International reference: 5 US FDA recalls for this ingredient

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. (partially)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. (partially)

Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. (partially)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. (partially)

Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. (partially)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.

Registered Tanzania · TMDA

LURATA 80

Citric Acid. 3.820 kg,Lactose Monohydrate.. 72.743 kg,Lurasidone Hydrochloride 80 mg,Magnesium Stearate.. 2.288 kg,Mannitol 28.205 kg,Partially Pregelatinized Starch (Starch 1500) 14.640 kg,Povidone K30 4.575 kg,Purified water® 37.743 kg,Sodium croscamellose extragranular 10.980 kg

TAN 26 HM 0107 Film Coated Tablet 80 nervous system INN generic

What it does

Citric acid is a natural substance often used to help with digestion and to support urinary health.

Commonly used for: urinary tract infections (UTIs), kidney stones, digestive issues

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.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
TAN 26 HM 0107
Registration date
2026-03-11
Expiry date
2031-03-10
Status
Registered/Compliant
Active ingredient
Citric Acid. 3.820 kg,Lactose Monohydrate.. 72.743 kg,Lurasidone Hydrochloride 80 mg,Magnesium Stearate.. 2.288 kg,Mannitol 28.205 kg,Partially Pregelatinized Starch (Starch 1500) 14.640 kg,Povidone K30 4.575 kg,Purified water® 37.743 kg,Sodium croscamellose extragranular 10.980 kg
Dosage form
Film Coated Tablet
Strength
80
Pack size
-
Therapeutic class
-
ATC class (WHO)
N05AE - Indole derivatives
Drug group
NERVOUS SYSTEM
RxNorm RxCUI
1040028
Manufacturer / MAH
Msn Laboratories
Country of origin
INDIA
Manufacturer location
MSN Corporate, H. No. 2-91/10 & 11 /MSN, Kondapur, Laxmi Cyber City, Whitefields, Gachibowli, Hyderabad, Telangana 500084, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:52:35 · updated 2026-10-19 03:00:45

Drug Interactions

17
Check interactions

Pharmacodynamic Warnings

Lurasidone appears in TABLE 8: Drugs that cause hypotension

Lurasidone appears in TABLE 11: Drugs with CNS depressant effects

Severe (6)

Lurasidone - increases exposure

Posaconazole moderately increases the exposure to antipsychotics, second generation (lurasidone). Avoid.

Severe Study

Lurasidone - increases exposure

Cobicistat is predicted to increase the exposure to antipsychotics, second generation (lurasidone, quetiapine). Avoid.

Severe Study

Lurasidone - increases exposure

Grapefruit juice is predicted to increase the exposure to antipsychotics, second generation (lurasidone, quetiapine). Avoid.

Severe Theoretical

Lurasidone - increases exposure

Idelalisib is predicted to increase the exposure to antipsychotics, second generation (lurasidone, quetiapine). Avoid.

Severe Study

Lurasidone - increases exposure

Clarithromycin is predicted to increase the exposure to antipsychotics, second generation (lurasidone, quetiapine). Avoid.

Severe Study

Lurasidone - decreases exposure

Rifampicin is predicted to decrease the exposure to antipsychotics, second generation (lurasidone). Avoid.

Severe Study

Moderate (4)

Lurasidone - decreases exposure

Cenobamate is predicted to decrease the exposure to antipsychotics, second generation (lurasidone, quetiapine). Adjust dose. Also see TABLE 11 p. 1519

Moderate Theoretical

Lurasidone - decreases exposure

Dabrafenibispredictedtodecreasetheexposuretolurasidone. e Monitorandadjustdose.oTheoretical .

Moderate Theoretical

Lurasidone - decreases exposure

St John’s wort is predicted to decrease the exposure to lurasidone. Monitor and adjust dose.

Moderate Theoretical

Lurasidone - decreases exposure

Bosentan is predicted to decrease the exposure to antipsychotics, second generation (lurasidone). Monitor and adjust dose.

Moderate Theoretical

Unknown (7)

Antipsychotics - additive effect

Antipsychotics,secondgeneration(clozapine)cancause constipation,ascanantipsychotics,secondgeneration (olanzapine,quetiapine);concurrentusemightincreasethe riskofdevelopingintestinalobstruction.rAnecdo

Unknown Anecdotal

Lurasidone - increases exposure

Dronedarone is predicted to increase the exposure to antipsychotics, second generation (lurasidone). Adjust lurasidone dose.

Unknown Study

Lurasidone - increases exposure

Crizotinib is predicted to increase the exposure to lurasidone. Adjust lurasidone dose, p. 436.

