TERBUTALINE SULFATE

PRODUCT IDENTIFICATION

CAS RN

EINECS RN

FORMULA

MOLE WEIGHT

CLASSIFICATION

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE

MELTING POINT

BOILING POINT

DENSITY

SOLUBILITY IN WATER

pH

VAPOR DENSITY

REFRACTIVE INDEX

FLASH POINT

INCOMPATIBLE MATERIALS

Strong oxidizing agents

Carbon monoxide, Carbon dioxide, Nitrogen oxides. Sulphur oxides

NFPA RATINGS

SAFETY

HAZARD NOTES

Target Organ Effect, Teratogen. Target Organs: Lungs, Heart, Nerves.

EYE

May cause eye irritation.

SKIN

May be harmful if absorbed through skin. May cause skin irritation.

INGESTION

May be harmful if swallowed.

INHALATION

May be harmful if inhaled. May cause respiratory tract irritation.

CHRONIC

TRANSPORT & REGULATORY INFORMATION

UN NO.

HAZARD SYMBOL

XN

RISK PHRASES

SAFETY PHRASES

26-36

Terbutaline is a member of a class of drugs called beta adrenergic receptor agonists (stimulators) that is used for treating asthma and other airway diseases. Other drugs in the same class of drugs include albuterol (Proventil), metaproterenol (Alupent), pirbuterol (Maxair), and salmeterol (Serevent). Asthma is a breathing problem caused by narrowing of air passages (bronchial tubes) through which air moves in and out of the lungs. These airways can be narrowed due to the accumulation of mucus, spasm of the muscles that surround them (bronchospasm), or swelling of their linings due to the accumulation of fluid. Airway narrowing leads to shortness of breath, wheezing, and cough. Terbutaline is a bronchodilator, a medication that dilates (expands) air passages in the lungs. It attaches to beta adrenergic receptors on muscles surrounding the air passages, causing the muscles to relax and dilate the air passages. Wider air passages allow more air to flow in and out of the lungs. Increased airflow reduces shortness of breath, wheezing, and cough. Terbutaline also is used for delaying premature labor by relaxing the muscles of the uterus that are responsible for expelling the fetus at delivery. The FDA approved terbutaline in 1974. (http://www.medicinenet.com/)

Ritodrine and terbutaline are sometimes used as tocolytic medicines to slow uterine contractions during preterm labor. Ritodrine and terbutaline are given through a vein (intravenously, or IV) and/or by injection. Use of terbutaline for the treatment of preterm labor is an unlabeled use of the medicine. Terbutaline has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of asthma and other breathing conditions, but it is also widely used to treat preterm labor. The longer ritodrine and terbutaline are used, the less effective they are at stopping contractions (an effect called tachyphylaxis). (http://www.questdiagnostics.com/)

Beta-sympathomimetics - salbutamol
These are the most widely used tocolytics and have been extensively studied in randomised controlled trials. Salbutamol has been the most widely used beta-sympathomimetic in Australia and was recommended by the NHMRC in its 1996 report1. It must be given intravenously, it has several maternal contraindications and significant maternal side effects. Recently more information has become available from trials comparing nifedipine (a calcium antagonist) atosiban (an oxytocin antagonist) and indomethacin (a prostaglandin antagonist) with beta-mimetics.
Calcium antagonists – nifedipine
Nifedipine is an equally effective tocolytic, as shown by a recent Cochrane Review 4. It is administered orally and has fewer maternal side effects. However, nifedipine is not approved for use in pregnancy and is classified as a risk Category C drug by the Australian Drug Evaluation Committee.
Oxytocin antagonists - atosiban
Atosiban appears to be as effective as beta-mimetics. It has fewer maternal side effects but is much more expensive than other options in preterm labour. However, it is not approved for use in Australia.
Prostaglandin antagonists – indomethacin
Indomethacin has been compared in small trials with beta-mimetics. These have suggested equal efficacy in delaying preterm birth but there are concerns about adverse affects on the fetal circulation.
Other agents – glyceryl trinitrate
Glyceryl trinitrate patches have been evaluated in a small number of women and there is insufficient evidence to support use in routine clinical practice. Clinicians should ensure their choice of agent is informed by the balance of evidence, as well as their experience in use of a given agent and in the light of advice from clinicians at the receiving hospital. Choice of tocolytic drug is also discussed in a recent RCOG draft evidence-based guideline for the use of tocolytics.(http://www.health.nsw.gov.au/)

SALES SPECIFICATION

APPEARANCE

IDENTIFICATION

pass A,B,C

ASSAY

0.3% max

LOSS ON DRYING

0.5% max

RESIDUE ON IGNITION

0.2% max

HEAVY METALS

20ppm max

0.5% max

PACKING

PRICE INFORMATION