Saturday, 7 April 2012

Touro CC-LD


Generic Name: dextromethorphan, guaifenesin, and pseudoephedrine (dex troe meth OR fan, gwye FEN e sin, soo doe e FED rin)

Brand Names: Altarussin CF, Ambifed-G DM, Relacon-DM NR, Robitussin Cold and Cough, Robitussin Pediatric Cough and Decongestant, Suda-Tussin DM, Touro CC, Touro CC-LD, Tussafed-LA


What is Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


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


The combination of dextromethorphan, guaifenesin, and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and chest congestion caused by the common cold or flu.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

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


What is the most important information I should know about Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine)?


Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant, expectorant, or cough suppressant. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before using Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine)?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use this medicine if you are allergic to dextromethorphan, guaifenesin, or pseudoephedrine.

Before taking this medicine, tell your doctor if you are allergic to any drugs or if you have emphysema or chronic bronchitis. You may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.


This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine)?


Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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


Take the medication with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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


Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include feeling restless or nervous.


What should I avoid while taking Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant, expectorant, or cough suppressant.

Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness, anxiety, restless feeling, or nervousness;




  • confusion, hallucinations; or




  • slow, shallow breathing.



Less serious side effects may include:



  • dizziness or headache,




  • a rash, or




  • nausea, vomiting, or stomach upset.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Touro CC-LD (dextromethorphan, guaifenesin, and pseudoephedrine)?


Before taking dextromethorphan, guaifenesin, and pseudoephedrine, tell your doctor if you are using any of the following drugs:



  • celecoxib (Celebrex);




  • cinacalcet (Sensipar);




  • darifenacin (Enablex);




  • imatinib (Gleevec);




  • quinidine (Quinaglute, Quinidex);




  • ranolazine (Ranexa)




  • ritonavir (Norvir);




  • sibutramine (Meridia);




  • terbinafine (Lamisil);




  • medicines to treat high blood pressure; or




  • antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.



This list is not complete and there may be other drugs that can interact with dextromethorphan, guaifenesin, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Touro CC-LD resources


  • Touro CC-LD Use in Pregnancy & Breastfeeding
  • Touro CC-LD Drug Interactions
  • Touro CC-LD Support Group
  • 0 Reviews for Touro CC-LD - Add your own review/rating


  • Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dextromethorphan/Guaifenesin/Pseudoephedrine MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Touro CC-LD with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about dextromethorphan, guaifenesin, and pseudoephedrine.


Alupent


Generic Name: Metaproterenol Sulfate
Class: Selective beta-2-Adrenergic Agonists
VA Class: RE102
CAS Number: 5874-97-5

Introduction

Bronchodilator; less selective than relatively selective β2-adrenergic agonists (e.g., albuterol).b c f h i j k


Uses for Alupent


Bronchospasm in Asthma


Symptomatic management of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).146 c g Manufacturer recommends against use with other β-adrenergic bronchodilators.c f (See Specific Drugs under Interactions.)


Current asthma management guidelines and most clinicians recommend anti-inflammatory therapy with an orally inhaled corticosteroid as first-line therapy for long-term control of persistent asthma, supplemented by intermittent, as-needed use of a short-acting, inhaled β2-agonist.j o


The National Asthma Education and Prevention Program (NAEPP) does not recommend nonselective β-adrenergic agonists, including metaproterenol,j k for treatment of asthma because of the associated potential for excessive cardiac stimulation, particularly in high doses.j


Bronchospasm in COPD


Symptomatic management of reversible bronchospasm in patients with COPD, including chronic bronchitis and emphysema.146 Manufacturer recommends against use with other β-adrenergic bronchodilators.c f (See Specific Drugs under Interactions.)


Alupent Dosage and Administration


General



  • Adjust dosage carefully according to individual requirements and response.146 c f g



Administration


Administer orally146 f or by oral inhalation via metered-dose inhaler or nebulizer.145 c


Oral Inhalation


Metered-dose Inhaler

Oral inhalation aerosol delivers approximately 0.65 mg from mouthpiece per metered spray; 7-g or 14-g canister delivers 100 or 200 metered sprays, respectively.c


Administer inhalation aerosol only with actuator provided by manufacturer.d


Shake the inhaler well before use.d


Avoid spraying aerosol into eyes.d


Place the mouthpiece of the inhaler well into the mouth with lips closed around it.d Exhale through nose as completely as possible.d Inhale slowly and deeply through mouth.d Actuate aerosol inhaler, hold breath for few seconds, withdraw mouthpiece, and exhale slowly.d


Allow ≥2 minutes to elapse between inhalations from aerosol inhaler.d


Clean inhalation aerosol inhaler by removing metal canister and running warm water through plastic mouthpiece.d If soap used, rinse thoroughly with plain water.d


Dosage


Available as metaproterenol sulfate; dosage expressed in terms of metaproterenol sulfate.145 c f


Pediatric Patients


Bronchospasm in Asthma

Oral

Oral solution in children <6 years of age (limited experience): 1.3–2.6 mg/kg daily.f


