FDA批准增加Tindamax的新适应证—细菌性阴道炎
Mission制药公司的替硝唑Tindamax(tinidazole)已被美国FDA批准用于细菌性阴道炎的治疗。细菌性阴道炎除可增加衣原体、淋病、HIV等各种性传播感染的易感性,引发骨盆炎症和子宫颈炎外,还能带来诸如流产、早产等妊娠问题。
美国有近1/3的妇女感染细菌性阴道炎。一项安慰剂对照研究将235名患细菌性阴道炎的妇女随机分为3组:Tindamax高剂量组(2g/d,服用2天),Tindamax低剂量组(1g/d,服用5天)和安慰剂组。与安慰剂组相比,Tindamax用药组疗效更好。3组的治愈率分别为27.4%、36.8%和5.1%。用药组和安慰剂组的副作用均很小,包括口中有金属味和恶心。
Tindamax优于当前细菌性阴道炎标准治疗药物metro-nidazole之处在于其疗程更短,仅需2～5天(视剂量而定),而metronidazole的疗程为7天,且需一日服用两次。此外,Tindamax耐受性更好。Mission制药公司希望Tindamax能成为细菌性阴道炎新的标准口服治疗药物。

通用名：替硝唑
英文通用名：Tinidazole
其他名称：替尼达唑, 替你净, 乐净, 快服净, 济得, 砜硝唑, 服净, 第孚, 净怡, 可立泰, 比适, 替消唑, 鹜马厌克, 康多利, 迪克新, 捷洛林, 替诺康, 乐净怡, 替硝唑片, 替硝唑注射液, 替硝唑阴道泡腾片
英文其他名称：Tricolam, Simplotan, Login, Finidazole, Fadazole, Fasigyn, Tinidazole Injection, Tinidazole Buccal Tablets, Tinidazole Capsules, Tinidazole Suppositories, Tinidazole Tablets, Tinidazole Vaginal Effervescent Tablets, Tinidazole for Injection, Tinidazole Vaginal Tablets, Concentrated Tinidazole Gargle
功能/功效：
1.用于治疗多种厌氧菌感染，如败血症、骨髓炎、腹腔感染、盆腔感染、鼻窦炎、支气管感染、肺炎、皮肤蜂窝组织炎、口腔感染及术后伤口感染。
2.可用于结肠或直肠手术、妇产科手术及口腔手术的术前预防用药。
注意事项：
1.交叉过敏 本药与其它咪唑类药物可能存在交叉过敏。
2.禁忌症
(1)对本药或其它咪唑类药物过敏者。
(2)活动性中枢神经系统疾患者。
(3)血液病患者或有此病史者。
(4)妊娠早期。
(5)哺乳妇女。
(6)12岁以下者。
不良反应：
本药不良反应较少且轻微。
1.胃肠道 常见恶心、呕吐、食欲减退、腹痛、便秘、口腔异味等胃肠道症状。
2.中枢神经系统 可有头痛、眩晕、共济失调等中枢神经系统症状，高剂量用药还可引起癫痫发作及周围神经病。
给药说明：
1.本药不宜与含铝的针头及套管接触，应缓慢静脉滴注，一次滴注时间不宜低于2小时，并避免与其它药物同时滴注。
2.口服片剂宜于餐间或餐后服用。
3.念珠菌感染者应用本药时症状可能加重，需同时给予抗真菌药治疗。
用法与用量：
成人
·常规剂量
·口服给药
1.厌氧菌感染：
(1)常用量为一次1g，一日1次，首剂加倍，疗程多为5-6日，口腔感染时疗程3日。
(2)用于急性齿龈炎时，可单次口服2g。
2.外科预防用药：一次2g。
制剂与规格：
替硝唑片
(1)0.15g。
(2)0.25g。
(3)0.5g。
贮法：避光，密封保存。
替硝唑胶囊
(1)0.2g。
(2)0.25g。
(3)0.5g。
贮法：避光，密封保存。
替硝唑含片 2.5mg。
贮法：遮光，密封，阴凉干燥处保存。
禁忌：
(1)对本药或其它咪唑类药物过敏者。
(2)活动性中枢神经系统疾患者。
(3)血液病患者或有此病史者。
(4)妊娠早期。
(5)哺乳妇女。
(6)12岁以下者。

