Volmax

Inhalational/Oral:

Albuterol may cause serious side effects, including:

• worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using albuterol and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
• heart problems including faster heart rate and higher blood pressure
• possible death in people with asthma who use too much albuterol
• allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
  • itchy skin
  • swelling beneath your skin or in your throat
  • rash
  • worsening trouble breathing
• low potassium levels in your blood
• worsening of other medical problems in people who also use albuterol including increases in blood sugar

Do not use albuterol if you are allergic to albuterol sulfate or any of the ingredients in albuterol. 

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if albuterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using albuterol.

Use albuterol exactly as your doctor tells you to use it.

Inhalational:

• Aerosol Spray
  • If your child needs to use albuterol, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use albuterol.
  • Each dose of albuterol should last up to 4 hours to 6 hours.
  • Do not increase your dose or take extra doses of albuterol without first talking to your doctor.
  • Get medical help right away if albuterol no longer helps your symptoms.
  • Get medical help right away if your symptoms get worse or if you need to use your inhaler more often.
  • While you are using albuterol, do not use other inhaled rescue medicines and asthma medicines unless your doctor tells you to do so.
  • Call your doctor if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms.
• Solution for Nebulization
  • The albuterol for nebulization is usually taken 3 or 4 times daily, as needed. More frequent use is not recommended.
  • Use the entire contents of one unit-dose vial. Adjust the flow rate to deliver albuterol over 5 to 15 minutes.
  • To control recurring bouts of bronchospasm, using albuterol for nebulization on a regular basis works best.
  • If the medication does not seem to be working, seek medical advice immediately. This is often a sign of seriously worsening asthma.
  • Efficacy and safety of this medication, when mixed with other drugs in a nebulizer, have not been determined.
  • The safety and efficacy of this medication have been established with the Pari LC Plus nebulizer and Pari PRONEB compressor. The safety and efficacy of albuterol for nebulization with other nebulizer systems have not been determined.
  • Albuterol for nebulization should be used with a jet nebulizer connected to an air compressor with adequate air flow. It should also be used with a mouthpiece or suitable face mask.

Oral

• The regular release tablets and syrup are usually taken three or four times a day.
• Albuterol extended release tablets must be swallowed whole with the aid of liquids.
• Do not crush or chew extended release tablets.

Inhalational:

Albuterol aerosol spray

• Do not use the inhaler after the expiration date, which is on the packaging it comes in.
• Store between 15° and 25° C (59° and 77° F). Avoid exposure to extreme heat and cold. For best results, canister should be at room temperature. Store the inhaler with the mouthpiece down. Shake well before each spray.
• Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.
• It is very important to keep the plastic actuator clean so the medicine will not build-up and block the spray. Do not try to clean the metal canister or let it get wet. The inhaler may stop spraying if it is not cleaned correctly. Wash the actuator at least once a week with warm water and let it air-dry completely.
• As with all aerosol medications, it is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing four “test sprays” into the air, away from your face.

A) Albuterol aerosol spray

• Before you reach 200 sprays, you should refill your prescription or ask your doctor if you need another prescription for albuterol HFA.
• Throw the inhaler away when you have used 200 sprays. You should not keep using the inhaler after 200 sprays even though the canister may not be completely empty because you cannot be sure you will receive any medicine.

B) Albuterol aerosol spray- with dose counter

• Discard albuterol inhaler when the counter reads 000 or 12 months after it is taken out of the foil pouch, whichever comes first.
• When the counter reads 020, contact your pharmacist for a refill or talk to your doctor to determine whether a prescription refill is needed.
• Never try to alter the numbers or remove the counter from the metal canister.
• Never immerse the canister in water to determine the amount of drug remaining in the canister.

Albuterol for nebulization

• ​Store at room temperature.
• Protect from light and excessive heat.
• Store vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within 1 week. Discard the vial if the solution is not colorless.
• Keep out of the reach of children.

Tablets

• Dispense in a well-closed, light-resistant container.
• Replace cap securely after each opening.
• Store at room temperature.

Syrup

• Store at controlled room temperature 15° to 30°C (59° to 86°F).
• Dispense in a tight, light-resistant container as defined in the USP/NF.
• Keep this and all drugs out of the reach of children.

In the U.S.

• Proventil
• Proventil Repetabs
• Ventolin
• Volmax
• VoSpire ER

In Canada

• Apo-Salvent Inhaler

Available Dosage Forms:

• Tablet
• Syrup
• Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Atomoxetine
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Imipramine
• Iobenguane I 123
• Levalbuterol
• Lofepramine
• Melitracen
• Nortriptyline
• Opipramol
• Protriptyline
• Tianeptine
• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizure disorders—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Volmax. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Swallow the extended-release tablet whole with water or liquids. Do not break, crush, or chew the tablet.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of bronchospasm:
  • For oral dosage form (syrup, tablets):
    • Adults and children older than 12 years of age—2 or 4 milligrams (mg) taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given 4 times per day.
    • Children 6 to 12 years of age—2 mg taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given 4 times per day.
    • Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight per dose, given 3 times per day, and each dose will not be more than 2 mg. Your doctor may increase your dose as needed up to a maximum dose of 12 mg per day, divided and given 3 times a day.
    • Children younger than 2 years of age—Use and dose must be determined by your child's doctor.
  • For oral dosage form (extended-release tablets):
    • Adults and children older than 12 years of age—8 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given every 12 hours.
    • Children 6 to 12 years of age—4 mg every 12 hours. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given every 12 hours.
    • Children younger than 6 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

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 Volmax) 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 Volmax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.