VILORESP Pulmicaps
FLUTCASONE FUROATE 100/200mcg and VILANTEROL 25mcg POWDER for
INHALATION
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each capsule
contains Fluticasone Furoate 100/200 mcg and Vilanterol 25 mcg.
INDICATION: Indicated for the treatment of asthma in
adults and adolescents aged 12 years and older where use of a
combination medicinal product (LABA and ICS) is appropriate: Patients
not adequately controlled with ICSs and ‘as needed’ inhaled SABA.
Patients already adequately controlled on both ICS and LABA.
DOSAGE AND METHOD OF ADMINISTRATION: VILORESP Pulmicaps
are for inhalation only and must not be swallowed. Use VILORESP
Pulmicaps with the INNOHALER. Administer one inhalation once daily at
the same time each day. Do not exceed one inhalation/24 hours.
CONTRAINDICATIONS: Contraindicated in Primary treatment
of status asthmaticus or other acute episodes of COPD or asthma and in
severe milk protein hypersensitivity or known hypersensitivity to
fluticasone furoate, vilanterol, or any excipients.
WARNING AND PRECAUTION: Vilanterol/fluticasone (V/F)
increase risks of serious asthma-related deaths when LABAs are used
alone but not when combined with ICS. Use caution in patients with
cardiovascular issues, immunosuppression, or other pre- existing
conditions, and avoid during acute episodes. Monitor for infections,
bone density, growth in children, and potential drug interactions.
UNDESIRABLE EFFECTS: May cause serious asthma-related
events (hospitalizations, intubations, death), cardiovascular effects
(palpitations, tachycardia), infections (Candida, pneumonia),
immunosuppression, adrenal suppression, bone density reduction,
hypersensitivity reactions, hyperglycemia, muscle spasms, tremors,
nervousness, and paradoxical bronchospasm.
DRUG INTERACTIONS: Use caution when using VILORESP with
strong CYP3A4 inhibitors (e.g., ketoconazole), beta-blockers, monoamine
oxidase inhibitors, and non-potassium-sparing diuretics due to increased
risks of systemic exposure, bronchospasm, potentiated cardiovascular
effects, and worsened hypokalaemia.
USE IN SPECIAL POPULATION: No dosage adjustment is
required in patients with renal impairment. Use with caution in patients
with moderate or severe hepatic impairment. There are insufficient data
on the use of fluticasone furoate or vilanterol in pregnant women.
Pregnant women using V/F should be closely monitored for risks such as
pre-eclampsia and adverse neonatal outcomes. During labor, use should be
limited due to potential beta-agonist interference with uterine
contractions unless benefits outweigh risks. In lactating women: analyze
risk benefit ration. These highlights do not include all the information
needed to use VILORESP Pulmicaps effectively and safely. Please refer to
full prescribing information [available on request].
FOR FURTHER INFORMATION, CONTACT: Medical Affairs;
Alkem House; Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra: 400
013. Prepared on 19th June 2024. Source: Prescribing Information
VILORESP Pulmicaps.