Medihaler-Iso

advertisement
What do you feel about the cost of the medicine? Is it expensive?

Medihaler-Iso uses


INDICATIONS AND USAGE

Medihaler-Iso hydrochloride injection is indicated:

  • For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
  • For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation).
  • For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available.
  • For bronchospasm occurring during anesthesia.
  • As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock.

CONTRAINDICATIONS

Use of Medihaler-Iso hydrochloride injection is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; and angina pectoris.

WARNINGS

Medihaler-Iso hydrochloride injection, by increasing myocardial oxygen requirements while decreasing effective coronary perfusion, may have a deleterious effect on the injured or failing heart. Most experts discourage its use as the initial agent in treating cardiogenic shock following myocardial infarction. However, when a low arterial pressure has been elevated by other means, Medihaler-Iso hydrochloride injection may produce beneficial hemodynamic and metabolic effects.

In a few patients, presumably with organic disease of the AV node and its branches, Medihaler-Iso hydrochloride injection has paradoxically been reported to worsen heart block or to precipitate Adams-Stokes attacks during normal sinus rhythm or transient heart block.

advertisement

PRECAUTIONS

General

Medihaler-Iso hydrochloride injection should generally be started at the lowest recommended dose. This may be gradually increased if necessary while carefully monitoring the patient. Doses sufficient to increase the heart rate to more than 130 beats per minute may increase the likelihood of inducing ventricular arrhythmias. Such increases in heart rate will also tend to increase cardiac work and oxygen requirements which may adversely affect the failing heart or the heart with a significant degree of arteriosclerosis.

Adequate filling of the intravascular compartment by suitable volume expanders is of primary importance in most cases of shock and should precede the administration of vasoactive drugs. In patients with normal cardiac function, determination of central venous pressure is a reliable guide during volume replacement. If evidence of hypoperfusion persists after adequate volume replacement, Medihaler-Iso hydrochloride injection may be given.

In addition to the routine monitoring of systemic blood pressure, heart rate, urine flow, and the electrocardiograph, monitor the response to therapy by frequent determination of the central venous pressure and blood gases. Closely observe patients in shock during Medihaler-Iso hydrochloride injection administration. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease the infusion rate or temporarily discontinue the infusion. Determinations of cardiac output and circulation time may also be helpful. Take appropriate measures to ensure adequate ventilation. Pay attention to acid-base balance and to the correction of electrolyte disturbances.

Drug Interactions

Medihaler-Iso hydrochloride injection and epinephrine should not be administered simultaneously because both drugs are direct cardiac stimulants and their combined effects may induce serious arrhythmias. The drugs may, however, be administered alternately provided a proper interval has elapsed between doses.

Avoid Medihaler-Iso when potent inhalational anesthetics such as halothane are employed because of potential to sensitize the myocardium to effects of sympathomimetic amines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of Medihaler-Iso hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that Medihaler-Iso hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Medihaler-Iso hydrochloride. It is also not known whether Medihaler-Iso hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Medihaler-Iso hydrochloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Medihaler-Iso hydrochloride injection is administered to a nursing woman.

Pediatric Use

Safety and efficacy of Medihaler-Iso in pediatric patients have not been established.

Intravenous infusions of Medihaler-Iso in refractory asthmatic children at rates of 0.05-2.7 mcg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. The risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines or aminophylline] that are especially likely to be present in these patients. If I.V. Medihaler-Iso is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including CPK-MB.

Geriatric Use

Clinical studies of Medihaler-Iso did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. There are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. In general, dose selection for elderly patients should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

advertisement

ADVERSE REACTIONS

The following reactions to Medihaler-Iso hydrochloride injection have been reported:

CNS: Nervousness, headache, dizziness, nausea, visual blurring.

Cardiovascular: Tachycardia, palpitations, angina, Adams-Stokes attacks, pulmonary edema, hypertension, hypotension, ventricular arrhythmias, tachyarrhythmias.

