Fluticasone and Salmeterol
(floo tik' a sone) (sal me' te role)
P Â - Caution when used during pregnancy
L Â - Caution when used during lactation
|Indication & Dosage||Inhalation
Adult:Â As combination containing salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg/dose of inhalation powder: 1 inhalation bid. As combination containing salmeterol 25 mcg and fluticasone propionate 50/125/250 mcg/dose of pressurised inhalation: 2 inhalation bid.
Child:Â 4-12 yr: As combination containing salmeterol 50 mcg and fluticasone propionate 100 mcg/ dose of inhalation powder: 1 inhalation bid; as combination containing salmeterol 25 mcg and fluticasone propionate 50 mcg/dose of pressurised inhalation: 2 inhalation bid. â‰¥12 yr: As combination containing salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg/dose of inhalation powder: 1 inhalation bid; as combination containing salmeterol 50/125/250 mcg and fluticasone propionate 50 mcg/dose of pressurised inhalation: 2 inhalation bid.
ChronicÂ obstructive pulmonary disease
Adult:Â As combination containing salmeterol 50 mcg and fluticasone propionate 500 mcg/dose of inhalation powder: 1 inhalation bid.
|Administration||May be taken with or without food.
|Contraindications||Not for primary treatment of status asthmaticus or other acute attacks of asthma.|
|Special Precautions||Pulmonary TB, severe cardiovascular disorders, heart rhythm abnormalities, DM, thyrotoxicosis, hypokalaemia. Patients at risk of decreased bone mineral content (e.g. smoking, old age, sedentary lifestyle, poor nutrition, family history of osteoporosis or long term use of drugs that may decrease bone mass (e.g. anticonvulsants and corticosteroids). Do not stop therapy abruptly; therapy should be down titrated. Advise patient to rinse mouth after inhalation. Monitor height of children on prolonged therapy. Pregnancy, lactation.|
|Adverse Drug Reactions||Mouth and throat candidiasis, throat irritation,
hoarseness/dysphonia, nasopharyngitis, lower respiratory tract infections (e.g. pneumonia and bronchitis), hypokalaemia, headache, tremors, palpitation,
muscle cramps. Prolonged high dose use may cause Cushing's syndrome, Cushingoid features, adrenal suppression, retardation of growth in children and
adolescents, bone mineral density decrease, cataract and glaucoma.
Potentially Fatal:Â Paradoxical bronchospasm.
|Drug Interactions||Increased fluticasone levels with CYP 3A4 inhibitors e.g ritonavir, ketoconazole, itraconazole. Additive effects with other Î²-agonist.Â Please consult detailed drug interactions before prescribing.|
|Pregnancy Category (US FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Inhalation:Â Do not store >30 Â°C.|
|Pharmacology||Salmeterol, a long acting Î²2-agonist
which acts locally in the lung to mediate bronchodilation. Fluticasone, a corticosteroid with mainly glucocorticoid activity, reduce symptoms and
exacerbations of asthma.
Onset:Â Bronchodilation: 10-20 minutes.
Duration:Â Bronchodilation: 12 hr
Absorption:Â Salmeterol: Negligible absorption after inhalation. Fluticasone: Poorly absorbed from the GI tract; oral bioavailability <1%; absolute bioavailability of inhaled fluticasone: 5-11% (depending on device used).
Distribution:Â Salmeterol: Protein binding: 96%. Fluticasone: Protein binding: 91%.
Metabolism:Â Salmeterol: Extensive hepatic metabolism by hydroxylation; terminal elimination half-lives: 5.5 hr. Fluticasone: Extensive first-pass metabolism by cytochrome CYP3A4.
Excretion:Â Salmeterol: Eliminated mainly in faeces; negligible amounts of unchanged salmeterol are detectable in urine or faeces. Fluticasone: Mainly excreted in faeces as metabolites and unchanged drug; <5% excreted in urine.
