Consumer medicine information

Atrovent Nasal

Ipratropium bromide

BRAND INFORMATION

Brand name

Atrovent Nasal, Atrovent Nasal Forte

Active ingredient

Ipratropium bromide

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Atrovent Nasal.

What is in this leaflet

This leaflet answers some common questions about Atrovent Nasal.

It does not contain all available information.

It does not take the place of talking to your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware.

Keep this information with your nasal spray. You may need to read it again later.

To find out more about Atrovent Nasal

You should ask your doctor or pharmacist if you have any questions about your medicine or if you have any trouble before, during or after using Atrovent Nasal.

What Atrovent Nasal is used for

Atrovent Nasal relieves the symptoms of a persistent runny nose associated with allergic rhinitis (hayfever) and non-allergic non-seasonal rhinitis.

Atrovent Nasal relieves a runny nose by acting directly on the mucous glands of the nose to decrease watery secretions.

Atrovent Nasal is known as an anticholinergic medicine. It belongs to one of several types of medicines used to treat the symptoms of rhinitis.

Before you use Atrovent Nasal

When not to use Atrovent Nasal

Do not use Atrovent Nasal if you are allergic to it or to any of the ingredients. These ingredients are listed in full at the end of this leaflet.

In some cases you should not use Atrovent Nasal if you are allergic to certain other medicines.

You must tell your doctor or pharmacist if you are allergic to any other medicine, particularly atropine or other anticholinergic medicines.

If you are uncertain as to whether you have these allergies you should raise those concerns with your doctor or pharmacist.

You should not use Atrovent Nasal if the packaging is torn or shows signs of tampering.

You should never use Atrovent Nasal after the EXPIRY DATE on the bottle or carton.

If you use it after the expiry date has passed, it may not work as well.

Before you start to use Atrovent Nasal

Before using Atrovent Nasal, you must tell your doctor or pharmacist if you have, or have had, any of the following conditions:

  • an eye problem called "glaucoma"
  • enlargement of the prostate gland
  • problems with passing urine
  • cystic fibrosis.

If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor or pharmacist.

Atrovent Nasal spray contains the (antimicrobial) preservative benzalkonium chloride which may cause irritation of the nasal lining (mucosa).

Before using Atrovent Nasal it is advisable to tell your doctor or pharmacist if you are taking any other medicines, obtained with or without a doctor's prescription, including medicines you buy from a pharmacy, supermarket or health food shop. In particular, you should tell your doctor if you are taking any other medicine containing ipratropium bromide or another anticholinergic agent such as atropine, hyoscine or hyoscyamine.

Pregnancy

Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication. Care is recommended during pregnancy, particularly in the first three months. The benefits of Atrovent Nasal must be assessed against any risks. Your doctor will discuss the risks and benefits of using Atrovent Nasal while you are pregnant.

Breastfeeding

Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication. Care is recommended if you are breastfeeding as it is not known if the active ingredient in Atrovent Nasal may pass into breast milk. The benefits of Atrovent Nasal must be assessed against any risks. Your doctor will discuss the risks and benefits of using Atrovent Nasal while you are breastfeeding.

Children

There is not enough information available to recommend the use of Atrovent Nasal in children under 12 years of age.

Using Atrovent Nasal

How to use Atrovent Nasal

At the end of this leaflet you will find directions on how to use Atrovent Nasal. Ask your doctor or pharmacist for advice if you have any problems with using this medicine.

Never spray Atrovent Nasal in or around your eyes. If you accidentally spray Atrovent Nasal into your eyes, you may have temporary blurring of vision and increased sensitivity to light, lasting up to a few hours.

Contact your doctor immediately for advice as to what treatment is needed.

Recommended Dose

Adults and children 12 years of age and over:

2 to 4 sprays into each nostril two or three times daily (at regular intervals).

If your doctor or pharmacist has changed this dose you should ask for further information from your doctor or pharmacist.

Do not take extra doses of Atrovent Nasal without consulting your doctor or pharmacist.

If you forget to take a dose

It is important to use Atrovent Nasal as directed.

