Respontin Nebules

advertisement
When are you taking this medicine?

Respontin Nebules uses



Respontin Nebules Inhalation Solution, 0.02%

Prescribing Information

DESCRIPTION

The active ingredient, Respontin Nebules monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-; a synthetic quaternary ammonium compound, chemically related to atropine.

Respontin Nebules Monohydrate C20H30BrNO3-H2O Mol. Wt. 430.4

Respontin Nebules is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media.

Respontin Nebules Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains Respontin Nebules, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.

Chemical Structure for Respontin Nebules Monohydrate

CLINICAL PHARMACOLOGY

Respontin Nebules is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve.

Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.

The bronchodilation following inhalation of Respontin Nebules is primarily a local, site-specific effect, not a systemic one. Much of an administered dose is swallowed but not absorbed, as shown by fecal excretion studies. Following nebulization of a 2 mg dose, a mean 7% of the dose was absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract. The half-life of elimination is about 1.6 hours after intravenous administration. Respontin Nebules is minimally (0 to 9% in vitro) bound to plasma albumin and a1-acid glycoproteins. It is partially metabolized. Autoradiographic studies in rats have shown that Respontin Nebules does not penetrate the blood-brain barrier. Respontin Nebules has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.

In controlled 12-week studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function (FEV1 increases of 15% or more) occurred within 15 to 30 minutes, reached a peak in 1 to 2 hours, and persisted for periods of 4 to 5 hours in the majority of patients, with about 25% to 38% of the patients demonstrating increases of 15% or more for at least 7 to 8 hours. Continued effectiveness of Respontin Nebules inhalation solution was demonstrated throughout the 12-week period. In addition, significant increases in forced vital capacity (FVC) have been demonstrated. However, Respontin Nebules did not consistently produce significant improvement in subjective symptom scores nor in quality of life scores over the 12-week duration of study.

Additional controlled 12-week studies were conducted to evaluate the safety and effectiveness of Respontin Nebules inhalation solution administered concomitantly with the beta adrenergic bronchodilator solutions metaproterenol and albuterol compared with the administration of each of the beta agonists alone. Combined therapy produced significant additional improvement in FEV1 and FVC. On combined therapy, the median duration of 15% improvement in FEV1 was 5 to 7 hours, compared with 3 to 4 hours in patients receiving a beta agonist alone.

advertisement

INDICATIONS AND USAGE

Respontin Nebules Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

CONTRAINDICATIONS

Respontin Nebules is contraindicated in known or suspected cases of hypersensitivity to Respontin Nebules, or to atropine and its derivatives.

WARNINGS

The use of Respontin Nebules inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of Respontin Nebules and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation.

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

PRECAUTIONS

General

Respontin Nebules should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.

Information for Patients

Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that Respontin Nebules inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Respontin Nebules Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that Respontin Nebules inhalation solution should be used consistently as prescribed throughout the course of therapy.

Drug Interactions

Respontin Nebules has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Respontin Nebules has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of Respontin Nebules.

Results of various mutagenicity studies were negative.

Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by Respontin Nebules administration. At doses above 90 mg/kg increased resorption and decreased conception rates were observed.

Pregnancy TERATOGENIC EFFECTS

Pregnancy Category B

Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of Respontin Nebules. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, Respontin Nebules should be used during pregnancy only if clearly needed.

NURSING MOTHERS

It is not known whether Respontin Nebules is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Respontin Nebules would reach the infant to a significant extent, especially when taken by inhalation since Respontin Nebules is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when Respontin Nebules is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population below the age of 12 have not been established.

advertisement

ADVERSE REACTIONS

Adverse reaction information concerning Respontin Nebules inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature.

All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.

Additional adverse reactions reported in less than three percent of the patients treated with Respontin Nebules include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis and acute eye pain have been reported.

Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of Respontin Nebules therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of Respontin Nebules equals or exceeds 2,000 mcg.

Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.

All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials.
PERCENT OF PATIENTS
Ipratropium Metaproterenol Ipratropium/

Metaproterenol

Albuterol Ipratropium/

Albuterol

(500 mcg t.i.d.) (15 mg t.i.d.) (500 mcg t.i.d./

15 mg t.i.d.)

