This action might not be possible to undo. Are you sure you want to continue?
etoricoxib 30 mg, 60 mg, 90 mg & 120 mg tablets
What is in this leaflet
This leaflet answers some common questions about ARCOXIA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ARCOXIA against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.
What ARCOXIA is used for
ARCOXIA is used for the following: 1 acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) 2 management of ankylosing spondylitis 3 relief of chronic musculoskeletal pain 4 relief of acute pain 5 to treat acute gouty arthritis Your doctor will prescribe ARCOXIA for you only after you have used other medicines for your condition and they have not been suitable for you. Your doctor will want discuss your treatment with ARCOXIA from time to time. It is important that you use the lowest dose that controls your pain and you should not take ARCOXIA for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses. Osteoarthritis Osteoarthritis is a joint disease. It results from the gradual breakdown of the cartilage that covers the joints and cushions the ends of bones. Symptoms of osteoarthritis include pain, tenderness, stiffness of one or more joints, and physical disability. The hips and knees are the most commonly affected joints, but other joints such as those of the hands and spine may also be affected. Osteoarthritis is more common in women than in men. Many factors can lead to the development of osteoarthritis including obesity and joint injury (eg. from sport). Rheumatoid Arthritis Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling and loss of function in the joints and inflammation in other body organs. Ankylosing Spondylitis Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
Gout Gout is a disorder characterised by sudden, recurring attacks of pain and inflammation in one or more joints. How ARCOXIA works ARCOXIA belongs to a group of medicines called cyclooxygenase-2 (COX-2) specific inhibitors (also known as Coxibs). The body produces two similar enzymes called COX-1 and COX-2. COX-1, among other functions, is involved with protecting the stomach, while COX-2 plays a role in joint inflammation and pain. ARCOXIA reduces pain and inflammation by blocking COX-2, an enzyme in the body. ARCOXIA does not block COX-1, the enzyme involved in protecting the stomach from ulcers. Other anti-inflammatory medicines (NSAIDs) block both COX-1 and COX-2. ARCOXIA relieves pain and inflammation with less risk of stomach ulcers compared to NSAIDs. However taking aspirin with ARCOXIA may reverse this benefit (see Before you take ARCOXIA, Taking Other Medicines). In clinical studies, the risk of developing ulcers on ARCOXIA was lower than with NSAIDs. Some people developed ulcers whether they were taking ARCOXIA or placebo in these studies; however the rate was higher on ARCOXIA. If any of the following symptoms: shortness of breath, chest pains or ankle swelling appear or worsen, stop your treatment with ARCOXIA and consult a doctor, as soon as is practical. If you have kidney, liver or heart disease, your doctor will want to appropriately keep a check on you. If you develop any symptoms that could indicate a severe allergic reaction such as an inability to breathe or a serious skin reaction you must consult a doctor on an urgent basis. Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and you should not take ARCOXIA for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses. ARCOXIA can increase blood pressure in some people, especially in high doses, and this could increase the risk of heart attacks and strokes. Your doctor will want to check your blood pressure from time to time, to make sure that it is safe to continue treatment. Your doctor may have prescribed ARCOXIA for another reason. Ask your doctor if you have any questions about why ARCOXIA has been prescribed for you. ARCOXIA is not addictive.
