hypertension (sometimes severe) has occurred with bupropion therapy either alone or in combination with transdermal nicotine in patients with and without pre-existing hypertension.1 Safety in patients with recent history of MI or unstable heart disease not established.1 142 143 168


Electroconvulsive Therapy (ECT)

Possible increased duration of motor and EEG seizures in certain patients.44 94 104 Some clinicians suggest that ECT can be safely performed 48 hours after discontinuance of bupropion.44


Specific Populations


Pregnancy

Category B.1 142 143 168 Bupropion pregnancy registry at 800-336-2176.1 142 143 168


Lactation

Distributed into milk; discontinue nursing or drug.1 2 64 142 143 168


Pediatric Use

Safety and efficacy not established in children <18 years of age.1 142 143 168


FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 142 143 161 162 168 However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.181 No suicides occurred in these pediatric trials.1 142 143 161 162 168 181


Carefully consider these findings when assessing potential benefits and risks of bupropion in a child or adolescent for any clinical use.1 142 143 162 168 162 161 167 181 (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders in Boxed Warning and also under Cautions.)


Has been used in a limited number of children 7–16 years of age for attention deficit disorder without unusual adverse effect.2 44 79 80 134 158


Has been used as extended-release preparation in adolescents for smoking cessation.152 (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment in Boxed Warning and also under Cautions.)


Geriatric Use

Use with caution;1 possible decreased clearance.1 142 143 No substantial differences in safety and efficacy relative to younger adults.1 2 142 143 168


In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.162 161 (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders in Boxed Warning and also under Cautions.)


Hepatic Impairment

Use with extreme caution in patients with severe hepatic cirrhosis and caution in patients with hepatic impairment (e.g., mild to moderate hepatic cirrhosis); reduced frequency and/or dosage and close monitoring for adverse effects required.1 142 143 168 (See Hepatic Impairment under Dosage and Administration.)


Renal Impairment

Use with caution; active metabolites may accumulate.1 142 143 168 177 Monitor closely for adverse effects (e.g., seizures); reduction in dosage and/or frequency may be necessary.1 142 143 168 177


Common Adverse Effects


Agitation, dry mouth, insomnia, headache/migraine, nausea/vomiting, constipation, tremor.1 3 6 7 19 44 47 50 134 142 143 152 168


Interactions for Bupropion Hydrochloride


Metabolized principally by CYP2B6; may also inhibit CYP2D6 and induce other hepatic microsomal enzymes.1 142 143 168


Drugs Affecting Hepatic Microsomal Enzymes


Potential pharmacokinetic interaction (altered serum concentrations of bupropion) with drugs that induce or inhibit CYP2B6.1 142 143 168


Drugs Metabolized by Hepatic Microsomal Enzymes


Substrates of CYP2D6: potential pharmacokinetic interaction (increased plasma substrate concentrations).1 142 143 168


Substrates of hepatic microsomal enzymes: potential pharmacokinetic interaction (altered substrate metabolism).1 142 143 168


Smoking Cessation


Smoking may induce enzymes and increase metabolism of some drugs.149 150 151 Therefore, cessation of smoking (with or without adjunctive use of bupropion) may result in decreased enzyme induction and altered metabolism of some drugs (e.g., theophylline, warfarin); consider dosage adjustment.143


Specific Drugs










Drug



Interaction



Comments



Alcohol



Possible neuropsychiatric effects or reduced alcohol tolerance1 142 143


Possible increased risk of seizures with excessive use of alcohol or abrupt withdrawal from alcohol1 142 143



Minimize or avoid alcohol consumption 1 142 143 168



Amantadine



Potential increased incidence of adverse

omalizumab


Generic Name: omalizumab (OH ma LIZ oo mab)

Brand Names: Xolair


What is omalizumab?

Omalizumab is an antibody that helps decrease allergic responses in the body.


Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old.


Omalizumab is usually given after other asthma medications have been tried without successful treatment of symptoms.


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


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


Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction: wheezing, tightness in your chest, trouble breathing; hives or skin rash; feeling anxious or light-headed, fainting; warmth or tingling under your skin; or swelling of your face, lips, tongue, or throat.


Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.


If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

What should I discuss with my healthcare provider before using omalizumab?


Do not use this medication if you are allergic to omalizumab.

To make sure you can safely take omalizumab, tell your doctor if you have any other medical conditions or if you take other medicines.


Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

While you are using omalizumab, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.


FDA pregnancy category B. Omalizumab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of omalizumab on the baby.


Omalizumab may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give omalizumab to a child younger than 12 years old.

How should I use omalizumab?


Omalizumab is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Omalizumab is usually given every 2 or 4 weeks.


Omalizumab is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.


Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Omalizumab will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.


If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


To be sure this medication is helping your condition, your doctor may want you to have allergy tests and lung function tests on a regular basis. Do not miss any scheduled visits to your doctor.


Store omalizumab in the refrigerator. Do not freeze. After mixing omalizumab with a diluent, store in the refrigerator and use it within 8 hours. Do not freeze. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

What happens if I miss a dose?


Contact your doctor if you miss a dose of omalizumab.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using omalizumab?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Omalizumab side effects


Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction:



  • wheezing, tightness in your chest, trouble breathing;




  • hives or skin rash;




  • feeling anxious or light-headed, fainting;




  • warmth or tingling under your skin; or




  • swelling of your face, lips, tongue, or throat.



Other serious side effects include easy bruising or bleeding, numbness, or unusual weakness.


Less serious side effects may include:



  • pain;




  • headache, tired feeling;




  • joint or muscle pain;




  • dizziness;




  • ear pain;




  • hair loss;




  • mild itching or skin rash;




  • sore throat or cold symptoms; or




  • redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Omalizumab Dosing Information


Usual Adult Dose for Asthma -- Maintenance:

150 to 300 mg subcutaneously every 4 weeks or 225 to 375 mg every 2 weeks, depending on pretreatment IgE levels and patient's weight.

30 to 60 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >600 to 700 intl units/mL give 375 mg subcutaneously every 2 weeks.

60 to 70 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >600 intl units/mL.

70 to 90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >500 intl units/mL.

>90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >300 intl units/mL.

Usual Pediatric Dose for Asthma -- Maintenance:

>=12 years: 150 to 300 mg subcutaneously every 4 weeks or 225 to 375 mg every 2 weeks, depending on pretreatment IgE levels and patient weight.

30 to 60 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >600 to 700 intl units/mL give 375 mg subcutaneously every 2 weeks.

60 to 70 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >600 intl units/mL.

70 to 90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >500 intl units/mL.

>90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >300 intl units/mL.


What other drugs will affect omalizumab?


Before using omalizumab, tell your doctor if you are receiving allergy shots.


There may be other drugs that can interact with omalizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More omalizumab resources


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


  • omalizumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Omalizumab Professional Patient Advice (Wolters Kluwer)

  • Omalizumab MedFacts Consumer Leaflet (Wolters Kluwer)

  • Omalizumab Monograph (AHFS DI)

  • Xolair Prescribing Information (FDA)

  • Xolair Consumer Overview



Compare omalizumab with other medications


  • Asthma, Maintenance


Where can I get more information?


  • Your pharmacist can provide more information about omalizumab.

See also: omalizumab side effects (in more detail)


Thursday 18 November 2010

Norzac




Norzac may be available in the countries listed below.


Ingredient matches for Norzac



Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Norzac in the following countries:


  • Ireland

International Drug Name Search

Wednesday 17 November 2010

Fénofibrate CristerS




Fénofibrate CristerS may be available in the countries listed below.


Ingredient matches for Fénofibrate CristerS



Fenofibrate

Fenofibrate is reported as an ingredient of Fénofibrate CristerS in the following countries:


  • France

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Doripenem


Pronunciation: DOR-i-PEN-em
Generic Name: Doripenem
Brand Name: Doribax


Doripenem is used for:

Treating infections caused by certain bacteria.


Doripenem is a carbapenem antibiotic. It works by killing sensitive bacteria.


Do NOT use Doripenem if:


  • you are allergic to any ingredient in Doripenem or to any other carbapenen or beta-lactam antibiotic (eg, meropenem)

  • you are taking probenecid

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



Before using Doripenem:


Some medical conditions may interact with Doripenem. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin antibiotic (eg, amoxicillin) or a cephalosporin antibiotic (eg, cephalexin)

  • if you have a history of seizures

  • if you have kidney problems or are on dialysis

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


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

  • Valproic acid because its effectiveness may be decreased by Doripenem

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


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


  • Doripenem is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Doripenem at home, carefully follow the injection procedures taught to you by your health care provider.

