In the US, Stri-Dex (salicylic acid topical) is a member of the following drug classes: topical acne agents, topical keratolytics and is used to treat Acne and Dermatological Disorders.
US matches:
Salicylic Acid is reported as an ingredient of Stri-Dex in the following countries:
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Evartan may be available in the countries listed below.
Tertatolol is reported as an ingredient of Evartan in the following countries:
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Pantoprazol G.E.S. may be available in the countries listed below.
Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantoprazol G.E.S. in the following countries:
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Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Rynatan is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Rynatan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Rynatan. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rynatan 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.
Use Rynatan as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Rynatan.
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; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Rynatan side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Rynatan at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rynatan out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Rynatan. 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.
Generic Name: Arformoterol Tartrate
Class: Selective beta-2-Adrenergic Agonists
Chemical Name: (2R,3R) - 2,3 - dihydroxybutanedioate - N - [2 - hydroxy - 5 - [(1R) - 1 - hydroxy - 2 - [[(1R) - 2 - (4 - methoxyphenyl) - 1 - methylethyl]amino]ethyl]phenyl] - formamide
Molecular Formula: C19H24N2O4•C4H6O6
CAS Number: 200815-49-2
Special Alerts:
[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.
Healthcare professionals are reminded that to ensure the safe use of these products:
Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: and .
REMS:
FDA approved a REMS for arformoterol tartrate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of arformoterol tartrate and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().
Possible increase in asthma†-related deaths in patients receiving certain long-acting β2-adrenergic bronchodilators (e.g., salmeterol) in addition to usual asthma therapy.1 14 15 16 17 18 19 (See Risk of Asthma or COPD-related Death under Cautions.)
Increased risk of asthma-related death may represent a class effect of long-acting β2-adrenergic agonists, including arformoterol.1 7 14 18 19 (See Advice to Patients.)
Bronchodilator; relatively selective long-acting β2-agonist.1 2 3 12 13
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Long-term treatment of bronchoconstriction associated with COPD, including chronic bronchitis and emphysema.1 3 6
Long-acting β2-adrenergic agonists recommended as maintenance therapy in patients with moderate (e.g., forced expiratory volume in 1 second [FEV1] ≥50 but <80% of predicted) to very severe COPD (e.g., FEV1 <30% of predicted or <50% of predicted plus chronic respiratory failure) who have persistent symptoms not relieved by as-needed therapy with short-acting bronchodilators (e.g., ipratropium, β2-adrenergic agonist).5 9
Regular treatment with long-acting bronchodilators more effective and convenient than treatment with short-acting bronchodilators.5 Superiority of one long-acting bronchodilator over another currently not established.11 If inadequate response, may use a combination of long-acting bronchodilators, such as a long-acting inhaled anticholinergic agent (tiotropium) and a long-acting β2-adrenergic agonist.5 9
In patients with severe (e.g., FEV1 <50% of predicted, history of repeated exacerbations) to very severe COPD, add regular treatment with an inhaled corticosteroid to long-acting bronchodilator therapy.5 9 11 If inadequate response or limiting adverse effects occur, add or substitute extended-release oral theophylline.9 11
Not to be used for immediate relief of acute exacerbations of COPD.1 6 Use short-acting inhaled β2-agonist intermittently (as needed) for acute symptoms of COPD.1 5 (See Acute Exacerbations of COPD under Cautions.) Efficacy and safety of long-acting bronchodilators, with or without inhaled corticosteroids, during acute exacerbations of COPD not established.1 5
When arformoterol therapy is initiated, discontinue regular use of short-acting, inhaled β2-adrenergic agonists, and use such agents only for relief of acute symptoms of COPD that are not controlled by arformoterol.1 2 6
Failure to respond to a previously effective dosage may indicate destabilization of COPD that requires reevaluation.1 Do not use extra/increased doses of arformoterol in such situations.1 2 6 (See Acute Exacerbations of COPD under Cautions.)
