NOVILEC-5

Indications

• Constipation
• Dietary fiber supplementation
• Irritable bowel syndrome
• Diverticular disease
• Weight management

Dosage

Children: Refer to appropriate guidelines for specific dosage; generally taken with adequate fluid intake.

Adults: Refer to appropriate guidelines for specific dosage; generally taken with adequate fluid intake.

Mechanism of action

Cellulose acts primarily as a bulk-forming laxative. It absorbs water in the intestines, which increases stool bulk and stimulates peristalsis, thus facilitating bowel movements. Additionally, cellulose is not digestible by human enzymes, leading to fermentation by gut bacteria, which may enhance gut health and alter gut microbiota composition.

Pharmacodynamics

Cellulose increases stool weight and frequency of bowel movements. It works by retaining water in the intestines, leading to softer stools and improved passage through the gastrointestinal tract. The bulking effect of cellulose can help alleviate constipation and promote overall digestive health. It may also play a role in cholesterol reduction and glycemic control through its effects on digestion and absorption of nutrients.

Pharmacokinetics

Cellulose is not absorbed into the bloodstream due to its indigestible nature. Instead, it passes through the gastrointestinal tract, where it adds bulk to the stool. Its fermentation by colonic bacteria produces short-chain fatty acids, which may have beneficial effects on colon health. The onset of action for cellulose as a laxative can vary but is generally within 24 to 72 hours after ingestion.

Adverse effects

• Bloating
• Flatulence
• Diarrhea
• Abdominal discomfort

Precautions

• Use with caution in patients with a history of gastrointestinal disorders.
• Monitor for potential allergic reactions in sensitive individuals.

Pregnancy

Cellulose is generally considered safe during pregnancy as it is a non-toxic, indigestible fiber.

Breast-feeding

Cellulose is also considered safe during breastfeeding; it is excreted in breast milk in negligible amounts.

Storage

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

Formulations

• Powder
• Capsules
• Tablets
• Granules

Indications

• Hypertension
• Essential hypertension

Dosage

Children: Refer to BNF for Children for specific dosing guidance.

Adults: Refer to BNF for specific dosing guidance.

Mechanism of action

Cilnidipine acts on the L-type calcium channels of blood vessels by blocking the incoming calcium and suppressing the contraction of blood vessels, thereby reducing blood pressure. It also works on the N-type calcium channel located at the end of the sympathetic nerve, inhibiting the emission of norepinephrine and suppressing the increase in stress blood pressure.

Pharmacodynamics

Administration of cilnidipine has been shown to present an antisympathetic profile in vitro and in vivo. It decreases blood pressure safely and effectively without excessive blood pressure reduction or tachycardia.

Contra-indications

• Hypersensitivity to cilnidipine or any of its components
• Severe hypotension
• Aortic stenosis
• Cardiogenic shock

Adverse effects

• Headache
• Dizziness
• Flushing
• Peripheral edema
• Palpitations
• Constipation
• Nausea

Interactions

• May enhance the effect of other antihypertensive agents
• Caution when used with calcium channel blockers
• May interact with drugs that affect cytochrome P450 enzymes

Precautions

• Use with caution in patients with hepatic or renal impairment
• Monitor blood pressure regularly during therapy
• Caution in elderly patients and those with a history of heart failure

Pregnancy

Cilnidipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult relevant guidelines.

Breast-feeding

It is not known whether cilnidipine is excreted in human milk. Caution should be exercised when administering to a nursing mother.

Storage

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

Formulations

• Tablets: 10 mg, 20 mg

Indications

• Used as an excipient in pharmaceutical formulations
• Improves solubility and stability of active ingredients
• Facilitates drug absorption

Dosage

Children: Refer to specific product guidelines as hydroxypropyl is typically used as an excipient and not dosed independently.

Adults: Refer to specific product guidelines as hydroxypropyl is typically used as an excipient and not dosed independently.

