Symbion 6/200mg Bexicap 10pcs

Indications of Symbion Bexicap 6/200 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 6/200 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 the 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 6/200 Capsule

Asthma

Dosage is individual and should be adjusted according to disease severity.  When a control has been achieved, the dose should be titrated to the lowest effective dose For Symbion® Bexicap, there are two treatment approaches:

Maintenance Therapy:  Symbion®  Bexicap is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as a rescue.

Single maintenance and reliever therapy: Symbion® Bexicap is taken as regular maintenance and as needed in response to symptoms.

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

The maximum dose is 4 Bexicap capsules, twice daily

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

The 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

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 to 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 capsules, twice daily

Interaction of Symbion Bexicap 6/200 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 6/200 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 the concurrent administration of the two compounds. 

Formoterol: Most common adverse events with Formoterol are tremors, 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, edema, and angioedema, 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.

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.