通用中文 | 美沙拉秦灌肠液 | 通用外文 | Mesalamine Enemas |
品牌中文 | 莎尔福 | 品牌外文 | Salofalk |
其他名称 | |||
公司 | Dr.Falk(Dr.Falk) | 产地 | 德国(Germany) |
含量 | 4g/60ml | 包装 | 7支/盒 |
剂型给药 | 储存 | 室温 | |
适用范围 | 适用于治疗溃疡性肠炎的急性发作。 |
通用中文 | 美沙拉秦灌肠液 |
通用外文 | Mesalamine Enemas |
品牌中文 | 莎尔福 |
品牌外文 | Salofalk |
其他名称 | |
公司 | Dr.Falk(Dr.Falk) |
产地 | 德国(Germany) |
含量 | 4g/60ml |
包装 | 7支/盒 |
剂型给药 | |
储存 | 室温 |
适用范围 | 适用于治疗溃疡性肠炎的急性发作。 |
【药品名称】
通用名称:美沙拉秦灌肠液(莎尔福)
商品名称:美沙拉秦灌肠液(莎尔福)
英文名称:Mesalazine Enemas
【主要成份】 本品主要成份为美沙拉秦。化学名称:5-氨基水杨酸。
【性 状】 本品为乳白色至淡棕色的均匀混悬状液体。
【适应症/功能主治】 本品适用于治疗溃疡性肠炎的急性发作。
【规格型号】7支(莎尔福)
【用法用量】每晚睡前用药,从肛门灌进大肠,每次一支4g,或遵医嘱。
【不良反应】 1.本品耐受性良好,主要不良反应为: (1)消化系统:偶见腹部不适、腹泻、胃肠胀气、恶心及呕吐等; (2)中枢神经系统:个别患者可见头痛、头晕等; (3)过敏反应:如同水杨酸及其衍生物一样,本品所出现的过敏反应呈现非剂量依赖性。极少数患者可见过敏性红肿、药物热、支气管痉挛、外周性心包心肌炎、急性胰腺炎和间质性肾炎等; (4)在用美沙拉秦治疗期间偶尔会有肺泡炎出现,个别病例可能出现全肠炎(pancolitis); (5)在一定条件下,一些与美沙拉秦有类似结构的药物可引起红斑狼疮样综合征,所以不排除美沙拉秦也有引起这种反应的可能性。 2.其他不良反应 (1)偶可观察到肌肉痛和关节痛; (2)活性组分的化学结构有可能引起正铁血红蛋白水平升高; (3)有报道在应用含有美沙拉秦的药物后,个别病例可见血液学改变,包括发育不全性贫血、粒细胞缺乏症、全血细胞减少、中性白细胞减少症、白细胞减少和血小板减少等; (4)偶有引起肝脏炎症(肝炎)的报道,罕见病例中有肝功能参数(转氨酶水平升高)改变。
【禁 忌】下列患者慎用本品: 1.对水杨酸类或其代谢成份或活性成份过敏者禁用; 2.严重肝、肾功能不全者禁用; 3.胃和十二指肠溃疡者禁用; 4.出血体质者(易引起出血)。
【注意事项】 1.使用本品应进行监测; 2.在治疗期间,在医生的指导下,应注意血细胞计数和尿检查。一般情况下,在治疗开始14天,就应该进行这些检查。此后,每用药4周,应进行相应检查,这种检查应进行2~3次。如果未见异常,每3个月应进行1次血浆尿素氮(BUN)、血肌酐和尿沉渣等反映肾功能的检查; 3.治疗期间,注意监测高铁血红蛋白值水平; 4.肺功能障碍的患者,特别是哮喘患者,在治疗期间,应密切进行监测; 5.对包含硫酸酯酶的制剂过敏的患者,只有在医学监测下,才能使用本品。治疗中,如果出现不可耐受的反应,如急性腹痛、痉挛、发热、严重头痛以及皮肤红斑等,应立即停用本品。
【儿童用药】由于缺乏相应年龄段儿童的使用经验。建议幼儿和小儿不使用本品。
【老年患者用药】高龄患者用本品应酌减。
【孕妇及哺乳期妇女用药】只有在严格的指征下,妊娠前三个月才能使用本品。需要生育的妇女,在开始妊娠前,除非没有其他药物可用,应尽可能少的使用本品;如果个体情况允许,妊娠的最后2~4周应停用本品。哺乳期妇女用药经验不足,如确需服用,须停止哺乳。
【药物相互作用】本品与下列药物同时使用,可能发生相互作用。 1.抗凝血药:可能加强抗凝血药的作用(增加胃肠道的出血倾向); 2.糖皮质激素:可能增加胃的不良反应; 3.磺胺类药物:可能加剧低血糖效应; 4.甲氨喋呤:可能增加甲氨喋呤的毒性; 5.丙磺舒和苯磺唑酮:可能降低排尿酸作用; 6.安体舒通和速尿:可能减弱利尿作用; 7.利福平:可能减弱抗结核作用。
【药物过量】如果发生药物过量情况,应尽快咨询医生,并加速排尿,本品无特异拮抗剂。
【药理毒理】美沙拉秦的体外实验表明其对一些炎症介质(前列腺素、白三烯B4、C4)的生物合成和释放有抑制作用,其作用机制Shiite通过抑制血小板激活因子的活性和抑制结肠粘膜脂肪酸氧化,来改善结肠粘膜炎症。对家兔溃疡性结肠炎口服给药亦有明显的治疗作用和良好的量效关系。
【药代动力学】本品灌肠后于肠内溶解吸收。美沙拉秦在肠壁和肝脏主要经乙酰化代谢,消除半衰期为0.5小时至2小时,血浆蛋白结合率43%,其乙酰化产物消除半衰期可达10小时,血浆蛋白结合率为75~83%。本品对肾无直接刺激,经肾排泄很少,主要通过大肠排泄。
【贮 藏】密封。
【包 装】7支/盒。
【有 效 期】24 月
【生产企业】Dr.Falk Pharma GmbH
Salofalk (Rectal)
Generic Name: mesalamine (Rectal route)
me-SAL-a-meen
Medically reviewed on Oct 4, 2018
Commonly used brand name(s)
In the U.S.
· Canasa
· Rowasa
· sfRowasa
In Canada
· Mesasal
· Pentasa
· Salofalk
Available Dosage Forms:
· Enema
· Suppository
