Specification

Flutrol 25/50mcg Inhaler 1?S

?Fluticasone 50 mcg Salmeterol 25 mcg

INTRODUCTION:-
FLUTROL 25/50MCG INHALER is a combination of Fluticasone and Salmeterol which belongs to theroup of medicines called Corticosteroids and Bronchodilators respectively. It is used to treat asthma and chronic obstructive pulmonary disease (COPD) in adults and in children (aged 4 years or above). It also helps in reducing the flare-ups of COPD symptoms.
Use FLUTROL 25/50MCG INHALER every day until your doctor tells you to stop. It is meant for inhalation use only. Do not stop using this medicine once your symptoms subside without consulting your doctor.
FLUTROL 25/50MCG INHALER should not be used to relieve a sudden asthma attack (such as sudden breathing problems). Instead contact your doctor or use a fast-acting ?rescue? inhaler to subside the symptoms.
Before using FLUTROL 25/50MCG INHALER inform your doctor if you have any lung infections, liver problems or heart problems. You must also inform your doctor if you have diabetes, hypertension, fits, overactive thyroid functions, osteoporosis, adrenalland problems or a weak immune system as a precaution.
FLUTROL 25/50MCG INHALER should be used in pregnant or breastfeeding women only if it is considered necessary by the physician. The most common side effects of using FLUTROL 25/50MCG INHALER are headache, cold, oral thrush or oral sores, throat irritation, hoarse voice, muscle pain and joint pain. Contact your doctor if any of these side effect worsens.
USES OF FLUTROL 25/50MCG INHALER:-
It is used in adults and in children (aged 4 years or above) to treat, prevent and manage the symptoms of:
Asthma

Chronic Obstructive Pulmonary Disease (COPD)
HOW FLUTROL 25/50MCG INHALER WORKS:-
FLUTROL 25/50MCG INHALER is a combination of two medicines namely, fluticasone and salmeterol. Fluticasone is an inhalation corticosteroid. It blocks the release of certain chemical messengers in the airways (such as prostaglandins, leukotrienes) that cause inflammation and swelling.
Salmeterol is a bronchodilator. It relaxes the smooth muscles of the airways and widens them. Collectively, they reduce airway inflammation, allows the air to pass through more freely and makes breathing easier.
DIRECTIONS FOR USE:-
Use FLUTROL 25/50MCG INHALER every day until your doctor tells you to stop. It is meant for inhalation use only. Inhale the medicine only through your mouth into the lungs and not via nose.
Closely follow the instructionsiven by your doctor regarding the number of inhalations and dosing intervals.
Prime the device by releasing 2-3 puffs in the air

Place the mouthpiece of the device between your teeth and close your mouth tightly

Breathe in slowly and deeply using your mouth through the mouthpiece while simultaneously pressing the top of the canister firmly to release a puff of medicine

Remove the device from your mouth and hold your breath for about 10 seconds or for as long as is comfortable

Repeat the same steps for further inhalations as well. Wait for about 30 seconds between each puff of medicine
Once inhalation is over, rinse your mouth with water and spit it out or brush your teeth.
Do not start using this medicine unless your doctor or health care provider has taught you how to use and you understand how to use it correctly.
SIDE EFFECTS OF FLUTROL 25/50MCG INHALER:-

COMMON

Headache

Common cold

Thrush in the mouth or throat (a yeast infection that causes sore, creamy-yellow, raised patches)

Sore tongue, hoarse voice, throat irritation

Muscle pain or cramps

Joint pain and swelling

Bruising and fractures

Inflammation of sinuses

Signs of low levels of potassium in blood (such as an uneven heartbeat, muscle weakness or cramps)

UNCOMMON

Diabetes (increased blood sugar levels)

Cataract (cloudy eyes)

Unusually fast or uneven heartbeat, tremor (feeling shaky)

Chest pain

Feeling worried, disturbance in sleep

Allergic skin rash

RARE

Slowing ofrowth in adolescents, bone thinning,laucoma, weightain

Cushing?s Syndrome (a disorder caused due to release of high levels of cortisol)

Changes in behavior (such as being unusually active and irritable)

Fungal infection in the esophagus which causes difficulties in swallowing
Stop using FLUTROL 25/50MCG INHALER and contact your doctor immediately if you experience any of the following side effects:
Severe allergic reactions (such as sudden wheezing, cough, shortness of breath, skin rash, itching, swelling of the face, lips, tongue or throat, breathing difficulties, sudden fast heartbeat which can cause fainting, light-headedness, collapse or even loss of consciousness)

Sign of pneumonia (a lung infection accompanied with fever, chills, increased cough production, increased breathing difficulties, excessive mucus production and change in mucus color)
HOW TO MANAGE SIDE EFFECTS:-

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Throat irritation:

Gargle your throat with salt water twice a day. Always try to drink warm water. Avoid chilled, cooled or sweetened food items or beverages. Drinking turmeric milk oringer tea mixed with honey and pepper powder can ease the soreness. Consult your doctor if the symptom did not improve.

