Salmeterol Xinafoate - Diskus (Serevent)

Trade Name : SEREVENT

GlaxoSmithKline LLC

POWDER, METERED

Strength 50 ug/1

SALMETEROL XINAFOATE Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Salmeterol Xinafoate - Diskus (Serevent) which is also known as SEREVENT and Manufactured by GlaxoSmithKline LLC. It is available in strength of 50 ug/1 per ml. Read more

Salmeterol Xinafoate - Diskus (Serevent) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Long-acting beta-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Use of background ICS was not required in this study. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
Use of SEREVENT DISKUS for the treatment of asthma as monotherapy without a concomitant ICS is contraindicated. Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS.
Arrayn- Pediatric and Adolescent Patients
Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of an ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA is recommended.
WARNING: ASTHMA-RELATED DEATH
See full prescribing information for complete boxed warning.

Long-acting beta-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthman- related death. A U.S. trial showed an increase in asthman- related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28u00a0weeks on salmeterol versus 3 out of 13,179 subjects on placebo). When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. ()
Prescribe SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. (, )
Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. ()

SEREVENT DISKUS is a LABA indicated for:
Important limitation of use: Not indicated for relief of acute bronchospasm. (, )

SEREVENT DISKUS should be administered by the orally inhaled route only.
More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) is not recommended as some patients are more likely to experience adverse effects. Patients using SEREVENT DISKUS should not use additional LABA for any reason. n

Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains salmeterol 50 mcg per blister.
Inhalation powder: Inhaler containing salmeterol (50 mcg) as a powder formulation for oral inhalation. ()

Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated .
The use of SEREVENT DISKUS is contraindicated in the following conditions:

No data

LABA, including salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death. Data from a large 28-week placebo-controlled U.S. trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most common adverse reactions (incidence u22655%) are:
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or n

No data

Hepatic impairment: Monitor patients for signs of increased drug exposure. ()

The expected signs and symptoms with overdosage of SEREVENT DISKUS are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). Overdosage with SEREVENT DISKUS can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias.
As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of SEREVENT DISKUS.
Treatment consists of discontinuation of SEREVENT DISKUS together with appropriate symptomatic 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 SEREVENT DISKUS. Cardiac monitoring is recommended in cases of overdosage.

The active component of SEREVENT DISKUS is salmeterol xinafoate, a beta-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-u03b1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure:
Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is CHNOu2022CHO. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.
SEREVENT DISKUS is a teal green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece.
Under standardized in vitro test conditions, SEREVENT DISKUS delivers 47 mcg of salmeterol base per blister when tested at a flow rate of 60u00a0L/min for 2 seconds.
In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min).
The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

No data

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SEREVENT DISKUS is supplied as a disposable teal green plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00).
SEREVENT DISKUS is also supplied in an institutional pack containing 28 blisters (NDC 0173-0520-00).
Store at room temperature between 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C); excursions permitted from 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
SEREVENT DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard SEREVENT DISKUS 6 weeks after opening the foil pouch or when the counter reads u201c0u201d (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Asthma-Related Death
Inform patients that salmeterol when used alone increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Inform patients that SEREVENT DISKUS should not be the only therapy for the treatment of asthma and must only be used as additional therapy when ICS do not adequately control asthma symptoms. Inform patients that when SEREVENT DISKUS is added to their treatment regimen they must continue to use their ICS.
Not for Acute Symptoms
Inform patients that SEREVENT DISKUS is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta-agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.
Instruct patients to seek medical attention immediately if they experience any of the following:
Tell patients they should not stop therapy with SEREVENT DISKUS without physician/provider guidance since symptoms may recur after discontinuation.
Not a Substitute for Corticosteroids
Advise all patients with asthma that they must also continue regular maintenance treatment with an ICS if they are taking SEREVENT DISKUS.
SEREVENT DISKUS should not be used as a substitute for oral or inhaled corticosteroids. The dosage of these medications should not be changed and they should not be stopped without consulting the physician, even if the patient feels better after initiating treatment with SEREVENT DISKUS.
Do Not Use Additional Long-acting Beta-agonists
Instruct patients not to use other LABA.
Immediate Hypersensitivity Reactions
Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of SEREVENT DISKUS. Patients should discontinue SEREVENT DISKUS if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take SEREVENT DISKUS.
Risks Associated with Beta-agonist Therapy
Inform patients of adverse effects associated with beta-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
Treatment of Exercise-Induced Bronchospasm
Patients using SEREVENT DISKUS for the treatment of EIB should not use additional doses for 12 hours. Patients who are receiving SEREVENT DISKUS twice daily should not use additional SEREVENT for prevention of EIB.
Trademarks are owned by or licensed to the GSK group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92020 GSK group of companies or its licensor.
SRD:15PI

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PRINCIPAL DISPLAY PANEL
NDC 0173-0521-00
Arrayn- Serevent Diskus
Arrayn- (salmeterol xinafoate inhalation powder)
Arrayn- 50 mcg
FOR ORAL INHALATION ONLY
Each blister contains 50 mcg of salmeterol base with lactose monohydrate.
Federal Law requires the dispensing of SEREVENT DISKUS with the Medication Guide inside the carton.
See prescribing information for dosing information.
R only
Arrayn- 1 DISKUS Inhalation Device Containing 1 Foil Strip of 60 Blisters
Made in Singapore
u00a92019 GSK group of companies or its licensor.

PRINCIPAL DISPLAY PANEL
NDC 0173-0520-00
Arrayn- Serevent Diskus
Arrayn- (salmeterol xinafoate inhalation powder)
Arrayn- INSTITUTIONAL PACK
50 mcg
FOR ORAL INHALATION ONLY
Each blister contains 50 mcg of salmeterol base with lactose monohydrate.
Federal Law requires the dispensing of SEREVENT DISKUS with the Medication Guide inside the carton.
See prescribing information for dosing information.
R only
Arrayn- 1 DISKUS Inhalation Device Containing 1 Foil Strip of 28 Blisters
Made in Singapore
u00a92019 GSK group of companies or its licensor.

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Salmeterol Xinafoate - Diskus (Serevent)

Trade Name : SEREVENT

POWDER, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Salmeterol Xinafoate - Diskus (Serevent)

Trade Name : SEREVENT

POWDER, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

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Browse from other international pharmaceuticals

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Canadian DIN

Swiss Drugs

NZ Drugs

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