Foracort Forte 12 Mcg+400 Mcg Capsules

Foracort Forte 12 Mcg+400 Mcg Capsules — Budesonide + Formoterol Rotacaps for Inhalation

Foracort Forte 12 Mcg+400 Mcg Capsules are dry-powder inhalation capsules (Rotacaps) containing Formoterol Fumarate 12 mcg and Budesonide 400 mcg per capsule, manufactured by Cipla Ltd. Each capsule is loaded into a Rotahaler inhaler device immediately before inhalation — the capsules are for inhalation only and must never be swallowed. Supplied in a bottle of 30 Rotacaps.

Foracort Forte Rotacaps deliver the same high-strength Budesonide + Formoterol combination as the Foracort Forte 400 Mcg pressurised inhaler, in a breath-actuated dry-powder format suited to patients who prefer or who can more reliably use a Rotahaler device over a pressurised MDI. This is a prescription-only maintenance medicine for asthma and COPD.

Composition

Pack: Bottle of 30 inhalation capsules (Rotacaps). For use with Rotahaler device. SKU: FORACORTFORT12MCGCAP.

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’s Rotacap inhalation system — developed to provide accessible dry-powder inhalation technology — is widely used across Asia, Africa, and the Middle East. Cipla holds WHO-GMP, USFDA, UKMHRA, and EMA-GMP certifications across its manufacturing network. The Foracort range is Cipla’s core Budesonide + Formoterol ICS/LABA combination portfolio.

How Foracort Forte Rotacaps Work — Dual Mechanism of Action

Each Foracort Forte 12+400 Mcg Rotacap delivers both an inhaled corticosteroid and a long-acting bronchodilator with complementary and synergistic mechanisms:

Budesonide (ICS — Anti-Inflammatory)

• Binds to intracellular glucocorticoid receptors in bronchial epithelial cells and eosinophils
• Suppresses transcription of pro-inflammatory cytokines (IL-4, IL-5, IL-13) and reduces airway eosinophil recruitment
• Decreases mucosal oedema, mucus hypersecretion, and airway hyperresponsiveness
• Upregulates beta-2 adrenoreceptor expression, enhancing formoterol’s bronchodilator effect
• Extensive first-pass hepatic metabolism limits systemic corticosteroid side 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 → phosphorylates myosin light-chain kinase → sustained bronchodilation
• Rapid onset (~1–3 minutes) with 12-hour duration, providing both quick symptom relief and sustained control
• Additional anti-inflammatory effects: inhibits mast cell degranulation and reduces airway microvascular permeability

Clinical Indications

• Asthma maintenance (adults and adolescents ≥12 years): Regular twice-daily maintenance treatment of asthma insufficiently controlled by an inhaled corticosteroid alone, or for patients already established on an ICS + LABA regimen. The Forte 400 mcg Budesonide strength is appropriate for patients at GINA Step 4–5 requiring high-dose ICS.
• COPD maintenance: Symptomatic relief and prevention of exacerbations in adults with moderate-to-severe COPD (GOLD Stage II–IV), particularly those with eosinophilic inflammation or frequent exacerbation history.

These Rotacaps are for regular maintenance use only — not for the relief of acute bronchospasm. Always keep a short-acting reliever inhaler (e.g. salbutamol) available for rescue use.

Dosage and Administration

• Standard dose: 1 capsule (Rotacap) inhaled twice daily — morning and evening. Under specialist direction, patients with more severe asthma may use up to 2 capsules twice daily. 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 cap from the Rotahaler. Hold the Rotahaler upright and open it by twisting the two halves.
  2. Place one Foracort Forte 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 Rotahaler).
  5. Place the mouthpiece in your mouth, seal your lips around it, and inhale the powder as deeply and forcefully as possible.
  6. Remove the Rotahaler, hold your breath for 10 seconds, then breathe out slowly.
  7. Open the Rotahaler to check the capsule is empty. If powder remains, close, hold horizontal, and inhale once more.
  8. Discard the empty capsule. Rinse mouth with water after use.
• Rinse mouth: After each use, rinse the mouth with water and spit out to prevent oral candidiasis and hoarseness.
• Rotahaler care: Clean the Rotahaler device regularly according to the manufacturer’s instructions. Replace periodically.

