Berosynt

Uses

Berosynt is used for the treatment of the symptoms of seasonal allergic rhinitis in patients aged 6 years and older and perennial allergic rhinitis in patients aged 12 years and older.

Berosynt is also used to associated treatment for these conditions: Asthma, Bronchoconstriction, Chronic Obstructive Pulmonary Disease (COPD), Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis

How Berosynt works

Glucocorticoids such as ciclesonide can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of glucocorticoids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Berosynt reduces inflammatory reaction by limiting the capillary dilatation and permeability of the vascular structures. These compounds restrict the accumulation of polymorphonuclear leukocytes and macrophages and reduce the release of vasoactive kinins. Recent research suggests that corticosteroids may inhibit the release of arachidonic acid from phospholipids, thereby reducing the formation of prostaglandins. Berosynt is a glucocorticoid receptor agonist. On binding, the corticoreceptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing an increase or decrease in expression of specific target genes, including suppression of IL2 (interleukin 2) expression.

Dosage

Berosynt dosage

1 spray (50 micrograms/spray) in each nostril once a day. The maximum total daily dosage should not exceed 2 sprays in each nostril (200 micrograms/day).

Priming information- Gently shake the bottle and prime Berosynt by actuating eight times before using for the first time or when not used for 4 consecutive days.

How to use the Nasal Spray

1. Tear the foil pouch at the indicated point.

2. Shake the bottle gently and remove the dust cover.

3. Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. If using for the first time or if you have not used it for 4 days or more, press the nasal applicator several times until a fine mist comes out from the container.

4. Gently blow the nose to clear the nostrils.

5. Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white collar of nasal applicator firmly down once to release a spray.

6. Breathe out through your mouth.

7. Repeat the above steps in the same/other nostril for consecutive doses.

Cleaning

The nasal spray should be cleaned at least once a week. The procedures are as follows -

Remove the dust cover. Gently pull off the nasal applicator. Wash the applicator and dust cover in warm water. Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat. Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Side Effects

Berosynt nasal spray is absorbed less into rest of the body; therefore fewer side effects are seen. However, few side-effects like headache, dizziness, nosebleed, stuffy nose, earache may occur.

Precaution

Berosynt nasal spray should be used with caution in patients with active or quiescent tuberculosis infection of the respiratory tract or in patients with untreated fungal, bacterial or systemic viral infections or ocular herpes simplex. Rare instances of nasal septal perforation, cataract, and glaucoma have been reported following intranasal application. Development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. Although systemic effects have been minimal with recommended doses of Berosynt nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Berosynt nasal spray should be avoided.

Interaction

Co-administration with a potent inhibitor of the cytochrome P450 3A4 system (e.g. ketoconazole, itraconazole and ritonavir or nelfinavir) should be considered with caution. The risk of clinical adverse effect (eg cushingoid syndrome) cannot be excluded.

Food Interaction

Berosynt Drug Interaction

Minor: budesonide / formoterol, albuterolUnknown: ipratropium, sulfamethoxazole / trimethoprim, ubiquinone, copper gluconate, chondroitin / glucosamine / methylsulfonylmethane, glycerin, escitalopram, metoprolol, metoprolol, nitroglycerin, acetaminophen, bioflavonoids, topiramate, thiamine, cyanocobalamin, ascorbic acid, cholecalciferol, cetirizine

Berosynt Disease Interaction

Moderate: hyperadrenocorticism, infections, ocular herpes simplex, ocular toxicities

Elimination Route

Berosynt and des-ciclesonide have negligible oral bioavailability (both less than 1%) due to low gastrointestinal absorption and high first-pass metabolism. The intranasal administration of ciclesonide at recommended doses results in negligible serum concentrations of ciclesonide.

Clearance

• 152 L/hr [Following IV administration of 800 mcg of ciclesonide]

Pregnancy & Breastfeeding use

Pregnancy: Pregnancy category C. Berosynt nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

Lactation: It is not known if Berosynt is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when administered to nursing women.

Contraindication

Primary treatment of severe acute asthma or status asthmaticus where intensive measures are needed.

Special Warning

There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (e.g. higher doses of Berosynt or a course of oral corticosteroids). Severe asthma exacerbations should be managed in the usual way.

Storage Condition

Store at a temperature not exceeding 30°C. Do not refrigerate. Protect from light and moisture. Keep away from eyes. Keep out of the reach of children. The bottle should be discarded after 120 actuations or 4 months after opening the pouch.

Innovators Monograph

You find simplified version here Berosynt