irbesartan reference
Reference image
(irbesartan · DailyMed)
Registered Tanzania · TMDA

Irovel 150 mg Tablet

Colloidal Silicon Dioxide 2 mg,Colloidal Silicon Dioxide BP Eq. to Silicon 1 mg,Crosscarmellose Sodium 10 mg,Crosscarmellose Sodium USP-NF/Ph.Eur. 2 mg,Irbesartan 150 mg,Lactose 95 mg,Magnesium Sterate 4 mg,Microcrystalline cellulose 30 mg,Poloxamer 188 1 mg,Pregelatinised Starch 20 mg,Starch 60 mg,Talc 8 mg

TAN 22 HM 0488 Oral tablet 150 blood and blood forming organs INN generic

What it does

Cellulose is a type of fiber that helps with digestion and promotes bowel health.

Commonly used for: constipation, irregular bowel movements

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
TAN 22 HM 0488
Registration date
2022-12-05
Expiry date
2027-12-04
Status
Registered/Compliant
Active ingredient
Colloidal Silicon Dioxide 2 mg,Colloidal Silicon Dioxide BP Eq. to Silicon 1 mg,Crosscarmellose Sodium 10 mg,Crosscarmellose Sodium USP-NF/Ph.Eur. 2 mg,Irbesartan 150 mg,Lactose 95 mg,Magnesium Sterate 4 mg,Microcrystalline cellulose 30 mg,Poloxamer 188 1 mg,Pregelatinised Starch 20 mg,Starch 60 mg,Talc 8 mg
Dosage form
Oral tablet
Strength
150
Pack size
-
Therapeutic class
-
ATC class (WHO)
B02BC - Local hemostatics
RxNorm RxCUI
2221
Manufacturer / MAH
Sun Pharma
Country of origin
INDIA
Manufacturer location
CTS, 1, SUN HOUSE, No. 201 B, Western Express Hwy, Geetanjali Railway Colony, Ram Nagar, Goregaon East, Mumbai, Maharashtra 400063, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:36:42 · updated 2026-10-26 03:00:43

Drug Interactions

1
Check interactions

Pharmacodynamic Warnings

Irbesartan appears in TABLE 7: Drugs that cause first dose hypotension

Irbesartan appears in TABLE 8: Drugs that cause hypotension

Irbesartan appears in TABLE 16: Drugs that increase serum potassium

Unknown (1)

Bulevirtide - affects efficacy

Irbesartanispredictedtoaffecttheefficacyofbulevirtide. Avoid.rTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About cellulose

Cellulose is a type of fiber that helps with digestion and promotes bowel health.

What it treats

  • constipation
  • irregular bowel movements

How it works

Cellulose adds bulk to the stool, making it easier to pass through the intestines.

Who it's for

Suitable for people looking to improve their digestive health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About colloidal

Colloidal solutions are often used in various medical treatments and can help improve the delivery of certain medications.

What it treats

  • supporting hydration
  • helping with nutrient absorption
  • improving medication effectiveness

How it works

Colloidal solutions contain small particles that can help carry and deliver substances in the body more effectively.

Who it's for

Adults and children who need assistance with hydration or nutrient delivery.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About crosscarmellose

Crosscarmellose is a substance used to help medications dissolve properly in the body.

What it treats

  • helps medications work better
  • improves absorption of oral medications

How it works

It acts as a disintegrant, breaking down tablets and capsules so the body can absorb the medicine more effectively.

Who it's for

It is used in various medications for adults and children who need assistance in absorbing medicine.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About dioxide

Dioxide is used in various medical applications, but specific details about its class or interactions are not provided.

How it works

The exact mechanism of action for dioxide is not specified, but it generally serves various therapeutic roles in medicine.

Who it's for

Dioxide may be suitable for individuals needing treatment related to its specific applications, but more information is needed to identify specific patient groups.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About irbesartan

Irbesartan is a medication that helps lower blood pressure and protect the kidneys.

