Brand name
: ROTAHALER (Rotacap)
Salmeterol and Fluticasone Propionate Rotacaps
Composition
Seroflo-100 Rotacaps
Each capsule contains
Salmeterol……………………50
mcg
(As Salmeterol Xinafoate)
Fluticasone propionate BP…. 100 mcg
Excipient……………………..q.s.
Seroflo 250 Rotacaps
Each capsule contains
Salmeterol……………………50
mcg
(As Salmeterol Xinafoate)
Fluticasone propionate BP…… 250 mcg
Excipient………………………q.s.
Seroflo-500 Rotacaps
Each capsule contains
Salmeterol …………………….50
mcg
(As Salmeterol Xinafoate)
Fluticasone propionate BP….. 500 mcg
Excipient……………………..q.s.
Description
Seroflo Rotacap is a combination of Fluticasone propionate, a synthetic
corticosteroid and salmeterol; a selective long acting beta 2 -agonist.
Fluticasone propionate is a synthetic, trifluorinated glucocorticoid
with potent anti-inflammatory activity.
Salmeterol is a selective long-acting beta-2-adrenoceptor agonist with
duration of action of at least 12 hours.
Indications
Seroflo Rotacap is indicated in the regular treatment of asthma, where
use of a combination (long acting beta-2-agonist and inhaled corticosteroid)
has been found to be appropriate and in patients with severe Chronic
Obstructive Pulmonary Disease
(COPD).
Dosage and Administration
Asthma:
Adults and adolescents 12 years and over
Seroflo - 100/250/500 : One Rotacap twice daily
Children 4 years and older
Seroflo - 100: One Rotacap twice daily
Chronic Obstructive Pulmonary Disease (COPD)
Seroflo – 250/500 : One Rotacap twice daily
Seroflo Rotacap should only be inhaled with the Rotahaler device.
Contraindications
Seroflo Rotacap is contraindicated in patients with a history of hypersensitivity
to any of the component of the drug product.
Warnings and Precautions
Patients should be made aware that Seroflo must be used daily for optimum
benefit, even when asymptomatic.
Seroflo should not be used to treat acute asthma symptoms for which
a fast and short-acting bronchodilator is required. Patients should
be advised to have their relief medication available at all times.
As with all inhaled medication containing corticosteroids, Seroflo
should be administered with caution in patients with pulmonary tuberculosis.
Seroflo should be administered with caution in patients with severe
cardiovascular disorders, including heart rhythm abnormalities, diabetes
mellitus, untreated hypokalaemia or thyrotoxicosis.
Potentially serious hypokalaemia may result from systemic beta-2-agonist
therapy but following inhalation at therapeutic doses plasma levels
of salmeterol are very low.
Paradoxical bronchospasm may occur. In such case Seroflo should be
discontinued immediately, the patient assessed and alternative therapy
instituted if necessary.
Systemic effects are much less likely to occur with inhaled corticosteroids
than with oral corticosteroids. Possible systemic effects include adrenal
suppression, growth retardation in children and adolescents, decrease
in bone mineral density, cataract and glaucoma. It is important, therefore,
that the dose is titrated to the lowest dose at which effective control
is maintained.
Drug Interactions
Even though plasma levels of salmeterol and fluticasone are very low,
potential interactions with other substrates or inhibitors of CYP
3A4 cannot be excluded.
Both non-selective and selective beta-blockers should be avoided in
patients with asthma, unless there are compelling reasons for their
use.
Concomitant use of other beta-adrenergic containing drugs can have
a potentially additive effect.
Pregnancy
Use of Seroflo in pregnancy should be considered only if the expected
benefit to the mother is greater than any possible risk to the foetus.
Lactation
Use of Seroflo in women who are breastfeeding should only be considered
if the expected benefit to the mother is greater than any possible
risk to the child.
Side Effects ROTAHALER (Rotacap Dispenser)
As Seroflo contain salmeterol and fluticasone propionate, the type
and severity of side effects associated with each of the compounds
may be expected. There is no incidence of additional side effects
following concurrent administration of the two compounds.
Side effects associated with
Salmeterol:
Tremor, palpitations and headache, have been reported, but tend to
be transient and reduce with regular therapy.
Cardiac arrhythmias muscle cramps and hypersensitivity reactions, including
rash, oedema and angioedema may occur in some patients.
Side effects associated with
Fluticasone propionate:
Hoarseness and candidiasis (thrush) of the mouth and throat can occur
in some patients. Cutaneous hypersensitivity reactions have been reported.
Both hoarseness and incidence of candidiasis may be relieved by gargling
with water after use of ROTAHALER (Rotacap).
Symptomatic candidiasis can be treated with topical anti-fungal therapy
whilst still continuing with ROTAHALER (Rotacap).
Overdosage
The signs and symptoms of Seroflo overdose are tremor, headache and
tachycardia. The preferred antidotes are cardioselective beta-blocking
agents, which should be used with caution in patients with a history
of bronchospasm. If higher than recommended dosage is continued over
prolonged periods, some degree of adrenal suppression may result.
Monitoring of adrenal reserve may be necessary.
