Usage
Sodium Tauroglycocholate, often used in combination with pancreatin, is prescribed for conditions related to indigestion or dyspepsia. These may include flatulence, bloating, a feeling of fullness after eating, heartburn, anorexia, and post-operative digestive upset. It is also indicated in cases of pancreatic and hepatic insufficiency and during convalescence (recovery after illness). It is classified as a digestive enzyme supplement because of its role in facilitating the breakdown and absorption of food. Sodium Tauroglycocholate itself acts as a bile salt, while other components of combination products, like pancreatin, provide the enzymes for food breakdown.
Alternate Names
Sodium tauroglycocholate is sometimes referred to as tauroglycocholic acid sodium salt. Brand names for combination products containing sodium tauroglycocholate include Enzar Forte and Dizec.
How It Works
Pharmacodynamics: Sodium Tauroglycocholate, a bile salt, emulsifies fats, breaking them down into smaller droplets and increasing their surface area. This facilitates the action of pancreatic lipase, an enzyme that digests fats. Enhanced fat digestion leads to better absorption of fats and fat-soluble vitamins. When combined with Pancreatin, which contains amylase, lipase and protease, it contributes to the complete digestion of carbohydrates, fats and proteins respectively.
Pharmacokinetics: Absorption of sodium tauroglycocholate occurs in the intestines. While precise details on its metabolism and elimination pathways are limited in available resources, bile salts, in general, are primarily metabolized in the liver and excreted through the biliary system into the intestines. Some may be reabsorbed through enterohepatic circulation, while the remainder is eliminated in the feces.
Mode of action: Sodium Tauroglycocholate acts as a surfactant, lowering the surface tension of fats, allowing them to be emulsified. This increases the accessibility of fats to pancreatic lipase, leading to their breakdown and absorption. It does not directly inhibit enzymes or modulate neurotransmitters. Elimination occurs primarily through the biliary system and feces, with some enterohepatic recirculation.
Dosage
Standard Dosage
Adults: One tablet with each meal. The tablet should be sucked (not chewed) briefly and then swallowed whole with water. Chewing may cause irritation to the oral mucosa. For pancreatic insufficiency, the dosage can be increased to two tablets, 2-3 times daily. However, it’s crucial to individualize the dosage based on the patient’s pancreatic function and clinical response.
Children: Dosage should be determined by a pediatrician, considering the child’s age, weight, and specific condition.
Special Cases:
- Elderly Patients: Start with a lower dose and adjust based on tolerance and effectiveness.
- Patients with Renal Impairment: Monitor closely and adjust dosage as needed based on renal function.
- Patients with Hepatic Dysfunction: Use with caution and adjust dosage according to liver function tests.
- Patients with Comorbid Conditions: Consider the overall health status and potential drug interactions when determining the dosage.
Clinical Use Cases
The combination of pancreatin and sodium tauroglycocholate is generally not indicated for specific clinical use cases such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is in managing digestive issues.
Dosage Adjustments
Dosage adjustments may be needed based on individual patient factors like renal or hepatic dysfunction, and the severity of digestive problems. Close monitoring is essential, especially in patients with pre-existing medical conditions.
Side Effects
Common Side Effects
The most common side effects are gastrointestinal and include nausea, vomiting, diarrhea, constipation, stomach pain, and bloating. Skin rashes, burning sensations around the mouth and anus, and acute toxicity have also been reported.
Rare but Serious Side Effects
Allergic reactions can occur but are less frequent. Severe abdominal discomfort, frequent/painful urination, and joint pain should be reported immediately. Intestinal strictures and blockage, requiring surgical decompression, have been reported in patients with cystic fibrosis, especially those with a history of intestinal complications or taking high doses of pancreatic enzymes.
Long-Term Effects
Long-term effects are not well documented in the provided sources.
Adverse Drug Reactions (ADR)
Clinically significant ADRs requiring immediate intervention would include severe allergic reactions, intestinal blockage, and hyperuricemia/hyperuricosuria.
Contraindications
Contraindications include hypersensitivity to any components of the drug, pork protein allergy (as pancreatin is typically derived from pork), acute pancreatitis, acute exacerbations of chronic pancreatitis, and known hypersensitivity to bile salts.
Drug Interactions
Sodium Tauroglycocholate can interact with antacids containing calcium carbonate or magnesium hydroxide, and with iron supplements. It can also interact with acarbose and miglitol. Information regarding interactions with other medications, OTC drugs, supplements, and food is limited in the provided sources. Alcohol interaction information is not available.
Pregnancy and Breastfeeding
Consult a doctor before use during pregnancy and breastfeeding. Limited information is available on the safety during these periods. A doctor should weigh the benefits and risks before prescribing.
Drug Profile Summary
- Mechanism of Action: Facilitates fat emulsification and absorption and aids in protein, carbohydrate, and fat digestion.
- Side Effects: Nausea, vomiting, diarrhea, constipation, abdominal pain, skin rash, burning sensations.
- Contraindications: Hypersensitivity to components, pork protein, acute pancreatitis, bile salt allergy.
- Drug Interactions: Antacids, iron, acarbose, miglitol.
- Pregnancy & Breastfeeding: Consult a physician. Safety information is limited.
- Dosage: One tablet with each meal. Adjust for pancreatic insufficiency and other medical conditions.
- Monitoring Parameters: Monitor for gastrointestinal issues, allergic reactions, and renal/hepatic function in relevant patients.
Popular Combinations
A common combination is with pancreatin. Another combination includes pancreatin, simethicone, and sodium tauroglycocholate.
Precautions
General precautions involve screening for allergies, metabolic disorders, and organ dysfunction. Specific populations like pregnant/breastfeeding women, children, and elderly should be monitored carefully. Lifestyle considerations, especially diet, may play a role in managing side effects like constipation.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Sodium Tauroglycocholate?
A: The typical dosage is one tablet with each meal for adults. This can be increased to two tablets 2-3 times daily for pancreatic insufficiency. Dosages should be adjusted in children, the elderly, and those with renal or hepatic impairment.
Q2: How should Sodium Tauroglycocholate be taken?
A: The tablet should be sucked (not chewed) for a few seconds and then swallowed whole with water.
Q3: What are the common side effects?
A: Common side effects include gastrointestinal issues like nausea, vomiting, diarrhea, and constipation.
Q4: Who should not take Sodium Tauroglycocholate?
A: Individuals with hypersensitivity to the drug or its components, pork protein allergy, acute pancreatitis, or bile salt allergy should not take this medication.
Q5: What are the signs of an allergic reaction?
A: Signs of an allergic reaction might include skin rash, itching, hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Seek medical attention immediately if any of these occur.
Q6: Can I take this medication during pregnancy or while breastfeeding?
A: Consult your physician before taking sodium tauroglycocholate during pregnancy or breastfeeding as safety data is limited.
Q7: Does this medication interact with any other drugs?
A: Known drug interactions include antacids with calcium carbonate or magnesium hydroxide, iron supplements, acarbose, and miglitol. Inform your doctor about all other medications you are taking.
Q8: What if I miss a dose?
A: If you miss a dose, take it as soon as you remember. If it is near the time of your next dose, skip the missed dose and resume your regular schedule. Do not double the dose.
Q9: What should I do if I experience severe side effects?
A: Discontinue use and consult a doctor immediately if you experience severe side effects such as severe abdominal pain, frequent/painful urination, joint pain, or signs of an allergic reaction.