What it treats

  • high blood pressure (hypertension)
  • kidney problems related to diabetes

How it works

Irbesartan works by blocking a substance in the body that causes blood vessels to tighten, helping them to relax and lower blood pressure.

Who it's for

Irbesartan is for adults with high blood pressure or certain kidney issues.

Drug class

Angiotensin-II receptor antagonists

Cautions

  • • Be careful if you are taking other medications that can lower blood pressure.
  • • Avoid medications that can cause low blood pressure.
  • • Watch out for drugs that may increase potassium levels in the blood.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About lactose

Lactose is a sugar found in milk and dairy products. It is often used as an excipient in medications.

What it treats

  • lactose intolerance
  • as a filler in tablets and capsules

How it works

Lactose helps improve the texture and stability of medications and is sometimes used as a sweetener.

Who it's for

Individuals who require lactose as part of their medication or those who consume dairy products.

Cautions

  • • May cause digestive issues in people with lactose intolerance.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About microcrystalline

Microcrystalline is a type of substance often used in medicines to help with various health issues. It is commonly used as a filler or binder in tablets and capsules.

What it treats

  • stomach issues
  • constipation
  • weight management

How it works

It helps to improve the texture of medicines and can assist in the absorption of other ingredients in the body.

Who it's for

Adults and children who need help with specific health conditions, as directed by a healthcare professional.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About poloxamer

Poloxamer is a type of surfactant used in various formulations to help improve the solubility and delivery of other ingredients.

What it treats

  • used in topical creams and gels
  • helps in drug delivery systems

How it works

Poloxamer works by reducing the surface tension of substances, making it easier for other ingredients to mix and be absorbed by the skin or other tissues.

Who it's for

Poloxamer is typically used for individuals needing enhanced delivery of medications or for skin treatments.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About pregelatinised

Pregelatinised is a modified form of starch used as a thickening agent and stabilizer in various products.

What it treats

  • thickening agent in food
  • stabilizer in pharmaceutical products

How it works

Pregelatinised starch helps improve the texture and consistency of products by absorbing water and forming a gel-like substance.

Who it's for

Suitable for people needing thickening agents in food or pharmaceuticals, including those with swallowing difficulties.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About silicon

Silicon is a mineral that may help support healthy bones and connective tissues.

What it treats

  • bone health
  • joint health
  • skin health

How it works

Silicon helps form collagen, which is important for maintaining the strength and elasticity of bones and tissues.

Who it's for

Silicon is for individuals looking to support their bone and joint health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About starch

Starch is a carbohydrate that serves as a source of energy and is often used in various food products.

What it treats

  • energy source
  • dietary supplement

How it works

Starch is broken down by the body into glucose, which provides energy for daily activities.

Who it's for

Starch can be used by anyone needing extra energy in their diet, particularly those with increased energy needs.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About sterate

Sterate is a medication used for various health conditions.

What it treats

  • Nutritional supplementation
  • Fat malabsorption disorders

How it works

Sterate helps improve the absorption of fats in the body, providing essential nutrients.

Who it's for

It is suitable for individuals needing additional nutritional support or those with specific digestive issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About talc

Talc is a mineral used primarily to absorb moisture and reduce friction. It is commonly found in various personal care products.

What it treats

  • skin irritation
  • diaper rash
  • chafing
  • sweating

How it works

Talc works by absorbing moisture and providing a smooth surface, which helps to prevent irritation and discomfort on the skin.

Who it's for

Talc is suitable for anyone needing relief from moisture-related skin issues, including babies and adults.

Cautions

  • • Avoid using on broken or irritated skin.
  • • Keep away from the eyes and mouth.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Irbesartan

BNF-referenced

Irbesartan is an angiotensin-II receptor antagonist commonly used to treat hypertension and to slow the progression of diabetic nephropathy in patients with type 2 diabetes. It works by blocking the action of angiotensin II, a potent vasoconstrictor, leading to vasodilation and reduced blood pressure. Irbesartan is usually administered orally and has a long duration of action, allowing for once-daily dosing.