 
Tindamax
Generic Name: tinidazole (tye NYE da zole)
Brand Names: Tindamax
What is Tindamax?
Tindamax (tinidazole) is an antibiotic that fights bacteria in the body.
Tindamax is used to treat certain infections caused by bacteria, such as infection of the intestines or vagina. It is also used to treat certain sexually transmitted infections.
Tindamax may also be used for purposes other than those listed in this medication guide.
Important information I should know about Tindamax?
You should not use Tindamax if you are allergic to tinidazole or metronidazole (Flagyl), or if you are in the first 3 months of pregnancy. You should not breast-feed a baby while you are taking Tindamax. However, you may begin nursing again 3 days after you take the last dose.
Do not keep any milk you collect with a breast pump while you are taking Tindamax.
Before you take Tindamax, tell your doctor if you have kidney disease (or if you are on dialysis), epilepsy or other seizure disorder, a blood cell disorder such as anemia or low platelets, or a weak immune system.
Take Tindamax for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.
Tindamax will not treat a viral infection such as the common cold or flu. Do not drink alcohol while taking this medicine and for at least 3 days after your treatment ends.
A medicine similar to tinidazole has caused cancer in laboratory animals. It is not known if tinidazole would have the same effect in animals, or in humans. Talk with your
doctor about your individual risk.
Before taking Tindamax
You should not use Tindamax if you are allergic to tinidazole or metronidazole (Flagyl), or if you are in the first 3 months of pregnancy. Tinidazole can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are taking Tindamax and for at least 3 days after your last dose.
You may begin nursing again 3 days after your last dose or Tindamax.
If you use a breast pump during treatment, throw out any milk you collect while taking Tindamax. Do not feed it to your baby.
To make sure you can safely take Tindamax, tell your doctor if you have any of these other conditions:
kidney disease (or if you are on dialysis);
epilepsy or other seizure disorder;
a blood cell disorder such as anemia or low platelets; or
a weak immune system.
FDA pregnancy category C. Do not take Tindamax during the first 3 months of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
See also: Tindamax information from Drugs.com pregnancy and breastfeeding warnings (in more detail)A medicine similar to tinidazole has caused cancer in laboratory animals. It is not known if tinidazole would have the same effect in animals, or in humans. Talk with your doctor about your individual risk.
How should I take Tindamax?
Take Tindamax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Take Tindamax with food.
Some infections are treated with only one dose. Follow your doctor's instructions.
Do not share Tindamax with another person, even if they have the same symptoms you have.
If you are treating a sexually transmitted infection, make sure your sexual partner seeks medical attention to be treated also.
Take this medication for the full prescribed length of time.
Your symptoms may improve before the infection is completely cleared.
Tindamax will not treat a viral infection such as the common cold or flu. Store at room temperature away from moisture and heat.
See also: Tindamax information from Drugs.com dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Tindamax?
Do not drink alcohol while taking Tindamax and for at least 3 days after your treatment ends. You may have unpleasant side effects such as fast heartbeats, severe nausea, vomiting, sweating, and warmth or tingling under your skin.
Check the label of the products and other medicines you use, such as mouthwash or cough and cold medicines.
Alcohol in these products can also cause a reaction if you use them while taking Tindamax.
Tindamax side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Tindamax: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:fever, chills, body aches, flu symptoms;numbness, burning pain, or tingly feeling; or
seizure (convulsions).
Less serious Tindamax side effects may include:
vaginal itching or discharge;
nausea, vomiting, loss of appetite, indigestion;
constipation, diarrhea, stomach cramps;
feeling weak or tired;
headache, dizziness; or
a metallic or bitter taste in your mouth;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
See also: Tindamax information from Drugs.com side effects (in more detail)
What other drugs will affect Tindamax?
Tell your doctor about all other medicines you use, especially:
any other antibiotic;
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
fluorouracil (Adrucil, Efudex, Carac, Flurorplex);
isoniazid (for treating tuberculosis);
lithium (Lithobid, Eskalith);
St. John's wort;
tacrolimus (Prograf);
an antidepressant such as nefazodone;
antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);
a barbiturate such as phenobarbital (Solfoton) and others;
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
HIV medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir(Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Solfoton), phenytoin (Dilantin), or primidone
(Mysoline).
This list is not complete and other drugs may interact with Tindamax. Tell your doctor about all medications you use.
This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about Tindamax.
What does my medication look like?
Tinidazole is available with a prescription under the brand name Tindamax. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Tindamax 500 mg - pink, oval, scored tablets.
Tindamax 250 mg - pink, round, scored capsules.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Tindamax only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that
effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States
and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
附件:

201132723132216.pdf
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注：以下产品不同规格和不同价格，购买时以咨询为准！
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产地国家: 美国
原产地英文商品名:
TINDAMAX 500mg/tab 60tabs/bottle
原产地英文药品名:
TINIDAZOLE
中文参考商品译名:
TINDAMAX 500毫克/片 60片/瓶
中文参考药品译名:
替硝唑
生产厂家中文参考译名:
MISSION PHARMA
生产厂家英文名:
MISSION PHARMA
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产地国家: 美国
原产地英文商品名:
TINDAMAX 500mg/tab 20tabs/bottle
原产地英文药品名:
TINIDAZOLE
中文参考商品译名:
TINDAMAX 500毫克/片 20片/瓶
中文参考药品译名:
替硝唑
生产厂家中文参考译名:
MISSION PHARMA
生产厂家英文名:
MISSION PHARMA

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产地国家: 美国
原产地英文商品名:
TINDAMAX 250mg/tab 40tabs/bottle
原产地英文药品名:
TINIDAZOLE
中文参考商品译名:
TINDAMAX 250毫克/片 40片/瓶
中文参考药品译名:
替硝唑
生产厂家中文参考译名:
MISSION PHARMA
生产厂家英文名:
MISSION PHARMA
该药品相关信息网址1:
http://www.tindamax.com/
该药品相关信息网址2:
http://www.drugs.com/tindamax.html
该药品相关信息网址3:
http://www.rxlist.com/tindamax-drug.htm