|ATC Classification||R03AC12 - salmeterol ; Belongs to the class of adrenergic
inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.Â
R03BA05 - fluticasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticooids.Â
D07AC17 - fluticasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.Â
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used as nasal decongestants.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|AROFLO-125 HFA||Aristopharma Ltd.||Salmeterol xinafoate INN 25mcg + fluticasone porpionate BP 125mcg||Inhaler (MDI)||120 MDI: 595.00 MRP|
|AROFLO-250 HFA||Aristopharma Ltd.||Salmeterol xinafoate INN 25mcg + fluticasone propionate BP 250mcg||Inhaler (MDI)||120 & 60 MDI: 795.00 & 430.00 MRP|
|AROFLO-50 HFA||Aristopharma Ltd.||Salmeterol xinafoate INN 25mcg + Fluticasone porpionate BP 50mcg||Inhaler (MDI)||120 MDI: 520.00 MRP|
|AROTIDE 25/125 INHALER||Eskayef Bangladesh Ltd||Salmeterol Xinafoate INN 25mcg + Fluticasone Porpionate BP 125mcg||Inhaler (MDI)||120 MDI, MRP: 575.00|
|AROTIDE 25/250 INHALER||Eskayef Bangladesh Ltd||Salmeterol xinafoate INN 25mcg + fluticasone propionate BP 250mcg||Inhaler (MDI)||120 MDI, MRP: 750.00|
|AXINAT-F Inhaler 125||The Acme Laboratories Ltd.||Salmeterol xinafoate INN 25mcg + Fluticasone porpionate BP 50mcg||Inhaler (MDI)||120 MDI: 577.16 MRP|
|AXINAT-F Inhaler 250||The Acme Laboratories Ltd.||Salmeterol xinafoate INN 25mcg + fluticasone porpionate BP 125mcg||Inhaler (MDI)||120 MDI: 752.83 MRP|
|BEXITROL F 25/250 Dose counter inhaler||Beximco Pharmaceuticals Ltd||Salmeterol 25mcg + Fluticasone propionate 250mcg||Metered Dose Inhaler||120MD: 895.00 MRP|
|BEXITROL F HFA25/125||Beximco Pharmaceuticals Ltd||Salmeterol 25mcg + fluticasone porpionate 125mcg||Metered Dose Inhaler||120MD: 595.00 MRP|
|BEXITROL F HFA25/250||Beximco Pharmaceuticals Ltd||Salmeterol 25mcg + fluticasone propionate 250mcg||Metered Dose Inhaler||120MD: 795.00 MRP|
|BEXITROL F HFA25/50||Beximco Pharmaceuticals Ltd||Salmeterol 25mcg + fluticasone propionate 50mcg||Metered Dose Inhaler||120MD: 520.00 MRP|
|BEXITROL F HFA60||Beximco Pharmaceuticals Ltd||Salmeterol 25mcg + fluticasone porpionate 250mcg||Metered Dose Inhaler||60MD: 430.00 MRP|
|BEXITROL F50/100||Beximco Pharmaceuticals Ltd||Salmeterol 5mcg + fluticasone propionate 100mcg||Metered Dose Inhaler||30's: 145.50 MRP|
|BEXITROL F50/250||Beximco Pharmaceuticals Ltd||Salmeterol 5mcg+ fluticasone porpionate 250mcg||Metered Dose Inhaler||30's: 276.00 MRP|
|BEXITROL F50/500||Beximco Pharmaceuticals Ltd||Salmeterol 5mcg + fluticasone porpionate 500mcg||Metered Dose Inhaler||30's: 450.00 MRP|
|BEXITROL Inhaler||Beximco Pharmaceuticals Ltd||Salmeterol 25mcg||Metered Dose Inhaler||200 MD: 190.00 MRP|
|SALFLU 100 Inhaler||The Acme Laboratories Ltd.||Salmeterol xinafoate INN 50mcg+ Fluticasone propionate BP 100mcg/actuation||Inhaler (DPI)||30's: 142.80 MRP|
|SALFLU 250 Inhaler||The Acme Laboratories Ltd.||Salmeterol xinafoate INN 50mcg+ Fluticasone propionate BP 250mcg/actuation||Inhaler (DPI)||30's: 271.20 MRP|
|SALFLU 500 Inhaler||The Acme Laboratories Ltd.||Salmeterol xinafoate INN 50mcg+ Fluticasone propionate BP 500mcg/actuation||Inhaler (DPI)||30's: 451.50 MRP|
|SERETIDE 100 Accuhaler (DPI)||GlaxoSmithKline Bangladesh Limited||Salmeterol xinafoate INN 60mcg + Fluticasone porpionate BP 100mcg||Accuhaler||60 doses unit: 918.00 MRP|
|SERETIDE 125 Evohaler (MDI)||GlaxoSmithKline Bangladesh Limited||Salmeterol xinafoate INN 25mcg+ Fluticasone propionate BP 125mcg/Evohaler||Evohaler||120 doses unit: 1000.00 MRP|
|SERETIDE 250 Accuhaler (DPI)||GlaxoSmithKline Bangladesh Limited||Salmeterol xinafoate INN 60mcg + fluticasone porpionate BP 250mcg||Accuhaler||60 doses unit: 1029.00 MRP|
|SERETIDE 250 Evohaler (MDI)||GlaxoSmithKline Bangladesh Limited||Salmeterol xinafoate INN 25mcg+ Fluticasone propionate BP 250mcg/Evohaler||Evohaler||120 doses unit: 1250.00 MRP|
|SERETIDE 50 Evohaler (MDI)||GlaxoSmithKline Bangladesh Limited||Salmeterol xinafoate INN 25mcg+ Fluticasone propionate BP 50mcg/Evohaler||Evohaler||120 doses unit: 750.00 MRP|
|SERETIDE 500 Accuhaler (DPI)||GlaxoSmithKline Bangladesh Limited||Salmeterol xinafoate INN 60mcg + fluticasone porpionate BP 500mcg||Accuhaler||60 doses unit: 1203.00 MRP|