Muscle pain or cramps:

Rub a pain-relieving balm or place a heat pack on the affected area for some time, as it could ease the pain. Do not move the affected area frequently. Try to do some simple movements every day which would improve blood circulation and reduce further incidence of muscle pain. Try to eat a well-balanced protein rich diet, so that it can help to repair and rebuild the damaged muscle. Consult your doctor if the symptom did not improve.

Joint pain:

Rub a pain-relieving balm or place a heat pack on the affected area for some time, as it could ease the pain. Do not move the affected area frequently. Consume calcium and vitamin supplements regularly, particularly if you are elderly. Consult your doctor if the symptom did not improve.

Allergic skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing whenoing outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS:-

PREGNANCY

FLUTROL 25/50MCG INHALER should be used in pregnant women only if it is considered necessary by the doctor. Your doctor may prescribe this medicine after outweighing the risk and benefits to you and your baby. Therefore, inform your doctor before using it.

BREASTFEEDING

FLUTROL 25/50MCG INHALER should be used in breastfeeding women only if it is considered necessary by the doctor. Therefore, consult your doctor for advice before using it.

DRIVING AND USING MACHINES

Do not drive or operate any heavy tools or machines if your ability is affected by FLUTROL 25/50MCG INHALER.

LIVER

FLUTROL 25/50MCG INHALER should be taken with caution in patients with liver diseases. Therefore, consult your doctor before using it.

ALLERGY

Do not use FLUTROL 25/50MCG INHALER if you are allergic to Salmeterol or Fluticasone.

LUNGS

FLUTROL 25/50MCG INHALER should be taken with caution among patients who have or previously had tuberculosis or any other lung infections. Therefore, consult your doctor before using it.

HEART DISEASE

FLUTROL 25/50MCG INHALER should be taken with caution in patients with heart diseases (such as irregular or fast heartbeat). Therefore, consult your doctor before using it.
OTHERS:-
FLUTROL 25/50MCG INHALER is not recommended for use in patients having:
Status asthmaticus (respiratory failure)

Acute asthma attacks
Before using FLUTROL 25/50MCG INHALER, inform your physician if you:
Have an over-active thyroidland

Have diabetes

Have high blood pressure

Have hypokalemia (low levels of potassium in blood)

Have fits (seizure)

Have osteoporosis (weak bones)

Have a weak immune system

Have or had eye problems (such aslaucoma, increased pressure in the eyes, cataracts)

Have viral, bacterial or fungal infections (Ex. measles, chickenpox)

Havelucose intolerance

Have problems in adrenalland (Ex. adrenal insufficiency)

Met with any major trauma (accidents) or undergone a surgery
Use in pediatrics:
FLUTROL 25/50MCG INHALER is not recommended for use in children younger than 4 years of age. Kindly consult your doctor before using it.
Use ineriatrics:
FLUTROL 25/50MCG INHALER should be taken with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before using it. Proper dose adjustments and careful monitoring are required in such patients.
INTERACTIONS:-
A. Drug-Drug interactions:
Before using FLUTROL 25/50MCG INHALER, inform your physician if you are taking any of the following medicines such as:
Other beta-blockers (used to treat high blood pressure or other heart conditions) Ex. atenolol, propranolol and sotalol

Medicines used to treat fungal infection (such as ketoconazole and itraconazole)

Medicines used to treat HIV infection (Ex. ritonavir, atazanavir, indinavir, nelfinavir, saquinavir or cobicistat)

Clarithromycin, erythromycin (used to treat bacterial infections)

Other corticosteroids (taken orally or via injections to treat pain or inflammation) Ex. dexamethasone

Potassium-sparging diuretics (used to treat high blood pressure by increasing urine output) Ex. spironolactone, acetazolamide

Other medicines that can cause bronchodilation (such as salbutamol, formoterol)