Oral solution in children 6–9 years of age or those weighing <27.3 kg: Usually, 10 mg 3 or 4 times daily.f


Conventional tablets in children 6–9 years of age or those weighing <27.3 kg: Usually, 10 mg 3 or 4 times daily.146


Oral solution in children >9 years of age or those weighing >27.3 kg: Usually, 20 mg 3 or 4 times daily.f


Conventional tablets in children >9 years of age or those weighing >27.3 kg: Usually, 20 mg 3 or 4 times daily.146


Oral Inhalation

Inhalation aerosol in children ≥12 years of age: 1.3 or 1.95 mg (2 or 3 inhalations).c Usually no need to repeat dosing more often than every 3–4 hours.c d If necessary, additional inhalations may be used, with dosage not exceeding 7.8 mg (12 inhalations) in any 24-hour period.c d


0.4 or 0.6% inhalation solution for nebulization in children ≥12 years of age: 10 or 15 mg (contents of 1 vial of 0.4 or 0.6% solution for nebulization, respectively) 3 or 4 times daily.145 Usually no need to repeat dosing more often than every 4 hours.145 g


Adults


Bronchospasm in Asthma

Oral

Usually, 20 mg 3 or 4 times daily.146 f


Oral Inhalation

Inhalation aerosol: 1.3 or 1.95 mg (2 or 3 inhalations).c Usually no need to repeat dosing more often than every 3–4 hours.d If necessary, additional inhalations may be used, with dosage not exceeding 7.8 mg (12 inhalations) in any 24-hour period.c d


0.4 or 0.6% inhalation solution for nebulization: 10 or 15 mg (contents of 1 vial of 0.4 or 0.6% solution for nebulization, respectively) 3 or 4 times daily.145 Usually no need to repeat dosing more often than every 4 hours.145 g


Bronchospasm in COPD

Oral Inhalation

Inhalation aerosol: 1.3 or 1.95 mg (2 or 3 inhalations).c Usually no need to repeat dosing more often than every 3–4 hours.d If necessary, additional inhalations may be used, with dosage not exceeding 7.8 mg (12 inhalations) in any 24-hour period.c d


0.4 or 0.6% inhalation solution for nebulization: 10 or 15 mg (contents of 1 vial of 0.4 or 0.6% solution for nebulization, respectively) 3 or 4 times daily.145 Usually no need to repeat dosing more often than every 4 hours.145 g


Prescribing Limits


Pediatric Patients


Bronchospasm

Asthma

Oral Inhalation

Inhalation aerosol in children ≥12 years of age: Maximum ≤7.8 mg (≤12 inhalations) total daily dosage.c


Adults


Bronchospasm in Asthma

Oral Inhalation

Inhalation aerosol: Maximum ≤7.8 mg (≤12 inhalations) total daily dosage.d


Bronchospasm in COPD

Oral Inhalation

Inhalation aerosol: Maximum ≤7.8 mg (≤12 inhalations) total daily dosage.d


Cautions for Alupent


Contraindications


Arrhythmias associated with tachycardia.145 146 c f


Known hypersensitivity to metaproterenol or any ingredients in formulation.145 146 c f


Warnings/Precautions


Warnings


Acute or Worsening Asthma

Oral inhalation therapy intended for acute symptomatic relief of bronchospasm.126 134 135


Failure to respond to previously effective dosage of metaproterenol may indicate seriously worsening asthma.112 126 134 135 Contact a clinician if control of mild asthma deteriorates. Reevaluate asthma therapy and institute alternative regimens or therapy.112 126 134 135


Excessive Doses

Fatalities have been associated with excessive use of inhaled sympathomimetic drugs; cardiac arrest occurred in several cases.145 c


Paradoxical Bronchospasm

Possible life-threatening, acute paradoxical bronchospasm.b c Occasionally occurs after repeated or excessive use of orally inhaled sympathomimetic amines.b g


Discontinue therapy immediately if bronchoconstriction occurs and institute alternative therapy.b c


Cardiovascular Effects

Possible clinically important cardiovascular effects, including cardiac arrhythmias (e.g., tachycardia), changes in BP, and related symptoms.146 b c f


Cautious use recommended in patients with cardiovascular disorders (e.g., ischemic heart disease, CAD, cardiac arrhythmias, hypertension, CHF).145 146 c f


Sensitivity Reactions


Rarely, immediate hypersensitivity reactions can occur.c f


Possible acute bronchospasm.b c (See Paradoxical Bronchospasm under Cautions.)


