Clinical medicine profile
Sodium Dehydrocholate/ Methixene/ Dimethylpolysiloxane / Glutamic Acid / Pepsin / Cellulose Pancreatin / Amylase / Lipase /protein
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
This profile needs source confirmation
Some sections contain general class guidance rather than medicine-specific evidence. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- As with all anti-cholinergics it is contra-indicated in narrow angle glaucoma, prostate hypertrophy with micturational disorders, intestinal atony, and myasthenia gravis.
- Other S/Es are biliary tract occlusion, acute hepatitis and other hepatic disorders, hepatic coma, gall bladder empyema.
Precautions
- [From component Glutamic Acid] WARNINGS Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur.
- FREQUENT EVALUATION AND LABORATORY DETERMINATIONS ARE NECESSARY FOR PROPER MONITORING OF PARENTERAL NUTRITION.
- Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolalities, blood cultures, and blood ammonia levels.
- Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen.
- Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.
- Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema.
- The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions.
- Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
- Hyperammonemia is of special significance in infants , as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation.
- This reaction appears to be dose-related and is more likely to develop during prolonged therapy.
- It is essential that blood ammonia be measured frequently in infants.
- Conservative doses of amino acids should be given, dictated by the nutritional status of the patient.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Adult and children over 12 years 1-2 tablet before each meal.
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- Irritable colon accompanied by complaints such as distension, sensation of bloating and diffuses of colic-like abdominal pain.
- Meteorism associated with enzyme deficiencies, aerophagia, and dyspepsia due to fermentation or putrefaction.
- Dyspepsia following biliary disorders and digestive disorders of nervous origin
Adverse effects
- Anti-cholinergic S/Es such as dry mouth, urine retention, tachycardia, palpitations, mydriasis, disturbed visual accommodation among others.
- It may cause allergic reactions.
Drug interactions
Open multi-drug checker ↗- Methixine is a tertiary anti-cholinergic, anti-spasmodic.
- Enzyme supplements help in relief of functional indigestion when due to enzyme deficiency or imbalance.
- Dimethylpolysiloxane is an anti-flatulent.
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Glutamic Acid.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Mechanism is agent-specific.
Read complete mechanism
Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
See product SmPC
are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Pregnancy, lactation & diet
[From component Glutamic Acid] Pregnancy Category C Animal reproduction studies have not been conducted with Aminosyn-PF 7%. It is also not known whether Aminosyn-PF 7% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-PF 7% should be given to a pregnant woman only if clearly needed.
[Dehydrocholate] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data. [Dimethylpolysiloxane] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data. [Glutamic Acid] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.