Administer by oral inhalation via nebulization twice daily (morning and evening) only.1 2 Do not administer inhalation solution orally.1
Using in vitro testing at a mean flow rate of 3.3 L/minute for an average of ≤6 minutes, Pari-LC Plus nebulizer connected to a Pari DURA-NEB 3000 compressor delivered approximately 27.6% of original dose at mouthpiece.1
For administration of arformoterol inhalation solution for nebulization in single-use units, open 1 vial and squeeze entire contents into nebulizer reservoir.2
Attach reservoir to mouthpiece or face mask and to compressor according to manufacturer’s instructions.2
Place mouthpiece of nebulizer in mouth or put on nebulizer face mask and turn on compressor.2 Breathe as calmly, deeply, and evenly as possible until nebulizer stops producing mist, about 5–10 minutes.2
Clean nebulizer after use according to manufacturer’s instructions.2
Safety and efficacy of arformoterol inhalation solution administered by a nebulizer other than the Pari-LC Plus nebulizer or a compressor other than Pari Dura-Neb 3000 compressor not established.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Commercially available as arformoterol tartrate; dosage expressed in terms of arformoterol.1
Delivery of oral inhalation solution to lungs depends on type of jet nebulizers used, performance of compressor, and other factors such patient’s inspiratory flow.1 (See Administration under Dosage and Administration.)
Usual dosage: 15 mcg twice daily via nebulization.1 13 Higher dosages provide no additional therapeutic benefit and increase risk of adverse effects.1 3 6 Maximum 30 mcg daily.1 2 6 13
Maximum 30 mcg daily.1 2 6 13
Dosage adjustment not required.1 6
Dosage adjustment not required.1 6
Dosage adjustment not required.1 6
No dosage adjustment required.1 (See Elimination: Special Populations, under Pharmacokinetics.)
Known hypersensitivity to arformoterol, formoterol, or any ingredient in formulation.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Data from large placebo-controlled safety study (Salmeterol Multicenter Asthma Research Trial [SMART]) suggest increased risk of asthma-related death in patients receiving another long-acting β2-adrenergic agonist, salmeterol, in addition to usual asthma therapy.1 14 15 16 17 18 (See Boxed Warning.)
While data from currently available studies do not show increased risk of asthma-related death with racemic formoterol, data from small clinical studies suggest higher incidence of serious asthma exacerbations with formoterol compared with placebo.1 7 18
Effects of arformoterol on rate of asthma-related deaths not established; not currently FDA-approved for use in asthma†.1
Not known whether rate of death is increased in patients with COPD receiving arformoterol.1 2 7 Data from large placebo-controlled study (TOwards a Revolution in COPD Health [TORCH]) evaluating survival in patients with COPD receiving salmeterol, fluticasone propionate, or both drugs over a 3-year period did not reveal an increased incidence of COPD-related or overall deaths in patients receiving salmeterol in addition to usual COPD therapy.22 23
Do not initiate therapy in patients with acutely deteriorating COPD, which may be life threatening;1 not indicated for treatment of acute episodes of bronchospasm (i.e., rescue therapy).1 6 Safety and efficacy of arformoterol for relief of acute symptoms of COPD not established.1 6
Failure to respond to a previously effective dosage of arformoterol or supplemental short-acting β2-agonist (e.g., increased need for additional short-acting β2-agonist) may indicate substantially worsening COPD.1 6 Promptly reevaluate COPD therapy.1 6 Do not use extra doses of arformoterol alone or with other long-acting, inhaled β2-adrenergic agonists (e.g., formoterol) for maintenance therapy of COPD or any other reason.1 2 6 7
Possible clinically important changes in systolic and/or diastolic BP, heart rate, ECG (e.g., flattening of T wave, prolongation of QTc interval, ST-segment depression) changes, and/or cardiovascular symptoms.1 3 6 13 Such effects uncommon with recommended dosage; may require discontinuance of drug.1 6
Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, or hypertension.1 6
Fatalities associated with excessive use of inhaled sympathomimetic drugs.1 6 Do not use higher than recommended dosage of arformoterol.1 6
Patients receiving arformoterol should not use additional arformoterol or other long-acting β2-adrenergic agonists for maintenance treatment of COPD.1 2 6
Immediate hypersensitivity reactions (e.g., anaphylactic reactions, urticaria, angioedema, rash, bronchospasm) reported.1 6
Possible acute, life-threatening, paradoxical bronchospasm may occur.1 6
Discontinue therapy immediately if bronchospasm occurs and institute alternative therapy.1 6
Possible hypokalemia; may increase risk of adverse cardiovascular effects.1 3 6 9 11 Hypokalemia usually transient, not requiring supplementation.1
Clinically important changes in blood glucose concentrations possible during long-term therapy at recommended dosage.1 3 6
Use with caution in patients with thyrotoxicosis.1 6
Use with caution in patients with seizure disorders and those unusually responsive to sympathomimetic amines.1 6
Category C.1
Distributed into milk in rats.1 Not known whether distributed into human milk.1 Use caution.1
Safety and efficacy not established.1 COPD does not occur in children.1
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 Incidence of ventricular ectopy in geriatric patients 65–75 years of age with arformoterol comparable to that with placebo.1
Because plasma concentrations of arformoterol may be increased in patients with hepatic impairment, use with caution and monitor patients closely.1 (See Absorption under Pharmacokinetics.)