General Precautions


Nervous System Effects

In high doses, possible CNS stimulation.b


Cautious use recommended in patients with seizure disorders and those with sensitivity to sympathomimetic amines.146 c


Metabolic Effects

Possible hypokalemia, which may increase risk of adverse cardiovascular effects.k l m


Cautious use recommended in patients with diabetes mellitus or hyperthyroidism.145 146 c f


Specific Populations


Pregnancy

Category C.c f g


Lactation

Not known whether metaproterenol is distributed into milk.c f g With oral inhalation solution, use caution.g Administer oral solution or inhalation aerosol to nursing women only if potential benefits to the woman outweigh the possible risk to infant.c f


Pediatric Use

Safety and efficacy of oral inhalation aerosol or solution for nebulization not established in children <12 years of age.c g


Safety and efficacy of oral tablets not established in children <6 years of age.146 b Safety and efficacy of oral solution demonstrated in limited number of pediatric patients <6 years of age.f


Common Adverse Effects


Inhalation aerosol: Nervousness, c headache,c dizziness,c palpitations,c GI distress,c tremor,c throat irritation,c nausea,c vomiting,c cough,c asthma exacerbation.c


Inhalation solution: Nervousness,g tachycardia,g tremor,g nausea.g


Oral tablets: Nervousness,146 tachycardia,146 tremor,146 headache,146 palpitations,146 nausea,146 GI distress,146 dizziness,146 asthma exacerbation, 146 insomnia,146 fatigue,146 diarrhea,146 bad taste,146 vomiting,146 drowsiness,146 syncope,146 hypertension,146 pruritus,146 appetite changes,146 dry throat,146 fever.146


Oral solution: Tachycardia,f nervousness,f tremor,f nausea,f headache.f


Interactions for Alupent


Specific Drugs





















Drug



Interaction



Comments



Antidepressants, tricyclic



Increased effect on vascular system146 c f



Use caution146 c f



β-Adrenergic blocking agents



Antagonism of pulmonary effects, bronchospasmb n



If concomitant use necessary, use cardioselective β-adrenergic blocker without intrinsic sympathomimetic activity (e.g., metoprolol, atenolol, esmolol); use low dosages initially and titrate upward with cautionn



MAO inhibitors



Increased effect on vascular system 146 c f



Use caution146 c f



Methylxanthine derivatives



Pharmacokinetic interaction unlikelye


Potential for increased cardiotoxic effects (e.g., arrhythmias)100 101 102 146 c g



Sympathomimetic agents



Additive effects and possible toxicityb c f



Concomitant use not recommendedc f


Exercise extreme care and allow sufficient time to elapse prior to administration of another sympathomimetic agent146 c (See Duration under Pharmacokinetics)


Alupent Pharmacokinetics


Absorption


Bioavailability


Oral bioavailability about 10%.f h


Onset


Oral inhalation aerosol: ≤1 minute.b


Oral: ≤15–30 minutes.146 b


Oral inhalation solution: ≤5–30 minutes.b g


Oral or oral inhalation: Peak effect ≤1 hour.b


Duration


Oral: ≤4 hours for oral solution and ≥4 hours for tablets.146 f


Oral inhalation aerosol: About 1–2.5 hours.c


Oral inhalation solution: 4–6 hours.g


Bronchodilating effect of metaproterenol persists for ≥1 hour longer than that of equipotent doses of isoproterenol.b


Distribution


Extent


Not known if metaproterenol is distributed into milk.c


Plasma Protein Binding


Approximately 10–15%.i


Elimination


Metabolism


Following oral administration, extensively metabolized in GI tract to sulfate conjugate.c i Following oral inhalation, may be excreted as glucuronic acid conjugates.145 147


Elimination Route


Oral: Excreted in urine (approximately 40%) mostly as sulfate metabolite.147 f i


Half-life


Biphasic: Terminal half-life 1.5–6 hours.h i


Stability


Storage


Oral


Solution and Tablets

Tight, light-resistant containers at 15–30°C.146 f Protect from moisture.146


Oral Inhalation


Oral inhalation aerosol: 15–25°C; avoid excessive humidity.c


Oral inhalation solution: ≤25°C.145 Discard solution if pinkish or darker than slightly yellow in color or if it contains a precipitate.g


ActionsActions



  • Stimulates β-adrenergic receptors with little or no effect on α-adrenergic receptors.b




  • Less selectivity for β2-receptors than albuterol.b j More selectivity for β2-receptors than isoproterenol.c f i




  • Stimulates the production of cyclic adenosine-3′,5′-monophosphate (cAMP),146 b f which mediates bronchial smooth muscle relaxation and inhibition of release of proinflammatory mediators from mast cells in airways.146 b c f




  • Decreases airway resistance.c f g




  • In high doses, may cause CNS stimulation and some cardiostimulatory effects, which may result in tachycardia and hypertension.b




  • Possible development of tolerance to bronchodilatory effects with prolonged therapy exceeding recommended dosages.b



Advice to Patients



  • Importance of adherence to dosing schedules of metaproterenol and concomitant therapy, including not exceeding recommended dosage or frequency of use unless otherwise instructed by a clinician.b f




  • Importance of using extreme care when considering administration of additional sympathomimetic agents.f Importance of allowing a sufficient interval of time to elapse before administering another sympathomimetic agent.f (See Specific Drugs under Interactions.)




  • Importance of contacting clinician if asthmatic symptoms worsen or adverse reactions or diminished response occurs with usual dosage;b f g do not increase dose or frequency of administration.c f




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




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




  • Importance of advising patients of other important precautionary information.146 c f g (See Cautions.)



