Ventolin (albuterol) is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs, and used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Albuterol inhalation is also used to prevent exercise-induced bronchospasm.
Manufacturer: GSK (GlaxoSmithKline), United Kingdom
What are its available dosage forms and Strengths?
The Ventolin HFA is available as:
- As an inhalation aerosol, Inhaler containing 108 mcg albuterol sulfate (90 mcg albuterol base) as an aerosol formulation for oral inhalation.
- Available as a plastic metered dose inhaler and contain from 60 or 200 metered spray doses for inhalation. The whole assembly is also fitted with the dose counter. Upon one actuation a dose of 108 mcg of albuterol sulfate or 90 mcg of albuterol base comes out from the mouthpiece.
In which conditions this drug can be used?
For treating the Bronchospasm
Ventolin HFA inhalation aerosol is used for treating and preventing the episodes of bronchospasm in the patients suffering from any sort of the obstructive disease of the airways. It can be administered in the patients of age 4 years or older. The recommended dose is 1 to 2 inhalations after every four to six hours.
For treating exercise Induced bronchospasm
It is also indicated for the treatment and prevention of the exercise induced bronchospasm. Usually, the recommended dose for both children and adults is 2 inhalations 15 to 30 minutes prior to exercise.
Your doctor will give you clear instructions on the number of puffs you can and should inhale each day. Following information is in no away a medical advice but merely FDA-approved information.
- In adults: For bronchospasm, you should inhale 2 puffs every 4-6 hours or as directed by your doctor.
For exercise-induced bronchospasm, inhale 2 puffs 15-30 minutes before exercise or any other strenuous physical activity.
- In children: 1-2 puffs. Ventolin should not be given to children under 4 years of age.
What the patients should know regarding its use and administration?
- This drug is only meant to be inhaled by oral route only.
- The patients should be advised to read the medication guide thoroughly before taking the medicine and each time when getting a refill as there may be a new information incorporated.
- Guide patients to avoid spraying in eyes, and if sprayed immediately rinse eyes with clean water.
- It should be discontinued immediately on the signs of hypersensitivity which may include cough, difficulty in breathing, and difficulty in swallowing, hoarseness, large, swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, noisy breathing, and redness of the skin, shortness of breath, skin rash, slow or irregular breathing, and tightness in the chest or wheezing.
- Educate patients on Ventolin HFA associated Paradoxical Bronchospasm and to immediately discontinue its use on experiencing worsened cases of breathing and wheezing.
- Some patients may require adjunct therapy of corticosteroids with Ventolin HFA for adequate control of asthma.
- It is to be used with caution in patients with cardiovascular diseases, asthma, glaucoma, diabetes, hypokalemia, hyperthyroidism, or seizures.
- Advise patients not to exceed the recommended doses as it could lead to a cardiac arrest or a severe acute asthmatic crisis and subsequent hypoxia.
- Patients who have Tachycardia secondary to a heart condition cannot use this drug.
How should you use Ventolin HFA?
- For the first time use, the priming of Ventolin HFA is necessary to ensure the proper dose for each actuation, for that purpose it is recommended to release at least four sprays into the air. The priming is also necessary if the inhaler is dropped or not been used for 2 weeks.
- Shake well before each spray.
- Do not exceed the recommended dose.
- To avoid the orifice blockage of the actuator cleaning is necessary at least once in a week. For that purpose, the actuator should be washed with warm water and then it should be allowed to air dry.
Contra-indications and precautions related to Proventil HFA use:
- It is contraindicated in those patients who have any history of developing any sort of allergic or hypersensitive reactions to the albuterol or any of the other components of this inhalation dosage form.
- It is contra-indicated in patients suffering from tachycardia that is secondary to a heart disease.
- The use of Ventolin HFA should be immediately stopped on the development of Paradoxical bronchospasm.
- It should be given with precaution to patients with cardiovascular disease, asthma, glaucoma, diabetes, hypokalemia, hyperthyroidism, or seizures and the blood pressures of such patients should be periodically measured.
What are the potential adverse reactions related to its use?
The following adverse drug reactions can occur due to Ventolin HFA
- Production of a life threatening condition called as paradoxical bronchospasms. Symptoms include coughing, breathing and trouble in breathing. It usually occurs when the inhaler is used for the first time. If the condition arises then the use of this inhaler should be discontinued immediately and alternative options should be considered.
