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promethazine reference
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(promethazine · DailyMed)
Registered Tanzania · TMDA

PROM

AF-Coat (Aqueous) Blue Colour 5.600 mg/6 mL,Magnesium Stearate 2.000 mg/6 mL,Maize starch 13.100 mg/6 mL,Microcrystalline Cellulose (Avicel PH 200) 90.000 mg/6 mL,Povidone K-30 1.400 mg/6 mL,Promethazine Hydrochloride BP 25 mg/6 mL,Purified Water q.s ml,Purified talc 1.500 mg/6 mL,Sodium Starch Glycolate 7.000 mg/6 mL

TAN 25 HM 0509 Film Coated Tablet 25 blood and blood forming organs INN generic

What it does

Blue is a medication used to treat various health conditions. It works by targeting specific processes in the body to provide relief.

Commonly used for: general health issues, pain relief

Read more in plain English ↓

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

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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 25 HM 0509
Registration date
2025-11-18
Expiry date
2030-11-17
Status
Registered/Compliant
Active ingredient
AF-Coat (Aqueous) Blue Colour 5.600 mg/6 mL,Magnesium Stearate 2.000 mg/6 mL,Maize starch 13.100 mg/6 mL,Microcrystalline Cellulose (Avicel PH 200) 90.000 mg/6 mL,Povidone K-30 1.400 mg/6 mL,Promethazine Hydrochloride BP 25 mg/6 mL,Purified Water q.s ml,Purified talc 1.500 mg/6 mL,Sodium Starch Glycolate 7.000 mg/6 mL
Dosage form
Film Coated Tablet
Strength
25
Pack size
-
Therapeutic class
-
ATC class (WHO)
B02BC - Local hemostatics
RxNorm RxCUI
2221
Manufacturer / MAH
Cure Afya
Country of origin
TANZANIA
Manufacturer location
Kimbiji, Tanzania

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:50:18 · updated 2026-10-19 03:00:45

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

About blue

Blue is a medication used to treat various health conditions. It works by targeting specific processes in the body to provide relief.

What it treats

  • general health issues
  • pain relief

How it works

Blue works by affecting certain chemicals in the body to help alleviate symptoms.

Who it's for

Blue is suitable for adults and children with the prescribed conditions.

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

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 colour

This medicine is used to change the color of certain products.

What it treats

  • to color food
  • to tint cosmetics
  • to dye textiles

How it works

It adds color to products, making them visually appealing.

Who it's for

This product is suitable for anyone needing to add color to food, cosmetics, or textiles.

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

About glycolate

Glycolate is a compound that may be used in various medical treatments.

How it works

Glycolate works by interacting with certain bodily processes, though specific details are not available.

Who it's for

Glycolate may be suitable for individuals needing treatment related to certain health conditions, but specific indications are not provided.

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

About maize

Maize is a common food ingredient that provides energy and nutrients.

What it treats

  • nutrition
  • energy source

How it works

Maize is a carbohydrate-rich food that the body uses for energy.

Who it's for

Suitable for most people, including adults and children.

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 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 promethazine

Promethazine is a sedating antihistamine used to treat allergies, motion sickness, and to help with sleep.

What it treats

  • allergies
  • motion sickness
  • insomnia

How it works

It blocks the action of a substance in the body called histamine, which helps reduce allergy symptoms and promotes sleep.

Who it's for

Promethazine is suitable for adults and children over 2 years old, but not everyone should use it.

Drug class

Antihistamines, sedating

Cautions

  • • Avoid using with other medications that have similar effects on the body.
  • • Use with caution if taking other drugs that can cause drowsiness.

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.

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: Promethazinehydrochloride

BNF-referenced

Promethazine hydrochloride is a first-generation antihistamine with anticholinergic properties. It is primarily used for its sedative effects and to treat allergic conditions, motion sickness, nausea, and vomiting. It acts by blocking H1 histamine receptors, leading to a reduction in allergic responses and sedation.

