Beclate Inhaler 200

BECLATE INHALER 200 by CIPLA LTD

Name

Brand Name: BECLATE INHALER 200 Common Name: Beclomethasone Dipropionate Inhalation Aerosol

Composition

Each actuation of BECLATE INHALER 200 delivers 200 mcg of Beclomethasone Dipropionate IP, suspended in propellant HFA 134a.

Uses

BECLATE INHALER 200 is a corticosteroid primarily used for the prophylactic management and long-term control of asthma symptoms in adults and adolescents. It helps in preventing symptoms like wheezing, shortness of breath, chest tightness, and coughing by reducing inflammation and swelling in the airways. It is also used to prevent or control symptoms of Chronic Obstructive Pulmonary Disease (COPD). This inhaler is not intended for immediate relief during an acute asthma attack.

Dosage and Administration

BECLATE INHALER 200 is for oral inhalation only and should be used regularly as prescribed, even when asymptomatic.

• Adults and Adolescents (12 years and older):
  • Mild Asthma: 100 to 200 micrograms per day in two divided doses.
  • Moderate Asthma: 200 to 400 micrograms per day in two divided doses.
  • Severe Asthma: 400 to 800 micrograms per day in two divided doses. The maximum recommended dose is 800 mcg per day in divided doses.

Administration Instructions: Shake the inhaler well before use. Prime the device by releasing two puffs into the air if using for the first time or if not used for more than 10 days. Place the mouthpiece in your mouth, seal with your lips, and inhale slowly and deeply while pressing down on the canister. Hold your breath for 5-10 seconds, then exhale slowly. Rinse your mouth with water after each use to help prevent oral thrush.

Side Effects

Common Side Effects:

• Hoarseness of voice
• Sore throat
• Oral thrush (white spots in the mouth and throat)
• Difficulty in swallowing
• Change in taste
• Cough
• Throat irritation

Serious Side Effects (seek immediate medical attention if experienced):

• Paradoxical bronchospasm (immediate increase in wheezing after dosing)
• Severe allergic reactions (sudden wheezing, shortness of breath, skin rash, swelling of face/lips/tongue/throat)
• Worsening of wheezing
• Blurred vision or other vision disturbances (may indicate ocular toxicities like glaucoma)

Precautions

• Do not stop treatment abruptly; dosage should be tapered slowly under medical supervision.
• Use with caution in patients with active or quiescent pulmonary tuberculosis, or other lung infections.
• Special care is necessary when transferring patients from systemic steroid therapy to inhaled beclomethasone, as adrenal insufficiency may occur. Patients should carry a steroid warning card.
• Inform your doctor if you are pregnant, breastfeeding, or have liver problems, kidney problems, weak bones, a weak immune system, or have recently had surgery.
• Avoid concomitant use with strong CYP3A inhibitors (e.g., ritonavir, cobicistat) as it may increase systemic effects.
• BECLATE INHALER 200 is generally not recommended for children younger than 12 years of age due to lack of safety data.
• This medication is a "preventer" and will not stop an asthma attack that has already started; a fast-acting bronchodilator (reliever inhaler) is needed for acute symptoms.

Storage

Store BECLATE INHALER 200 at room temperature, below 30°C. Keep it in a cool and dry place, away from direct sunlight, excessive heat, or cold, and do not refrigerate. Keep out of the sight and reach of children.

What is BECLATE INHALER 200 used for?

BECLATE INHALER 200 is a corticosteroid medication primarily used for the long-term management and prevention of asthma symptoms and chronic obstructive pulmonary disease (COPD). It helps to control symptoms such as wheezing, shortness of breath, chest tightness, and coughing. This inhaler is a "preventer" and is not intended for the immediate relief of acute asthma attacks. For sudden asthma attacks, a fast-acting rescue inhaler should be used.

How does BECLATE INHALER 200 work?