It is not known if ARCOXIA passes into breast milk. chest pain (angina). You and your doctor should discuss whether you should stop breast-feeding or not take ARCOXIA. bypass surgery. talk to your doctor. runny or blocked nose. • you have or have had any medical conditions. a heart attack. ARCOXIA works equally well in older and younger adult patients. ARCOXIA should not be given to children. Therefore. your doctor will want to appropriately keep a check on you. Adverse experiences may occur at a higher incidence in older patients compared to younger patients. it may not work. 4 you have had heart failure. ARCOXIA has not been adequately studied in children. heart attack or a blocked artery in your heart 1 narrow or blocked arteries of the extremities 2 kidney disease 3 liver disease 4 dehydration.Before you take ARCOXIA When you must not take it Do not take ARCOXIA if: 1 you have an allergy to ARCOXIA or any of the ingredients listed at the end of this leaflet 2 the packaging is torn or shows signs of tampering 3 the expiry date on the pack has passed. a stroke or mini stroke (TIA or transient ischaemic attack) 5 you have high blood pressure that is not well controlled on blood pressure medication 6 you are having major surgery on your heart or arteries 7 you have serious liver disease. If you take this medicine after the expiry date has passed. If there is a need to consider using ARCOXIA during your pregnancy. No dosage adjustment is necessary for older patients. pinkish itchy swellings on the skin (hives). If you are elderly (ie over 65 years of age). Symptoms of an allergic reaction may include asthma. narrow or blocked arteries of the extremities (peripheral arterial disease). ARCOXIA is not recommended for use during late pregnancy. Before you start to take it Tell your doctor if: • you are pregnant or intend to become pregnant. especially the following: 0 history of angina. • you are breast-feeding or plan to breast-feed. for example by a prolonged bout of vomiting or diarrhoea 5 history of stomach bleeding or ulcers 6 heart failure 7 high blood pressure 8 swelling due to fluid retention 9 • you have had an allergic reaction to aspirin or other anti-inflammatory medicines (commonly known as NSAIDs). If you are not sure whether you should start taking ARCOXIA. . your doctor will discuss with you the benefits and risks of using it.
it may hide fever and may make you think.10 • you have an infection. mistakenly. that you are better or that your infection is less serious than it might be. such as foods. preservatives or dyes 12 • you have a history of stroke or mini stroke . 11 • you have any allergies to any other medicines or any other substances. If you take ARCOXIA while you have an infection.
If you have not told your doctor about any of the above. Taking other medicines Tell your doctor if you are taking any other medicines. high cholesterol or smoking. supermarket or health food shop. If you are currently taking low dose aspirin for the prevention of a heart attack or stroke. These include: 1 non-steroidal anti-inflammatory medicines (NSAIDs). you should continue to do so unless specified by your Doctor. which should only be used for the acute painful period. or you may need to take different medicines. ARCOXIA cannot replace aspirin for this purpose.1 you have conditions which increase your risk of coronary artery disease or atherosclerosis such as high blood pressure. medicines used to lower high blood pressure or treat heart failure 5 lithium. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ARCOXIA. For the relief of chronic musculoskeletal pain the recommended dose is 60 mg once a day. including medicines that you buy without a prescription from your pharmacy. a medicine used to treat a certain type of depression 6 birth control pills 7 hormone replacement therapy 8 methotrexate. Doses greater than those recommended for each condition have either not demonstrated additional efficacy or have not been studied. Some medicines should not be taken with ARCOXIA. tell them before you take any ARCOXIA. the daily doses stated above for each condition should not be exceeded. You may need different amounts of your medicine. diabetes. swelling. the recommended dose is 30 mg or 60 mg once a day. used to relieve pain. For rheumatoid arthritis the recommended dose is 90 mg once a day. Some medicines and ARCOXIA may interfere with each other. How to take ARCOXIA How much to take Take ARCOXIA only when prescribed by your doctor. Therefore. and other symptoms of inflammation 2 aspirin when used regularly for conditions other than to prevent heart attack or stroke ARCOXIA can be taken with low dose aspirin. For the relief of gout attacks the recommended dose is 120 mg once a day. a medicine used to suppress the immune system These medicines may be affected by ARCOXIA or may affect how well it works. . These include: 1 warfarin. For ankylosing spondylitis the recommended dose is 90 mg once a day. an antibiotic used to treat tuberculosis and other infections 3 water pills (diuretics) 4 ACE inhibitors and angiotensin receptor blockers. a medicine used to prevent blood clots 2 rifampicin. For osteoarthritis.
