Accuneb

Name: Accuneb

Commonly used brand name(s)

In the U.S.

  • Accuneb
  • ProAir HFA
  • Proair Respiclick
  • Proventil
  • Proventil HFA
  • ReliOn Ventolin HFA
  • Ventolin
  • Ventolin HFA

In Canada

  • Alti-Salbutamol Inhalation Aerosol
  • Apo-Salvent
  • Salbutamol
  • Salbutamol Nebuamp
  • Salbutamol Respirator Solution
  • Ventolin Inhaler
  • Ventolin Nebules P.F.
  • Ventolin Respirator
  • Ventolin Rotacaps

Available Dosage Forms:

  • Aerosol Powder
  • Solution
  • Capsule
  • Powder
  • Suspension

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Precautions While Using Accuneb

It is very important that your doctor check the progress of you or your child 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 should not be used together with other inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

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.

Talk to your doctor or get medical help right away if:

  • Your symptoms do not improve or they become worse after using this medicine.
  • Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), 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 serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using 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.

Accuneb Description

Accuneb® (albuterol sulfate) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows:

The molecular weight of albuterol sulfate is 576.7 and the empirical 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 is salbutamol.

Accuneb (albuterol sulfate) Inhalation Solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED).

Accuneb (albuterol sulfate) Inhalation Solution does not require dilution prior to administration by nebulization. For Accuneb, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Accuneb should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).

How is Accuneb Supplied

Accuneb (albuterol sulfate) Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg and 1.25 mg, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of Accuneb (albuterol sulfate) Inhalation Solution is available in a shelf carton containing multiple foil pouches.

Accuneb® (albuterol sulfate) Inhalation Solution, 0.63 mg (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-692-03                5 foil pouches, each containing 5 vials, total 25 vials per carton

Accuneb® (albuterol sulfate) Inhalation Solution, 1.25 mg (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-693-03                5 foil pouches, each containing 5 vials, total 25 vials per carton

Rx Only.

STORAGE

Store between 2°C and 25°C (36°F - 77°F). Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Dey®
A Mylan Company

Dey Pharma, L.P., Napa, CA 94558

03-492-27
MAR 11
U.S. Pat. No. 6,702,997

Manufacturer

  • Dey Pharma, LP

  • Mylan Specialty L.P.

Other Requirements

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.

Albuterol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: A US FDA pregnancy category: C Comments: -This drug is known to cross the placental barrier, as evidenced by increases in fetal heart rate. -Beta-agonists, including this drug, may potentially interfere with uterine contractility. -In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and the dose adjusted as necessary to maintain optimal control. -In some countries, intravenous injection presentations of this drug have been approved for delay pre-term labor (tocolytic agent) and should not be used in the management of uncomplicated premature labor.

Epidemiological studies and postmarketing case reports following inhaled administration of this drug do not consistently demonstrate a risk of major birth defects or miscarriage. In animal reproduction studies, subcutaneous administration to pregnant mice evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID). A study in pregnant rats demonstrated that drug-related material was transferred from the maternal circulation to the fetus. There are no controlled data in human pregnancy. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with this drug. Some of the mothers were taking multiple medications during their pregnancies. A relationship between the use of this drug and congenital anomalies has not been established. Profuse uterine bleeding following spontaneous abortion has been reported after the use of this drug. Special care is required in pregnant diabetic women. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Administrative Information

LactMed Record Number

6

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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