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Ondem
Last reviewed: 23.04.2024
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Ondham is a substance that prevents the development of nausea along with vomiting; it is an antagonist drug acting against the 5HT3-terminations of serotonin.
Drugs used in radiotherapy or cytostatic treatment can increase serotonin in the small intestine, which causes the development of vomiting reflex - activates the end of 5-HT3 serotonin, and arousal develops in the afferent receptors of the vagus nerve. At the same time, a serotonin release is carried out in the postretire area, which, through the central system, initiates the development of the gag reflex.
The drug blocks the activity of trigger mechanisms responsible for the appearance of the gag reflex.
[1]
Indications Ondema
It is used in case of nausea together with vomiting, which are caused by radiation treatment or cytotoxic chemotherapy.
Appointed to prevent the development and disposal of existing vomiting with nausea after the end of surgical procedures.
[2]
Pharmacodynamics
Ondansetron is a highly selective antagonist of serotonin 5HT3 endings with a powerful therapeutic effect.
The drug eliminates or prevents vomiting with nausea, which develops as a result of radiation therapy or cytotoxic chemotherapy procedures, and in addition to nausea with vomiting associated with surgical operations.
The principle of influence of ondansetron is not yet fully defined. There is an assumption that the drug blocks the appearance of gag reflex, providing an antagonistic effect on the endings of 5HT3, located in the region of neurons of the CNS and PNS.
Ondem reduces the psychomotor activity of the patient, while not having a sedative effect.
Pharmacokinetics
After drug administration, plasma Cmax values are noted after a 10-minute period. Distribution volume is 140 l. Most of the portions used are involved in intrahepatic metabolism. In an unchanged state, up to 5% of the drug is excreted in the urine. The half-life is about 3 hours (for older people - 5 hours).
Intlasma protein binding is 70-76%.
In individuals with moderate severity of renal impairment (CC values are 15–60 ml / minute), the total clearance and distribution volume of the drug decreases, resulting in a clinically insignificant extension of the substance’s half-life.
In people with insufficiency of the liver of a chronic nature (in the severe stage, the indicators) of the total clearance of ondansetron decrease significantly, simultaneously with the extension of the half-life (up to 15-32 hours).
Dosing and administration
Vomiting along with nausea, developing with radiation or chemotherapy.
The emethogenic potential of cancer treatment varies with the size of the dosage, as well as the combination of radiation therapy regimens with chemotherapy. The selection of the batch mode is determined by the severity of the emetogenic effect.
Adults.
Emetogenic chemo and radiation therapy.
For intramuscular and intravenous injections, administration of 8 mg of the substance is required via injection, at low speed (at least half a minute), immediately before the start of the treatment session.
To prevent the occurrence of prolonged or delayed vomiting (appears after the first 24 hours), it is necessary to take the medicine orally.
Highly chemotherapeutic chemotherapy procedures (for example, high portions of ciplatin).
The drug is used in the form of a single dose of 8 mg (w / m or w / w), which is injected before the start of the chemotherapy session. Portions above 8 mg (up to 16 mg) are allowed to be administered exclusively via iv infusion (using 0.9% NaCl or another suitable solvent — 50-100 ml of the substance). The duration of infusion is at least 15 minutes. At one time you can not use more than 16 mg of the drug.
In case of highly chemotherapeutic treatment, the dosage of 8 mg (or lower) is not required to be dissolved - it is administered via IV or IM injection at a low speed (at least 0.5 minutes) immediately before the start of the procedure. Next, the drug is used 2 times a day - in / in or in / m injection of 8 mg of the drug after 2 and 4 hours; or a continuous infusion (for 24 hours) of the 1st mg / hour of the substance can be used.
Increase drug efficacy during the highly chemotherapeutic course of chemotherapy can be achieved with the help of a 1-fold supplemental application of 20 mg of dexamethasone before the procedure.
Use for the age subgroup of 0.5-17 years.
In pediatrics, Ondem is administered via an infusion, pre-dissolved in 0.9% NaCl or another suitable solvent. This procedure lasts at least 15 minutes. A portion of the drug is calculated based on the area of the body surface or the weight of the child.
Selection of portions, taking into account the surface area of the patient.
The introduction is carried out immediately before the start of the procedure - 1-fold injection dosage of 5 mg / m 2; while in / in portion should be a maximum of 8 mg. After 12 hours, oral administration of the drug begins, which may last another 5 days.
Selection of portions based on weight.
A single injection of the drug is 0.15 mg / kg; A / v portion can be a maximum of 8 mg of a substance. During the first day, it is allowed to perform another 2 intravenous drugs with a 4-hour break. After 12 hours, a switch to oral administration of the drug takes place - its duration may be another 5 days.
Elderly people.
People over the age of 65 need to dissolve any dosing injections for intravenous infusion, and then inject over a 15-minute period; in case of need for reuse, the interval between injections should be at least 4 hours.
Persons aged 65-74 years are prescribed an initial dosage of the drug, which is 8 or 16 mg; it is required to enter it through infusion (15 minutes). You can continue therapy with a dose of 8 mg, which is administered 2 times a day. This infusion lasts 15 minutes, and the interval between treatments is at least 4 hours.
People over 75 years of age are first given intravenously with a maximum of 8 mg of the drug (minimum 15-minute infusion). Later, the same 8 mg of the drug is administered 2 times per day (15-minute infusion with a minimum of 4-hour intervals between them).
Persons with impaired hepatic function.