It is important that you use the lowest dose that controls your pain and you should not take ARCOXIA for longer than necessary. you should not take more than 60 mg every other day or 30 mg a day. Otherwise. They may differ from the information contained in this leaflet. When taking the tablets. For the relief of gout attacks or other types of pain. ARCOXIA is usually only needed for a few days. Do not halve the tablet. It will also help you remember when to take the dose. especially with high doses. This is because the risk of heart attacks and strokes might increase after prolonged treatment. and then go back to taking your tablet(s) as you would normally. swallow them with a glass of water. you may need to take ARCOXIA for a few days or for a longer period. talk to your doctor. If you forget to take it If it is almost time for your next dose. take it as soon as you remember. Follow all directions given to you by your doctor carefully. Taking ARCOXIA at the same time each day will have the best effect. ask your pharmacist for some hints. ask your doctor or pharmacist for help. How to take it ARCOXIA comes as tablets. Your doctor will want to discuss your treatment from time to time. If you do not understand the instructions on the box. . When to take it Take your ARCOXIA at about the same time each day. Continue taking ARCOXIA for as long as your doctor prescribes. It does not matter if you take ARCOXIA before or after food. Depending on your condition. skip the dose you missed and take your next dose when you are meant to.If you have mild liver disease. If you are not sure how long to take ARCOXIA. If you have trouble remembering to take your tablets. talk to your doctor or pharmacist. If you are not sure whether to skip the dose. For osteoarthritis and rheumatoid arthritis ARCOXIA helps relieve your symptoms but it does not cure it. If you have moderate liver disease. How long to take it Do not use ARCOXIA for longer than your doctor says. Do not take a double dose to make up for the dose that you missed. you should not take more than 60 mg a day.
ARCOXIA may hide fever and may make you think.If you take too much (overdose) Immediately telephone your doctor or National Poisons Centre (telephone 0800 POISON or 0800 764 766). although it is thought to be unlikely to have any effect on these activities. but it is important not to overdo it. ARCOXIA may cause certain adverse effects in some people. tell your doctor immediately. Do this even if there are no signs of discomfort or poisoning. before starting any exercise. tell your doctor. While you are using ARCOXIA Things you must do If you become pregnant while taking ARCOXIA. Make sure you know how you react to ARCOXIA before you drive a car or operate machinery. or bloody diarrhoea You may need urgent medical attention. Walking is good exercise. If you are about to be started on any new medicine. Things you must not do Do not give ARCOXIA to anyone else. however. Some people may need a dietician's help to lose weight. tell your doctor immediately 1 vomiting blood or material that looks like coffee grounds 2 bleeding from the back passage. including dizziness and tiredness. 3 Hot and cold treatments. that you are better or that your infection is less serious than it might be. 1 Exercise . If you notice any of the following. or go to accident and emergency at your nearest hospital. tell your doctor and pharmacist that you are taking ARCOXIA. black sticky bowel motions (stools). However. Talk to your doctor or pharmacist about these measures and for more information. mistakenly. as with many medicines. The effect of ARCOXIA on the ability to drive a car or operate machinery has not been studied. if you think that you or anyone else may have taken too much ARCOXIA. 4 Using support devices. .your doctor may suggest losing some weight to help reduce the strain on your joints. 2 Weight .regular exercise can help reduce pain and disability from osteoarthritis by increasing muscle strength and reducing the load on joints. If you get an infection while taking ARCOXIA. even if they have the same condition as you. Things to be careful of Be careful driving or operating machinery until you know how ARCOXIA affects you. Things that would be helpful for your osteoarthritis Some self help measures suggested below may help your condition. ask your doctor about the best kind of programme for you.
.Adverse Effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ARCOXIA.
Ask your doctor or pharmacist to answer any questions you may have. vomiting 2 heartburn. also called hives or nettlerash 5 severe stomach pain 6 passing little or no urine . most of the time they are not. All medicines can have adverse effects. including painful burning when passing urine 12 wheezing 13 signs of an infection of the breathing passages. sore throat.ARCOXIA helps most people with osteoarthritis. which may occur without warning 3 skin rash or itchiness 4 pinkish. cough These are the more common adverse effects of ARCOXIA. the following have been reported: 1 taste alteration 2 high levels of potassium in the blood 3 anxiety 4 depression 5 restlessness 6 drowsiness 7 severe increase in blood pressure 8 confusion 9 hallucinations 10 platelets decreased 11 blurred vision These are usually the mild adverse effects of ARCOXIA. Additionally. rheumatoid arthritis. but it may have unwanted adverse effects in a few people. including runny nose. uncomfortable feeling or pain in the stomach 3 mouth ulcers 4 diarrhoea 5 swelling of the legs. menstrual pain. Sometimes they are serious. indigestion. ankles or feet 6 high blood pressure 7 headache 8 dizziness 9 unusual tiredness or weakness 10 difficulty sleeping (insomnia) 11 signs of urinary tract infection. itchy swellings on the skin. Tell your doctor if you notice or have any of the following and they worry you: 1 feeling sick (nausea). gout or other types of pain. You may need medical treatment if you get some of the adverse effects. Tell your doctor immediately if you notice any of the following: 1 redness of the skin 2 severe skin reactions.
