Newbutin 300mg, with the active ingredient Trimebutin, is commonly indicated in the treatment regimen for digestive dysfunction, irritable bowel syndrome, and for children who frequently experience vomiting, constipation, or diarrhea.
1. What is Newbutin?
Newbutin 300mg is formulated in the form of extended-release film-coated tablets, oval-shaped, and white in color.
The components of Newbutin include:
- Active ingredient: Trimebutine maleate at a dosage of 300mg;
- Excipients such as Lactose, Calcium hydrophosphate, Microcrystalline cellulose, Povidone, Ammonio methacrylate copolymer, Light anhydrous silicic acid, Talc, Magnesium stearate, Opadry OY-C-7000A, Isopropanol, Methylene chloride.
2. Pharmacological characteristics of Newbutin 300mg
2.1. Pharmacodynamics
Trimebutine maleate in Newbutin is an active ingredient with non-competitive antispasmodic effects, along with the ability to antagonize serotonin and a moderate affinity for opioid receptors. Therefore, Newbutin only reduces abnormal gastrointestinal motility without affecting normal motility.
Additionally, studies have shown that Trimebutin does not cause certain side effects such as pupil dilation or increased sweating, and Newbutin is considered safe during treatment, including in children and the elderly.
2.2. Pharmacokinetics
Some studies on the metabolism of Newbutin in humans indicate that C14-Trimebutine maleate or the free base form of Trimebutin is rapidly absorbed after oral administration. The peak concentration of the radioactive C14 label of Trimebutin in plasma is reached in approximately 1 hour.
After absorption and metabolism, Newbutin 300mg is primarily excreted through urine, with a small amount (about 5 to 12%) of the radioactive label found in feces. The half-life of the active ingredient Trimebutin is relatively short, but the half-life of the radioactive label is approximately 10 - 12 hours.
3. Indications and contraindications of Newbutin 300mg
Newbutin is indicated for use in the following cases:
- Gastroesophageal reflux;
- Hiatal hernia;
- Abdominal pain due to gastritis or peptic ulcers;
- Indigestion, nausea, vomiting;
- Colonic dysfunction, including allergic colitis and irritable bowel syndrome;
- Irritable bowel syndrome;
- Abdominal pain and bowel dysfunction not due to infection, such as diarrhea and constipation;
- Postoperative ileus;
- Reduction of pyloric and colonic spasms during endoscopy.
Furthermore, there are some cases where Newbutin 300mg should not be used (Contraindications):
- Patients with a history of allergy or hypersensitivity to Trimebutin or any excipients in Newbutin;
- Women who are pregnant or breastfeeding should not use Newbutin
Newbutin is not recommended for children under 12 years of age.
4. Dosage and administration of Newbutin
Depending on the specific individual and the severity of the condition, the doctor will provide appropriate guidance for the use of Newbutin 300mg. The usual dosage is as follows:
- Adults: Take 1 Newbutin 300mg tablet three times a day;
- Children over 12 years: Take 1 Newbutin 300mg tablet 1-2 times a day.
Trimebutin vverdose and management:
- To date, there have been no reports or evidence of Newbutin overdose;
- If an overdose occurs after taking Newbutin, gastric lavage should be performed, and symptomatic and supportive treatment should be provided as appropriate.
5. Some notes when using Newbutin
- Keep the medication out of reach of children.
- Newbutin 300mg should be stored in a sealed container, in a cool place, and away from direct sunlight.
- When using Newbutin, patients should avoid using wet or dirty hands to handle the medication;
- Patients should take the medication immediately after removing it from the packaging; if the outer packaging is torn or damaged, it should not be used.
- Newbutin 300mg provides rapid relief of digestive disorder symptoms. However, to minimize the risk of unwanted side effects, patients must strictly adhere to the doctor's instructions regarding the use of this product;
- Although the potential for Trimebutin to cause fetal malformations has not been reported in animal studies, this does not prove the safety of using Newbutin for pregnant women. Therefore, the use of Newbutin 300mg is not recommended for pregnant or breastfeeding individuals.
6. Unwanted effects of Newbutin
The Newbutin 300mg product is generally well-tolerated and relatively safe. Therefore, only a few rare cases have reported unwanted effects such as:
- Symptoms of fatigue, and sensations of temperature fluctuations;
- Mild diarrhea;
- Nausea and vomiting;
- Constipation;
- Indigestion;
- Mild sedation;
- Light-induced dizziness.
Although these effects are rare, patients should promptly inform their doctor of any abnormalities during treatment with Newbutin 300mg.
7. Drug interactions of Newbutin 300mg
Animal studies have shown that the active ingredient Trimebutin maleate may prolong the duration of D-tubocurarine when treated with curare drugs. Additionally, no other drug interactions have been reported during the clinical trials of the Newbutin 300mg product.
To arrange an appointment, please call HOTLINE or make your reservation directly HERE. You may also download the MyVinmec app to schedule appointments faster and manage your reservations more conveniently.
