COLOSPAS FIBRO SACHET

Indications

• Irritable bowel syndrome
• Smooth muscle spasm
• Cholestatic pruritus

Dosage

Children: For children aged 12–17 years: 15 mg three times a day, taken at least one hour before food, with a maximum of 120 mg per day.

Adults: 135–150 mg three times a day, preferably taken 20 minutes before meals.

Mechanism of action

Mebeverine acts as a direct spasmolytic agent, targeting the smooth muscle of the gastrointestinal tract. It inhibits the influx of calcium ions into the smooth muscle cells, which is crucial for muscle contraction. By preventing this influx, mebeverine induces relaxation of the smooth muscle, thereby reducing spasms and associated pain.

Pharmacodynamics

The primary pharmacodynamic effect of mebeverine hydrochloride is its ability to relieve smooth muscle spasms in the gastrointestinal tract. This leads to a reduction in abdominal pain and discomfort associated with conditions like irritable bowel syndrome. The onset of action can vary, but patients typically experience relief within a short period after administration, particularly when taken before meals.

Pharmacokinetics

Mebeverine hydrochloride is administered orally and is characterized by low systemic absorption. Its pharmacokinetic profile includes rapid metabolism, with metabolites excreted primarily via urine. The drug has a short half-life, necessitating multiple doses throughout the day to maintain therapeutic effects. The timing of administration is important, as taking the medication 20 minutes before meals enhances its efficacy.

Contra-indications

• Paralytic ileus

Adverse effects

• Angioedema
• Facial edema
• Skin reactions
• Arrhythmias
• Decreased bronchial secretion
• Mydriasis

Interactions

• Propantheline

Precautions

• Caution in hepatic impairment
• Caution in renal impairment
• May suppress lactation

Pregnancy

Manufacturer advises avoiding use unless essential, as limited information is available.

Breast-feeding

Manufacturer advises avoiding use due to potential suppression of lactation.

Storage

Store in a cool, dry place away from light.

Formulations

• Mebeverine hydrochloride 135 mg tablets
• Mebeverine hydrochloride 200 mg modified-release capsules
• Mebeverine hydrochloride 100 mg modified-release capsules

Indications

• Constipation
• Irritable bowel syndrome (IBS)
• Diverticular disease
• Cholesterol management
• Blood sugar control in diabetes

Dosage

Children: For children, it is recommended to consult a healthcare provider for appropriate dosing based on age and weight, as specific pediatric dosing

Adults: For adults, the typical dosage is 1 to 2 teaspoons (5 to 10 grams) of psyllium husk taken 1 to 3 times daily, mixed with at least 8 ounces of water or other liquid.

Mechanism of action

Psyllium husk acts as a bulk-forming laxative. It is not digested by the body, but when mixed with water, it expands and forms a viscous gel. This gel increases the bulk of the stool and triggers peristalsis, enhancing bowel movements. Additionally, it may slow down the absorption of carbohydrates and fats, contributing to its cholesterol-lowering and blood sugar-regulating effects.

Pharmacodynamics

The primary pharmacodynamic effect of husk is its ability to increase stool bulk and water content, which facilitates easier passage of stool through the intestines. This leads to improved bowel regularity and relief from constipation. Furthermore, psyllium husk has been shown to have a mild effect on lowering serum cholesterol levels, particularly low-density lipoprotein (LDL) cholesterol, and may improve glycemic control in patients with type 2 diabetes.

Pharmacokinetics

Psyllium husk is not absorbed systemically; it remains in the gastrointestinal tract, where it exerts its effects. The onset of action for bowel regulation typically occurs within 12 to 72 hours after ingestion, depending on the individual's digestive transit time and fluid intake. Adequate hydration is essential to maximize its efficacy and prevent potential gastrointestinal obstruction.

Adverse effects

• Bloating
• Abdominal cramping
• Diarrhea
• Nausea

Precautions

• Ensure adequate fluid intake when using husk to prevent gastrointestinal obstruction
• Monitor for allergic reactions in sensitive individuals

Pregnancy

Generally considered safe to use during pregnancy, but always consult a healthcare provider.

Breast-feeding

Considered safe while breastfeeding, but consult a healthcare provider for personalized advice.

Storage

Store in a cool, dry place, away from direct sunlight and moisture.

Formulations

• Psyllium husk powder
• Psyllium husk capsules
• Psyllium husk granules

Indications

• Constipation
• Irritable bowel syndrome
• Diverticular disease
• Hyperlipidemia

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines in children.

