Decomit

Decomit

beclometasone

Manufacturer:

Beximco Pharma

Distributor:

Pharmatech Resources
Full Prescribing Info
Contents
Beclomethasone diproprionate.
Description
Beclomethasone dipropionate BP, the active ingredient of Decomit nasal spray, is an anti-inflammatory steroid having the chemical name 9-chloro-11β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione, 17,21-dipropionate. Decomit nasal spray is a metered dose manual pump spray unit containing a microcrystalline suspension of Beclomethasone Dipropionate in a mixture of suspending agents.
Action
Pharmacology:Pharmacodynamics: Beclomethasone inhibits the adherence of neutrophils and monocyte-macrophages to the capillary endothelial cells of the inflamed area. It blocks the effect of macrophage migration inhibitory factor. Beclomethasone also decreases the activation of plasminogen to plasmin and by inhibition of phospholipase A2 activity it reduces the formation of prostaglandins and leucotrienes in the local tissue.
Pharmacokinetics: Beclomethasone Dipropionate (BDP) given intranasally (200 μg) to volunteers was not detectable in plasma or urine. It is transformed slowly and incompletely to 17-Beclomathasone monopropionate (17-BMP) when incubated with bronchial secretions in vitro. When incubated with human lung tissue, BDP is rapidly hydrolyzed (half-life of 10 min.) in the presence of lysosomal esterases to 17-BMP, which has a half-life of 12 h. 17-BMP is very stable in lung tissue with only 10% being converted to beclomethasone after 2 h.
Indications/Uses
Decomit nasal spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever and vasomotor rhinitis. Beclomethasone Dipropionate nasal spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal.
Dosage/Direction for Use
Adults and children: The recommended dosage is two applications into each nostril twice daily. For same patients, a dosage regimen of a single application into each nostril three or four times daily may be preferred. Total daily administration should not normally exceed eight applications.
For full therapeutic benefit, regular usage is essential. The cooperation of the patient should be sought to comply with the regular dosage schedule and it should be explained that maximum effect may not be obtained within the first few applications.
For children under six years, there are insufficient clinical data to recommend use.
Administration: Decomit nasal spray is for administration by the intranasal route only.
Contraindications
Decomit nasal spray is contraindicated in patients with a history of hypersensitivity to any of its components.
Special Precautions
Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Decomit nasal spray.
Care must be taken while transferring patients from systemic steroid treatment to Decomit nasal spray if there is any reason to suppose that their adrenal function is impaired.
Systemic effects may rarely occur. These include hypothalamic-pituitary-adrenal (HPA) suppression and growth retardation in children.
Although Decomit nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances necessitate appropriate additional therapy particularly to control eye symptoms.
Use In Pregnancy & Lactation
Use in Pregnancy: Beclomethasone Dipropionate has been given to pregnant women for the duration of pregnancy without evidence of any fetal abnormalities, although cleft palate has been observed in animal tests.
Side Effects
As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.
Rare cases of raised intra-ocular pressure or glaucoma in association with intranasal formulations of beclomethasone dipropionate have been reported.
Drug Interactions
None is known.
Caution For Usage
Instructions for Use: Before using: 1. Shake the bottle gently, then remove the dust cap.
2. Hold the bottle with forefinger and middle finger on either side of the nozzle and thumb underneath the bottle.
3. Before using Nasal Spray for the first time, or if have not used it for a longer period, follow the instructions as follows.
With the nozzle pointing away, press several times until a fine uniform mist comes out of the nozzle.
4. Blow nose gently.
5. Close one nostril and put the nozzle in other nostril. Tilt head slightly forward keeping the nozzle in the upright position.
6. Start to breathe in through the nose and while breathing in, press down with the fingers once to release a spray.
7. Breathe out through the mouth. Repeat steps 6 and 7 to have a second spray.
8. Repeat steps 5, 6 and 7 for the other nostril.
9. After use: Wipe the nozzle with a clean cloth and replace the dust cap.
Note: The first time use of Nasal Spray, patient may sneeze a few times. This is because the lining of the nose is very sensitive. This is not likely to happen after the first few dose.
Decomit can, at times cause, a few side effects in certain hypersensitive individuals. If patient notice any bleeding from the nose or experience any other discomfort, please inform physician.
Cleansing: Nasal Spray should be cleaned at least once a week.
1. Push the nozzle upwards to detach from the bottle.
2. Wash the nozzle and dust cap in warm water. Shake off excess water and leave to dry in a warm place. Avoid excessive heat.
3. Replace the nozzle and dust cap.
4. If the nozzle becomes blocked, remove it and soak in warm water. Rinse under a cold tap. Allow to dry and refit. Do not use a pin or other sharp objects to unblock the nozzle.
Note for Users: 1. Use Nasal spray as directed by physician. Do not exceed the recommended dose.
2. It takes a few days for the medicine to work hence, it is very important that the patient uses it regularly. Do not stop treatment even if the patient feels better unless told by the physician.
3. This medicine has been specially recommended by the physician for the patient. Do not allow any other person to use it.
4. Keep Nasal Spray out of reach of children.
Storage
Decomit nasal spray shoud be stored at a temperature below 30°C but do not refrigerate.
Protect from frost and direct sunlight.
Shelf-Life:
2 months on opening.
ATC Classification
R01AD01 - beclometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Nasal spray 50 mcg/dose x 200 doses.
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