Usage
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This combination medication is primarily prescribed for the relief of gastrointestinal symptoms associated with functional dyspepsia (non-ulcer dyspepsia), chronic gastritis, gastroesophageal reflux disease (GERD), and other conditions involving excessive gas and heartburn. Symptoms may include heartburn, nausea, vomiting, bloating, and upper abdominal discomfort.
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Pharmacological Classification: This is a combination product containing a gastroprokinetic agent (mosapride) and an antiflatulent (dimethicone).
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Mechanism of Action: Mosapride increases gastrointestinal motility by acting as a 5-HT4 receptor agonist, stimulating acetylcholine release in the gut. Dimethicone relieves gas by reducing the surface tension of gas bubbles in the GI tract, allowing them to coalesce and be expelled more easily.
Alternate Names
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No widely recognized alternate names exist for the combination itself. However, the individual components have various brand names depending on the region and manufacturer.
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Brand Names: Moza MPS, M Pride Mps, Mosar plus are some of the brand names under which this combination is marketed.
How It Works
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Pharmacodynamics: Mosapride enhances coordinated gastrointestinal motility by stimulating 5-HT4 receptors, increasing acetylcholine release. Dimethicone acts physically to reduce surface tension of gas bubbles.
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Pharmacokinetics: Mosapride is metabolized in the liver, primarily by CYP3A4. Both mosapride and its metabolites are excreted in urine and feces. Dimethicone is not absorbed systemically and is eliminated unchanged in the feces.
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Mode of Action: Mosapride’s 5-HT4 receptor agonism enhances propulsive motor activity in the gut. Dimethicone works through its anti-foaming action, decreasing the surface tension of gas bubbles.
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Receptor binding, enzyme inhibition, or neurotransmitter modulation: Mosapride binds to and activates 5-HT4 receptors.
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Elimination pathways: Mosapride is eliminated via hepatic metabolism (CYP3A4) and renal/fecal excretion. Dimethicone is eliminated unchanged in the feces.
Dosage
Standard Dosage
Adults:
- One tablet (containing 5 mg mosapride and 125 mg dimethicone) three times daily, taken before or after meals. The total daily dose of mosapride is usually 15 mg.
Children:
- The safety and efficacy in children have not been established, and it is generally not recommended for pediatric use.
Special Cases:
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Elderly Patients: A reduced dose of 2.5 mg of mosapride three times a day is recommended due to potential age-related decline in renal and hepatic function.
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Patients with Renal Impairment: A reduced initial dose of mosapride (e.g., 2.5 mg three times daily) is advised, with adjustments based on response and renal function.
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Patients with Hepatic Dysfunction: Similar to renal impairment, a lower initial dose of mosapride and careful monitoring are recommended.
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Patients with Comorbid Conditions: Dosage adjustments may be necessary based on specific comorbid conditions and potential drug interactions.
Clinical Use Cases
The primary use case is for the management of dyspepsia, GERD, and other conditions with similar gastrointestinal symptoms. Specific dosage adjustments for procedures like intubation, surgical procedures, or ICU use are not routinely recommended.
Dosage Adjustments
- Dose modifications are based on renal/hepatic function and patient response.
- Consult product-specific guidelines for detailed adjustments.
Side Effects
Common Side Effects
- Diarrhea
- Dry mouth
- Stomach pain
- Headache
- Dizziness
- Insomnia
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling, breathing difficulties)
- Abnormal heartbeats
- Severe dizziness
Long-Term Effects
- Limited data on long-term use; generally recommended for short-term symptomatic relief.
Adverse Drug Reactions (ADR)
- QT prolongation (rare but potentially serious)
Contraindications
- Hypersensitivity to mosapride or dimethicone
- Gastrointestinal hemorrhage
- Mechanical bowel obstruction
- Pregnancy and lactation (safety not established)
Drug Interactions
- Mosapride may interact with erythromycin, ketoconazole, quinine, amiodarone, sotalol, haloperidol, terfenadine, and other CYP3A4 inhibitors.
- Avoid alcohol, grapefruit juice, and smoking as they can interact with mosapride.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not established. Use is generally avoided during pregnancy due to limited safety data.
- Breastfeeding: Not established. Avoid use or discontinue breastfeeding if use is deemed necessary.
Drug Profile Summary
- Mechanism of Action: Mosapride: 5-HT4 receptor agonist enhancing GI motility; Dimethicone: Antiflatulent reducing gas bubble surface tension.
- Side Effects: Diarrhea, dry mouth, stomach pain, headache, dizziness, insomnia. Rare: QT prolongation, allergic reactions.
- Contraindications: Hypersensitivity, GI hemorrhage, bowel obstruction, pregnancy, breastfeeding.
- Drug Interactions: Erythromycin, ketoconazole, CYP3A4 inhibitors, alcohol, grapefruit juice.
- Pregnancy & Breastfeeding: Avoid due to limited safety information.
- Dosage: Adults: 5 mg mosapride + 125 mg dimethicone thrice daily. Elderly/Renal/Hepatic impairment: Reduced dose.
- Monitoring Parameters: Monitor for QT prolongation and other adverse effects.
Popular Combinations
- While commonly used as a fixed-dose combination, it’s not typically combined with other medications for synergistic effects.
Precautions
- General Precautions: Screen for allergies, pre-existing conditions (especially heart, liver, kidney conditions).
- Specific Populations: Avoid or use with caution in pregnant/breastfeeding women, children, and the elderly.
- Lifestyle Considerations: Avoid alcohol, smoking.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dimethicone + Mosapride?
A: Adults: One tablet (5mg mosapride/125mg dimethicone) three times daily. Elderly and patients with hepatic or renal impairment may require dose reduction. Pediatric use is not recommended.
Q2: What are the common side effects?
A: Diarrhea, dry mouth, stomach pain, headache, dizziness, and insomnia are common.
Q3: Is it safe during pregnancy or breastfeeding?
A: Safety hasn’t been established; avoid use during pregnancy and breastfeeding.
Q4: What are the contraindications?
A: Hypersensitivity, gastrointestinal bleeding, bowel obstruction.
Q5: How does Mosapride work?
A: It’s a prokinetic agent acting as a 5-HT4 receptor agonist, stimulating GI motility.
Q6: How does Dimethicone work?
A: It’s an antiflatulent that reduces the surface tension of gas bubbles, allowing for their easier passage.
Q7: Are there any serious drug interactions?
A: Mosapride can interact with certain antibiotics (erythromycin), antifungals, and other drugs metabolized by CYP3A4.
Q8: Can it be used in children?
A: No, safety and efficacy in children have not been established.
Q9: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s close to the next dose. Do not double the dose.
Q10: What conditions does this combination treat?
A: It treats symptoms of functional dyspepsia, chronic gastritis, GERD, and other conditions with excessive gas or heartburn.