Indications

  • Hypertension
  • Diabetic nephropathy in patients with type 2 diabetes

Dosage

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

Adults: Initially 75–150 mg once daily, may be increased to 300 mg once daily if tolerated.

Mechanism of action

Irbesartan prevents angiotensin II binding to the AT1 receptor in tissues such as vascular smooth muscle and the adrenal gland. It binds to the AT1 receptor with over 8500 times more affinity than to the AT2 receptor. By blocking angiotensin II from binding, irbesartan induces vascular smooth muscle relaxation and inhibits aldosterone secretion, which together lower blood pressure. This action counteracts the vasoconstrictive and sodium-retaining effects of angiotensin II.

Pharmacodynamics

Irbesartan is an effective angiotensin receptor blocker that lowers blood pressure and has a wide therapeutic index. It is well-tolerated at doses up to 900 mg daily, although typical therapeutic doses range from 150 mg. Its long half-life allows for once-daily dosing, making it convenient for patient adherence.

Pharmacokinetics

Irbesartan is well absorbed following oral administration, with peak plasma concentrations occurring within 1-2 hours. It undergoes extensive hepatic metabolism, primarily by glucuronidation, and is excreted via the urine and feces. The elimination half-life is approximately 11 hours, which supports its once-daily dosing regimen. Renal impairment may necessitate cautious use, especially in patients with creatinine clearance less than 30 mL/min.

Contra-indications

  • Hypersensitivity to irbesartan or any of the excipients
  • Severe hepatic impairment
  • Bilateral renal artery stenosis or stenosis in a solitary kidney

Adverse effects

  • Dizziness
  • Fatigue
  • Hypotension
  • Angioedema
  • Elevated blood urea or creatinine
  • Hyperkalemia
  • Gastrointestinal disturbances

Interactions

  • Irbesartan and bulevirtide: Unknown (affects efficacy)
  • Other antihypertensive agents may have additive effects
  • Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of irbesartan

Precautions

  • Caution in patients with a history of angioedema
  • Monitor renal function in patients with renal impairment
  • Use with caution in patients with diabetes or heart failure

Pregnancy

Irbesartan is contraindicated during pregnancy due to potential harm to the fetus, particularly in the second and third trimesters.

Breast-feeding

Caution is advised as it is not known if irbesartan is excreted in human milk.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • Irbesartan 75 mg tablets
  • Irbesartan 150 mg tablets
  • Irbesartan 300 mg tablets
  • Oral suspension (special order)
BNF 85 (British National Formulary) p.212 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: cellulose

Cellulose is a complex carbohydrate and a key structural component of the plant cell wall. It is an indigestible polysaccharide made up of linear chains of glucose molecules linked by β-1,4-glycosidic bonds. As a dietary fiber, cellulose contributes to digestive health by promoting bowel regularity and is commonly used as a laxative and bulking agent in various food products and pharmaceuticals.

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

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: colloidal

Colloidal solutions are mixtures in which small particles are dispersed throughout a continuous medium. They can be used in various medical applications, including as intravenous fluids for volume expansion and as drug delivery systems. Colloidal solutions can improve the solubility and stability of drugs, enhancing their therapeutic effects.

Indications

  • Hypovolemic shock
  • Severe burns
  • Postoperative fluid replacement
  • Sepsis
  • Trauma management

Dosage

Children: Refer to established guidelines for specific dosing, as it varies based on the type of colloidal solution used and the clinical condition being treated.

Adults: Refer to established guidelines for specific dosing, as it varies based on the type of colloidal solution used and the clinical condition being treated.

Mechanism of action

Colloidal solutions work by maintaining oncotic pressure in the blood, thus helping to retain fluid within the vascular system. This is primarily due to the large molecular weight of the colloidal particles, which cannot easily pass through capillary walls. The presence of colloids in the blood helps to draw water into the circulation, increasing blood volume and improving tissue perfusion.