Preparations


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


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






































Metaproterenol Sulfate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



10 mg/5 mL*



Metaproterenol Sulfate Syrup



Novex, Par, Silarx



Tablets



10 mg*



Metaproterenol Sulfate Tablets



Par, Teva, Watson



20 mg*



Metaproterenol Sulfate Tablets



Par, Teva, Watson



Oral Inhalation



Aerosol



0.65 mg/metered spray



Alupent (with chlorofluorohydrocarbon propellants)



Boehringer Ingelheim



Solution, for nebulization



0.4%



Metaproterenol Sulfate Inhalation Solution



Dey



0.6%



Metaproterenol Sulfate Inhalation Solution



Dey



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References


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



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120. Lai CKW, Twentyman OP, Holgate ST. The effect of an increase in inhaled allergen dose after rimiterol hydrobromide on the occurrence and magnitude of the late asthmatic response and the asssociated change in nonspecific bronchial responsiveness. Am Rev Respir Dis. 1989; 140:917-23. [IDIS 310468] [PubMed 2572192]



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123. Cockcroft DW, McParland CP, Britto SA et al. Regular inhaled salbutamol and airway responsiveness to allergen. Lancet. 1993; 342:833-7. [IDIS 320479] [PubMed 8104272]



124. Mullen ML, Mullen B, Carey M. The association between β-agonist use and death from asthma: a meta-analytic integration of case-control studies. JAMA. 1993; 270:1842-5. [IDIS 320909] [PubMed 8105113]



125. Reviewers’ comments (personal observations) on Salmeterol 12:12.



126. National Institutes of Health, National Heart, Lung, and Blood Institute. Global Initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 1995 Jan:77-100. NIH/NHLBI Publication No. 95-3659.



127. Devoy MAB, Fuller RW, Palmer JBD. Are there any detrimental effects of the use of inhaled long-acting β2-agonists in the treatment of asthma? Chest. 1995; 107:1116-24.



128. McFadden ER Jr. Perspectives in β2-agonist therapy: vox clamantis in deserto vel lux in tenebris? J Allergy Clin Immunol. 1995; 95:641-51.



129. Crane J, Burgess C, Pearce N et al. Asthma deaths in New Zealand. BMJ. 1992; 304:1307. [IDIS 296806] [PubMed 1606438]



130. Crane J, Pearce N, Flatt A et al. Prescribed fenoterol and death from asthma in New Zealand, 1981-83: case-control study. Lancet. 1989; 1:917-22. [IDIS 254874] [PubMed 2565417]



131. Pearlman DS, Chervinsky P, LaForce C et al. A comparison of salmeterol with albuterol in the treatment of mild-to-moderate asthma. N Engl J Med. 1992; 327:1420-5.



132. D’Alonzo GE, Nathan RA, Henochowicz S et al. Salmeterol xinafoate as maintenance therapy compared with albuterol in patients with asthma. JAMA. 1994; 271:1412-6.



133. Drazen JM, Israel E, Boushey HA et al. Comparison of regularly scheduled with as- needed use of albuterol in mild asthma. N Engl J Med. 1996; 335:841-7.



134. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. 1997 Feb.



135. National Institutes of Health, National Heart, Lung, and Blood Institute. Global Initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2002 Feb. NIH/NHLBI Publication No. 02-3659. Available from website. Accessed Sep. 26, 2002



136. National Heart, Lung, and Blood Institute/World Health Organization. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, MD: National Heart, Lung, and Blood Institute, Global Initiative for Chronic Obstructive Lung Disease, World Health Organization; 2001. Available at: . Accessed Sep. 26, 2002.



137. American Thoracic Society. ATS Statement: Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995;152(Suppl):S78-120.



138. Veterans’ Health Administration Department of Veteran Affairs. The pharmacologic management of chronic obstructive pulmonary disease. Washington, DC: Veterans’ Health Administration; 1999 June. Pharmacy Benefits Management No. 99-0012. Available from website. Accessed Sep. 30, 2002.



139. Veterans’ Health Administration, Department of Veterans’ Affairs. VHA/DOD clinical practice guideline for the management of chronic obstructive pulmonary disease: complete summary. Washington, DC: Veterans’ Health Administration; 1999 Aug.



140. Boehringer Ingelheim. Atrovent (ipratropium bromide) inhalation aerosol prescribing information. Ridgefield, CT; 1999 Mar.



141. ATS/ERS Standards for the diagnosis and management of patients with COPD. New York, NY: American Thoracic Society, European Respiratory Society; 2004. Available from website. Accessed Dec. 8, 2004.



142. O’Donnell DE, Aaron S, Bourbeau J et al. State of the art compendium: Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease. Can Respir J. 2004; 11 (Suppl. B):7B-59B. [PubMed 15340581]



143. Celli BR, Macnee W. Standard for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004; 23:932-46. [PubMed 15219010]



144. National Heart, Lung, and Blood Institute/World Health Organization. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, MD: National Heart, Lung, and Blood Institute, Global Initiative for Chronic Obstructive Lung Disease, World Health Organization; 2005 Sep. Available from website. Accessed Oct. 5, 2005.



