BECLOMETHASONE NASAL SPRAY SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BECLOMETHASONE DIPROPIONATE

Available from:

APOTEX INC

ATC code:

R01AD01

INN (International Name):

BECLOMETHASONE

Dosage:

50MCG

Pharmaceutical form:

SUSPENSION

Composition:

BECLOMETHASONE DIPROPIONATE 50MCG

Administration route:

NASAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

CORTICOSTEROIDS

Product summary:

Active ingredient group (AIG) number: 0106320002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-18

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
BECLOMETHASONE NASAL SPRAY
Beclomethasone Dipropionate Aqueous Suspension
50 mcg / ACT
(0.05% w / w)
Apotex Standard
Corticosteroid for Nasal Use
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
September 18, 2020
WESTON, ONTARIO
M9L 1T9
CONTROL NUMBER: 238573
2
PRODUCT MONOGRAPH
PR
BECLOMETHASONE NASAL SPRAY
Beclomethasone Dipropionate Aqueous Suspension
50 mcg / ACT
(0.05% w / w)
Apotex Standard
THERAPEUTIC CLASSIFICATION
Corticosteroid for Nasal Use
ACTIONS AND CLINICAL PHARMACOLOGY
Beclomethasone dipropionate is a potent anti-inflammatory steroid with
strong topical and weak
systemic activity. When inhaled intranasally at therapeutic doses, it
has a direct anti-
inflammatory action within the nasal mucosa, the mechanism of which is
not yet completely
defined. The minute amount absorbed in therapeutic doses has not been
shown to exert any
apparent clinical systemic effects.
INDICATIONS AND CLINICAL USE
BECLOMETHASONE NASAL SPRAY (beclomethasone dipropionate) is indicated
for treatment of
perennial and seasonal allergic rhinitis, poorly responsive to
conventional treatment.
Beclomethasone dipropionate can significantly delay the recurrence of
nasal polyps in those
patients who have undergone nasal polypectomy. In those patients in
whom polyps do recur,
beclomethasone dipropionate aqueous suspension can prevent their
increase in size.
CONTRAINDICATIONS
BECLOMETHASONE NASAL SPRAY (beclomethasone dipropionate) is
contraindicated for
patients with: active or quiescent tuberculosis of the respiratory
tract or; untreated fungal,
bacterial or viral infections.
BECLOMETHASONE NASAL SPRAY is also contraindicated in patients with a
history of
3
hypersensitivity to any of the ingredients of these preparations.
WARNINGS
Careful attention must be given to patients previously treated for
prolonged periods with systemic
corticosteroids. Transfer to BECLOMETHASONE NASAL SPRAY
(beclomethasone
dipropionate) may cause withdrawal symptoms, e.g., joint and/or
muscular pain, lassitude and
depression. In severe