Actions of Fusiwal-B in details
Pharmacology: Fusiwal-B inhalation powder contains beclomethasone dipropionate, which is a synthetic steroid derivative. The clinical efficacy of beclomethasone dipropionate in the treatment of asthma is based on its strong topical anti-inflammatory activity on the mucosa of the lungs. Inhaled beclomethasone dipropionate has not been found to have the systemic effects typical of steroids at daily doses <1500 mcg. Long-term studies have shown that after the initiation of inhaled beclomethasone dipropionate in patients with bronchial asthma, the dose of systemic corticosteroids may be constantly reduced. There is no evidence that Fusiwal-B would damage tracheobronchial mucosa or increase the incidence of respiratory infections. Approximately 10-25% of the inhaled drug dose reaches the lungs and the biggest fraction of the dose is retained in the upper airways and mouth and is swallowed.
Fusiwal-B treatment should be regular because the beneficial effects of the medication will appear only after a few days' use and the maximal effect will be attained only after several weeks. Beclomethasone dipropionate has no effect in an acute attack.
When shifting from freon-based metered dose aerosols to inhalation powders, it is optimal to choose a dispenser, which is used in the same way as the patient's previous inhaler except for the hand-lung coordination. Also similarity of the drug doses between the new and previous dispenser is an advantage to the patient.
The clinical efficacy and tolerability of Fusiwal-B are the same as those of a corresponding dose of beclomethasone dipropionate from a freon-based inhalation aerosol given through an inhalation chamber.
How should I take Fusiwal-B?
This section provides information on the proper use of a number of products that contain beclomethasone. It may not be specific to Fusiwal-B. Please read with care.
Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine is only used in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, rinse it off right away and call your doctor.
To use the spray:
- When you use the medicine for the first time or if you have not used this medicine for 7 days in a row, you must prime the spray. Press down fully on the top of the canister four times or until a fine spray comes out.
- After you prime the nasal spray, there will only be 120 doses or sprays.
- Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
- Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril.
- Hold your breath for a few seconds then breathe out slowly through your mouth.
- Spray the opposite nostril using the same steps.
- Do not blow your nose after using the spray.
- Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.
- Do not remove the canister from the actuator. Qnasl™ nasal aerosol canister should only be used with the Qnasl™ nasal aerosol actuator.
- Throw this medicine away after you use 120 sprays or when the dose indicator read zero "0".
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal dosage form (spray):
- For treatment of allergic rhinitis:
- Adults and children 12 years of age and older—2 sprays in each nostril once a day. Each spray contains 80 micrograms (mcg).
- Adults and children 4 to 11 years of age—1 spray in each nostril once a day.
- Children younger than 4 years of age—Use and dose must be determined by your doctor.
- For treatment of allergic rhinitis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Fusiwal-B administration
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe use, and directions for priming and disposal of the nasal spray. Ask your doctor or pharmacist if you have any questions.
The usual dose of Fusiwal-B is 1 to 2 sprays into each nostril once per day. Follow your doctor's instructions. Shake the Fusiwal-B bottle well just before each use.
The usual dose of Qnasl is 2 sprays into each nostril once per day. Follow your doctor's instructions.
It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.
To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.
Store in an upright position at room temperature, away from moisture and heat.
Throw away the Fusiwal-B nasal spray after you have used 180 sprays, even if there is still medicine left in the bottle.
Throw away the Qnasl nasal spray after you have used 120 sprays, or if the dose indicator shows a zero.
Fusiwal-B pharmacology
Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic halogenated corticosteroid. Animal studies show that beclomethasone dipropionate has potent glucocorticoid and weak mineralocorticoid activity.
The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. The precise mechanism of the aerosolized drug's action in the nose is also unknown. Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally. The effect of beclomethasone dipropionate on hypothalamic-pituitary-adrenal (HPA) function have been evaluated in adult volunteers by other routes of administration. Studies with beclomethasone dipropionate by the intranasal route which may demonstrate that there is more or that there is less absorption by this route of administration. There was no suppression of early morning plasma cortisol concentrations when beclomethasone dipropionate was administered in a dose of 1000 mcg per day for 1 month as an oral aerosol or for 3 days by IM injection. However, partial suppression of plasma cortisol concentration was observed when beclomethasone dipropionate was administered in doses of 2000 mcg per day either by oral aerosol or intramuscular injection form. Immediate suppression of plasma cortisol concentrations was observed after single doses of 4000 mcg of beclomethasone dipropionate. Suppression of HPA function (reduced early morning plasma cortisol levels) has been reported in adult patients who received 1600-mcg daily doses of oral beclomethasone dipropionate for 1 month. In clinical studies using beclomethasone dipropionate intranasally, there was no evidence of adrenal insufficiency.
The effect of beclomethasone dipropionate nasal spray on HPA function was not evaluated but would not be expected to differ from intranasal beclomethasone dipropionate aerosol.
In one study in asthmatic children, the administration of inhaled beclomethasone at recommended daily doses for at least 1 year was associated with a reduction in nocturnal cortisol secretion. The clinical significance of this finding is not clear. It reinforces other evidence, however, that topical beclomethasone may be absorbed in amounts that can have systemic effects and that physicians should be alert for evidence of systemic effects, especially in chronically treated patients.
Beclomethasone dipropionate is sparingly soluble. When given by nasal inhalation in the form of an aqueous or aerosolized suspension, the drug is deposited primarily in the nasal passages. A portion of the drug is swallowed. Absorption occurs rapidly from all respiratory and gastrointestinal tissues. There is no evidence of tissue storage of beclomethasone dipropionate or its metabolites. In vitro studies have shown that tissue other than the liver (lung slices) can rapidly metabolize beclomethasone dipropionate to beclomethasone 17- monopropionate and more slowly to free becloethasone (which has very weak anti-inflammatory activity). However, irrespective of the route of entry, the principal route of excretion of the drug and its metabolites is the feces. In humans, 12% to 15% of an orally administered dose of beclomethasone dipropionate is excreted in the urine as both conjugated and free metabolites of the drug.
Studies have shown that the degree of binding to plasma proteins is 87%.
References
- NCIt. "Fusidic Acid: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- EPA DSStox. "Fusidic acid: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