145. Dey. Metaproterenol sulfate (0.4 and 0.6%) inhalation solution. Napa , CA; 1998 Apr.



146. Par Pharmaceuticals. Metaproterenol tablets prescribing information. Spring Valley, NY; 2000 Sep.



147. MacGregor TR, Nastasi L, Farina PR et al. Isolation and characterization of metaproterenol-3-O-sulfate: a conjugate of metaproterenol in human urine. Drug Metab Dispos. 1983; 160:568-73.



b. AHFS drug information 2007. McEvoy GK, ed. Metaproterenol. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1321-3.



c. Boehringer Ingelheim Pharmaceuticals Inc. Alupent (metaproterenol sulfate) inhalation aerosol prescribing information. Ridgefield, CT; 1999 Feb.



d. Boehringer Ingelheim Pharmaceuticals Inc. Alupent (metaproterenol sulfate) inhalation aerosol patient instructions. Ridgefield, CT; 1999 Feb.



e. Upton RA. Pharmacokinetic interactions between theophylline and other medication. Clin Pharmacokinet. 1991; 20:66-80. [PubMed 1674242]



f. Apotex Corporation. Metaproterenol sulfate oral solution prescribing information. Weston, FL; 2005 May.



g. Dey. Metaproterenol sulfate (0.4 and 0.6%) inhalation solution prescribing information. Napa , CA; 2006 Jan.



h. Kelly HW. New β2-adrenergic agonist aerosols. Clin Pharm. 1985; 4:393-403. [PubMed 2864159]



i. Hatch F, McKellop K, Hansen G et al. Relative bioavailability of metaproterenol in humans utilizing a single-dose, stable isotope approach. J Pharm Sci. 1986; 75:886-90. [PubMed 3783458]



j. National Asthma Education Program Expert Panel Report. Executive summary: guidelines for the diagnosis and management of asthma—update on selected topics 2002. NIH Publication No. 02-5075. Bethesda, MD: National Institutes of Health, National Heart, Lung, and Blood Institute; 2002 Jun.



k. Burgess CD, Windom HH, Pearce N et al. Lack of evidence for beta-2 receptor selectivity: a study of metaproterenol, fenoterol, isoproterenol, and epinephrine in patients with asthma. Am Rev Respir Dis. 1991; 143(2):444-6. [PubMed 1671326]



l. Gelmont DM, Balmes JR, Yee A. Hypokalemia induced by inhaled bronchodilators. Chest. 1988; 94:763-6. [PubMed 3168573]



m. Salpeter SR, Ormiston TM, Salpeter EE. Cardiovascular effects of β-agonists in patients with asthma and COPD. Chest. 2004; 125:2309-21. [PubMed 15189956]



n. Tafreshi MJ, Weinacker AB. Beta-adrenergic-blocking agents in bronchospastic diseases: a therapeutic dilemma. Pharmacotherapy. 1999; 19:974-8. [PubMed 10453968]



o. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention. NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2006 Nov. Available from website. Accessed Aug 9, 2007.



More Alupent resources


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  • Alupent Support Group
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  • Alupent Prescribing Information (FDA)

  • Alupent MedFacts Consumer Leaflet (Wolters Kluwer)

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Monday, 2 April 2012

Sirolimus Solution


Pronunciation: sir-OH-li-mus
Generic Name: Sirolimus
Brand Name: Rapamune

Sirolimus Solution decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, persistent sore throat, chills, fever), any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.


Sirolimus Solution may increase the risk of severe side effects, including death, when used with certain other immunosuppressants in liver or lung transplant patients. Use of Sirolimus Solution in liver or lung transplant patients is not recommended.





Sirolimus Solution is used for:

Preventing organ rejection after a kidney transplant. It is used with other medicines. It may also be used for other conditions as determined by your doctor.


Sirolimus Solution is an immunosuppressant. It works by blocking the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.


Do NOT use Sirolimus Solution if:


  • you are allergic to any ingredient in Sirolimus Solution

  • you have had a liver or lung transplant

  • you are taking astemizole, certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), certain macrolide antibiotics (eg, clarithromycin, erythromycin), rifabutin, rifampin, tacrolimus, telithromycin, or terfenadine

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



Before using Sirolimus Solution:


Some medical conditions may interact with Sirolimus Solution. 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 able to become pregnant

  • 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 liver problems, kidney problems, high cholesterol or triglycerides, low blood platelet levels, diabetes, or a history of lung or breathing problems

  • if you are on dialysis, have recently received or are scheduled to receive a vaccine, or have a history of tuberculosis (TB) or have ever had a positive TB skin test

  • if you have had multiple organ transplants, an organ retransplanted, or a previous transplant that was rejected

