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formoterol fumarate

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Overview

What is Foradil?

FORADIL AEROLIZER consists of a capsule dosage form containing a dry powder formulation of FORADIL (formoterol fumarate) intended for oral inhalation only with the AEROLIZER Inhaler.

      Each clear, hard gelatin capsule contains a dry powder blend of 12 mcg of formoterol fumarate and 25 mg of lactose (which contains trace levels of milk proteins) as a carrier.

      The active component of FORADIL is formoterol fumarate, a racemate. Formoterol fumarate is a selective beta-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is

      Formoterol fumarate has a molecular weight of 840.9, and its empirical formula is (CHNO)•CHO•HO. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether.

      The AEROLIZER Inhaler is a plastic device used for inhaling FORADIL. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time. Under standardized in vitro testing at a fixed flow rate of 60 L/min for 2 seconds, the AEROLIZER Inhaler delivered 10 mcg of formoterol fumarate from the mouthpiece. Peak inspiratory flow rates (PIFR) achievable through the AEROLIZER Inhaler were evaluated in 33 adult and adolescent patients and 32 pediatric patients with mild-to-moderate asthma. Mean PIFR was 117.82 L/min (range 34-188 L/min) for adult and adolescent patients, and 99.66 L/min (range 43-187 L/min) for pediatric patients. Approximately ninety percent of each population studied generated a PIFR through the device exceeding 60 L/min.

      To use the delivery system, a FORADIL capsule is placed in the well of the AEROLIZER Inhaler, and the capsule is pierced by pressing and releasing the buttons on the side of the device. The formoterol fumarate formulation is dispersed into the air stream when the patient inhales rapidly and deeply through the mouthpiece.



What does Foradil look like?



What are the available doses of Foradil?

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What should I talk to my health care provider before I take Foradil?

Sorry No records found

How should I use Foradil?

FORADIL AEROLIZER is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.

      Long-acting beta-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death (see WARNINGS). Use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

FORADIL capsules should be administered only by the oral inhalation route and only using the AEROLIZER Inhaler (see the accompanying Medication Guide). FORADIL capsules should always be stored in the blister, and only removed IMMEDIATELY BEFORE USE.


What interacts with Foradil?

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What are the warnings of Foradil?

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What are the precautions of Foradil?

Sorry No Records found


What are the side effects of Foradil?

Sorry No records found


What should I look out for while using Foradil?

Because of the risk of asthma-related death and hospitalization, use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (see Warnings – Asthma Related Death).

FORADIL (formoterol fumarate) is contraindicated in patients with a history of hypersensitivity to formoterol fumarate or to any components of this product.

ASTHMA RELATED DEATH

Long-acting beta

-adrenergic agonists, such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.

Because of this risk, use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.


What might happen if I take too much Foradil?

The expected signs and symptoms with overdosage of FORADIL AEROLIZER are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, and insomnia. Metabolic acidosis may also occur. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of FORADIL AEROLIZER.

      Treatment of overdosage consists of discontinuation of FORADIL AEROLIZER together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of FORADIL AEROLIZER. Cardiac monitoring is recommended in cases of overdosage.

      The minimum acute lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 53,000 and 25,000 times the maximum recommended daily inhalation dose in adults and children, respectively, on a mg/m basis). The median lethal oral doses in Chinese hamsters, rats, and mice provide even higher multiples of the maximum recommended daily inhalation dose in humans.


How should I store and handle Foradil?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). For the oral solution, use within 45 days of first opening the bottle.Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). For the oral solution, use within 45 days of first opening the bottle.FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.Prior to dispensing: After dispensing to patient: Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.Keep out of the reach of children.Manufactured by:Novartis Pharma AG, Basle, SwitzerlandDistributed by:Schering Corporation, a subsidiary of MERCK & CO., INC.Whitehouse Station, NJ 08889, USACopyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.All rights reserved.May 2011Additional barcode labeling by:Physicians Total Care, Inc.Tulsa, Oklahoma 74146


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Formoterol fumarate is a long-acting selective beta-adrenergic receptor agonist (beta-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In vitro studies have shown that formoterol has more than 200-fold greater agonist activity at beta-receptors than at beta-receptors. Although beta-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta-receptors are the predominant receptors in the heart, there are also beta-receptors in the human heart comprising 10%-50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta-agonists may have cardiac effects.

      The pharmacologic effects of beta-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

      In vitro tests show that formoterol is an inhibitor of the release of mast cell mediators, such as histamine and leukotrienes, from the human lung. Formoterol also inhibits histamine-induced plasma albumin extravasation in anesthetized guinea pigs and inhibits allergen-induced eosinophil influx in dogs with airway hyper-responsiveness. The relevance of these in vitro and animal findings to humans is unknown.

Non-Clinical Toxicology
Because of the risk of asthma-related death and hospitalization, use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (see Warnings – Asthma Related Death).

FORADIL (formoterol fumarate) is contraindicated in patients with a history of hypersensitivity to formoterol fumarate or to any components of this product.

ASTHMA RELATED DEATH

Long-acting beta

-adrenergic agonists, such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.

Because of this risk, use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see ). Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs.

















In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate.

Use in Surgical Patients:

FORADIL AEROLIZER should not be used to treat acute symptoms of asthma. FORADIL AEROLIZER has not been studied in the relief of acute asthma symptoms and extra doses should not be used for that purpose. When prescribing FORADIL AEROLIZER, the physician should also provide the patient with an inhaled, short-acting beta-agonist for treatment of symptoms that occur acutely, despite regular twice-daily (morning and evening) use of FORADIL AEROLIZER. Patients should also be cautioned that increasing inhaled beta-agonist use is a signal of deteriorating asthma. (See Information for Patients and the accompanying Medication Guide.)

      Formoterol fumarate, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and/or diastolic blood pressure, pulse rate and electrocardiograms have been seen infrequently in individual patients in controlled clinical studies with formoterol. Doses of the related beta-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

      Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

      Clinically significant changes in blood glucose and/or serum potassium were infrequent during clinical studies with long-term administration of FORADIL AEROLIZER at the recommended dose.

      FORADIL AEROLIZER contains lactose, which contains trace levels of milk proteins. Allergic reactions to products containing milk proteins may occur in patients with severe milk protein allergy.

      FORADIL capsules should ONLY be used with the AEROLIZER Inhaler and SHOULD NOT be taken orally.

      FORADIL capsules should always be stored in the blister, and only removed IMMEDIATELY before use.

Long-acting beta

-adrenergic agonists (LABA), including formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death and may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Clinical trials with FORADIL AEROLIZER suggested a higher incidence of serious asthma exacerbations in patients who received FORADIL AEROLIZER than in those who received placebo. (See WARNINGS)

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).