DOSAGE AND ADMINISTRATION
Inhalation
Adults
Two inhalations three or four times daily.
Children
One or two inhalations two, three or four times daily.
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Health
2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler is indicated in
the treatment of asthma, once the need for inhaled corticosteroid therapy
has been established.
Health 2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler may be used
with a Spacer device in patients who find it difficult to synchronise aerosol
actuation with inspiration of breath.
(iii) DESCRIPTION OF DOSAGE FORM
Health
2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler is a combination
of Salbutamol and Beclomethasone dipropionate.
Salbutamol is a beta-adrenergic stimulant which has a highly selective action
on the receptors in bronchial muscle resulting in bronchodilation, and in
therapeutic doses has little or no action on the cardiac receptors.
Beclomethasone is a synthetic glucocorticoid with a potent anti-inflammatory
activity and weak mineralocorticoid activity. This association of Salbutamol
and Beclomethasone is specially provided for those patients who require regular
doses of both drugs for treatment of their obstructive airways disease.
(iv)
CONTRAINDICATIONS
Hypersensitivity to any of the components of the formulation.
WARNINGS AND PRECAUTIONS
Patients should be instructed on the proper use of Health 2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler, to ensure that the drugs reach the target areas in the lungs. Patients should be made aware that Health 2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler should be used regularly for optimum benefit. However, patients should be regularly reassessed so that their continuing need for corticosteroid therapy can also be reviewed.
Health 2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler is not for use in acute attacks but for routine long-term management, so some patients will require a separate Health 2000 Salbutamol 100 mcg Inhaler for relief of acute bronchospasm. However, should the effect of the additional Health 2000 Salbutamol 100 mcg Inhaler or the relief provided by the Health 2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler last for less than four hours, patients should be advised that this may indicate that their asthma is worsening and to seek medical advice in case treatment with inhaled corticosteroids needs to be increased or treatment with systemic corticosteroids needs to be started or increased.
As there may be adverse effects associated with excessive dosing of bronchodilators the dosage or frequency of administration should only be increased on medical advice.
In the
majority of patients no significant adrenal suppression occurs until doses
of 1,600 mg of Beclomethasone dipropionate per day are exceeded. Reduction
of plasma cortisol levels has been reported in some patients who received
2,000 mg per day of inhaled Beclomethasone dipropionate.
For those patients who are steroid-dependent it is advisable to commence therapy
with Beclomethasone dipropionate (Health 2000 Beclomethasone 50 mcg Inhaler)
as a separate aerosol.
Patients who have been weaned in the previous few months from long-term systemic corticosteroids need special consideration until the hypothalamic-pituitary-adrenal system has recovered sufficiently to enable the patient to cope with emergencies such as trauma, surgery or infections.
Such patients
should carry a warning card indicating that they need supplementary systemic
steroid during periods of stress, until their adrenocortical function has
become normal. These patients should also be given a supply of oral steroid
to use in an emergency when their airways obstruction worsens.
Caution
The metal canister of the Health 2000 Salbutamol 100 mcg and Beclomethasone
50 mcg Inhaler is pressurised. It should not be broken, punctured or burnt,
even when apparently empty.
(v) SIDE EFFECTS
Salbutamol
Mild tremor and headache have been rarely reported. These usually disappear
with continued treatment. Paradoxical bronchospasm has been reported with
orally inhaled Salbutamol. Paradoxical bronchospasm frequently occurs with
the first use of a new canister. If it occurs, the therapy should be discontinued
immediately and alter-native therapy instituted.
Beclomethasone
Dipropionate
Bronchospasm, cough, and/or wheezing may occur in some patients following
oral inhalation of Beclomethasone dipropionate, especially in asthmatic patients
with hyperactive airways. Candidiasis of the mouth and throat (thrush) occurs
in some patients, the incidence of which is increased with doses greater than
400 µg of Beclomethasone dipropionate per day. Patients with high blood
levels of Candida precipitins, indicating a previous infection, are most likely
to develop this complication. Some patients may find it helpful to rinse their
mouth thoroughly with water after inhalation.
Storage
Health 2000 Salbutamol 100 mcg and Beclomethasone 50 mcg Inhaler should be
stored in a cool place but should not be refrigerated. It should be kept out
of reach of children.
(vi) TOXIC EFFECTS
BECLOMETASONE DIPROPIONATE
MUTAGENICITY
Studies have not been performed to date to evaluate the mutagenic potential
of Beclometasone dipropionate.
CARCINOGENICITY
No evidence of carcinogenicity was observed when rats were given the drug
for 95 weeks (13 weeks by oral inhalation [up to 0.4 mg/kg daily] and 82 weeks
by combined oral and inhalation routes [ up to 2.4 mg/kg daily, about 40 times
the maximum recommended human intranasal dosage on a mg/m2 basis] ).
TERATOGENICITY
No teratogenicity or embryocidal effects were seen in rats when exposed to
an inhalation dose of 0.1 mg/kg plus oral doses of up to 10 mg/kg/day for
combined daily dose of 10.1 mg/kg (approximately 97 times the maximum recommended
human daily inhalation dose on mg/m2 basis). There are no adequate and well-controlled
studies in pregnant women. Beclometasone dipropionate should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
SALBUTAMOL
MUTAGENICITY
AND CARCINOGENICITY
No mutagenic potential was found in “in vitro” tests and no carcinogenic
effects were seen in mice; in rats at very high doses an increase of benign
mesovarian leiomyomas was found, as an expression of the excessive b-blocker
pharmacological activity.
TERATOGENICITY
Salbutamol is a known teratogen in rodent species. Teratogenicity studies
have been carried out by the inhaled and oral routes in mice, rats and rabbits.
In mice and rabbits, Salbutamol showed effects at high dose levels typical
of a potent corticosteroid, e.g., retardation of fetal growth and cleft palate.
There are no adequate and well-controlled studies in pregnant women during
worldwide marketing experience, various congenital anomalies, including cleft
palate and limb defects, have been reported in the offspring of patients being
treated with Salbutamol.