Xanthine medicines (used to treat asthma) Ex. theophylline and aminophylline

Nefazodone (used to treat depression)

Medicines used to treat depression such as (rasagiline, selegiline, phenelzine, amitriptyline, nortriptyline, doxepin, imipramine, desipramine)
Overdosage:
If you or anyone else accidentally inhaled excessive amount of this medicine, contact your doctor immediately oro to the hospital straight away. Symptoms of overdosage might include shortness of breath, chest pain, fast heartbeat, feeling shaky, dizziness, headache, muscle weakness and joint pain.
SYNOPSIS:-
Drug :?? Fluticasone, Salmeterol

Pharmacological Category :?? Corticosteroids, Beta-1 receptor agonists

Therapeutic Indication :?? Asthma, COPD

Dosage Forms :?? Autohaler, Blisters, Capsule, Inhalation capsule, Octacaps, Respicaps,?Rotacaps, Trans caps,?Nexcaps, Accuhaler, Inhaler,?Ciphaler, Multihaler

MORE INFORMATION

Keep FLUTROL 25/50MCG INHALER out of reach of children

Store FLUTROL 25/50MCG INHALER at room temperature
FAQs ABOUT FLUTROL 25/50MCG INHALER:-
What is the use of FLUTROL 25/50MCG INHALER?
FLUTROL 25/50MCG INHALER is used to treat asthma and chronic obstructive pulmonary disease (COPD) in adults and in children (aged 4 years or above). It also helps in reducing flare-ups of COPD symptoms.
How FLUTROL 25/50MCG INHALER works in my body?
FLUTROL 25/50MCG INHALER relaxes the smooth muscles of the airways and widens them. It also reduces the inflammation of airway tract. Therefore, it allows the air to pass through more freely and makes breathing easier.
Can FLUTROL 25/50MCG INHALER be used on an asthma attack?
FLUTROL 25/50MCG INHALER is only used to prevent or manage the symptoms of asthma and COPD (such as breathlessness or wheezing). If your asthma or breathingets worse suddenly, contact your doctor immediately oro to the straight away to avoid further exacerbation of the attack. Meanwhile use a fast-acting rescue inhaler containing salbutamol along with this medicine.
Is FLUTROL 25/50MCG INHALER safe?
FLUTROL 25/50MCG INHALER is considered safe at doses prescribed by the physician.
What are the side effects of using FLUTROL 25/50MCG INHALER?
The most common side effects of using FLUTROL 25/50MCG INHALER are headache, cold, oral thrush or oral sores, throat irritation, hoarse voice, muscle pain and joint pain. Contact your doctor if any of these side effect worsens.
Can I stop using FLUTROL 25/50MCG INHALER once my symptoms subside?
No. Use FLUTROL 25/50MCG INHALER every day until your doctor tells you to stop. Do not stop using this medicine abruptly or reduce the dose without consulting your doctor, as it could make your breathing even worse. Your doctor will access your disease condition regularly and will increase or decrease the dose accordingly.
Will FLUTROL 25/50MCG INHALER more effective if taken at higher doses?
Always consume the dose prescribed for you by your physician. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and severity of the disease. Do not take a higher dose of this medicine without consulting your doctor as it could lead to unwanted side effects. It your symptoms are not relieved by the prescribed dose, consult your doctor so that he might adjust the dose according to your health condition or can suggest an alternative therapy.
I?m pregnant. Can I use FLUTROL 25/50MCG INHALER?
FLUTROL 25/50MCG INHALER should be used in pregnant women only if it is considered necessary by the physician. Your doctor will prescribe you with FLUTROL 25/50MCG INHALER after evaluating the risks and benefits of the therapy.
Can FLUTROL 25/50MCG INHALER be used in children?
FLUTROL 25/50MCG INHALER is considered safe for use in children (aged 4 years or above). However, it is not recommended for use in children younger than 4 years due to lack of safety data. Kindly consult your doctor before taking.
How long will it take for FLUTROL 25/50MCG INHALER to relieve the symptoms and how long the effects can last?
Generally, FLUTROL 25/50MCG INHALER takes about 10-15 minutes to relieve the symptoms of asthma or COPD. However, the onset of action slightly differs from person to person based upon their disease condition. The effects of FLUTROL 25/50MCG INHALER can last for 12-18 hours, because salmeterol present in this medicine is considered as a longer-acting beta-1 adrenergic agonist.
