IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (Page 4 of 5)

ADVERSE REACTIONS

Adverse reaction information concerning Ipratropium Bromide and Albuterol Sulfate Inhalation Solution was derived from the 12-week controlled clinical trial.

ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S) AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE
Body System COSTART Term Albuterol n (%) Ipratropium n (%) Ipratropium and Albuterol n (%)
NUMBER OF PATIENTS 761 754 765
N (%) Patients with AE 327 (43.0) 329 (43.6) 367 (48.0)
BODY AS A WHOLE
Pain 8 (1.1) 4 (0.5) 10 (1.3)
Pain chest 11 (1.4) 14 (1.9) 20 (2.6)
DIGESTIVE
Diarrhea 5 (0.7) 9 (1.2) 14 (1.8)
Dyspepsia 7 (0.9) 8 (1.1) 10 (1.3)
Nausea 7 (0.9) 6 (0.8) 11 (1.4)
MUSCULO-SKELETAL
Cramps leg 8 (1.1) 6 (0.8) 11 (1.4)
RESPIRATORY
Bronchitis 11 (1.4) 13 (1.7) 13 (1.7)
Lung Disease 36 (4.7) 34 (4.5) 49 (6.4)
Pharyngitis 27 (3.5) 27 (3.6) 34 (4.4)
Pneumonia 7 (0.9) 8 (1.1) 10 (1.3)
UROGENITAL
Infection urinary tract 3 (0.4) 9 (1.2) 12 (1.6)

Additional adverse reactions reported in more than 1% of patients treated with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution included constipation and voice alterations.

In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritus, and urticaria.

Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, mydriasis, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat and metabolic acidosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

HOW SUPPLIED

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 in pouch until time of use. Supplied in cartons as listed below.

NDC 60429-975-30 30 vials per carton / 30 vials per foil pouch

NDC 60429-975-60 60 vials per carton / 30 vials per foil pouch

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

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL

Patient’s Instructions for Use

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.

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

Instructions for Use

  1. Remove one vial from the foil pouch. Place remaining vials back into pouch for storage.
  2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).

    Figure 1

  3. Connect the nebulizer to the mouthpiece or face mask (Figure 2).

    Figure 2

  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.

    Figures 3 and 4
    (click image for full-size original)

  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).

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203 for
Ritedose Pharmaceuticals, LLC
Columbia, SC 29203

DEC 2013

RPIN0053

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Marketed by:

GSMS, Inc.

Camarillo, CA USA 93012

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