1. Disclaimer
The information provided in this report is intended for educational and professional reference purposes only and does not replace professional medical advice, diagnosis, or treatment.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
2. Summary
Spasmo-Amrase® is a multi-component gastrointestinal combination product formulated as enteric-coated tablets. It integrates digestive enzymes (pancreatin, papain), a bile extract, an antiflatulent agent (dimethicone), and a musculotropic antispasmodic (mebeverine).
The formulation is designed to address multifactorial digestive disorders, including impaired digestion, gas retention, abdominal bloating, and gastrointestinal smooth-muscle spasm, particularly in conditions associated with pancreatic or biliary insufficiency.
3. Brand Name
Spasmo-Amrase®
4. Category
- Digestive enzyme combination (Digestant)
- Antiflatulent
- Antispasmodic
- Choleretic (via bile salts)
5. Active Ingredients
- Pancreatin
- Papain
- Ox-bile extract
- Dimethicone
- Mebeverine hydrochloride
6. Pharmaceutical Form & Strength
Form: Enteric-coated tablets
Typical composition per tablet (as consistently reported across sources):
- Pancreatin: 300 mg
- Papain: 50 mg
- Ox-bile extract: 30 mg
- Dimethicone: 30 mg
- Mebeverine HCl: 50 mg
Note: Exact strengths and presentations may vary by market and should be confirmed from the most recent official product leaflet.
7. Manufacturer & Marketing Authorization Holder
Amriya Pharmaceutical Industries, Alexandria, Egypt.
Current marketing authorization status should be verified with local regulatory authorities.
8. Mechanism of Action
- Pancreatin: A porcine-derived enzyme complex (amylase, lipase, protease) that catalyzes digestion of carbohydrates, fats, and proteins in the small intestine.
- Papain: A plant-derived proteolytic enzyme (from Carica papaya) that enhances protein hydrolysis and complements pancreatic proteases.
- Ox-bile extract: Supplies bile salts that emulsify dietary fats, facilitating lipase action and absorption of fats and fat-soluble vitamins (A, D, E, K).
- Dimethicone: A pharmacologically inert antifoaming agent that reduces surface tension of gas bubbles, enabling their coalescence and expulsion.
- Mebeverine HCl: A direct-acting smooth-muscle antispasmodic that relieves gastrointestinal spasm without clinically relevant anticholinergic effects.
Enteric coating protects acid-labile enzymes from gastric degradation and ensures intestinal release.
9. Spectrum of Activity
Not applicable in the antimicrobial sense.
Functionally, the product provides:
- Broad digestive enzyme activity (carbohydrates, proteins, fats)
- Antiflatulent action
- Smooth-muscle relaxation throughout the gastrointestinal tract
10. Pharmacokinetics
- Pancreatin, papain, dimethicone, and bile salts: Act locally in the gastrointestinal lumen with negligible systemic absorption.
- Mebeverine: Orally absorbed, undergoes extensive first-pass metabolism; metabolites (e.g., veratric acid derivatives) are primarily excreted in urine.
- Enteric coating: Delays drug release until intestinal pH is reached.
11. Indications
- Functional dyspepsia and indigestion
- Abdominal bloating and flatulence
- Post-operative gaseous distension
- Abdominal colic associated with gastrointestinal spasm
- Malabsorption syndromes, including:
- Pancreatic insufficiency (e.g., chronic pancreatitis, post-pancreatectomy)
- Biliary insufficiency
- Short bowel syndrome
- Post-prandial fullness associated with impaired digestion
12. Administration
- Route: Oral
- General dosing (as commonly reported):
1–2 tablets, up to three times daily, preferably immediately before or during meals, or as directed by a physician.
13. Method of Preparation
Not applicable.
This is a ready-to-use oral solid dosage form. Tablets must be swallowed whole.
14. Contraindications
- Known hypersensitivity to any component or excipients
- Acute pancreatitis or acute exacerbation of chronic pancreatitis
- Paralytic ileus or intestinal obstruction
- Known allergy to porcine or bovine-derived products
15. Warnings & Precautions
- Do not crush or chew tablets (enteric coating integrity is essential).
- Use caution in patients with allergies to animal proteins or papaya.
- Long-term or high-dose pancreatic enzyme use should be medically supervised.
- Rare cases of fibrosing colonopathy have been reported with very high doses of pancreatic enzymes (primarily in cystic fibrosis).
- Patients with significant hepatic or biliary disease should consult a physician before use.
16. Drug Interactions
No well-documented clinically significant interactions are established; however:
- Antacids or acid-suppressive agents may theoretically affect enteric-coating performance.
- Pancreatic enzymes may reduce the efficacy of α-glucosidase inhibitors (e.g., acarbose).
- Enzymes and bile salts may interfere with iron or folic acid absorption in susceptible patients.
17. Side Effects
Generally well tolerated.
Occasionally reported:
- Gastrointestinal discomfort (nausea, abdominal pain, diarrhea or constipation)
- Hypersensitivity reactions (rash, urticaria, pruritus)
Rare adverse effects are typically related to individual components or high-dose, prolonged use.
18. Use in Special Populations
- Pregnancy: Limited controlled data; use only if clearly needed and prescribed.
- Lactation: Systemic exposure is expected to be minimal; caution advised.
- Pediatrics: Safety and dosing should be determined by a healthcare professional.
- Elderly: No specific dose adjustment generally required; comorbidities should be considered.
19. Storage Conditions
- Store below 25–30 °C (or as stated on the official pack)
- Protect from moisture and heat
- Keep out of reach of children
20. Additional Sections
No additional scientifically significant sections identified beyond those already included.
21. Frequently Asked Questions (FAQ)
Q1: Why is Spasmo-Amrase enteric-coated?
A: To protect digestive enzymes from gastric acid and ensure intestinal release.
Q2: Can the tablet be crushed or chewed?
A: No. This destroys the enteric coating and reduces efficacy.
Q3: Is it mainly an enzyme supplement or an antispasmodic?
A: It is a combination product addressing digestion, gas, and intestinal spasm simultaneously.
Q4: Is it suitable for vegetarians?
A: No. It contains porcine-derived pancreatin and bovine-derived bile extract.
22. References
- Manufacturer’s product leaflet and prescribing information (Amriya Pharmaceutical Industries)
- Martindale: The Complete Drug Reference
- British National Formulary (BNF): Pancreatin and Mebeverine monographs
- Standard gastroenterology and clinical pharmacology textbooks
