Foracort 200 Mcg + 6 Mcg Capsules

Foracort 200 Mcg + 6 Mcg Capsules — Budesonide + Formoterol Lower-Strength Rotacaps for Inhalation

Foracort 200 Mcg + 6 Mcg Capsules are dry-powder inhalation capsules (Rotacaps) containing Budesonide 200 mcg and Formoterol Fumarate 6 mcg per capsule, manufactured by Cipla Ltd. Each capsule is loaded into a Rotahaler device immediately before inhalation — the capsules are designed exclusively for inhalation and must never be swallowed. Supplied in a bottle of 30 Rotacaps.

Foracort 200+6 Mcg Rotacaps are the lower-strength formulation in the Foracort Rotacap range, delivering half the Budesonide dose (200 mcg vs 400 mcg) and half the Formoterol dose (6 mcg vs 12 mcg) of the Forte variants. This strength is well-suited for patients at GINA Step 3–4 requiring a moderate-dose inhaled corticosteroid combined with a long-acting bronchodilator. This is a prescription-only maintenance medicine for asthma and COPD.

Composition

Pack: Bottle of 30 inhalation capsules (Rotacaps). For use with Rotahaler device only.

About Cipla Ltd

Cipla Ltd, founded in 1935 and headquartered in Mumbai, India, is a world-leading pharmaceutical company and global pioneer in affordable respiratory medicine. Cipla developed the Rotacap dry-powder inhalation system to provide accessible, breath-actuated inhaled therapy widely used across Asia, Africa, and the Middle East. Cipla holds WHO-GMP, USFDA, UKMHRA, and EMA-GMP certifications across its manufacturing facilities. The Foracort range — covering multiple ICS/LABA strengths in both pressurised MDI and Rotacap formats — is Cipla’s flagship combination respiratory portfolio.

How Foracort 200+6 Works — Dual Mechanism of Action

Each Foracort 200+6 Mcg Rotacap delivers a moderate-dose inhaled corticosteroid and a long-acting bronchodilator with synergistic and complementary mechanisms:

Budesonide (ICS — Anti-Inflammatory)

• Binds to intracellular glucocorticoid receptors in bronchial epithelial and immune cells
• Suppresses transcription of pro-inflammatory cytokines (IL-4, IL-5, IL-13) and reduces airway eosinophil accumulation
• Reduces airway mucosal oedema, mucus hypersecretion, and bronchial hyperresponsiveness
• Upregulates beta-2 adrenoreceptor expression, amplifying formoterol’s bronchodilator effect
• Extensive first-pass hepatic metabolism limits systemic corticosteroid effects at inhaled doses

Formoterol Fumarate (LABA — Bronchodilator)

• Highly selective partial agonist at beta-2 adrenoreceptors on bronchial smooth muscle
• Increases intracellular cAMP → activates protein kinase A → relaxes bronchial smooth muscle → sustained bronchodilation
• Rapid onset (~1–3 minutes) with 12-hour duration, allowing twice-daily dosing
• Additional anti-inflammatory effects including inhibition of mast cell degranulation and airway microvascular permeability

The 200/6 mcg dose combination is clinically equivalent to international medium-dose ICS/LABA regimens (such as Budesonide/Formoterol 200/6 mcg, marketed globally as Symbicort Turbuhaler among others) and is appropriate for many patients who do not require the high-dose Forte 400/12 mcg strength.

Clinical Indications

• Asthma maintenance (adults and adolescents ≥12 years): Regular twice-daily maintenance treatment for patients with asthma not adequately controlled by an ICS alone, or for patients already on a medium-dose ICS/LABA combination. Appropriate for GINA Step 3–4.
• COPD maintenance: Reduction of symptoms and prevention of exacerbations in adults with moderate-to-severe COPD (GOLD Stage II–IV), particularly those with eosinophilic inflammation or a history of frequent exacerbations.

These Rotacaps are for regular maintenance use only — not for the relief of acute bronchospasm or breathlessness attacks. Keep a short-acting reliever inhaler (e.g. salbutamol) available for rescue use at all times.