In people with similar disorders, having a moderate or severe nature, there is a significant decrease in clearance, and the term serum half-life of the component increases. Such patients can be administered per day with a maximum of 8 mg of Ondem.
Postoperative vomiting with nausea.
Adults.
In order to prevent the occurrence of postoperative disorders (vomiting with nausea), 4 mg of the drug should be injected intramuscularly or via intravenous injection (low speed) during the anesthesia injection process.
When nausea is already present, the same dosage portion is used along with vomiting, which is used slowly intravenously or intramuscularly.
At children's age (since 1st month, and till the 17th anniversary).
To prevent or eliminate postoperative vomiting with nausea in a child operated under general anesthesia, 0.1 mg / kg of the drug is used (maximum 4 mg of the substance) through a slow injection (at least half a minute) before anesthesia, during this injection, and also after it or after surgery.
[9]
Use Ondema during pregnancy
There is no information as to whether it is safe to use the drug during pregnancy. Experiments with the participation of animals showed that Ondam did not have a negative impact on embryonic and fetal development, and also on the course of pregnancy, the peri-, as well as the postnatal period. But, due to the lack of confirmation of this data regarding a person, it is not necessary to prescribe medication for pregnant women.
Also, experimental tests revealed that ondansetron passes inside the mother's milk in animals. Therefore, when the need for the use of the drug is necessary to abandon breastfeeding.
Contraindications
Side effects Ondema
The main side signs are:
- immune disorders: immediate intolerance symptoms (sometimes can be severe, even reaching anaphylaxis);
- Disorders of the NA: convulsions, headaches and movement disorders (among them extrapyramidal manifestations - dystonic symptoms, ocular crisis, and dyskinesia that does not lead to persistent clinical complications), and besides dizziness - mainly at high rates of drug administration;
- problems with visual function: short-term visual impairment (eye opacity), as well as temporary blindness (mainly after IV injection). Blindness often disappears after 20 minutes;
- cardiac disorders: arrhythmias, bradycardia, and at the same time pain in the sternum (accompanied by ST depression or not) and prolongation of the QT interval (this also includes trembling or ventricular fibrillation);
- vascular disorders: lower blood pressure and hot flashes, or a feeling of warmth;
- problems affecting the organs of the sternum and respiratory tract: hiccups;
- lesions of the digestive system: constipation;
- signs of the hepatobiliary system: not accompanied by symptoms of increased values of liver activity. It is mainly noted in people using chemotherapeutic agents that contain cisplatin;
- lesions of the subcutaneous tissue and epidermis: toxic rash (for example, PET);
- systemic disorders: local manifestations in the injection area.
During post-registration observations, the following violations were recorded:
- CVS lesions: discomfort and pain in the sternum, palpitations, extrasystole, fainting, tachycardia (this includes its supraventricular and ventricular types), changes in ECG readings and atrial fibrillation;
- signs of intolerance: anaphylaxis and anaphylactic symptoms, rashes, bronchial spasm, urticaria, angioedema, and itching;
- Disorders of the function of the National Assembly: chorea, paresthesia, burning sensation, diplopia and myoclonus, and in addition, gait disorder, lingual protrusion and restlessness;
- systemic manifestations and local signs: pain, redness and burning sensation in the injection area, as well as an increase in temperature;
- others: the development of hypokalemia.
Overdose
Ondansetron, depending on the size of the portion increases the values of the QT-interval. When drug poisoning is necessary to monitor the ECG.
Symptoms of overdose include severe obstipation, visual impairment, a decrease in BP values, and vasovagal signs with a temporary AV-blockade of the 2nd degree. All these manifestations disappeared completely and independently.
The drug does not have an antidote, therefore, during intoxication, symptomatic and supportive measures are taken.
It is impossible to use ipecac for the elimination of ondansetron poisoning, because its effect will not develop due to the antiemetic effect of Ondem.
Interactions with other drugs
Ondansetron does not slow down or speed up the metabolic processes of other medicines when combined with it. Testing conducted demonstrated that the drug does not interact with furosemide, lignocaine, temazepam, alcoholic beverages, and in addition with morphine, thiopental, alfentanil, propofol and tramadol.
The drug is involved in the exchange, along with a variety of hepatic hemoprotein P450 enzymes, as well as CYP3A4 along with CYP2D6, as well as CYP1A2. A variety of exchange enzymes allows, at standard parameters, to compensate for the slowing down or weakening of the activity of any of them (possibly with a genetic deficiency of the CYP2D6 element) by the influence of other enzymes, as a result of which there is no effect on the system clearance (or it will be insignificant).
Carefully, Ondam should be combined with drugs, prolonging the QT-interval or leading to a violation of the salt balance.
The use of the drug in combination with apomorphine hydrochloride is prohibited, because it can lead to a strong decrease in blood pressure values and loss of consciousness.
In people using potential inducer substances of the component CYP3A4 (for example, carbamazepine with phenytoin, as well as rifampicin), the clearance level of the drug increases, and its blood values decrease.
The development of serotonin intoxication (with changes in mental status, neuromuscular disorders and autonomic lability) develops in the case of combined use of the drug along with other serotonergic drugs - for example, SSRIs, as well as SPRIs.
Information obtained during some clinical tests showed that ondansetron is able to weaken the analgesic effect of tramadol.
The introduction of the drug together with substances that prolong the values of the QT-interval, leads to additional prolongation.
The combined use of Ondem and cardiotoxic drugs (for example, anthracyclines) increases the likelihood of developing arrhythmias.
Attention!
To simplify the perception of information, this instruction for use of the drug "Ondem" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.
Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.