Some of these may be symptoms of an allergic reaction to ARCOXIA. You may need urgent medical attention.These may be serious adverse effects. .
or bloody diarrhoea 12 shortness of breath. and may occur at any time during use and without warning 10 vomiting blood or material that looks like coffee grounds 11 bleeding from the back passage.a blue green apple shaped biconvex film coated tablet debossed 101 on one side and ACX 30 on the other. and comes in boxes of 30 tablets. Do not store it or any other medicine in the bathroom or near a sink.a dark green apple shaped biconvex film coated tablet debossed 200 on one side and ARCOXIA 60 on the other. anaphylactic/anaphylactoid reactions including shock) 2 abnormal rhythm of the heart (atrial fibrillation and arrhythmia) 3 heart failure 4 palpitations (fast or irregular heart beats) 5 feeling of tightness. wheezing. ask your pharmacist what to do with any that are left over. Heat and dampness can destroy some medicines. . and comes in boxes of 10 tablets and 30 tablets. Product description What it looks like ARCOXIA comes as four strengths of tablets: 1 30 mg tablet . Do not leave it in the car or on window sills. lips. Keep it where children cannot reach it. Keep ARCOXIA in a cool dry place where the temperature stays below 30°C. 2 60 mg tablet . Disposal If your doctor tells you to stop taking ARCOXIA. black sticky bowel motions (stools). tongue or throat which may cause difficulty in swallowing or breathing (hypersensitivity reactions. Do not be alarmed by this list of possible adverse effects. You may need urgent medical attention. Tell your doctor if you notice any other effects. stop taking ARCOXIA and tell your doctor immediately or go to Accident and Emergency at your nearest hospital: 1 swelling of the face. Other adverse effects not listed above may also occur in some patients. A locked cupboard at least oneand-a-half metres above the ground is a good place to store medicines.If any of the following happen. After using ARCOXIA Storage Keep your tablets in the blister pack until it is time to take them. or the tablets have passed their expiry date. You may not experience any of them. If you take the tablets out of the blister pack they may not keep well. pressure or heaviness in the chest (angina) 6 yellowing of the skin and eyes (jaundice) 7 serious kidney problems 8 serious liver problems 9 stomach ulcers that may become serious and may bleed. or trouble breathing These may be serious adverse effects.
Inactive ingredients: 30 mg..... 90 mg and 120 mg tablets 1 calcium hydrogen phosphate (anhydrous) 2 carnauba wax 3 microcrystalline cellulose 4 lactose monohydrate 5 croscarmellose sodium 6 hypromellose 7 magnesium stearate 8 titanium dioxide 9 glycerol triacetate 10 The 30 mg.a white apple shaped biconvex film coated tablet debossed 202 on one side and ARCOXIA 90 on the other. a subsidiary of Merck & Co. NJ. Manufacturer/Supplier ARCOXIA is marketed in New Zealand by: Merck Sharp & Dohme (New Zealand) Limited P O Box 99 851 Newmarket Auckland NEW ZEALAND Tel: 0800 500 673 This leaflet was prepared inJune 2010 CP-ACX. USA All Rights Reserved .1 90 mg tablet . 2 120 mg tablet . and comes in boxes of 30 tablets. USA Copyright © 2010 Merck Sharp & Dohme Corp.. sucrose. Whitehouse Station. 60 mg. a subsidiary of Merck & Co. and comes in boxes of 10 tablets. Ingredients Active ingredient: ARCOXIA 30 mg tablet contains 30 mg etoricoxib. NJ. Inc. ARCOXIA 60 mg tablet contains 60 mg etoricoxib.. ARCOXIA 120 mg tablet contains 120 mg etoricoxib. ARCOXIA 90 mg tablet contains 90 mg etoricoxib. Inc. ARCOXIA does not contain gluten.a pale green apple shaped biconvex film coated tablet debossed 204 on one side and ARCOXIA 120 on the other. tartrazine or any other azo dyes. 60 mg and 120 mg tablets also contain yellow ferric oxide and indigo carmine lake. Whitehouse Station.0510(010610) ®Registered Trademark of Merck Sharp & Dohme Corp.