If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time.

Overdose

Seek medical advice if you have used more than the recommended or prescribed dose of Atrovent Nasal.

Immediately telephone your doctor, pharmacist or the Poisons Information Centre (telephone 13 11 26 in Australia).

Do this even if there are no signs of discomfort or poisoning.

Signs of overdose may include increased heart rate, dry mouth, and blurred vision.

While using Atrovent Nasal

Things you must do

Contact your doctor immediately if you experience eye pain or discomfort, or any disturbances with your sight (blurred vision, visual halos or coloured images) during or after using Atrovent Nasal.

If the spray from Atrovent Nasal comes into direct contact with the eyes, it may cause eye pain, blurring of vision and increased sensitivity to light.

It may also cause a more serious eye problem, known as glaucoma, to develop or worsen. The following symptoms may be associated with glaucoma: red eyes, eye pain or discomfort, sight disturbances (blurred vision, visual halos or coloured images).

Therefore, it is very important to follow the Directions For Use carefully and avoid contact with the eyes.

Tell your doctor or pharmacist if you begin taking any other medicine while you are using Atrovent Nasal.

If symptoms persist, seek medical advice.

Things you must not do

Do not use Atrovent Nasal when the medicine is running out and it is no longer possible to obtain a firm spray.

Ability to Drive or Operate Machinery

If side effects are experienced such as dizziness, blurred vision or dilated pupils (mydriasis) whilst using Atrovent Nasal sprays do not drive or operate machinery.

Side effects

You should be aware that all medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing.

Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of using this medicine.

Adverse effects are usually mild to moderate and transient.

Reported side effects of Atrovent Nasal include:

  • dryness of the nose, nose bleeds, nasal irritation.
  • headache, nausea and local irritation (such as a burning sensation)
  • dry mouth, sore mouth and swelling of the mouth
  • sore throat, discomfort when swallowing (also known as pharyngitis), swelling of the throat and throat irritation (e.g. dry throat)
  • infections of the air passages.
  • eye disturbances such as red eyes, eye pain or discomfort, blurred vision, visual halos or coloured images, increased sensitivity to light
  • fast or irregular heart beat
  • change in bowel movements
  • urinary retention (difficulty passing urine).
  • allergic reactions such as skin rash, swelling of the tongue, lips and face, and difficulty breathing.
  • Serious allergic (anaphylactoid) reactions have also been reported.

Tell your doctor or pharmacist as soon as possible if you experience any side effects during or after using Atrovent Nasal, so that these may be properly treated. In addition, unexpected effects, not listed above, can occur with any medicine.

You should tell your doctor or pharmacist if you notice anything unusual, during or after using Atrovent Nasal.

After using Atrovent Nasal

Care and cleaning

It is recommended that the spray adaptor be cleaned after use.

Storage

Atrovent Nasal should be kept in a cool, dry place where the temperature stays below 25°C.

Do not store in direct sunlight or heat and protect from freezing.

Keep Atrovent Nasal where young children cannot reach it.

Disposal

If you will not be needing Atrovent Nasal anymore, the unused medicine should be returned to your pharmacist so that it can be disposed of safely.

Product Description

What Atrovent Nasal is

Atrovent Nasal is the brand name of your medicine. It is a clear, colourless solution in amber glass bottles. Each bottle contains 15 mL of solution which provides at least 180 metered doses.

Atrovent Nasal is identified by an Australian Registration Number and this number appears on the pack (AUST R 53362).

Ingredients

Each spray of Atrovent Nasal contains

22 micrograms of ipratropium bromide monohydrate [equivalent to ipratropium bromide 21 micrograms] in purified water.

Other ingredients include:

  • benzalkonium chloride as a preservative
  • disodium edetate
  • sodium chloride (salt)
  • sodium hydroxide
  • hydrochloric acid

Manufacturer

Atrovent Nasal is made in Italy and supplied in Australia by:

Sanofi Consumer Healthcare,
87 Yarraman Place, Virginia,
Qld 4014 Australia.
Toll-free: 1800 818 806

Date of preparation: 08 August 2019

atrovent-ccds0260-00-cmiv6-08aug19

Atrovent® Nasal

Ipratropium bromide monohydrate

Directions For Use

Important Information:

Read complete directions carefully and use only as directed.

