VoSpire ER

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

You or your child may also be taking an antiinflammatory medicine, such as a steroid, together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause allergic reactions. Stop using the medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, swelling, or any type of allergic reaction after taking this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

• It is used to open the airways in lung diseases where spasm may cause breathing problems.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take Vospire ER. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more of this medicine or use it more often than you have been told. Deaths have happened when too much of Vospire ER was taken. Talk with your doctor.
• Call your doctor right away if your normal dose does not work well, if your signs get worse, or if you need to use this medicine more often than normal.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you are taking digoxin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Vospire ER.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Vospire ER or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vospire ER. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Albuterol extended-release tablets 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 (±) α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α’-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 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 in a cellulosic material that serves as a diffusion-release membrane. In addition each tablet contains the following inactive ingredients: Calcium sulfate, carnauba wax, ethylcellulose, ferric oxide black, hypromellose, ink-thinner XI, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, shellac, stearic acid, titanium dioxide, triacetin, D&C Yellow #10, (4 mg only) and FD&C Blue #1 (4 mg only).

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

Cardiovascular Effects: Albuterol extended-release tablets, like all 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 after administration of albuterol extended-release tablets at recommended doses, if they occur, the drug 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 significance of these findings is unknown. Therefore, albuterol extended-release tablets, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

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 extended-release tablets than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the 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.

Paradoxical Bronchospasm: Albuterol extended-release tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol extended-release tablets should be discontinued immediately and alternative therapy instituted.

Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol in children.

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)

     Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)

     Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured By:

PLIVA® Inc.

East Hanover, NJ 07936

For:

DAVA Pharmaceuticals, Inc.

Fort Lee, New Jersey 07024, USA

0600-01 Rev. 9/06

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• inhalation aerosol powder, inhalation capsule, inhalation powder, inhalation solution, inhalation suspension

Along with its needed effects, albuterol (the active ingredient contained in Vospire ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking albuterol:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Fast, irregular, pounding, or racing heartbeat or pulse

• Cough
• difficulty breathing
• difficulty with swallowing
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• tightness in the chest
• wheezing

• Agitation
• anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• extra heartbeats
• fainting
• hallucinations
• headache
• irritability
• lightheadedness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or jerking of all extremities
• nervousness
• nightmares
• pounding in the ears
• restlessness
• sudden loss of consciousness
• sweating
• total body jerking
• unusual feeling of excitement
• vomiting

Some side effects of albuterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness
• feeling of warmth
• irritability
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• trouble with holding or releasing urine
• trouble sleeping
• unable to sleep

• Sleepiness
• unusual drowsiness

• Bad, unusual, or unpleasant (after) taste
• change in taste
• feeling of constant movement of self or surroundings
• gagging
• rough, scratchy sound to voice
• sensation of spinning
• tightness in the throat

Applies to albuterol: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation capsule, inhalation powder, inhalation solution, oral syrup, oral tablet, oral tablet extended release

General

The most commonly reported adverse reactions are: Taste alteration (bad, unpleasant and unusual taste), mouth and throat irritation, fine tremor (usually of the hands), nausea, sweating, restlessness, headache and dizziness. These undesirable effects may subside on continuation of treatment.[Ref]

Cardiovascular

Very common (10% or more): Peripheral vasodilation, increase in heart rate
Common (1% to 10%): Palpitations, tachycardia, pallor
Rare (0.01% to 0.1%): Myocardial ischemia, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extra systoles)
Very rare (less than 0.01%): Cardiovascular collapse, thrombopenia
Frequency not reported: Angina, hypertension, hypotension, flushing[Ref]

Nervous system

Very common (10% or more): Headache (up to 18.8%), tremor (up to 24.2%), excitement (up to 20%), nervousness (up to 15%)
Common (1% to 10%): Migraine, dizziness, shakiness, hyperkinesia, emotional lability
Uncommon (0.1% to 1%): Somnolence, dizziness, drowsiness, restlessness, irritability
Frequency not reported: Central nervous system stimulation[Ref]

Dermatologic

Common (1% to 10%): Skin/Appendage Infection (1.7%), pruritus, rash, erythema, urticaria, angioedema, sweating[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, nausea, oropharyngeal pain, vomiting, increased appetite
Uncommon (0.1% to 1%): Epigastric pain, stomach ache, loss of appetite
Rare (less than 0.1%): Sore mouth
Frequency not reported: Oropharyngeal edema, throat irritation, altered taste, glossitis, tongue ulceration, gagging, drying or irritation of the oropharynx[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Rare (less than 0.1%): Nephritis
Frequency not reported: Difficulty in micturition[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction
Very rare (less than 0.01%): angioedema, urticaria, bronchospasm, hypotension and collapse[Ref]

Immunologic

Common (1% to 10%): Lymphadenopathy[Ref]

Local

Common (1% to 10%): Application site reaction (mouth and throat irritation, burning sensation of the tongue)
Frequency not reported: Slight pain or stinging (IM injection)[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscles cramps
Uncommon (0.1% to 1%): Myalgia
Very rare (less than 0.01%): Fine tremor (particularly of hands)
Frequency not reported: Myoclonus[Ref]

Other

Common (1% to 10%): Cold symptoms, flue syndrome, pain, pyrexia, hyperactivity, excitement
Uncommon (0.1% to 1%): Epistaxis, fatigue, otitis media,
Frequency not reported: Weakness[Ref]

Psychiatric

Common (1% to 10%): Tenseness
Uncommon (0.1% to 1%): Sleepiness, sleep disturbance
Rare (0.01% to 0.1%): Hallucinations
Very rare (less than 0.01%): Insomnia[Ref]

Respiratory

Common (1% to 10%): Asthma exacerbation (13%), chest pain, bronchitis, sinus headache, upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough
Very rare (less than 0.01%): Paradoxical bronchospasm, bronchospasm
Frequency not reported: Aggravated bronchospasm, asthma exacerbation, chest discomfort, pulmonary edema[Ref]

Ocular

Uncommon (0.1% to 1%): Dilated pupils, conjunctivitis[Ref]

Metabolic

Rare (less than 0.1%): Hypokalemia, hyperglycemia, increase of insulin, free fatty acids, glycerol and ketone bodies
Postmarketing reports: Metabolic acidosis, lactic acidosis[Ref]

Some side effects of Vospire ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.