通用中文 | 盐酸恩丹西酮片 | 通用外文 | Ondansetron HCl |
品牌中文 | 品牌外文 | Ondem-4 | |
其他名称 | 昂丹司琼 奥丹西龙 Zofran 枢复宁 | ||
公司 | Alkem(Alkem) | 产地 | 印度(India) |
含量 | 4mg | 包装 | 500片/盒 |
剂型给药 | 片剂 口服 | 储存 | 室温 |
适用范围 | 用于放射治疗和细胞毒类药物化疗引起的呕吐。 |
通用中文 | 盐酸恩丹西酮片 |
通用外文 | Ondansetron HCl |
品牌中文 | |
品牌外文 | Ondem-4 |
其他名称 | 昂丹司琼 奥丹西龙 Zofran 枢复宁 |
公司 | Alkem(Alkem) |
产地 | 印度(India) |
含量 | 4mg |
包装 | 500片/盒 |
剂型给药 | 片剂 口服 |
储存 | 室温 |
适用范围 | 用于放射治疗和细胞毒类药物化疗引起的呕吐。 |
药品名称和成分
别名: 恩丹西酮, 枢复宁, 昂丹司琼, 奥丹西龙
外文名: Ondansetron Hydrochloride , Zofran
主要成分:盐酸恩丹西酮
药理作用
是一种高选择性的5-羟色胺3受体拮抗剂,即一种新的强效止吐药。该药控制恶心呕吐的机理,是拮抗外周和中枢神经元5-羟色胺3受体,从而阻断因化疗和放疗等因素引起小肠的5-羟色胺释放,通过5-羟色胺3受体引起迷走传入神经兴奋而导致的呕吐反射。有高效选择性作用,因而不具有其他止吐药的副作用,如锥体外系反应、过度镇静等。
药代动力学
文献报导,本品口服后约2小时血药浓度达高峰,绝对生物利用度约60%,血浆蛋白结合率约70~76%,药物终末消除半衰期约3小时,老年人可能延长至5小时,代谢物由粪和尿排出。
适应症
用于放射治疗和细胞毒类药物化疗引起的呕吐。
用法用量
1 对于高度催吐的化疗药引起的呕吐:化疗前15分钟、化疗后4小时、8小时各静脉注射恩丹西酮注射液8mg,化疗以后每8小时口服恩丹西酮片8mg,连用5天。
2 对催吐程度不太强的化疗药引起的呕吐:化疗前15分钟静脉注射恩丹西酮注射液8mg,以后每8小时口服恩丹西酮片8mg,连用5天。
3 对于放射治疗引起的呕吐:首剂须于放疗前1至2小时口服片剂8mg,以后每8小时口服8mg,疗程视放疗的疗程而定。
4 任何疑问,请遵医嘱!
不良反应
可有头痛,腹部不适,便秘,偶有短暂性无症状转氨酶升高。上述反应轻微,无须特殊处理。
禁忌症
1 胃肠道梗阻者不用。
2 对本品过敏者禁用。
注意事项
1 孕妇慎用。
2 哺乳期妇女慎用,若使用本品应停止哺乳。
规格
片剂 4mg,8mg(以C18H19N3O计)
口服液 4mg/5ml
贮藏
遮光,密闭,在阴凉干燥处保存。
Ondem 4 Mg tablet is an antiemetic medication used for patients on cancer chemotherapy and radiation therapy to help with nausea and vomiting. It blocks the action of a chemical that causes nausea and vomiting. It may be used as a tablet, dissolving tablet, film, or solution. It also comes in intravenous or IV form to be administered in patients. It is manufactured by Alkem Laboratories Ltd.
Uses and benefits of Ondem:
Ondem is primarily prescribed to -
· Prevent post-surgical or chemotherapy-induced nausea and vomiting
· Treat diarrhoea -predominant irritable bowel syndrome
Side Effects of Ondem:
A medicine may interact with other medicines, food items or beverages. This medicine may also interact and exhibit certain side effects. Some of the side effects associated with Ondem 4 mg are:
· Constipation and headache . A headache is sometimes accompanied by chest pain and dizziness .
· Muscle spasms or stiffness of the muscles.
· Temporary blurred vision or loss of vision.
· Fast heartbeat or uneven heartbeat and uncontrollable sweating.
· Yellowing of the eyes or the skin.
· Hallucinations and low blood pressure leading to fainting.