Dosage and Administration

• Standard dose: 1 capsule (Rotacap) inhaled twice daily — morning and evening. Under specialist direction, 2 capsules twice daily may be used in patients with more severe or poorly controlled asthma. Do not exceed 4 capsules per day.
• ⚠️ Important — Rotacaps must NOT be swallowed. They are designed exclusively for inhalation using a Rotahaler device.
• How to use with a Rotahaler:
  1. Remove the mouthpiece cap. Hold the Rotahaler upright and open it by twisting the two halves apart.
  2. Place one Foracort 200+6 Rotacap into the Rotacap slot with the transparent end facing down.
  3. Close the Rotahaler. Hold it horizontal and twist to pierce the capsule (you will hear a click).
  4. Breathe out fully (not into the device).
  5. Place the mouthpiece in your mouth, seal your lips around it, and inhale the powder as deeply and forcefully as you can.
  6. Remove the Rotahaler, hold your breath for up to 10 seconds, then exhale slowly.
  7. Open the Rotahaler and inspect the capsule. If powder remains, close and inhale once more.
  8. Discard the empty capsule. Rinse mouth with water after use and spit out.
• Rinse mouth: Rinsing the mouth with water after each dose helps prevent oral candidiasis and hoarseness. Do not swallow the rinse water.
• Rotahaler care: Clean the Rotahaler device regularly according to the manufacturer’s instructions to maintain optimal powder flow and hygiene.

Special Populations

• Children under 12: Not routinely recommended at this strength. Lower-dose Rotacaps (Foracort 100 mcg) may be appropriate under specialist paediatric guidance.
• Elderly: No dose adjustment required. The Rotahaler’s breath-actuated design may benefit elderly patients who have difficulty coordinating a pressurised MDI.
• Pregnancy: Use only when the benefit of controlled asthma outweighs the risk. Uncontrolled asthma is more hazardous to mother and foetus than appropriate inhaled therapy at the minimum effective dose. Use under obstetric supervision.
• Breastfeeding: Inhaled budesonide and formoterol are excreted in breast milk at very low levels. Standard doses are generally considered compatible with breastfeeding. Discuss with your doctor.
• Renal impairment: Minimal systemic absorption from inhaled route; no dose adjustment required.
• Hepatic impairment: Severe hepatic disease may increase systemic budesonide exposure. Monitor for corticosteroid side effects.

Precautions

• Not for acute relief: Foracort 200+6 Mcg Rotacaps are a maintenance treatment, not a rescue inhaler. Use a fast-acting reliever (salbutamol) for sudden breathlessness.
• Paradoxical bronchospasm: If inhalation causes immediate worsening of wheeze or breathlessness, stop using and contact your doctor promptly.
• Oral thrush (candidiasis): Rinse mouth with water after every dose. Report white patches inside the mouth or throat to your doctor — antifungal treatment may be prescribed without stopping Foracort.
• HPA axis suppression: At standard doses, clinically significant adrenal suppression is uncommon, but risk increases with higher doses or prolonged use. Avoid abrupt discontinuation of systemic corticosteroids during transition to inhaled therapy.
• Cardiovascular effects: Formoterol may cause tachycardia, palpitations, and mild QTc prolongation. Use with caution in patients with pre-existing cardiac arrhythmias or structural heart disease.
• Hypokalaemia: High-dose beta-2 agonists may cause low serum potassium, particularly when combined with diuretics or theophylline. Monitor susceptible patients.
• Bone density: Long-term high-dose inhaled corticosteroid use may affect bone mineral density. Supplementary calcium and vitamin D are recommended for patients on long-term inhaled corticosteroid therapy.

Contraindications

• Hypersensitivity to budesonide, formoterol fumarate, lactose, or any excipient
• Active pulmonary tuberculosis (untreated or inadequately treated)
• Severe hypersensitivity to milk proteins (the capsule contains lactose as a carrier)

Side Effects

Common (≥1/100): Throat irritation, hoarseness, dry mouth, oral candidiasis, headache, mild tremor, mild palpitations.

Uncommon (≥1/1,000): Tachycardia, dizziness, insomnia, skin bruising, mild adrenal suppression with prolonged high-dose use.

Rare but serious: Paradoxical bronchospasm, severe hypersensitivity/anaphylaxis, hypokalaemia, features of Cushing’s syndrome (at very high prolonged doses), glaucoma, cataracts, growth retardation in children.

