Ipratropium Bromide and Albuterol Sulfate (Page 4 of 4)

OVERDOSAGE

The effects of overdosage with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well absorbed systemically after oral or aerosol administration. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmia, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. Treatment consists of discontinuation of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 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 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 540 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/m 2 basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 and 2000 mg/kg, respectively (approximately 240 and 1100 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/m 2 basis, respectively). The inhalation median lethal dose has not been determined in animals. The oral median lethal dose of ipratropium bromide in mice, rats and dogs is greater than 1000 mg/kg, approximately 1700 mg/kg and approximately 400 mg/kg, respectively (approximately 1400, 4600, and 3600 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis, respectively).

DOSAGE AND ADMINISTRATION

The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.

The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.

A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study. The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below.

NDC: 70518-2250-00

PACKAGING: 10 in 1 POUCH, 6 in 1 POUCH, 3 mL in 1 VIAL SINGLE DOSE TYPE 0

Storage and Handling

PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use.

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

Rx Only

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Patient Package Insert

Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should only be used under the direction of a physician. Your physician and pharmacist have more information about Ipratropium Bromide and Albuterol Sulfate Inhalation Solution and the condition for which it has been prescribed. Contact them if you have additional questions.

STORING YOUR MEDICINE

Store Ipratropium Bromide and Albuterol Sulfate Inhalation Solution between 2°C and 25°C (36°F and 77°F). Vials should be protected from light before use, therefore, keep unused vials in the foil pouch or carton. Do not use after the expiration (EXP) date printed on the carton.

DOSE

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial for each nebulizer treatment.

INSTRUCTIONS FOR USE

FOLLOW THESE DIRECTIONS FOR USE OF YOUR NEBULIZER / COMPRESSOR OR THE DIRECTIONS GIVEN BY YOUR HEALTHCARE PROVIDER. A TYPICAL EXAMPLE IS SHOWN NEARBY.

  1. Remove one vial from the foil pouch. Place remaining vials back into the pouch for storage.
  2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). b5387e98-figure-05
  3. Connect the nebulizer to the mouthpiece or face mask (Figure 2). b5387e98-figure-06
  4. Connect the nebulizer to the compressor
  5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor. b5387e98-figure-07b5387e98-figure-08
  6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5 — 15 minutes). At this point, the treatment is finished.
  7. Clean the nebulizer (see manufacturer’s instructions).
b5387e98-figure-05b5387e98-figure-06b5387e98-figure-07b5387e98-figure-08

PATIENT INFORMATION

Ipratropium Bromide 0.5 mg
and Albuterol Sulfate 3 mg*
Inhalation Solution

*Equivalent to 2.5 mg albuterol base

Prescription Only.

Read the patient information that comes with Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is a combination of two medicines called bronchodilators. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg contains albuterol sulfate, which is a beta-adrenergic agonist, and ipratropium bromide, which is an anticholinergic. These two medicines work together to help open the airways in your lungs. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is used to help treat airway narrowing (bronchospasm) that happens with chronic obstructive pulmonary disease (COPD) in adult patients who need to use more than one bronchodilator medicine.

Who should not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3mg?

Do not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg if you: Are allergic to any of the ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg or to atropine. The active ingredients are albuterol sulfate and ipratropium bromide. See the end of this leaflet for a complete list of ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg.

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg has not been studied in patients younger than 18 years of age.

What should I tell my doctor before I start using Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

Tell your doctor about all of your conditions, including if you:

  • Have heart problems. This includes coronary artery disease and heart rhythm problems.
  • Have high blood pressure
  • Have diabetes
  • Have or had seizures
  • Have a thyroid problem called hyperthyroidism
  • Have an eye problem called narrow-angle glaucoma
  • Have liver or kidney problems
  • Have problems urinating due to bladder-neck blockage or an enlarged prostate (men)
  • Are pregnant or planning to become pregnant. It is not known if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg can harm your unborn baby. You and your doctor will have to decide if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is right for you during a pregnancy.
  • Are breastfeeding. It is not known if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg passes into your milk or if it can harm your baby. You and your doctor should decide whether you should take Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg or breastfeed, but not both.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg and other medicines can interact. This may cause serious side effects. Especially tell your doctor if you take:

  • Other medicines that contain anticholinergics such as ipratropium bromide. This also includes medicines used for Parkinson’s disease.
  • Other medicines that contain beta-agonists such as albuterol sulfate. These are usually used to treat airway narrowing (bronchospasm).
  • Medicines called beta-blockers. These are usually used for high blood pressure or heart problems.
  • Medicines called “water pills” (diuretics).
  • Medicines for depression called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants.

