International reference: 1 US FDA recall for this ingredient

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. (pressurized)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Malawi.

Registered Malawi · PMRA

BECASONE 50MCG/DOSE INHALER

BECLOMETHASONE PRESSURIZED INHALATION

PMPB/PL401/83 INHALER alimentary tract and metabolism INN generic

What it does

Beclomethasone is a medication used to help reduce inflammation in the body.

Commonly used for: asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis (hay fever)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL401/83
Registration date
03/09/2015
Expiry date
30/06/2021
Status
Registered
Active ingredient
BECLOMETHASONE PRESSURIZED INHALATION
Dosage form
INHALER
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A07EA - Corticosteroids acting locally
RxNorm RxCUI
1347
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:42 · updated 2026-09-29 04:33:05

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About beclomethasone

Beclomethasone is a medication used to help reduce inflammation in the body.

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • allergic rhinitis (hay fever)

How it works

It works by decreasing swelling and irritation in the airways, making it easier to breathe.

Who it's for

This medication is typically for people with asthma or other breathing problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About inhalation

Inhalation medications are used to help deliver medicines directly to the lungs, making them effective for respiratory conditions.

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • allergic reactions affecting breathing

How it works

These medications work by opening the airways in the lungs, making it easier to breathe.

Who it's for

Inhalation therapies are suitable for individuals with breathing difficulties such as asthma or COPD.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About pressurized

Pressurized formulations are used in various medical treatments, often for delivering medication effectively.

How it works

Pressurized medications help deliver drugs in a fine mist or spray, making it easier for the body to absorb them.

Who it's for

This type of medication is typically for patients who need specific delivery methods for their treatment.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: beclomethasone

BNF-referenced

Beclomethasone is a synthetic corticosteroid used primarily for its anti-inflammatory and immunosuppressive properties. It is commonly administered via inhalation, intranasal spray, or topical formulations. Inhaled beclomethasone is effective in managing chronic respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD), while intranasal preparations are used for allergic rhinitis.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Allergic rhinitis
  • Nasal polyps

Dosage

Children: For children aged 5 to 12 years with asthma, the usual inhaled dose is 50 to 200 micrograms twice daily. For allergic rhinitis, refer to the BNF for Children

Adults: For asthma, the usual dose of inhaled beclomethasone is 100 to 400 micrograms twice daily, adjusted based on clinical response. For allergic rhinitis, 200 to 400 micrograms as a nasal spray may be administered once daily.

Mechanism of action

Beclomethasone acts by binding to glucocorticoid receptors in the cytoplasm of target cells. This complex translocates to the nucleus, where it influences gene transcription, leading to the downregulation of pro-inflammatory cytokines and the upregulation of anti-inflammatory proteins. This mechanism results in decreased inflammation, mucus production, and airway hyper-responsiveness.

Pharmacodynamics

The anti-inflammatory effects of beclomethasone are attributed to its ability to inhibit the release of inflammatory mediators, including leukotrienes and prostaglandins. It also reduces the recruitment of inflammatory cells to the site of inflammation. The onset of action for inhaled beclomethasone may take several hours to days, with maximum benefits typically observed after continuous use.

Pharmacokinetics

Beclomethasone is well-absorbed following inhalation, with a significant portion undergoing first-pass metabolism in the liver, thereby reducing systemic exposure. Its half-life is approximately 2.5 hours, but the duration of action may extend due to the drug's accumulation in lung tissue. The elimination of beclomethasone is primarily hepatic, with metabolites excreted in urine and feces.

Contra-indications

  • Hypersensitivity to beclomethasone or any of its components
  • Untreated systemic fungal infections

Adverse effects

  • Cushing's syndrome
  • Adrenal suppression
  • Osteoporosis
  • Growth retardation in children
  • Skin thinning
  • Increased risk of infections
  • Oral candidiasis

Interactions

  • CYP3A4 inhibitors may increase systemic exposure to beclomethasone
  • Vaccines (live) may have reduced efficacy

Precautions

  • Use with caution in patients with active or quiescent tuberculosis
  • Monitor for signs of adrenal insufficiency
  • Consider risks in patients with diabetes mellitus
  • Use with caution in patients with hypertension

Pregnancy

Beclomethasone is classified as category C. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Beclomethasone is excreted in breast milk, caution should be exercised when administering to nursing women.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Inhalation aerosol
  • Nasal spray
  • Topical cream
  • Topical lotion

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: inhalation

Inhalation therapy involves the administration of medication directly into the respiratory system, primarily targeting conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders. This route allows for rapid onset of action and localized effects while minimizing systemic side effects. Common inhaled medications include bronchodilators, corticosteroids, and combination therapies.