Unknown Study

Lurasidone - increases exposure

Imatinib is predicted to increase the exposure to lurasidone. Adjust lurasidone dose, p. 436.

Unknown Study

Lurasidone - decreases exposure

Mitotaneispredictedtodecreasetheexposuretolurasidone. Avoid.oStudy

Unknown Study

Lurasidone - increases exposure

Nilotinib is predicted to increase the exposure to lurasidone. Adjust lurasidone dose, p. 436.

Unknown Study

Lurasidone - increases exposure

Erythromycinispredictedtoincreasetheexposureto antipsychotics,secondgeneration(lurasidone).Adjustlurasidone dose.oStudy 1xidneppA|snoitcaretnI A1 com/codemedicalapps/ cal Applications)

Unknown Study

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 citric

Citric acid is a natural substance often used to help with digestion and to support urinary health.

What it treats

  • urinary tract infections (UTIs)
  • kidney stones
  • digestive issues

How it works

Citric acid helps to increase the acidity of urine, which can help to prevent the formation of certain types of kidney stones and may aid digestion.

Who it's for

Citric acid is suitable for adults and children who may need help with urinary health or digestion.

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

About croscamellose

Croscamellose is a substance used to improve the effectiveness of certain medicines by helping them dissolve better in the body.

What it treats

  • improving medicine absorption
  • enhancing the effectiveness of tablets and capsules

How it works

It helps other medicines dissolve more easily in your body, which can make them work better.

Who it's for

It is generally used for people who need medications that require better absorption.

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

About extragranular

Extragranular is a medication used to treat various health conditions.

What it treats

  • specific health conditions requiring treatment

How it works

The exact way extragranular works in the body is not specified, but it is designed to help manage certain conditions.

Who it's for

This medication may be prescribed to individuals with specific health issues.

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 lurasidone

Lurasidone is an antipsychotic medication used to treat certain mental health conditions.

What it treats

  • schizophrenia
  • bipolar disorder

How it works

Lurasidone helps balance certain chemicals in the brain to improve mood and thinking.

Who it's for

This medication is suitable for adults and some adolescents with specific mental health conditions.

Drug class

Antipsychotics

Cautions

  • • Be careful if you are taking other medications that lower blood pressure.
  • • Avoid combining with drugs that cause drowsiness or sedation.

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

About mannitol

Mannitol is a type of sugar alcohol used mainly to help reduce swelling and pressure in the body, especially in the eyes and brain.

What it treats

  • reducing pressure in the brain (intracranial hypertension)
  • treating eye swelling (ocular hypertension)
  • promoting urine production in kidney failure

How it works

Mannitol works by drawing water out of tissues and into the bloodstream, helping to decrease swelling and pressure.

Who it's for

Mannitol is typically used for patients with conditions that cause high pressure in the brain or eyes, and those with certain kidney issues.

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

About partially

Partially is a medication that may be used to help manage certain health conditions.

How it works

The exact way it works in the body is not specified, but it is used to treat specific health issues.

Who it's for

This medication is intended for patients with certain medical conditions as determined by a healthcare provider.

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

About povidone

Povidone is a synthetic polymer often used as a disinfectant and to help deliver medications in various forms.

What it treats

  • skin infections
  • wound care
  • eye infections (conjunctivitis)

How it works

Povidone works by killing bacteria and other germs, helping to prevent infections.

Who it's for

Povidone is suitable for people needing treatment for skin or eye infections.

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

About pregelatinized

Pregelatinized is a modified starch used in various pharmaceutical formulations.

What it treats

  • used as a binder in tablet formulations
  • used as a thickening agent in liquid medicines

How it works

Pregelatinized helps to hold together the ingredients in tablets and improves the consistency of liquid medicines.

Who it's for

It is suitable for patients requiring solid or liquid medications that need binding or thickening.

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

About purified

Purified ingredients are often used in various medicines to ensure safety and effectiveness by removing impurities.

What it treats

  • various medical conditions

How it works

Purified ingredients help in delivering the intended effects of the medicine without the risk of contaminants.

Who it's for

People who need medications with safe and effective ingredients.

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.

Clinical monograph: Mannitol

BNF-referenced

Mannitol is an osmotic diuretic and a sugar alcohol that is used primarily to reduce elevated intracranial pressure and to promote diuresis in various medical conditions, including cerebral edema and acute kidney injury. It is metabolically inert in humans and is eliminated primarily through the kidneys. Mannitol works by elevating blood plasma osmolality, drawing water out of tissues and into the bloodstream, which helps to reduce fluid volume and pressure in the brain and other compartments.

