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Ipratropium Bromide

Brand name: ATROVENT nasal ®

 

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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

Ipratropium Bromide is available as a 15 ml. spray (containing 180 metered doses).

ACTIVITY

Ipratropium BromideL relieves the symptoms of rhinitis, such as sneezing, nasal congestion and runny nose.

INDICATIONS

Ipratropium Bromide is indicated for the symptomatic relief of rhinorrhoea in allergic and non-allergic rhinitis.

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CONTRAINDICATIONS

Ipratropium Bromide 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 Ipratropium Bromide. 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. Ipratropium Bromide 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, Ipratropium Bromide should be used with caution in these patients.

Pregnancy and lactation:
Although preclinical studies have shown no risks, the safety of Ipratropium Bromide during human pregnancy has not been established. The benefits of using Ipratropium Bromide 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 Ipratropium Bromide is administered to nursing mothers.

Effects of Ipratropium Bromide on ability to drive:
None known.

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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 Ipratropium Bromide 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 Ipratropium Bromide 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.

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INTERACTIONS

The concomitant use of Ipratropium Bromide with other drugs commonly prescribed for perennial rhinitis, such as antihistamines, decongestants or nasal steroids does not increase the incidence of side effects. Ipratropium Bromide 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 Ipratropium Bromide, 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 Ipratropium Bromide 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 Ipratropium Bromide. 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

Ipratropium Bromide must not be used after the expiry date indicated on the carton

 

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