INTRODUCTION

COMBITIDE 500MCG OCTACAPS is a combination of Fluticasone and Salmeterol which belongs to the group of medicines called Corticosteroids and Bronchodilators respectively. It is used to treat asthma and chronic obstructive pulmonary disease (COPD). It also helps in reducing the flare-ups of COPD symptoms.

Asthma is a long-term respiratory disease in which your airways become inflamed, swollen and narrowed. It also causes excessive mucous secretion in the airways which makes it difficult for the air to pass through, leading to unpleasant symptoms like wheezing, difficulty in breathing, chest pain and/or cough.

COPD is a lung disease characterized by chronic lung inflammation and obstructed air flow within the airways. It causes wheezing, breathing difficulties, cough with mucus production and chest pain.

Use COMBITIDE 500MCG OCTACAPS every day until your doctor tells you to stop. It is meant for inhalation use only and therefore do not the swallow the medicine. Do not stop using this medicine once your symptoms subside without consulting your doctor. It is suitable for use both in adults and in adolescents (aged 12 years or above).

COMBITIDE 500MCG OCTACAPS 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 containing salbutamol to subside the symptoms.

Before using COMBITIDE 500MCG OCTACAPS 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, adrenal gland problems or a weak immune system as a precaution.

COMBITIDE 500MCG OCTACAPS should be used in pregnant and breastfeeding women only if it is considered necessary by the physician. The most common side effects of using COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS

It is used to treat, prevent and manage the symptoms of:

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

HOW COMBITIDE 500MCG OCTACAPS WORKS

COMBITIDE 500MCG OCTACAPS is a combination of two medicines namely, fluticasone and salbutamol. 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 COMBITIDE 500MCG OCTACAPS every day until your doctor tells you to stop. It is meant for inhalation use only. Do not swallow this medicine.

Only use this medicine along with a suitable inhalation device that is recommended by your doctor. Do not stop using this medicine once your symptoms subside without consulting your doctor.

Follow the instruction given in the enclosed leaflet.

• Hold the device vertically
• Insert the capsule into the capsule chamber or into the hole present in the device
• To release the dry powder from the capsule, adjust the device (either rotate the base of the device or press the button meant for piercing the capsule) according to information given in the enclosed leaflet or the type of the device used
• Breathe out completely and place the mouthpiece between your teeth
• Close your mouth tightly around the mouthpiece and slightly tilt your head backwards
• Breath in through your mouth deeply and rapidly
• Hold your breath for 10 seconds or for as long as is comfortable and then breathe out normally
• If the emptied powder is not completely inhaled, once again breath in through your mouthpiece
• After inhalation, wipe the mouthpiece with a dry tissue and close the device after use
• Once inhalation is over, rinse your mouth with water and spit it out or brush your teeth

Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. 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 COMBITIDE 500MCG OCTACAPS

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 or ginger 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 when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

PREGNANCY

COMBITIDE 500MCG OCTACAPS 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

COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS.

LIVER

COMBITIDE 500MCG OCTACAPS should be taken with caution in patients with liver diseases. Therefore, consult your doctor before using it.

ALLERGY

Do not use COMBITIDE 500MCG OCTACAPS if you are allergic to Salmeterol or Fluticasone.

LUNGS

COMBITIDE 500MCG OCTACAPS should be taken with caution among patients who have or previously had any Tuberculosis or any other lung infections. Therefore, consult your doctor before using it.

HEART DISEASE

COMBITIDE 500MCG OCTACAPS should be taken with caution in patients with heart diseases (such as irregular or fast heartbeat). Therefore, consult your doctor before using it.

INTERACTIONS

A. Drug-Drug interactions:

Before using COMBITIDE 500MCG OCTACAPS, 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 or go 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

MORE INFORMATION

• Keep COMBITIDE 500MCG OCTACAPS out of reach of children
• Store COMBITIDE 500MCG OCTACAPS at room temperature

FAQs ABOUT COMBITIDE 500MCG OCTACAPS

What is the use of COMBITIDE 500MCG OCTACAPS?

COMBITIDE 500MCG OCTACAPS is used to treat asthma and chronic obstructive pulmonary disease (COPD). It also helps in reducing flare-ups of COPD symptoms.