Indications

  • Allergic conditions such as hay fever
  • Motion sickness
  • Nausea and vomiting
  • Sedation
  • Insomnia associated with urticaria
  • Pruritus

Dosage

Children: Child 2–4 years: 5 mg twice daily, alternatively 5–15 mg once daily, dose to be taken at night. Child 5–9 years: 5–10 mg twice daily, alternatively 10–25 mg once daily, dose to be taken at night. Child 10–17 years: 10–20 mg 2–3 times a day, alternatively 25 mg once daily, dose to be taken

Adults: 10–20 mg 2–3 times a day, alternatively 25 mg once daily, dose to be taken at night.

Mechanism of action

Promethazine hydrochloride works by antagonizing H1 histamine receptors, which inhibits the actions of histamine, a chemical involved in allergic reactions. Additionally, it has anticholinergic effects, which can help in reducing nausea and motion sickness by affecting the vestibular system.

Pharmacodynamics

Promethazine exhibits sedative, antiemetic, and antihistaminic properties. The sedative effects are due to its ability to cross the blood-brain barrier and block central H1 receptors, while the antiemetic effects are mediated through its action on the chemoreceptor trigger zone and vestibular pathways. The anticholinergic activity contributes to its effectiveness in controlling motion sickness.

Pharmacokinetics

Promethazine is well absorbed following oral administration, with peak plasma concentrations occurring within 1-2 hours. It has a long half-life of approximately 10-19 hours, allowing for once or twice daily dosing in most indications. The drug is extensively metabolized in the liver, primarily through cytochrome P450 enzymes, and eliminated mainly via urine. It is also noted for its potential for accumulation in patients with impaired hepatic function.

Contra-indications

  • Hypersensitivity to promethazine or any of its components
  • Patients with a history of angle-closure glaucoma
  • Patients with severe respiratory depression
  • Children under 2 years of age (unlicensed use for sedation)

Adverse effects

  • Drowsiness
  • Dizziness
  • Blurred vision
  • Dry mouth
  • Nausea
  • Urinary retention
  • Paradoxical excitability in children
  • Agranulocytosis
  • Seizures
  • Insomnia
  • Skin reactions
  • Leukopenia
  • Anxiety
  • Restlessness
  • Fatigue
  • Photosensitivity reaction

Interactions

  • Increased sedative effects when used with alcohol or other CNS depressants
  • Anticholinergic effects may be enhanced when used with other anticholinergic agents
  • May interact with other antihistamines, increasing the risk of side effects

Precautions

  • Use with caution in elderly patients due to increased susceptibility to anticholinergic side effects
  • May cause sedation; caution patients about performing tasks requiring alertness (e.g., driving)
  • Monitor for increased effects in combination with other sedatives
  • Not suitable for long-term use in children under 2 years of age without specialist advice

Pregnancy

Most manufacturers advise avoidance during pregnancy; however, no evidence of teratogenicity has been established. Use in late pregnancy may lead to adverse effects in neonates.

Breast-feeding

Most antihistamines are excreted in breast milk; while not known to be harmful, manufacturers typically advise against use during breastfeeding.

Storage

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

Formulations

  • Tablets: 10 mg, 25 mg
  • Oral solution: 5 mg/5 mL
  • Injection: 25 mg/mL
BNF 85 (British National Formulary) p.332 BNF for Children 2019-2020 p.205 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: blue

Blue, also known as methylene blue, is a synthetic dye that has been used for various therapeutic purposes, including the treatment of methemoglobinemia, a condition where hemoglobin is oxidized and unable to carry oxygen effectively. Additionally, it has applications in treating certain infections and as a surgical marker.

Indications

  • Methemoglobinemia
  • Urinary tract infections
  • Surgical marking
  • Treatment of certain types of cyanide poisoning

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing information.

Adults: Refer to the relevant clinical guidelines or the BNF for specific dosing recommendations.

Mechanism of action

Methylene blue acts as a reducing agent, converting methemoglobin back to its functional form, hemoglobin. This is primarily achieved through its action as an electron donor, facilitating the reduction of ferric iron (Fe3+) in hemoglobin to ferrous iron (Fe2+), thereby restoring its oxygen-carrying capacity. It also exhibits antimicrobial properties through its ability to generate reactive oxygen species when exposed to light, which can inhibit bacterial growth.

Pharmacodynamics

The pharmacodynamics of methylene blue involve its role in enhancing oxygen delivery in patients suffering from methemoglobinemia. By converting methemoglobin back to hemoglobin, it effectively increases the amount of hemoglobin available for oxygen transport. The drug also shows effects on the vascular system, where it can induce vasodilation and influence blood pressure.

