Breon Acucap^®

Breon@Acucap is the preparation of Vilanterol and Fluticasone Furoate. Vilanterol is a LABA. The pharmacologic effects of betaæadrenoceptor agonist drugs, including Vilanterol, are  at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3',5' adenosine  monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells,
especially from mast cells. Fluticasone Furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids have been shown to have a wide ran e of actions on multiple cell types and mediators involved in inflammation. Specific effects of Fluticasone Furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB. These anti-inflammatory actions of corticosteroids may contribute to their efficacy.

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Indication
Breon@Acucap is indicated for-
• Maintenance treatment of chronic obstructive pulmonary disease (COPD)
• Treatment of asthma Breon@Acucap is not indicated for the
relief of acute bronchospasm.

Route of administration: Breon Acucap should be administered by the orally inhaled route only.

Special instruction: Breon@Acucap should be used at the same time every day. Do not use Breon@Acucap more than 1 time every 24 hours. After inhalation, the patient should rinse the mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis. Acucap must not be swallowed. Only to be used with aculizer.

Chronic obstructive pulmonary disease: Breon@Acucap 25/100 should be administered as 1 inhalation once daily. The maximum recommended dose is I inhalation of Breon@Acucap 25/100 once daily, the only strength indicated for the treatment of COPD. If shortness of breath occurs in the period between doses, an inhaled, short acting betaæagonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Asthma: The recommended starting dose is Breon@Acucap 25/100 or Breon@Acucap 25/200 administered as1 inhalation once daily. The maximum  recommended dose is 1 inhalation of Breon@Acucap 25/200 once daily. For patients who do not respond adequately to Breon@Acucap 25/100, increasing the dose to Breon@Acucap 25/200 may provide additional improvement in asthma control. If asthma symptoms arise in the period between doses, an inhaled, short acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Geriatric use: NO adjustment Of the dosage of this combination in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out.

Hepatic impairment: Use this combination with caution in patients with moderate or severe hepatic impairment.

Renal impairment: No dosage adjustment is required in patients with renal impairment.

Pregnancy: There are insufficient data on the use of this combination in pregnant women. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. Because of the potential for beta-agonist interference with uterine contractility, use of this combination during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. Lactation: There is no information available on the presence of fluticasone furoate or vilanterol in human milk, the effects on the breastfed child or the effects on milk production. Low concentrations of other ICS have been detected in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this combination and any potential adverse effects on the breastfed child from fluticasone furoate or vilanterol or from the underlying maternal condition. Use in children and adolescents The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.

Lactation: There is no information available on the presence of fluticasone furoate or vilanterol in human milk, the effects on the breastfed child or the effects on milk production. Low
concentrations of other ICS have been detected in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for
this combination and any potential adverse effects on the breastfed child from fluticasone furoate or vilanterol or from the underlying maternal condition.

Use in children and adolescents: The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.

Indacaterol increases the risk of asthma related death. So, it is not indicated for the treatment of asthma. Do not initiate in acutely deteriorating COPD or to treat acute symptoms. If paradoxical bronchospasm occurs, discontinue this combination immediately and institute alternative therapy. Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, sensitivity to sympathomimetic drugs, diabetes mellitus and ketoacidosis. Use with caution in patients with narrow angle glaucoma, prostatic hyperplasia or bladder neck obstruction. Be alert to hypokale mia and hyperglycemia.

LABA monotherapy increases the risk of serious asthma related events. Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms. Do not use in combination with an additional medicine containing a LABA because of risk of overdose. Increased risk of pneumonia in patients with COPD. Monitor patients for signs Here is the extracted text from the image:and symptoms of pneumonia. Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. There is risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to this combination. Hypercorticism and adrenal suppression may occur with very high doses or at the regular dose in susceptible individuals. If such changes occur, discontinue this combination slowly. If paradoxical bronchospasm occurs, discontinue this combination and institute alternative therapy. Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. Assess for decrease in bone mineral density initially and periodically thereafter. Glaucoma and cataracts may occur with long term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use this combination long term. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis. Increased blood glucose levels have been reported. Also, be alert to hypokalemia.

This combination is contraindicated in patients with known hypersensitivity to vilanterol and fluticasone furoate or any components of this product. It is also contraindicated in patients with primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.

Drug interaction with medication:
When used with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole), it may cause systemic corticosteroid and cardiovascular effects. When used with monoamine oxidase inhibitors and tricyclic antidepressants, use with extreme caution because it may potentiate effect of vilanterol on vascular system. Use cautiously when used with beta-blockers, because it may block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Electrocardiographic changes and/or hypokalemia associated with non-potassium sparing diuretics may worsen with concomitant beta-agonists.

Drug interaction with food and others: Not applicable.

No human overdose data has been reported for this combination. Treatment of overdose consists of discontinuation of this combination together with the institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdose.

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Breon Acucap 25/100 Inhalar: Each Acucap capsule contains Vilanterol 25 mcg as Vilanterol Trifenatate INN and Fluticasone Furoate INN 100 mcg.

Breon Acucap 25/200 Inhaler: Each Acucap capsule contains Vilanterol 25 mcg as Vilanterol Trifenatate INN and
Fluticasone Furoate INN 200 mcg.

Store in a cool below 25C) and dry place protected from light. Keep away from the reach of children.

Packing

BreonAcucap 25/100 Inhaler:Carton of 30 Acucap capsules in blister pack

BreonAcucap 25/200 Inhaler:Carton of 30 Acucap capsules in blister pack