Why Might Terbutaline Cause an Increased Heart Rate in Mom and/or Baby?
What is Terbutaline Sulfate and how is it used?
Terbutaline Sulfate is a prescription medicine used to treat the symptoms of Cough (Bronchospasm). Terbutaline Sulfate may be used alone or with other medications.
Terbutaline Sulfate belongs to a course of drugs chosen Beta2 Agonists; Extravasatin Antidotes.
It is non known if Terbutaline Sulfate is safe and effective in children younger than 12 years of age.
What are the possible side furnishings of Terbutaline Sulfate?
Terbutaline Sulfate may cause serious side furnishings including:
- uncontrollable shaking,
- nervousness,
- dizziness,
- drowsiness,
- difficulty falling comatose or staying comatose,
- weakness,
- headache,
- nausea,
- sweating, and
- dry oral cavity
Get medical help right away, if you take any of the symptoms listed to a higher place.
The nearly mutual side effects of Terbutaline Sulfate include:
- tremor,
- nervousness,
- dizziness,
- headache,
- drowsiness,
- palpitation,
- rapid heart rate,
- shortness of breath,
- chest discomfort,
- nausea,
- airsickness,
- weakness,
- flushed feeling,
- sweating,
- hurting at the injection site,
- anxiety,
- muscle cramps, and
- dry mouth
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are non all the possible side effects of Terbutaline Sulfate. For more than information, enquire your doctor or pharmacist.
Clarification
Terbutaline sulfate injection, USP is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of solution contains 1 mg of terbutaline sulfate, USP (0.82 mg of the free base), sodium chloride for isotonicity, hydrochloric acid for adjustment to a target pH of iv and water for injection, USP Terbutaline sulfate is (±)-α-[(tert- butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (table salt). The molecular formula is (C12H19NO3)two • H2SO4 and the structural formula is
Terbutaline sulfate, USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acerb acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65.
INDICATIONS
Terbutaline sulfate injection is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
DOSAGE AND Administration
Vials should exist used just for subcutaneous administration and non intravenous infusion. Sterility and authentic dosing cannot be assured if the vials are not used in accordance with DOSAGE AND Administration.
Discard unused portion afterwards single patient use.
The usual subcutaneous dose of terbutaline sulfate injection is 0.25 mg injected into the lateral deltoid area. If meaning clinical improvement does not occur within 15 to thirty minutes, a second dose of 0.25 mg may be administered. If the patient then fails to answer within some other 15 to xxx minutes, other therapeutic measures should be considered. The total dose within 4 hours should non exceed 0.five mg.
Note: Parenteral drug products should exist inspected visually for particulate affair and discoloration prior to administration, whenever solution and container allow.
HOW SUPPLIED
Terbutaline Sulfate Injection, USP is available in a i mL single dose articulate glass vials as follows:
| NDC Number | Terbutaline Sulfate Injection, USP | Vial/Package Size |
| 0703-1271-04 | 1 mg/mL (0.25 mL of solution will provide the usual clinical dose of 0.25 mg) | 1 mL unmarried dose vial 25 per shelf tray |
Shop at 20° to 25°C (68° to 77°F) [encounter USP Controlled Room Temperature].
Protect from light by storing vials in original carton until dispensed.
Practice non utilize if solution is discolored.
Discard unused portion after single patient employ.
Issued: February 2004. SICOR Pharmaceuticals, Inc. Irvine, CA 92618. FDA Rev engagement: n/a
QUESTION
Asthma is a chronic respiratory affliction. See AnswerSIDE EFFECTS
Adverse reactions observed with terbutaline are similar to those unremarkably seen with other sympathomimetic agents. All these reactions are transient in nature and normally practice not crave handling.
The following table compares agin reactions seen in patients treated with terbutaline sulfate injection (0.25 mg and 0.five mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients.
