Label: ALBUTEROL SULFATE solution

Pharmacokinetics:Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus, and expired air. Most of the absorbed dose was recovered in urine collected during the 24 hours after drug administration.

Following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. Following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). The pharmacokinetics of albuterol following administration of 0.63 mg (0.021%) or 1.25 mg (0.042%) albuterol inhalation solution by nebulization have not been determined in children 2 to 12 years old.

Paradoxical Bronchospasm:As with other inhaled beta-adrenergic agonists, albuterol inhalation solution can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, albuterol  inhalation solution should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Use of Anti-Inflammatory Agents:The use of beta-adrenergic bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids).

Deterioration of Asthma:Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol  inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids).

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is, therefore, essential that the physician instruct the patient in the need for further evaluation, if his/her asthma becomes worse.

Cardiovascular Effects:Albuterol  inhalation solution, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for albuterol inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol inhalation solution, like all other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Immediate Hypersentivity Reactions:Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.

General:Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. As with other beta-agonists, inhaled and intravenous albuterol may produce a significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring potassium supplementation.

Information for Patients:The action of albuterol inhalation solution may last up to six hours, and therefore it should not be used more frequently than recommended. Do not increase the dose or frequency of medication without consulting your physician.

If you find that treatment with albuterol inhalation solution becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as albuterol inhalation solution include palpitations, chest pain, rapid heart rate, tremor, or nervousness.

If you are pregnant or nursing, contact your physician about the use of albuterol inhalation solution. Effective and safe use of albuterol inhalation solution includes an understanding of the way it should be administered.

If the solution in the vial changes color or becomes cloudy, you should not use it. The drug compatibility (physical and chemical), clinical efficacy, and safety of albuterol inhalation solution, when mixed with other drugs in a nebulizer, have not been established.

See illustrated Patient’s Instructions for Use

Drug Interactions:Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution. Albuterol inhalation solution should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or within 2 weeks of discontinuation of such agents, since the action of albuterol on the vascular system may be potentiated.

Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol inhalation solution, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

Carcinogenesis, Mutagenesis, Impairment of Fertility:In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2 mg/kg (approximately equivalent to the maximum recommended daily inhalation dose for albuterol sulfate on a mg/m 2 basis). In another study, this effect was blocked by the co-administration of propranolol, a non-selective beta-adrenergic antagonist.

In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 500 mg/kg (approximately 140 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 50 mg/kg (approximately 20 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH 1strain mouse micronucleus assay.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 30 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis).

Labor and Delivery:Oral albuterol has been shown to delay pre-term labor in some reports. There are presently no well-controlled studies that demonstrate that it will stop pre-term labor or prevent labor at term. Because of the potential for beta-agonist interference with uterine contractility, use of albuterol inhalation solution for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Albuterol has not been approved for the management of pre-term labor. The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including pulmonary edema, have been reported following administration of albuterol to women in labor.

Nurisng Mothers:It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:Safety and effectiveness of albuterol inhalation solution 1.25 mg (0.042%) and 0.63 mg (0.021%) have been established in pediatric patients between the ages of 2 and 12 years. The use of albuterol  inhalation solution in these age groups is supported by evidence from adequate and well-controlled studies of albuterol  inhalation solution in children age 6 to 12 years and published reports of albuterol sulfate trials in pediatric patients 3 years of age and older. The safety and effectiveness of albuterol  inhalation solution in children below 2 years of age have not been established.

STORAGE:

Store between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat.  Store unit-dose vials in protective foil pouch at all times.

Once removed from the foil pouch, use vial within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Rx Only

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

For Customer Service,

Call: 1-844-874-7464

Issued:02/2025

IC 3032

Manufactured By:
Nephron Pharmaceuticals Corporation
West Columbia, SC 29172

Storing your medication:Store albuterol  inhalation solution between 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Vials should be protected from light before use, therefore keep unused vials in the foil pouch.

Once removed use within one week. Discard the vial if the solution is not colorless. 

Keep out of  reach of children. Do not use after the expiration date printed on the vial.

Dose:Albuterol inhalation solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use  new vial with each nebulizer treatment.

FOR USE IN CHILDREN AGES 2 TO 12. See accompanying prescribing information. 

Patient's Instruction For Use

1. Remove one vial from the foil pouch.

2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).

3. Connect the nebulizer to the mouthpiece or face mask (Figure 2).

4. Connect the nebulizer to the compressor.

5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor.

6. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5-15 minutes). At this point, the treatment is finished.

7.Clean the nebulizer (see manufacturer's instructions).

Note: Use only as directed by your physcian. More frequent administration or higher doses are not recommended.

PATIENT INFORMATION

Albuterol Inhalation Solution, USP

0.021%* (0.63 mg* / 3 mL) and 0.042%* (1.25mg* / 3mL)

*Potency expressed as albuterol

Prescription Only.