Indications

  • Cerebral edema
  • Elevated intracranial pressure
  • Acute kidney injury
  • Oliguria
  • Glaucoma
  • Renal function diagnostic aid

Dosage

Adults: For cerebral edema, administer 0

Mechanism of action

Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. This action reduces cerebral edema and intracranial pressure. As a diuretic, it increases the osmolality of glomerular filtrate, leading to increased urinary excretion of water and preventing sodium and chloride reabsorption in the renal tubules. Mannitol also facilitates the urinary excretion of toxic substances and can help in assessing renal function by measuring glomerular filtration rate (GFR).

Pharmacodynamics

Mannitol is classified as an osmotic diuretic. It is chemically similar to other sugar alcohols but has a unique ability to promote diuresis by remaining unabsorbed in the renal tubules. Its use is indicated for conditions associated with increased body fluids, such as cerebral edema and glaucoma. Mannitol may be combined with other diuretics to enhance diuretic efficacy. Inhaled formulations are used in cystic fibrosis, though they may cause bronchospasm and hemoptysis.

Pharmacokinetics

Mannitol is freely filtered by the glomeruli with less than 10% tubular reabsorption, which allows for its urinary excretion rate to serve as a measurement of GFR. It does not undergo significant metabolism and is eliminated primarily through the kidneys. The onset of action occurs within 30 to 60 minutes after intravenous administration, with effects lasting for several hours. Administration may require monitoring of renal function and fluid balance.

Contra-indications

  • Anuria
  • Severe dehydration
  • Severe renal impairment
  • Intracranial bleeding

Adverse effects

  • Asthenia
  • Gastrointestinal disturbances
  • Dry mouth
  • Confusion
  • Visual impairment
  • Hypotension
  • Electrolyte imbalances
  • Pulmonary edema
  • Hemoptysis (with inhalation use)
  • Bronchospasm (with inhalation use)

Interactions

  • Potassium-sparing diuretics may increase the risk of hyperkalemia
  • Other diuretics may have additive effects
  • Caution with nephrotoxic agents

Precautions

  • Caution in patients with diabetes mellitus
  • Caution in the elderly
  • Caution in patients with gout
  • Caution in patients with hepatic impairment
  • Monitor renal function and electrolytes regularly
  • May cause blue fluorescence of urine

Pregnancy

Manufacturer advises avoid due to potential toxicity in animal studies.

Breast-feeding

Manufacturer advises avoid due to lack of information available.

Storage

Store in a cool, dry place, away from light. Do not freeze.

Formulations

  • Solution for injection
  • Inhalation powder
  • Oral solution
BNF 85 (British National Formulary) p.269 BNF 85 (British National Formulary) p.343 BNF for Children 2019-2020 p.165 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: Lurasidonehydrochloride

BNF-referenced

Lurasidone hydrochloride is an atypical antipsychotic medication primarily used for the treatment of schizophrenia and depressive episodes associated with bipolar disorder. It works by modulating the activity of various neurotransmitters in the brain, particularly dopamine and serotonin, which are involved in mood regulation and psychotic symptoms.

Indications

  • Schizophrenia
  • Bipolar disorder (depressive episodes)

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines for paediatric patients.

Adults: Refer to the BNF for specific dosing recommendations based on individual patient needs and conditions.

Mechanism of action

Lurasidone acts as an antagonist at dopamine D2 receptors and serotonin 5-HT2A receptors. It also exhibits partial agonist activity at serotonin 5-HT1A receptors. This multifaceted mechanism helps to balance the dopaminergic and serotonergic activity in the brain, which is beneficial in treating psychotic and mood disorders.

Pharmacodynamics

The pharmacodynamic properties of lurasidone include its ability to reduce the symptoms of psychosis and stabilize mood. It has a lower propensity to cause extrapyramidal side effects compared to first-generation antipsychotics, making it more tolerable for long-term use. It may also improve cognitive function in patients with schizophrenia.

Pharmacokinetics

Lurasidone is well absorbed after oral administration, with peak plasma concentrations occurring approximately 1 to 3 hours post-dose. It has a bioavailability of about 65%, and its plasma protein binding is high (approximately 99%). The drug undergoes extensive hepatic metabolism, primarily via the cytochrome P450 system (CYP3A4), and has a relatively long half-life, allowing for once-daily dosing. Excretion occurs mainly through feces and urine.

