Foracort G Inhaler

FORACORT G Inhaler by Cipla Ltd.

FORACORT G Inhaler is a combination medication designed for the long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults. It is not intended for the relief of acute asthma or sudden breathing problems.

Composition

Each actuation delivers:

• Budesonide IP: 200 mcg (an inhaled corticosteroid)
• Glycopyrronium (as Glycopyrrolate IP): 12.5 mcg (a long-acting muscarinic antagonist)
• Formoterol Fumarate Dihydrate IP: 6 mcg (a long-acting beta2-adrenergic agonist) The active ingredients are suspended in propellant HFA134a.

Uses

FORACORT G Inhaler is prescribed for:

• Long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).
• Improving lung function by reducing airway inflammation and relaxing the muscles around the airways.
• Decreasing symptoms such as shortness of breath, wheezing, and chest tightness.
• Prevention of COPD symptom flare-ups.

Dosage and Administration

The recommended dose is two inhalations twice daily (morning and evening). Each two-inhalation dose delivers Budesonide 400 mcg, Glycopyrronium 25 mcg, and Formoterol Fumarate 12 mcg. Patients should not take more than two inhalations twice daily. After inhalation, rinse the mouth thoroughly with water and spit it out to help reduce the risk of oral candidiasis (thrush). This medicine is for inhalation use only and may be used with a spacer device.

Side Effects

Common Side Effects:

• Oral candidiasis (thrush)
• Headache
• Dry mouth
• Throat irritation, hoarseness
• Nausea
• Muscle spasms
• Upper respiratory tract infection

Serious Side Effects:

• Chest pain or irregular heartbeat
• Worsening breathing problems (paradoxical bronchospasm)
• High blood pressure
• Eye pain or vision changes
• Signs of infection (fever, chills)

Precautions

• FORACORT G Inhaler is not for acute relief of bronchospasm or acutely deteriorating COPD.
• Caution is advised in patients with cardiovascular disorders, narrow-angle glaucoma, urinary retention, or diabetes mellitus.
• Discuss any liver or kidney problems with your doctor before use.
• Avoid or limit alcohol consumption while using this medicine.
• Drug interactions may occur with beta-blockers, CYP3A4 inhibitors (e.g., ketoconazole, ritonavir), diuretics, monoamine oxidase inhibitors, and tricyclic antidepressants.
• The safety and efficacy of FORACORT G Inhaler have not been established in children.
• Pregnant or breastfeeding individuals should consult their doctor before using this medicine.

Storage

Store FORACORT G Inhaler at room temperature, away from moisture and heat. Do not freeze. Keep out of the reach of children and pets.

FORACORT G Inhaler, manufactured by Cipla Ltd., is a combination medication primarily used for the long-term management of chronic obstructive pulmonary disease (COPD). It contains three active ingredients: budesonide, glycopyrronium, and formoterol fumarate.

Here are some frequently asked questions about FORACORT G Inhaler:

What is FORACORT G Inhaler used for?

FORACORT G Inhaler is indicated for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It helps to improve lung function, reduce airway inflammation, relieve bronchial smooth muscle constriction, and prevent COPD symptom flare-ups such as wheezing, breathlessness, and coughing. It is not intended for the relief of acute symptoms or sudden breathing problems.

How does FORACORT G Inhaler work?

FORACORT G Inhaler combines three active ingredients that work in different ways to improve breathing in COPD.

• Budesonide is an inhaled corticosteroid (ICS) that reduces inflammation in the airways. It works by blocking the release of substances that cause inflammation, thereby decreasing swelling, mucus production, and sensitivity in the airways.
• Glycopyrronium is a long-acting muscarinic antagonist (LAMA) or anticholinergic. It helps relax the muscles around the airways, preventing them from tightening and thus reducing airway constriction.
• Formoterol fumarate is a long-acting beta2-adrenergic agonist (LABA). It stimulates specific receptors in the lungs, causing the bronchial muscles to relax and widen, which improves airflow for approximately 12 hours.

Together, these components provide comprehensive relief from breathing difficulties and improve lung function.

What is the usual dosage for FORACORT G Inhaler?

The recommended dose of FORACORT G Inhaler is two inhalations twice daily, once in the morning and once in the evening. It's important not to exceed two inhalations twice daily. Always follow the dosage prescribed by your doctor. After inhalation, it is recommended to rinse your mouth with water without swallowing.

What are the possible side effects of FORACORT G Inhaler?

Common side effects may include oral candidiasis (a fungal infection in the mouth, also known as thrush), headache, dry mouth, throat irritation, hoarseness, and muscle spasms. Other reported side effects include nausea, upper respiratory tract infection, increased heart rate, and trembling. If oral candidiasis occurs, rinsing your mouth with water after each use can help reduce the risk. Serious side effects, though less common, can include chest pain, irregular heartbeat, worsening breathing problems, high blood pressure, and eye pain or vision changes.

Is FORACORT G Inhaler safe during pregnancy or breastfeeding?

Caution is advised regarding the use of FORACORT G Inhaler during pregnancy and breastfeeding. There are no adequate and well-controlled studies specifically on the combination of budesonide, glycopyrronium, and formoterol in pregnant women. While studies on inhaled budesonide alone have not shown an increased risk of abnormalities, formoterol fumarate has caused structural abnormalities in animal studies at very high doses. For breastfeeding, information on the presence of glycopyrronium or formoterol fumarate in human milk is not available, but budesonide is known to be present in human milk. It is crucial to consult your healthcare provider to weigh the potential benefits against any risks before using this medicine during pregnancy or breastfeeding.

Can FORACORT G Inhaler be taken with other medications?

FORACORT G Inhaler can interact with certain medications.

• Beta-blockers (e.g., propranolol, atenolol) may reduce the effectiveness of formoterol, potentially leading to decreased bronchodilation.
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) can increase the systemic exposure to budesonide, potentially raising the risk of side effects.
• Diuretics (e.g., furosemide, hydrochlorothiazide) may increase the risk of low potassium levels when taken with FORACORT G Inhaler.
• Other anticholinergics (e.g., tiotropium, ipratropium) or other long-acting beta2-agonists (LABAs) should be used with caution or avoided, as they may increase the risk of side effects.
• Monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants can potentiate the effects of adrenergic agonists on the cardiovascular system. Always inform your doctor about all medicines, vitamins, and herbal supplements you are taking.

What precautions should be taken when using FORACORT G Inhaler?

• FORACORT G Inhaler is not for acute asthma attacks or sudden breathing problems; use a short-acting bronchodilator for rescue therapy.
• Rinse your mouth with water after each use to help prevent fungal infections (oral candidiasis).
• Do not exceed the recommended dosage, as excessive use of inhaled sympathomimetic drugs can lead to serious cardiovascular effects.
• Use with caution if you have cardiovascular disorders, narrow-angle glaucoma, urinary retention, or diabetes, as the components may worsen these conditions.
• If your symptoms worsen or your rescue inhaler becomes less effective, contact your doctor immediately.
• Avoid smoking, as it irritates and damages the lungs and can worsen your condition.

What happens if a dose is missed?

If you miss a dose of FORACORT G Inhaler, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten dose.

How should FORACORT G Inhaler be stored?

Store FORACORT G Inhaler at room temperature, generally below 30°C (86°F), and keep it in a dry place, away from direct heat and sunlight. Do not freeze the inhaler. Ensure it is kept out of the reach of children and pets.