【成    份】化学名称：(一)一(S)一9一氟一2，3一二氢一3一甲基一10一(4一甲基一1-哌嗪基一7一氧代一7H一吡啶并[1，2，3一de]一1，4一苯并恶嗪一6一羧酸半水合物

【适应症】适应菌种：对本制剂敏感的葡萄球菌属、链球菌属、肺炎球菌、肠球菌属、细球菌属、莫拉氏菌属、棒状杆菌属、克雷白氏菌属、肠杆菌属、沙雷氏菌属、变形菌属、摩氏摩根菌、流感嗜血杆菌、结膜炎嗜血杆菌(科一威氏杆菌)、假单胞菌属、绿脓杆菌、嗜麦芽黄单胞菌、不动杆菌属、丙酸杆菌。
适应症：用于治疗眼睑炎、睑腺炎、泪囊炎、结膜炎、睑板腺炎、角膜炎以及用于眼科围手术期的无菌化疗法。

【规    格】5ml：24．4mg(以左氧氟沙星计)

【用法用量】一般1天3次、每次滴眼1滴，根据症状可适当增减。对角膜炎的治疗在急性期每15～30分钟滴眼1次，对严重的病例在开始30分钟内每5分钟滴眼1次，病情控制后逐渐减少滴眼次数。治疗细菌性角膜溃疡推荐使用高浓度的抗生素滴眼制剂。

【不良反应】注册上市时：在共计472例中，出现不良反应的为8例(1．69％)。主要的不良反应为眼刺激感4件(O．85％)、眼瘙痒感3件(O．64％)等。
  上市后使用情况调查(第7次安全性定期报告)：在共计6136例中，出现不良反应的有42例(0．68％)。
  主要的不良反应为弥漫性表层角膜炎等角膜障碍12件(0．20％)、眼睑炎等9件(0．15％)、眼刺激感6件(0．10％)等。
  1．严重不良反应：休克、过敏样症状：有可能引起休克、过敏样症状，应充分进行观察。当发现红斑、皮疹、呼吸困难、血压降低、眼睑浮肿等症状时应停止给药，予以妥善的处置。
  2．滴眼毒性：未见眼刺激性及眼毒性。
  3．抗原性：无。

【药代动力学】
  1．血中浓度
    将本品以1次2滴、一天4次给健康成人连续滴眼2周，最终滴眼1小时后的血中浓度为定量界限(O．01g／m1)以下。
  2．动物的眼组织内分布(有色家兔、有色大鼠、狗)
    用标记的左氧氟沙星滴眼液以1次50ul给有色家兔滴眼时，15分钟后在球结膜和睑结膜的最高浓度(Cmax)分别为1433．8ng eq／g和1058．8ng eq／g，30分钟后在角膜和房水的最高浓度(Cmax)分别为6839．5ng eq／g和842．8ng eq／g。之后随着时间的推移而减少；2小时后在含黑色素组织的虹膜、睫状体和视网膜色素上皮、脉络膜的最高浓度(Cmax)分别为11514．4ng eq／g和3269．6ng eq／g，之后缓慢消失。
 此外，对有色大鼠也显示出了同样的状况。在以1次1ul、一天3次连续滴眼1周后，最终滴眼1小时后在角膜、房水和玻璃体等眼组织中的放射源浓度分别为2270．8 ng eq/g、267．1ng eq／g、372．0ng eq/g。之后随着时间的推移而减少；最终滴眼1小时后在虹膜、睫状体和视网膜色素上皮、脉络膜分别为185047．6 ng eq/g、36549．6ng eq/g，之后缓慢消失。用0．3％左氧氟沙星滴眼液对比格狗以1次1滴、一天4次连续滴眼2周后，最终滴眼24小时后的眼组织内浓度为：虹膜、睫状体为39．4ug/g，脉络膜、视网膜色素上皮为12．3ug/g，眼组织中的含黑色素组织显示出了较高的分布。而向去除色素上皮的视网膜之分布却很少。
  3．其他不良反应：发现不良反应时应采取停止给药等妥善的处置。

