Beclate 400 Mcg Capsules

Description

What are Beclate 400 Mcg Capsules?

Beclate 400 Mcg Capsules are dry powder inhalation capsules manufactured by Cipla Ltd., one of India’s leading pharmaceutical companies. Each capsule contains 400 micrograms (mcg) of Beclometasone Dipropionate as the active ingredient. Beclometasone dipropionate is an inhaled corticosteroid (ICS) used in the long-term management of asthma.

Important: These capsules are for inhalation only. They must be used with a compatible dry powder inhaler (DPI) device and must never be swallowed. The capsule is placed into the inhaler device, pierced, and the powder is inhaled directly into the lungs through the mouth.

Beclate 400 is a maintenance (preventer) therapy — it reduces airway inflammation and helps prevent asthma symptoms over time. It is not a reliever inhaler and does not provide immediate relief during an acute asthma attack. A short-acting bronchodilator (such as salbutamol) should always be available for sudden symptom relief. Each pack contains 10 capsules.

Composition and Product Details

Brand Name	Beclate 400
Generic Name	Beclometasone Dipropionate
Strength	400 mcg per capsule
Dosage Form	Dry powder capsule for inhalation (NOT for oral use)
Pack Size	10 capsules (1 strip)
Manufacturer	Cipla Ltd., India
Therapeutic Class	Inhaled Corticosteroid (ICS) / Anti-asthmatic
Prescription Required	Yes

About Cipla Ltd. and the Beclate Brand

Cipla Ltd. is a globally recognised Indian pharmaceutical company, established in 1935 and headquartered in Mumbai. Cipla is one of the world’s leading manufacturers of respiratory medicines, with a portfolio that spans pressurised metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), nebuliser solutions, and oral formulations for asthma and COPD. The company operates in over 80 countries and is approved by multiple international regulatory authorities including the US FDA, the UK MHRA, the WHO-PQ programme, and the European EMA.

The Beclate brand is Cipla’s proprietary range of beclometasone dipropionate products for respiratory use. The range includes inhalation capsules and pressurised inhalers across different strengths, providing flexible dosing options for the range of asthma severity levels encountered in clinical practice. Beclate 400 Mcg Capsules represent the higher-dose capsule option within the range, intended for patients with moderate-to-severe persistent asthma who require high-dose ICS therapy as part of a step-up treatment plan.

About Beclometasone Dipropionate

Beclometasone Dipropionate (BDP) is one of the longest-established inhaled corticosteroids in clinical use, having been available for asthma treatment since the early 1970s. It was among the first ICS agents to replace oral corticosteroids in chronic asthma management, dramatically improving the safety profile of long-term asthma therapy by delivering anti-inflammatory action directly to the airways rather than systemically.

BDP remains a widely used and trusted ICS in clinical guidelines including those of the Global Initiative for Asthma (GINA) and the British Thoracic Society (BTS). At 400 mcg per capsule, Beclate 400 provides a high-dose ICS option relevant to patients on steps 3–4 of standard asthma management step-up therapy, or for COPD management in combination with long-acting bronchodilators as directed by a physician.

How Beclate 400 Mcg Works

Beclometasone dipropionate is a glucocorticoid prodrug that is converted to its active metabolite, beclometasone-17-monopropionate (17-BMP), in the lung tissue. 17-BMP binds with high affinity to the intracellular glucocorticoid receptor, suppressing the expression of pro-inflammatory cytokines and mediators involved in the pathogenesis of asthma.

When inhaled as a dry powder, BDP is deposited across the upper and lower airways. Its anti-inflammatory actions include:

• Reduction of eosinophilic airway inflammation: BDP suppresses the recruitment and activation of eosinophils in the bronchial mucosa, reducing the chronic inflammation that drives asthma symptoms and exacerbations.
• Inhibition of pro-inflammatory cytokines: BDP downregulates interleukin-4 (IL-4), IL-5, and IL-13 — cytokines central to type 2 airway inflammation — along with reducing mast cell activation and mucosal oedema.
• Reduced airway hyper-responsiveness: Sustained treatment with BDP reduces the sensitivity of airways to triggers such as allergens, cold air, exercise, and respiratory infections, leading to fewer and less severe asthma attacks.
• Decreased mucus hypersecretion: Airway inflammation drives excessive mucus production in asthma; BDP suppresses this process, improving airway clearance.

