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Ventolin HFA

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Ventolin HFA

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Paradoxical Bronchospasm

Inhaled albuterol sulfate can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, VENTOLIN HFA (albuterol sulfate inhalation aerosol) should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

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 VENTOLIN HFA (albuterol sulfate inhalation aerosol) than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Use of Anti-Inflammatory Agents

The use of beta-adrenergic agonist 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, to the therapeutic regimen.

Cardiovascular Effects

VENTOLIN HFA (albuterol sulfate inhalation aerosol) , like all other beta2-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, VENTOLIN HFA (albuterol sulfate inhalation aerosol) may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical relevance of these findings is unknown. Therefore, VENTOLIN HFA (albuterol sulfate inhalation aerosol) , like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Do Not Exceed Recommended Dose

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of albuterol sulfate inhalation aerosol, as demonstrated by cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Discontinue VENTOLIN HFA if immediate hypersensitivity reactions occur.

Coexisting Conditions

VENTOLIN HFA (albuterol sulfate inhalation aerosol) , like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Hypokalemia

As with other beta-agonists, albuterol may produce 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 supplementation.

Patient Counseling Information

See FDA-Approved Patient Labeling

Frequency of Use

The action of VENTOLIN HFA (albuterol sulfate inhalation aerosol) should last up to 4 to 6 hours. VENTOLIN HFA (albuterol sulfate inhalation aerosol) should not be used more frequently than recommended. Do not increase the dose or frequency of doses of VENTOLIN HFA (albuterol sulfate inhalation aerosol) without consulting the physician. If patients find that treatment with VENTOLIN HFA (albuterol sulfate inhalation aerosol) becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.

Priming and Cleaning

Priming: Patients should be instructed that priming VENTOLIN HFA (albuterol sulfate inhalation aerosol) is essential to ensure appropriate albuterol content in each actuation. Patients should prime VENTOLIN HFA (albuterol sulfate inhalation aerosol) before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA (albuterol sulfate inhalation aerosol) , patients should release 4 sprays into the air away from the face, shaking well before each spray.

Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, patients should be instructed to wash the actuator and dry thoroughly at least once a week. Patients should be informed that detailed cleaning instructions are included in the Information for the Patient leaflet.

Dose Counter

Patients should be informed that VENTOLIN HFA (albuterol sulfate inhalation aerosol) has a dose counter that starts at 204 and counts down each time a spray is released. Patients should be informed to discard VENTOLIN HFA (albuterol sulfate inhalation aerosol) when the counter reads 000 (after 200 sprays have been used) or 6 months after removal from the moisture-protective foil pouch, whichever comes first. When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed. Patients should never try to alter the numbers or remove the counter from the metal canister. Patients should never immerse the canister in water to determine the amount of drug remaining in the canister.

Paradoxical Bronchospasm

Patients should be informed that VENTOLIN HFA (albuterol sulfate inhalation aerosol) can produce paradoxical bronchospasm. If paradoxical bronchospasm occurs, patients should discontinue VENTOLIN HFA (albuterol sulfate inhalation aerosol) .

Concomitant Drug Use

While patients are using VENTOLIN HFA (albuterol sulfate inhalation aerosol) , other inhaled drugs and asthma medications should be taken only as directed by the physician.

Common Adverse Effects

Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.

Pregnancy

Patients who are pregnant or nursing should contact their physicians about the use of VENTOLIN HFA (albuterol sulfate inhalation aerosol) .

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2.0 mg/kg (approximately 14 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In another study this effect was blocked by the coadministration 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 of up to 500 mg/kg (approximately 1,700 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/m² 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 AH1 strain 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 340 times the maximum recommended daily inhalation dose for adults on a mg/m² basis).

Use In Specific Populations

Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well-controlled studies of VENTOLIN HFA (albuterol sulfate inhalation aerosol) or albuterol sulfate in pregnant women. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity. VENTOLIN HFA (albuterol sulfate inhalation aerosol) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at exposures approximately equal to the maximum recommended human dose (MRHD) for adults on a mg/m² basis and in 10 of 108 (9.3%) fetuses at approximately 8 times the MRHD. Similar effects were not observed at approximately one eleventh of the MRHD. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control).

In a rabbit reproduction study, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 680 times the MRHD.