  • if you or a family member has a history of skin cancer

  • if you previously took cyclosporin and have recently stopped taking it

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


  • Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because the risk of a serious side effect (angioedema) involving swelling of the mouth, face, lips, tongue, throat, and hands; trouble swallowing or breathing; and unexplained hoarseness may be increased

  • Amiodarone, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), bromocriptine, cimetidine, cisapride, cyclosporine, danazol, diltiazem, dronedarone, hepatitis C virus (HCV) protease inhibitors (eg, boceprevir), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), metoclopramide, mibefradil, nicardipine, streptogramins (eg, dalfopristin), telithromycin, troleandomycin, or verapamil because they may increase the risk of Sirolimus Solution's side effects, including kidney problems

  • Medicines that may harm the kidney (eg, aminoglycosides [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

  • Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, rifamycins (eg, rifabutin, rifampin, rifapentine), or St. John's wort because they may decrease Sirolimus Solution's effectiveness

  • Astemizole , calcineurin inhibitors (eg, tacrolimus), fibrates (eg, fenofibrate), HMG-CoA reductase inhibitors (eg, atorvastatin), mycophenolate, or terfenadine because the risk of their side effects may be increased by Sirolimus Solution

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


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


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

  • Take Sirolimus Solution by mouth. You may take it with or without food. However, you must take it the same way each time for it to work best. If you take Sirolimus Solution on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.

  • Use the dosing syringe that comes with Sirolimus Solution to measure your dose. Keep the bottle upright while you measure your dose. If bubbles form in the syringe, empty the syringe into the bottle and start over. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Empty the measured medicine from the syringe into a glass or plastic container that has at least 2 oz (60 mL) of water or orange juice in it. Do not mix with any other liquid. Stir well and drink at once. Refill the container with at least 4 oz (120 mL) of water or orange juice, stir well, and drink at once.

  • You may draw a dose into the syringe, cap the syringe, and keep the medicine in the syringe for up to 24 hours before using it. The syringe should be stored at room temperature, up to 77 degrees F (25 degrees C), or in the refrigerator. Once you have mixed the medicine in liquid, you must drink it right away.

  • Throw away each syringe after 1 use.

  • If you spill Sirolimus Solution on your skin, wash it off right away with soap and water. If you get Sirolimus Solution in your eyes, rinse at once with cool tap water.

  • Sirolimus Solution may become hazy when refrigerated. If this occurs, allow it to stand at room temperature and shake gently until the haze disappears. This will not affect the effectiveness of Sirolimus Solution.

  • If it is necessary to wipe the mouth of the bottle, use a dry cloth so that no water or other liquid enters the bottle.

  • If you are also taking cyclosporine, take Sirolimus Solution 4 hours after your cyclosporine dose, unless your doctor tells you otherwise.

  • Grapefruit and grapefruit juice may increase the risk of side effects from Sirolimus Solution. Do not eat grapefruit or drink grapefruit juice while you take Sirolimus Solution.

  • Sirolimus Solution works best if it is taken at the same time each day. Continue to take Sirolimus Solution even if you feel well. Do not miss any doses.

  • Do not stop taking Sirolimus Solution without first checking with your doctor.

  • If you miss a dose of Sirolimus Solution, 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 Sirolimus Solution.



Important safety information:


  • Do not change your dose of Sirolimus Solution without first checking with your doctor.

  • Sirolimus Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Some patients treated with Sirolimus Solution have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine). Discuss any questions or concerns with your doctor.

  • Sirolimus Solution may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Discuss any questions or concerns with your doctor.

  • To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Sirolimus Solution. Talk with your doctor before you receive any vaccine.

  • Sirolimus Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Do not switch between the tablet and solution forms of Sirolimus Solution without first checking with your doctor. The same doses may not be equally effective.

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

  • If you may become pregnant, you must use an effective form of birth control before you start taking Sirolimus Solution. You will need to continue to use birth control while you take Sirolimus Solution and for 12 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.

  • Decreased sperm production has occurred in some men taking Sirolimus Solution. Normal sperm production has usually returned when Sirolimus Solution was stopped. Discuss any questions or concerns with your doctor.

  • Patients who take Sirolimus Solution after an organ transplant may have an increased risk of developing high blood sugar or diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

  • Lab tests, including complete blood cell counts, kidney function, urine protein, blood cholesterol and triglyceride levels, and sirolimus blood levels, may be performed while you take Sirolimus Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Sirolimus Solution should be used with extreme caution in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.

  • Sirolimus Solution should be used with extreme caution in CHILDREN younger than 18 years old who are considered to be at high immunological risk; safety and effectiveness in these children have not been confirmed.

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


Possible side effects of Sirolimus Solution:


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:



Acne; constipation; diarrhea; headache; joint pain; nausea; stomach pain.



