DRUGS & SUPPLEMENTS

Saventrine

Name: Saventrine drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Saventrine uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
Saventrine reviews

INDICATIONS AND USAGE

Saventrine 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 Saventrine 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

Saventrine 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, Saventrine injection may produce beneficial hemodynamic and metabolic effects.

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

PRECAUTIONS

General

Saventrine 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, Saventrine 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 Saventrine 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

Saventrine 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 Saventrine 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 Saventrine have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that Saventrine injection may be carcinogenic or mutagenic or that it impairs fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Saventrine. It is also not known whether Saventrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Saventrine 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 Saventrine injection is administered to a nursing woman.

Pediatric Use

Safety and efficacy of isoproterenol in pediatric patients have not been established.

Intravenous infusions of isoproterenol 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. isoproterenol 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 Saventrine 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.

ADVERSE REACTIONS

The following reactions to Saventrine 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, Saventrine 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 Saventrine 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 isoproterenol hydrochloride injection until patient’s condition stabilizes. Blood pressure, pulse, respiration, and ECG should be monitored.

It is not known whether Saventrine is dialyzable.

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

DOSAGE AND ADMINISTRATION

Start Saventrine 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

Saventrine is a registered trademark of Hospira, Inc. used under license.

5 mL

NDC 0187-4330-05

Rx only

Isuprel®

Isoproterenol 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

Saventrine pharmaceutical active ingredients containing related brand and generic drugs:

Isoproterenol Hydrochloride

Saventrine available forms, composition, doses:

Saventrine destination | category:

Human:
Antiasthmatic and COPD preparations
Cardiac drugs
Non-selective beta-adrenergic agonists

Saventrine Anatomical Therapeutic Chemical codes:

C01CA02 - Isoprenaline
R03AB02 - Isoprenaline
R03CB01 - Isoprenaline

Saventrine pharmaceutical companies:

References

Dailymed."ISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"isoproterenol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"isoproterenol". http://www.drugbank.ca/drugs/DB0106... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Saventrine?

Depending on the reaction of the Saventrine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Saventrine 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 Saventrine 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 Saventrine, 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 Saventrine 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.