Foratec Respules 15 Mcg/2 Ml

What is Foratec Respules 15 Mcg/2 Ml?

Foratec Respules 15 Mcg/2 Ml is a bronchodilator inhalation solution containing Formoterol Fumarate 15 mcg in a 2 mL unit-dose vial (respule) for use with a nebuliser. Formoterol is a long-acting beta-2 adrenergic agonist (LABA) — a class of bronchodilators that relax the muscles in the walls of the airways, making it easier to breathe. Unlike some other LABAs, formoterol also has a relatively rapid onset of action, making it useful for both maintenance treatment and acute symptom relief in select clinical contexts.

Foratec Respules are used primarily in the management of chronic obstructive pulmonary disease (COPD) and asthma, to prevent and relieve bronchospasm (airway narrowing). The respule formulation is designed for nebuliser administration only — the unit-dose vial is opened and the solution is placed into a jet or mesh nebuliser, which converts the liquid into a fine mist that can be inhaled directly into the lungs.

Foratec Respules 15 Mcg/2 Ml are manufactured by Cipla Ltd., one of India’s leading pharmaceutical companies. Each respule (unit-dose vial) contains 2 mL of solution with 15 mcg of formoterol fumarate.

Prescription only (Rx). For nebuliser use only. Use exactly as directed by your doctor or respiratory specialist.

Composition

Component	Detail
Active ingredient	Formoterol Fumarate 15 mcg per 2 mL unit-dose vial
Drug class	Long-acting beta-2 adrenergic agonist (LABA); bronchodilator
Formulation	Solution for nebulisation (inhalation), unit-dose respule
Volume per respule	2 mL
Manufacturer	Cipla Ltd., India
Medicine type	Generic (Rx — prescription required)

About Cipla Ltd.

Cipla Ltd. is one of India’s largest and most internationally recognised pharmaceutical companies, founded in 1935 and headquartered in Mumbai. Cipla is known globally for making high-quality, affordable medicines, particularly in the areas of respiratory care, antiretroviral therapy, and other therapeutic categories. Its manufacturing facilities meet the standards of international regulatory authorities including the US FDA, the UK MHRA, the South African MCC, and the WHO. Cipla’s respiratory portfolio is particularly strong; it was among the first companies to make affordable inhalers accessible to patients in low- and middle-income countries. Cipla is listed on the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE) of India.

How Formoterol Works

Formoterol belongs to the long-acting beta-2 adrenergic agonist (LABA) class of bronchodilators. Its mechanism of action involves the following steps:

• When inhaled, formoterol reaches the bronchial smooth muscle cells lining the airways of the lungs.
• It binds selectively to beta-2 adrenergic receptors (β₂ receptors) on the surface of these smooth muscle cells.
• This binding activates the enzyme adenylate cyclase, which increases intracellular levels of cyclic AMP (cAMP).
• Higher cAMP levels activate protein kinase A, which phosphorylates myosin light-chain kinase and other proteins responsible for smooth muscle contraction — this leads to relaxation of bronchial smooth muscle and widening (dilation) of the airways.
• The result is bronchodilation: narrowed or constricted airways open up, airflow resistance decreases, and breathing becomes easier.
• Formoterol also reduces the release of inflammatory mediators from mast cells and inhibits microvascular leakage in the airway mucosa, contributing to its anti-bronchoconstrictor effects.

Key pharmacokinetic features of formoterol:

• Onset of action: Rapid — bronchodilation begins within 1–3 minutes of inhalation, making formoterol faster-acting than salmeterol (another LABA).
• Duration of action: Up to 12 hours, allowing twice-daily dosing for most indications.
• Beta-2 selectivity: Formoterol is highly selective for beta-2 receptors; at therapeutic doses, cardiovascular (beta-1) effects are minimal but can occur at higher doses.

Indications: When Is Foratec Respules Prescribed?

