Albuterol Extended-Release Tablets

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• If you are not able to get the breathing attack under control. Get help right away.
• Chest pain or pressure or a fast heartbeat.
• Very nervous and excitable.
• Very bad headache.
• Very bad dizziness or passing out.
• Peak flow measurement low.
• This medicine may sometimes cause very bad breathing problems. This may be life-threatening. When this happens with a puffer (inhaler) or with liquid for breathing in, most of the time it happens right after a dose and after the first use of a new canister or vial of this medicine (albuterol extended-release tablets). If you have trouble breathing, breathing that is worse, wheezing, or coughing, get medical help right away.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Headache.
• Dizziness.
• Upset stomach.
• Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Albuterol Extended-Release Tablets, USP contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name (±) a1-[(tert-butyl-amino)methyl]-4-hydroxy-m-xylene-a, a´-diol sulfate (2:1) (salt), and the following structural formula:

Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C13H21NO3)2•H2SO4. Albuterol sulfate, USP is a white crystalline powder, soluble in water and slightly soluble in ethanol.

The World Health Organization recommended name for albuterol base is salbutamol.

Each tablet for oral administration contains 4 mg or 8 mg of albuterol as 4.8 mg or 9.6 mg, respectively, of albuterol sulfate, USP. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, triacetin and xanthan gum. The 8 mg tablets also contain the following coloring agents: FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.

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 aerosol medications, cardiac arrest and even death may be associated with abuse of Albuterol Extended-Release Tablets.

Treatment consists of discontinuation of Albuterol Extended-Release Tablets 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 Extended-Release Tablets.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg, (approximately 250 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 200 times the maximum recommended daily oral 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 110 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 90 times the maximum recommended daily oral dose for children on a mg/m2 basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg, (approximately 500 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 400 times the maximum recommended daily oral dose for children on a mg/m2 basis).

The following dosages of Albuterol Extended-Release Tablets are expressed in terms of albuterol base:

Usual Dosage

The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Patients currently maintained on albuterol tablets or albuterol sulfate syrup can be switched to Albuterol Extended-Release Tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol Extended-Release Tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.