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 or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); calf or leg pain, redness, tenderness, or swelling; chest pain; fainting; fast or irregular heartbeat; mental or mood changes; muscle pain, cramps, or tenderness; new or worsening breathing problems (eg, shortness of breath); new or worsening cough; night sweats; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; skin growths or discoloration; swelling of the hands, ankles, feet, or stomach; swelling or soreness of the mouth or tongue; swollen glands or veins; symptoms of infection (eg, chills, fever, frequent or painful urination, sore throat, unusual vaginal discharge or odor); symptoms of kidney problems (eg, blood in the urine, change in the amount of urine, difficult or painful urination); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of PML (eg, changes in thinking, strength, or vision; confusion; depression; disorientation; loss of balance or coordination; one-sided weakness; trouble walking or talking); tremor; unusual bleeding or bruising; unusual lumps; unusual tiredness or weakness; unusual weight gain or loss; vision changes; wound healing problems.



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: Sirolimus 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 Sirolimus Solution:

Store Sirolimus Solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do NOT freeze. If necessary, the bottle may be stored at room temperature, up to 77 degrees F (25 degrees C), for no more than 15 days. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after the bottle has been open for 1 month. Keep Sirolimus Solution out of the reach of children and away from pets.


General information:


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

  • Sirolimus Solution 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 Sirolimus Solution. 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 Sirolimus resources


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


Compare Sirolimus with other medications


  • Organ Transplant, Rejection Prophylaxis

Saturday, 31 March 2012

Xyzal Solution



Pronunciation: LEE-voe-se-TIR-a-zeen
Generic Name: Levocetirizine
Brand Name: Xyzal


Xyzal Solution is used for:

Treating allergy symptoms and chronic hives. It may also be used for other conditions as determined by your doctor.


Xyzal Solution is an antihistamine. It works by blocking a substance in the body called histamine. This helps to decrease allergy symptoms and hives.


Do NOT use Xyzal Solution if:


  • you are allergic to any ingredient in Xyzal Solution or to cetirizine

  • you have severe kidney problems or you are receiving dialysis

  • the patient is a child 6 months to 11 years old who has kidney problems

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



Before using Xyzal Solution:


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


  • 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 or liver problems

Some MEDICINES MAY INTERACT with Xyzal Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • Ritonavir or theophylline because they may increase the risk of Xyzal Solution's side effects

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


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


  • Take Xyzal Solution by mouth with or without food. Take it in the evening unless your doctor tells you otherwise.

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

  • If you miss a dose of Xyzal Solution, 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 Xyzal Solution.



Important safety information:


  • Xyzal Solution may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Xyzal Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Xyzal Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • The risk of drowsiness may be greater if you take Xyzal Solution in high doses. Do NOT take more than the recommended dose without checking with your doctor.

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

  • Xyzal Solution should be used with extreme caution in CHILDREN younger than 6 months; safety and effectiveness in these 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 Xyzal Solution while you are pregnant. Xyzal Solution is found in breast milk. Do not breast-feed while taking Xyzal Solution.


Possible side effects of Xyzal Solution:


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:



Constipation; diarrhea; drowsiness; dry mouth; sore throat; tiredness; weakness.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; dark urine; difficult or painful urination; dizziness; ear pain; fainting; fast or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, aggression, agitation); nosebleeds; seizure; shortness of breath; vision problems (eg, blurred vision); vomiting; yellowing of the eyes or skin.



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: Xyzal 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 agitation; irritability; restlessness; severe drowsiness.


Proper storage of Xyzal Solution:

Store Xyzal Solution between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xyzal Solution out of the reach of children and away from pets.


General information:


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

  • Xyzal Solution 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 Xyzal Solution. 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 Xyzal resources


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


Compare Xyzal with other medications


  • Allergies
  • Hay Fever
  • Urticaria

Friday, 30 March 2012

Alti-Amoxi Clav



Generic Name: amoxicillin and clavulanate (Oral route)


a-mox-i-SIL-in, KLAV-ue-la-nate poe-TAS-ee-um


Commonly used brand name(s)

In the U.S.


  • Amoclan

  • Augmentin

  • Augmentin ES-600

  • Augmentin XR

In Canada


  • Alti-Amoxi Clav

  • Apo-Amoxi Clav

  • Novo-Clavamoxin 125

  • Novo-Clavamoxin 250

  • Ratio-Amoxi Clav 250f

Available Dosage Forms:


  • Tablet

  • Tablet, Extended Release

  • Powder for Suspension

  • Tablet, Chewable

Therapeutic Class: Antibiotic


Pharmacologic Class: Penicillin, Aminopenicillin


Uses For Alti-Amoxi Clav


Amoxicillin and clavulanate combination is used to treat bacterial infections in many different parts of the body.


Amoxicillin and clavulanate combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.


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


Before Using Alti-Amoxi Clav


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


Allergies


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


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate chewable tablets and oral suspension in children.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate tablets in children weighing 40 kilograms (kg) or more. However, safety and efficacy have not been established in children weighing less than 40 kg.


Appropriate studies have not been performed on the relationship of age to the effects of amoxicillin and clavulanate extended-release tablets in teenagers and children younger than 16 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxicillin and clavulanate combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving amoxicillin and clavulanate combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is 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.