|SEROXYN 25/125 Inhaler||ACI Ltd.||Salmeterol xinafoate INN 25mcg+ Fluticasone propionate BP 125mcg/actuation||Inhaler (MDI)||120 MDI: 577.17 MRP|
|SEROXYN 25/250 Inhaler||ACI Ltd.||Salmeterol xinafoate INN 25mcg+ Fluticasone propionate BP 250mcg/actuation||Inhaler (MDI)||120 MDI: 752.83 MRP|
|TICAMET 100||Square Pharmaceuticals Ltd.||Salmeterol + Fluticasone 50 mcg + 100 mcg||Cozycap||5x6's: 195.60 MRP|
|TICAMET 125||Square Pharmaceuticals Ltd.||Salmeterol + Fluticasone (25 mcg + 125 mcg)/puff||HFA Inhaler (CFC-Free)||120 puffs: 596.79 MRP|
|TICAMET 250||Square Pharmaceuticals Ltd.||Salmeterol + Fluticasone (25 mcg + 250 mcg)/puff||HFA Inhaler (CFC-Free)||120 puffs: 797.39 MRP|
|TICAMET 250 COZYCAP||Square Pharmaceuticals Ltd.||Salmeterol + Fluticasone 50 mcg + 100 mcg||Cozycap||5x6's: 360.90 MRP|
|TICAMET 50||Square Pharmaceuticals Ltd.||Salmeterol + Fluticasone (25 mcg + 50 mcg)/puff||HFA Inhaler (CFC-Free)||120 puffs: 521.57 MRP|
In a large clinical study, more patients with asthma who used salmeterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients with asthma who did not use salmeterol. If you have asthma, use of salmeterol may increase the risk that you will develop serious or fatal asthma problems. There is not enough information available to tell whether inhaling fluticasone with salmeterol increases, decreases, or does not change this risk.
Your doctor will only prescribe fluticasone and salmeterol if your asthma is so severe that two medications are needed to control it.You will never use salmeterol alone; you must always use it along with another asthma controller medication such as fluticasone. Children and teenagers who need to be treated with salmeterol will probably be treated with a combination product that combines salmeterol and another medication such as fluticasone in a single inhaler to make it easier for them to use both medications as prescribed.
Because of the risks of using salmeterol, you should only use fluticasone and salmeterol as long as both medications are needed to bring your asthma symptoms under control. Once your asthma is controlled, your doctor will probably tell you to stop using salmeterol but continue using fluticasone or another asthma medication. Your doctor will probably prescribe a different inhaler that contains only one medication to use instead of the fluticasone and salmeterol combination inhaler.
Do not use fluticasone and salmeterol if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately:
Talk to your doctor about the risks of using this medication.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluticasone and salmeterol and each time you refill your prescription. Read the information carefully and ask your doctor if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Why is this medication prescribed?
The combination of fluticasone and salmeterol is used to prevent wheezing, shortness of breath, coughing, and chest tightness caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
How should this medicine be used?
The combination of fluticasone and salmeterol comes as a powder to inhale by mouth using a specially designed inhaler. It is usually used twice a day, in the morning and evening, about 12 hours apart. Use fluticasone and salmeterol at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Use fluticasone and salmeterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Talk to your doctor about how you should take your other oral or inhaled medications for asthma during your treatment with salmeterol and fluticasone inhalation. If you were using a short-acting beta agonist inhaler such as albuterol (Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications or stop taking any of your medications without talking to your doctor.
Do not use fluticasone and salmeterol during an attack of asthma or COPD. Your doctor will prescribe a short-acting inhaler to use during attacks.
Fluticasone and salmeterol inhalation controls asthma and COPD but does not cure these conditions. It may take a week or longer before you feel the full benefit of fluticasone and salmeterol. Continue to use fluticasone and salmeterol even if you feel well. Do not stop using fluticasone and salmeterol without talking to your doctor. If you stop using fluticasone and salmeterol inhalation, your symptoms may return.
