Active Substance: Trabectedin.
Overview
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This medicine contains an important and useful components, as it consists of
Trabectedinis available in the market in concentration
Aluminium Hydroxide + Magnesium Trisilicate
The combination of **aluminum hydroxide** and **magnesium trisilicate** is commonly used as an **antacid** to treat conditions such as **heartburn**, **indigestion**, and **gastric ulcers**. However, there are several precautions to consider: - **Pregnancy and Breastfeeding**: This combination is generally considered **safe** for short-term use during pregnancy (Category C). However, excessive use or prolonged therapy should be avoided, especially in **high doses**, due to the potential risks to the fetus, such as **aluminum toxicity**. The use during breastfeeding should be cautious, as **aluminum** can pass into breast milk, but in minimal quantities. Magnesium's effect on lactation is less concerning, though high doses should be avoided. - **Renal Impairment**: Care is required in patients with **renal dysfunction** as **aluminum** and **magnesium** can accumulate in the body. In patients with **chronic kidney disease**, prolonged use can lead to **aluminum toxicity**, causing **neurotoxicity**, **bone disease**, and other complications. For those with moderate to severe renal impairment, the drug should be used with caution or avoided. - **Electrolyte Imbalance**: **Magnesium trisilicate** may cause **hypermagnesemia** (high magnesium levels), particularly in patients with **renal insufficiency**, leading to **muscle weakness**, **respiratory depression**, and **cardiac arrest** in severe cases. It is crucial to monitor **serum magnesium** levels during treatment. - **Long-Term Use**: Chronic use of this combination can lead to **alkalosis** (an excessively alkaline state) and **electrolyte disturbances**. It is important to avoid prolonged use without medical supervision. - **Gastrointestinal Disorders**: Caution is needed in patients with conditions such as **bowel obstruction** or **appendicitis**, as antacids like aluminum hydroxide and magnesium trisilicate can mask the symptoms of more serious gastrointestinal conditions. **Monitoring Parameters**: - **Serum Electrolytes**: Regular monitoring of **magnesium** and **calcium** levels is recommended to avoid imbalances, especially in at-risk patients (e.g., those with renal disease). - **Renal Function**: Serum creatinine and glomerular filtration rate (GFR) should be checked regularly, particularly for patients with pre-existing kidney issues, to ensure proper dosing and avoid toxicity. - **Signs of Toxicity**: Watch for signs of **hypermagnesemia**, such as **nausea**, **vomiting**, **bradycardia**, **muscle weakness**, or **hypotension**.
The combination of **aluminum hydroxide** and **magnesium trisilicate** is indicated for the relief of symptoms related to **acid-related gastrointestinal conditions**: - **Heartburn**: This combination works by neutralizing stomach acid and providing relief from the discomfort caused by acid reflux. - **Indigestion**: Often characterized by discomfort or bloating in the stomach, this medication helps alleviate these symptoms by reducing acidity. - **Gastroesophageal Reflux Disease (GERD)**: It may be used to manage mild to moderate GERD symptoms, where stomach acid irritates the esophagus. - **Peptic Ulcers**: It may provide symptomatic relief from gastric ulcers and duodenal ulcers by neutralizing stomach acid and helping to protect the gastric lining. - **Dyspepsia**: It provides short-term relief for patients suffering from **dyspepsia** (a condition involving upper abdominal discomfort or pain). The combination of aluminum hydroxide and magnesium trisilicate is also useful for **hyperacidity** and **gastric hypersecretion**, and in certain cases, it can be used for relief of **gastric upset** caused by other medical treatments, such as **NSAIDs**.
This combination is contraindicated in the following conditions: - **Renal Failure**: This combination is **contraindicated** in patients with **severe renal impairment** because **aluminum** and **magnesium** can accumulate in the body, leading to potentially severe **toxicity**. - **Hypersensitivity**: Patients with a known **allergy** or **hypersensitivity** to any component of this combination (aluminum, magnesium, or any excipients) should avoid use. - **Gastrointestinal Obstruction**: Patients with suspected or diagnosed **bowel obstruction** should not use this combination, as it may worsen symptoms or mask underlying issues. - **Hypermagnesemia**: The combination should be avoided in patients with **pre-existing hypermagnesemia** (high magnesium levels), as it could exacerbate the condition. - **Aluminum Toxicity**: Patients with a history of **aluminum toxicity** (often in those with chronic kidney disease) should avoid this combination due to the risk of **neurotoxicity** and **bone disease**.
