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RXDRUG-DR-XY29330

BRICALIN Terbutaline Sulfate 500mcg / mL Solution for IM/IV/SC Injection 1mL 1's

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Description

Indications/Uses

Terbutaline is given as the sulfate for its bronchodilating properties in reversible airways obstruction, as occurs in asthma and in some patients with chronic obstructive pulmonary disease. It also decreases uterine contractility and may be used to arrest premature labor.
 

Dosage/Direction for Use

Terbutaline sulfate may be given by subcutaneous, intramuscular, or slow intravenous injection in the treatment of severe forms of bronchospasms. A dose of 250 to 500 mcg may be given up to four times daily. A suggested dose by injection for children over 2 years of age is 10 mcg per kg body-weight to a maximum total dose of 300 mcg. Terbutaline sulfate may also be given by intravenous infusion, as a solution containing 3 to 5 mcg per mL at a rate of 0.5 to 1 mL per minute for adults.
Terbutaline sulfate is also used to arrest uncomplicated premature labor between 24 and 33 weeks of gestation. It is given by intravenous infusion in glucose 5%, preferably by syringe pump when the concentration is 100 mg per mL. If no syringe pump is available then the concentration of the infusion should be 10 mcg per mL. The recommended initial rate of infusion is 5 mcg per minute increased by 2.5 mcg per minute at intervals of 20 minutes until contraindications stop. Usually a rate up to 10 mcg per minute is sufficient; rates in excess of 20 mcg per minute should not be used and if that maximum rate does not delay labor then the infusion should be stopped. Once the contraction has ceased and the infusion has been given for one hour, the dose may be decreased by 2.5 mcg per minute at 20-minute intervals to the lowest maintenance dose that produces continued suppression of contractions.
Or as prescribed by a physician.
 

Overdosage

Overdosage may cause depression of the central nervous system with marked reduction of body temperature and symptoms of drowsiness and coma, particularly in children. Treatment of overdosage is symptomatic but the preferred antidote to overdosage with Terbutaline a cardioselective beta-blocking agent, but beta blocking drugs should be used with caution in patients with a history of bronchospasm.
 

Contraindications

Terbutaline sulfate is contraindicated in patients with a history of hypersensitivity to any of its components. It is also contraindicated in patients sensitive to sympathomimetic amines. Terbutaline should not be administered during the 1st and 2nd trimester of pregnancy or in premature labor associated with toxemia of pregnancy or antepartum hemorrhage.
It should not be used in neonates.
 

Warnings

This product contains sodium metabisulfate that may cause serious allergic type reactions in certain susceptible patients. Do not use if know to be hypersensitive to bisulfites. This preparation also contains benzyl alcohol; prolonged use can cause benzyl alcohol poisoning. Its use should be avoided in children below two years of age.
 

Special Precautions

Terbutaline and other beta agonist should be given with caution in hyperthyroidism, myocardial insufficiency, arrhythmias, susceptibility to OT-interval prolongation, hypertension, and diabetes mellitus.
In severe asthma particular caution is also required to avoid inducing hypokalemia as this effect may be potentiated by hypoxia or by concomitant administration of other anti-asthma drugs; plasma-potassium concentrations should be monitored.
Beta2 agonist such as Terbutaline is not appropriate for use alone in the treatment of more than mild asthma. Increasing need for, or decreased duration of effect of, inhaled Terbutaline and other short-acting beta2 agonist indicates deterioration of asthma control and the likely requirement for increased anti-inflammatory therapy.
 

Adverse Reactions

Terbutaline sulfate and other beta agonists may cause fine tremor of skeletal muscle (particularly the hands), palpitations, tachycardia, nervous tension, headaches, peripheral vasodilation, and rarely muscle cramps. Inhalation causes fewer side-effects than systemic administration, and more selective beta2 agonists cause fewer side-effects than less selective beta agonists. Potentially serious hypokalemia has been reported after large doses. Hypersensitivity reactions have occurred, including paradoxical bronchospasm, angioedema, urticaria, hypotension and collapse.
 

Drug Interactions

Concomitant administration of Terbutaline and other betaagonist with corticosteroids, diuretics, or xanthines increases the risk of hypokalemia, and monitoring of potassium concentrations is recommended n severe asthma, where such combination therapy is the rule.
Hypokalemia produced by beta2 agonists may result in an increased susceptibility to digitalis-induced arrhythmias.
Corticosteroids and betaagonists may both produce falls in plasma potassium concentrations; there is evidence that such falls can be exacerbated by concomitant administration. The possibility of enhanced hyperglycemic effects from such a combination should also be remembered.
Hypokalemia is known to be possible side-effect during treatment with beta2 agonists such as Terbutaline and this may be enhanced during concomitant diuretic therapy; in addition, the arrhythmogenic potential of this interaction may be clinically important in patients with ischemic heart disease.
An enhanced hypokalemic effect may occur during coadministration of Terbutaline with theophylline.
 

Storage

Store at temperatures not exceeding 30˚C.
 

Action

Pharmacology: Terbutaline is a direct-acting sympathomimetic with predominantly beta-adrenergic activity and a selective action on betareceptors (a beta2 agonist). This results in its bronchodilating action being more prominent than its effect on the heart.
Pharmacokinetics: Terbutaline is variably absorbed. It is accordingly excreted in the urine partly as the inactive conjugated and partly as unchanged Terbutaline. The half-life is reported to be about 3 to 4 hours. There is some placental transfer. Traces are distributed into breast milk.
 

MedsGo Class

Antiasthmatic & COPD Preparations

Features

Dosage
500 mcg / mL
Ingredients
  • Terbutaline
Packaging
Solution for Injection (I.M./I.V./S.C./) 1ml x 1's
Generic Name
Terbutaline Sulfate
Registration Number
DR-XY29330
Classification
Prescription Drug (RX)
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