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【成份】

本品主要成份为美沙拉秦。

【性状】

本品为土黄色椭圆形肠溶衣片，除去包衣后显浅棕色。

【适应症】

1.用于溃疡性结肠炎的治疗：包括急性发作的治疗和防止复发的维持治疗；2.用于克罗恩病急性发作期的治疗。

【用法用量】

根据临床个体病例需要，推荐成人按下述日剂量服用：
克罗恩病（急性发作期）：每日总量1.5g-4.5g，一次1-3片，一日3次。 溃疡性结肠炎(急性发作期)：每日总量1.5g-3.0g，一次1-2片，一日3次；溃疡性结肠炎(维持期)：每日总量1.5g，一次1片，一日3次。
常规给药方法：
分别在早、中、晚餐前1小时服用。必须大量液体整片吞服（不能嚼碎）。在急性发作期和维持治疗中，为获得理想的治疗效果，建议持续、规律的服用本品。由医生确定使用疗程。国外推荐溃疡性结肠炎或克罗恩病急性发作期一般服用8-12周。

【药理毒理】

药理作用
美沙拉秦的抗炎作用机制尚不完全清楚。体外研究显示美沙拉秦对肠黏膜前列腺素的含量有一定影响，具有清除活性氧自由基的功能，对脂氧合酶可能起到一定的抑制作用。
本品系美沙拉秦的肠溶片，口服后在肠道释放美沙拉秦．美沙拉秦到达肠道后主要局部作用于肠黏膜和黏膜下层组织。美沙拉秦的生物利用度或血浆浓度与治疗效果无关。
毒理研究
毒理研究中发现美沙拉秦大剂量重复口服给药具肾毒性（肾乳头坏死、近曲小管上皮损伤或整个肾单位损伤）。这些发现的临床相关性尚不清楚。动物研究没有发现美沙拉秦具有致突变一致畸、致癌作用。

【生产企业】

Losan 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 Salofalk

In 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:

Allergies

Tell 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.

Pediatric

Appropriate 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.

Geriatric

Appropriate 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 Feeding

There 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 Medicines

Although 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/Alcohol

Certain 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 Problems

The 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 mesalamine

This 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.

Dosing

The 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 Dose

If 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.

Storage

Keep 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 Salofalk

It 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 Effects

Along 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.