Albuterol Sulfate (Page 4 of 5)

OVERDOSAGE

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.

Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate inhalation aerosol. Treatment consists of discontinuation of albuterol sulfate inhalation aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol sulfate inhalation aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). The inhalation median lethal dose has not been determined in animals.

DOSAGE AND ADMINISTRATION

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. Each actuation of albuterol sulfate inhalation aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.

Albuterol sulfate Inhalation Aerosol contains 200 inhalations per canister. The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the background behind the number in the dose indicator display window changes to red at 20 actuations or lower. Albuterol sulfate Inhalation Aerosol should be discarded when the dose indicator display window shows zero.

Exercise Induced Bronchospasm Prevention

The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise.

To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see PRECAUTIONS, Information for Patients section). Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage.

If a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

HOW SUPPLIED

Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with an attached dose indicator, a light blue plastic actuator and dark blue dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 0054-0742-87).

Rx only. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, canister should be at room temperature before use.

SHAKE WELL BEFORE USING.

The light blue actuator supplied with albuterol sulfate inhalation aerosolshould not be used with any other product canisters, and actuator from other products should not be used with albuterol sulfate inhalation aerosolcanister. The correct amount of medication in each canister cannot be assured after 200 actuations, and when the dose indicator display window shows zero, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.

Albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Manufactured by Aeropharm GmbH
D-07407 Rudolstadt, Germany

Distributed by: Hikma
Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Rev. July 2021

46293491

INSTRUCTIONS FOR USE Albuterol Sulfate Inhalation Aerosol With Dose Indicator (al bue’ter ol sul’fate)

Read this Instructions for Use before you start using albuterol sulfate inhalation aerosol and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Your doctor should show you how your child should use albuterol sulfate inhalation aerosol.

Important Information:

Albuterol sulfate inhalation aerosol is for oral inhalation use only.
Take albuterol sulfate inhalation aerosol exactly as your doctor tells you to.

Albuterol sulfate inhalation aerosol comes as a canister with a dose indicator. The dose indicator is located on the top of the canister that fits into an actuator (See Figure A). The dose indicator display window will show you how many puffs of medicine you have left. A puff of medicine is released each time you press the center of the dose indicator.

Do not use the Albuterol Sulfate Inhalation Aerosol actuator with a canister of medicine from any other inhaler.
Do not use the Albuterol Sulfate Inhalation Aerosol canister with an actuator from any other inhaler.
Fig-A
(click image for full-size original)

Figure A

Before you use albuterol sulfate inhalation aerosol for the first time make sure that the pointer on the dose indicator is pointing to the right of the “200” inhalation mark in the dose indicator display window (See Figure A).

Each canister of albuterol sulfate inhalation aerosol contains 200 puffs of medicine. This does not include the sprays of medicine used for priming your inhaler.

The dose indicator display window will continue to move after every 10 puffs.
The number in the dose indicator display window will continue to change after every 20 puffs.
The color in the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure B). This is when you need to refill your prescription or ask your doctor if you need another prescription for albuterol sulfate inhalation aerosol.
Fig-B
(click image for full-size original)

Figure B

Priming your albuterol sulfate inhalation aerosol inhaler: Before you use albuterol sulfate inhalation aerosol for the first time, you should prime your inhaler. If you do not use your albuterol sulfate inhalation aerosol for more than 2 weeks, you should re-prime it before use.

Remove the cap from the mouthpiece (See Figure C). Check inside the mouthpiece for objects before use.
Make sure the canister is fully inserted into the actuator.
Hold the inhaler in an upright position away from your face and shake the inhaler well.
Press down fully on the center of the dose indicator to release a spray of medicine. You may hear a soft click from the dose indicator as it counts down during use.
Repeat the priming step 3 more times to release a total of 4 sprays of medicine. Shake the inhaler well before each priming spray.
After the 4 priming sprays, the dose indicator should be pointing to 200. There are now 200 puffs of medicine left in the canister.
Your inhaler is now ready to use.

Using your albuterol sulfate inhalation aerosol inhaler:

Step 1: Shake the inhaler well before each use. Remove the cap from the mouthpiece (see Figure C). Check inside the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

Fig-C
(click image for full-size original)

Figure C

Step 2: Breathe out as fully as you comfortably can through your mouth. Hold the inhaler in the upright position with the mouthpiece pointing towards you and place the mouthpiece fully into the mouth (See Figure D). Close your lips around the mouthpiece.

Fig-D
(click image for full-size original)

Figure D

Step 3: While breathing in deeply and slowly, press down on the center of the dose indicator with your index finger until the canister stops moving in the actuator and a puff of medicine has been released (See Figure D). Then stop pressing the dose indicator.

Step 4: Hold your breath as long as you comfortably can, up to 10 seconds. Remove the inhaler from your mouth, and then breathe out.

Step 5: If your doctor has prescribed additional puffs of albuterol sulfate inhalation aerosol , wait 1 minute, then shake the inhaler well. Repeat steps 3 through 5 in the section “Using your albuterol sulfate inhalation aerosol inhaler”.

Step 6: Replace the cap right away after use.

Cleaning your albuterol sulfate inhalation aerosol inhaler:

It is very important that you keep the mouthpiece clean so that medicine will not build up and block the spray through the mouthpiece. Clean the mouthpiece 1 time each week or if your mouthpiece becomes blocked (See Figure F).

Step 1: Remove the canister from the actuator and take the cap off the mouthpiece. Do not clean the metal canister or let it get wet.

Step 2: Wash the mouthpiece through the top and bottom with warm running water for 30 seconds (See Figure E).

Fig-E
(click image for full-size original)

Figure E

Step 3: Shake off as much water from the mouthpiece as you can.

Step 4: Look in the mouthpiece to make sure any medicine buildup has been completely washed away. If the mouthpiece is blocked with buildup, little to no medicine will come out of the mouthpiece (See Figure F). If there is any buildup, repeat Steps 2 through 4 in the section “Cleaning your albuterol sulfate inhalation aerosol inhaler”.

Fig-F
(click image for full-size original)

Figure F

Step 5: Let the mouthpiece air-dry such as overnight (See Figure G). Do not put the canister back into the actuator if it is still wet.

Fig-G
(click image for full-size original)

Figure G

Step 6: When the mouthpiece is dry, put the canister back in the actuator and put the cap on the mouthpiece.

Note: If you need to use your albuterol sulfate inhalation aerosol inhaler before it is completely dry, put the canister back in the actuator and shake the inhaler well. Press down on the center of the dose indicator 2 times to release a total of 2 sprays into the air, away from your face. Take your dose as prescribed then clean and air-dry your inhaler as described in the section “Cleaning your albuterol sulfate inhalation aerosol inhaler”.

How should I store albuterol sulfate inhalation aerosol?

Store albuterol sulfate inhalation aerosol at room temperature between 20° to 25°C (68° to 77°F).
Store with the mouthpiece down.
Avoid exposing albuterol sulfate inhalation aerosol to extreme heat and cold.
Do not puncture or burn the canister.
Keep your albuterol sulfate inhalation aerosol inhaler and all medicines out of the reach of children.

Manufactured by

Aeropharm GmbH

D-07407 Rudolstadt, Germany

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Rev. July 2021

46293491

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