Do not spray in or around your eyes.

Do not pierce the nozzle or attempt to enlarge the hole. The hole in the nozzle is a special size to allow the correct dose of Atrovent Nasal to enter your nostril when you depress the spray pump.

Do not shake the bottle.

To Use:

  1. Remove protective cap.
  2. Before using the spray pump for the first time, rapidly activate the spray pump 5 to 7 times until an even spray mist is released (see Figure 1). Your Atrovent Nasal is now primed and ready for use.

With subsequent use, the spray pump is immediately functional. However, if the spray pump has not been used for more than 24 hours, it will require repriming.
  1. Blow nose thoroughly before using the nasal spray.
  2. Keeping the bottle upright, insert the spray adaptor into the nostril and activate the spray pump firmly while breathing in gently through the nose (see Figure 2).
Administer the number of sprays as recommended or as prescribed by your doctor or pharmacist and then repeat in the other nostril.

  1. Replace protective cap after use.
  2. Store upright
  3. To Clean:
If the nasal tip becomes clogged, remove protective cap. Hold the nasal tip under running, warm tap water (see Figure 3) for about a minute. Dry the nasal tip, reprime the nasal pump spray (step 2 above), and replace the protective cap.

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Atrovent Nasal, Atrovent Nasal Forte

Active ingredient

Ipratropium bromide

Schedule

S2

 

Name of the medicine

Ipratropium bromide.

Excipients.

Benzalkonium chloride, disodium edetate, sodium chloride, sodium hydroxide, hydrochloric acid and purified water.

Description

Chemical name.

(1R,3r,5S,8r)-8-isopropyl- 3-(±)-tropoyloxytropanium bromide. Molecular formula: C20H30NO3Br. MW: 412.37.
Ipratropium bromide is a synthetic quaternary ammonium compound, chemically related to atropine.
The addition of an N-isopropyl group distinguishes the molecule from atropine and is responsible for a lower lipid solubility. The compound is freely soluble in lower alcohols and water, existing in an ionised state in aqueous solutions.
Atrovent Nasal spray is available in two strengths in a pH adjusted (pH 4.0 to 5.0) isotonic aqueous solution.
Atrovent Nasal - 0.03% ipratropium bromide (22 microgram per metered dose); and
Atrovent Nasal Forte - 0.06% ipratropium bromide (44 microgram per metered dose).
Both products also contain benzalkonium chloride, disodium edetate, sodium chloride, sodium hydroxide, hydrochloric acid and purified water.

Pharmacology

Ipratropium bromide is an anticholinergic agent which inhibits vagally mediated reflexes by antagonising the action of acetylcholine. In humans ipratropium bromide has antisecretory properties and, when applied locally, inhibits secretions from the serous and seromucous glands lining the nasal mucosa, at dosages below those at which neurologic, ophthalmic, cardiovascular and gastrointestinal effects are usually seen.
Intranasal ipratropium bromide is effective in controlling the severity and duration of rhinorrhoea in patients with allergic and nonallergic perennial rhinitis and the common cold.
Nasal provocation trials in perennial rhinitis patients using Atrovent Nasal showed a dose dependent increase in inhibition of methacholine induced nasal secretion with an onset of action within minutes.
Ipratropium bromide does not alter physiologic nasal functions (e.g. sense of smell, ciliary beat frequency, mucociliary clearance or the air conditioning capacity of the nose), as shown in controlled clinical trials with intranasal fluorocarbon propelled Atrovent metered aerosol.

Pharmacokinetics.