Pharmacodynamics

The pharmacodynamics of colloidal solutions are centered on their ability to exert osmotic pressure, which helps maintain blood volume and pressure. This effect is particularly important in conditions such as hypovolemia and shock, where fluid replacement is necessary to restore hemodynamic stability. The efficacy of colloidal solutions can vary depending on the type of colloid used, as well as the underlying clinical condition being treated.

Pharmacokinetics

Colloidal solutions are typically administered intravenously and their pharmacokinetics can vary based on the specific formulation. Generally, colloids are distributed throughout the vascular compartment and have a longer duration of action compared to crystalloids, as they remain in circulation longer. The elimination of colloids is primarily through the reticuloendothelial system, where they are metabolized or eliminated by the liver and spleen. Factors such as particle size and composition can influence their distribution and clearance.

Adverse effects

  • Allergic reactions
  • Injection site reactions
  • Nausea
  • Vomiting
  • Headache
  • Fever

Precautions

  • Use with caution in patients with known allergies to any component of the formulation
  • Monitor for signs of hypersensitivity during administration
  • Consider volume overload in patients with cardiac or renal impairment

Pregnancy

The safety of colloidal solutions during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether colloidal solutions are excreted in human milk. Caution should be exercised when administering to breastfeeding mothers.

Storage

Store at room temperature, protect from light, and do not freeze. Keep out of reach of children.

Formulations

  • Colloidal silver
  • Colloidal gold
  • Colloidal iron
  • Other metal colloids

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: crosscarmellose

Crosscarmellose sodium is a modified cellulose derivative used as a disintegrant in pharmaceutical formulations. It enhances the dissolution of active pharmaceutical ingredients by facilitating rapid disintegration of tablets and capsules in the gastrointestinal tract. It is particularly useful in formulations where a quick release of medication is desired.

Indications

  • Tablet formulation
  • Capsule formulation
  • Rapid release of active pharmaceutical ingredients

Dosage

Children: Refer to specific product guidelines for exact formulations. Typically used in concentrations of 1-5% in solid dosage forms.

Adults: Refer to specific product guidelines for exact formulations. Typically used in concentrations of 1-5% in solid dosage forms.

Mechanism of action

Crosscarmellose sodium works by swelling upon contact with water, leading to the rapid disintegration of the dosage form. This process increases the surface area of the active ingredient, promoting faster dissolution and absorption in the gastrointestinal tract. It does not possess any pharmacological activity of its own but acts as a functional excipient.

Pharmacodynamics

As a disintegrant, crosscarmellose sodium aids in the breakdown of solid dosage forms, allowing for quicker release and absorption of active ingredients. Its effectiveness is influenced by factors such as the formulation's composition, the presence of other excipients, and the conditions within the gastrointestinal environment.

Pharmacokinetics

Crosscarmellose sodium is not absorbed in the gastrointestinal tract and does not undergo metabolism. It functions primarily as a physical agent that enhances the disintegration of the dosage form. Its safety profile is well-established, and it is considered non-toxic and non-irritating.

Pregnancy

Crosscarmellose is considered safe for use during pregnancy as it is not systemically absorbed, but consult a healthcare provider for specific cases.

Breast-feeding

Crosscarmellose is not absorbed systemically and is generally considered safe during breastfeeding, but consult a healthcare provider for specific cases.

Storage

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

Formulations

  • Tablets
  • Capsules
  • Powders

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: dioxide

Dioxide refers to a class of chemical compounds that contain two oxygen atoms bonded to another element or group. The most commonly referenced dioxide is carbon dioxide (CO2), a colorless, odorless gas produced by respiration in animals and plants and by the combustion of organic matter. In a clinical context, dioxides are often involved in various physiological processes and can play roles in drug mechanisms, particularly with respect to gas exchange and acid-base balance in the body.