The side effects of aluminum hydroxide and magnesium trisilicate are generally mild but can vary depending on the individual: - **Common Side Effects**: - **Constipation** (due to aluminum content) - **Diarrhea** (due to magnesium content) - **Abdominal discomfort**, **bloating**, or **gas** - **Less Common but Serious Side Effects**: - **Electrolyte Imbalances**: Extended use or high doses can lead to **hypermagnesemia** (excess magnesium), which can cause **hypotension**, **respiratory depression**, and **cardiac arrest** in severe cases. - **Aluminum Toxicity**: Prolonged use in individuals with kidney dysfunction can result in **aluminum toxicity**, causing **neurotoxicity**, **bone disease**, or **dementia**. - **Nausea** or **vomiting** may occur, particularly when taken in larger doses. - **Muscle weakness**, **fatigue**, and **bradycardia** may indicate **hypermagnesemia**. If these symptoms are persistent, dose reduction or discontinuation of therapy should be considered.
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The combination of **aluminum hydroxide** and **magnesium trisilicate** functions as an **antacid** by neutralizing excess stomach acid: - **Aluminum Hydroxide**: This compound reacts with hydrochloric acid (HCl) in the stomach to form aluminum chloride and water, decreasing the acidity. It also provides a **protective** coating over the stomach lining, helping to reduce the irritation caused by acid. - **Magnesium Trisilicate**: Magnesium trisilicate reacts with hydrochloric acid to form **magnesium chloride**, **silicic acid**, and **water**, further reducing stomach acidity. Magnesium has a mild **laxative** effect, which helps to counterbalance the constipating effect of aluminum hydroxide. These two ingredients work synergistically to neutralize stomach acid, providing relief from the discomfort of acid reflux, heartburn, or ulcer-related pain. The **pharmacokinetics** of both aluminum and magnesium are relatively slow, providing a lasting neutralization effect. However, the potential for side effects such as **electrolyte imbalances** or **toxicity** in patients with compromised kidney function requires careful monitoring.
This combination has several significant drug interactions: - **Other Antacids**: When combined with other antacids or acid-suppressing medications (such as **H2 blockers** or **proton pump inhibitors**), the effects of aluminum hydroxide and magnesium trisilicate may be enhanced, leading to excessive alkalization of the stomach. - **Digoxin**: Magnesium can interact with **digoxin**, a heart medication, by affecting its **cardiac conduction**, leading to possible **toxicity**. Serum **digoxin** levels should be monitored if the two are used together. - **Tetracyclines** and **Quinolone Antibiotics**: The antacid combination can **decrease the absorption** of certain **antibiotics**, including **tetracyclines** (e.g., **doxycycline**) and **quinolones** (e.g., **ciprofloxacin**). It is advisable to space the administration of these antibiotics and the antacid by at least **2 hours**. - **Thyroid Medications**: **Levothyroxine** and other thyroid hormone replacements may have their absorption reduced if taken concurrently with aluminum and magnesium-based antacids. A **2-hour gap** between doses is recommended. - **Iron Supplements**: The absorption of **iron** may be reduced when combined with aluminum or magnesium antacids, as the elevated pH can impair iron solubility. The same **2-hour gap** should be followed for this interaction. There are no prominent interactions with food or alcohol; however, **alcohol** may exacerbate gastrointestinal irritation, and it should be avoided or limited during treatment.
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- The usual dose for adults is **5-15 mL** taken **1 to 3 times daily**, typically after meals and at bedtime for **heartburn** and **indigestion**. For more severe conditions such as **gastric ulcers**, dosing may be increased to **15 mL** up to **4 times daily**. - It should be administered **orally**, with plenty of water to avoid irritation of the stomach lining. - **Titration** should be done based on symptom relief, but prolonged use should be avoided, especially in those with kidney dysfunction.
For children, the dosing should be based on the child's age and weight, and the medication should be prescribed by a pediatrician. Typically, for children over 12 years, the adult dose can be used, but for younger children, the dose should be reduced, and only short-term use is recommended. Always consult with a healthcare provider before giving this medication to children.
In patients with **renal impairment**, the use of aluminum hydroxide and magnesium trisilicate should be done with caution. Because both **aluminum** and **magnesium** can accumulate in the body, particularly in patients with **renal dysfunction**, dose adjustments and **closer monitoring of renal function** are required. **Creatinine levels** and **serum electrolytes** (particularly magnesium and calcium) should be monitored regularly.
Information not available