Ipratropium bromide is a quaternary amine that is poorly absorbed into the systemic circulation from the nasal mucosa. The active ingredient is absorbed very quickly and peak plasma concentrations are reached only minutes after inhalation.
Renal excretion of the active ingredient is given as 46% of the dose after intravenous administration, 3% of the dose after oral inhalation, and 3 to 5% of the dose after single intranasal administration.
The systemic absorption of ipratropium bromide across inflamed nasal mucosa due to the common cold was not altered. Following chronic dosing in rhinitis patients the amount of unchanged ipratropium bromide excreted in the urine over a 24 hour period at steady state was 3 to 6% of the dose.
The drug is minimally (less than 20%) bound to plasma proteins. The ipratropium ion does not cross the blood-brain barrier, consistent with the quaternary amine structure of the molecule.
The systemic bioavailability after intranasal administration as estimated from renal excretion is less than 13% of the dose.
The basic pharmacokinetic parameters were calculated from the plasma level data after intravenous administration. A rapid biphasic decline in plasma is noted for ipratropium. The half-life of the terminal elimination phase was about 1.6 hours. The half-life for elimination of the active ingredient and the metabolites was 3.6 hours, as determined by radiolabelling. The main metabolites found in the urine bind poorly to the muscarinic receptor. The total clearance of the active ingredient is 2.3 L/minute. Approximately 40% of clearance is renal (0.9 L/minute) and 60% non-renal i.e. mainly hepatometabolic. The volume of distribution (Vz) is 338 L (approximately 4.6 L/kg).

Clinical Trials

Studies on the relief of rhinorrhoea associated with the common cold.

There were two pivotal double blind, randomised clinical trials (00729A and 00730A), which assessed the safety and efficacy of Atrovent Nasal sprays on the symptomatic relief of rhinorrhoea associated with the common cold. A total of 1276 patients were involved in these studies.
The primary endpoints in the two studies were the objective measure of rhinorrhoea using nasal discharge weights and the subjective measurement of the severity of rhinorrhoea by the patient's assessments of rhinorrhoea, sneezing and nasal congestion using a visual analog scale.
In trial 00729A, patients received either two sprays of Atrovent Nasal Forte (88 microgram/nostril) or placebo, four times daily for four days. In trial 00730A, patients received no treatment or two sprays of Atrovent Nasal (44 microgram/nostril), Atrovent Nasal Forte (88 microgram/nostril), or 0.12% (176 microgram/nostril), or saline vehicle three times daily for four consecutive days.
In trial 00729A, it was demonstrated that treatment with Atrovent Nasal Forte resulted in less nasal discharge, with a difference between the groups of 14% on day 1, 23% on day 2 and 18% for the average of the two test days. This difference achieved statistical significance on day 2 (p = 0.01) as well as for the average of the two days (p = 0.02). Excluding patients with relatively minor rhinorrhoea, among patients with at least 1.0 g of nasal discharge at baseline, the average difference between the two groups on the two days was even greater, 23% (p = 0.003).
The patient's daily assessment of symptoms of rhinorrhoea, nasal congestion and sneezing for the four days of treatment indicated that treatment with Atrovent Nasal Forte resulted in an improvement in rhinorrhoea which was significantly better than that with placebo over the first two days (p = 0.02) and approached significance over the last two days (p = 0.06). There was no difference between the two treatment groups with respect to sneezing and nasal congestion.
In trial 00730A, it was demonstrated that all groups showed a substantial reduction in nasal discharge weight from baseline which persisted through the six hour observation period postdose in day 1 and the three hour period postdose on day 2. The reduction was significantly greater for those groups receiving blinded treatment, including vehicle, compared to the no treatment group. Treatment with Atrovent Nasal 88 microgram/nostril and 176 microgram/nostril resulted in significantly less nasal discharge than vehicle (p < 0.02), with a difference in mean hourly discharge weight ranging from 21% to 35% for the 88 microgram/nostril group and 26% to 33% for the 176 microgram/nostril group.
The patient's daily assessment of severity of rhinorrhoea indicated that treatment with Atrovent Nasal sprays produced a dose related improvement in rhinorrhoea over the vehicle for the average of days 1 and 2, and for the average of days 3 and 4. This difference between Atrovent Nasal sprays and vehicle achieved statistical significance for all three Atrovent groups on days 1 and 2 and, for the higher dose groups, on days 3 and 4. The results of the analysis of sneezing and nasal congestion in all groups showed a slight improvement over the treatment period, however there were no statistically significant differences noted among the treatment groups.