Before you use fluticasone and salmeterol inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.
To use the inhaler, follow these steps:
If you will be using a new inhaler for the first time, remove it from the box and the foil wrapper. Fill in the blanks on the inhaler label with the date that you opened the pouch and the date 1 month later when you must replace the inhaler.
Hold the inhaler in one hand, and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.
Hold the inhaler in a level, horizontal position with the mouthpiece toward you. Slide the lever away from you as far as it will go until it clicks.
Every time the lever is pushed back, a dose is ready to inhale. You will see the number in the dose counter go down. Do not waste doses by closing or tilting the inhaler, playing with the lever, or advancing the lever more than once.
Hold the inhaler level and away from your mouth, and breathe out as far as you comfortably can.
Keep the inhaler in a level, flat position. Put the mouthpiece to your lips. Breathe in quickly and deeply though the inhaler, not through your nose.
Remove the inhaler from your mouth, and hold your breath for 10 seconds or as long as you comfortably can. Breathe out slowly.
You will probably taste or feel the salmeterol powder released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of fluticasone and salmeterol, call your doctor or pharmacist.
Rinse your mouth with water, but do not swallow.
Put your thumb on the thumbgrip and slide it back toward you as far as it will go. The inhaler will click shut.
Never exhale into the inhaler, take the inhaler apart, or wash the mouthpiece or any part of the inhaler. Keep the inhaler dry. Do not use the inhaler with a spacer.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor for more information.
What special precautions should I follow?
Before using fluticasone and salmeterol,
- tell your doctor if you are allergic to fluticasone, salmeterol, any other medications, milk protein, or any foods.
- tell your doctor if you use another LABA such as formoterol or salmeterol. These medications should not be used with fluticasone and salmeterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using.
- tell your doctorÂ what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole, itraconazole, and ketoconazole; beta-blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol; cimetidine; clarithromycin; cyclosporine; danazol; delavirdine; diltiazem; diuretics; fluoxetine; fluvoxamine; HIV protease inhibitors such as atazanavir, indinavir, nelfinavir, ritonavir, and saquinavir; isoniazid; other medications for asthma or COPD; medications for seizures; metronidazole; nefazodone; oral contraceptives; telithromycin; troleandomycin; verapamil; and zafirlukast. Also tell your doctorÂ if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine; and monoamine oxidase Â inhibitors, including isocarboxazid, phenelzine, selegiline, and tranylcypromine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become weak and fragile), and if you have or have ever had high blood pressure, irregular heartbeat, seizures, hyperthyroidism (overactive thyroid), diabetes, tuberculosis (TB), glaucoma (an eye disease), any condition that affects your immune system, liver disease, or heart disease. Also tell your doctor if you have a herpes eye infection or any other type of infection and if you smoke or use tobacco products, if you do not eat a healthy diet, or if you do not exercise very often.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluticasone and salmeterol, call your doctor.
- if you are having surgery, including dental surgery, tell your doctor or dentist that you are using fluticasone and salmeterol.
- tell your doctor if you have never had chickenpox or measles and have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medication.
What should I do if I forget a dose?
Skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.
What side effects can this medication cause?
Fluticasone and salmeterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
muscle and bone pain
red or dry eyes
shaking of a part of your body that you cannot control
- sleep problems
Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately:
coughing, wheezing, or chest tightness that begins soon after you inhale fluticasone and salmeterol
swelling of the face, throat, tongue, lips, hands, feet, ankles, or lower legs
choking or difficulty swallowing
noisy, high-pitched breathing
pounding fast, or irregular heartbeat
burning or tingling in the hands or feet
white patches in the mouth
fever, chills, and other signs of infection
Fluticasone and salmeterol may cause children to grow more slowly. Your child's doctor will monitor your child's growth carefully. Talk to your child's doctor about the risks of giving this medication to your child.
Fluticasone and salmeterol may increase the risk that you will develop glaucoma, cataracts, or osteoporosis. You will probably need to have regular eye exams and bone tests during your treatment with fluticasone and salmeterol. Talk to your doctor about the risks of using this medication.
Fluticasone and salmeterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Throw away the inhaler 1 month after you remove it from the foil overwrap or after every blister has been used (when the dose indicator reads 0), whichever comes first. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose,Â consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
fast, pounding, or irregular heartbeat
shaking of a part of your body that you cannot control
muscle cramps or weakness
lack of energy
difficulty falling asleep or staying asleep
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref:Â Â U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.