Cicol-D
Generic Name
Rabeprazole Sodium + Domperidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Cicol-D is a combination medication containing Rabeprazole, a proton pump inhibitor, and Domperidone, a prokinetic agent. It is used to treat conditions involving excess stomach acid production and impaired gastric motility, such as gastroesophageal reflux disease (GERD), dyspepsia, and peptic ulcers.
Uses & Indications
Dosage
Adults
One capsule once daily, preferably before breakfast. Dosage duration depends on the clinical condition and response.
Elderly
No specific dose adjustment is usually required, but caution is advised in patients with severe hepatic impairment.
Renal_impairment
No dose adjustment is required for mild to moderate renal impairment. For severe impairment, caution is advised.
How to Take
Cicol-D capsules should be taken orally, swallowed whole with water, preferably in the morning before breakfast. Do not chew or crush the capsule.
Mechanism of Action
Rabeprazole selectively inhibits the H+/K+-ATPase enzyme system (proton pump) at the secretory surface of the gastric parietal cells, thereby blocking the final step of acid production. Domperidone is a dopamine D2 receptor antagonist that acts both peripherally on the chemoreceptor trigger zone (CTZ) to produce antiemetic effects and centrally on the gastrointestinal tract to improve motility, increasing esophageal peristalsis and gastric emptying.
Pharmacokinetics
Onset
Rabeprazole's acid-suppressing effect begins within 1 hour, with full effect within 2-3 days. Domperidone's prokinetic effect begins within 30-60 minutes.
Excretion
Rabeprazole and its metabolites are primarily excreted in the urine (approximately 90%), with a small amount in feces. Domperidone is excreted approximately 60% via feces and 30% via urine.
Half life
Rabeprazole has a plasma half-life of 1-2 hours. Domperidone has a plasma half-life of 7-9 hours.
Absorption
Rabeprazole is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 2-5 hours. Domperidone is also rapidly absorbed, reaching peak plasma levels within 1 hour.
Metabolism
Rabeprazole is extensively metabolized in the liver, primarily by CYP2C19 and CYP3A4. Domperidone is also extensively metabolized in the liver by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Rabeprazole, Domperidone, or any excipients.
- Patients with known gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Patients with prolactin-releasing pituitary tumor (prolactinoma).
- Patients with moderate to severe hepatic impairment (for Domperidone).
- Concurrent use with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) or drugs that prolong QT interval.
Drug Interactions
Warfarin
Increased INR/prothrombin time with Rabeprazole.
Methotrexate
Increased Methotrexate levels with PPIs.
Itraconazole, Ketoconazole, Atazanavir
Reduced absorption due to reduced gastric acidity.
Drugs prolonging QT interval (e.g., Amiodarone, Haloperidol)
Increased risk of cardiac arrhythmias with Domperidone.
Potent CYP3A4 inhibitors (e.g., Erythromycin, Clarithromycin, Ketoconazole)
Increased Domperidone plasma levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, and extrapyramidal reactions (for Domperidone). There is no specific antidote. Treatment should be symptomatic and supportive, including gastric lavage and activated charcoal.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Domperidone is excreted in human milk; therefore, its use during lactation should be avoided or breast-feeding discontinued.
Side Effects
Contraindications
- Hypersensitivity to Rabeprazole, Domperidone, or any excipients.
- Patients with known gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Patients with prolactin-releasing pituitary tumor (prolactinoma).
- Patients with moderate to severe hepatic impairment (for Domperidone).
- Concurrent use with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) or drugs that prolong QT interval.
Drug Interactions
Warfarin
Increased INR/prothrombin time with Rabeprazole.
Methotrexate
Increased Methotrexate levels with PPIs.
Itraconazole, Ketoconazole, Atazanavir
Reduced absorption due to reduced gastric acidity.
Drugs prolonging QT interval (e.g., Amiodarone, Haloperidol)
Increased risk of cardiac arrhythmias with Domperidone.
Potent CYP3A4 inhibitors (e.g., Erythromycin, Clarithromycin, Ketoconazole)
Increased Domperidone plasma levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, and extrapyramidal reactions (for Domperidone). There is no specific antidote. Treatment should be symptomatic and supportive, including gastric lavage and activated charcoal.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Domperidone is excreted in human milk; therefore, its use during lactation should be avoided or breast-feeding discontinued.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Available in pharmacies, hospitals, and clinics
Approval Status
DGDA approved
Patent Status
Off-patent
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of Rabeprazole-Domperidone combination in improving symptoms of GERD and dyspepsia compared to monotherapy. Studies confirm its role in rapid acid suppression and improved gastric emptying.
Lab Monitoring
- No routine lab monitoring is generally required.
- Consider monitoring magnesium levels in patients on long-term PPI therapy, especially with diuretics.
- Vitamin B12 levels may be monitored in patients on prolonged PPI therapy.
Doctor Notes
- Prescribe for the shortest effective duration to minimize risks, especially for Domperidone due to cardiac concerns.
- Review the need for continued PPI therapy periodically.
- Counsel patients on lifestyle modifications to manage symptoms effectively.
- Assess patient's cardiovascular risk factors before prescribing Domperidone.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Swallow the capsule whole; do not chew, crush, or break it.
- Take it preferably before breakfast for best results.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Report any unusual or severe side effects to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Cicol-D may cause dizziness or drowsiness in some individuals. If you experience these effects, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid trigger foods such as fatty foods, spicy foods, caffeine, and acidic beverages.
- Avoid lying down immediately after meals; wait at least 2-3 hours.
- Elevate the head of your bed to reduce nighttime reflux symptoms.
- Maintain a healthy weight.
- Quit smoking and reduce alcohol consumption.
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