Studies on the relief of rhinorrhoea associated with allergic and nonallergic perennial rhinitis.

Trials 00612A and 00847A were double blind parallel group studies in patients with allergic perennial rhinitis. In trial 00612A, patients received Atrovent Nasal Forte (88 microgram/nostril, three times daily), and Atrovent Nasal (44 microgram/nostril, three times daily) or placebo. In trial 00847A, patients received Atrovent Nasal Forte (88 microgram/nostril, twice daily), Atrovent Nasal 0.12% (176 microgram/nostril, twice daily), or placebo.
The studies indicated that doses of 44, 88 and 176 microgram/nostril were significantly better in reducing both the severity and duration of rhinorrhoea (p < 0.01) than placebo, averaged over an eight week treatment period. No significant difference was found between the different strengths of Atrovent solutions. The reduction in the severity and duration was maintained in all treatment groups with significant differences between Atrovent and placebo occurring either in the first two to three weeks or throughout the eight weeks. There is no evidence of an increased advantage of using a 176 microgram dose in more severe rhinorrhoea. Furthermore, Atrovent Nasal sprays were well tolerated in patients who received treatment for up to 12 months.
Trial 00848A was a double blind, parallel group study in patients with nonallergic perennial rhinitis. In this trial, patients received Atrovent Nasal Forte (88 microgram/nostril, twice daily), Atrovent Nasal 0.12% (176 microgram/nostril twice daily), or placebo, for an eight week treatment period. Doses of 176 microgram and 88 microgram/nostril were effective when administered twice daily. Although the majority of patients (> 80%) tolerated the 176 microgram/nostril dose well, 10% to 17% of patients experienced excessive nasal dryness (greater than placebo) when maintained on a fixed dosing regimen of Atrovent nasal spray 88 microgram or 176 microgram/nostril twice daily.
The safety and efficacy of Atrovent Nasal and Atrovent Nasal Forte beyond 12 months in patients with perennial rhinitis has not been established.

Indications

Atrovent Nasal and Atrovent Nasal Forte are indicated for the symptomatic relief of rhinorrhoea associated with allergic and nonallergic perennial rhinitis, and the common cold.

Contraindications

Known hypersensitivity to atropine or its derivatives, or to any of the ingredients of Atrovent Nasal and Atrovent Nasal Forte.

Precautions

General.

Atrovent Nasal sprays should be used with caution in patients predisposed to narrow angle glaucoma, or with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder neck obstruction). Patients with cystic fibrosis using anticholinergics may be more prone to gastrointestinal motility disturbances.
Atrovent Nasal sprays contains the (antimicrobial) preservative benzalkonium chloride which may cause irritation of the nasal mucosa.
There have been isolated reports of ocular complications (mydriasis, increased intraocular pressure, narrow angle glaucoma, eye pain) as a result of direct eye contact with ipratropium bromide aerosol formulations. Thus, patients must be instructed in the correct administration of Atrovent Nasal sprays and should be reminded to read and follow the directions for use in the Consumer Medicine Information leaflet carefully.
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, treatment with miotic drops should be initiated and specialist advice sought immediately.
Immediate hypersensitivity reactions may occur after administration of Atrovent Nasal sprays, as demonstrated by rare cases of urticaria, angio-edema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

Use in children.

The safety and effectiveness of Atrovent Nasal and Atrovent Nasal Forte in patients below the age of 12 years has not been established.

Effects on ability to drive and use machines.

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment with Atrovent Nasal sprays. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.

Effects on fertility.

Clinical data on fertility are not available for ipratropium bromide.

Use in pregnancy.