Beclate 400 does not cause immediate bronchodilation. It is a preventer inhaler — its protective anti-inflammatory effects develop gradually over days to weeks of regular use. Clinical guidelines recommend taking preventer inhalers consistently every day, including on days when symptoms are absent, to maintain the anti-inflammatory benefit.

Indications and Uses

Beclate 400 Mcg Capsules are indicated for:

• Persistent asthma (maintenance therapy): Long-term prophylactic treatment of moderate-to-severe persistent asthma in adults and adolescents who require regular inhaled corticosteroid therapy at a higher dose step. Reduces the frequency and severity of asthma attacks, relieves chronic symptoms, and reduces reliance on short-acting bronchodilator relievers.
• Step-up asthma management: For patients inadequately controlled on lower-dose ICS therapy (e.g., 200 mcg beclometasone or equivalent) in whom a dose increase is clinically warranted, as guided by GINA or BTS step-up criteria.

Beclate 400 is not a bronchodilator and does not relieve acute breathlessness. A short-acting bronchodilator (such as salbutamol) must always be available for acute symptom relief.

Dosage and Administration

The dose of beclometasone must be individually determined by the prescribing physician based on asthma severity, previous ICS treatment, and clinical response. General dosing guidelines for beclometasone dipropionate DPI capsules in adults are:

• Moderate persistent asthma: 400 mcg twice daily (total: 800 mcg/day)
• Severe persistent asthma: 400–800 mcg twice daily, as directed by the physician
• Step-down: Once optimal asthma control is maintained for at least 3 months, the physician may consider a dose reduction to the lowest effective dose

How to use Beclate 400 Capsules (DPI inhalation technique):

1. Remove one capsule from the blister strip immediately before use; do not store capsules outside the blister packaging.
2. Insert the capsule into the compatible dry powder inhaler device as per the device’s instructions.
3. Pierce the capsule using the device’s piercing button or mechanism.
4. Exhale fully and completely away from the inhaler mouthpiece.
5. Place the mouthpiece firmly between your lips and teeth, tilt your head slightly back, then inhale deeply and forcefully through the mouth — the rushing airflow draws the powder out of the capsule.
6. Hold your breath for 5–10 seconds, then exhale slowly away from the device.
7. Check whether the capsule is empty by opening the device; if powder remains, re-pierce and inhale again.
8. Rinse your mouth thoroughly with water and spit out after every dose to reduce the risk of oral candidiasis (thrush).

Never swallow the capsule. Never use the capsule with a metered-dose inhaler (pMDI) device. The compatible DPI device is not included in the pack and must be obtained separately.

Special Populations

Elderly (≥65 years)

No specific dose adjustment is required in elderly patients with normal hepatic function. Monitor for systemic corticosteroid effects including bone density changes with long-term high-dose therapy.

Renal Impairment

No dose adjustment is necessary for mild-to-moderate renal impairment; BDP is primarily metabolised hepatically.

Hepatic Impairment

Beclometasone dipropionate undergoes significant first-pass hepatic metabolism to its active metabolite and inactive products. Systemic exposure may be increased in severe hepatic impairment; use with caution and under close medical supervision in this group.

Paediatric Use

The 400 mcg capsule strength is generally used for adults and adolescents (≥12 years). Children with asthma typically require lower doses and age-appropriate inhaler devices. Consult a paediatric respiratory specialist for guidance. Growth should be monitored in children receiving long-term inhaled corticosteroids, as ICS use has been associated with a small reduction in growth velocity at higher doses.