Indications

  • Monitoring respiratory function
  • Assessment of metabolic status
  • Management of respiratory acidosis
  • Management of respiratory alkalosis

Dosage

Children: Dosing for interventions related to carbon dioxide levels in pediatric patients should be guided by clinical protocols and the BNF for Children.

Adults: Dosing for interventions related to carbon dioxide levels is typically based on clinical assessment and individual patient needs. Refer to clinical guidelines for specific scenarios.

Mechanism of action

Carbon dioxide acts primarily as a signaling molecule in the body, influencing respiratory drive and blood pH. It is produced during cellular respiration and is a critical component of the bicarbonate buffering system, which helps maintain acid-base homeostasis. Elevated levels of CO2 in the blood stimulate ventilation in the lungs, increasing the rate of gas exchange and facilitating the removal of excess CO2.

Pharmacodynamics

The pharmacodynamic effects of dioxides, particularly carbon dioxide, are closely related to its concentration in the blood. As CO2 levels increase, it leads to respiratory acidosis, which can stimulate the respiratory centers in the brain to increase ventilation. Conversely, low levels of CO2 can cause respiratory alkalosis, potentially leading to decreased respiratory drive. CO2 also plays a role in vasodilation and can affect blood flow and pressure through its influence on smooth muscle tone.

Pharmacokinetics

Carbon dioxide is produced endogenously during metabolic processes and is transported in the bloodstream primarily in three forms: dissolved in plasma, as bicarbonate ions (HCO3-), and bound to hemoglobin. The half-life of CO2 in the bloodstream is very short due to its rapid exchange with alveolar gas in the lungs. The elimination of CO2 occurs through exhalation, making it a dynamic component of respiratory physiology.

Pregnancy

Data on the effects of dioxide during pregnancy are limited. Caution is advised due to potential risks associated with exposure.

Breast-feeding

Limited data are available regarding the excretion of dioxide in human milk. Caution is recommended.

Storage

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

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: lactose

BNF-referenced

Lactose is a disaccharide sugar composed of galactose and glucose, primarily found in milk and dairy products. It serves as a source of energy and is metabolized by the enzyme lactase. In individuals with lactase deficiency, lactose can lead to gastrointestinal symptoms such as bloating, diarrhea, and abdominal pain.

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

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: microcrystalline

Microcrystalline cellulose is a refined wood pulp, commonly used as an excipient in pharmaceutical formulations. It serves as a bulking agent and stabilizer in tablets and capsules, improving the physical properties of the drug formulation. It is characterized by its ability to absorb moisture and provide a suitable texture for various dosage forms.

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.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: poloxamer

Poloxamer is a nonionic surfactant and polymer that is used in various pharmaceutical formulations. It is known for its ability to reduce surface tension and enhance the solubility and stability of drugs in aqueous solutions. Poloxamer is often used in topical preparations, oral formulations, and as a drug delivery agent, particularly in formulations designed for controlled release.

Indications

  • Topical drug delivery
  • Emulsifying agent in pharmaceutical formulations
  • Stabilizing agent in aqueous solutions
  • Controlled drug release systems

Dosage

Children: Refer to specific product guidelines for dosing, as it varies based on formulation and intended use.

Adults: Refer to specific product guidelines for dosing, as it varies based on formulation and intended use.

Mechanism of action

Poloxamer acts primarily by reducing the surface tension at the interface between different phases, such as oil and water. This property allows it to stabilize emulsions and improve the solubility of poorly soluble drugs. Additionally, poloxamer can form micelles in solution, encapsulating hydrophobic drugs and facilitating their delivery in the body.

Pharmacodynamics

Poloxamer exhibits surfactant properties that can enhance drug absorption and bioavailability by altering the permeability of biological membranes. Its action as a solubilizing agent can improve the pharmacological effects of drugs by ensuring they remain in a bioavailable form longer. The polymeric nature of poloxamer can also lead to sustained release of encapsulated drugs, prolonging their therapeutic effect.