Incidence (%) of Adverse Reactions
| Terbutaline (%) | Epinephrine (%) | |||
| 0.25 mg | 0.5 mg | 0.25 mg | 0.five mg | |
| N=77 | N=205 | N=153 | N=61 | |
| Reaction | ||||
| Cardinal Nervous System | ||||
| Tremor | 7.viii | 38.0 | sixteen.3 | eighteen.0 |
| Nervousness | 16.ix | 30.vii | eight.5 | 31.1 |
| Dizziness | one.3 | ten.ii | 7.8 | 3.3 |
| Headache | 7.8 | viii.8 | 3.3 | ix.8 |
| Drowsiness | 11.7 | nine.8 | 14.four | eight.2 |
| Cardiovascular | ||||
| Palpitations | 7.8 | 22.nine | 7.eight | 29.5 |
| Tachycardia | 1.iii | 1.5 | 2.vi | 0.0 |
| Respiratory | ||||
| Dyspnea | 0.0 | two.0 | ii.0 | 0.0 |
| Chest discomfort | 1.three | 1.5 | 2.6 | 0.0 |
| Gastrointestinal | ||||
| Nausea/airsickness | i.3 | 3.9 | 1.three | 11.five |
| Systemic | ||||
| Weakness | ane.3 | 0.5 | 2.6 | 1.6 |
| Flushed feeling | 0.0 | ii.4 | one.three | 0.0 |
| Sweating | 0.0 | 2.4 | 0.0 | 0.0 |
| Pain at injection site | 2.6 | 0.five | 2.6 | ane.6 |
| Note: Some patients received more than than one dosage force of terbutaline sulfate and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth ( < 0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration. | ||||
DRUG INTERACTIONS
The concomitant use of terbutaline with other sympathomimetic agents is not recommended, since the combined consequence on the cardiovascular organisation may be deleterious to the patient.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Terbutaline should be administered with extreme caution to patients beingness treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of terbutaline on the vascular system may be potentiated.
Beta-Blockers
Beta-adrenergic receptor blocking agents not only block the pulmonary result of beta-agonists, such as terbutaline, simply may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. Nonetheless, under certain circumstances, eastward.g., as prophylaxis afterward myocardial infarction, there may exist no acceptable alternatives to the utilize of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
Diuretics
The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is non known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
WARNINGS
Deterioration of Asthma
Asthma may deteriorate acutely over a menstruation of hours or chronically over several days or longer. If the patient needs more doses of terbutaline sulfate than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible demand for anti-inflammatory handling, east.g., corticosteroids.
Employ of Anti-Inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should exist given to calculation anti-inflammatory agents, eastward.g., corticosteroids.
Cardiovascular Furnishings
Terbutaline sulfate, similar all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse charge per unit, claret pressure level, and/or symptoms. Although such effects are uncommon later assistants of terbutaline sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists take been reported to produce electrocardiogram (ECG) changes, such as flattening of the T moving ridge, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, terbutaline sulfate, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Seizures
At that place have been rare reports of seizures in patients receiving terbutaline sulfate; seizures did not recur in these patients after the drug was discontinued.
PRECAUTIONS
Tocolysis
Terbutaline sulfate has not been approved and should non exist used for tocolysis. Serious agin reactions may occur afterwards assistants of terbutaline sulfate to women in labor. In the mother, these include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia. Increased fetal heart charge per unit and neonatal hypoglycemia may occur every bit a result of maternal administration.
Full general
Terbutaline, equally with all sympathomimetic amines, should be used with circumspection in patients with cardiovascular disorders, including ischemic center disease, hypertension, and cardiac arrhythmias; in patients with hyperthyroidism or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines or who accept convulsive disorders. Pregnant changes in systolic and diastolic claret pressure have been seen and could exist expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Firsthand hypersensitivity reactions and exacerbations of bronchospasm accept been reported after terbutaline assistants.
Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce agin cardiovascular effects. The decrease is usually transient, not requiring supplementation.
Large doses of intravenous terbutaline have been reported to beal pre-existing diabetes mellitus and ketoacidosis.
Carcinogenesis, Mutagenesis, Harm of Fertility
In a two-year study in Sprague-Dawley rats, terbutaline sulfate caused a significant and dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of l mg/kg and in a higher place (approximately 810 times the maximum recommended daily subcutaneous (sc) dose for adults on a mg/m2 basis). In a 21-month study in CD-1 mice, terbutaline sulfate showed no evidence of tumorigenicity at dietary doses up to 200 mg/kg (approximately 1,600 times the maximum recommended daily sc dose for adults on a mg/mii ground). The mutagenicity potential of terbutaline sulfate has not been adamant.
Reproduction studies in rats using terbutaline sulfate demonstrated no impairment of fertility at oral doses upwards to 50 mg/kg (approximately 810 times the maximum recommended daily sc dose for adults on a mg/mtwo basis).
Pregnancy
Teratogenic Furnishings: Pregnancy Category B
A reproduction report in Sprague-Dawley rats revealed terbutaline sulfate was not teratogenic when administered orally at doses up to 50 mg/kg (approximately 810 times the maximum recommended daily sc dose for adults on a mg/m2 basis). A reproduction study in New Zealand white rabbits revealed terbutaline sulfate was not teratogenic when administered orally at doses up to 50 mg/kg (approximately ane,600 times the maximum recommended daily sc dose for adults on a mg/m2 basis).