- Ventolin HFA is a beta-2 adrenoceptor agonist so it can also produce cardiovascular adverse effects in some patients such as changes in the pulse rates and blood pressures.
- Some immediate hypersensitive or serious allergic reactions like urticaria, hives, swelling of mouth and tongue, rashes, hypotension, bronchospasm and anaphylaxis can also occur
- In some patients the use of this inhaler can also cause hypokalemia which may aggravate the cardiovascular adverse effects.
Side effects associated with the Ventolin HFA use
Some of the common side effects include:
- Sore throat
- Respiratory tract infections
- Muscular pain
- Increased heart rate
- Chest pain
- Nervous system disturbance
How can Ventolin HFA interact with other drugs?
- This inhaler should not be used in combination with the other sympathomimetic aerosol bronchodilators.
- It should also be used with caution in the patients who experience cardiovascular diseases as it can interact with the following cardiovascular drugs.
- Beta adrenoceptor blockers
- Loop and thiazide diuretics
- Agents like tricyclic antidepressants and monoamine oxidase inhibitors
Can this drug be used in the specific populations?
- During pregnancy and related cases: Albuterol comes under the C category of pregnancy drugs because there are not any ample and well-controlled studies of Ventolin HFA Inhalation Aerosol or albuterol sulfate in pregnant women. Albuterol sulfate has been found to be teratogenic in mice. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for beta-agonist interference with uterine contractility, use of albuterol for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
- During Lactation: Care should be exercised when administering albuterol sulfate in a nursing woman, because of the probable tumorigenicity shown for albuterol in animal studies and absence of experience with the use of Ventolin HFA Inhalation Aerosol by nursing mothers.
- In Pediatrics: The safety and efficacy of Ventoli HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been proven.
- In Geriatrics: Extraordinary care should be given to elderly patients who have a related cardiovascular disease that could be adversely affected by beta-agonists.
How this drug acts pharmacologically?
Mode of action: This drug is a short-acting beta-2 agonist. It acts by activating the beta (β)-2 adrenergic receptors present on the smooth muscles of the bronchial airways. As the result of its actions the adenyl cyclase is activated which ultimately leads to an increased intracellular concentration of cyclic adenosine monophosphate (cAMP). The increased cAMP activates another enzyme that is known as protein kinase A. Due to its activation the intracellular calcium concentration is decreased and the phosphorylation of myosin is also stopped. As a result, the smooth muscles of all the airways of the respiratory tract are relaxed.
When compared with another beta-adrenoceptor agonist isoproterenol, this drug albuterol has shown good results in the controlled clinical trials with fewer side effects especially cardiovascular related adverse effects.
Pharmacokinetics of Ventolin HFA
When the dose of albuterol is delivered by using a propellant HFA-134a the observed mean time to reach the maximum peak concentration (Tmax.) in the blood was 0.42 hours. Whereas, the Tmax. for CFC-propelled metered albuterol inhaler was 0.17 hours. Ventolin HFA has a plasma half-life (t-1/2) of 4.6 hours approximately. The peak plasma concentration (Cmax.) is approx. 3ng/ml at a dose of 1080mcg of albuterol. Only 10% of this drug binds to the plasma proteins, it gets metabolized in liver and has an elimination half-life of 3-8 hours. The predominant route for excretion of albuterol is urine.
Toxicology of Ventolin HFA:
- It was found neither mutagenic nor clastogenic (clastogen is a mutagenic agent giving rise to or inducing disruption or breakages of chromosomes, leading to sections of the chromosome being deleted, added, or rearranged) during pre-clinical and clinical studies.
- Ventolin HFA did not demonstrate any harmful effects to the reproduction system or fertility of the rats.
- Albuterol sulfate has been found to be teratogenic in mice. There are no satisfactory and well-controlled studies of albuterol sulfate in pregnant females.
- This agent is not suggested for the management of preterm labor because of the risks of adverse events like pulmonary edema.
What should you tell your doctor before taking this medication?
To make sure Ventolin HFA is safe for you, tell your doctor if you have:
- a heart disease, high blood pressure, congestive heart failure;
- a heart rhythm disorder;
- a seizure disorder such as epilepsy;
- overactive thyroid; or
- low levels of potassium in your blood.
What are the storage requirements for Ventolin HFA?
It should be stored at room temperature between 68°F and 77°F (20°C and 25°C). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL BEFORE EACH SPRAY. Keep out of reach of children. Avoid spraying in eyes. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or an incinerator.