Pharmacokinetics

Poloxamer is poorly absorbed when administered orally and is primarily excreted unchanged in the feces. Its absorption through the skin is minimal, making it more suitable for topical applications. The pharmacokinetics can vary based on the formulation and route of administration, with its action typically being localized rather than systemic.

Adverse effects

  • Skin irritation
  • Allergic reactions
  • Gastrointestinal disturbances
  • Headache

Precautions

  • Use with caution in patients with known allergies to surfactants
  • Assess for skin sensitivity before use
  • Monitor for adverse reactions during therapy

Pregnancy

Safety during pregnancy has not been established. Use only if clearly needed and potential benefits justify the risks.

Breast-feeding

It is not known whether poloxamer is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep container tightly closed.

Formulations

  • Poloxamer 188 (used as a surfactant in various formulations)
  • Poloxamer 407 (used in pharmaceutical formulations and drug delivery systems)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: pregelatinised

Pregelatinised starch is a modified starch used as an excipient in pharmaceutical formulations. It is created by pre-gelatinizing starch granules through a process of heating and moisture, making it soluble in cold water. This property allows it to be used as a binder, disintegrant, and thickening agent in tablet and capsule formulations. It enhances the bioavailability of active pharmaceutical ingredients by improving their solubility.

Indications

  • Used as a binder in tablet formulations
  • Serves as a disintegrant to improve drug release
  • Acts as a thickening agent in liquid formulations
  • Enhances bioavailability of poorly soluble drugs

Dosage

Children: Dosage is dependent on the specific formulation and intended use. Refer to formulation guidelines for appropriate concentrations.

Adults: Dosage is dependent on the specific formulation and intended use. Refer to formulation guidelines for appropriate concentrations.

Mechanism of action

Pregelatinised starch acts primarily as a thickening agent and binder in pharmaceutical formulations. When mixed with water, it swells and forms a gel-like consistency, which helps in the uniform distribution of active ingredients and enhances their release and absorption in the gastrointestinal tract. Its ability to gel enables better disintegration of tablets upon administration, facilitating the dissolution of the drug.

Pharmacodynamics

The pharmacodynamics of pregelatinised starch is closely related to its physical properties as a polymer. Upon contact with water, it hydrates and expands, creating a viscous solution that can improve the release profile of drugs. This can lead to enhanced dissolution rates of poorly soluble compounds, improving their bioavailability. Additionally, it can impact the stability and shelf-life of formulations by providing a protective matrix for active ingredients.

Pharmacokinetics

Pregelatinised starch is not absorbed systemically as it primarily acts as an excipient. It undergoes gastrointestinal transit without significant degradation. Its function is to facilitate the release and absorption of the active pharmaceutical ingredients in the formulation rather than exhibiting pharmacokinetic properties of its own.

Pregnancy

Pregelatinised starch is generally considered safe for use during pregnancy, but it is recommended to consult a healthcare provider before use.

Breast-feeding

Pregelatinised starch is considered safe during breastfeeding, but it is advisable to seek medical advice.

Storage

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

Formulations

  • Powder
  • Capsules
  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: silicon

BNF-referenced

Silicon, represented by the molecular formula Si, is a metalloid that plays a significant role in various biological processes, particularly in the formation of connective tissues and bone. It is thought to contribute to the structural integrity of collagen and other extracellular matrix components. Silicon is not classified as an essential element in the human diet, but it is involved in the metabolism of minerals and may affect bone health and formation.

Indications

  • Potential role in bone health
  • Support for connective tissue formation
  • May aid in mineral metabolism

Dosage

Children: There is no established clinical dosage for silicon in paediatric populations, as it is not classified as an essential nutrient.

Adults: There is no established clinical dosage for silicon in adults, as it is not classified as an essential nutrient.