. Etoricoxib works by blocking the production of Prostaglandins. chemicals in the body which cause pain. weight gain and change in appetite. Do not try to repeat the dose. diabetes. Guidelines before taking Etoricoxib The drug is not recommended for pregnant females or breast feeding mothers. dizziness and fluid retention in the body. Other side effects of Etoricoxib are headaches. gas. hypertension. diarrhoea.How does Etoricoxib work? As per the FDA information. in response to injury or certain diseases. indigestion and nausea. What are the common dosages of Arcoxia? The dosage for taking Etoricoxib largely depends upon what you are being treated for. heart. Other problems like related to kidney. altered taste. The medication works faster if it is taken without food or empty stomach. tingling sensation. you should tell your doctor about it. Overdose of Etoricoxib can lead to serious repercussions. swelling and inflammation. People with diabetes. Some of the uncommon symptoms reported by the patients were depression. The drug also causes gastrointestinal effects such as abdominal pain. porphyries or any inflammatory bowel disease should also be reported to the doctor before beginning medication for Etoricoxib. If you have stomach problems like reflux or indigestion. continue with your daily schedule by skipping the dose. Since no cyclo-oxygenase is produced in the body. Do not take over dose of the drug. then no prostaglandins are produced to cause inflammation in the body. Side Effects of Etoricoxib The doctor will monitor your blood pressure when putting you on medication for Etoricoxib. and high cholesterol or have a tendency to smoke showed greater susceptibility of suffering a stroke or a heart attack. It contains non-steroidal anti-inflammatory chemical that blocks the action of Cyclo-oxygenase is involved in producing prostaglandins. Usually the recommended dose of the tablets is once daily. If you miss you dose. anxiety. liver high blood pressure.
Ltd. 15700AMZ01120000 15700AMZ01121000 Date of listing in the NHI reimbursement price Feb 1983 Feb 1983 Date of initial marketing in Japan Feb 1983 Feb 1983 Date of latest reexamination Dec 1991 Date of latest approval of indications May 1985 Storage MYONAL should be stored at room temperature. carmellose.) MYONAL tablets in bottle package should be protected from light and moisture after opening the cap of bottle. corn starch. Composition Tablets 50 mg: Each white. hydrated silicon dioxide. (MYONAL granules absorb moisture easily. (Light and moisture may occur discoloration of the tablets. Press-through packages of MYONAL tablet should be protected from light after opening outer package.) MYONAL granules in bottle should be protected from moisture after opening the cap of bottle.) Patients with a history of hypersensitivity to any ingredients of MYONAL.For improvement of myotonic symptoms Myonal→ Tablets 50 mg Myonal→ Granules 10 % <Eperisone hydrochloride preparation> Prescription drug Tablets 50 mg Granules 10 % Approval No. of Japan 871249 . calcium stearate.) Expiration date MYONAL should be used before the expiration date indicated on the package or label. precipitated calcium carbonate. It contains carnauba wax. povidone and macrogol 6000 as inactive ingredients. sucrose. 1 Revised: October 2010 (11th version) Standard Commodity Classification No. stearic acid. CONTRAINDICATIONS (MYONAL is contraindicated in the following patients. microcrystalline cellulose. pullulan. sugar-coated tablet contains 50 mg of eperisone hydrochloride. DESCRIPTION 1. Caution : Use only as directed by a physician. Granules 10%: . (Light may occur discoloration of the tablets.. talc. hydroxypropylcellulose. white shellac. titanium oxide.Eisai Co.