Foratec Respules 15 Mcg/2 Ml are used for the following conditions:

• Maintenance treatment of COPD (chronic obstructive pulmonary disease): Regular twice-daily nebulisation with formoterol helps maintain airway patency, reduces breathlessness, and improves exercise tolerance in patients with moderate-to-severe COPD. In COPD, formoterol can be used as a standalone bronchodilator without an inhaled corticosteroid (ICS), as part of a single-agent or combination LAMA/LABA/ICS regimen, depending on the stage and phenotype of disease.
• Maintenance treatment of asthma: In patients with persistent asthma already on regular inhaled corticosteroid (ICS) therapy who require additional long-acting bronchodilator control. Important: In asthma, formoterol (like all LABAs) must only be used together with an ICS, never as a sole treatment for asthma.
• Prevention of exercise-induced bronchospasm (EIB): A single dose inhaled prior to exercise can prevent exercise-triggered airway narrowing in susceptible patients.
• Acute bronchospasm relief: Because of its rapid onset, formoterol may be used in some clinical protocols for acute relief of bronchospasm, particularly in patients where a nebulised solution is more appropriate than an MDI (e.g., acutely breathless hospital patients, young children, elderly patients with difficulty using inhalers).

Foratec Respules should be used only for confirmed or clinically suspected bronchospastic airway disease. The choice of formulation, dose, and whether to use it with an ICS should be guided entirely by the treating doctor or respiratory specialist.

Dosage and Administration

Foratec Respules 15 Mcg/2 Ml are for inhalation via nebuliser only. They must not be swallowed, injected, or used with a pressurised metered-dose inhaler (pMDI). Each 2 mL unit-dose vial is designed for a single nebulisation session; any remaining solution after use must be discarded.

How to Use Foratec Respules with a Nebuliser

1. Wash hands thoroughly before use.
2. Twist and pull the top off the unit-dose respule to open it.
3. Squeeze the entire contents of the respule into the nebuliser cup/reservoir of your nebuliser device.
4. Assemble the nebuliser according to the device manufacturer’s instructions, attach the face mask or mouthpiece, and start the nebuliser.
5. Breathe in and out normally (tidal breathing) through the mask or mouthpiece until the nebulisation is complete (the mist stops). This typically takes 5–10 minutes depending on the nebuliser.
6. After use, clean the nebuliser according to the device’s instructions.

Dosage Guidance

Dosage is determined entirely by the prescribing doctor. Typical adult regimens for formoterol nebuliser solution are once or twice daily depending on indication and clinical response. Do not increase the dose or frequency without consulting your doctor. If symptoms are worsening or additional doses are needed beyond those prescribed, contact your doctor promptly — this may indicate deteriorating disease control requiring medical review.

Do not give to children without specialist guidance. Paediatric dosing requires individual assessment by a paediatric respiratory specialist.

Special Populations

Elderly Patients

Elderly patients may be more sensitive to the cardiovascular side effects of formoterol (tachycardia, palpitations, tremor). Renal function and electrolytes (particularly potassium) should be monitored. No specific dose adjustment is required based on age alone, but clinical assessment is advisable.

Patients with Renal or Hepatic Impairment

Limited data exist on formoterol use in severe renal or hepatic impairment. Standard precautions apply; consult the prescribing information or a specialist for guidance in these patients.

Pregnancy

The safety of formoterol in human pregnancy is not fully established. Animal studies have shown some adverse effects at high doses. Formoterol should be used during pregnancy only if the potential benefit clearly outweighs the possible risk to the foetus. Poorly controlled asthma or COPD can itself be harmful in pregnancy, so the treating clinician will weigh all risks carefully. Inform your doctor immediately if you are or may be pregnant.

Breastfeeding

It is not known whether formoterol passes into breast milk at clinically significant levels. The decision to continue breastfeeding during treatment should be made in consultation with the treating doctor, weighing the benefit of therapy to the mother against any potential risk to the infant.

Paediatric Use

Foratec Respules may be used in children under specialist respiratory supervision when nebulised bronchodilator therapy is appropriate. Dosage in children must be determined by a paediatric respiratory specialist based on age, weight, and clinical status.

