Usage
Cinitapride + Pantoprazole is prescribed for the management of gastroesophageal reflux disease (GERD), including erosive esophagitis, and other conditions associated with excessive stomach acid production, such as dyspepsia, peptic ulcers (duodenal and gastric), and Zollinger-Ellison syndrome. It is also utilized in combination with antibiotics for Helicobacter pylori infections.
Pharmacological Classification:
This combination drug falls into two categories:
- Pantoprazole: Proton Pump Inhibitor (PPI)
- Cinitapride: Prokinetic Agent
Alternate Names
While the generic name is Cinitapride + Pantoprazole, it is marketed under various brand names, including Pantostrum CT, Cintodac, and Eiref C.
How It Works
Pharmacodynamics:
- Pantoprazole: Suppresses gastric acid secretion by irreversibly inhibiting H+/K+ ATPase (proton pump) in gastric parietal cells. This reduces basal and stimulated acid secretion, regardless of the stimulus.
- Cinitapride: Promotes gastrointestinal motility by stimulating 5-HT4 receptors and blocking dopamine D2 receptors. This increases the pressure of the lower esophageal sphincter (LES), accelerates gastric emptying, and improves antroduodenal coordination.
Pharmacokinetics:
- Pantoprazole: Absorbed rapidly after oral administration. Metabolized extensively in the liver (primarily by CYP2C19), with renal elimination of metabolites.
- Cinitapride: Also absorbed well orally. Metabolized in the liver with primarily renal excretion.
Mode of Action:
- Pantoprazole: Binds to the proton pump, inhibiting the final step of acid production in parietal cells.
- Cinitapride: Enhances acetylcholine release in the myenteric plexus, stimulating gut motility, and influences serotonin and dopamine receptor activity.
Dosage
Standard Dosage
Adults:
One capsule containing 3mg Cinitapride and 40mg Pantoprazole, taken orally once daily, approximately 30-60 minutes before a meal (usually breakfast). The duration of treatment is condition-dependent and determined by the physician.
Children:
Not recommended for children as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Caution advised; dosage adjustments may be necessary based on renal/hepatic function.
- Patients with Renal Impairment: Dose modification required; close monitoring needed.
- Patients with Hepatic Dysfunction: Caution required; dosage adjustments may be needed.
- Patients with Comorbid Conditions: Consider individual patient factors, such as diabetes, cardiovascular disease, when adjusting dosage.
Clinical Use Cases
Dosages for these specific clinical settings require careful consideration of patient factors and should be under the guidance of a specialist:
- Intubation: Not typically indicated.
- Surgical Procedures: May be used pre-operatively for specific indications, but not routinely.
- Mechanical Ventilation: Not indicated.
- Intensive Care Unit (ICU) Use: Use with caution; individualized dosing.
- Emergency Situations: Not typically indicated.
Dosage Adjustments
Dose adjustments are based on individual factors, such as renal function, hepatic impairment, comedications, and patient response to therapy. Therapeutic drug monitoring might be beneficial in select cases.
Side Effects
Common Side Effects:
Headache, diarrhea, nausea, abdominal pain, flatulence, constipation, dizziness, rash.
Rare but Serious Side Effects:
Allergic reactions (angioedema, anaphylaxis), severe abdominal pain, bloody or black stools, jaundice, liver dysfunction, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Long-Term Effects:
Osteoporosis, hypomagnesemia, vitamin B12 deficiency (with prolonged use).
Adverse Drug Reactions (ADR):
Tardive dyskinesia (with Cinitapride), QT prolongation.
Contraindications
- Hypersensitivity to Cinitapride, Pantoprazole, or substituted benzimidazoles.
- Gastrointestinal bleeding, mechanical obstruction, or perforation.
- Tardive dyskinesia related to neuroleptic use.
- Concomitant use of certain medications (e.g., rilpivirine, atazanavir).
- Severe liver disease.