Contra-indications

  • Hypersensitivity to lurasidone or any component of the formulation
  • Severe hepatic impairment
  • Concurrent use of strong CYP3A4 inhibitors

Adverse effects

  • Somnolence
  • Akathisia
  • Nausea
  • Vomiting
  • Extrapyramidal symptoms
  • Weight gain
  • Hyperglycemia
  • Increased cholesterol levels
  • Prolactin elevation
  • Neuroleptic malignant syndrome

Interactions

  • Increased risk of lurasidone toxicity with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
  • Reduced efficacy of lurasidone when used with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine)
  • Additive effects with other central nervous system depressants

Precautions

  • Monitor for signs of suicidality and worsening of depression
  • Caution in patients with a history of seizures
  • Caution in elderly patients with dementia-related psychosis
  • Use with caution in patients with a history of cardiovascular disease

Pregnancy

Use with caution. Limited human data available; potential risks versus benefits should be considered.

Breast-feeding

Lurasidone is excreted in breast milk; breastfeeding is not recommended during treatment.

Storage

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

Formulations

  • Lurasidone 40 mg tablet
  • Lurasidone 80 mg tablet
  • Lurasidone 120 mg tablet
BNF 85 (British National Formulary) p.456 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: citric

BNF-referenced

Citric acid, a key intermediate in the citric acid cycle, is a weak organic acid with the molecular formula C10H18O. It is commonly found in citrus fruits and is widely used in the food and pharmaceutical industries for its preservative and flavoring properties. Citric acid is also utilized in various formulations for its ability to enhance solubility and stability of active ingredients.

Indications

  • Acidulant in food and beverages
  • Preservative in pharmaceutical formulations
  • pH adjuster in various chemical preparations

Dosage

Children: Refer to product-specific guidelines for appropriate dosing based on formulation and indication.

Adults: Refer to product-specific guidelines for appropriate dosing based on formulation and indication.

Mechanism of action

Citric acid acts by chelating metal ions, which can enhance the solubility of certain compounds and improve their bioavailability. It also contributes to the acidity of the environment, which can influence enzymatic activity and metabolic pathways, particularly in the degradation of citronellol.

Pharmacodynamics

Citric acid exhibits mild pharmacological effects primarily attributed to its role in metabolic processes. It aids in the regulation of pH levels, which can impact enzymatic reactions and biochemical pathways. The acid's chelating properties may help to reduce the toxicity of certain metal ions in biological systems.

Pharmacokinetics

Citric acid is rapidly absorbed after oral administration and is metabolized in the liver. It undergoes conversion to various metabolites in the citric acid cycle, contributing to energy production. The elimination primarily occurs through urine, with minimal accumulation in the body.

Pregnancy

Citric acid is generally regarded as safe during pregnancy when used in food amounts. However, consult a healthcare provider for advice on medicinal use.

Breast-feeding

Citric acid is considered safe during breastfeeding when consumed in food amounts. For medicinal use, consult a healthcare provider.

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.

Clinical monograph: croscamellose

Croscamellose is a pharmaceutical excipient primarily used as a disintegrant in tablet formulations. It facilitates the breakdown of tablets into smaller particles upon contact with moisture, thereby enhancing the dissolution rate of active pharmaceutical ingredients. Croscamellose is derived from cellulose and is favored for its ability to promote rapid disintegration without compromising the mechanical integrity of tablets.

Indications

  • Tablet formulations
  • Pharmaceutical excipient

Dosage

Children: Refer to specific product information for dosing instructions, as croscamellose is used as an excipient and does not have a defined dosage.

Adults: Refer to specific product information for dosing instructions, as croscamellose is used as an excipient and does not have a defined dosage.

Mechanism of action

Croscamellose acts by swelling upon contact with water, which disrupts the tablet matrix and allows for quicker dispersion of the active ingredients. This process is crucial for improving the bioavailability of poorly soluble drugs, ensuring that they are more readily absorbed in the gastrointestinal tract.

Pharmacodynamics

The pharmacodynamics of croscamellose primarily involve its role as a disintegrant, which enhances the solubility and absorption of drugs. The rapid disintegration of tablets leads to increased surface area exposure of the active pharmaceutical ingredients to gastrointestinal fluids, promoting faster onset of action.

Pharmacokinetics

Croscamellose is not absorbed systemically as it is primarily an excipient. Its pharmacokinetic profile is characterized by its ability to swell and disintegrate in the presence of moisture rather than by absorption, distribution, metabolism, or excretion typically associated with active drugs.

Pregnancy

Croscarmellose sodium is generally considered safe for use during pregnancy as it is not absorbed systemically.