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not e'er predictive of human being responses, terbutaline should be used during pregnancy merely if the potential benefits justify the potential risk to the fetus.
Use In Labor and Commitment
Considering of the potential for beta-agonist interference with uterine contractility, use of terbutaline for relief of bronchospasm during labor should exist restricted to those patients in whom the benefits clearly outweigh the risk.
Terbutaline crosses the placenta. After single dose Four administration of terbutaline to 22 women in tardily pregnancy who were delivered past elective Cesarean section due to clinical reasons, umbilical blood levels of terbutaline were found to range from xi% to 48% of the maternal blood levels.
Nursing Mothers
It is non known whether this drug is excreted in human being milk. Therefore, terbutaline should be used during nursing merely if the potential benefit justifies the possible gamble to the newborn.
Pediatric Use
Terbutaline is not recommended for patients under the age of 12 years because of bereft clinical information to constitute condom and effectiveness.
Geriatric Use
Clinical studies of terbutaline sulfate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses betwixt the elderly and younger patients. In full general, dose selection for an elderly patient should exist cautious, unremarkably starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Overdosage & Contraindications
OVERDOSE
The median sc lethal dose of terbutaline sulfate in mature rats was approximately 165 mg/kg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The median sc lethal dose of terbutaline sulfate in young rats was approximately two,000 mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m2 basis).
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of whatsoever of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry oral fissure, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. There is no specific antidote. Handling consists of discontinuation of terbutaline together with advisable symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, begetting in listen that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of terbutaline.
CONTRAINDICATIONS
Terbutaline sulfate injection is contraindicated in patients known to exist hypersensitive to sympathomimetic amines or whatever component of this drug production.
CLINICAL PHARMACOLOGY
Terbutaline is a beta-adrenergic receptor agonist. In vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential upshot on beta2-adrenergic receptors. While information technology is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data betoken that there is a population of beta2-receptors in the homo heart, existing in a concentration betwixt 10% to 50%. The precise function of these receptors has non been established. (See WARNINGS.) Controlled clinical studies in patients given terbutaline subcutaneously accept not revealed a preferential beta2-adrenergic effect.
The pharmacologic effects of beta-adrenergic agonists, including terbutaline, are at least in part owing to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3',five'-adenosine monophosphate (cAMP). Increased cAMP levels are associated with relaxation of bronchial polish muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Controlled clinical studies have shown that terbutaline relieves bronchospasm in acute and chronic obstructive pulmonary affliction past significantly increasing pulmonary menses rates (e.g., an increase of 15% or more in FEV1). After subcutaneous administration of 0.25 mg of terbutaline, a measurable modify in expiratory catamenia rate ordinarily occurs within 5 minutes, and a clinically meaning increase in FEVi occurs within 15 minutes. The maximum result usually occurs within 30 to 60 minutes, and clinically significant bronchodilator activity may continue for 1.v to four hours. The duration of clinically significant comeback is comparable to that observed with equimilligram doses of epinephrine.
Preclinical
Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histological testify of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.
Pharmacokinetics
Subcutaneous assistants of 0.5 mg of terbutaline sulfate to 17 good for you, adult, male person subjects resulted in mean (SD) peak plasma terbutaline concentration of nine.6 (iii.half-dozen) ng/mL, which was observed at a median (range) fourth dimension of 0.v (0.08 to one.0) hours later on dosing. The mean (SD) AUC (0 to 48) and total body clearance values were 29.4 (xiv.2) hr•ng/mL, and 311 (112) mL/min respectively. The concluding half-life was determined in 9 of the 17 subjects and had a hateful (SD) of 5.7 (2.0) hours.
After subcutaneous assistants of 0.25 mg of terbutaline sulfate to two male subjects, elevation terbutaline serum concentrations of five.2 and 5.iii ng/mL were observed at about twenty minutes after dosing.
Elimination half-life of the drug in ten of 14 patients was approximately 2.9 hours after subcutaneous administration, merely longer elimination half-lives (between 6 to 14 hours) were institute in the other 4 patients. Well-nigh 90% of the drug was excreted in the urine at 96 hours subsequently subcutaneous assistants, with about 60% of this being unchanged drug. It appears that the sulfate conjugate is a major metabolite of terbutaline and urinary excretion is the main road of elimination.
PATIENT INFORMATION
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
From 
Written report Issues to the Food and Drug Administration
Yous are encouraged to report negative side furnishings of prescription drugs to the FDA. Visit the FDA MedWatch website or call one-800-FDA-1088.
Source: https://www.rxlist.com/terbutaline-sulfate-drug.htm
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