coated granules having a faint characteristic odor INDICATIONS ⋅ Improvement of myotonic conditions caused by the following diseases: Neck-shoulder-arm syndrome. Product description Brand Appearance name Dosage form and identification code Face Reverse Lateral Description Sugar-coated MYONAL tablets Tablets 50mg Diameter (mm) 7. lactose hydrate. povidone. 2. It contains carmellose. scapulohumeral periarthritis and low back pain ⋅ Spastic paralysis caused by the following diseases: Cerebrovascular disorders.Each gram of white to yellowish white granules contains 100 mg of eperisone hydrochloride. light anhydrous silicic acid. cervical spondylosis. infantile cerebral . corn starch.5 Weight (mg) 162 Thickness (mm) 4.2 White MYONAL Granules 10% Granules White to yellowish white. polyvinylacetal diethylaminoacetate and macrogol 6000 as inactive ingredients. spastic spinal paralysis. sequela of surgical trauma (including cerebrospinal tumor). sequela of trauma (spinal injury and head injury). talc. amyotrophic lateral sclerosis.
The dosage may be adjusted depending on the patient’s age and symptoms. an analogue compound. Patients should be cautioned against engaging in potentially hazardous activities requiring alertness. In the event of such symptoms. Mechanism unknown 4. light-headedness. Drug Interactions Precautions for coadministration (MYONAL should be administered with care when coadministered with the following drugs. Symptoms. spinal vascular disorders. PRECAUTIONS 1. Ltd.. such as operating machinery or driving a car. and Treatment Mechanism and Risk Factors Methocarbamol It has been reported that disturbance of visual accommodation occurred after the concomitant use of methocarbamol with tolperizone hydrochloride.] 2. subacute myelo-optico neuropathy (SMON) and other encephalomyelopathies 2 Eisai Co. DOSAGE AND ADMINISTRATION Tablets 50 mg: The usual adult dosage for oral use is 3 tablets (150 mg of eperisone hydrochloride) daily in three divided doses after meals.5 g (150 mg of eperisone hydrochloride) daily in three divided doses after meals. 3. Granules 10%: The usual adult dosage for oral use is 1.palsy.) (1) Patients with a history of drug hypersensitivity (2) Patients with hepatic function disorder [MYONAL may aggravate hepatic function.) Drugs Signs. the dosage should be reduced or treatment discontinued. spinocerebellar degeneration. Important Precautions Weakness. The dosage may be adjusted depending on the patient’s age and symptoms. Careful Administration (MYONAL should be administered with care in the following patients. Adverse Reactions . sleepiness or other symptoms may occur.
itching. etc. stomach discomfort.1% <0. Renal note 1) Proteinuria and Elevation of BUN.. (2) Other adverse reactions 5% > ≥ 0. headache and numbness in the extremities Stiffness and tremor in the extremities Gastrointestinal Nausea/vomiting. edema of the face or other parts and dyspnea etc.Adverse reactions were reported in 416 of 12. insomnia. Patients should be carefully observed. etc. etc. itching.315 patients (3. 2) Oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome) Serious dermatopathy such as oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) may occur. treatment should be discontinued and appropriate measures taken.1% Incidence unknown Hepatic note 1) Elevation of AST (GOT). In the event of symptoms such as redness. treatment discontinued and appropriate measures taken. patients should be carefully observed. anorexia. blistering. ocular congestion or stomatitis. constipation and thirst Stomatitis and feeling of enlarged . abdominal pain. Hematologic note 1) Anemia Hypersensitivity note 2) Rash Pruritus erythema exudativum multiforme Psychoneurologic Sleepiness. erythema. diarrhea. urticaria. ALT(GPT) and Al-P. (At the end of the reexamination period) (1) Clinically significant adverse reactions (incidence unknown) 1) Shock and anaphylactoid reactions Since shock and anaphylactoid reactions may occur.38%). in the event of symptoms such as fever.