Therapeutic Class: Gastrointestinal Agent
Chemical Class: Salicylate, Non-Aspirin
Uses For Salofalk
Mesalamine is used to treat an inflammatory bowel disease, such as ulcerative colitis. Mesalamine suppositories are used to treat mild to moderate active ulcerative proctitis (inflammation of the rectum). It works inside the intestines (bowels) to reduce the inflammation and other symptoms of the disease.
This medicine is available only with your doctor's prescription.
Before Using SalofalkIn deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
AllergiesTell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
PediatricAppropriate studies have not been performed on the relationship of age to the effects of mesalamine in the pediatric population. Safety and efficacy have not been established.
GeriatricAppropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mesalamine in the elderly. However, elderly patients are more likely to have blood problems (eg, neutropenia, pancytopenia) and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.
Breast FeedingThere are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with MedicinesAlthough certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
· Aceclofenac
· Acemetacin
· Amtolmetin Guacil
· Bromfenac
· Bufexamac
· Celecoxib
· Clonixin
· Dexibuprofen
· Dexketoprofen
· Diclofenac
· Dipyrone
· Droxicam
· Etodolac
· Etofenamate
· Etoricoxib
· Felbinac
· Fenoprofen
· Fepradinol
· Feprazone
· Floctafenine
· Flufenamic Acid
· Flurbiprofen
· Ibuprofen
· Indomethacin
· Ketoprofen
· Lornoxicam
· Loxoprofen
· Lumiracoxib
· Meclofenamate
· Mefenamic Acid
· Meloxicam
· Mercaptopurine
· Morniflumate
· Nabumetone
· Naproxen
· Nepafenac
· Niflumic Acid
· Nimesulide
· Nimesulide Beta Cyclodextrin
· Oxaprozin
· Oxyphenbutazone
· Parecoxib
· Phenylbutazone
· Piketoprofen
· Piroxicam
· Proglumetacin
· Propyphenazone
· Proquazone
· Rofecoxib
· Sulindac
· Tenoxicam
· Tiaprofenic Acid
· Tolfenamic Acid
· Tolmetin
· Valdecoxib
· Varicella Virus Vaccine, Live
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
· Tamarind
· Warfarin
Interactions with Food/Tobacco/AlcoholCertain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical ProblemsThe presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
· Allergy to salicylates (eg, aspirin) or
· Allergy to saturated vegetable fat—Should not be used in patients with these conditions.