Read the patient information that comes with albuterol  inhalation solution before using it and each time you get a refill for your child. There may be new information. This leaflet does not take the place of talking to your child’s doctor about your child’s medical condition or treatment.

What is albuterol  inhalation solution?

Albuterol  inhalation solution is a medicine that is used for the relief of bronchospasms caused by asthma in children ages 2 to 12 years. Bronchospasm is the tightening and swelling of the muscles around the airways. Albuterol inhalation solution can help relax these airway muscles for up to 6 hours so that your child may breathe more easily.

Who should not use albuterol  inhalation solution?

Do not give your child albuterol  inhalation solution if he or she is allergic to any of its ingredients. The active ingredient is albuterol sulfate. See the end of this leaflet for a complete list of ingredients.

What should I tell my child’s doctor before giving albuterol  inhalation solution?

Tell your child’s doctor about all of your child’s medical conditions including if your child has:

• Heart problems
• High blood pressure
• Seizures
• A thyroid problem called hyperthyroidism
• Diabetes

Tell your child’s doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. Albuterol  inhalation solution and some other medicines can affect each other and may cause serious side effects. Especially tell your child’s doctor if your child is taking or using:

• Any short-acting bronchodilator medicines (sometimes called rescue inhalers)
• Epinephrine
• Medicines called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants or has stopped taking them in the past 2 weeks. These medicines are usually used for mental problems.
• Medicines called beta-blockers (used for heart problems and high blood pressure)
• Certain diuretic medicines (water pills)
• Digoxin

Know the medicines your child takes. Keep a list of them and show it to your child’s doctor and pharmacist each time your child gets a new medicine.

How should albuterol  inhalation solution be given?

Read the Patient’s Instructions for Usethat comes with albuterol  inhalation solution. Ask your pharmacist for these instructions if they are not with your medicine. Keep the instructions with albuterol  inhalation solution because you may want to read them again.

• Give albuterol  inhalation solution exactly as prescribed for your child. Do not change your child’s dose or how often it is used without talking to your child’s doctor first.
• Albuterol  inhalation solution is breathed into the lungs. Albuterol  inhalation solution is used with a special breathing machine called a nebulizer. Do not mix other medicines with albuterol  inhalation solution in the nebulizer. Do not use albuterol  inhalation solution that is not clear and colorless.
• Call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with albuterol  inhalation solution.
• Call your child’s doctor right away if your child needs to use albuterol  inhalation solution more often than prescribed.
• Albuterol inhalation solution has not been studied for treating acute attacks of bronchospasm (rescue use). Your child may need a different medicine for rescue use.
• If you give your child too much albuterol  inhalation solution, call your child’s doctor right away.

What are the side effects with albuterol  inhalation solution?

Albuterol  inhalation solution may cause the following serious side effects:

• Worsening of the tightening and swelling of the muscles around your child’s airways (bronchospasm).This side effect can be life-threatening. Call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with albuterol  inhalation solution.
• Serious and life-threatening allergic reactions. Symptoms of a serious allergic reaction include:
  • Hives, rash
  • Swelling of your child’s face, eyelids, lips, tongue, or throat, and trouble swallowing
  • Worsening of your child’s breathing problems such as wheezing, chest tightness or shortness of breath
  • Shock (loss of blood pressure and consciousness).

The most common side effects with albuterol  inhalation solution include a fast or irregular heartbeat, chest pain, shakiness, or nervousness.

How should albuterol  inhalation solution be stored?

• Store albuterol  inhalation solution at room temperature, or 68°F to 77°F (20°C to 25°C) in its tightly closed container.
• Protect vials from light before use. Therefore, keep unused vial(s) in the foil pouch or carton. Once removed from the foil pouch, use vial(s) within one week.
• Do not use albuterol inhalation solution after the expiration date printed on the vial.
• Do not use albuterol  inhalation solution that is not clear and colorless.
• Safely, discard albuterol  inhalation solution that is out-of-date or no longer needed.
• Keep albuterol  inhalation solution and all medicines out of the reach of children.

General Information about albuterol  inhalation solution

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use albuterol  inhalation solution for a condition for which it was not prescribed. Do not give albuterol  inhalation solution to other people, even if they have the same symptoms your child has. It may harm them.

This leaflet summarizes the most important information about albuterol  inhalation solution. If you would like more information, talk with your child’s doctor. You can ask your child’s doctor or pharmacist for information about albuterol  inhalation solution that is written for health professionals.

What are the ingredients in albuterol  inhalation solution?

Active Ingredient:albuterol sulfate
Inactive Ingredients:sodium chloride and sulfuric acid

Rx Only

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

For Customer Service,

Call: 1-844-874-7464

Issued:02/2025

IC 3035

Manufactured By:
Nephron Pharmaceuticals Corporation
West Columbia, SC 29172