Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TERBUTALINE SULPHATE
IDAMAN PHARMA MANUFACTURING SDN BHD
TERBUTALINE SULPHATE
1000 Tablets; 500 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
BRONKINE TABLET 2.5MG Terbutaline sulphate (2.5mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Bronkine Tablet 2.5mg is used for 2. How Bronkine Tablet 2.5mg works 3. Before you use Bronkine Tablet 2.5mg 4. How to use Bronkine Tablet 2.5mg 5. While you are using it 6. Side Effects 7. Storage and Disposal of Bronkine Tablet 2.5mg 8. Product Description 9. Product Registration Holder and Manufacturer 10. Date of Revision WHAT BRONKINE TABLET 2.5MG IS USED FOR Bronkine Tablet 2.5mg is used to relief and prevent tightening of chest and difficulties in breathing. HOW BRONKINE TABLET 2.5MG WORKS It helps to open up the airways in the lung by relaxing muscle of the airways. BEFORE YOU USE BRONKINE TABLET 2.5MG - _When you must not use it _ Do not take this medicine if you are allergy or hypersensitive to: 1. Terbutaline sulphate. 2. Any of the other ingredients listed at the end of this leaflet. Do not take this medicine after the expiry date. If you are not sure whether you should be taking this medicine, talk to your pharmacist or doctor. - _Before you start to use it _ This medicine should not be used if you have medical conditions such as: 1. Heart disease. 2. Diabetes. 3. Overactive thyroid gland. 4. High blood pressure _ _ _Pregnancy and breast-feeding _ If you are pregnant, trying to get pregnant or think you may be pregnant or are breastfeeding ask your doctor or pharmacist for advice before taking any medicine. Terbutaline should be taken with caution during the early pregnancy since it relaxes the womb. Terbutaline released in breast milk does not give therapeutic effects in infant. - _Taking other medicines _ Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Bronkine Tablet 2.5mg can affect the way that some medicines work and some medicines can have an effect on Bronkine Tablet 2.5mg. In particular, tell your doctor or pharmacist if you Lesen Sie das vollständige Dokument
IDAMAN PHARMA MANUFACTURING BRONKINE TABLET 2.5MG DESCRIPTION Clean, uniform, small, round, flat, bevel edged tablet and scored on one side. Colour: White to off white. Each tablet contains Terbutaline Sulphate 2.5mg. Source of Lactose: Bovine ROUTE OF ADMINISTRATION Oral PHARMACODYNAMICS Terbutaline is a selective beta2-adrenergic stimulant having the following pharmacological effects:- i) In the lung - bronchodilation; increased mucociliary clearance; suppression of oedema and anti-allergic effects. ii) In skeletal muscle - stimulates Na+/K+ transport and also causes depression of subtetanic contractions in slow- contracting muscle. iii) In uterine muscle - inhibition of uterine contractions. iv) In the CNS - low penetration of the blood-brain barrier at therapeutic doses, due to the highly hydrophilic nature of the molecule. v) In the CVS - administration of terbutaline results in cardiovascular effects mediated through beta2-receptors in the peripheral arteries and in the heart e.g. in healthy subjects, 0.25 - 0.5mg injected s.c. is associated with an increase in cardiac output (up to 85% over controls) due to an increase in heart rate and a larger stroke volume. The increase in heart rate is probably due to a combination of a reflex tachycardia via a fall in peripheral resistance and a direct positive chronotropic effect of the drug. PHARMACOKINETICS Basic parameters have been evaluated in man after oral administration of therapeutic doses:- _Oral dose: _ Renal clearance (CLR) - 1.925 ml/min. (males) Renal clearance (CLR) - 2.32 ml/min. (females) Terminal half-life t½ has been determined after single and multiple dosing (mean values varied between 16-20 hours). _Bioavailability: _ Food reduces bioavailability following oral dosing (10% on average). Fasting values of 14-15% have been obtained. _Metabolism: _ The main metabolite after oral dosing is the sulfate conjugate and also some glucoronide conjugate can be found in the urine. INDICATIONS Indicated for the relief and prevention of bronchospasm in bronch Lesen Sie das vollständige Dokument