Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PYRIDOSTIGMINE BROMIDE
A. MENARINI SINGAPORE PTE. LTD.
PYRIDOSTIGMINE BROMIDE
20 Tablet Tablets; 150Tablet Tablets
LABIANA PHARMACEUTICALS SLU
_ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 MESTINON DRAGEES TABLET _Pyridostigmine Bromide (60mg)_ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Mestinon is used for 2. How Mestinon works 3. Before you use Mestinon 4. How to use Mestinon 5. While you are taking Mestinon 6. Side effects 7. Storage and Disposal of Mestinon 8. Product Description 9. Manufacturer 10. Product Registration holder WHAT MESTINON IS USED FOR Mestinon is used for the treatment of myasthenia gravis. This is a condition whereby you have muscle weakness and tiredness especially on repeated use. HOW MESTINON WORKS MESTINON belongs to a group of medicines called cholinergic antimyasthenics. It works by preventing the breakdown of a chemical called acetylcholine. This chemical is needed to stimulate muscle movement. BEFORE YOU USE MESTINON - _Taking other medicines_ _ _ _ _ Tell your doctor if you have or have had any of the following medical medical conditions (ie: kidney problem) or taking any other medicines, including medicines obtained without a prescription. Some medicines and Mestinon may interfere with each other. These include: • muscle relaxants • atropine contained in medicines for travel sickness and stomach cramps, or use in surgery (injection) or used as an antidote to insecticide poisoning (tablets) Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while taking medication. _- Pregnancy and Lactation_ _ _ The safety of Mestinon for use during pregnancy has not been established. Hence, it should only be used strictly as directed by your doctor. Since it is not known whether the active ingredient in MESTINON passes into breast milk, nursing mothers are advised to refrain from breast feeding their babies during treatment. Your doctor can advise you of the risks and benefits of taking MESTINON while you are pregnant or breast feeding. Ask your doctor or pharmacisr for advice before taking any medicine. HOW TO USE MESTINON - _How much to use _ When using Mestinon, it is important Přečtěte si celý dokument
Mestinon ® Pyridostigmine Bromide Information for Physicians Mestinon ® Dragées 60 mg Mestinon ® Tablet 10 mg MESTINON ® Pyridostigmine Bromide Vagotonic, antimyasthenic COMPOSITION Tablets 10 mg: round biconvex tablets, white to off white coloured and odourless. Dragées (sugar-coated tablets) 60 mg: round biconvex sugar-coated tablets, orange-white or pale orange coloured. PROPERTIES AND EFFECTS Pyridostigmine, the active ingredient of Mestinon ® is a cholinesterase inhibitor. It is characterized by the gentle onset, smooth course, comparatively long duration and gradual decline of its cholinergic action. Pyridostigmine has an antagonistic effect on non-depolarising muscle relaxants only. It has a synergistic effect on depolarizing muscle relaxants. PHARMACOKINETICS _Absorption_ Pyridostigmine, like other medicines of the same type, is not fully absorbed from the intestinal tract. Bioavailability following oral administration is 3 - 8 %. Considerably higher doses are therefore required for oral as opposed to parenteral administration. _Distribution_ Peak plasma concentrations were reached in the fasting state approximately 1.5 - 2 hours after administration of 120 mg pyridostigmine. The increase in active ingredient is delayed when taken with food. The distribution volume averages 1.4 L/kg body weight. Pyridostigmine is not noticeably bound to plasma proteins and does not cross the blood-brain barrier. Blood plasma levels of 20 - 60 ng/ml are required in order to obtain the desired therapeutic effect with myasthenia gravis. _Metabolism_ Pyridostigmine is metabolized to 3-hydroxy-N-methylpyridine and other unidentified metabolites. _Elimination_ Mean values of around 1.5 hours are given for the elimination half life. This can, however, be prolonged up to three times over in individual cases. Mean plasma clearance in healthy volunteers is given as 0.36 - 0.65 L/kg/h. No confirmed data are available regarding the potential accumulation of unchanged pyridostigmine or active metabolites. Since the dosage must, Přečtěte si celý dokument