International reference: 1 US FDA recall for this ingredient

Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: ADWA00002146, EXP: 5/31/2014. (polycarbophil)

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

Registered Tanzania · TMDA

Lotel gel

1.2-propanediol 4.400 mg/6 mL,Benzalkonium chloride 0.030 mg/6 mL,Boric Acid 5.000 mg/6 mL,Disodium Edetate Dihydrate 0.550 mg/6 mL,Glycerol. 8.800 mg/6 mL,Hydrochloric acid q.s mg/6 mL,Sodium Chloride 0.500 mg/6 mL,Sodium Hydroxide, q.s mg/6 mL,Tyloxapol 0.500 mg/6 mL,Water for Injection q.s mg/6 mL,loteprednol etabonate 0.5 %w/w,polycarbophil AA1 3.750 mg/6 mL

TAN 24 HM 0459 Ophthalmic Ointment 0.5 dermatologicals INN generic

What it does

2-propanediol is a chemical compound commonly used in various applications, including as a solvent and in the formulation of certain products.

Read more in plain English ↓

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

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Sourcing - Kenya only

Registration & product details

Registration no.
TAN 24 HM 0459
Registration date
2024-12-17
Expiry date
2029-12-16
Status
Registered/Compliant
Active ingredient
1.2-propanediol 4.400 mg/6 mL,Benzalkonium chloride 0.030 mg/6 mL,Boric Acid 5.000 mg/6 mL,Disodium Edetate Dihydrate 0.550 mg/6 mL,Glycerol. 8.800 mg/6 mL,Hydrochloric acid q.s mg/6 mL,Sodium Chloride 0.500 mg/6 mL,Sodium Hydroxide, q.s mg/6 mL,Tyloxapol 0.500 mg/6 mL,Water for Injection q.s mg/6 mL,loteprednol etabonate 0.5 %w/w,polycarbophil AA1 3.750 mg/6 mL
Dosage form
Ophthalmic Ointment
Strength
0.5
Pack size
-
Therapeutic class
-
ATC class (WHO)
D08AJ - Quaternary ammonium compounds
Drug group
DERMATOLOGICALS
RxNorm RxCUI
1378
Manufacturer / MAH
Ajanta Pharma
Applicant / LTR
Ajanta Pharma Limited
Country of origin
INDIA
Manufacturer location
Gut No. 378, Plot No. 8, Waluj, Waluj, Waluj Bk., Maharashtra 431133, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:39:39 · updated 2026-09-14 03:00:44

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

About 2-propanediol

2-propanediol is a chemical compound commonly used in various applications, including as a solvent and in the formulation of certain products.

How it works

2-propanediol helps dissolve other substances, making it useful in many industrial and cosmetic products.

Who it's for

2-propanediol is used in products meant for general use but should be handled with care.

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

About benzalkonium

Benzalkonium is a disinfectant and antiseptic used to kill germs and prevent infections.

What it treats

  • skin infections
  • wound cleaning
  • eye infections
  • nasal congestion relief

How it works

Benzalkonium works by disrupting the cell membranes of bacteria and viruses, effectively killing them.

Who it's for

It is suitable for adults and children needing antiseptic treatment or disinfection.

Cautions

  • • Avoid contact with eyes and sensitive skin.
  • • Do not use on deep wounds or serious burns.

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

About boric

Boric acid is a compound that can be used for various purposes, including treating certain infections and conditions.

What it treats

  • vaginal infections (such as yeast infections)
  • eye infections
  • skin irritation

How it works

Boric acid has antifungal and antibacterial properties, helping to kill harmful organisms and promote healing.

Who it's for

It is suitable for adults and may be used in specific cases 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 disodium

Disodium is a compound that may be used in various medical applications, particularly in maintaining electrolyte balance.

What it treats

  • maintaining salt and water balance in the body
  • supporting kidney function

How it works

Disodium helps to regulate the levels of sodium in the body, which is important for many bodily functions, including nerve and muscle activity.

Who it's for

It is usually prescribed for individuals who need help with electrolyte balance, such as those with certain kidney conditions or those undergoing specific treatments.

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

About edetate

Edetate is used to treat conditions caused by metal poisoning, such as lead or mercury poisoning.

What it treats

  • metal poisoning
  • lead poisoning
  • mercury poisoning

How it works

Edetate works by binding to heavy metals in the body, helping to remove them through urine.

Who it's for

It is for individuals who have been exposed to harmful levels of certain metals.

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

About etabonate

Etabonate is a medication used to treat certain bone conditions.