Seek immediate medical help if you experience sudden worsening of breathlessness after inhalation, rapid or irregular heartbeat with dizziness, or signs of a severe allergic reaction (throat swelling, hives, collapse).

Drug Interactions

• Beta-blockers: Antagonise formoterol’s bronchodilator effect. Non-selective beta-blockers are contraindicated in asthma.
• QT-prolonging drugs: Tricyclic antidepressants, antipsychotics, and some antibiotics may increase the risk of arrhythmia with formoterol. Use with caution.
• Diuretics, xanthines, corticosteroids: Additive hypokalaemia risk with high-dose beta-2 agonist use; monitor serum potassium in susceptible patients.
• MAO inhibitors: Do not use within 2 weeks of an MAOI — risk of severe cardiovascular effects.
• CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir): Increase systemic budesonide exposure; monitor for signs of corticosteroid excess.

Storage Instructions

• Store below 30°C in a dry place. Protect from moisture and direct sunlight.
• Keep the bottle tightly closed. Do not store Rotacaps inside the Rotahaler device between doses.
• Keep out of reach of children.
• Do not use past the expiry date printed on the bottle label.

Related Products

For patients requiring higher-dose ICS/LABA therapy, see the Foracort Forte range: Foracort Forte 12 Mcg+400 Mcg Capsules (Budesonide 400 mcg + Formoterol 12 mcg Rotacaps) and Foracort Forte 400 Mcg Inhaler (pressurised MDI version of the same Forte strength).

Frequently Asked Questions

What is the difference between Foracort 200+6 and Foracort Forte 400+12 Rotacaps?

Both products contain the same two medicines — Budesonide (ICS) and Formoterol (LABA) — but at different strengths. Foracort 200+6 delivers half the dose: 200 mcg Budesonide + 6 mcg Formoterol per capsule, compared with 400 mcg + 12 mcg in the Forte variant. The 200+6 strength is used for moderate-severity asthma or COPD. Your doctor will prescribe the strength that best matches your level of disease control and severity.

Can I use Foracort 200+6 Rotacaps to treat a sudden asthma attack?

No. Foracort 200+6 Mcg Rotacaps are a maintenance (preventive) treatment taken twice daily every day — they are not designed for rapid rescue of acute breathlessness. Always carry a separate fast-acting reliever inhaler such as salbutamol for sudden symptoms. If you have a severe or worsening attack, use your reliever and seek emergency medical help.

Do Rotacaps work differently from an MDI inhaler?

Both deliver medicine into the lungs, but via different mechanisms. A pressurised MDI (metered-dose inhaler) sprays a measured aerosol that you inhale simultaneously with pressing the canister. A Rotacap is a dry-powder capsule that you load into a Rotahaler; your own breath draws the powder from the capsule into your lungs. Many patients — including those with arthritis, children, and older adults — find Rotahaler devices easier to coordinate. The therapeutic effect is equivalent when used correctly.

How do I know if I am inhaling the powder correctly from a Rotacap?

After inhaling, open the Rotahaler and check the capsule. It should appear empty or nearly empty. If significant powder remains, close the device and inhale once more as firmly as possible. A quick, forceful inhalation empties the capsule more reliably than a slow, gentle breath. Your doctor or pharmacist can demonstrate the correct technique and check your inhaler use at each review.

What should I do if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed one and continue as normal. Never inhale two capsules at once to make up for a missed dose. Contact your doctor if you are unsure what to do.

References

1. NHS — Budesonide Inhalers. National Health Service, UK.
2. MedlinePlus — Formoterol Oral Inhalation. U.S. National Library of Medicine.
3. EMA — European Public Assessment Report: Budesonide/Formoterol (Symbicort). European Medicines Agency.
4. GINA 2024 — Global Initiative for Asthma Strategy Report. Global Initiative for Asthma.

Disclaimer: This product information is provided for general educational purposes only. Foracort 200 Mcg + 6 Mcg Capsules are a prescription-only medicine for inhalation. They must be used only as directed by a qualified healthcare professional. This content does not constitute medical advice and must not be used to self-diagnose or self-treat. IndoGenMed.org supplies this product to licensed healthcare professionals and registered pharmacies only.