· Symptoms such as fever , rash, swelling of the lips tongue, throat, or chills, may indicate a serious allergic reaction to the medication
Common Dosage of Ondem:
Emetogenic chemotherapy
During emetogenic cancer chemotherapy, adults may be asked to take a dose as high as 24mg. The dose is usually taken 30 minutes before starting the procedure.
For children undergoing chemotherapy three doses of 0.15 mg are given. The first dose is given 30 minutes before the start of chemotherapy, followed by the next doses which are given after 4 and 8 hours respectively.
Dosage related to initial and repeat courses of emetogenic cancer chemotherapy
· Adult - After the completion of chemotherapy, a dose of 8mg is advised every 12 hours for at least 2 days.
· Children (12-17 years) - After completion of the chemotherapy, a dose of 8 mg is given three times a day. The first dose is given 30 minutes before the start of chemotherapy, followed by 8mg dose 4 and 8 hours after the first dose.
· Children (4-11 years) - 4 mg medicine thrice a day is advised for children of 4 to 11 years of age.
· Children (6-18 months) - Three doses of 0.15 is given to children up to 18 years of age.
Dosage for vomiting and nausea occurring after a surgery -
16 mg dose is given 1 hour before the effect of anaesthesia.
· Missed Dose: If a patient misses a dose, it must be taken as soon as possible. However, if it is already time for the next dose, patients must refrain from taking a double dose.
· Overdose: In case of an overdose, patients must be managed with a suitable supportive therapy. The patients must consult a doctor as soon as they observe any symptoms of overdose such as anxiety, dilation of the pupil, high/low blood pressure, rapid heart rate, etc.
Composition and Nature of Ondem:
Ondem is an antiemetic i.e. it is used for the treatment of vomiting and nausea, which is caused as a result of cancer treatment or radiation therapy. Ondem 4 mg may also be given post-surgery to avoid side effects. It blocks serotonin, which is a natural substance that induces vomiting. The active ingredient in this medicine is Ondansetron (4mg).
Related Warnings/Precautions: When to avoid Ondem?
· The patients must inform their doctor about any on-going medicines or any herbal products they have been consuming.
· The doctor must also be informed about any medical conditions a patient suffers from.
· If a person is allergic to the components of Ondem, they must avoid taking this medicine.
· The use of Ondem 4 mg tablet may change Electrocardiogram monitoring results. Inform the doctor about this medicine before undergoing an ECG test.
· Ondem 4 mg tablet is unsafe for pregnant women.
· This may make patients sleepy; therefore, driving or operating heavy machinery is not suggested after taking Ondem.
· Patients allergic to histamine receptor antagonists may develop allergic reactions such as anaphylaxis and spasm of bronchial muscle.
· Patients may develop serotonin syndrome with the consumption of this tablet.
· Patients must foretell the doctor about any previous liver problems.
· Regular cardiac function tests and liver function tests may be necessary for patients using Ondem 4 mg, and they should be carefully monitored for possible side-effects.
· Using this tablet and Apomorphine together increases the risk of fainting and dizziness highly and may cause loss of consciousness. It is highly advisable that patients do not use the two medicines together .
Substitutes for Ondem:
Two widely available alternatives to Ondem 4 mg tablet that use the same active ingredient and are also used to prevent nausea and vomiting reaction in chemotherapy and radiation therapy patients are:
· Preset Tablet manufactured by Ipca Laboratories Pvt Ltd.
· Onditron Tablet manufactured by Wockhardt Ltd
Ondem Interactions with Other Drugs:
Interaction with medicines - When two or more medicines are taken together, they may interact with each other leading to severe side-effects. Some of the drug interactions exhibited by Ondem 4 mg tablet are:
· Amitriptyline: Using Ondem 4 mg tablet along with Amitriptyline increases the risk of hallucinations, along with other side-effects like changes in blood pressure , excessive sweating and fever, and confusion. Appropriate dose adjustments should be considered, and the doctor may consider changing the medication to a less harmful substitute.
· Apomorphine: It is not recommended to use both these medications together as the appropriate response may not be felt.
· Amiodarone : Use of Ondem 4 mg tablet with Amiodarone is not recommended. Using these two medications together increases the risk of dizziness, fainting, lightheadedness, and may cause difficulty in breathing. Doctors may choose to change the medication. If the benefits are high enough, then patients using both medications together should be having regular cardiac function tests and under monitoring by a doctor. The doctor will make regular dose adjustments.
· Carbamazepine: Ondem 4 mg tablet may not work as desired if used along with Carbamazepine. The patient may still face nausea. The doctor may consider changing the medication or using changes in the dose to help the patient.
