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ATROVENT nasal ® Ipratropium bromide
Atrovent nasal is prescribed for the symptomatic relief of rhinorrhoea
in allergic and non-allergic rhinitis
COMPOSITION AND PRESENTATION
1 ml. solution contains:
Ipratropium bromide monohydrate 0,31 mg.*
* equivalent to 0,30 mg. ipratropium bromide (anhydrous)
One spray releases 21,7 mcg. ipratropium bromide monohydrate, equivalent
to 21 mcg. ipratropium bromide (anhydrous).
Excipients:
Sodium chloride, benzalkonium chloride, disodium edetate, hydrochloric
acid, sodium hydroxide and purified water, q.s.
Pharmaceutical form and contents of container
ATROVENT NASAL is available as a 15 ml. spray (containing
180 metered doses).
CONTRAINDICATIONS
ATROVENT NASAL is contraindicated in patients known to be hypersensitive
to atropine or its derivatives or to any other component of the product.
PRECAUTIONS
There have been isolated reports of ocular complications (for example,
mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye
pain) when aerosolised ipratropium bromide either alone or in combination
with an adrenergic beta2-agonist, has come into contact with the eyes.
Thus patients must be instructed in the correct administration of ATROVENT
NASAL. Eye pain or discomfort, blurred vision, visual halos or coloured
images in association with red eyes from conjunctival congestion and corneal
oedema may be signs of acute narrow-angle glaucoma. Should any combination
of these symptoms develop, specialist advice should be sought immediately.
ATROVENT NASAL should be used with caution in patients predisposed to
narrow-angle glaucoma, or with prostatic hyperplasia or bladder neck obstruction.
WARNING
As patients with cystic fibrosis may be prone to gastro-intestinal motility
disturbances, ATROVENT NASAL should be used with caution in these patients.
Pregnancy and lactation:
Although preclinical studies have shown no risks, the safety of ATROVENT
NASAL during human pregnancy has not been established. The benefits of
using ATROVENT NASAL during a confirmed or suspected pregnancy must be
weighed against possible hazards to the unborn child. It is not known
whether ipratropium bromide is excreted into human milk. It is unlikely
that ipratropium bromide would reach the infant to an important extent,
when taken intranasally. However, because many drugs are excreted into
human milk, caution should be exercised when ATROVENT NASAL is administered
to nursing mothers.
Effects on ability to drive:
None known.
POSOLOGY
The usual recommended dosage is as follows:
Adults and adolescents over 12 years of age:
2 sprays into each nostril two or three times a day.
Children from 6 to 12 years of age:
2 sprays into each nostril two times a day.
However optimum dosage varies with the response of the
individual patient and should be determined by a doctor.
PATIENT'S INSTRUCTIONS FOR USE
1. Remove protective cap.
2. Before using the spray pump for the first time, activate
repeatedly (about seven times) until an even spray mist is released. To
activate the pump, hold the bottle between the thumb and index and middle
fingers. Make sure the bottle points upright and away from the eyes. Press
thumb firmly and quickly against the bottle. The pump is now ready for
use. If the pump has not been used for more than 24 hours, you will have
to activate the bottle again by one or two sprays.
3. Before using the Atrovent nasal spray, blow your nose
to clear nostrils.
4. Close one nostril by gently placing a finger against
the side of the nose, tilt the head slightly forward. While holding the
bottle as shown in figure 1, insert the tip into the other nostril (see
fig. 2). Point the tip toward the back and outer side of the nose.
5. Activate the pump once by pressing firmly and quickly
upwards with the thumb. Following each spray, sniff deeply and breathe
out through the mouth.
6. After spraying the nostril and removing the tip, tilt
the head backwards for a few seconds to let the spray spread over the
back of the nose.
7. Repeat steps 4 through 6 in the same nostril.
8. Repeat steps 4 to 7 in the other nostril.
9. Replace protective cap after use.
If ATROVENT NASAL is accidentally sprayed
into the eyes, immediately flush the eyes with cool tap water. If the
nasal tip becomes clogged, remove the protective cap. Hold the nasal tip
under running, warm tap water for about a minute. Dry the nasal tip, activate
the nasal spray pump (step 2 above) and replace the protective cap.
INTERACTIONS
The concomitant use of ATROVENT NASAL with other drugs commonly prescribed
for perennial rhinitis, such as antihistamines, decongestants or nasal
steroids does not increase the incidence of side effects. ATROVENT NASAL
is minimally absorbed into the systemic circulation; nonetheless, there
is some potential for additive interaction with other concomitantly administered
anticholinergic medications, including ipratropium bromide-containing
aerosols for oral inhalation.
OVERDOSE
No symptoms specific to overdose have been encountered. In view of the
wide therapeutic range and topical administration of ATROVENT NASAL, no
serious anticholinergic symptoms are to be expected. Minor systemic manifestation
of anticholinergic action, including dry mouth, visual accommodation disturbances
and increase of heart rate may occur.
ADVERSE EFFECTS
The most frequent local undesirable effects of ATROVENT NASAL are nasal
reactions including epistaxis, dryness of the nose and nasal irritation.
Headache, nausea and local irritation (e.g. burning sensation) may occur
as non-specific reactions in association with use of ATROVENT NASAL. Potential
systemic anticholinergic effects are dry mouth and dry throat. Ocular
side effects (mydriasis, increased intraocular pressure, narrow-angle
glaucoma, eye pain, blurred vision or visual accommodation disturbances),
increase of heart rate and palpitations, urinary retention and gastrointestinal
motility disturbances have been reported in isolated patients in association
with use of ipratropium bromide either intranasally or after oral inhalation.
Allergic-type reactions such as skin rash, angioedema and urticaria may
occur. If you experience any other adverse reaction not mentioned above,
please talk to your doctor or pharmacist.
Expiry
This medication must not be used after the expiry date indicated on the
carton
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