Drug Interactions
Cinitapride + Pantoprazole can interact with several medications:
- CYP450 Interactions: Pantoprazole is primarily metabolized by CYP2C19. Concomitant use with CYP2C19 inhibitors (e.g., fluconazole, voriconazole) may increase Pantoprazole levels.
- Other Drug Interactions: NSAIDS (aspirin, naproxen), duloxetine, levothyroxine, atorvastatin, clopidogrel, cyanocobalamin, phenothiazines, digoxin, anticholinergics, opioid analgesics, and certain antiviral medications (e.g., rilpivirine, atazanavir).
Pregnancy and Breastfeeding
- Pregnancy: Not recommended unless the benefits outweigh the risks. Data regarding safety in pregnancy are limited.
- Breastfeeding: Exercise caution. Pantoprazole is excreted in breast milk, although at low levels with a 40mg dose. Consider the benefits to the mother versus potential risk to the infant.
Drug Profile Summary
- Mechanism of Action: Pantoprazole inhibits gastric acid secretion, Cinitapride promotes gut motility.
- Side Effects: Headache, diarrhea, nausea, abdominal pain, flatulence, constipation, rash, dizziness. Serious side effects include allergic reactions, liver dysfunction, and GI bleeding.
- Contraindications: Hypersensitivity, GI bleeding/obstruction/perforation, tardive dyskinesia, severe liver disease.
- Drug Interactions: NSAIDS, certain antidepressants, thyroid medications, statins, anticoagulants, digoxin, anticholinergics, and others.
- Pregnancy & Breastfeeding: Use with caution. Not recommended unless benefits outweigh risks.
- Dosage: Adults: 1 capsule (40mg Pantoprazole/3mg Cinitapride) before a meal. Dose adjustments needed for renal/hepatic dysfunction.
- Monitoring Parameters: Liver function tests, kidney function tests, magnesium levels (with long-term use), signs of GI bleeding.
Popular Combinations
This combination itself is a popular combination aimed at both reducing acid and improving motility in GERD. Adding specific antibiotics for H. pylori eradication is another common strategy.
Precautions
- Pre-existing medical conditions (liver/kidney disease, osteoporosis) require close monitoring and possible dosage adjustments.
- Pregnant/Breastfeeding: Discuss risks and benefits with a healthcare professional.
- Children/Elderly: Use with caution; pediatric use not recommended.
- Alcohol, Smoking: Avoid or minimize to reduce exacerbation of GERD symptoms.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cinitapride + Pantoprazole?
A: One capsule (40mg Pantoprazole, 3mg Cinitapride) once daily, taken 30-60 minutes before a meal. Dose adjustments may be necessary for patients with liver or kidney disease.
Q2: How does Cinitapride + Pantoprazole work?
A: Pantoprazole inhibits acid production in the stomach, while Cinitapride improves the movement of food through the digestive system. This combined action reduces symptoms of GERD.
Q3: What are the common side effects?
A: Common side effects include headache, diarrhea, nausea, abdominal pain, and flatulence.
Q4: Is this combination safe during pregnancy?
A: Limited safety data exist for pregnancy; only use if benefits clearly outweigh risks. Discuss with your obstetrician.
Q5: Can I take this medicine with antacids?
A: Generally, yes, but discuss the timing of antacids with your doctor for optimal effectiveness of both medications.
Q6: How long does it take to see improvement in symptoms?
A: Patients usually experience some relief within a few days, but full effect may take up to 4 weeks.
Q7: Are there any serious drug interactions I should be aware of?
A: Yes, interactions with warfarin, certain antifungals, some antiviral medications, and other drugs are possible. Provide a full medication list to your physician.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose.
Q9: What if I experience severe side effects?
A: Stop taking the medicine and consult with a doctor immediately.
Q10: Can I stop taking the medicine once my symptoms improve?
A: No, do not discontinue the medicine without consulting your physician. Premature discontinuation can lead to recurrence of symptoms.