Pain (unspecified),1 chest pain,1 back pain,1 diarrhea,1 sinusitis,1 leg cramps,1 dyspnea,1 rash,1 flu syndrome,1 peripheral edema,1 lung disorder.1
Minimally metabolized by CYP2D6 and CYP2C19 isoenzymes;1 does not inhibit CYP isoenzymes 1A2, 2A6, 2C9/10, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.1 6
Inhibitors of CYP2D6: Pharmacokinetic interaction unlikely; dosage adjustment not required.1
Potential pharmacodynamic interaction (increased risk of ventricular arrhythmias).1 Use concomitantly with extreme caution.1 13
Drug | Interaction | Comments |
|---|---|---|
β-Adrenergic blocking agents | Potential for antagonism of pulmonary effects, resulting in severe bronchospasm in COPD patients1 | If concomitant therapy necessary, consider cautious use of cardioselective β-adrenergic blocker without intrinsic sympathomimetic activity (e.g., metoprolol, atenolol, esmolol)1 10 Use low dosages of cardioselective β-adrenergic blocker initially and titrate upward with caution10 |
Antidepressants, tricyclic | Potential for increased cardiovascular effects1 6 | Use concomitantly with extreme caution1 6 |
Corticosteroids | Possible potentiation of hypokalemic effects1 6 | |
Diuretics, potassium-depleting | Potential for additive hypokalemia and/or ECG changes, especially when recommended β-agonist dose exceeded1 5 | Use concomitantly with caution1 |
MAO inhibitors | Possible potentiation of cardiovascular effects1 | Use concomitantly with extreme caution1 |
Paroxetine | Pharmacokinetic interaction unlikely with potent CYP2D6 inhibitors (e.g., paroxetine)1 | Arformoterol dosage adjustment not necessary1 |
Sympathomimetic agents | Potential additive pharmacologic effects1 | Use caution with concomitant sympathomimetic agents administered by any route1 |
Xanthine derivatives | Possible potentiation of hypokalemic effects1 13 |
Approximately 25% of systemic exposure from GI absorption; majority of systemic exposure from pulmonary absorption.1 12 13
Peak plasma concentration usually attained within 0.25–1 hour.1 6 13
Clinically important bronchodilation (e.g., increase in FEV1 of 15%): Median of 6.7 minutes.1 6 13
Peak effects occur within 1–3 hours.1 6
12 hours.1 6
In patients with mild to severe hepatic impairment, systemic exposure was 1.3- to 2.4-fold higher than in healthy individuals.1 12 (See Hepatic Impairment under Cautions.)
In patients with mild to severe renal impairment, no marked differences in extent of systemic exposure compared with that in healthy individuals.1
52–65%.1 13
Extensively metabolized in liver, principally to glucuronide (by uridine disphosphoglucuronosyltransferase [UGT] isoenzymes) and sulfate conjugates.1 6 12 13 Metabolized to limited extent by CYP2D6 and CYP2C19 isoenzymes to O-desmethyl metabolite.1 12 13
Excreted in urine (67%) mainly as metabolites and in feces (22%) over 14 days.1
Averages 26 hours at steady state.1 6 12 13
In otherwise healthy individuals with reduced CYP2D6 and/or UGT1A1 activity, no change in systemic exposure compared with healthy individuals with normal enzyme activities.1 (See Special Populations under Dosage and Administration.)
