Label: IPRATROPIUM BROMIDE spray, metered

The active ingredient in ipratropium bromide nasal solution is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate (endo, syn)-, (+)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is:

Ipratropium bromide is a white to off-white crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media.

Ipratropium bromide nasal solution, 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 mcL) in an isotonic, aqueous solution. It also contains the following inactive ingredients: benzalkonium chloride, edetate disodium, purified water and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH to 4.5 to 4.9.  Each bottle contains 165 sprays.

Ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis.

The safety and effectiveness of the use of ipratropium bromide nasal solution, 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.

Ipratropium bromide nasal solution, 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.

Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with ipratropium bromide nasal solution 0.06% should be stopped at once and alternative treatment should be considered.

Adverse reaction information on ipratropium bromide nasal solution, 0.06% in patients with the common cold was derived from two multicenter, vehicle-controlled clinical trials involving 1,276 patients (195 patients on  ipratropium bromide nasal solution, 0.03%, 352 patients on ipratropium bromide nasal solution, 0.06%, 189 patients on ipratropium bromide nasal spray, 0.12%, 351 patients on vehicle and 189 patients receiving no treatment).

Table 1 shows adverse events reported for patients who received ipratropium bromide nasal solution, 0.06% at the recommended dose of 84 mcg per nostril, or vehicle, administered three or four times daily, where the incidence is 1% or greater in the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group.

 Ipratropium bromide nasal solution, 0.06% was well tolerated by most patients. The most frequently reported adverse events were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate in nature, none was considered serious, and none resulted in hospitalization. No patient required treatment for nasal dryness, and only three patients (<1%) required treatment for epistaxis, which consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly). No patient receiving ipratropium bromide nasal solution, 0.06% was discontinued from the trial due to either nasal dryness or bleeding.

Adverse events reported by less than 1% of the patients receiving ipratropium bromide nasal solution, 0.06% during the controlled clinical trials that are potentially related to ipratropium bromide's local effects or systemic anticholinergic effects include: taste perversion, nasal burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation, pharyngitis, tachycardia, thirst, tinnitus, and blurred vision. No controlled trial was conducted to address the relative incidence of adverse events for three times daily versus four times daily therapy.

Nasal adverse events seen in the clinical trial with seasonal allergic rhinitis (SAR) patients (see Table 2) were similar to those seen in the common cold trials. Additional events were reported at a higher rate in the SAR trial due in part to the longer duration of the trial and the inclusion of Upper Respiratory Tract Infection (URI) as an adverse event. In common cold trials, URI was the disease under study and not an adverse event.

There were no reports of allergic-type reactions in the controlled clinical common cold and SAR trials.

Acute overdosage by intranasal administration is unlikely since ipratropium bromide is not well absorbed systemically after intranasal or oral administration. Following administration of a 20 mg oral dose (equivalent to ingesting more than two bottles of ipratropium bromide nasal solution, 0.06%) to 10 male volunteers, no change in heart rate or blood pressure was noted. Following a 2 mg intravenous infusion over 15 minutes to the same 10 male volunteers, plasma ipratropium concentrations of 22 to 45 ng/mL were observed (>100 times the concentrations observed following intranasal administration). Following intravenous infusion these 10 volunteers had a mean increase of heart rate of 50 bpm and less than 20 mmHg change in systolic or diastolic blood pressure at the time of peak ipratropium levels.

For Symptomatic Relief of Rhinorrhea Associated with the Common Cold

The recommended dose of ipratropium bromide nasal solution, 0.06% is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of ipratropium bromide nasal solution, 0.06% for children age 5 to11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day).

The safety and effectiveness of the use of ipratropium bromide nasal solution, 0.06% beyond four days in patients with the common cold have not been established.

For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic Rhinitis

The recommended dose of ipratropium bromide nasal solution, 0.06% is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older.

The safety and effectiveness of the use of ipratropium bromide nasal solution, 0.06% beyond three weeks in patients with seasonal allergic rhinitis have not been established.

Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.

Product: 50090-5968

NDC: 50090-5968-0 165 SPRAY, METERED in a BOTTLE, PUMP / 1 in a CARTON

Ipratropium Bromide Nasal Solution, 0.06%

Nasal spray

(ip" ra troe' pee um broe' mide)

Rx Only

Read complete instructions carefully before using.

In order to ensure proper dosing, do not attempt to change the size of the spray opening.

Ipratropium Bromide Nasal Solution, 0.06% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. Do not use Ipratropium Bromide Nasal Solution, 0.06% for longer than four days for a common cold or three weeks for seasonal allergic rhinitis unless instructed by your physician.

Read complete instructions carefully and use only as directed.

To Use

1. Remove the clear plastic dust cap and the green safety clip from the nasal spray pump (Figure 1). The safety clip prevents the accidental discharge of the spray in your pocket or purse.

   

            

   Figure 1

                                                                                
2. The nasal spray pump must be primed before Ipratropium Bromide Nasal Solution, 0.06% is used for the first time. To prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. Make sure the bottle points upright and away from your eyes. Press your thumb firmly and quickly against the bottle seven times (Figure 2). The pump is now primed and can be used. Your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays. If you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays. 

   

   Figure 2

                                          
3. Before using  Ipratropium Bromide Nasal Solution, 0.06%, blow your nose gently to clear your nostrils if necessary.
4. Close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril (Figure 3). Point the tip toward the back and outer side of the nose. 

   

   Figure 3

                                                                                  
5. Press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. Following each spray, sniff deeply and breathe out through your mouth.
6. After spraying the nostril and removing the unit, tilt your 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 through 7 in the other nostril (i.e., two sprays per nostril).
9. Replace the clear plastic dust cap and safety clip.
10. At some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. You should not take extra doses or stop using Ipratropium Bromide Nasal Solution, 0.06% without consulting your physician.

To Clean

If the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. Hold the nasal tip under running, warm tap water (Figure 4) for about a minute. Dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip.

                                                 

          Figure 4 

Caution   

Ipratropium Bromide Nasal Solution, 0.06% is intended to relieve your rhinorrhea (runny nose) with regular use. It is therefore important that you use Ipratropium Bromide Nasal Solution, 0.06% as prescribed by your physician. For most patients, some improvement in runny nose is apparent following the first dose of treatment with Ipratropium Bromide Nasal Solution, 0.06%. Do not use Ipratropium Bromide Nasal Solution, 0.06% for longer than four days for your cold or three weeks for seasonal allergic rhinitis unless instructed by your physician.

Do not spray Ipratropium Bromide Nasal Solution, 0.06% in your eyes. Should this occur, immediately flush your eye with cool tap water for several minutes. If you accidentally spray Ipratropium Bromide Nasal Solution, 0.06% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. Should acute eye pain or blurred vision occur, contact your doctor.

Should you experience excessive nasal dryness or episodes of nasal bleeding, contact your doctor.

If you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using Ipratropium Bromide Nasal Solution, 0.06%.

If you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using Ipratropium Bromide Nasal Solution, 0.06%.

Address medical inquiries to Apotex Corp: (800) 706-5575.

Storage

Store tightly closed at 20°to  25°C (68° to  77°F)[See USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children.

Manufactured by:                              Manufactured for:

Apotex Inc.                                      Apotex Corp.

Toronto, Ontario                               Weston, FL

Canada M9L 1T9                              33326

May 2014