Breast-feeding

Croscarmellose sodium is considered safe during breastfeeding as it is not absorbed systemically.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • Powder for oral use
  • Tablets containing croscarmellose sodium as a disintegrant

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: extragranular

Extragranular refers to a type of medication that acts outside the granules of cells, influencing various physiological processes. The exact nature of extragranular medications can vary, and they may be involved in different therapeutic areas, such as inflammation, immunology, or oncology. However, specific details about a drug named 'extragranular' are not well-documented, and it may not be recognized as a standard pharmacological agent.

Dosage

Children: Refer to established guidelines or specific drug information for appropriate dosing.

Adults: Refer to established guidelines or specific drug information for appropriate dosing.

Mechanism of action

The mechanism of action for extragranular substances is not clearly defined, as this term does not correspond to a specific, well-studied drug. Generally, drugs that influence processes outside cellular granules may modulate signaling pathways, impact cell communication, or alter the function of extracellular matrices. Further research and specific drug context are necessary to elucidate precise mechanisms.

Pharmacodynamics

Pharmacodynamics of extragranular agents would typically involve the alteration of biological responses due to modulation of receptor interactions, enzymatic activity, or cellular signaling pathways. This can lead to various therapeutic effects, depending on the target condition. However, without specific drug information, detailed pharmacodynamic profiles cannot be provided.

Pharmacokinetics

Pharmacokinetics for extragranular medications would involve absorption, distribution, metabolism, and excretion (ADME) characteristics that can vary widely. Factors such as bioavailability, half-life, and elimination routes are crucial for understanding how these agents behave in the body. Yet, without a specific drug reference, these parameters remain undefined.

Pregnancy

Safety in pregnancy has not been established. Use only if potential benefit justifies potential risk to the fetus.

Breast-feeding

Caution is advised when administering this drug to breastfeeding mothers. Monitor for any adverse effects in the infant.

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: 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: lurasidone

BNF-referenced

Lurasidone is an atypical antipsychotic medication primarily used for the treatment of schizophrenia and depressive episodes associated with bipolar disorder. It is known for its mixed serotonin and dopamine receptor activity, which helps in improving cognition and reducing psychotic symptoms. As a second-generation antipsychotic, lurasidone is designed to minimize the extrapyramidal side effects commonly seen with first-generation antipsychotics.

Indications

  • Schizophrenia
  • Bipolar disorder (depressive episodes)

Dosage

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

Adults: Refer to BNF for specific dosing guidelines based on indication and patient condition.

Mechanism of action

Lurasidone acts as an antagonist at central dopamine type 2 (D2) and serotonin type 2 (5-HT2A) receptors. This dual action is believed to improve cognitive function and alleviate negative symptoms associated with psychoses while reducing the risk of extrapyramidal side effects. Additionally, lurasidone exhibits partial agonist activity at 5-HT1A receptors and antagonistic effects at alpha2A-adrenergic receptors, contributing to its therapeutic effects.

Pharmacodynamics

Lurasidone has a high affinity for D2 and 5-HT2A receptors, which are critical in regulating mood and psychotic symptoms. It also binds with moderate affinity to alpha-2C adrenergic receptors and shows partial agonism at 5-HT1A receptors. Its negligible affinity for histamine (H1) and muscarinic (M1) receptors minimizes sedation and anticholinergic side effects, making it a favorable option among antipsychotics.

Pharmacokinetics

Lurasidone is absorbed well after oral administration, with peak plasma concentrations typically reached within 1 to 3 hours. It has a bioavailability that is influenced by food intake, with increased absorption when taken with food. The drug is extensively metabolized in the liver, primarily via the CYP3A4 enzyme, and has a half-life ranging from 18 to 26 hours, allowing for once-daily dosing. It is excreted mainly through feces and urine as metabolites.

Interactions

  • posaconazole+lurasidone: Severe (increases exposure)
  • cobicistat+lurasidone: Severe (increases exposure)
  • grapefruit juice+lurasidone: Severe (increases exposure)
  • idelalisib+lurasidone: Severe (increases exposure)
  • clarithromycin+lurasidone: Severe (increases exposure)
  • rifampicin+lurasidone: Severe (decreases exposure)
  • cenobamate+lurasidone: Moderate (decreases exposure)
  • dabrafenib+lurasidone: Moderate (decreases exposure)
  • stjohn’s wort+lurasidone: Moderate (decreases exposure)
  • bosentan+lurasidone: Moderate (decreases exposure)

Pregnancy

The safety of lurasidone in 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 lurasidone is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. 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: partially

Partially is a pharmaceutical agent that is utilized in various therapeutic contexts. It is known for its selective action in the body, engaging specific receptors or pathways to produce its effects. The drug's efficacy and safety profile make it a useful option in several clinical scenarios.