(2.5 mg t.i.d.) (500 mcg t.i.d./

2.5 mg t.i.d.)

n = 219 n = 212 n = 108 n = 205 n = 100
Body as a Whole-General Disorders
Headache 6.4 5.2 6.5 6.3 9.0
Pain 4.1 3.3 0.9 2.9 5.0
Influenza-like symptoms 3.7 4.7 6.5 0.5 1.0
Back Pain 3.2 1.9 1.9 2.4 0.0
Chest Pain 3.2 4.2 5.6 2.0 1.0
Cardiovascular Disorders
Hypertension/Hypertension Aggravated 0.9 1.9 0.9 1.5 4.0
Central & Peripheral Nervous System
Dizziness 2.3 3.3 1.9 3.9 4.0
Insomnia 0.9 0.5 4.6 1.0 1.0
Tremor 0.9 7.1 8.3 1.0 0.0
Nervousness 0.5 4.7 6.5 1.0 1.0
Gastrointestinal System Disorders
Mouth Dryness 3.2 0.0 1.9 2.0 3.0
Nausea 4.1 3.8 1.9 2.9 2.0
Constipation 0.9 0.0 3.7 1.0 1.0
Musculo -skeletal System Disorders
Arthritis 0.9 1.4 0.9 0.5 3.0
Respiratory System Disorders (Lower)
Coughing 4.6 8.0 6.5 5.4 6.0
Dyspnea 9.6 13.2 16.7 12.7 9.0
Bronchitis 14.6 24.5 15.7 16.6 20.0
Bronchospasm 2.3 2.8 4.6 5.4 5.0
Sputum Increased 1.4 1.4 4.6 3.4 0.0
Respiratory Disorder 0.0 6.1 6.5 2.0 4.0
Respiratory System Disorders (Upper)
Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2 16.0
Pharyngitis 3.7 4.2 5.6 2.9 4.0
Rhinitis 2.3 4.2 1.9 2.4 0.0
Sinusitus 2.3 2.8 0.9 5.4 4.0
advertisement

OVERDOSAGE

Acute systemic overdosage by inhalation solution is unlikely since Respontin Nebules is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose. The oral LD50 of Respontin Nebules ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 mg/kg in dogs.

DOSAGE AND ADMINISTRATION

The usual dosage of Respontin Nebules inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Respontin Nebules inhalation solution unit-dose vials contain 500 mcg Respontin Nebules, USP anhydrous in 2.5 mL normal saline. Respontin Nebules inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Respontin Nebules Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

HOW SUPPLIED

Respontin Nebules Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL.

NDC 0591-3798-83, 25 vials in a foil pouch

NDC 0591-3798-30, 30 vials in a foil pouch

NDC 0591-3798-60, 60 vials, two foil pouches of 30 each

Each vial is made from a low density polyethylene (LDPE) resin.

Vials are supplied in a foil pouch.

Store between 59°F (15°C) and 86°F (30°C).

Protect from light.

Store unused vials in the foil pouch.

ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution.

Rx Only

Distributed by:

Watson Pharma, Inc.

Corona, CA 92880 USA

Manufactured by:

The Ritedose Corporation

1 Technology Circle

Columbia, SC 29203

JAN 2013

advertisement

Patient’s Instructions for Use

Respontin Nebules

INHALATION SOLUTION 0.02%

Read complete instructions carefully before using.

  • Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir (Figure 1).

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

  • Connect the nebulizer to the compressor.
  • Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask and turn on the compressor. If a face mask is used, care should be taken to avoid leakage around the mask as temporary blurring of vision, pupil enlargement, precipitation or worsening of narrow-angle glaucoma, or eye pain may occur if the solution comes into direct contact with the eyes.

  • Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished.
  • Clean the nebulizer.

Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour but not with other drugs. Drug stability and safety of Respontin Nebules Inhalation Solution when mixed with other drugs in the nebulizer have not been established.

Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

ADDITIONAL INSTRUCTIONS:

_

_

_

_

_

_

_

Distributed by:

Watson Pharma, Inc.

Corona, CA 92880 USA

Manufactured by:

The Ritedose Corporation

1 Technology Circle

Columbia, SC 29203

JAN 2013

Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir. Connect the nebulizer reservoir to the mouth piece or face mask Sit in a comfortable, upright position; place the mouthpiece in your mout

Respontin Nebules pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Respontin Nebules available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Respontin Nebules destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Respontin Nebules Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Respontin Nebules pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


advertisement

References

  1. Dailymed."IPRATROPIUM BROMIDE SOLUTION [WATSON LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ALBUTEROL SULFATE; IPRATROPIUM BROMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "ipratropium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Respontin Nebules?

Depending on the reaction of the Respontin Nebules after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Respontin Nebules not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Respontin Nebules addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sdrugs.com conducted a study on Respontin Nebules, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Respontin Nebules consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 19 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2021 "sdrugs.com". All Rights Reserved