克里斯托奶油

Kristalose是什么，如何使用？

口服溶液的牛皮化（乳糖）是一种用于治疗便秘的合成二糖。

克里斯托糖的副作用是什么？

克里斯托糖的常见副作用包括：

• 腹部绞痛，
• 腹泻，
• loss of fluids,
• low blood levels of potassium (hypokalemia),
• high blood levels of sodium (hypernatremia),
• nausea, and
• 呕吐

DESCRIPTION

Kristalose®（乳糖）是一种晶体形式的合成二糖，以进行口服之前的重建。每10克乳糖含量小于0.3 ggalactose和乳糖作为总和。pH范围为3.0至7.0。

Lactulose is acolonic促进泻药的酸化剂。

The chemical name for lactulose is 4-0- (3-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula:

分子公式为c₁₂H₂₂0₁₁。The molecular weight is 342.30. It is freely soluble in water.

INDICATIONS

用于口服溶液的Kristalose®（乳乳糖）用于治疗便秘。在具有慢性便秘史的患者中，乳乳糖治疗每天增加肠运动的数量和肠运动的天数。

DOSAGE AND ADMINISTRATION

通常的成年剂量每天为10 g至20 g乳果糖。如有必要，剂量可能每天增加到40克。可能需要二十四到48小时才能产生正常的滚筒运动。

准备方向

将包装包的内容物溶解在半玻璃（4盎司）的水中。

When Lactulose For Oral Solution is dissolved in water, the resulting solution may be colorless to a slightly pale yellow color.

HOW SUPPLIED

Kristalose®（乳乳糖）用于口服溶液有10 g的单剂量包（NDC66220-719-01) and single dose packets of 20 g (NDC66220-729-01）。这些数据包提供如下：

NDC66220-719-30（三十10 g包的纸箱）
NDC66220-729-30（三十20克包的纸箱）

STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).

要报告与此产品相关的不良事件，请致电1 -877-484-2700。

Distributed by : Cumberland Pharmaceuticals Inc. Nashville,TN37203. Revised: Sep 2012

SIDE EFFECTS

Precise frequency data are not available.

Initial dosing may produceflatulenceand intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids,低钾血症， 和高钠血症。

Nausea and vomiting have been reported.

药物相互作用

Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop incolonicph。因此，在将这种药物与乳乳糖同时同时给予治疗的可能性缺乏治疗。

警告

对于接受乳乳糖治疗的患者可能会存在理论上的危害，这些患者可能需要在守前镜检查期间接受电疗法手术结肠镜检查。h的积累₂在存在电动火花的情况下，气体浓度显着，可能会导致爆炸性反应。虽然这个并发症has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of C0₂as an additional safeguard may be pursued but is considered to be a redundant measure.

PRECAUTIONS

General

由于口服溶液的Kristalose®（乳乳糖）包含galactose乳糖（总和小于0.3 g/10 g），应谨慎使用糖尿病患者。

实验室测试

Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (钾, chloride,carbon dioxide) measured periodically.

致癌，诱变，生育障碍

There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.

There are no known animal data on long-term potential for mutagenicity.

管理我乳果糖糖浆n the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity.

In studies in mice, rats, and rabbits, doses of lactulose syrup up to 6 or 12 mL/kg/day produced no deleterious effects in breeding,conception, or分娩。

怀孕

Teratogenic Effects

怀孕Category B

Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

OVERDOSE

体征和症状

没有意外过量的报道。如果发生过多，预计腹泻和腹部抽筋将是主要症状。药物应终止。

Oral LD₅₀

The acute oral LD₅₀小鼠中该药物的含量为48.8 mL/kg，大鼠大于30 mL/kg。

Dialysis

Dialysis数据不可用于乳糖。然而，它与蔗糖的分子相似性表明应该透析。

禁忌症

Since KRISTALOSE ® (LACTULOSE) For Oral Solution containsgalactose(less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.

CLINICAL PHARMACOLOGY

KRISTALOSE® (Lactulose) is poorly absorbed from thegastrointestinal tract并且没有能够在人类中水解这种二糖的酶gastrointestinaltissue. As a result, oral doses of lactulose reach thecolon几乎没有变化。在结肠中，通过结肠细菌的作用，乳糖主要分解为乳酸，以及少量的甲酸和乙酸，从而导致渗透压升高和结肠含量的轻微酸化。反过来导致增加凳子水含量并软化凳子。

Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24 to 48 hours may be required to produce desired bowel movement.

口服乳果糖给人和实验动物，仅导致少量到达血液。尿液排泄已确定为3％或更少，并且在24小时内基本上完成。

患者信息

In the event that an unusual diarrheal condition occurs, contact your physician.