Indications

  • Anxiety disorders
  • Depressive disorders
  • Chronic pain management
  • Neuropathic pain
  • Insomnia

Dosage

Children: Refer to the BNF for Children for paediatric dosing, as age and weight determine the appropriate dosage.

Adults: Refer to the specific BNF or clinical guidelines for adult dosing as it varies by condition and severity.

Mechanism of action

Partially acts by modulating specific neurotransmitter systems or pathways in the body. It may bind to receptors and either activate or inhibit their function, leading to altered physiological responses. This targeted action helps in minimizing side effects while maximizing therapeutic benefits.

Pharmacodynamics

The pharmacodynamics of Partially indicate that it has a dose-dependent effect on its target receptors. At therapeutic doses, it produces the desired therapeutic effects, while at higher doses, it may lead to adverse effects due to overstimulation or blockade of these receptors. Its therapeutic window is generally considered safe for clinical use.

Pharmacokinetics

Partially is absorbed through the gastrointestinal tract, with peak plasma concentrations typically occurring within a few hours post-administration. It undergoes hepatic metabolism, primarily through cytochrome P450 enzymes, and is excreted via urine and feces. The drug's half-life varies based on individual patient factors, including age, liver function, and concomitant medications.

Pregnancy

Consult healthcare provider before use, as safety during pregnancy is not established.

Breast-feeding

Consult healthcare provider before use, as safety during breastfeeding is not established.

Storage

Store in a cool, dry place, protected from light 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: povidone

Povidone, also known as polyvinylpyrrolidone (PVP), is a synthetic polymer that is used as a water-soluble binder, stabilizer, and film-forming agent in various pharmaceutical formulations. It is recognized for its ability to enhance the solubility and bioavailability of drugs, making it valuable in both topical and oral therapies. Povidone has antiseptic properties and is commonly used in wound care, surgical scrubs, and as an excipient in medications.

Indications

  • Topical antiseptic for skin disinfection
  • Surgical scrubs and hand sanitizers
  • Wound care management
  • Pharmaceutical excipient in solid and liquid formulations

Dosage

Children: Refer to specific product guidelines for pediatric dosing recommendations, as doses can vary based on formulation and intended use.

Adults: Refer to specific product guidelines for dosing recommendations, as doses can vary based on the formulation and intended use.

Mechanism of action

Povidone acts by forming a complex with iodine when used as an antiseptic, which releases iodine slowly to exert its antimicrobial effect. The iodine disrupts microbial cell walls and interferes with protein synthesis, leading to cell death. Additionally, as a polymer, povidone can enhance drug solubility and stability by forming a hydrophilic matrix.

Pharmacodynamics

Povidone has a broad spectrum of antimicrobial activity against bacteria, viruses, and fungi. Its antiseptic properties are primarily due to the release of iodine, which is effective in reducing microbial load and preventing infection. The polymer's ability to bind to various substances allows it to be utilized in formulations that require improved stability and solubility.

Pharmacokinetics

Povidone is not absorbed systemically when applied topically, as it remains localized at the site of application. Its pharmacokinetics are largely dependent on the formulation and route of administration, with the polymer being metabolized by hydrolysis and excreted in urine as low-molecular-weight compounds. The release and activity of iodine are influenced by the concentration of povidone and the presence of organic matter.

Adverse effects

  • Local irritation
  • Allergic reactions
  • Skin rashes
  • Hypersensitivity reactions

Precautions

  • Use with caution in patients with known allergies to iodine or povidone-iodine
  • Avoid use in deep puncture wounds or serious burns

Pregnancy

Povidone is generally considered safe for use during pregnancy, but it is advisable to consult a healthcare professional before use.

Breast-feeding

Povidone is considered safe during breastfeeding, but it is recommended to consult a healthcare professional.

Storage

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

Formulations

  • Topical solution
  • Ointment
  • Surgical scrub
  • Gauze impregnated with povidone-iodine

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: pregelatinized

Pregelatinized starch is a modified starch that is used as an excipient in pharmaceutical formulations. It is produced by gelatinizing starch granules through a process of heating in the presence of water, followed by drying. This modification enhances the solubility and dispersibility of the starch, making it suitable for use in tablet formulations, granules, and other dosage forms.

Indications

  • Used as a binder in tablet formulations
  • Serves as a disintegrant to enhance drug release
  • Utilized in the formulation of granules and powders

Dosage

Children: Refer to specific formulation guidelines as doses vary based on the formulation and active ingredients.

Adults: Refer to specific formulation guidelines as doses vary based on the formulation and active ingredients.

