Usage
This combination medication is primarily used to treat gastrointestinal discomfort. It is classified as a gastrointestinal agent with anticholinergic, antacid, antiseptic, and carminative properties.
It’s prescribed for:
- Hyperacidity
- Indigestion
- Gastric ulcers
- Diarrhea
- Flatulence
- Nausea
- Upset stomach
- Belching
- Dysentery
Alternate Names
- Stomach Fit
- Stomafit
- Gastoma
How It Works
Pharmacodynamics:
- Belladonna dry extract: Exerts anticholinergic effects, reducing stomach acid secretion and gut motility. This helps control hyperacidity, spasms, and pain.
- Bismuth Ammonium Citrate: Acts as an antacid, neutralizing stomach acid and forming a protective layer over the stomach lining. It also exhibits some antibacterial properties against H. pylori.
- Menthol: Provides a soothing effect on the stomach lining and relaxes intestinal muscles, easing discomfort and aiding digestion. It also has mild analgesic and carminative properties.
- Thymol: Acts as a carminative, aiding in relieving gas and promoting digestion. It also possesses antiseptic and antibacterial properties.
Pharmacokinetics:
The pharmacokinetics of this combination product are not well-defined as a whole. Information about individual components is as follows:
- Belladonna dry extract: Atropine, the primary active component, is well-absorbed from the gastrointestinal tract. It is metabolized in the liver and excreted primarily in the urine.
- Bismuth Ammonium Citrate: Poorly absorbed from the GI tract. Most is excreted in the feces, causing darkening of the stool. A small amount is absorbed and excreted renally.
- Menthol and Thymol: Absorption, metabolism, and excretion details for these components in this specific formulation are not readily available. Generally, these compounds are readily absorbed and metabolized in the liver.
Mechanism of Action:
- Belladonna dry extract (Atropine): Competitively antagonizes muscarinic acetylcholine receptors, inhibiting parasympathetic activity. This leads to decreased gastric acid secretion, reduced gut motility, and decreased spasms.
- Bismuth Ammonium Citrate: Neutralizes gastric acid through chemical reaction. It also may inhibit the activity of H. pylori.
- Menthol: Stimulates cold-sensitive TRPM8 receptors, producing a cooling sensation and relaxing smooth muscles in the GI tract.
- Thymol: Its carminative action is thought to be related to its ability to stimulate gastrointestinal motility and reduce gas formation.
Dosage
Standard Dosage
Adults:
5-10 ml (1-2 teaspoons) taken orally three times daily after meals with half a cup of water.
Children:
Use in children under 12 is generally not recommended. Some sources suggest use in children older than 6, but clear dosing guidelines are lacking. Pediatric use should be under strict physician supervision.
Special Cases:
- Elderly Patients: Dosage adjustments may be necessary. Consult a physician.
- Patients with Renal Impairment: Use with caution. Dosage adjustments may be required. Consult a physician.
- Patients with Hepatic Dysfunction: Use with caution. Dosage adjustments may be required. Consult a physician.
- Patients with Comorbid Conditions: Consult a physician for personalized recommendations, especially for patients with glaucoma, heart disease, myasthenia gravis, bleeding problems, or gout.
Clinical Use Cases
Dosage for specific clinical situations (intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations) is not established for this combination. It is primarily used for gastrointestinal discomfort management, not acute/critical care.
Dosage Adjustments
Dose modifications may be needed based on patient response and tolerance. Patients with renal or hepatic impairment require careful monitoring and potential dosage adjustments by a physician.
Side Effects
Common Side Effects:
- Darkening of the tongue and stools (harmless and temporary)
- Constipation
- Dry mouth
- Blurred vision
- Dizziness
- Drowsiness
- Nausea
Rare but Serious Side Effects:
- Allergic reactions (rash, itching, difficulty breathing, swelling)
- Worsening of glaucoma
- Cardiac arrhythmias
Long-Term Effects:
Chronic complications from prolonged use are not well-documented but may include dependence on the belladonna component.
Adverse Drug Reactions (ADR):
Clinically significant ADRs requiring immediate intervention include severe allergic reactions, significant cardiovascular effects (e.g., tachycardia, palpitations), and acute urinary retention.
Contraindications
- Hypersensitivity to any components
- Severe renal or hepatic disease
- Myasthenia gravis
- Glaucoma
- Urinary retention
- Obstructive gastrointestinal disorders
- Severe ulcerative colitis
- Toxic megacolon
Drug Interactions
- MAO inhibitors: Increased risk of hypertension and tachycardia.
- Antihistamines: Increased drowsiness and dizziness.
- Anticholinergics: Additive anticholinergic effects.
- Antacids/H2 blockers/Proton pump inhibitors: Potential alteration of bismuth absorption.
Pregnancy and Breastfeeding
Consult a doctor before using this medication during pregnancy and breastfeeding. Safety in these conditions hasn’t been fully established. Belladonna is generally considered unsafe during pregnancy.
Drug Profile Summary
- Mechanism of Action: Multifactorial: anticholinergic (Belladonna), antacid (Bismuth), carminative/soothing (Menthol/Thymol)
- Side Effects: Constipation, dry mouth, blurred vision, dizziness, drowsiness, nausea, darkening of tongue/stool. Rarely, allergic reactions.
- Contraindications: Hypersensitivity, severe renal/hepatic disease, myasthenia gravis, glaucoma, urinary retention, GI obstruction.
- Drug Interactions: MAO inhibitors, antihistamines, other anticholinergics.
- Pregnancy & Breastfeeding: Consult a physician; generally avoided.
- Dosage: Adults: 5-10 ml TID after meals. Children: Not recommended under 12.
- Monitoring Parameters: Monitor for anticholinergic side effects, especially in the elderly.
Popular Combinations
This medication is not typically combined with other drugs.
Precautions
- Pre-existing medical conditions (glaucoma, heart disease, myasthenia gravis)
- Pregnancy and breastfeeding: Consult a doctor.
- Children and elderly: Use with caution and adjust dose as needed.
- Alcohol: May potentiate drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for this medication?
A: Adults: 5-10 ml (1-2 teaspoons) three times daily after meals. Children under 12: Generally not recommended.
Q2: Can I take this medication if I am pregnant or breastfeeding?
A: Consult your doctor. It is generally not recommended due to the belladonna component.
Q3: What are the common side effects?
A: Darkening of stool and tongue, constipation, dry mouth, blurred vision, dizziness, drowsiness.
Q4: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose.
Q5: Can this medication interact with other medicines I am taking?
A: Yes, potential interactions exist with MAO inhibitors, antihistamines, and other anticholinergic drugs. Inform your doctor about all medications you are taking.
Q6: How does this medication work?
A: It works through multiple mechanisms: reducing acid secretion (belladonna, bismuth), protecting the stomach lining (bismuth), relieving gas (thymol, menthol), and reducing spasms (belladonna, menthol).
Q7: Can I use this medication long-term?
A: Consult your physician for guidance on long-term use.
Q8: Is this medication safe for patients with kidney or liver disease?
A: Use with caution in patients with severe renal or hepatic impairment. Dosage adjustments may be needed. Consult your physician.
Q9: Can this medication cause allergic reactions?
A: Yes, allergic reactions are possible. Seek immediate medical help if you experience symptoms such as rash, itching, difficulty breathing, or swelling.