Special Populations

• Children under 12: Not recommended at this strength. Paediatric doses (Foracort 100 or 200 mcg Rotacaps) may be appropriate under specialist supervision.
• Elderly: No dose adjustment required. The Rotahaler’s breath-actuated design may be advantageous for elderly patients who struggle with the hand-breath coordination required for a pMDI.
• Pregnancy: Use only when the benefit outweighs the risk. Uncontrolled asthma is more hazardous to mother and foetus than appropriate inhaled therapy. Use the minimum effective dose under obstetric supervision.
• Breastfeeding: Inhaled budesonide and formoterol appear in breast milk at very low levels. Standard inhaled doses are considered compatible with breastfeeding. Discuss with your doctor.
• Renal impairment: Minimal systemic absorption; no dose adjustment required.
• Hepatic impairment: Severe disease may increase systemic budesonide levels. Monitor for corticosteroid side effects.

Precautions

• Not for acute relief: Foracort Forte Rotacaps are maintenance therapy only. Use a fast-acting reliever inhaler for sudden breathlessness.
• Paradoxical bronchospasm: If inhalation causes immediate worsening of wheeze or breathlessness, discontinue and contact your doctor.
• Oral thrush (candidiasis): Always rinse mouth with water after use. Report white patches in the mouth or throat to your doctor — antifungal treatment can be given without stopping Foracort.
• HPA axis: At the Forte 400 mcg dose (especially with 2 capsules twice daily), adrenal suppression may occur. Avoid abrupt stopping of systemic steroids during transition to inhaled therapy.
• Cardiovascular: Formoterol may cause tachycardia and QTc prolongation. Use with caution in patients with existing cardiac conditions or on QT-prolonging drugs.
• Hypokalaemia: High-dose beta-2 agonists combined with diuretics or theophylline may lower serum potassium. Monitor in susceptible patients.
• Bone density: Long-term high-dose inhaled corticosteroid use may reduce bone mineral density. Supplementary calcium and vitamin D are recommended for long-term users.

Contraindications

• Hypersensitivity to budesonide, formoterol fumarate, lactose, or any excipient
• Active pulmonary tuberculosis (untreated)
• Severe hypersensitivity to milk proteins

Side Effects

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

Uncommon (≥1/1,000): Tachycardia, dizziness, insomnia, skin bruising, mild adrenal suppression at high doses.

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

Seek immediate medical help if you experience sudden severe breathlessness or chest tightness after inhalation, rapid or irregular heartbeat with dizziness, or signs of a severe allergic reaction.

Drug Interactions

• Beta-blockers: Antagonise formoterol’s bronchodilator effect. Non-selective beta-blockers are contraindicated in asthma.
• QT-prolonging drugs: Tricyclic antidepressants, antipsychotics, and quinolones may increase arrhythmia risk with formoterol.
• Diuretics, xanthines, corticosteroids: Additive hypokalaemia risk with high-dose beta-2 agonist use.
• MAO inhibitors: Do not use within 2 weeks of an MAOI — risk of severe cardiovascular effects from formoterol.
• CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir): Increase systemic budesonide exposure; monitor for 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 in the Rotahaler device.
• Keep out of reach of children.
• Do not use Rotacaps past the expiry date on the bottle.

Related Products

Also available in the Foracort Forte range: Foracort Forte 400 Mcg Inhaler (pressurised MDI version of the same Forte strength). For a lower maintenance dose, see Foracort 200 Mcg + 6 Mcg Capsules.

Frequently Asked Questions

What are Rotacaps and how are they different from an inhaler spray?

Rotacaps are small dry-powder capsules that are loaded into a Rotahaler device and punctured just before inhalation. When you breathe in through the Rotahaler, the powder is released and inhaled into the lungs. Unlike a pressurised MDI (spray inhaler), there is no need to coordinate pressing a button and breathing in simultaneously — making Rotacaps easier for many patients. The medicine delivered is identical, but the device mechanism differs.

Can I swallow Foracort Forte Rotacaps?

No. Foracort Forte Rotacaps are for inhalation only and must never be swallowed. If a capsule is accidentally swallowed, the medicine will not work and you should inform your doctor. Always load the capsule into the Rotahaler as instructed.

How do I know if the Rotacap is empty?

After inhaling, open the Rotahaler and look at the capsule. An empty capsule will appear clear or collapsed. If you can still see powder inside, close the Rotahaler and inhale again. Discard all used capsules — do not reuse them.

Foracort Forte Rotacaps vs Foracort Forte 400 Inhaler — which should I use?

Both deliver the same dose of Budesonide 400 mcg + Formoterol 12 mcg. The choice depends on which device you can use more reliably. The Rotahaler is breath-actuated and may be easier for patients who find coordinating a spray inhaler difficult. Your doctor or pharmacist can advise and demonstrate both devices.

What should I do if I forget a dose?

Take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular schedule. Never take a double dose to make up for a missed one. Contact your doctor if you are unsure.

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 Forte 12 Mcg+400 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.