2–8°C.1 Store single-use vials in protective foil pouch to protect from light until used.1 Unopened foil pouches may be kept at 20–25°C for ≤6 weeks.1 Discard such unopened foil pouches after >6 weeks or after manufacturer’s labeled expiration date (whichever comes first).1
Once foil pouch has been opened, use immediately.1 Discard vial if solution discolored.1
For information on systemic interactions resulting from concomitant use, see Interactions.
For information on systemic interactions resulting from concomitant use, see Interactions.
Compatible with ipratropium bromide, acetylcysteine, or budesonide oral inhalation solution when admixed extemporaneously.21 22
Arformoterol is the active R, R-enantiomer of racemic formoterol.1 3 6 12 Arformoterol is twice as potent as racemic formoterol.12 13
Stimulates β2-adrenergic receptors and apparently has little or no effect on β1-adrenergic or muscarinic receptors.1 4 7 8
Stimulates production of cyclic adenosine-3′, 5′-monophosphate (cAMP), which mediates numerous cellular responses, including bronchial smooth muscle relaxation and inhibition of release of proinflammatory mediators (e.g., histamine, leukotrienes) from mast cells in airways.1 5 8 11 12 13
Inhibits allergen-induced infiltration of eosinophils into airways and histamine-induced extravasation of plasma proteins (e.g., albumin) in animal models.1
Long-term maintenance therapy (e.g., >6 weeks) has been associated with development of tolerance to bronchodilatory effects as evidenced by some decrease in FEV1 at the end of the dosing interval.1 13 22
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of providing patient with a copy of the manufacturer’s patient information and medication guide.1 2
Advise of potential for increased risk of asthma†-related death with long-acting β2-adrenergic agonists.1 19 20
Advise of potential for adverse effects, such as palpitations, rapid heart rate, tremor, nervousness, or chest pain.1 2
Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of nebulizer delivery system.1 2
Importance of adherence to dosing schedules, including not exceeding recommended dosage or frequency of use unless otherwise instructed by clinician.1
Importance of advising patient that if a dose of arformoterol is missed, the next dose should be taken at the regularly scheduled time; dose should not be doubled.1 2
Importance of not discontinuing arformoterol therapy without medical supervision, as symptoms may worsen.2
Importance of all patients being provided with and instructed in use of short-acting, inhaled β2-adrenergic bronchodilator as supplemental therapy for acute COPD symptoms.1
Importance of discontinuing regular use of a short-acting, inhaled β-adrenergic bronchodilator when initiating maintenance therapy with arformoterol and instituting intermittent use of a short-acting bronchodilator (not arformoterol) to relieve acute symptoms of COPD.1 2
Importance of not using arformoterol to relieve acute symptoms or exacerbations of COPD.1
Importance of contacting clinician immediately if decreased effectiveness occurs and/or breathing problems worsen quickly; do not increase dose or frequency of administration or add therapy with other long-acting, inhaled β2-adrenergic agonists.1 2 6
Importance of contacting a clinician immediately if short-acting β2-adrenergic agonist becomes less effective (e.g., increased dosage or frequency of administration) for acute symptoms of COPD.1 2 6
Importance of promptly contacting a clinician if symptoms of serious allergic reaction occur, including rash, hives, breathing problems, and swelling of face, mouth, or tongue.1 2
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, vitamins, and herbal supplements, as well as any concomitant illnesses (e.g., heart problems, high BP, seizures, thyroid disorders, diabetes mellitus, liver disorders).1 2
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral Inhalation | Solution, for Nebulization | 7.5 mcg (of arformoterol) per mL | Brovana | Sepracor |
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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Sepracor. Brovana (arformoterol tartrate) inhalation solution prescribing information. Marlborough, MA; 2006 Oct.
2. Sepracor. Brovana (arformoterol tartrate) inhalation solution medication guide. Marlborough, MA; 2006 Oct.
3. Baumgartner RA, Hanania NA, Calhoun WJ et al. Nebulized arformoterol in patients with COPD: A 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007; 29:261-78. [PubMed 17472819]
4. Anon. Arformoterol: (R,R)-eformoterol, (R,R)-formoterol, aformoterol tartrate, eformoterol-Sepracor, formoterol-Sepracor, R,R-eformoterol, R,R-formoterol. Drugs R&D. 2004; 5:25-7.