Can FLUTROL 25/50MCG INHALER cause infection in the mouth?
Yes. FLUTROL 25/50MCG INHALER may cause fungal infections of the mouth (oral thrush). To avoid this, make sure to rinse your mouth with water after inhaling the medicine. However, if an infection develops, consult your doctor.
What happens when you forget to use FLUTROL 25/50MCG INHALER?
If you forget to use FLUTROL 25/50MCG INHALER, use it as soon as you remember. However, if it?s time for the next dose, skip the missed dose and take the next dose. Do not use a double dose to compensate the missed dose.
Can FLUTROL 25/50MCG INHALER be used if you have an infection?
Inform your doctor if you have any bacterial, fungal or viral infection before using FLUTROL 25/50MCG INHALER. Your doctor will evaluate your existing health condition and advise changes in treatment accordingly. Also, inform your doctor if have exposure to an infectious environment or with a person with infectious diseases, as FLUTROL 25/50MCG INHALER may mask your symptoms of the infection.
REFERENCES-
1. KD. Tripathi. Drugs for Cough and Bronchial Asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 221-224 & 230-233.
2.?Monikaappa,?Wolfgang Zachgo,?Andrea von Berg,?Wolfgang Kamin,?Catrin Stern-Str?ter,?Gratiana Steinkamp,?VIAPAED Studyroup. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 2009. [Accessed on 16th November 2022]?https://pubmed.ncbi.nlm.nih.gov/19824054/
3.?Stephen J Fowler,?Graeme P Currie,?Brian J Lipworth. Step-down therapy with low-dose fluticasone-salmeterol combination or medium-dose hydrofluoroalkane 134a-beclomethasone alone. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. June 2002. [Accessed on 16th November 2022]?https://pubmed.ncbi.nlm.nih.gov/12063520/
4.?G P Currie,?N J Syme-Grant,?L C McFarlane,?F A Carey,?B J Lipworth. Effects of low dose fluticasone/salmeterol combination on surrogate inflammatory markers in moderate persistent asthma. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July 2003 [Accessed on 16th November 2022]?https://pubmed.ncbi.nlm.nih.gov/12823118/
5.?Rashmi Mehta, Kylie Riddell, Ashutoshupta, Margaret Louey. Comparison of the Pharmacokinetics of Salmeterol and Fluticasone Propionate 50/100 ?g Delivered in Combination as a Dry Powder Via a Capsule-Based Inhaler and a Multi-Dose Inhaler. ScienceDirect. March 2015. [Accessed on 16th November 2022]?https://www.researchgate.net/publication/274089299_Comparison_of_the_Pharmacokinetics_of_Salmeterol_and_Fluticasone_Propionate_50100_g_Delivered_in_Combination_as_a_Dry_Powder_Via_a_Capsule-Based_Inhaler_and_a_Multi-Dose_Inhaler
6.?Xiaofen Jin, Lianfang Wu, Ji Wang and?Malong Feng. The comparison of fluticasone propionate/formoterol with fluticasone propionate/salmeterol for paediatric asthma: a meta-analysis of randomized controlled trials. NCBI; PMC US National Library of Medicine, National Institute of Health. June 2021. [Accessed on 16th November 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8330866/
7.laxo Wellcome Production. Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 16th November 2022]?https://www.medicines.org.uk/emc/files/pil.5504.pdf
8. Cipla Ltd. SEROFLO Rotacaps?(Salmeterol Fluticasone propionate). Ciplamed.com. [Revised in August 2020]. [Accessed on 16th November 2022]?https://www.ciplamed.com/content/seroflo-rotacaps
9. Cipla Ltd. SEROFLO Inhaler?(Salmeterol Fluticasone propionate). Ciplamed.com. [Revised in March 2020]. [Accessed on 16th November 2022]?https://www.ciplamed.com/content/seroflo-inhaler
10.laxoSmithKline. U.S. Food & Drug Administration. [Accessed on 16th November 2022]?https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf
USEFUL DIAGNOSTIC TESTS:-
Absolute eosinophil count

Complete blood count

VIDEOS

Fluticasone Salmeterol INHALER ? Drug Information
Fluticasone Salmeterol INHALER : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage
PRODUCT DETAILS:-
Net Qty

1 N
Item Weight

40
Ingredient

Fluticasone 50MCG Salmeterol 25MCG
Hsn Code

30049099

Additional information

Weight
40 g

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