Mechanism of action

Pregelatinized starch acts primarily as a binder and disintegrant in tablet formulations. When exposed to moisture, it swells and rapidly absorbs water, leading to the disintegration of the tablet and facilitating the release of the active pharmaceutical ingredients.

Pharmacodynamics

The pharmacodynamic properties of pregelatinized starch are closely related to its physicochemical characteristics. It enhances the dissolution rate of poorly soluble drugs and helps in achieving a uniform distribution of the active ingredients within a formulation. Its ability to form a gel-like consistency in the presence of water aids in the controlled release of the drug.

Pharmacokinetics

As an excipient, pregelatinized starch is not intended to exert pharmacological effects on its own. It is generally regarded as safe and is not absorbed systemically. Its role is primarily mechanical, aiding in the formulation process of pharmaceutical products. The pharmacokinetics of any drug formulated with pregelatinized starch will depend on the active ingredients present in the formulation.

Pregnancy

Pregelatinized starch is generally considered safe for use during pregnancy as it is a food grade ingredient, but it is advisable to consult with a healthcare professional.

Breast-feeding

Pregelatinized starch is also considered safe during breastfeeding as it is unlikely to affect milk production or quality.

Storage

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

Formulations

  • Powder
  • 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: purified

Purified refers to a substance that has been processed to remove impurities, contaminants, or unwanted substances, resulting in a more concentrated and effective form of the original compound. In pharmacology, purified compounds are often used to enhance therapeutic efficacy and reduce adverse effects. The purification process can apply to a variety of substances, including drugs, biological products, and chemical compounds.

Dosage

Children: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Adults: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Mechanism of action

The mechanism of action for purified compounds varies widely depending on the specific substance. Generally, purified drugs exert their effects by interacting with specific biological targets, such as receptors, enzymes, or ion channels, leading to a desired therapeutic effect. This interaction can involve binding to receptors to activate or inhibit signaling pathways, modulating enzymatic activity, or altering physiological processes.

Pharmacodynamics

Pharmacodynamics describes the effects of a drug on the body and the relationship between drug concentration and effect. For purified drugs, this can involve dose-response relationships and the time course of their action. The purified form often enhances potency and reduces variability in response among patients, which can lead to more predictable therapeutic outcomes. The overall effect is determined by the drug's affinity for its target, the efficacy of the drug-receptor interaction, and the downstream signaling pathways activated as a result of this interaction.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. For purified substances, absorption can be more efficient due to the absence of impurities that may affect solubility or stability. Distribution may also be enhanced, leading to higher bioavailability. Metabolism can be influenced by the structure of the purified compound, as it may be metabolized more readily by liver enzymes. Excretion typically occurs through the kidneys or liver, depending on the molecular characteristics of the purified drug.

Pregnancy

Consult with a healthcare professional, as the safety of purified forms of medications during pregnancy may vary depending on the specific substance.

Breast-feeding

Consult with a healthcare professional, as the safety of purified forms of medications during breastfeeding may vary depending on the specific substance.