Mechanism of action

Hydroxypropyl functions primarily as a solubilizing agent, which aids in the dissolution of poorly soluble drugs. It interacts with water and other solvents to improve the dispersion of pharmaceutical compounds, thereby enhancing their bioavailability. Hydroxypropyl may also facilitate the permeability of drug molecules through biological membranes, contributing to their overall efficacy.

Pharmacodynamics

The pharmacodynamics of hydroxypropyl relate to its role in improving the physicochemical properties of drug formulations. By increasing solubility and stability, hydroxypropyl can enhance the absorption of drugs administered via various routes, including oral and topical. Its non-toxic nature allows for safe incorporation into formulations, making it suitable for a wide range of applications.

Pharmacokinetics

The pharmacokinetics of hydroxypropyl have not been extensively studied as it primarily acts as an excipient rather than an active pharmaceutical ingredient. When used in formulations, it is typically not absorbed into systemic circulation in significant amounts, thereby minimizing potential systemic effects. Hydroxypropyl is generally regarded as safe when used in appropriate amounts in drug formulations.

Pregnancy

Hydroxypropyl is not classified for use during pregnancy, and its safety has not been established. Caution is advised.

Breast-feeding

There is limited information on the excretion of hydroxypropyl in human milk. Caution is advised when administering to breastfeeding women.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

Indications

• Lactose intolerance
• As a filler or excipient in pharmaceutical formulations

Dosage

Children: Refer to the BNF for Children for specific dosing information based on age and clinical context.

Adults: Refer to the BNF for specific dosing information based on clinical context.

Mechanism of action

Lactose is metabolized in the intestine by the enzyme lactase into its constituent monosaccharides, glucose and galactose. In individuals with lactase deficiency, unabsorbed lactose passes into the colon, where it is fermented by bacteria, leading to gas production and osmotic effects that contribute to diarrhea.

Pharmacodynamics

The pharmacodynamics of lactose are primarily related to its effects on gastrointestinal function. In healthy individuals, lactose is effectively broken down into glucose and galactose, which are absorbed and utilized for energy. In individuals with lactose intolerance, the unabsorbed lactose can cause osmotic diarrhea and colonic fermentation, leading to discomfort and symptoms associated with lactose intolerance.

Pharmacokinetics

Lactose is not absorbed in the gastrointestinal tract until it is hydrolyzed into glucose and galactose by lactase. The absorption of glucose and galactose occurs in the small intestine. The half-life is not applicable as lactose is not typically administered as a medication but is rather ingested as a natural component of food. Its metabolism primarily occurs in the intestine.

Adverse effects

• Bloating
• Diarrhea
• Abdominal pain
• Flatulence

Precautions

• Use with caution in patients with lactose intolerance.
• Consider potential for gastrointestinal upset in sensitive individuals.

Pregnancy

Lactose is generally considered safe for use during pregnancy. However, consult a healthcare professional for individual advice.

Breast-feeding

Lactose is safe to use while breastfeeding, as it is a natural sugar present in breast milk.

Storage

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

Formulations

• Powder
• Granules
• Tablets
• Syrup

Indications

• Hyperlipidemia
• Type 2 Diabetes Mellitus
• Metabolic Syndrome
• Cardiovascular Risk Reduction

Dosage

Children: Refer to specific prescribing information for pediatric dosing guidelines, as pediatric doses must be determined based on age, weight, and clinical condition.

Adults: Refer to specific prescribing information for adult dosing guidelines, as doses may vary based on the condition being treated and patient-specific factors.

Mechanism of action

Lowsub is believed to exert its effects through modulation of certain enzymatic pathways, influencing the metabolism of lipids and glucose. It may interact with specific receptors or transporters, leading to improved cellular uptake of glucose and enhanced lipid profiles, thus contributing to better cardiovascular health.

Pharmacodynamics

The pharmacodynamics of Lowsub involve its ability to affect metabolic processes, leading to changes in blood lipid levels and glucose metabolism. It may also have anti-inflammatory effects, contributing to its therapeutic benefits in conditions associated with metabolic syndrome and cardiovascular disease.