Pregnancy and Breastfeeding

Poorly controlled asthma during pregnancy poses significant risks to both mother and foetus. Inhaled beclometasone at therapeutic doses is generally considered acceptable in pregnancy; the risk of stopping effective asthma treatment outweighs the theoretical risk of the medicine. Consult your doctor before making any changes to treatment during pregnancy or breastfeeding.

Precautions and Warnings

• Not for acute attacks: Beclate 400 does not relieve acute bronchospasm. Always have a short-acting bronchodilator (reliever inhaler) available. Seek emergency care if breathing difficulties are severe or unresponsive to the reliever.
• Oral candidiasis (thrush): Inhaled corticosteroid deposition in the mouth and throat can lead to fungal infection. Rinsing the mouth with water and spitting out after every dose is essential to minimise this risk.
• Hoarseness and dysphonia: Local corticosteroid effect on the larynx may cause voice changes. Rinsing helps reduce but may not fully prevent this.
• Systemic corticosteroid effects: At high doses or with long-term therapy, ICS can cause systemic effects including adrenal suppression, reduced bone mineral density, cataracts, and raised intraocular pressure. Use the lowest effective dose, particularly in children and patients receiving long-term therapy.
• Transferring from oral steroids: Patients switching from systemic oral corticosteroids to inhaled BDP may experience symptoms of adrenal insufficiency during the transition. Transfer must be gradual and closely medically supervised.
• Respiratory infections: ICS can increase susceptibility to respiratory infections including pneumonia, particularly in COPD patients. Report new or worsening respiratory symptoms to your doctor promptly.
• Paradoxical bronchospasm: Rarely, an inhaled dose may cause immediate worsening of wheezing and breathlessness (paradoxical bronchospasm). Discontinue immediately, use a reliever bronchodilator, and contact your doctor.

Contraindications

• Hypersensitivity to beclometasone dipropionate or any excipient in the formulation
• Acute asthma attacks or rapidly deteriorating asthma (BDP does not provide immediate bronchodilation)
• Use as a reliever inhaler or for sudden symptom relief

Possible Side Effects

Common (may affect up to 1 in 10 users)

• Oral and pharyngeal candidiasis (thrush) — greatly reduced by rinsing mouth after use
• Hoarseness or dysphonia (voice changes)
• Throat irritation or mild cough after inhalation

Uncommon

• Headache
• Nausea
• Skin bruising (thin skin, particularly at high doses over long periods)

Rare but Serious

• Adrenal suppression — particularly at high doses long-term; may manifest as fatigue, weakness, or hypotension under stress
• Paradoxical bronchospasm — immediate worsening after inhalation; discontinue and seek medical attention
• Hypersensitivity reactions including rash, urticaria, angioedema
• Growth retardation in children with prolonged high-dose ICS use — monitor height regularly
• Raised intraocular pressure / cataracts with long-term high-dose ICS use

Report any unexpected or concerning side effects to your doctor or pharmacist.

Drug Interactions

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, cobicistat, clarithromycin): These drugs inhibit the hepatic enzymes responsible for BDP and 17-BMP metabolism, increasing systemic corticosteroid exposure. Avoid concurrent use where possible; if unavoidable, monitor closely for increased corticosteroid adverse effects.
• Systemic corticosteroids: Additive systemic corticosteroid effects if used alongside oral or injectable steroids; monitor for adrenal suppression during prolonged combined use.
• Other inhaled corticosteroids: Concurrent use of multiple ICS preparations is not recommended unless specifically prescribed; this can increase systemic corticosteroid exposure without additional clinical benefit.

Related Respiratory Products on IndoGenMed

IndoGenMed carries a range of inhaled corticosteroid products across multiple strengths and formats for asthma and COPD management:

• Beclate 200 Mcg Inhaler — Beclometasone 200 mcg in a pressurised metered-dose inhaler (pMDI) format. Suitable for patients who prefer or require an MDI device rather than a DPI capsule, or who require the lower 200 mcg per actuation dose.
• Beclate 200 Mcg Capsules — Beclometasone 200 mcg DPI capsules for patients requiring a lower ICS dose step, or for step-down therapy from the 400 mcg capsule once asthma control is well established.
• Budecort 400 Mcg Capsules — Budesonide 400 mcg DPI capsules by Cipla, an alternative high-dose ICS in the same capsule inhalation format for patients or physicians who prefer budesonide over beclometasone.