【禁    忌】对本品的成份、氧氟沙星及喹喏酮类抗菌制剂有过敏既往史的患者。

【注意事项】
    1．为了防止耐药菌的出现等，原则上应确认敏感性，尽量将用药时间控制在治疗疾病所需的最少时间以内。
    2．本品对甲氧苯青霉素耐药性葡萄球菌(MRSA)的有效性尚未得到证实。当MRSA所致的感染较为明显、临床症状无改善时，应尽快使用抗MRSA作用较强的药物。
    3．仅用于滴眼。
    4．为了防止污染药液，滴眼时应注意避免容器的前端直接接触眼部。

【孕妇及哺乳期妇女用药】对孕妇或可能妊娠的妇女，只有在其治疗的有益性高于可能发生的危险性时方可给药。(对妊娠期间的安全性尚不明确)

【儿童用药】根据日本可乐必妥滴眼液上市后使用情况调查的结果，在15岁以下儿童的1160例中，1岁以下的186例中未见有不良反应，在1岁至15岁用药者中出现不良反应的为4例(点状角膜炎、眼瘙痒症、接触性角膜炎、荨麻疹)

【老年用药】通常，老年人的生理功能有所降低，应注意予以减量等。

【药物相互作用】尚不明确。

【药物过量】尚不明确

【贮    藏】密封容器，避光，室温保存(1～30℃)。

【原产地英文商品名】IQUIX 1.5% EYE DROPS 5mls/bottle
【原产地英文药品名】LEVOFLOXACIN
【中文参考商品译名】IQUIX 1.5%滴眼液 5毫升/瓶
【中文参考药品译名】左氧氟沙星
【生产厂家中文参考译名】参天制药
【生产厂家英文名】SANTEN

Iquix Drops
Generic Name: Levofloxacin (LEE-voe-FLOX-a-sin)
Brand Name: Iquix

-----------------------------------------------------

Iquix Drops are used for:
Treating corneal ulcers caused by bacteria sensitive to Iquix Drops. It may also be used for other conditions as determined by your doctor.

Iquix Drops are a fluoroquinolone eye drop. It works by blocking bacteria from reproducing in the eye.

-----------------------------------------------------

NOT use Iquix Drops if:
you are allergic to any ingredient in Iquix Drops or to any other fluoroquinolone antibiotic (eg, ciprofloxacin, gatifloxacin)

Contact your doctor or health care provider right away if any of these apply to you.

-----------------------------------------------------

Before using Iquix Drops:
Some medical conditions may interact with Iquix Drops. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Iquix Drops. Because little, if any, of Iquix Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Iquix Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

-----------------------------------------------------

How to use Iquix Drops:
Use Iquix Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Iquix Drops are only for the eye. Do not get it in your nose or mouth.
To use Iquix Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
Do not wear contact lenses while you are using Iquix Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
Iquix Drops works best if it is used at the same time each day.
To clear up your infection completely, use Iquix Drops for the full course of treatment. Keep using it even if you feel better in a few days.
Do not miss any doses of Iquix Drops. If you miss a dose of Iquix Drops, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Iquix Drops.

-----------------------------------------------------

Important safety information:
Iquix Drops may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Iquix Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Be sure to use Iquix Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Iquix Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

If you notice vision changes, vaginal irritation or itching, or white patches in your mouth, contact your doctor at once.

Diabetes patients - Iquix Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Iquix Drops should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Iquix Drops while you are pregnant. Iquix Drops are found in breast milk. If you are or will be breast-feeding while you take Iquix Drops, check with your doctor. Discuss any possible risks to your baby.

-----------------------------------------------------

Possible side effects of Iquix Drops:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Blurred vision; headache; strange taste.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); double vision or other vision changes; eye itching or pain; eye or eyelid swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

-----------------------------------------------------

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Iquix Drops:
Store Iquix Drops at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Iquix Drops out of the reach of children and away from pets.

-----------------------------------------------------

General information:
If you have any questions about Iquix Drops, please talk with your doctor, pharmacist, or other health care provider.
Iquix Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Iquix Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.