[Drug name]

Generic name: Levonorgestrel and Quinestrol Tablets

English Name: Levonorgestrel and Quinestrol Tablets

[Ingredients]

This product is a compound preparation. Each tablet contains 6 mg of Levonorgestrel and 3 mg of Quinestrol.

[Description]

It is a film-coated tablet with white or almost white core.

[Indication]

The product is effective to inhibition of ovulation and it is a long acting oral contraceptive for women.

[Strength]

Each tablet contains 6 mg of Levonorgestrel and 3 mg of Quinestrol.

[Usage and dosage]

1.      The initial administration should be taken after lunch on the fifth day of the menstrual cycle and take the second pill 20 days later. Or take a pill on the fifth and tenth day of menstrual cycle respectively. Then take a pill every month on the date of your second administration. Usually there will be withdrawal bleeding 6~12 days after the administration.

2.      The woman who is switching from the short acting oral contraceptive pill will take one long acting pill on the next day after finishing the 22 short acting pills. Afterwards, take one pill on the same date when you take the first long-acting pill in every month.

[Adverse reactions]

1.      Morning sickness-like effects. It is similar to that of the short acting contraceptives, but even worse. It is serious in the beginning a few periods. Usually it happens 8~12 hours after the administration. Therefore take the pill after lunch so that the most serious side effects will occur during the sleeping time when the patient can tolerate the side effects better.

2.     Increasing leucorrhea. This is the most common side effect of long acting oral contraceptives and usually begins after 3~6 periods.

3.     It is possible for few women to suffer menorrhagia or amenorrhea.

4.     Other side effects include stomachache, edema, breast tenderness, headache, etc.

[Contraindications]

This drug is contraindicated in patients with hysteromyoma, lump in breast, hepatic insufficiency, renal insufficiency, cardiovascular diseases, history of thrombus, hypertension, diabetes, hyperthyroidism, mental illness or melancholia and hyperlipoidemia.

[Precautions]

1.      It is a suitable contraceptive product for the couples who live together for a long time. Only one tablet is taken every month. However, the administration should be taken in accordance with the instructions given by the medical staff.

2.      It is a normal phenomenon that the menstruation will occur 10~15 days after initial administration and the first two menstruations become shorter than regular one. The menses will become normal since the third cycle.

3.      Some individuals will suffer vaginal bleeding because of insufficient estrogen in vivo. But the irregular vaginal bleeding can be cured by taking one Ethinylestradiol tablet (0.005~0.01mg) daily or under supervision of a physician.

4.      Take medical examination periodically during you take this medicine for contraception. Stop administration as soon as unusual results are found

5.      If you want to have a baby, stop taking this medicine and take other contraceptive measures for six months. Then it is safe for you to bear a baby.

6.      It is contraindicated in the patients with acute hepatitis, chronic hepatitis, renal insufficiency, tumor, hysteromyoma, lump in breast, diabetes, thrombotic diseases, cardiac disease, women in lactation, serious hypertension. It is not suitable for the patients with history of menoxenia or amenorrhea and patients who haven’t recovered normal menstruation after delivery or abortion .

7.      If a smoking woman takes oral contraceptives, she has a higher risk to have cardiovascular diseases such as apoplexy, myocardial infarction etc than non-smoking women. Therefore, the woman  who take contraceptives should stop smoking or the smoking woman (especially over 35-40 years old) should not take contraceptives.

8.      Stop administration as soon as the following symptoms occur: suspected pregnancy, thrombo-embolism disease, disorder of vision, serious headache caused by unknown reason or migraine, hypertension, abnormal liver function, deprementia, ischemic heart disease etc.

9.      Take this medicine strictly following the instruction. If you miss pills you could suffer breakthrough bleeding or get pregnant.

10.   The recommended administration period is 3~5 years. After that the women should stop administration and be observed for several month. Those who pass the medical examinations can continue to take this drug.

[Usage for pregnant women or women in lactation]

1.      It is contraindicated in the pregnant women.

2.      This medicine can cause the decrease of breast milk. The women in lactation should take this medicine half a year after delivery.

[Usage for children] No data available.

[Usage for aged people] No data available.

[Drug Interactions]

1.      The following drugs will affect the contraceptive effect: antibiotic drugs will restrain the multiplication of enteral bacteria, reduce the disintegration of combined substances of hormone, decrease the enterohepatic circulation; drugs inducing hepatic enzymes such as rifampicin, hypnotic and anticonvulsant, antipyretic analgesic; tricyclic antidepressant drug will compete congenerous metabolism in the liver with this drug.

2.     The effectiveness of the following drugs will be decreased when co-administered with contraceptives: anti-hypertension drugs, anticoagulant drugs, hypoglycemic drug such as insulin and oral hypoglycemic drug.  The effectiveness of Tricyclic antidepressant drugs will be increased when co-administered with contraceptives.

[Overdose]

At present, no overdose cases are reported. If overdose occurs, gastric lavage should be performed immediately.

[Pharmacology and toxicology]

Quinestrol is a kind of long acting estrogen. It is absorbed by gastrointestinal tract and stored in the adipose tissue after taking orally. Then quinestrol is released slowly in the form of ethinyl estradiol. It inhibits ovulation by restraining hypothalamus-hypophysis-ovary to achieve the long acting contraception. When co-administered with progestogen, a synergistic action on the inhibition of ovulation can be gained. Meanwhile it can change the endometrium to the secretion condition to cause withdrawal bleeding which occurs periodically. The contraceptive efficacy is over 98% if one tablet is taken every month.

[Storage]

Sealed and protect from light.

[Packing]

Packaged with aluminum foil and PVC blister.

6 tablets per blister strip and 1 blister strip per box.

[Shelf Life]
60 months

[Specification]

Pharmacopoeia of The People’s Republic of China 2005, Volume II

[Product Licence Number] Guoyaozhunzi H11021378

[Manufacturer]

Name:  Beijing Zizhu Pharmaceutical Co., Ltd.

Manufacture site: No. 27, Chaoyang North Rd, Chaoyang District, Beijing

Postal code: 100024

Hotlines:

0086-10-62240419, 0086-10-62262389 (after-sales service)

0086-10-65483355-2221 (production)

Fax: 0086-10-62219316

Website: http:// www.zizhu-pharm.com