Storage Instructions

• Store below 30°C in a cool, dry place away from direct sunlight, heat, and humidity
• Keep capsules in the original blister packaging until immediately before use; exposing capsules to moisture or air causes powder clumping
• Do not refrigerate or freeze the capsules
• Store out of reach of children
• Do not use capsules after the printed expiry date
• Clean the inhaler device regularly as per the device manufacturer’s instructions

Frequently Asked Questions

Q: Can I swallow Beclate 400 capsules if I don’t have an inhaler device?

A: No. Beclate 400 capsules are strictly for inhalation and must never be swallowed. They contain beclometasone dry powder in a formulation designed to be delivered directly to the lungs through a compatible DPI inhaler device. Swallowing the capsule will not deliver the medicine to the airways and could result in unnecessary systemic steroid exposure. If you do not have a compatible DPI device, contact your doctor or pharmacist for guidance before using the product.

Q: How long does Beclate 400 take to control asthma symptoms?

A: Beclate 400 is a preventer inhaler, not a reliever. Some patients notice an improvement in symptoms within a few days of starting, but the full protective anti-inflammatory effect typically develops over 2–4 weeks of consistent daily use. It is essential to take Beclate 400 every day as prescribed — including on symptom-free days — to maintain the treatment benefit. Stopping suddenly or using it only on symptomatic days allows airway inflammation to return and increases the risk of asthma attacks.

Q: How is Beclate 400 different from Beclate 200 Mcg Capsules?

A: Both Beclate 400 Mcg Capsules and Beclate 200 Mcg Capsules contain beclometasone dipropionate in DPI capsule form and are manufactured by Cipla. The difference is the per-capsule dose: 400 mcg versus 200 mcg. Beclate 400 is used for moderate-to-severe persistent asthma requiring high-dose ICS therapy, while Beclate 200 is appropriate for mild-to-moderate asthma or for dose reduction (step-down) once asthma is well controlled. Your doctor determines the appropriate strength based on your asthma severity and control.

Q: How do I reduce the risk of oral thrush with Beclate 400?

A: Oral candidiasis (thrush) is the most common side effect of inhaled corticosteroids and occurs because powder particles deposit in the mouth and throat, where they can suppress local immune defences. The NHS and asthma guidelines recommend rinsing your mouth thoroughly with water and spitting out — do not swallow — after every use of your preventer inhaler. This step washes away the residual corticosteroid powder before it can be absorbed through the mouth. Brushing your teeth after using the inhaler provides additional protection. If oral thrush develops despite rinsing, notify your doctor, who can prescribe antifungal treatment.

Q: What should I do if I miss a dose of Beclate 400?

A: If you miss a 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 take the next one at the regular time. Do not double up on doses. If you regularly forget doses, consider setting a reminder. Missing doses of a preventer inhaler reduces its protective benefit and can lead to worsening asthma control; contact your doctor if you are struggling to maintain your routine.

References

1. NHS. Beclometasone inhalers. NHS.uk. Available at: https://www.nhs.uk/medicines/beclometasone-inhalers/
2. MedlinePlus. Beclomethasone Oral Inhalation. U.S. National Library of Medicine. Available at: https://medlineplus.gov/druginfo/meds/a682159.html
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2023. Available at: https://ginasthma.org
4. British Thoracic Society (BTS) / Scottish Intercollegiate Guidelines Network (SIGN). British Guideline on the Management of Asthma. Available at: https://www.brit-thoracic.org.uk
5. European Medicines Agency (EMA). Beclometasone dipropionate — Summary of Product Characteristics. Available at: https://www.ema.europa.eu