Mechanism of action

Silicon is believed to enhance the synthesis of glycosaminoglycans and collagen, which are important for the structural integrity of connective tissues. It may also influence the activity of certain enzymes involved in bone mineralization, thus playing a role in maintaining bone density and health.

Pharmacodynamics

The pharmacodynamics of silicon is not fully elucidated; however, it is thought to involve the modulation of bone metabolism and the promotion of connective tissue health. Silicon may have a synergistic effect with other minerals, such as calcium and magnesium, aiding in their utilization and metabolism in the body.

Pharmacokinetics

The pharmacokinetics of silicon is complex, as it is not absorbed through typical gastrointestinal pathways. Instead, silicon is thought to be taken up in the form of silicates and then distributed throughout the body, particularly in connective tissues. The elimination of silicon occurs primarily through renal excretion, with some variations depending on dietary intake and individual metabolism.

Pregnancy

Silicon is generally considered safe during pregnancy, as it is a naturally occurring element in the human body. However, specific recommendations regarding supplementation should be followed based on the advice of a healthcare provider.

Breast-feeding

Silicon is present in breast milk in small amounts. Its safety during breastfeeding is generally regarded as acceptable, although supplementation should be approached with caution and under medical advice.

Storage

Silicon should be stored in a cool, dry place, protected from light and moisture. Follow specific storage recommendations provided by the manufacturer if available.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: starch

Starch is a polysaccharide carbohydrate consisting of a large number of glucose units joined by glycosidic bonds. It is a major energy source in the human diet and is found in numerous food sources such as grains, legumes, and tubers. In a clinical setting, starch can also be used as an excipient in various pharmaceuticals and is sometimes utilized in enteral nutrition formulations.

Indications

  • Nutritional supplementation
  • Energy source in enteral nutrition
  • Excipient in pharmaceutical formulations

Dosage

Children: Refer to specific guidelines or product inserts for dosing information, as it can vary based on the context of use.

Adults: Refer to specific guidelines or product inserts for dosing information, as it can vary based on the context of use.

Mechanism of action

Starch is broken down into glucose units by enzymes such as amylase during digestion. The glucose is then absorbed in the intestines and utilized for energy production in the body's cells. This pathway involves hydrolysis of the glycosidic bonds, converting starch into simpler sugars.

Pharmacodynamics

Starch primarily serves as an energy source. Its digestion and absorption lead to an increase in blood glucose levels, which provides energy for metabolic processes. In this context, it plays a crucial role in maintaining energy homeostasis in the body.

Pharmacokinetics

Starch is not absorbed in its polymeric form; it must first be enzymatically hydrolyzed into simpler sugars such as maltose and glucose. The digestion and absorption of starch occur predominantly in the small intestine, with glucose being readily absorbed into the bloodstream. The rate of absorption can vary depending on the type of starch and its physical form.

Adverse effects

  • Allergic reactions
  • Gastrointestinal discomfort
  • Diarrhea
  • Constipation

Precautions

  • Use with caution in individuals with known allergies to starch or starch derivatives
  • Monitor for gastrointestinal symptoms in patients with a history of digestive disorders

Pregnancy

Starch is generally considered safe for use during pregnancy. However, it should be consumed in moderation as part of a balanced diet.

Breast-feeding

Starch is deemed safe for nursing mothers when used in moderation as part of a balanced diet.

Storage

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

Formulations

  • Powder
  • Granules
  • Tablets
  • Suspensions

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: sterate

Sterate is a term often associated with stearate salts, which are derivatives of stearic acid. These salts are typically utilized as excipients in pharmaceutical formulations, serving various functions such as stabilizers, emulsifiers, and lubricants. They help improve the solubility and bioavailability of active pharmaceutical ingredients.

Dosage

Children: Refer to specific product formulations for guidelines, as dosing can vary based on the formulation and therapeutic context.

Adults: Refer to specific product formulations for guidelines, as dosing can vary based on the formulation and therapeutic context.