(Category B1)
The safety of Atrovent Nasal and Atrovent Nasal Forte administered during pregnancy has not yet been established. The benefits of using Atrovent Nasal sprays when pregnancy is present or suspected must be weighed against possible hazards to the fetus.
Studies of rats, mice and rabbits showed no embryotoxic or teratogenic effects following inhalation at doses considerably higher than those recommended to man. Animal reproduction studies have shown no evidence of embryotoxic or teratogenic effects as a result of ipratropium bromide at oral doses up to 10 mg/kg/day (mice and rabbits) and 90 mg/kg/day (rats), or inhalation doses up to 1.5 mg/kg/day (rats) and 1.8 mg/kg/day (rabbits). In male and female rats, a slight increase in resorption rate was observed with oral doses of 90 mg/kg/day.

Use in lactation.

It is not known whether ipratropium bromide is excreted in human milk. Although lipid insoluble quaternary cations pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to an important extent, especially when taken intranasally. However, since many drugs are excreted in human breast milk, caution should be exercised when Atrovent Nasal and Atrovent Nasal Forte are administered to a nursing mother.

Interactions

There is no evidence that the concomitant use of Atrovent Nasal sprays with other drugs commonly prescribed for perennial rhinitis (antihistamines, decongestants and nasal steroids) and the common cold (decongestants), increases the incidence of side effects.
Atrovent Nasal sprays are minimally absorbed into the systemic circulation; nonetheless, there is some potential for an additive interaction with other concomitantly administered anticholinergic medications, including ipratropium bromide containing aerosols for oral inhalation.

Adverse Effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of Atrovent Nasal sprays. As with all topical therapy Atrovent Nasal spray may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during postapproval use of the drug.
The most frequent side effects reported in clinical trials were epistaxis, nasal dryness, headache, nasal discomfort and throat irritation.
Adverse events are usually mild to moderate and transient. In the majority of cases, nasal dryness and epistaxis resolved with continued treatment or a dose reduction. There was no evidence of nasal rebound (a clinically significant increase in rhinorrhoea, posterior nasal drip, sneezing or nasal congestion severity compared to baseline) upon discontinuation of double blind therapy in the clinical trials. There were no drug related serious or anticholinergic adverse reactions with the exception of dry mouth.

Immune system disorders.

Anaphylactic reaction; hypersensitivity.

Nervous system disorders.

Headache; dizziness.

Eye disorder.

Accommodation disorder; mydriasis; intraocular pressure increased; glaucoma; eye pain; vision blurred; halo vision; conjunctival hyperaemia; corneal oedema.

Cardiac disorders.

Supraventricular tachycardia; atrial fibrillation; heart rate increased; palpitations.

Respiratory, thoracic and mediastinal disorders.

Epistaxis; nasal dryness; throat irritation; nasal discomfort; dry throat; bronchospasm; laryngospasm; pharyngeal oedema.

Gastrointestinal disorders.

Dry mouth; nausea; gastrointestinal motility disorder (including reports of change in bowel motions and habits, dyspepsia, gastrointestinal reflux and flatulence)1; oedema mouth; stomatitis.

Skin and subcutaneous tissue disorders.

Rash; angioedema; pruritus; urticaria.

Renal and urinary disorders.

Urinary retention.
1 The definition is based on a post hoc review of all ADR terms reported in the defined study dataset. Terms that report a clinically related term with greater medical specificity were excluded and added to the more specific term (e.g. nausea, vomiting).

Atrovent Nasal.

Percentages of adverse events reported in controlled clinical trials for 705 patients with perennial rhinitis who received Atrovent Nasal (44 microgram/ nostril) or placebo two or three times daily, where the prevalence in the Atrovent group is 2.0% or greater and exceeds the prevalence in the placebo group, are listed below. Percentage prevalences in placebo patients are provided in parentheses.
Headache 9.8% (9.2%); upper respiratory tract infection 9.8% (7.2%); pharyngitis 8.1% (4.6%); epistaxis 9.0% (4.6%); nasal dryness 5.1% (0.9%); nasal irritation 2.0% (1.7%); other nasal symptoms 3.1% (1.7%); nausea 2.2% (0.9%).