  • Methotrexate

  • Venlafaxine

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


  • Acenocoumarol

  • Desogestrel

  • Dienogest

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Khat

  • Levonorgestrel

  • Medroxyprogesterone Acetate

  • Mestranol

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Probenecid

  • Warfarin

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Diarrhea or

  • Liver disease—Use with caution. May make these conditions worse.

  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Kidney disease, severe—The extended-release tablets should not be used in patients with this condition.

  • Liver disease, history of with amoxicillin and clavulanate combination or

  • Mononucleosis ("mono")—Should not be used in patients with these conditions.

  • Phenylketonuria (PKU)—The chewable tablet and oral suspension contain phenylalanine, which can make this condition worse.

Proper Use of amoxicillin and clavulanate

This section provides information on the proper use of a number of products that contain amoxicillin and clavulanate. It may not be specific to Alti-Amoxi Clav. Please read with care.


Take this medicine exactly as directed by your doctor. 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.


You may take this medicine with or without meals. However, it is best to take this medicine at the start of a meal or snack to avoid an upset stomach.


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


If you are using the chewable tablets, chew the tablet completely before swallowing.


There are certain flavors that can be mixed with the oral suspension to make it taste better. If you or your child do not like the taste of this medicine, ask your pharmacist about these flavorings.


Keep the oral suspension refrigerated. Shake it well before measuring the dose. Use a dosing spoon or medicine dropper to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the dosing spoon or dropper with water after each use.


Do not change brands or dosage forms of amoxicillin and clavulanate combination without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, ask your pharmacist about the change.


Dosing


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


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


  • For bacterial infections:
    • For oral dosage form (chewable tablets, suspension):
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.

      • Children and infants above 3 months of age and weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given every 8 hours, or 25 to 90 mg/kg/day, divided and given every 12 hours.

      • Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 12 hours.


    • For oral dosage form (extended-release tablets):
      • Adults—2000 milligrams (mg) every 12 hours.

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


    • For oral dosage form (tablets):
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.

      • Children weighing less than 40 kilograms (kg)—Use and dose must be determined by your doctor.



Missed Dose


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


Storage


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.


Store the chewable tablets, regular tablets, and extended-release tablets at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Store the oral suspension in the refrigerator. Throw away any unused portion after 10 days. Keep from freezing.


Precautions While Using Alti-Amoxi Clav


If your symptoms do not improve within a few days, or if they become worse, check with your doctor.


This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.


Amoxicillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.


Amoxicillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g., condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.


Before you or your child have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.


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.


Alti-Amoxi Clav 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:


Less common
  • Hives or welts

  • itching

  • itching of the vagina or genital area

  • pain during sexual intercourse

  • redness of the skin

  • skin rash

  • thick, white vaginal discharge with no odor or with a mild odor

Rare
  • Bloody or cloudy urine

  • fever

  • greatly decreased frequency of urination or amount of urine

  • seizures

  • swelling of the feet or lower legs

Incidence not known
  • Abdominal or stomach cramps or tenderness

  • back, leg, or stomach pains

  • black, hairy tongue

  • black, tarry stools

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • bloating

  • blood in the stools

  • bloody nose

  • chest pain

  • chills

  • clay-colored stools

  • cough or hoarseness

  • cracks in the skin

  • dark urine

  • diarrhea

  • diarrhea, watery and severe, which may also be bloody

  • difficulty with breathing

  • difficulty with moving

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • fever with or without chills

  • general body swelling

  • general feeling of tiredness or weakness

  • headache

  • heavier menstrual periods

  • increased thirst

  • joint or muscle pain

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

  • light-colored stools

  • loss of appetite

  • loss of heat from the body

  • lower back or side pain

  • muscle stiffness

  • nausea or vomiting

  • pain

  • pain, swelling, or redness in the joints

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

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

  • rash

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • red, swollen skin

  • scaly skin

  • shortness of breath

  • sore throat

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

  • swollen glands

  • tightness in the chest

  • troubled breathing with exertion

  • unpleasant breath odor

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • unusual weight loss

  • upper right abdominal pain

  • vomiting of blood

  • wheezing

  • white patches in the mouth or throat or on the tongue

  • white patches with diaper rash

  • yellow eyes or skin

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


Symptoms of overdose
  • Abdominal or stomach pain

  • bloody or cloudy urine

  • diarrhea

  • fever

  • greatly decreased frequency of urination or amount of urine

  • pain or burning while urinating

  • skin rash

  • sleepiness

  • swelling of the feet or lower legs

  • vomiting

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:


Rare
  • Anxiety

  • dry mouth

  • hyperventilation

  • irregular heartbeats

  • irritability

  • nervousness

  • restlessness

  • shaking

  • sleeplessness

  • tooth discoloration

  • trouble sitting still

  • trouble with sleeping

  • unable to sleep

Incidence not known
  • Burning feeling in the chest or stomach

  • indigestion

  • redness, swelling, or soreness of the tongue

  • stomach upset

  • swelling or inflammation of the mouth

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: Alti-Amoxi Clav side effects (in more detail)



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