Pharmacokinetics

Lowsub is absorbed after oral administration and is subject to first-pass metabolism. Its bioavailability can be affected by food intake. The drug is metabolized in the liver, and its metabolites are excreted primarily via the kidneys. The elimination half-life varies depending on individual patient factors, including age and renal function.

Pregnancy

Not enough data available to establish safety during pregnancy. Consult healthcare provider.

Breast-feeding

Not enough data available to establish safety during breastfeeding. Consult healthcare provider.

Storage

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

Indications

• Used as an excipient in tablet formulations
• Used as a bulking agent in capsule formulations
• Used in food products as a thickener or stabilizer

Dosage

Children: Refer to specific product guidelines as dosage will depend on the formulation and the active ingredients.

Adults: Refer to specific product guidelines as dosage will depend on the formulation and the active ingredients.

Mechanism of action

Microcrystalline cellulose acts as a non-digestible filler that enhances the flow properties of powders during the manufacturing of tablets and capsules. It does not have a direct pharmacological action on the body but ensures that the active ingredients are effectively delivered to the patient.

Pharmacodynamics

As a non-active ingredient, microcrystalline cellulose does not exert pharmacodynamic effects typical of active pharmaceutical ingredients. Its primary role is to provide a stable and consistent matrix for the drug, facilitating the release of the active compound once ingested.

Pharmacokinetics

Microcrystalline cellulose is not absorbed in the gastrointestinal tract; it passes through the digestive system largely unchanged. It adds bulk to the stool, which may aid in promoting regular bowel movements. The substance is excreted in feces, where it contributes to dietary fiber intake.

Pregnancy

Data regarding the use of microcrystalline cellulose during pregnancy is limited. It is advisable to consult with healthcare professionals before use.

Breast-feeding

Microcrystalline cellulose is considered safe during breastfeeding, as it is not absorbed systemically.

Storage

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

Indications

• Used as an acidulant in food and beverages
• Utilized in pharmaceutical formulations to enhance stability
• Serves as a buffering agent in various preparations

Dosage

Children: Refer to specific formulation guidelines for dosage; no standard dose established.

Adults: Refer to specific formulation guidelines for dosage; no standard dose established.

Mechanism of action

Tartaric acid acts primarily as a mild acid, contributing to the acidity of solutions and influencing the solubility and stability of compounds. It can also play a role in stabilizing the pH of formulations, which can enhance the bioavailability of specific drugs. The precise molecular interactions of tartaric acid in biological systems are not fully elucidated but involve the modulation of pH and ionic strength.

Pharmacodynamics

Tartaric acid does not exhibit significant pharmacological activity on its own but influences the properties of other compounds when used in pharmaceutical preparations. Its role as an acidulant can enhance the solubility of certain drugs, thereby improving their absorption and therapeutic efficacy. The acid's buffering capacity can also help maintain a stable environment for drug stability.

Pharmacokinetics

Tartaric acid is absorbed in the gastrointestinal tract, although specific pharmacokinetic parameters such as half-life, peak plasma concentration, and elimination pathways are not well-defined in the literature. It is generally metabolized in the body to various metabolites, primarily through normal metabolic pathways, with renal excretion of its conjugates. Its effects are more related to its role in formulations rather than systemic pharmacodynamics.

Pregnancy

Tartaric acid is generally recognized as safe when used in food and beverages. However, specific safety during pregnancy has not been extensively studied, thus caution is advised.

Breast-feeding

There is limited information on the safety of tartaric acid during breastfeeding, but it is considered to be safe in normal dietary amounts.

Storage

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

Formulations

• Tartaric acid powder
• Tartaric acid solution

Mechanism of action

Cilnidipine acts on the L-type calcium channels of blood vessels by blocking the incoming calcium and suppressing the contraction of blood vessels, thereby reducing blood pressure. Cilnidipine also works on the N-type calcium channel located at the end of the sympathetic nerve, inhibiting the emission of norepinephrine and suppressing the increase in stress blood pressure.

Pharmacodynamics

Administration of cilnidipine has been shown to present an antisympathetic profile in vitro and in vivo. It decreases blood pressure safely and effectively without excessive blood pressure reduction or tachycardia.