5. 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; 2006 Nov. Available at: . Accessed 2007 Jun 25.
6. Sepracor. General summary for Brovana (arformoterol tartrate) inhalation solution. Marlborough, MA; undated.
7. Schering. Foradil (formoterol fumarate) aerolizer inhalation powder prescribing information. Kenilworth, NJ; 2006 Jun.
8. Moore RH, Khan A, Dickey BF. Long-acting inhaled β2-agonists in asthma therapy. Chest. 1998; 113:1095-108. [IDIS 404630] [PubMed 9554653]
9. O’Donnell DE, Aaron S, Bourbeau J et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease. 2007 update. Can Respir. 2007; 14 (Suppl. B):5B-32B.
10. Tafreshi MJ, Weinacker AB. Beta-adrenergic-blocking agents in bronchospastic diseases: a therapeutic dilemma. Pharmacotherapy. 1999; 19(8):974-8. [PubMed 10453968]
11. American Thoracic Society and European Respiratory Society. Standards for the diagnosis and management of patients with COPD. New York, NY: American Thoracic Society, European Respiratory Society; 2005 Sep 8. Available from website. Accessed 2007 Aug 2.
12. Cada DJ, Levien T, Baker DE. Arformoterol tartrate. Hosp Pharm. 2007; 42:447-54.
13. Abdelghany O, Merl MY. Arformoterol: the first nebulized long-acting beta2-adrenergic agonist. Formulary. 2007; 42:99-109.
14. Rickard KA. Dear healthcare professional letter regarding important safety information on the use of Serevent in patients with asthma. Rockville, MD: US Food and Drug Administration; 2003 Jan 23. Available from website.
15. Food and Drug Administration. Study of asthma-drug halted. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2003 Jan 23. Available at [no longer available online].
16. Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005; 366:1261-2. [IDIS 541200] [PubMed 16214589]
17. GlaxoSmith Kline. GlaxoSmithKline clinical trial register: salmeterol studies. SLGA5011: a double-blind, randomized, placebo-controlled surveillance study of asthma event outcomes in subjects receiving either usual pharmacolotherapy of asthma or usual pharmacotherapy plus salmeterol 42 mcg twice daily. Research Triangle Park, NC. Available from website. Accessed 2007 Aug 29.
18. Food and Drug Administration. FDA alert for healthcare professionals on formoterol fumarate inhalation powder (marketed as Foradil Aerolizer). Rockville, MD: US Food and Drug Administration; 2005 Nov. Available from website. Accessed 2005 Nov 18.
19. GlaxoWellcome. Serevent Diskus (salmeterol xinafoate) inhalation powder prescribing information. Research Triangle Park, NC; 2007 May.
20. Food and Drug Administration FDA public health advisory on Serevent Diskus (salmeterol xinafoate inhalation powder), Advair Diskus (fluticasone propionate & salmeterol inhalation powder), and Foradil Aerolizer (formoterol fumarate inhalation powder). Rockville, MD: US Food and Drug Administration; 2006 May 15. Available from website. Accessed 2005 Nov 18.
21. Bonasia P, Cook C, Cheng Y et al. Compatibility of arformoterol tartrate inhalation solution with three nebulized drugs. Curr Med Res Opin. 2007; 23:2477-83. [PubMed 17784997]
22. Sepracor, Marlborough, MA: Personal communication.
23. Calverley PMA, Anderson JA, Celli B et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007; 356:775-89. [PubMed 17314337]
In the US, Cefzil (cefprozil systemic) is a member of the drug class second generation cephalosporins and is used to treat Bladder Infection, Bronchitis, Kidney Infections, Otitis Media, Pneumonia, Sinusitis, Skin Infection, Tonsillitis/Pharyngitis and Upper Respiratory Tract Infection.
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Rivotril may be available in the countries listed below.
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| SPC | Summary of Product Characteristics (UK) |
Atebloc may be available in the countries listed below.
