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炔诺酮片,妇康Micronor(Norethindrone Tablets)

2011-09-29 23:09:51 作者：新特药房来源：中国新特药网天津分站浏览次数：1112 文字大小：【大】【中】【小】

简介： 英文药名: Micronor (Norethindrone Tablets) 中文药名: 炔诺酮片,妇康生产品牌药厂家: Janssen-Ortho 药品名称中文通用名称: 炔诺酮英文通用名称: Norethisterone 其它名称: 乙炔类黄体酮, ...

关键字：炔诺酮片妇康Micronor(Norethindrone Tablets)

英文药名: Micronor (Norethindrone Tablets)

中文药名: 炔诺酮片,妇康

生产品牌药厂家: Janssen-Ortho

药品名称

中文通用名称: 炔诺酮
英文通用名称: Norethisterone
其它名称: 乙炔类黄体酮, 妇康, Noraethisteronum, Norethindrone, Micronor, 去甲脱氢羟孕酮, Norlutin, 炔诺酮滴丸, 炔诺酮片, Norethisterone Pills, Norethisterone Tablets
产品分类: 西药\女性生殖系统用药\孕激素类及抗孕激素类药
适应症

1.用于女性口服避孕(单用或与雌激素合用)。
2.也用于痛经、闭经、月经不调、功能性子宫出血、妇女不育症、子宫内膜异位症及子宫内膜增生过度等。
用法用量

成人
•常规剂量
•口服给药
1.用作短效口服避孕药：包括复方炔诺酮片、膜或纸片以及口服避孕片(膜)0号，从月经周期第5日开始服药，一日1片(或1格)，晚饭后服用为宜(上夜班者早饭后服)，连服22日，服完药后等月经来潮，在下次月经的第5日继续服药。
2.用作探亲避孕药：探亲避孕丸、炔诺酮滴丸：于同房当晚开始服用，每晚1丸。同房10日之内，必须连服10丸；同房半个月，连服14丸；超过半个月者，服完14丸后接着改服短效口服避孕药，直至探亲期结束。
3.功能性子宫出血：一次5mg，每8小时1次，连用3日，血止后，改为每12小时1次，7日后改为一次2.5-3.75mg维持，连续用2周左右。也有以下用法：一次5mg，每8小时1次，连用2-3日，血止后，改为每12小时1次，根据出血量，每3日减量1/3，逐渐递减至维持量一日2.5-3.75mg，再连续用2周左右。
4.痛经或子宫内膜增生过度：从月经第5日开始，一次2.5mg，一日1次，连服20日。3-6个周期为一疗程。
5.子宫内膜异位症：一日10-30mg。开始时一日10mg，每2周后增加5mg，最高为一日30mg，分次服，连续服用6-9个月。
6.乳腺癌姑息治疗：一日剂量可达60mg。
7.闭经或围绝经期综合征：炔雌醇0.025-0.05mg或己烯雌酚0.5-1mg，每晚1次连服20-22日，最后5日合用本药，一次2.5mg，一日2次。停药后2-7日出现撤退性出血。
8.经前期综合征：于月经周期第14日起，一日2.5-5mg，连服10日。
任何疑问，请遵医嘱！
给药说明

1.人工流产者应于流产后首次月经来潮的第5日开始用药。
2.漏服或迟服有可能导致避孕失败，故必须每日定时服药；如有漏服，应在24小时内补服。
3.服药期间可能发生子宫内膜突破出血，应仔细检查除外器质性疾病的可能。并可每日加服炔雌醇0.005-0.015mg；一般会有经量减少、经期偏短现象，不必处理。
4.用作短效口服避孕服药22日后，一般停药3-4日即来月经；如第7日仍无月经来潮，应开始服用下一月的药。若连续停经2-3个月，应予停药；也可考虑加服炔雌醇每日0.005-0.01mg。
不良反应