Important Safety Warnings

WARNING: LABAs in Asthma — Do Not Use Without an Inhaled Corticosteroid

Long-acting beta-2 agonists (LABAs), including formoterol, must not be used as the sole treatment for asthma. Clinical trials have shown that LABA monotherapy in asthma is associated with an increased risk of severe asthma attacks and asthma-related death. Formoterol in asthma must always be used in combination with an inhaled corticosteroid (ICS). If you are using Foratec Respules for asthma, confirm with your doctor that you are also using an appropriate ICS. If you are not, contact your doctor immediately. This restriction does not apply to COPD, where formoterol monotherapy is used appropriately.

Do Not Use for Rapidly Worsening Asthma or Status Asthmaticus

Foratec Respules are not a substitute for oral or intravenous corticosteroids, which are the cornerstone of treatment for severe asthma attacks (status asthmaticus). If asthma is rapidly deteriorating or not responding to bronchodilator treatment, seek emergency medical attention immediately. Do not increase the dose of Foratec Respules in place of emergency treatment.

Cardiovascular Effects

Formoterol, like all beta-2 agonists, can cause cardiovascular effects including tachycardia (fast heart rate), palpitations, and in susceptible patients, QTc interval prolongation and arrhythmias. Use with caution in patients with pre-existing cardiovascular disease (ischaemic heart disease, hypertension, arrhythmias), and inform your doctor if you develop chest pain, rapid heart rate, or irregular heartbeat during treatment.

Hypokalaemia (Low Potassium)

High doses of beta-2 agonists can cause a clinically significant fall in serum potassium (hypokalaemia), particularly when combined with xanthines (theophylline), corticosteroids, or diuretics. Hypokalaemia can cause muscle weakness and cardiac arrhythmias. Potassium levels should be monitored in high-risk patients, particularly in acute severe respiratory illness where higher doses of bronchodilators may be needed.

Paradoxical Bronchospasm

Rarely, formoterol and other inhaled bronchodilators can cause paradoxical bronchospasm — a sudden increase in wheeze and breathlessness immediately after use, rather than improvement. If this occurs, stop using Foratec Respules and contact your doctor immediately. An alternative bronchodilator should be prescribed.

Precautions

• Thyrotoxicosis (overactive thyroid): Beta-2 agonists may worsen symptoms of thyrotoxicosis. Use with caution in patients with known thyroid disease.
• Diabetes mellitus: Beta-2 agonists can raise blood glucose levels. Blood glucose should be monitored more closely in diabetic patients starting or increasing formoterol therapy.
• Phaeochromocytoma: Use with caution; sympathomimetic effects may be exaggerated.
• Frequency of use: Increased use of formoterol beyond the prescribed dose suggests inadequate disease control and should prompt urgent medical review — never increase doses independently.
• Nebuliser hygiene: Nebulisers must be cleaned according to the manufacturer’s instructions after every use to prevent contamination and microbial growth, which could cause respiratory infections.
• Storage of opened respules: Once opened, the respule must be used immediately and any remaining solution discarded. Do not store opened respules for later use.

Contraindications

Foratec Respules 15 Mcg/2 Ml must not be used in patients with:

• Known hypersensitivity to formoterol fumarate or any excipient in the formulation
• Asthma treated without a concurrent inhaled corticosteroid (LABA monotherapy in asthma is contraindicated)
• Severe or unstable asthma not under regular specialist care

Use with caution (risk–benefit assessment required) in: severe cardiovascular disease, hypertrophic obstructive cardiomyopathy, tachyarrhythmias, QT prolongation, severe hypokalaemia, thyrotoxicosis, and uncontrolled diabetes.

Side Effects

Like all medicines, Foratec Respules can cause side effects. Most side effects from formoterol are dose-related and related to its beta-2 adrenergic activity.

