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DRUGS & SUPPLEMENTS
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Ipranase
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Ipranase uses
- Description
- Clinical pharmacology
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- Patient’s instructions for use
Ipranase Inhalation Solution, 0.02%
Prescribing Information
DESCRIPTION
The active ingredient, Ipranase 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.
Ipranase Monohydrate C20H30BrNO3-H2O Mol. Wt. 430.4
Ipranase 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.
Ipranase Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains Ipranase, 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 Ipranase Monohydrate
CLINICAL PHARMACOLOGY
Ipranase 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 Ipranase 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. Ipranase 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 Ipranase does not penetrate the blood-brain barrier. Ipranase 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 Ipranase inhalation solution was demonstrated throughout the 12-week period. In addition, significant increases in forced vital capacity (FVC) have been demonstrated. However, Ipranase 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 Ipranase 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.
INDICATIONS AND USAGE
Ipranase 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
Ipranase is contraindicated in known or suspected cases of hypersensitivity to Ipranase, or to atropine and its derivatives.
WARNINGS
The use of Ipranase 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 Ipranase 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 Ipranase, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.
PRECAUTIONS
General
Ipranase 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 Ipranase inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipranase Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that Ipranase inhalation solution should be used consistently as prescribed throughout the course of therapy.
Drug Interactions
Ipranase has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipranase 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 Ipranase.
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 Ipranase 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 Ipranase. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, Ipranase should be used during pregnancy only if clearly needed.
NURSING MOTHERS
It is not known whether Ipranase is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Ipranase would reach the infant to a significant extent, especially when taken by inhalation since Ipranase is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when Ipranase is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population below the age of 12 have not been established.
ADVERSE REACTIONS
Adverse reaction information concerning Ipranase 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 Ipranase 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 Ipranase therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of Ipranase 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 |
OVERDOSAGE
Acute systemic overdosage by inhalation solution is unlikely since Ipranase 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 Ipranase 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 Ipranase 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. Ipranase inhalation solution unit-dose vials contain 500 mcg Ipranase, USP anhydrous in 2.5 mL normal saline. Ipranase inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipranase Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
HOW SUPPLIED
Ipranase 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
Patient’s Instructions for Use
Ipranase
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 Ipranase 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:
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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
Ipranase pharmaceutical active ingredients containing related brand and generic drugs:
Ipranase pharmaceutical active ingredients containing related brand and generic drugs:
Ipranase available forms, composition, doses:
Ipranase destination | category:
Ipranase Anatomical Therapeutic Chemical codes:
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References
- Dailymed."IPRATROPIUM BROMIDE SOLUTION [WATSON LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- 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).
- "ipratropium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Ipranase?Depending on the reaction of the Ipranase after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ipranase 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 Ipranase 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.
Review
sdrugs.com conducted a study on Ipranase, 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 Ipranase 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
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The information was verified by Dr. Rachana Salvi, MD Pharmacology