Indications of Symbion Bexicap 6/100 Capsule

Symbion® Bexicap is indicated in the regular treatment of asthma, where the use of  a  combination  (long‐acting,  beta2‐agonist  and  inhaled corticosteroid)  has  been  found to be appropriate. It is also indicated in the symptomatic treatment of severe  chronic  obstructive  pulmonary  disease  (COPD),  with  a  history  of  repeated  exacerbations despite regular therapy with long‐acting bronchodilators.

Pharmacology of Symbion Bexicap 6/100 Capsule

Budesonide is an anti-inflammatory corticosteroid with high glucocorticoid action but low mineralocorticoid activity. Inflammation has a significant role in the development of asthma. Corticosteroids suppress various cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic induced inflammation. Corticosteroids’ anti-inflammatory properties may contribute to their effectiveness in asthma.

Formoterol Fumarate Dihydrate is a long-acting, selective 2 – adrenergic agonist with a quick start of action. Inhaled Formoterol Fumarate Dihydrate BP works as a bronchodilator locally in the lungs. The pharmacological effects of 2-adrenoceptor agonist medicines are due to the activation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of ATP to cyclic AMP. Increased cyclic AMP levels relax bronchial smooth muscle and prevent the production of acute hypersensitivity mediators from cells, particularly mast cells.

Dosage & Administration of Symbion Bexicap 6/100 Capsule

Asthma

Dosage  is  individual  and  should  be  adjusted  according  to  disease  severity.  When

control has been achieved, the dose should be titrated to the lowest effective dose

For Symbion® Bexicap, there are two treatment approaches:

1. Maintenance Therapy:  Symbion®  Bexicap  is  taken  as  regular  maintenance

treatment with a separate rapid acting bronchodilator as rescue.

1. Single maintenance and reliever therapy: Symbion® Bexicap is taken as regular

maintenance and as needed in response to symptoms.

1. Maintenance Therapy:  Patients  should  be  advised  to  have  their  separate  rapid

acting bronchodilator available for rescue use at all times.

Adults (18 Years and Older)

Symbion® 6/100 Bexicap capsule: 1‐2 Bexicap capsules, twice daily

Maximum dose is 4 Bexicap capsules, twice daily

Symbion® 6/200 Bexicap capsule: 1‐2 Bexicap capsule, twice daily

Maximum dose is 4  Bexicap capsules twice daily

Adolescents (12‐17 Years)

Symbion® 6/100 Bexicap capsule: 1‐2 Bexicap capsules, twice daily

Symbion®  6/200  Bexicap: 1‐2 Bexicap capsules, twice daily

Children (6‐11 Years)

Symbion® 6/100  Bexicap: 2 Bexicap capsules, twice daily

1. Single Maintenance  and  Reliever  Therapy  (For  Symbion  6/100  Bexicap  and

6/200 only)

Patients  take  a  daily maintenance  dose  of  Symbion®  Bexicap  and in  combination

take  Symbion®  Bexicap  as  needed  in  response  to  symptoms.  Patients  should  be

advised to always have Symbion® Bexicap available for use.

Adults (18 years and older): The recommended maintenance dosage is 2 inhalations

per  day  as  maintenance  therapy  (either  one  inhalation  twice  daily,  or  two

inhalations  in  either  the  morning  or  the  evening),  although  some  patients  may

require two inhalations twice daily.

Patients should take 1 additional inhalation as needed in response to symptoms. If

symptoms persist after a few minutes, an additional inhalation should be taken.

Not more than 6 inhalations should be taken on any single occasion.

A  total  daily  dose  of  more  than  8  inhalations  is  not  normally  needed;  however,  a

total daily dose of up of 12 inhalations could be used  for a limited period. Patients

using  more  than  8  inhalations  daily  should  be  strongly  recommended  to  seek

medical advice.

COPD (Chronic Obstructive Pulmonary Disease)

Symbion® 6/200 Bexicap: 2 Bexicap capsule, twice daily

Interaction of Symbion Bexicap 6/100 Capsule

The metabolic conversion of Budesonide is impeded by substances metabolized by  CYP P450 3A4 (e.g. itraconazole, ritonavir). The concomitant administration of these  potent inhibitors of CYP P450 3A4 may increase plasma levels of Budesonide. The  concomitant use of these drugs should be avoided unless the benefit outweighs the  increased risk of systemic side‐effects.  In patients using potent CYP3A4 inhibitors,  Symbion® Bexicap maintenance and reliever therapy is not recommended.

Contraindications

Symbion® Bexicap is contraindicated in patients with a history of hypersensitivity  to any of the components of the drug product.

Side Effects of Symbion Bexicap 6/100 Capsule

Since  Symbion®  Bexicap  contains  both  Budesonide  and  Formoterol,  the  same

pattern  of  undesirable  effects  as  reported  for  these  substances  may  occur.  No

increased  incidence  of  adverse  reactions  has  been  seen  following  concurrent

administration of the two compounds.

Formoterol: Most common adverse events with Formoterol are tremor, palpitations,

headache etc. some uncommon and rare adverse events that occurred in the groups

receiving Formoterol are cardiac arrhythmias, muscle cramps, and hypersensitivity

reactions such as rash, oedema and angio‐oedema etc.

Budesonide:  The  incidence  of  common  adverse  events  with  Budesonide  are

oropharyngeal  candidiasis,  hoarseness  or  throat  irritation,    dysphonia,  back  pain,

nausea,sinusitis, adrenal suppression, etc.

Pregnancy & Lactation

Budesonide and Formoterol Fumarate administration in pregnant women and nursing mothers should be considered only if the predicted benefit to the mother outweighs any potential harm to the fetus.

Precautions & Warnings

Treatment with a combination of Budesonide and Formoterol should not be begun to treat a severe exacerbation or if patients have markedly worsening or severely deteriorating asthma.

Therapeutic Class

Respiratory corticosteroids, long-acting selective -adrenoceptor stimulants

Storage Conditions

Keep away from direct sunlight and keep in a cool, dry location. Store at temperatures no higher than 30° C. Keep out of children’s reach. Keep away from the cold.

Pharmaceutical Name of Symbion Bexicap 6/100 Capsule

Beximco Pharma Ltd

Generic of Symbion Bexicap 6/100 Capsule

Budesonide + Formoterol Fumarate Dihydrate