Common Side Effects (may affect up to 1 in 10 people)

• Tremor (hand or finger shaking) — usually mild and resolves with continued use
• Headache
• Palpitations (awareness of heartbeat)
• Tachycardia (increased heart rate)
• Muscle cramps

Less Common Side Effects (may affect up to 1 in 100 people)

• Dizziness or nervousness
• Sleep disturbance or insomnia
• Dry mouth or throat irritation
• Nausea
• Hypokalaemia (low potassium — usually clinically significant only at high doses)
• Prolongation of the QTc interval on ECG

Rare but Serious — Seek Immediate Medical Help

• Paradoxical bronchospasm (sudden severe worsening of breathing after use)
• Severe allergic/hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, hypotension)
• Serious cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia)
• Significant hypokalaemia causing muscle weakness or cardiac effects

Drug Interactions

Tell your doctor and pharmacist about all medicines you are taking before starting Foratec Respules. Important interactions include:

• Beta-blockers (propranolol, atenolol, bisoprolol, carvedilol): Competitively block beta-2 receptors and can completely antagonise the bronchodilator effect of formoterol. Non-selective beta-blockers (e.g. propranolol) are contraindicated in asthma and COPD. Even cardioselective beta-blockers (e.g. atenolol, bisoprolol) should be used with caution and ideally avoided in reactive airways disease.
• QT-prolonging medicines: Medicines that prolong the QT interval (certain antiarrhythmics, antipsychotics, fluoroquinolone antibiotics, macrolide antibiotics, certain antihistamines) may have additive QT-prolonging effects with formoterol. Combined use requires ECG monitoring.
• Xanthine derivatives (theophylline, aminophylline): Additive risk of hypokalaemia, tachycardia, and other cardiovascular adverse effects. Monitor electrolytes and cardiac function.
• Systemic corticosteroids and diuretics: Combined use can increase the risk of hypokalaemia. Monitor serum potassium, particularly in acute respiratory illness requiring high bronchodilator doses.
• MAOIs, tricyclic antidepressants (amitriptyline, nortriptyline): May potentiate the cardiovascular effects of formoterol (hypertension, tachycardia). Combination requires careful monitoring; avoid co-administration within 14 days of stopping an MAOI.
• Other sympathomimetics (e.g. salbutamol, epinephrine): Additive cardiovascular effects. Avoid routine concurrent use of multiple short- and long-acting beta agonists unless clinically necessary.

Storage Instructions

• Store below 25°C (77°F) in a cool, dry place, away from heat and direct sunlight.
• Do not freeze. Freezing can damage the respule integrity.
• Keep in the original foil/strip packaging until immediately before use to protect from light and moisture.
• Once a respule is removed from the strip and opened, it must be used immediately. Discard any unused portion.
• Keep out of the reach of children.
• Do not use after the expiry date printed on the pack or respule label.
• Dispose of used respules and empty packaging responsibly — do not discard medicines in household waste or pour down the sink. Return to a pharmacy for appropriate disposal where available.

Related Products

Patients using a long-acting bronchodilator for asthma or COPD may also benefit from these related respiratory products available on Indogenmed:

• Beclate 200 Mcg Inhaler (Beclometasone Dipropionate) — a pressurised metered-dose inhaler (pMDI) containing beclometasone, an inhaled corticosteroid (ICS). Essential combination partner for formoterol when treating persistent asthma: LABAs must always be used with an ICS in asthma to reduce the risk of severe attacks.
• Beclate 200 Mcg Capsules (Beclometasone for Rotahaler) — beclometasone dipropionate in capsule form for use with a Rotahaler dry powder inhaler device. An alternative ICS delivery option for patients who find pMDIs difficult to coordinate, and an appropriate ICS to pair with formoterol nebulisation in asthma.
• Beclate 400 Mcg Capsules (Beclometasone 400 Mcg for Rotahaler) — a higher-strength beclometasone ICS capsule for patients with moderate-to-severe persistent asthma requiring greater corticosteroid coverage alongside their long-acting bronchodilator.