Atrovent Nasal Forte.

Adverse reaction information on Atrovent Nasal Forte is derived from two controlled clinical trials involving 1276 patients with the common cold. Of these patients, 352 patients received Atrovent Nasal Forte at the recommended dose of 88 microgram per nostril, and 351 patients received placebo administered three or four times daily. The list below indicates the frequency of adverse events reported by patients who received Atrovent Nasal Forte or placebo where the prevalence in the Atrovent group is 1% or greater and exceeds the prevalence in the placebo group (percentage prevalences in placebo patients are provided in parentheses).
Epistaxis 5.4% (1.4%); blood tinged nasal mucus 2.8% (0.9%); dry mouth/ throat 1.4% (0.3%); nasal congestion 1.1% (0.0%); nasal dryness 4.8% (2.8%).
Atrovent Nasal Forte was well tolerated by most patients. The most frequently reported adverse reactions were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate in nature, none requiring hospitalisation. No patient required treatment for nasal dryness, and three patients (< 1%) required treatment for epistaxis, which consisted of local application of pressure or a moisturising agent. No patient discontinued from the trial due to either nasal dryness or bleeding.
The following list indicates the frequency of adverse events from pooled perennial rhinitis controlled studies reported by patients who received Atrovent Nasal Forte or placebo where the prevalence in the Atrovent group is 2% or greater (percentage prevalences in placebo patients are provided in parentheses).
Epistaxis 8.3% (5.1%); blood tinged nasal mucus 4.9% (2.4%); dry mouth/ throat 3.1% (0.3%); nasal congestion 2.8% (1.2%); nasal dryness 9.2% (3.3%); pharyngitis 5.5% (1.8%); taste perversion 4.9% (1.2%); coughing 2.8% (1.2%); myalgia 2.2% (0.9%).

Dosage and Administration

For symptomatic relief of rhinorrhoea associated with allergic or nonallergic perennial rhinitis.

Adults and children 12 years of age and over.

The recommended dose is 44 microgram to 88 microgram into each nostril 2 to 3 times a day. This is equivalent to 2 to 4 sprays of Atrovent Nasal or 1 to 2 sprays of Atrovent Nasal Forte into each nostril, 2 to 3 times a day.
The dose may be reduced when symptoms of rhinorrhoea improve.

For symptomatic relief of rhinorrhoea associated with the common cold.

Adults and children 12 years of age and over.

The recommended dose is 88 microgram into each nostril 3 to 4 times a day. This is equivalent to 4 sprays of Atrovent Nasal or 2 sprays of Atrovent Nasal Forte into each nostril, 3 to 4 times a day. Treatment for the common cold should be limited to 4 days.
The dose may be reduced when symptoms of rhinorrhoea improve.

Overdosage

Acute overdosage by intranasal administration is unlikely since ipratropium bromide is not well absorbed systemically after intranasal or oral administration. No symptoms of specific overdosage have been encountered. In view of the wide therapeutic range and topical administration of Atrovent Nasal sprays, no serious anticholinergic symptoms are expected. Minor systemic signs of anticholinergic action including dry mouth, visual accommodation disorder and tachycardia may occur. Should signs of serious anticholinergic toxicity appear, cholinesterase inhibitors may be considered.

Presentation

Atrovent Nasal is supplied in pump-activated, metered dose containers of 15 mL (180 metered doses), containing 314 microgram/mL ipratropium bromide. Each valve actuation delivers 70 microL [22 microgram of ipratropium bromide equivalent to ipratropium bromide (anhydrous) 21 microgram] of the solution.
Atrovent Nasal Forte is supplied in pump-activated, metered dose containers of 10 mL (120 metered doses) and 15 mL (180 metered doses), containing 626.2 microgram/mL ipratropium bromide. Each valve actuation delivers 70 microL [44 microgram ipratropium bromide equivalent to ipratropium bromide (anhydrous) 42 microgram] of the solution.

Storage

Atrovent Nasal sprays should be protected from heat and subzero temperatures. Store below 25°C.

Poison Schedule

S2.