Mechanism of action

Stearates, such as magnesium stearate, function primarily by reducing friction during tablet manufacturing and enhancing the flow properties of powders. They do not exert a therapeutic pharmacological action in the body but facilitate the delivery of other active substances.

Pharmacodynamics

Given that stearates are primarily excipients, they do not exhibit traditional pharmacodynamic properties as active drugs do. Their role is to optimize the formulation of drugs, enhancing physical characteristics such as texture and consistency, which indirectly affect the performance of the active ingredients.

Pharmacokinetics

Stearates are poorly absorbed in the gastrointestinal tract due to their lipid nature. When ingested, they may pass through the digestive system with minimal systemic absorption. Their primary action occurs at the site of formulation, where they assist in the dispersion and release of active ingredients rather than being metabolized or exerting effects in the body.

Pregnancy

The safety of sterate during pregnancy has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether sterate is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

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

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: talc

BNF-referenced

Talc is a mineral composed of magnesium, silicon, and oxygen, commonly used in various pharmaceutical applications due to its excellent absorptive properties. It is often employed as an excipient in drug formulations and as a bulking agent in tablets and powders. Talc is also utilized in some medical procedures, such as pleurodesis, to prevent the recurrence of pleural effusions.

Indications

  • Used as an excipient in drug formulations
  • Pleurodesis for the management of recurrent pleural effusions

Dosage

Children: Refer to specific guidelines for paediatric use, as dosing may differ based on age and clinical condition.

Adults: Refer to specific guidelines for the appropriate dosage in pleurodesis and other applications, as it may vary based on clinical context.

Mechanism of action

Talc exhibits very good absorptive properties, allowing it to absorb moisture and other substances effectively. This characteristic is particularly useful in pharmaceutical formulations, where it may enhance the stability and texture of the drug product.

Pharmacodynamics

Talc's primary pharmacodynamic effect is its ability to act as an inert filler and bulking agent in pharmaceutical preparations. It does not have any intrinsic pharmacological activity but serves to improve the physical properties of formulations, such as flowability and compressibility.

Pharmacokinetics

Talc is not absorbed systemically when used as an excipient or in medical procedures. Its effects are local, and it remains in the site of application, where it functions primarily as a mechanical agent. The pharmacokinetics of talc in the context of its use in pleurodesis involves its ability to promote adhesion of the pleural surfaces, thereby preventing fluid accumulation.

Pregnancy

Talc is classified as a substance with minimal systemic absorption, but safety during pregnancy has not been well established. Consult relevant guidelines.

Breast-feeding

Talc is not expected to be absorbed in significant amounts; however, caution is advised and consult guidelines.

Storage

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

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Irbesartan

PubChem CID 3749

Molecular formula: C25H28N6O

Mechanism of action

Irbesartan prevents angiotensin II binding to the AT<sub>1</sub> receptor in tissues like vascular smooth muscle and the adrenal gland. Irbesartan and its active metabolite bind the AT<sub>1</sub> receptor with 8500 times more affinity than they bind to the AT<sub>2</sub> receptor. Irbesartan's prevention of angiotensin II binding causes vascular smooth muscle relaxation and prevents the secretion of aldosterone, lowering blood pressure. Angiotensin II would otherwise bind to the AT<sub>1</sub> receptor, inducing vasoconstriction and aldosterone secretion, raising blood pressure. Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system (RAS) and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor and no agonist activity. Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.

Pharmacodynamics

Irbesartan is an angiotensin receptor blocker used to treat hypertension and diabetic nephropathy. It has a long duration of action as it is usually taken once daily and a wide therapeutic index as doses may be as low as 150mg daily but doses of 900mg/day were well tolerated in healthy human subjects.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: lactose

PubChem CID 6134

Molecular formula: C12H22O11

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: silicon

PubChem CID 5461123

Molecular formula: Si

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: talc

PubChem CID 165411828

Molecular formula: H2Mg3O12Si4

Mechanism of action

It has very good absorptive properties.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.