1.少见恶心、呕吐、头昏、乏力、嗜睡等类早孕反应及不规则出血、闭经、乳房胀感、皮疹等，停药后一般可自行消失。
2.偶见过敏反应。
3.可见血糖升高。
注意事项

1.禁忌症
(1)对本药过敏。
(2)心血管疾病(尤其是高血压)。
(3)血栓性疾病或有血栓病史(晚期癌瘤治疗除外)。
(4)胆囊疾病。
(5)肝、肾功能不全。
(6)糖尿病。
(7)哮喘。
(8)癫痫。
(9)偏头痛。
(10)原因不明的阴道出血。
(11)乳房肿块，或已知或怀疑有乳房及生殖系统恶性肿瘤(晚期癌瘤治疗除外)。
2.慎用
(1)精神抑郁。
(2)子宫肌瘤。
(3)有肝、肾病史(作为避孕药使用时)。
3.药物对妊娠的影响早孕妇女用药后，可使女胎外阴男性化，导致婴儿先天性性畸形，故妊娠头4个月内妇女不宜使用本药，至少应在妊娠前3个月停药。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为X级。
4.药物对哺乳的影响哺乳妇女服药后可能减少乳汁分泌，故产后半年后方可使用本药。
5.用药前后及用药时应当检查或监测
(1)用药前应全面查体，并特别注意乳腺与盆腔检查及宫颈细胞学检查。
(2)长期或大量用药需注意检查肝功能和血电解质，并特别注意乳房检查。
(3)本药可对体内血脂浓度和血糖产生不良影响，应定期检查血脂以及监测血糖或尿糖。
(4)本药还可改变人体的凝血机制，有增加血栓发生的危险，建议定期检查凝血因子。

MICRONOR - norethindrone tablet
Physicians Total Care, Inc.

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Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, and povidone.

CLINICAL PHARMACOLOGY

1. Mode of Action

ORTHO MICRONOR® progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.

2. Pharmacokinetics

Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

INDICATIONS AND USAGE

1. Indications

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

2. Efficacy

If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.

Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.
	% of Women Experiencing an Unintended Pregnancy within the First Year of Use		% of Women Continuing Use at One Year*
Method (1)	Typical Use † (2)	Perfect Use‡ (3)	(4)
Chance#	85	85
SpermicidesÞ	26	6	40
Periodic abstinence	25		63
Calendar		9
Ovulation Method		3
Sympto-Thermalß		2
Post-Ovulation		1
Capà
Parous Women	40	26	42
Nulliparous Women	20	9	56
Sponge
Parous Women	40	20	42
Nulliparous Women	20	9	56
Diaphragmà	20	6	56
Withdrawal	19	4
Condomè
Female (Reality®)	21	5	56
Male	14	3	61
Pill	5		71
Progestin Only		0.5
Combined		0.1
IUD
Progesterone T	2.0	1.5	81
Copper T380A	0.8	0.6	78
LNg 20	0.1	0.1	81
Depo-Provera®	0.3	0.3	70
Norplant® and Norplant-2®	0.05	0.05	88
Female Sterilization	0.5	0.5	100
Male Sterilization	0.15	0.10	100

Adapted from Hatcher et al, 1998, Ref. # 1.
§ Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.

*Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year†Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ‡Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.§The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).¶However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.#The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.ÞFoams, creams, gels, vaginal suppositories, and vaginal film.ßCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.àWith spermicidal cream or jelly.èWithout spermicides.

ORTHO MICRONOR® Tablets have not been studied for and are not indicated for use in emergency contraception.

CONTRAINDICATIONS

Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:

Known or suspected pregnancy
Known or suspected carcinoma of the breast
Undiagnosed abnormal genital bleeding
Hypersensitivity to any component of this product
Benign or malignant liver tumors
Acute liver disease

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.

ORTHO MICRONOR® does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.

1. Ectopic Pregnancy

The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.

2. Delayed Follicular Atresia/Ovarian Cysts

If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.

3. Irregular Genital Bleeding

Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.

4. Carcinoma of the Breast and Reproductive Organs

Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk.

A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.

This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.

Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. Hepatic Neoplasia

Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

PRECAUTIONS

1. General

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

2. Physical Examination and Follow up

It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.

3. Carbohydrate and Lipid Metabolism

Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.

Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3 , LDL, or VLDL.

4. Drug Interactions

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.

5. Interactions with Laboratory Tests

The following endocrine tests may be affected by progestin-only oral contraceptive use:

Sex hormone-binding globulin (SHBG) concentrations may be decreased.
Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).

6. Carcinogenesis

See WARNINGS section.

7. Pregnancy

Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.

8. Nursing Mothers

In general, no adverse effects have been found on breastfeeding performance or on the health, growth or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.

9. Pediatric Use

Safety and efficacy of ORTHO MICRONOR® Tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

10. Fertility Following Discontinuation

The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

11. Headache The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause. INFORMATION FOR THE PATIENT

See "Detailed Patient Labeling" for detailed information.
Counseling issues

The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:

The necessity of taking pills at the same time every day, includingthroughout all bleeding episodes.
The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.
The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.
The need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.
The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.

ADVERSE REACTIONS

Adverse reactions reported with the use of POPs include:

Menstrual irregularity is the most frequently reported side effect.
Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.
Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.
Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

OVERDOSAGE

There have been no reports of serious ill effects from overdosage, including ingestion by children.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, ORTHO MICRONOR® must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.

HOW SUPPLIED

ORTHO MICRONOR® (0.35 mg norethindrone) Tablets are available in a DIALPAK® Tablet Dispenser

(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.

STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).