· Phenytoin : The patient should consider a different drug if advised by the doctor as the correct effect of Ondem 4 mg tablet may not be felt if both drugs are used together. The doctor may also consider keeping the patient under monitoring and changing the dosage as and when required.
· Cyclophosphamide: The use of Ondem 4 mg tablet with cyclophosphamide will usually mean that the effect of cyclophosphamide will not be felt. If both medications must be used together then the doctor should consider dosage adjustment. Otherwise, the doctor and patient should discuss appropriate replacements.
Interaction with diseases -
· Liver Disease: A history of liver diseases like hepatitis, jaundice , or cirrhosis that require drugs such as TB drugs, or HIV drugs may change the prescription. Patients who need to use Ondem and such drugs must monitor themselves carefully, including regular liver function tests under medical supervision.
Interaction with alcohol – Consumption of Ondem 4 mg tablet with alcohol may amplify the dizziness and sleepiness. Therefore, it is advised that patients may refrain from taking alcohol with this medicine. However, no adverse effect on the health has been noticed with the consumption of alcohol with this drug.
· QT Prolongation: If the patient has any past history of heart disease, including a family history ofarrhythmia or any condition that would require the use of drugs that cause QT interval prolongation such as antipsychotics or arrhythmia drugs, the doctor may choose to change the medication. The patient requires careful monitoring and regular cardiac function tests for safe usage.
How to Use Ondem?
For Ondem 4 mg to work efficiently, it must be consumed properly in the manner mentioned below -
It can be taken with or without food. It should be swallowed and not chewed or broken before consumption.
How Ondem 4 MG Works ?
Ondem works by blocking serotonin which is a chemical messenger responsible for vomiting and nausea. It works on both the small intestine and the brain to control vomiting.
When Ondem is Prescribed?
Ondem is usually prescribed to prevent vomiting and nausea that a patient experiences after surgery, radiation session or chemotherapy.
How to Store Ondem 4 MG Tablet?
Ondem must be -
· Stored at room temperature.
· Kept away from the reach of pets and children.
· Not kept under direct heat or sunlight.
· Not kept at places where it can retain moisture such as near the bathroom or kitchen sink.
·
FAQs
1) What is Ondem 4 MG Tablet used to treat?
Ans: Ondem is used to prevent nausea and vomiting associated to highly emetogenic cancer chemotherapy .
2) What are the side effects of Ondem 4 MG?
Ans: Some of the most common side effects associated with Ondem include constipation, diarrhoea, flushing, headache, feeling of discomfort, fever etc.
3) Can I use alcohol while using Ondem?
Ans: Patients are advised not to drink alcohol as it may induce excessive sleepiness. No specific counter-effects are noted, but it is wiser to refrain from alcohol when taking this medicine.
4) Can pregnant patients use Ondem?
Ans: Unless unavoidable, it is advised that pregnant patients do not use Ondem 4 MG tablet. Such patients should discuss viable alternatives with the doctor, although the doctor may still advise this tablet if the benefits outweigh the risks.
5) What happens if I miss Ondem 4 MG?
Ans: If a patient misses a dose it must be taken immediately as soon as one remembers about it. However, if it is already time for the next dose, one must skip the missed dose.
6) What happens if I overdose Ondem?
Ans: Overdose of Ondem may cause several side effects such as anxiety or agitation, chest pain, cold sensation, dizziness, hives, increased levels of liver enzymes, involuntary contractions of the diaphragm, muscle pain, severe itching , shivers, temporary loss of consciousness, transient blindness etc. If any of these symptoms appear, doctor must be consulted immediately.
7) Does Ondem cause drowsiness?
Ans: Yes. Ondem may induce drowsiness along with other side effects.
8) Is Ondem safe for pregnant women?
Ans: Yes. Ondem is safe for pregnant women and is one of the most commonly prescribed medicines to treat nausea and vomiting during pregnancy.
9) What is Ondem prescribed for?
Ans: Ondem is prescribed with other medicines to prevent nausea and vomiting caused by cancer drug treatment.
10) How does Ondem work?
Ans: Ondem works by blocking the action of a chemical substance that causes nausea and vomiting.
11) Can I drive after consuming Ondem 4 MG tablet?
Ans: Ondem may induce sleepiness and drowsiness. Therefore, it is suggested that the patients avoid driving after consuming this medicine.
12) Does Ondem 4 MG cause any allergic reactions?
Ans: If some patient is already allergic to histamine receptor antagonists, they are at a higher risk of developing allergic reactions such as anaphylaxis and bronchospasm.