Pharmacokinetics

Methylene blue is rapidly absorbed after intravenous administration, with peak plasma concentrations occurring within 1 to 3 hours. It is extensively distributed in body tissues and fluids, including the liver, kidneys, and lungs. The drug undergoes hepatic metabolism, primarily through the cytochrome P450 system, and is excreted mainly through urine. The half-life ranges from 5 to 24 hours, depending on the dosage and individual patient factors.

Pregnancy

Consult healthcare provider before use, as safety in 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 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: 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: colour

BNF-referenced

Colour is a compound with the molecular formula C13H18N2O, commonly recognized for its application in various industries, including pharmaceuticals and food. Its properties can vary based on its specific formulation and context of use. It is important to consult detailed sources for information regarding its use in clinical settings.

Mechanism of action

The precise mechanism of action is not well-documented in the provided resources. However, compounds with similar molecular structures often interact with biological pathways through modulation of neurotransmitter systems or receptor activity.

Pharmacodynamics

Pharmacodynamics for compounds like Colour typically involve interactions at the cellular level, influencing physiological responses through receptor binding and modulation of signaling pathways. The specific effects and potency would depend on the context of use and formulation.

Pharmacokinetics

Information on the pharmacokinetics of Colour, including absorption, distribution, metabolism, and excretion, is not provided in the available resources. Generally, pharmacokinetic properties will vary significantly based on formulation and route of administration.

Pregnancy

Safety in pregnancy has not been established. Use only if the benefits outweigh the risks.

Breast-feeding

Caution is advised. There are no adequate studies in breastfeeding women.

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: glycolate

BNF-referenced

Glycolate is an intermediate in the metabolism of ethylene glycol, a compound that can cause toxicity when ingested. The toxicity arises primarily from its conversion to glycolic acid and other harmful metabolites. Glycolate and its relation to ethylene glycol's elimination kinetics have been studied, revealing important insights into their toxicokinetics in animal models.

Dosage

Children: Refer to specific clinical guidelines for dosing in children, as no standard paediatric dosage is specified in the provided resources.

Adults: Refer to specific clinical guidelines for dosing, as no standard adult dosage is specified in the provided resources.

Mechanism of action

Ethylene glycol toxicity results from its metabolism to glycolic acid and other toxic metabolites. Glycolate accumulates in the body and is eliminated more slowly than ethylene glycol itself. The renal excretion of both compounds plays a crucial role in their elimination, accounting for a significant portion of the administered dose.

Pharmacodynamics

The pharmacodynamics of glycolate are closely tied to its role as a metabolite of ethylene glycol. Its accumulation can lead to metabolic acidosis, although minimal clinical effects have been observed at low doses. The relationship between glycolate and ethylene glycol indicates that glycolate may contribute to the overall toxic effects of ethylene glycol ingestion.

Pharmacokinetics

The pharmacokinetics of glycolate indicate that it reaches peak plasma levels between 4-6 hours after the administration of ethylene glycol. The elimination half-life of ethylene glycol is approximately 1.7 hours in rats and 3.4 hours in dogs. Glycolate is predominantly eliminated through renal excretion, with about 5% of the dose being excreted unchanged.

Pregnancy

There is limited data on the safety of glycolate in pregnancy. Caution is advised.

Breast-feeding

Data on the excretion of glycolate in human milk is not available. Caution is advised.

Storage

Store at room temperature, away 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: maize

Maize, also known as corn, is a cereal grain first domesticated by indigenous peoples in southern Mexico about 10,000 years ago. It is a staple food in many parts of the world and is used for human consumption, animal feed, and as a raw material in various industrial processes. Maize is rich in carbohydrates, particularly starch, and provides essential nutrients such as vitamins B and E, magnesium, and dietary fiber.

Indications

  • Nutritional support
  • Source of carbohydrates
  • Dietary fiber source
  • Animal feed

Dosage

Children: As with adults, there are no specific dosing recommendations for maize for children. It can be introduced into the diet in age-appropriate forms and quantities, keeping in mind the overall dietary balance.

Adults: There are no specific dosing recommendations for maize as it is typically consumed as part of a balanced diet. It can be included in daily meals in various forms such as whole kernels, flour, or as part of dishes.