Atenolol is reported as an ingredient of Atebloc in the following countries:
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In the US, Thiola (tiopronin systemic) is a member of the drug class miscellaneous genitourinary tract agents and is used to treat Cystinuria.
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USAN
0000773-76-2
C9-H5-Cl2-N-O
214
Antiinfective, quinolin-derivative
Dermatological agent: Antiseborrheic
8-Quinolinol, 5,7-dichloro-
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| USAN | United States Adopted Name |
Fusibet may be available in the countries listed below.
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In the US, Equetro (carbamazepine systemic) is a member of the drug class dibenzazepine anticonvulsants and is used to treat Bipolar Disorder.
US matches:
Carbamazepine is reported as an ingredient of Equetro in the following countries:
International Drug Name Search
Cellufresh may be available in the countries listed below.
Carmellose sodium salt (a derivative of Carmellose) is reported as an ingredient of Cellufresh in the following countries:
International Drug Name Search
Generic Name: buprenorphine (oral) (byoo pre NOR feen)
Brand Names: Subutex
Buprenorphine is an opioid (narcotic) medication that is similar to morphine.
Buprenorphine is used to treat narcotic addiction.
Buprenorphine may also be used for purposes not listed in this medication guide.
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.
To make sure you can safely take buprenorphine, tell your doctor if you have any of these other conditions:
asthma, COPD, sleep apnea, or other breathing disorders;
liver disease (especially hepatitis B or C);
kidney disease;
a thyroid disorder;
stomach problems;
enlarged prostate, urination problems;
gallbladder disease;
curvature of the spine;
Addison's disease (an adrenal gland disorder);
a history of mental illness, personality disorder, or psychotic episode;
a history of drug or alcohol addiction; or
a history of seizures, head injury, or brain tumor.
The buprenorphine sublingual tablet should be placed under the tongue and allowed to dissolve. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.
To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.
See also: Buprenorphine dosage (in more detail)
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, weak pulse, weak or shallow slowed breathing (breathing may stop).
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.
slow or shallow breathing;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may be more likely to occur, such as:
headache;
stomach pain, nausea, vomiting, constipation;
warmth or tingly feeling;
chills, increased sweating;
weakness;
back pain;
anxiety, depression;
sleep problems (insomnia); or
runny nose.
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.
Usual Adult Dose for Opiate Dependence:
Initial dose: 8 mg sublingually on day 1.
Maintenance dose: Rapidly titrate to the recommended target dose of 16 mg/day. In clinical trials, patients received 8 mg on day 1 and 16 mg on day 2 and thereafter. Further dose adjustments may be made in 2 mg to 4 mg increments up to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment. The usual daily range is 4 mg to 24 mg sublingually.
The tablets should be placed under the tongue at the same time and allowed to dissolve. If patients are taking more than 2 tablets per dose and cannot hold more than 2 under the tongue comfortably, they should use 2 tablets at a time, allowing them to dissolve completely before taking more tablets.
For patients taking heroin or short-acting opioids, the first dose should be administered at least 4 hours after the patient last used opioids or preferably when early withdrawal symptoms appear.
Withdrawal symptoms may occur during buprenorphine induction treatment of patients taking methadone or long-acting opioids, especially high opioid doses or when buprenorphine is administered shortly after the last opioid dose. The optimal time for the first dose has not been reported.
The optimal method of tapering to discontinuation has not been reported.
Usual Adult Dose for Pain:
IM or IV:
Initial: 0.3 mg slow IM or IV every 6 hours as needed. May repeat once 30 to 60 minutes after the initial dose. Maximum single dose: 0.6 mg (IM only)
Transdermal patches: Apply 1 patch to a hairless or nearly hairless intact skin site. There are 8 possible application sites: upper outer arm, upper chest, upper back, and side of the chest (on both sides of the body). The patch is worn for 7 days. Maximum dose: 20 mcg/hour
Usual Pediatric Dose for Pain:
Less than 2 years: Safety and effectiveness have not been established.
2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours.
13 to 18 years: 0.3 mg IM or slow IV every 6 hours; may repeat dose in 30 to 60 minutes.
