Usage
- Ornithine + Pancreatin is prescribed for hepatic encephalopathy, indigestion, and pancreatitis (inflammation of the pancreas). It is also used to treat conditions like fatty liver, cystic fibrosis, hepatitis B, and hyperammonemia due to acute and chronic hepatitis.
- Pharmacological Classification: This combination drug falls into two categories:
- Ornithine L-aspartate: Hepatoprotective agent
- Pancreatin: Digestive enzyme
- Mechanism of Action: Ornithine L-aspartate aids in ammonia detoxification in the liver, while pancreatin provides digestive enzymes to improve the digestion of fats, proteins, and carbohydrates.
Alternate Names
- L-Ornithine L-Aspartate + Pancreatin
- Normohep (brand name example)
- Hepres (brand name example)
How It Works
- Pharmacodynamics: Ornithine L-aspartate stimulates the urea cycle, converting ammonia to urea, which is then excreted by the kidneys. This reduces the elevated blood ammonia levels seen in hepatic encephalopathy. Pancreatin contains lipase, protease, and amylase, enzymes crucial for breaking down dietary fats, proteins, and carbohydrates, respectively, promoting efficient digestion.
- Pharmacokinetics:
- Ornithine L-aspartate: Rapidly absorbed from the gastrointestinal tract and metabolized in the liver. Eliminated primarily through renal excretion.
- Pancreatin: Not absorbed systemically; acts locally in the gastrointestinal tract. Degraded in the distal small intestine and colon.
- Mode of Action: Ornithine L-aspartate enhances the activity of two key enzymes in the urea cycle: carbamoyl phosphate synthetase and ornithine transcarbamylase. Pancreatin’s enzymes hydrolyze fats, proteins, and starches for absorption.
- Elimination Pathways: Ornithine L-aspartate is primarily eliminated via renal excretion, while pancreatin is degraded in the GI tract and its components are subsequently metabolized.
Dosage
Standard Dosage
Adults:
- 1-2 tablets, three times daily, taken orally after meals. Each tablet typically contains 150mg of L-Ornithine L-Aspartate and 100mg of Pancreatin.
Children:
- Not generally recommended for children under 18, as safety and efficacy have not been established. However, some sources indicate usage with caution and under strict medical supervision. Pediatric dosing should be determined by a physician based on age and weight.
Special Cases:
- Elderly Patients: Start with a lower dose and titrate upwards as needed, considering renal and hepatic function.
- Patients with Renal Impairment: Use with caution; dosage adjustments may be required.
- Patients with Hepatic Dysfunction: Close monitoring is essential, with dosage adjustments individualized.
- Patients with Comorbid Conditions: For patients with diabetes, monitor blood glucose levels closely as pancreatin may affect glucose control.
Clinical Use Cases
Specific dosage recommendations for clinical scenarios like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations are not typically provided for this medication. Dosage in such settings should be determined by the treating physician based on the patient’s condition.
Dosage Adjustments
Dosage modifications may be necessary based on factors such as renal/hepatic function, metabolic disorders, drug interactions, and individual patient response. Consult with the treating physician for adjustments.
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Bloating
- Flatulence
Rare but Serious Side Effects
While rare, some patients, especially those with cystic fibrosis on high doses, may develop fibrosing colonopathy. Allergic reactions are also possible, ranging from mild skin reactions to severe anaphylaxis.
Long-Term Effects
Long-term use, especially at high doses, can increase the risk of hyperuricemia and gout. Chronic high doses in children with cystic fibrosis have been associated with fibrosing colonopathy and colonic strictures.
Contraindications
- Hypersensitivity to any component of the medication, including pork protein (as pancreatin is often derived from porcine sources).
- Acute pancreatitis
- Gastrectomy
- Pancreatectomy
- Pregnancy (unless specifically directed by a physician).
Drug Interactions
- Antacids and acid-suppressing drugs (e.g., omeprazole, ranitidine) can reduce the effectiveness of pancreatin.
- Anticoagulants (e.g., warfarin, heparin): May have altered effects due to pancreatin.
- Diabetes medications (e.g., insulin, gliclazide): Pancreatin might affect blood glucose control.
- Medications metabolized by the liver (e.g., paracetamol): Potential for altered drug levels due to L-ornithine L-aspartate’s effects on liver function.
- Herbal products, over-the-counter medicines, and some prescription drugs (e.g., acarbose, miglitol): Potential for reduced efficacy or increased side effects.
- Alcohol should be avoided, as it can exacerbate liver damage.
Pregnancy and Breastfeeding
The safety of Ornithine + Pancreatin during pregnancy and breastfeeding is not well-established. Consult a physician before using this medication during pregnancy or while breastfeeding.
Drug Profile Summary
- Mechanism of Action: Ornithine L-aspartate facilitates ammonia detoxification, and pancreatin provides digestive enzymes.
- Side Effects: Nausea, vomiting, diarrhea, constipation, abdominal pain, bloating. Rarely, fibrosing colonopathy or allergic reactions.
- Contraindications: Hypersensitivity, acute pancreatitis, gastrectomy, pancreatectomy.
- Drug Interactions: Antacids, anticoagulants, diabetes medications, medications metabolized by the liver, alcohol.
- Pregnancy & Breastfeeding: Use with caution and only under medical supervision.
- Dosage: Adults: 1-2 tablets three times daily after meals. Dosage adjustments needed for special populations.
- Monitoring Parameters: Liver function tests, ammonia levels, blood glucose (in diabetics), renal function, stool characteristics.
Popular Combinations
This medication is not typically used in combination with other drugs for its primary indications.
Precautions
- Evaluate renal and hepatic function prior to initiating therapy.
- Screen for pork protein allergy.
- Monitor patients with diabetes for changes in blood glucose levels.
- Advise patients to maintain adequate hydration, especially when taking pancreatin.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ornithine + Pancreatin?
A: The standard adult dose is 1-2 tablets three times daily after meals. Pediatric dosage, if used, must be carefully determined by a physician. Dosage adjustments are required for patients with renal/hepatic impairment and other relevant conditions.
Q2: Can Ornithine + Pancreatin be used during pregnancy?
A: The safety during pregnancy is not well-established. Use only under strict medical supervision and if the potential benefits outweigh the risks.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, bloating, and flatulence.
Q4: How does Ornithine + Pancreatin interact with alcohol?
A: Alcohol should be avoided as it can worsen liver damage, especially in patients with hepatic encephalopathy.
Q5: Can this medication be crushed or chewed?
A: It’s generally recommended to swallow the tablets whole with water. Crushing or chewing can affect drug release and efficacy.
Q6: How should Ornithine + Pancreatin be stored?
A: Store in a cool, dry place away from direct sunlight and moisture.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it’s close to your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Q8: What are the signs of an overdose?
A: Overdose may present with gastrointestinal symptoms like severe diarrhea, nausea, vomiting, abdominal pain, and bloating. Seek immediate medical attention if overdose is suspected.
Q9: Can this medication be used in patients with kidney disease?
A: It should be used with caution in patients with renal impairment, and dosage adjustments may be necessary. Close monitoring of kidney function is advised.
