Ispaghula Husk [Psyllium] + Senna Extract

Approved Indications:

• Chronic Constipation: Relief and long-term management of functional or idiopathic constipation.
• Irritable Bowel Syndrome (IBS): Particularly useful in the constipation-predominant subtype (IBS-C).
• Hemorrhoids: To soften stools and reduce straining during defecation.
• Anal Fissures: Supports healing by promoting soft, easily passable stools.
• Postoperative Bowel Regulation: Especially following anorectal surgery.
• Hypercholesterolemia: As an adjunct to diet for reducing total and LDL cholesterol levels.
• Type 2 Diabetes Mellitus: To help improve glycemic control as part of dietary fiber intake.
• Diverticular Disease: To prevent complications by regulating bowel movements.
• Pregnancy-Related Constipation: Safe fiber supplement for bowel regularity.

Clinically Accepted Off-Label Uses:

• Obesity (Adjunct in Weight Loss): Promotes satiety and may reduce caloric intake.
• Gastroesophageal Reflux Disease (GERD): May alleviate symptoms by delaying gastric emptying.
• Chronic Kidney Disease (CKD): Fiber intake may benefit gut health and uremic toxin clearance.

General Administration:

• Route: Oral
• Formulations: Powder for reconstitution, granules, capsules
• Administration Tips: Always take with at least 150–250 mL of water. Adequate hydration is essential to avoid intestinal blockage.

Adults:

• Constipation:
  3.5–7 g (approximately 1 rounded teaspoon) 1–3 times daily, mixed with water or juice.
• Hyperlipidemia:
  5–10 g twice daily with meals.
• Diabetes:
  5–10 g twice daily before meals.

Pediatrics:

• Children 6–12 years:
  2.5–5 g once or twice daily with water.
• Children <6 years:
  Not recommended unless under strict medical supervision.

Elderly:

• Same as adult dosing; ensure sufficient fluid intake and monitor for impaction.

Special Populations:

• Renal Impairment: No dosage adjustment required.
• Hepatic Impairment: No dosage adjustment required.
• Pregnancy & Lactation: Safe with standard dosing.

Ispaghula husk is a natural hydrophilic mucilloid composed of soluble and insoluble fiber. Upon ingestion, it absorbs water and forms a gelatinous mass that increases stool bulk, triggering peristalsis via mechanical stimulation of the intestinal walls. Additionally, the soluble fiber content binds bile acids, reducing cholesterol absorption, and slows glucose absorption, contributing to improved lipid and glycemic profiles. The prebiotic effect promotes growth of beneficial colonic bacteria, enhancing gut health.

• Absorption: Not systemically absorbed; exerts its effect locally in the gastrointestinal tract.
• Onset of Action: Typically within 12 to 72 hours after the first dose.
• Distribution: Not applicable due to lack of systemic absorption.
• Metabolism: Partially fermented by colonic bacteria into short-chain fatty acids.
• Excretion: Excreted unchanged in feces; fermentation products absorbed and metabolized.
• Half-life: Not applicable.

• Pregnancy: Considered safe; does not cross the placenta or affect fetal development. No teratogenic effects reported.
• Breastfeeding: Safe during lactation; not excreted into breast milk. No adverse effects in nursing infants.
• Caution: Advise adequate hydration to avoid bowel obstruction.

• Primary Class: Bulk-forming Laxative
• Subcategory: Dietary Fiber Supplement / Hypolipidemic Adjunct

• Known hypersensitivity to psyllium or any formulation excipients
• Esophageal or gastrointestinal obstruction
• Fecal impaction
• Difficulty swallowing or dysphagia
• Acute abdomen or undiagnosed abdominal pain
• Severe dehydration without fluid replacement

• Esophageal Obstruction: Risk increases if not taken with sufficient water.
• Aspiration Risk: Use caution in elderly or neurologically impaired patients.
• Diabetic Patients: Monitor blood glucose as fiber may affect absorption of medications.
• Allergic Reactions: Rare cases of anaphylaxis and asthma exacerbation reported due to powder inhalation.
• Pre-existing GI Conditions: Avoid in strictures, megacolon, or ileus.
• Monitoring: Watch for signs of bowel obstruction, especially in immobilized patients or those with reduced GI motility.

Common Side Effects:

• Gastrointestinal:
• Bloating
• Flatulence
• Abdominal cramping
• Diarrhea (initial days)

Less Common but Serious:

• Respiratory:
• Bronchospasm (from powder inhalation)
• Hypersensitivity reactions (rhinitis, urticaria)
• Gastrointestinal:
• Fecal impaction
• Esophageal or intestinal obstruction (if taken with inadequate fluids)

• Drug Absorption Delay: Psyllium may reduce the absorption of:
• Digoxin
• Warfarin
• Lithium
• Carbamazepine
• Iron supplements

Recommendation: Administer other oral medications at least 1 hour before or 2–4 hours after psyllium.

• Hypoglycemics: Enhances glucose control; may potentiate effects of antidiabetic agents.
• Alcohol: No known interactions.
• CYP450: Not metabolized via hepatic enzymes; no CYP450 involvement.

• Dietary Fiber Guidelines (WHO & AHA): Psyllium included as a recommended soluble fiber for lipid-lowering and glycemic control.
• Cholesterol-Lowering: Endorsed by the FDA and other global health bodies as an adjunct to diet in patients with hypercholesterolemia.
• IBS Management: Recent guidelines from the American College of Gastroenterology (ACG) include psyllium as first-line therapy for constipation-predominant IBS.

• Temperature: Store below 25°C (77°F) in a dry place.
• Humidity: Protect from moisture and humidity.
• Light: Store in a tightly closed opaque container.
• Handling:
• Do not use wet spoons to scoop powder.
• Avoid inhaling dry powder during preparation.
• Shelf-life: Refer to product packaging; typically stable for 24–36 months unopened.