Indications

Asthma: Beclomethasone dipropionate/Formoterol fumarate dihydrate is indicated in the regular treatment of asthma when a combination product (inhaled corticosteroid and long-acting 2-agonist) is appropriate: patients who are not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled rapid-acting 2-agonist or patients who are already adequately controlled on both inhaled corticosteroids and inhaled rapid-acting.

COPD: Symptomatic treatment for patients with severe COPD (FEV1 50% predicted normal) and a history of exacerbations who have considerable symptoms despite long-acting bronchodilator medication.

Pharmacology of Betameson 20 Ointment

Inhaling beclomethasone dipropionate at prescribed levels provides a glucocorticoid anti-inflammatory effect in the lungs, resulting in fewer symptoms and exacerbations of asthma with fewer side effects than systemically taken corticosteroids. In individuals with reversible airway obstruction, formoterol is a selective 2-adrenergic agonist that relaxes bronchial smooth muscle. The bronchodilating action occurs quickly, usually within 1-3 minutes of inhalation, and lasts for 12 hours following a single dose.

Dosage of Betameson 20 Ointment

Adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations.

Children and adolescents under 18 years: The safety and efficacy in children and adolescents under 18 years of age have not been established yet. No data are available on the drug in children under 12 years of age. Therefore the drug is not recommended for children and adolescents under 18 years until further data become available.

Administration

Although using an inhaler appears to be simple, most patients are unaware of how to use it properly. When an inhaler is used incorrectly, less medication reaches the lungs. Asthma episodes can be avoided or lessened with proper and consistent usage of the inhaler.

Following simple steps can help to use Inhaler effectively (According to “National Asthma Guidelines for Medical Practitioners” published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as fully as comfortably possible & hold the inhaler upright.
5. Place the actuator into the mouth between the teeth and close the lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly and add fully to the canister to release medicine.
7. Remove the inhaler from the mouth. Continue holding your breath for at least 10 seconds or as long as it is comfortable.
8. If the doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse your mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around the mouthpiece, or you may not be breathing in as you press the can. This indicates a failure of the technique. If this happens, repeat the procedure from step 4 carefully. Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove the canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Interactions of Betameson 20 Ointment

In asthmatic individuals, beta-blockers (including eye drops) should be avoided. Formoterol’s effect will be diminished or eliminated if beta-blockers are used for medical reasons. Concurrent use of other beta-adrenergic medicines, on the other hand, can have potentially synergistic effects, thus caution is advised when theophylline or other beta-adrenergic drugs are prescribed with formoterol. Quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors, and tricyclic antidepressants might extend the QTc interval and raise the risk of ventricular arrhythmias when taken together.

Contraindications

Patients with hypersensitivity to any component of this product should avoid it.

Side Effects of Betameson 20 Ointment

Because the medicine comprises beclometasone dipropionate and formoterol fumarate dihydrate, adverse responses to each of the components are possible. Pharyngitis, oral candidiasis, headaches, and dysphonia are all common adverse effects.

Pregnancy & Lactation

There are no clinical studies on the drug’s use in pregnant women. Animal experiments using a combination of beclometasone dipropionate and formoterol showed signs of reproductive harm after high systemic exposure. There are no relevant clinical data on the drug’s use in human breastfeeding. Although no data from animal studies are available, it is plausible to infer that beclometasone dipropionate, like other corticosteroids, is released in milk.

Precautions & Warnings

In patients with cardiac arrhythmias, especially third-degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heartbeat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, particularly acute myocardial infarction, ischaemic heart disease, and congestive heart failure, the drug should be used with caution (which may include monitoring). When treating individuals with a known or suspected extension of the QTc interval (QTc >0.44 seconds), either hereditary or drug-induced, caution should be exercised. Formoterol is a drug that can be used to treat a variety of ailments.

Therapeutic Class

Respiratory corticosteroids

Storage Conditions

Store in the refrigerator (2-8°C) before giving to the patient (for a maximum of 15 months). After dispensing, keep the product at a temperature of no more than 30°C (for a maximum of 2 months).

Pharmaceutical Name of Betameson 20 Ointment

Square Pharmaceuticals Ltd