Adults: Refer to the BNF for specific dosing recommendations, typically starting with a standard dose that can be adjusted based on individual response.

Mechanism of action

Ispaghula acts as a soluble fiber that increases the water content and bulk of the stool. This action stimulates peristalsis (the wave-like muscle contractions of the intestines) and facilitates easier passage of stool through the gastrointestinal tract. It may also contribute to the modulation of intestinal microbiota and has prebiotic effects, promoting the growth of beneficial gut bacteria.

Pharmacodynamics

Ispaghula exhibits its pharmacodynamic effects through its ability to absorb water and swell in the gastrointestinal tract, which increases stool mass and triggers bowel movements. This bulk-forming property helps alleviate constipation and maintains bowel health. Additionally, the gel-like substance formed can slow down the absorption of glucose and cholesterol, providing further metabolic benefits.

Pharmacokinetics

Ispaghula is not absorbed in the gastrointestinal tract, which means it does not have systemic effects. It passes through the digestive system and is excreted unchanged. The onset of action typically occurs within 12 to 72 hours after ingestion, depending on the individual and the volume of fluid consumed with the fiber. Adequate hydration is necessary for optimal efficacy.

Contra-indications

• Intestinal obstruction
• Severe dehydration
• Dysphagia

Adverse effects

• Abdominal bloating
• Flatulence
• Diarrhea
• Constipation
• Esophageal obstruction

Interactions

• May reduce the absorption of concomitantly administered oral medications due to its bulk-forming properties
• Caution should be exercised when taken with anticoagulants as it may affect their absorption

Precautions

• Adequate fluid intake should be ensured to prevent esophageal obstruction
• Caution in patients with a history of gastrointestinal disorders

Pregnancy

Generally considered safe for use during pregnancy, but it is advisable to consult a healthcare provider.

Breast-feeding

Considered safe during breastfeeding; however, maternal hydration should be maintained.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

• Powder for oral suspension
• Granules for oral intake
• Tablets

Indications

• Irritable bowel syndrome
• Functional bowel disorders
• Abdominal cramps
• Gastrointestinal spasm

Dosage

Children: For children aged 10 years and above, the dosage is typically 135 mg three times daily before meals, while children aged 5 to 10 years may be prescribed a lower dose based on clinical judgment. For precise dosing in children, refer to the BNF for Children.

Adults: The usual adult dose for mebeverine is 135 mg taken three times daily before meals.

Mechanism of action

Mebeverine acts as a selective spasmolytic agent, inhibiting the contraction of smooth muscle in the gastrointestinal tract. It works by interfering with the calcium influx in smooth muscle cells, reducing spasms without significantly affecting normal gastrointestinal motility.

Pharmacodynamics

Mebeverine is effective in decreasing intestinal motility and helping to relieve abdominal pain and discomfort associated with gastrointestinal spasms. It does not inhibit the gastrointestinal secretions and is considered to have a direct effect on the muscle tissue, providing symptomatic relief in patients with IBS.

Pharmacokinetics

Mebeverine is rapidly absorbed following oral administration, with peak plasma concentrations occurring within a few hours. It undergoes extensive metabolism in the liver, producing several metabolites, some of which may retain spasmolytic activity. The elimination half-life is approximately 1 to 2 hours, and it is primarily excreted through urine, with a small fraction excreted unchanged.

Contra-indications

• Hypersensitivity to mebeverine or any of its components
• Severe inflammatory bowel disease
• Obstruction of the gastrointestinal tract

Adverse effects

• Nausea
• Vomiting
• Abdominal pain
• Dizziness
• Headache
• Skin rash
• Allergic reactions

Interactions

• Mebeverine may enhance the effects of other anticholinergic drugs
• There are no known significant drug interactions reported

Precautions

• Use with caution in patients with a history of gastrointestinal obstruction
• Consult a physician if symptoms persist or worsen
• Not recommended for use in children without medical advice

Pregnancy

Mebeverine should be used in pregnancy only if clearly needed, and the potential benefits outweigh the risks. Consult a healthcare provider.

Breast-feeding

Mebeverine is not known to be excreted in human milk. Caution is advised when administered to breastfeeding women.

Storage

Store at room temperature, away from moisture and direct sunlight. Keep out of reach of children.

Formulations

• Tablets
• Capsules
• Oral suspension