In a few patients, presumably with organic disease of the AV node and its branches, Medihaler-Iso hydrochloride injection has been reported to precipitate Adams-Stokes seizures during normal sinus rhythm or transient heart block.

Respiratory: Dyspnea.

Other: Flushing of the skin, sweating, mild tremors, weakness, pallor.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

The acute toxicity of Medihaler-Iso hydrochloride in animals is much less than that of epinephrine. Excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis.

In case of accidental overdosage as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, reduce rate of administration or discontinue Medihaler-Iso hydrochloride injection until patient’s condition stabilizes. Blood pressure, pulse, respiration, and ECG should be monitored.

It is not known whether Medihaler-Iso hydrochloride is dialyzable.

The oral LD50 of Medihaler-Iso hydrochloride in mice is 3,850 mg/kg ± 1,190 mg/kg of pure drug in solution.

advertisement

DOSAGE AND ADMINISTRATION

Start Medihaler-Iso injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.


Route of

Administration


Preparation of Dilution


Initial

Dose


Subsequent

Dose Range Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.


Bolus intravenous injection


Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP


0.02 mg to 0.06 mg

(1 mL to 3 mL of diluted solution)


0.01mg to 0.2 mg

(0.5 mL to 10 mL of diluted solution)


Intravenous infusion


Dilute 10 mL (2 mg) in 500 mL of 5% Dextrose Injection, USP


5 mcg/min. (1.25 mL of diluted solution per minute)


Intramuscular


Use Solution undiluted


0.2 mg (1 mL)


0.02 mg to 1 mg

(0.1 mL to 5 mL)


Subcutaneous


Use Solution undiluted


0.2 mg (1 mL)


0.15 mg to 0.2 mg

(0.75 mL to 1 mL)


Intracardiac


Use Solution undiluted


0.02 mg (0.1 mL)


There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.


Route of Administration


Preparation of Dilution Concentrations up to 10 times greater have been used when limitation of volume is essential.


Infusion Rate Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.


Intravenous infusion


Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP


0.5 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of diluted solution)


Recommended dosage for adults with bronchospasm occurring during anesthesia:


Route of Administration


Preparation of Dilution


Initial Dose


Subsequent Dose


Bolus intravenous injection


Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP


0.01 mg to 0.02 mg

(0.5 mL to 1 mL of diluted solution)


The initial dose may be repeated when necessary


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

HOW SUPPLIED


NDC Number


Container


Concentration


Fill


Quantity


0187-4330-01


Ampul


0.2 mg/mL


1 mL


UNI-AMP pak of 25


0187-4330-05


Ampul


1 mg/5 mL (0.2 mg/mL)


5 mL


10 ampuls per carton


Protect from light. Keep in opaque container until used.

Store at 20° to 25°C (68° to 77°F).

Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Manufactured by:

Hospira, Inc.

McPherson, KS 67460 USA

9445502

Rev. 08/2016

Medihaler-Iso is a registered trademark of Hospira, Inc. used under license.

©Valeant Pharmaceuticals North America LLC

5 mL

NDC 0187-4330-05

Rx only

Isuprel®

Medihaler-Iso HC1

Injection, USP

1 mg/5 mL (0.2 mg/mL)

Intravenous, Subcutaneous,

Intramuscular or Intracardiac Use Only.

Protect from light.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Valeant Pharmaceuticals North America LLC

advertisement

Medihaler-Iso 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.


Medihaler-Iso 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.


Medihaler-Iso 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.


Medihaler-Iso 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.


Medihaler-Iso 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. "isoproterenol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "isoproterenol". http://www.drugbank.ca/drugs/DB0106... (accessed August 28, 2018).
  3. "isoproterenol: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Medihaler-Iso?

Depending on the reaction of the Medihaler-Iso after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Medihaler-Iso 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 Medihaler-Iso 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 Medihaler-Iso, 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 Medihaler-Iso 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 11 here

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

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