such as reduction in dosage under careful supervision. [The safety of MYONAL in pregnant women has not been established.] 7. treatment should be discontinued. 8. it is advisable to take measures. treatment should be discontinued and appropriate measures taken. urinary incontinence and feeling of residual urine General Weakness. light-headedness and generalized fatigue Muscle hypotonia and dizziness Others Hot flushes Diaphoresis and edema Note 1) Since these symptoms may occur. if the PTP sheet is swallowed.. [It has been reported that MYONAL is excreted in breast milk in an animal study (in rats). Delivery or Lactation (1) MYONAL should only be used in pregnant women or women suspected of being pregnant. the sharp corners of the sheet may puncture the esophageal mucosa. 6. Note 2) In the event of such symptoms. if the expected therapeutic benefits are evaluated to outweigh the possible risk of treatment. 5.abdomen Urinary Urinary retention. instruct the patient to remove the drug from the package prior to use. Use in the Elderly Since the elderly often have a physiological hypofunction. causing perforation and resulting in serious complications such as mediastinitis.] (2) It is advisable to avoid the administration of MYONAL to nursing mothers. [It has been reported that. When MYONAL must be used. Ltd. In the event of such abnormalities. Use during Pregnancy. Pediatric Use Safety in children has not been established (insufficient clinical experience).] . breast feeding should be discontinued during treatment. 3 For drugs that are dispensed in a press-through package (PTP). Precautions concerning Use Caution in handing over drug (tablets) Eisai Co. patients should be carefully observed.
6 to 1. The plasma concentration profiles of eperisone hydrochloride determined at days 8 and 14 did not significantly vary from those of the first day.1% (234/449) was achieved.3% (197/466) and 45. Neck-shoulder-arm syndrome. eperisone hydrochloride suppresses mono and poly-synaptic reflex potentials induced through spinal nerve efferent root stimulation to a similar degree. 5 . (When fairly effective responses are included.E. elimination half-life (t1/2) was 1.) 2 . n=8) Note) A single dose of 150 mg is unapproved.4%. Spastic paralysis In open labeled clinical trials and a double blind clinical trial. 8) (2) Suppression of spinal reflexes In spinal cats. the usefulness of MYONAL has been established for spastic paralysis associated with diseases such as cerebrovascular disturbances. 8) . and the area under the plasma concentrationtime curve (AUC) was 19.6 to 1.9 hr.5 to 7. Skeletal muscle relaxation (1) Inhibition of experimentally-induced muscle rigidity Eperisone hydrochloride suppresses intercollicular sectioninduced decerebrate rigidity (©-rigidity) and ischemic decerebrate rigidity (〈-rigidity) in rats dose-dependently. an efficacy rate of 52.4) 2.8 hr. The time to reach the peak plasma concentration (tmax) ranged from 1. scapulohumeral periarthritis and low back pain In open labeled clinical trials and a double blind controlled clinical trial undertaken to determine the effects of MYONAL on myotonic symptoms associated with these diseases.1% (174/386).9 ng/mL. CLINICAL STUDIES 1. 1) Plasma concentration of eperisone hydrochloride in the course of oral administration at a single dose of 150note) mg/day for 14 consecutive days (means ± S. Improvement rates for rigidity and stiffness in patients with spastic paralysis were 42. the peak plasma concentration (cmax) was 7. the efficacy rate was as high as 80. spastic spinal paralysis or cervical spondylosis.PHARMACOKINETICS Blood concentration Eperisone hydrochloride was administered orally to 8 healthy adult male volunteers at a single dose of 150 mg/day note) for 14 consecutive days and the plasma concentration was determined at days 1. 8 and 14.7 to 21.1 ng ⋅ hr/mL. respectively..7) PHARMACOLOGY 1.