In another rabbit study, an albuterol sulfate/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHD [see Animal Toxicology and/or Pharmacology]

Labor and Delivery

Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA (albuterol sulfate inhalation aerosol) for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Nursing Mothers

Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of VENTOLIN HFA are excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of VENTOLIN HFA (albuterol sulfate inhalation aerosol) by nursing mothers, 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. Caution should be exercised when VENTOLIN HFA (albuterol sulfate inhalation aerosol) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of VENTOLIN HFA (albuterol sulfate inhalation aerosol) in children 4 years of age and older has been established based upon two 12-week clinical trials in patients 12 years of age and older with asthma and one 2-week clinical trial in patients 4 to 11 years of age with asthma [see Clinical Studies, ADVERSE REACTIONS]. The safety and effectiveness of VENTOLIN HFA (albuterol sulfate inhalation aerosol) in children under 4 years of age has not been established. Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA (albuterol sulfate inhalation aerosol) in patients under 4 years of age and the findings are described below.

Two 4-week randomized, double-blind, placebo-controlled studies were conducted in 163 pediatric patients from birth to 48 months of age with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). VENTOLIN HFA (albuterol sulfate inhalation aerosol) or placebo HFA was delivered with either an AeroChamber Plus® Valved Holding Chamber or an Optichamber® Valved Holding Chamber with mask 3 times daily. In one study, VENTOLIN HFA (albuterol sulfate inhalation aerosol) 90 mcg (N = 26), VENTOLIN HFA (albuterol sulfate inhalation aerosol) 180 mcg (N = 25), and placebo HFA (N = 26) were administered to children between 24 and 48 months of age. In the second study, VENTOLIN HFA (albuterol sulfate inhalation aerosol) 90 mcg (N = 29), VENTOLIN HFA (albuterol sulfate inhalation aerosol) 180 mcg (N = 29), and placebo HFA (N = 28) were administered to children between birth and 24 months of age. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving VENTOLIN HFA (albuterol sulfate inhalation aerosol) 90 mcg, VENTOLIN HFA (albuterol sulfate inhalation aerosol) 180 mcg, and placebo in either study.

In a third study, VENTOLIN HFA (albuterol sulfate inhalation aerosol) was evaluated in 87 pediatric patients younger than 24 months of age for the treatment of acute wheezing. VENTOLIN HFA (albuterol sulfate inhalation aerosol) was delivered with an AeroChamber Plus Valved Holding Chamber in this study. There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between VENTOLIN HFA (albuterol sulfate inhalation aerosol) 180 mcg and VENTOLIN HFA 360 mcg.

In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA (albuterol sulfate inhalation aerosol) via holding chambers with facemasks. The studies were conducted with 2 different holding chambers with facemasks (small and medium size). The in vitro study data when simulated to patients suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with facemask will be comparable to the dose delivered in adults without a spacer and facemask per kilogram of body weight (Table 2). However, clinical studies in children under 4 years of age described above suggest that either the optimal dose of VENTOLIN HFA (albuterol sulfate inhalation aerosol) has not been defined in this age-group or VENTOLIN HFA (albuterol sulfate inhalation aerosol) is not effective in this age-group. The safety and effectiveness of VENTOLIN HFA (albuterol sulfate inhalation aerosol) administered with or without a spacer device in children under 4 years of age has not been demonstrated.

Table 2: In Vitro Medication Delivery Through AeroChamber Plus® Valved Holding Chamber With a Facemask

Age Facemask Flow Rate (L/min) Holding Time (seconds) Mean Medication Delivery Through AeroChamber Plus (mcg/actuation) Body Weight 50th Percentile (kg)* Medication Delivered per Actuation (mcg/kg)
6 to 12 Months Small 4.9 0 18.2 7.5-9.9 1.8-2.4
2 19.8 2.0-2.6
5 13.8 1.4-1.8
10 15.4 1.6-2.1
2 to 5 Years Small 8.0 0 17.8 12.3-18.0 1.0-1.4
2 16.0 0.9-1.3
5 16.3 0.9-1.3
10 18.3 1.0-1.5
2 to 5 Years Medium 8.0 0 21.1 12.3-18.0 1.2-1.7
2 15.3 0.8-1.2
5 18.3 1.0-1.5
10 18.2 1.0-1.5
> 5 Years Medium 12.0 0 26.8 18.0 1.5
2 20.9 1.2
5 19.6 1.1
10 20.3 1.1
*Centers for Disease Control growth charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion (2000). Ranges correspond to the average of the 50th percentile weight for boys and girls at the ages indicated.
A single inhalation of VENTOLIN HFA (albuterol sulfate inhalation aerosol) in a 70-kg adult without use of a valved holding chamber and facemask delivers approximately 90 mcg, or 1.3 mcg/kg.

Geriatric Use

Clinical studies of VENTOLIN HFA (albuterol sulfate inhalation aerosol) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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