How COMBITIDE 500MCG OCTACAPS works in my body?

COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS be used on an asthma attack?

COMBITIDE 500MCG OCTACAPS is only used to prevent or manage the symptoms of asthma and COPD (such as breathlessness or wheezing). If your asthma or breathing gets worse suddenly, contact your doctor immediately or go 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 COMBITIDE 500MCG OCTACAPS safe?

COMBITIDE 500MCG OCTACAPS is considered safe at doses prescribed by the physician.

What are the side effects of using COMBITIDE 500MCG OCTACAPS?

The most common side effects of using COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS once my symptoms subside?

No. Use COMBITIDE 500MCG OCTACAPS every day until your doctor tells you to stop. Do not stop taking 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 COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS?

COMBITIDE 500MCG OCTACAPS should be used in pregnant women only if it is considered necessary by the physician. Your doctor will prescribe you with COMBITIDE 500MCG OCTACAPS after evaluating the risks and benefits of the therapy.

Can COMBITIDE 500MCG OCTACAPS be used in children?

COMBITIDE 500MCG OCTACAPS is considered safe for use in children and adolescents aged 12 years or above. However, it is not recommended for use in children younger than 12 years due to lack of safety data. Kindly consult your doctor before taking.

How long will it take for COMBITIDE 500MCG OCTACAPS to relieve the symptoms and how long the effects can last?

Generally, COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS can last for 12-18 hours, because salmeterol present in this medicine is considered as a longer-acting beta-1 adrenergic agonist.

Can COMBITIDE 500MCG OCTACAPS cause infection in the mouth?

Yes. COMBITIDE 500MCG OCTACAPS 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 COMBITIDE 500MCG OCTACAPS?

If you forget to use COMBITIDE 500MCG OCTACAPS, 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 COMBITIDE 500MCG OCTACAPS be used if you have an infection?

Inform your doctor if you have any bacterial, fungal or viral infection before using COMBITIDE 500MCG OCTACAPS. 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 COMBITIDE 500MCG OCTACAPS 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. Robert Chan, Ana R Sousa, Peter Hynds , Farshid Homayoun-Valiani, Dawn Edwards, Maggie Tabberer. Assessment of the efficacy and safety of fluticasone propionate and salmeterol delivered as a combination dry powder via a capsule-based inhaler versus a multi-dose inhaler in patients with chronic obstructive pulmonary disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 2017. [Accessed on 16th November 2022] https://pubmed.ncbi.nlm.nih.gov/28115223/#article-details

3. Rashmi Mehta, Peter T.Daley-Yates, Kevin Jenkins, Joseph Bianco, Anastasia Stylianou, Margaret D. Louey, Robert H. Chan.  Pharmacokinetics of fluticasone propionate and salmeterol delivered as a combination dry powder via a capsule-based inhaler and a multi-dose inhaler. Pulmonary Pharmacology and Therapeutics. ScienceDirect. October 2014. [Accessed on 16th November 2022] https://www.sciencedirect.com/science/article/abs/pii/S1094553914000820

4. Jinming Gao and Roy A Pleasants. Role of the fixed combination of fluticasone and salmeterol in adult Chinese patients with asthma and COPD. NCBI; PMC US National Library of Medicine, National Institute of Health. April 2015. [Accessed on 16th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4403740/

5. Christopher J Cates and Toby J Lasserson. Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2010. [Accessed on 16th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4015852/

6. Orion Corporation. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 16th November 2022] https://www.medicines.org.uk/emc/files/pil.9224.pdf

7. Cipla (EU) limited. Electronic Medicines Compendium (EMC). [Revised in June 2022] [Accessed on 16th November 2022] https://www.medicines.org.uk/emc/files/pil.10146.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. Teva Pharmaceuticals Europe B.V. European Medical Agency. [Accessed on 16th November 2022] https://www.ema.europa.eu/en/documents/product-information/aerivio-spiromax-epar-product-information_en.pdf

10. Central Drugs Standard Control Organization. Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation. Salmeterol xinafoate + fluticasone propionate. [Accessed on 16th November 2022] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Absolute eosinophil count
• Complete blood count

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 17 Nov 2022 | 06:42 PM(IST)