· Allergy to sulfasalazine (Azulfidine®) or
· Kidney disease, or history of or
· Liver disease or
· Myocarditis (heart disease), history of or
· Pericarditis (heart disease), history of or
· Stomach blockage—Use with caution. May make these conditions worse.
Proper Use of mesalamineThis section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Salofalk. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
For best results, empty your bowel just before using the rectal enema or suppository.
If you are using the enema:
· This medicine usually comes with patient directions. Read them carefully before using this medicine.
· Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.
· Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.
· Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.
· Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.
· Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.
If you are using the suppository:
· Never take rectal suppositories by mouth.
· Remove one suppository from the strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.
· Before inserting a suppository, go to the bathroom and empty your bladder and, if possible, have a bowel movement.
· This medicine will stain any surface it touches (eg, clothing, bedsheets, floors, countertops, etc.). To protect your clothing, consider wearing a sanitary napkin or adult undergarment such as Depend®. Protect your sheets by placing a waterproof pad on your bed. These pads, often called Chux® pads or underpads, are available from a medical supply store.
· Wash your hands with soap and water before and after using this medicine. Remove the foil or wrapper from the suppository before inserting it.
· Do not keep the suppository in your hand too long or it may begin to melt.
· To make the suppository easier to insert, you may use a lubricating gel such as K-Y® Jelly, but do not use petroleum jelly (Vaseline®).
· Insert suppository (pointed end first) completely into rectum with gentle pressure.
· The medicine needs to remain in your body for 1 to 3 hours or longer, depending on your doctor's advice. Try not to use the bathroom for at least that length of time after inserting the suppository.
DosingThe dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
· For ulcerative colitis or proctitis:
o For rectal dosage form (enema):
o Adults—4 grams (1 unit) every night for 3 to 6 weeks.
o Children—Use and dose must be determined by your doctor.
o For rectal dosage form (suppository):
o Adults—1000 milligrams (mg) inserted into your rectum once a day at bedtime for 3 to 6 weeks.
o Children—Use and dose must be determined by your doctor.
Missed DoseIf you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
StorageKeep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
You may store the suppositories in the refrigerator, but do not freeze them.
Store the enema at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Precautions While Using SalofalkIt is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Urine or blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have bloody urine, decreased amount of urine, lower back or side pain, swelling of the face, fingers, or lower legs, or unusual tiredness or weakness. These could be symptoms of kidney problems.
Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.
Tell your doctor right away if you experience chest pain or trouble breathing.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.
Mesalamine may stain clothing, fabrics, flooring, painted surfaces, marble, granite, vinyl, enamel, or other surfaces it touches.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Salofalk Side EffectsAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common or rare
· Abdominal or stomach cramps or pain (severe)
· anxiety
· back pain (severe)
· bloody, black, or tarry stools
· blue or pale skin
· bright red blood in the stool
· chest pain, possibly moving to the left arm, neck, or shoulder
· chills
· diarrhea (severe)
· fast heartbeat
· fever
· headache (severe)
· nausea or vomiting
· skin rash
· stomach cramps, tenderness, or pain
· swelling of the stomach
· unusual tiredness or weakness
· watery or bloody diarrhea
· yellow eyes or skin
Incidence not known
· Blood in the urine
· change in the frequency of urination or amount of urine
· cough
· dark-colored urine
· difficulty with breathing
· drowsiness
· general feeling of tiredness or weakness
· high fever
· increased thirst
· light-colored stools
· loss of appetite
· lower back or side pain
· painful or difficult urination
· pale skin
· sore throat
· sores, ulcers, or white spots on the lips or in the mouth
· stomach pain, continuing
· swelling of the feet or lower legs
· swollen glands
· troubled breathing
· unexplained or unusual bleeding or bruising
· weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
· Abdominal or stomach cramps or pain (mild)
· bloated or full feeling
· excess air or gas in the stomach or intestines
· gas or flatulence
· headache (mild)
· passing gas
Less common
· Acne
· diarrhea
· dizziness
· leg or joint pain
· loss of hair
· rectal pain or irritation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.