Frequently Asked Questions (FAQs)

1. What is the difference between Foratec Respules and a formoterol dry powder inhaler (DPI)?

Foratec Respules 15 Mcg/2 Ml are a solution for nebulisation — the liquid is converted into an inhalable mist by a nebuliser device. A dry powder inhaler (DPI) contains formoterol as a fine powder that is released when the patient inhales through the device. Respules have advantages in patients who have difficulty generating sufficient inspiratory flow to use a DPI effectively — for example, those with severe COPD or acute bronchospasm, young children, or very elderly patients. Nebulisers are also more suitable in clinical or hospital settings. However, they are more time-consuming to use and require nebuliser equipment and hygiene maintenance.

2. Can I use Foratec Respules more frequently if my breathing gets worse?

No — never increase the dose or frequency of Foratec Respules beyond what your doctor has prescribed without consulting them first. If your breathing is worsening despite regular use, or if you are needing additional doses to control symptoms, this suggests your underlying asthma or COPD is not well controlled and requires medical review. Your doctor may need to adjust your overall treatment regimen — adding or increasing an ICS, adding a long-acting muscarinic antagonist (LAMA), or initiating oral corticosteroids. Increasing formoterol doses independently can increase the risk of cardiovascular side effects and mask deteriorating disease.

3. Can formoterol be used for asthma without an inhaled corticosteroid (ICS)?

No — formoterol (and all LABAs) must never be used as the only treatment for asthma. Clinical trials demonstrated that LABA monotherapy in asthma increases the risk of asthma-related hospitalisation and death compared to ICS alone or ICS + LABA combinations. The safe use of formoterol in asthma requires a concurrent ICS that is prescribed and maintained throughout treatment. The ICS reduces airway inflammation; the LABA provides bronchodilation. Either alone is insufficient for adequate asthma control in most patients with persistent disease. This restriction does not apply to COPD, where LABAs can be used as monotherapy.

4. How does Foratec Respules 15 Mcg/2 Ml differ from Foratec or Foradil capsules?

Foratec comes in several formulations including dry powder inhalers (DPI capsules for Aerolizer/Handihaler-type devices) and respules for nebulisation. The respule formulation (Foratec Respules 15 Mcg/2 Ml) is a liquid unit-dose designed specifically for use with a jet or mesh nebuliser. The DPI capsules (e.g., Foradil/Foratec for Aerolizer) contain dry powder that is inhaled directly from the device. Both deliver formoterol but via different mechanisms. The right formulation for a patient depends on their age, ability to use devices correctly, severity of their condition, and the clinical setting.

5. What should I do if I miss a dose?

If you miss a scheduled dose, take it as soon as you remember — unless it is almost time for your next scheduled dose, in which case skip the missed dose and continue with your regular schedule. Do not double up by taking two doses at once. If you are unsure, contact your doctor or pharmacist for advice. Missing a dose of a maintenance bronchodilator may temporarily worsen breathlessness, so ensure you have a reliever (short-acting bronchodilator) available as directed by your doctor.

References

1. MedlinePlus (US National Library of Medicine). Formoterol Oral Inhalation. Available at: https://medlineplus.gov/druginfo/meds/a603025.html [Accessed November 2026].
2. US Food and Drug Administration (FDA). Foradil Aerolizer (Formoterol Fumarate) — Prescribing Information. Available at: FDA Prescribing Information — Foradil [Accessed November 2026].
3. European Medicines Agency (EMA). Formoterol-containing products — Summary of Product Characteristics. Available at: https://www.ema.europa.eu/ [Accessed November 2026].
4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD: 2024 Report. Available at: https://goldcopd.org/ [Accessed November 2026].
5. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention: 2024 Update. Available at: https://ginasthma.org/ [Accessed November 2026].

Disclaimer: This information is provided for educational purposes only and does not replace professional medical advice, diagnosis, or treatment. Foratec Respules is a prescription medicine that must only be used under the direction of a qualified doctor or respiratory specialist. If you experience any adverse effects or worsening of symptoms during treatment, contact your healthcare provider promptly. In a respiratory emergency, seek immediate medical attention.