Ask your doctor or pharmacist if you are not sure if you take any of these types of medicines. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacists when you get a new medicine.

How should I use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

  • Read the Patient’s Instructions for Use that you get with your prescription. Talk to your doctor or pharmacist if you have any questions.
  • Take Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg exactly as prescribed by your doctor. Do not change your dose or how often you use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg without talking to your doctor. Inhale Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg through your mouth and into your lungs using a machine called a nebulizer.
  • Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg may help to open your airways for up to 5 hours after taking this medicine. If Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg does not help your airway narrowing (bronchospasm) or your bronchospasm gets worse, call your doctor right away or get emergency help if needed.

What should I avoid while using Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

Do not get Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg in your eyes. Be careful not to spray Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg in your eyes while you are using your nebulizer. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg can cause the following short-term eye problems:

  • Enlarged pupils
  • Blurry vision
  • Eye pain

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg can cause a serious eye problem called narrow-angle glaucoma or worsen the narrow-angle glaucoma you already have.

What are the possible side effects with Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg may cause the following serious side effects:

  • Worsening of the narrowing in your airways (bronchospasm). This side effect can be life-threatening and has happened with both of the medicines that are in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg. Stop Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg and call your doctor right away or get emergency help if your breathing problems get worse while or after using Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg.
  • Serious and life-threatening allergic reactions. Symptoms of a serious allergic reaction include:
    • Hives, rash
    • Swelling of your face, eyelids, lips, tongue, or throat, and trouble swallowing
    • Worsening of your breathing problems such as wheezing, chest tightness or shortness of breath
    • Shock (loss of blood pressure and consciousness)

The most common side effects with Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg include lung disease, sore throat, chest pain, constipation, diarrhea, bronchitis, urinary tract infection, leg cramps, nausea, upset stomach, voice changes, and pain.

These are not all the side effects with Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg. For a complete list, ask your doctor or pharmacist.

How should I store Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

  • Store Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg between 36° and 77°F (2° and 25°C). Protect from light. Keep the unused vials in the foil pouch or carton.
  • Safely discard Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg that is out-of-date or no longer needed.
  • Keep Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg and all medicines out of the reach of children.

General advice about Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg for a condition for which it was not prescribed. Do not give Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg that is written for health professionals.

What are the ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

Active Ingredients: ipratropium bromide and albuterol sulfate.

Inactive Ingredients: sodium chloride, water for injection, and hydrochloric acid to adjust pH.

DRUG: Ipratropium Bromide and Albuterol Sulfate

GENERIC: Ipratropium Bromide and Albuterol Sulfate

DOSAGE: SOLUTION

ADMINSTRATION: RESPIRATORY (INHALATION)

NDC: 70518-2250-0

PACKAGING: 3 mL in 1 VIAL, SINGLE-USE

OUTER PACKAGING: 6 in 1 POUCH

OUTER PACKAGING: 10 in 1 POUCH

ACTIVE INGREDIENT(S):

  • IPRATROPIUM BROMIDE 0.5mg in 3mL
  • ALBUTEROL SULFATE 3mg in 3mL

INACTIVE INGREDIENT(S):

  • WATER
  • SODIUM CHLORIDE
  • HYDROCHLORIC ACID
Remedy_Label
(click image for full-size original)
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
ipratropium bromide and albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2250(NDC:0487-0201)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPRATROPIUM BROMIDE (IPRATROPIUM) IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 3 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2250-0 10 POUCH in 1 CARTON contains a POUCH
1 6 VIAL, SINGLE-USE in 1 POUCH This package is contained within the CARTON (70518-2250-0) and contains a VIAL, SINGLE-USE
1 3 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH and a CARTON (70518-2250-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076749 08/02/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 07/2021 REMEDYREPACK INC.

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