BECLATE INHALER 200 contains Beclomethasone Dipropionate, which is a prodrug that is rapidly converted into an active monoester (17-BMP) within the body. This active metabolite is a potent corticosteroid that works by reducing and preventing inflammation and swelling in the lungs and airways. It achieves this by stopping the release of certain chemical messengers from cells in the lungs and breathing passages that trigger inflammatory reactions, thereby widening the airways and making breathing easier.

What is the usual dosage for BECLATE INHALER 200?

The dosage of BECLATE INHALER 200 can vary depending on the severity of the asthma and should always be determined by a doctor. For adults and adolescents, typical daily doses range from 100 to 800 micrograms, usually taken in two divided doses. For mild asthma, it might be 100 to 200 micrograms per day; for moderate asthma, 200 to 400 micrograms per day; and for severe asthma, 400 to 800 micrograms per day. It is crucial to use the inhaler regularly, even when asymptomatic, and to ensure proper inhalation technique for optimal delivery of the medication to the lungs. The lowest effective dose should be maintained once symptoms are under control.

What are the possible side effects of BECLATE INHALER 200?

Common side effects of BECLATE INHALER 200 may include oral thrush (white spots in the mouth and throat), hoarseness of voice, sore throat, cough, and a change in taste. To minimize the risk of oral thrush, it is recommended to rinse your mouth thoroughly with water and spit it out after each use of the inhaler. Less common but more serious side effects can include severe allergic reactions (such as sudden wheezing, rash, itching, or swelling of the face, lips, tongue, or throat), paradoxical bronchospasm (immediate worsening of breathing after use), blurred vision, glaucoma (increased intraocular pressure), and, in rare cases with prolonged high doses, systemic effects like Cushing's syndrome. If any persistent or worsening side effects occur, medical advice should be sought.

Is BECLATE INHALER 200 safe during pregnancy or breastfeeding?

There is inadequate evidence regarding the safety of beclomethasone dipropionate during human pregnancy or lactation. It is advised to inform your doctor if you are pregnant, suspect you may be pregnant, or are breastfeeding before using BECLATE INHALER 200. Your doctor will weigh the potential benefits against any possible risks to the mother and baby before prescribing. While small amounts of beclomethasone may be excreted in breast milk, the potential for significant levels is considered low at the dosages used for direct inhalation.

Can BECLATE INHALER 200 be taken with other medications?

Beclomethasone is generally less dependent on CYP3A metabolism compared to some other corticosteroids, making drug interactions unlikely in general. However, caution and appropriate monitoring are advised with the concomitant use of strong CYP3A inhibitors (e.g., ritonavir, cobicistat), as systemic effects cannot be entirely excluded. BECLATE Inhaler contains a small amount of ethanol, so a theoretical potential for interaction exists in particularly sensitive patients taking disulfiram or metronidazole. Always inform your doctor about all medications and supplements you are currently taking.

What precautions should be taken while using BECLATE INHALER 200?

Several precautions should be observed when using BECLATE INHALER 200. It should not be stopped abruptly. Patients should rinse their mouth with water after each use to help prevent oral thrush. It is crucial to use the correct inhaler technique to ensure the medication reaches the lungs effectively. Special care is necessary for patients with active or quiescent pulmonary tuberculosis, liver problems, or a weak immune system. Caution is also advised for patients with a history of cataracts, glaucoma, or increased intraocular pressure, as the medicine may worsen these conditions. Children receiving prolonged treatment with inhaled corticosteroids should have their height regularly monitored due to the possibility of growth retardation. If transferring from oral steroid therapy, careful monitoring of adrenocortical function is necessary.

What happens if a dose of BECLATE INHALER 200 is missed?

If you miss a dose of BECLATE INHALER 200, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Consistent daily use is important for effective asthma control.

How should BECLATE INHALER 200 be stored?

BECLATE INHALER 200 should be stored in a cool and dry place, away from direct sunlight. It should be kept out of the sight and reach of children. The product information typically recommends storing it at room temperature, generally below 30°C, and advises against refrigeration. Do not store or use near an open flame or discard in an incinerator.