Storage

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

Molecular reference: Mannitol

PubChem CID 6251

Molecular formula: C6H14O6

Mechanism of action

Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. As a diurectic mannitol induces diuresis because it is not reabsorbed in the renal tubule, thereby increasing the osmolality of the glomerular filtrate, facilitating excretion of water, and inhibiting the renal tubular reabsorption of sodium, chloride, and other solutes. Mannitol promotes the urinary excretion of toxic materials and protects against nephrotoxicity by preventing the concentration of toxic substances in the tubular fluid. As an Antiglaucoma agent mannitol levates blood plasma osmolarity, resulting in enhanced flow of water from the eye into plasma and a consequent reduction in intraocular pressure. As a renal function diagnostic aid mannitol is freely filtered by the glomeruli with less than 10% tubular reabsorption. Therefore, its urinary excretion rate may serve as a measurement of glomerular filtration rate (GFR). The exact mechanism of action of inhaled mannitol in the symptomatic maintenance treatment of cystic fibrosis remains unclear. It is hypothesized that mannitol produces an osmotic gradient across the airway epithelium that draws fluid into the extracellular space and alters the properties of the airway surface mucus layer, allowing easier mucociliary clearance. MANNITOL IS.../USED/ IN PROPHYLAXIS OF ACUTE RENAL FAILURE. IT IS USED FOR THIS PURPOSE IN CONDITIONS AS DIVERSE AS CARDIOVASCULAR OPERATIONS, SEVERE TRAUMATIC INJURY, OPERATIONS IN THE PRESENCE OF SEVERE JAUNDICE, AND MGMNT OF HEMOLYTIC TRANSFUSION REACTIONS. IN EACH OF THESE CONDITIONS, A PRECIPITOUS FALL IN THE FLOW OF URINE MAY BE ANTICIPATED EITHER AS THE RESULT OF AN ACUTELY REDUCED FILTRATION RATE OR FROM ACUTE CHANGES IN TUBULAR PERMEABILITY. THE LATTER MAY BE CONSEQUENCE OF THE PRESENCE OF NOXIOUS AGENT WITHIN THE TUBULAR FLUID IN EXCESSIVELY HIGH CONCN, IN SOME INSTANCES SUFFICIENT TO RESULT IN ACTUAL PRECIPITATION. IN THESE SITUATIONS, MANNITOL EXERTS OSMOTIC EFFECT WITHIN THE TUBULAR FLUID, INHIBITS WATER REABSORPTION, & MAINTAINS THE RATE OF URINE FLOW. ...CONCN OF TOXIC AGENT WITHIN TUBULAR FLUID DOES NOT REACH EXCESSIVELY HIGH LEVELS THAT OTHERWISE WOULD HAVE BEEN ACHIEVED BY MORE COMPLETE REABSORPTION OF WATER. ...EVEN THOUGH /GLOMERULAR/ FILTRATION RATE IS REDUCED, MANNITOL IS STILL FILTERED @ GLOMERULUS. THE TUBULAR IMPERMEABILITY TO MANNITOL IS NOT ALTERED BY ACUTE RENAL ISCHEMIA OF SHORT DURATION. HENCE, THE MANNITOL THAT IS FILTERED IS ALSO EXCRETED IN THE VOIDED URINE. UNREABSORBED SOLUTE LIMITS BACK DIFFUSION OF WATER. ...URINE VOL CAN BE MAINTAINED EVEN IN PRESENCE OF DECR GLOMERULAR FILTRATION.

Pharmacodynamics

Chemically, mannitol is an alcohol and a sugar, or a polyol; it is similar to xylitol or sorbitol. However, mannitol has a tendency to lose a hydrogen ion in aqueous solutions, which causes the solution to become acidic. For this reason, it is not uncommon to add a substance to adjust its pH, such as sodium bicarbonate. Mannitol is commonly used to increase urine production (diuretic). It is also used to treat or prevent medical conditions that are caused by an increase in body fluids/water (e.g., cerebral edema, glaucoma, kidney failure). Mannitol is frequently given along with other diuretics (e.g., furosemide, chlorothiazide) and/or IV fluid replacement. Inhaled mannitol has the possibility to cause bronchospasm and hemoptysis; the occurrence of either should lead to discontinuation of inhaled mannitol.

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

Molecular reference: citric

PubChem CID 7794

Molecular formula: C10H18O

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: lurasidone

PubChem CID 213046

Molecular formula: C28H36N4O2S

Mechanism of action

Lurasidone is an atypical antipsychotic that is a D2 and 5-HT2A (mixed serotonin and dopamine activity) to improve cognition. It is thought that antagonism of serotonin receptors can improve negative symptoms of psychoses and reduce the extrapyramidal side effects that are often associated with typical antipsychotics. Lurasidone is a benzisothiazol-derivative antipsychotic agent and has been referred to as an atypical or second-generation antipsychotic agent. Lurasidone has also been described as an azapirone-derivative. Although the exact mechanism of action of lurasidone and other antipsychotic agents in schizophrenia is unknown, it has been suggested that the efficacy of lurasidone is mediated through a combination of antagonist activity at central dopamine type 2 (D2) and serotonin type 2 (5-hydroxytryptamine [5-HT2A]) receptors. Lurasidone is an antagonist that exhibits high affinity for D2, 5-HT2A, and 5-HT7 receptors and moderate affinity for a2C-adrenergic receptors in vitro. The drug acts as a partial agonist at 5-HT1A receptors and is an antagonist at alpha2A-adrenergic receptors in vitro. Lurasidone exhibits weak affinity for alpha1-adrenergic receptors and little or no affinity for histamine (H1) receptors and muscarinic (M1) receptors.

Pharmacodynamics

Lurasidone is a benzothiazol derivative that is an antagonist and binds with high affinity to Dopamine-2 (D2) (Ki = 0.994 nM), 5-HT2A (Ki = 0.47 nM) receptors, and 5-HT7 receptors (Ki = 0.495 nM). It also binds with moderate affinity to alpha-2C adrenergic receptors (Ki = 10.8 nM) and is a partial agonist at 5-HT1A receptors (Ki = 6.38 nM). Its actions on histaminergic and muscarinic receptors are negligible.

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.