Accordingly. Eperisone hydrochloride suppresses the spontaneous discharge of ©-motor neurons. Analgesic action and inhibition of the pain reflex in the spinal cord When eperisone hydrochloride is perfused into the spinal cord of rats. it improves the cybex torque curve and electromyogram and facilitates voluntary movements. eperisone hydrochloride reduces muscle spindle sensitivity via the ©-motor neurons.15) 3. Vasodilatation and Augmentation of blood flow (1) Vasodilatory action Eperisone hydrochloride dilates the blood vessels due to Ca++-antagonistic action (in guinea pigs) on the vascular smooth muscle and muscular sympatholytic actions (in humans). external and internal carotid arteries and vertebral arteries in humans.. 17) PHYSICOCHEMISTRY Nonproprietary name: Eperisone Hydrochloride (JAN) Eperisone (INN) Chemical name: (2RS)-1-(4-Ethylphenyl)-2-methyl-3-piperidin-1-ylpropan-1one monohydrochloride Molecular formula: C17H25NO ⋅ HCl Molecular weight: 295. such as extension and flexion of the extremities. 10. but does not act directly on muscle spindles in animals. but the reflex returns with the withdrawal of eperisone hydrochloride. 16) 4. Ltd. muscle. Structural formula: and enantiomer Description: . 9) 2. 12 .(3) Reduction of muscle spindle sensitivity via ©-motor neurons Eperisone hydrochloride suppresses the activity of afferent nerve fibers (Ia fibers) from human muscle spindles at 20 min after administration. 11) (2) Augmentation of blood flow Eperisone hydrochloride increases the volume of blood flow in skin. without reducing the muscular force. This suggests that eperisone hydrochloride possesses an analgesic action at the spinal cord level.85 4 Eisai Co. 8. Facilitation of voluntary movement When eperisone hydrochloride is used in the treatment of spastic paralysis in patients with cerebral apoplexy. monkeys and dogs. a tail pinch-induced pain reflex is suppressed.
1981. 1988.. A solution of eperisone hydrochloride in methanol (1 in 100) shows no optical rotation. 19. Consult. 1610. J.: 8th AOCN Satellite Symposium. Exp. et al. Med. Abs. et al. Ltd. 12. Exp. 235. 1703..: Biomed. 6) Kobayashi I. et al. It is freely soluble in water. 142. 15) Mano T. 8) Tanaka K. et al.: ibid.. et al. 2073. Eval. Med.: J. Ther.: Jap. 3. Clin.: Electroenceph. et al. 1987. 1981.150 (21Tabs. ⋅ 50).⋅ 150) in press-through packages.: Prog. et al. 1983. 58. 17) Watanabe S. 1983. Clin. 1989. Thermography. in methanol and in acetic acid (100). Melting point: About 167°C (decomposition) PACKAGING MYONAL Tablets 50 mg: Boxes of 100. crystalline powder. et al.000. et al.. 21. japon. 66. Report.: ibid.. 19. et al.. 60. New Remed. 1989.. 6423. 1991. 7) Tohgi H.. Kinki. Report. 9) Mano T. 11) Iwase S.000 and 3. 77. 14) Sugimoto H. et al.. S49. Neurophysiol.Eperisone hydrochloride occurs as a white. 237. 511. 1981.050 (21 Tabs. 1984. 1. Pharmacol.: J. et al.: Brain Nerve. 9. 231.: Jap. 2049. et al. 1982. 1493. 95. 210 (21Tabs. J. REQUEST FOR DRUG INFORMATION SHOULD BE MADE TO: Customer Information Service . Exp. et al. 1987. 13) Nanao K.⋅ 10).. and bottles of 500 MYONAL Granules 10%: Cans of 100 g REFERENCES 1) Tanaka S. Jpn. 3. et al. et al. S1238. 16. 63. 10) Fujioka M. 757. 1982. 3) Tawara T. 1985. 12) Motomura K. 1981. 391.: Clin. 33. REQUEST FOR LITERATURE SHOULD BE MADE TO: Safety Management Department Fax: 03-3811-2710 Eisai Co.: Clin. 4882. 1.: Folia pharmacol.: Clin. Assoc. et al. soluble in ethanol (99. Clin. japon. 2) Hanai K.: Med. Med. 16) Ishizuki M. Orthop.5).: 73th Folia pharmacol. 9. 4) Tsuyama N.. 1982. 5) Kuroiwa Y.
. 6-10. Koishikawa 4-chome. 112-8088 . Ltd.Free Dial: 0120-419-497 Eisai Co. Tokyo. Bunkyo-ku. Ltd. Manufactured and marketed by: Eisai Co..
This action might not be possible to undo. Are you sure you want to continue?
We've moved you to where you read on your other device.
Get the full title to continue reading from where you left off, or restart the preview.