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Thursday, 15 May 2008

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    PRODUCT INFORMATION
    VENTOLIN®
    (albuterol, USP)
    Inhalation Aerosol
    Bronchodilator Aerosol
    For Oral Inhalation Only
    DESCRIPTION: The active component of VENTOLIN Inhalation Aerosol is albuterol, USP,
    racemic (α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α,α′-diol) and a relatively selective
    beta2-adrenergic bronchodilator having the following chemical structure:
    Albuterol is the official generic name in the United States. The World Health Organization
    recommended name for the drug is salbutamol. The molecular weight of albuterol is 239.3, and
    the empirical formula is C13H21NO3. Albuterol is a white to off-white crystalline solid. It is
    soluble in ethanol, sparingly soluble in water, and very soluble in chloroform.

    Brand name: Proventil
    Generic name: Albuterol

    What is the most important information I should know about Proventil?

    • Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

    What is Proventil Ventolin Albuterol?

    • Proventil (Ventolin, Albuterol) works by relaxing muscles in the airways to improve breathing.
    • Proventil (Ventolin, Albuterol)is used to treat bronchospasm (wheezing, shortness of breath) associated with reversible obstructive airway disease such as asthma.
    • Proventil (Ventolin, Albuterol)may also be used for conditions other than those listed in this medication guide.

    What should I discuss with my healthcare provider before taking Proventil?

    • Before taking Proventil (Ventolin, Albuterol), tell your doctor if you have
      • heart disease or high blood pressure;
      • epilepsy or another seizure disorder;
      • diabetes;
      • an overactive thyroid (hyperthyroidism);
      • difficulty swallowing;
      • liver disease; or
      • kidney disease.
    • You may not be able to take Proventil (Ventolin, Albuterol)or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
    • Proventil (Ventolin, Albuterol)is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Do not take Proventil without first talking to your doctor if you are pregnant or could become pregnant during treatment.
    • It is not known whether Proventil (Ventolin, Albuterol)passes into breast milk. Do not take Proventil without first talking to your doctor if you are breast-feeding a baby.

    How should I take Proventil?

    • Take Proventil (Ventolin, Albuterol)exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
    • Take each dose with a full glass of water.
    • To ensure that you get a correct dose, measure the liquid forms of Proventil with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
    • Do not break, crush, or chew the Volmax or Proventil Repetabs tablets. These are specially formulated to release the medication slowly in the body. The Volmax tablets have an outer shell that is not absorbed by the body. Occasionally, this shell may be seen in the stool. This is not a problem as the medication has been absorbed by the body.
    • Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.
    • Store the Volmax brand of Proventil tablets in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius).
    • Store all other forms of Proventil at room temperature away from moisture and heat.

    What happens if I miss a dose?

    • Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

    What happens if I overdose?

    • Seek emergency medical attention.
    • Symptoms of an Proventil overdose may include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

    What should I avoid while taking Proventil?

    • Avoid situations that may worsen your respiratory condition such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

    What are the possible side effects of Proventil?

    • Stop taking Proventil and seek emergency medical attention if you experience any of the following serious side effects:
      • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or
      • chest pain or irregular heartbeats.
    • Other, less serious side effects may be more likely to occur. Continue to take Proventil and talk to your doctor if you experience
      • headache;
      • dizziness or lightheadedness;
      • insomnia;
      • tremor or nervousness;
      • sweating;
      • nausea, vomiting, or diarrhea; or
      • dry mouth.
    • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

    What other drugs will affect Proventil?

    • Before taking Proventil, tell your doctor if you are taking any of the following medicines:
      • a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL), propranolol (Inderal), acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), nadolol (Corgard), or pindolol (Visken);
      • a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), or protriptyline (Vivactil);
      • a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);
      • another oral or inhaled bronchodilator; or
      • caffeine, diet pills, or decongestants.
    • You may not be able to take Proventil, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medications listed above.
    • Drugs other than those listed here may also interact with Proventil or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

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