Mechanism of action

Maize primarily acts as a source of energy due to its high carbohydrate content. The complex carbohydrates in maize are broken down into glucose, which is then utilized by the body for energy production. It also contributes to dietary fiber intake, which can aid in digestive health and regulation of blood sugar levels.

Pharmacodynamics

The consumption of maize influences blood glucose and insulin levels due to its carbohydrate content. It has a relatively low glycemic index when consumed in whole form, which can help in managing blood sugar levels. The dietary fiber present in maize can also promote satiety and aid in weight management.

Pharmacokinetics

The digestion of maize begins in the mouth with salivary amylase breaking down starches into simpler sugars. In the stomach and small intestine, enzymes further break down these carbohydrates. The resultant glucose is absorbed into the bloodstream, where it is transported to cells for energy production. The absorption rate can vary based on the form of maize consumed (e.g., whole kernels versus processed forms).

Pregnancy

Maize is generally considered safe for consumption during pregnancy as it is a staple food and provides essential nutrients.

Breast-feeding

Maize is safe to consume while breastfeeding and can provide important nutrients to both the mother and the infant.

Storage

Store in a cool, dry place, away from moisture and pests. Properly sealed containers can help prolong shelf life.

Formulations

  • Whole maize grains
  • Maize flour (cornmeal)
  • Maize starch
  • Maize oil

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: 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: promethazine

BNF-referenced

Promethazine is a sedating antihistamine belonging to the phenothiazine class, primarily used for its antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. It acts as an antagonist at multiple receptor sites including histamine H1, muscarinic, and dopamine receptors, contributing to its therapeutic applications in treating allergic reactions, nausea, vomiting, and as a sleep aid.

Indications

  • Allergic reactions
  • Nausea and vomiting
  • Motion sickness
  • Sedation
  • Anxiety and tension

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing recommendations.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

Promethazine functions as a competitive antagonist of histamine H1 receptors, which diminishes the effects of histamine in allergic reactions. It also antagonizes post-synaptic mesolimbic dopamine, alpha adrenergic, muscarinic, and NMDA receptors. This multifaceted action is responsible for its sedative properties, utility in anxiety and tension, as well as its effectiveness in controlling nausea and vomiting.

Pharmacodynamics

Promethazine exhibits its antihistaminic effects by blocking H1 receptors, leading to reduced allergic response, sedation, and antiemetic effects. The sedative effects typically last between 4 to 6 hours, although they can extend up to 12 hours. Caution is advised regarding potential CNS and respiratory depression, as well as a reduced seizure threshold and possible bone marrow suppression.

Pharmacokinetics

Promethazine is absorbed from the gastrointestinal tract and has a variable bioavailability. It is extensively metabolized in the liver, primarily via the cytochrome P450 enzyme system, and has a long half-life, which contributes to its prolonged effects. The drug is excreted primarily in urine as metabolites. Its pharmacokinetic profile can be influenced by factors such as age and liver function.

Contra-indications

  • Hypersensitivity to promethazine or any of its components.
  • Children under 2 years of age due to the risk of severe respiratory depression.
  • Comatose states or patients with severe central nervous system depression.

Adverse effects

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Constipation
  • Confusion
  • Extrapyramidal symptoms
  • Severe respiratory depression
  • Hypotension

Interactions

  • Increased sedation with alcohol and CNS depressants.
  • May enhance the effects of other antihistamines.
  • Concomitant use with monoamine oxidase inhibitors (MAOIs) may increase the risk of severe side effects.

Precautions

  • Use with caution in patients with asthma, cardiovascular disease, or glaucoma.
  • Monitor for signs of respiratory depression, particularly in pediatric and elderly patients.
  • Caution advised when driving or operating machinery due to sedative effects.

Pregnancy

Promethazine is classified as category C. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Promethazine is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

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

Formulations

  • Tablets
  • Syrup
  • Injection

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.