Indications

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Allergic Rhinitis
  • Cystic Fibrosis
  • Pulmonary Hypertension

Dosage

Children: Refer to specific inhaled medication guidelines for paediatric dosing.

Adults: Refer to specific inhaled medication guidelines for adult dosing.

Mechanism of action

Inhaled medications can have various mechanisms of action depending on the specific drug. For example, beta-2 adrenergic agonists stimulate beta-2 receptors on bronchial smooth muscle, leading to bronchodilation. Corticosteroids inhibit the expression of inflammatory mediators and reduce airway inflammation, while anticholinergics block acetylcholine from binding to its receptors, resulting in decreased bronchoconstriction.

Pharmacodynamics

The pharmacodynamics of inhaled medications involve their interaction with specific receptors or pathways in the lungs. Bronchodilators cause relaxation of the bronchial smooth muscle, leading to increased airflow. Corticosteroids effectively reduce inflammation and mucus production in the airways, thereby improving respiratory function and reducing exacerbations of asthma and COPD. The rapid delivery of these drugs to the site of action enhances their efficacy.

Pharmacokinetics

Inhaled medications have distinct pharmacokinetic properties. The onset of action can be very rapid, often within minutes, due to direct delivery to the lungs. The bioavailability depends on factors such as particle size, inhalation technique, and the type of inhaler used. Systemic absorption is generally lower than with oral medications, which minimizes systemic side effects. The duration of action varies based on the specific drug class; for example, short-acting beta agonists provide quick relief, while long-acting agents offer prolonged effects.

Pregnancy

Consult healthcare provider for risk assessment and guidance, as safety data may vary depending on the specific inhalation formulation.

Breast-feeding

Consult healthcare provider, as some inhalation medications may be excreted in breast milk and could affect the infant.

Storage

Store in a cool, dry place away from direct sunlight. Check specific product guidelines for temperature and humidity requirements.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: pressurized

Pressurized formulations are commonly used in various medical treatments, particularly for inhalation therapies. They deliver medication in a fine mist or aerosol form, allowing for targeted delivery to the respiratory system. These formulations are often used in the management of conditions such as asthma and chronic obstructive pulmonary disease (COPD).

Indications

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Allergic Rhinitis
  • Acute Bronchospasm
  • Exercise-Induced Bronchospasm

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing information, as it varies by medication and condition.

Adults: Refer to the specific product information for adult dosing, as it varies by medication and condition.

Mechanism of action

Pressurized drug delivery systems, such as metered-dose inhalers (MDIs), utilize propellants to create an aerosolized mist of medication. The active pharmaceutical ingredient is usually a bronchodilator, corticosteroid, or a combination, which works by relaxing bronchial smooth muscles, reducing inflammation, and improving airflow in the lungs.

Pharmacodynamics

The pharmacodynamics of pressurized inhalation therapies depend on the specific drug used. For instance, beta-2 adrenergic agonists lead to bronchodilation by stimulating beta-2 receptors in the bronchial smooth muscle, while corticosteroids reduce inflammation by inhibiting various inflammatory processes and immune responses in the airways.

Pharmacokinetics

The pharmacokinetics of drugs delivered via pressurized systems varies widely depending on the active ingredient. Generally, the onset of action is rapid due to direct delivery to the lungs, with peak effects occurring within minutes to hours. Systemic absorption may occur, though this is often limited compared to oral or intravenous routes. The half-life, metabolism, and excretion depend on the specific drug component.

Pregnancy

Use during pregnancy only if clearly needed. Assess the risks and benefits with a healthcare provider.

Breast-feeding

Use with caution. Monitor the infant for potential side effects.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: beclomethasone

PubChem CID 20469

Molecular formula: C22H29ClO5

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.