  • Do not use Doripenem if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • To clear up your infection completely, use Doripenem for the full course of treatment. Keep using it even if you feel better in a few days.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Doripenem, 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 Doripenem.



Important safety information:


  • Doripenem only works against bacteria; it does not treat viral infections (eg, the common cold).

  • Be sure to use Doripenem for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Long-term or repeated use of Doripenem may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • If severe diarrhea or stomach pain or cramping develop during treatment or within several months after treatment with Doripenem, check with your doctor or pharmacist right away. Do not treat it with nonprescription (over-the-counter) medicines.

  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

  • Use Doripenem with caution in the ELDERLY; they may be more sensitive to its effects.

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

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Doripenem while you are pregnant. It is not known if Doripenem is found in breast milk. If you are or will be breast-feeding while you are taking Doripenem, check with your doctor. You will need to discuss the risks to your baby.


Possible side effects of Doripenem:


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:



Headache; mild diarrhea; nausea.



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); bloody stools; chest pain; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach cramps or pain; shortness of breath; unusual tiredness or weakness; unusual vaginal odor, itching, or discharge.



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: Doripenem 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 Doripenem:

Doripenem is usually handled and stored by a health care provider. If you are using Doripenem at home, store Doripenem as directed by your pharmacist or health care provider. Keep Doripenem out of the reach of children and away from pets.


General information:


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

  • Doripenem 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 Doripenem. 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 Doripenem resources


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


  • Doripenem Professional Patient Advice (Wolters Kluwer)

  • Doripenem Monograph (AHFS DI)

  • doripenem Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Doribax Prescribing Information (FDA)

  • Doribax Consumer Overview



Compare Doripenem with other medications


  • Intraabdominal Infection
  • Kidney Infections
  • Urinary Tract Infection

Tuesday 9 November 2010

Ferro Gluconato Sinclair




Ferro Gluconato Sinclair may be available in the countries listed below.


Ingredient matches for Ferro Gluconato Sinclair



Ferrous Gluconate

Ferrous Gluconate is reported as an ingredient of Ferro Gluconato Sinclair in the following countries:


  • Italy

International Drug Name Search

Sunday 7 November 2010

Trifosfaneurina




Trifosfaneurina may be available in the countries listed below.


Ingredient matches for Trifosfaneurina



Thiamine

Thiamine phosphate (a derivative of Thiamine) is reported as an ingredient of Trifosfaneurina in the following countries:


  • Portugal

International Drug Name Search

Wednesday 3 November 2010

Memodrin




Memodrin may be available in the countries listed below.


Ingredient matches for Memodrin



Aniracetam

Aniracetam is reported as an ingredient of Memodrin in the following countries:


  • Greece

International Drug Name Search

Thursday 21 October 2010

Flutamid Kanoldt




Flutamid Kanoldt may be available in the countries listed below.


Ingredient matches for Flutamid Kanoldt



Flutamide

Flutamide is reported as an ingredient of Flutamid Kanoldt in the following countries:


  • Germany

International Drug Name Search

Saturday 16 October 2010

Serasept




Serasept may be available in the countries listed below.


Ingredient matches for Serasept



Polihexanide

Polihexanide is reported as an ingredient of Serasept in the following countries:


  • Germany

International Drug Name Search

Friday 15 October 2010

Eryacnen




Eryacnen may be available in the countries listed below.


Ingredient matches for Eryacnen



Erythromycin

Erythromycin is reported as an ingredient of Eryacnen in the following countries:


  • Brazil

  • Chile

  • Costa Rica

  • Dominican Republic

  • El Salvador

  • Guatemala

  • Honduras

  • Mexico

  • Nicaragua

  • Panama

  • Peru

International Drug Name Search

Saturday 9 October 2010

AquaTears




AquaTears may be available in the countries listed below.


Ingredient matches for AquaTears



Carbomer

Carbomer is reported as an ingredient of AquaTears in the following countries:


  • Austria

International Drug Name Search

Thursday 7 October 2010

Deucoval




Deucoval may be available in the countries listed below.


Ingredient matches for Deucoval



Naproxen

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


  • Chile

International Drug Name Search

Saturday 2 October 2010

Duplicam




Duplicam may be available in the countries listed below.


Ingredient matches for Duplicam



Meloxicam

Meloxicam is reported as an ingredient of Duplicam in the following countries:


  • Czech Republic

International Drug Name Search