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: Promethazinehydrochloride

PubChem CID 6014

Molecular formula: C17H20N2S.ClH

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

Molecular reference: colour

PubChem CID 21786582

Molecular formula: C13H18N2O

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

Molecular reference: glycolate

PubChem CID 757

Molecular formula: C2H4O3

Mechanism of action

Ethylene glycol toxicity results from its metabolism to glycolic acid and other toxic metabolites. The accumulation of glycolate and the elimination kinetics of ethylene glycol and its metabolites are not well understood, so studies with male Sprague-Dawley rats and mixed breed dogs have been carried out. Ethylene glycol was administered by gavage to rats and dogs which were placed in metabolic cages for urine and blood sample collection at timed intervals. The peak plasma level of ethylene glycol occurred at 2 hr after dosing and that of glycolate between 4-6 hr. The rate of ethylene glycol elimination was somewhat faster in rats with a half-life of 1.7 hr compared to 3.4 hr in dogs. The maximum plasma level of glycolate was greater in rats although the pattern of accumulation was similar to that in dogs. Glycolate disappeared from the plasma at the same time as ethylene glycol, suggesting a slower rate of elimination of the metabolite than that of ethylene glycol. Renal excretion of ethylene glycol was an important route for its elimination accounting for 20-30% of the dose. Renal excretion of glycolate represented about 5% of the dose. Ethylene glycol induced an immediate, but short lived diuresis compared to that in control rats. Minimal clinical effects (mild acidosis with no sedation) were noted at these doses of ethylene glycol (1-2 g/kg) in both rats and dogs. The results indicate that the toxicokinetics of ethylene glycol and glycolate were similar in both species. The effect of 0.35 to 0.8 mmol/kg glycolic acid and 1.0 to 4.4 mmol/kg sodium glycolate on cyclopropane-epinephrine induced cardiac arrhythmias was examined using dogs. Doses of 0.35 to 0.5 mmol/kg glycolic acid increased the duration of arrhythmias in the 13 dogs tested, whereas doses >0.5 mmol/kg decreased or totally eliminated the arrhythmias in each of 11 dogs. Depression was observed for many of the dogs at higher doses. Sodium glycolate was much less effective in decreasing the arrhythmias, with 3 mmol/kg being required and its action being transient.

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

Molecular reference: promethazine

PubChem CID 4927

Molecular formula: C17H20N2S

Mechanism of action

Promethazine is a an antagonist of histamine H1, post-synaptic mesolimbic dopamine, alpha adrenergic, muscarinic, and NMDA receptors. The antihistamine action is used to treat allergic reactions. Antagonism of muscarinic and NMDA receptors contribute to its use as a sleep aid, as well as for anxiety and tension. Antagonism of histamine H1, muscarinic, and dopamine receptors in the medullary vomiting center make promethazine useful in the treatment of nausea and vomiting. Promethazine is a phenothiazine derivative with potent sedative properties. Although the drug can produce either CNS stimulation or CNS depression, CNS depression manifested by sedation is more common with therapeutic doses of promethazine. The precise mechanism of the CNS effects of the drug is not known. Although it has been reported that the drug has slight antitussive activity, this may result from its anticholinergic and CNS depressant effects. In therapeutic doses, promethazine appears to have no substantial effect on the cardiovascular system. Although rapid IV administration of promethazine may produce a transient fall in blood pressure, blood pressure usually is maintained or slightly elevated when the drug is given slowly. Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H1 receptor antagonist, but does not block the release of histamine. Structural differences from the neuroleptic phenothiazines result in its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. The development of phenothiazine derivatives as psychopharmacologic agents resulted from the observation that certain phenothiazine antihistaminic compounds produced sedation. In an attempt to enhance the sedative effects of these drugs, promethazine and chlorpromazine were synthesized. Chlorpromazine is the pharmacologic prototype of the phenothiazines. The pharmacology of phenothiazines is complex, and because of their actions on the central and autonomic nervous systems, the drugs affect many different sites in the body. Although the actions of the various phenothiazines are generally similar, these drugs differ both quantitatively and qualitatively in the extent to which they produce specific pharmacologic effects. /Phenothiazine General Statement/ For more Mechanism of Action (Complete) data for Promethazine (18 total), please visit the HSDB record page.

Pharmacodynamics

Promethazine is is a histamine H1 antagonist that can be used for it's ability to induce sedation, reduce pain, and treat allergic reactions. Promethazine's effects generally last 4-6h but can last up to 12h. Patients should be counselled regarding CNS and respiratory depression, reduce seizure threshold, and bone marrow depression.

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.