Tell your doctor about all other medicines you use, especially:
conivaptan (Vaprisol);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
nefazodone;
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate, Rimactane), or telithromycin (Ketek);
antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);
heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax) lorazepam (Ativan), clorazepate (Tranxene), triazolam (Halcion), flurazepam (Dalmane), or temazepam (Restoril).
This list is not complete and other drugs may interact with buprenorphine. 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.
See also: buprenorphine side effects (in more detail)
Doxapram hydrochloride (a derivative of Doxapram) is reported as an ingredient of Doxapram Hydrochloride Injection in the following countries:
International Drug Name Search
Otofa may be available in the countries listed below.
Rifamycin is reported as an ingredient of Otofa in the following countries:
Rifamycin sodium salt (a derivative of Rifamycin) is reported as an ingredient of Otofa in the following countries:
International Drug Name Search
Ixacor may be available in the countries listed below.
Ezetimibe is reported as an ingredient of Ixacor in the following countries:
International Drug Name Search
de-fer-OX-a-meen
In the U.S.
Available Dosage Forms:
Therapeutic Class: Heavy Metal Chelator
Deferoxamine injection is used to remove excess iron from the body in anemia or thalassemia patients who have many blood transfusions. It is also used with other medicines to treat acute iron poisoning, especially in small children.
Deferoxamine combines with iron in the blood. The combination of iron and deferoxamine is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.
deferoxamine is to be administered only by or under the immediate supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, deferoxamine is used in certain patients with the following medical condition:
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 deferoxamine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to deferoxamine 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.
Appropriate studies have not been performed on the relationship of age to the effects of deferoxamine injection in children younger than 3 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of deferoxamine injection in the elderly. However, elderly patients are more likely to have vision or hearing problems, and age-related kidney or heart problems, which may require caution and an adjustment in the dose for patients receiving deferoxamine injection.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 receiving deferoxamine, 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 deferoxamine 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.
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.
The presence of other medical problems may affect the use of deferoxamine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you deferoxamine in a hospital or clinic. You may also be taught how to give your medicine at home. deferoxamine is given as a shot under your skin, into a muscle, or into a vein.
Deferoxamine may sometimes be given at home to patients who do not need to be in the hospital. If you are receiving deferoxamine at home, make sure you clearly understand and carefully follow your doctor's instructions.
Use a new needle, unopened vial, or syringe each time you inject your medicine.
You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.
Do not take vitamin C supplements unless your doctor has told you to do so.
The dose of deferoxamine 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 deferoxamine. 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.
Call your doctor or pharmacist for instructions.
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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.
Store the medicine that has been mixed at room temperature and use it within 3 hours. Throw away any mixed medicine that has not been used within this time.
It is very important that your doctor check the progress of you or your child at regular visits to make sure that deferoxamine is working properly and to decide if you should continue to use it. Blood and urine tests must be done regularly to check for unwanted effects .
Deferoxamine may cause some people to have hearing and vision problems within a few weeks after they start using it. This usually occurs if you are receiving high doses of deferoxamine and using it for a long period of time. If you or your child notice any problems with your hearing or vision, such as blurred vision, difficulty with night vision, or difficulty with seeing colors, check with your doctor as soon as possible.
Check with your doctor right away if you or your child have the following symptoms while using deferoxamine: agitation, confusion, decreased urine output, lethargy, muscle twitching, rapid weight gain, seizures, or swelling of the face, ankles, or hands. These may be symptoms of a serious kidney problem.
deferoxamine may cause slow growth. If your child is using deferoxamine, the doctor will need to keep track of your child's height and weight every 3 months to make sure that your child is growing properly.
Stop using deferoxamine and check with your doctor right away if you or your child develop fever, shortness of breath, chest pain or tightness, trouble with breathing, or wheezing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome.
Before you have any medical tests, tell the medical doctor in charge that you or your child are using deferoxamine. The results of some tests (e.g., magnetic resonance imaging or MRI) may be affected by deferoxamine.
deferoxamine may make you dizzy, drowsy, lightheaded, or trouble in hearing or seeing clearly. Make sure you know how you react to deferoxamine before you drive, use machines, or do other jobs that require you to be alert or able to see well.
deferoxamine may cause your urine to turn red in color. This is normal and is nothing to worry about.
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.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
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:
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: deferoxamine Injection side effects (in more detail)
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