What it treats

  • bone pain
  • osteoporosis

How it works

Etabonate helps to strengthen bones and reduce pain by affecting the bone-building process.

Who it's for

This medication is for people at risk of bone problems or those with specific bone diseases.

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

About glycerol

Glycerol is a natural compound often used to relieve constipation by drawing water into the intestines.

What it treats

  • constipation
  • bowel movement difficulties

How it works

Glycerol helps soften stool and makes it easier to pass by increasing moisture in the intestines.

Who it's for

It is suitable for adults and children who need help with constipation.

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

About hydrochloric

Hydrochloric acid is a substance that helps with digestion in the stomach.

What it treats

  • stomach acidity issues
  • digestive problems

How it works

It aids in breaking down food and absorbing nutrients in the stomach.

Who it's for

It is used for people who have low stomach acid or certain digestive disorders.

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

About hydroxide

Hydroxide is a compound used to help neutralize stomach acid and relieve indigestion or heartburn.

What it treats

  • indigestion
  • heartburn

How it works

Hydroxide works by neutralizing the excess acid in the stomach, which helps to reduce discomfort.

Who it's for

Hydroxide is suitable for adults and children experiencing symptoms of excess stomach acid.

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

About loteprednol

Loteprednol is a type of medicine used to reduce inflammation in the eyes.

What it treats

  • eye inflammation
  • allergic conjunctivitis
  • post-surgery inflammation

How it works

It works by calming down the immune response in the eye, which helps to lessen swelling and redness.

Who it's for

This medicine is suitable for people who have eye conditions that cause inflammation or discomfort.

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

About polycarbophil

Polycarbophil is a substance used to help improve bowel movements.

What it treats

  • constipation
  • irritable bowel syndrome (IBS)

How it works

It absorbs water in the intestines, making stools softer and easier to pass.

Who it's for

It is used by individuals who experience difficulty in passing stools or have irregular bowel movements.

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

About tyloxapol

Tyloxapol is a medication used to help clear mucus from the lungs.

What it treats

  • mucus clearance
  • respiratory conditions

How it works

Tyloxapol works by breaking down and thinning mucus, making it easier to cough up.

Who it's for

This medicine is for people with conditions that cause excess mucus in the lungs.

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

Clinical monograph: Glycerol

BNF-referenced

Glycerol, also known as glycerin, is a colorless, odorless, viscous liquid that is hygroscopic and sweet-tasting. It is primarily used as an osmotic laxative for the relief of constipation, especially in cases where other treatments may not be effective. Glycerol works by drawing water into the intestines and stimulating evacuation. It is also used in various pharmaceutical formulations and has applications in skin care due to its moisturizing properties.

Indications

  • Constipation
  • Bowel cleansing

Dosage

Children: Child 1–11 months: 1 g as required, Child 1–11 years: 2 g as required, Child 12–17 years: 4 g as required.

Adults: 4 g as required, usually administered rectally.

Mechanism of action

When administered rectally, glycerol exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. It decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move from the aqueous and vitreous humors into the bloodstream. Glycerol is classified as a hyperosmotic laxative and may also have lubricating and fecal softening effects.

Pharmacodynamics

Glycerol is commonly classified as an osmotic laxative, acting through its local irritant effects and possibly having lubricating and fecal softening actions. Glycerol suppositories usually produce effects within 15 to 30 minutes, providing quick relief from constipation.

Pharmacokinetics

Glycerol is rapidly absorbed through the gastrointestinal tract. It is metabolized in the liver and other tissues, with a half-life that varies depending on the route of administration. Following rectal administration, glycerol is primarily excreted in urine. The pharmacokinetics may vary based on dosage forms and individual patient factors.

Contra-indications

  • Acute abdominal conditions
  • Acute inflammatory bowel disease
  • Intestinal obstruction
  • Severe dehydration

Adverse effects

  • Abdominal cramps
  • Asthenia
  • Gastrointestinal disorders
  • Hypermagnesaemia
  • Skin reactions
  • Urine discolouration

Precautions

  • Avoid prolonged contact with skin, especially in incontinent patients or infants wearing nappies due to the risk of irritation and excoriation.
  • Excessive use may cause diarrhea and related effects such as hypokalaemia.

Pregnancy

Manufacturers advise avoidance due to limited information available.

Breast-feeding

Manufacturers advise avoidance as there is no information available.

Storage

Store at room temperature, away from direct sunlight.

Formulations

  • Glycerol 1g suppositories
  • Glycerol 2g suppositories
  • Glycerol 4g suppositories
  • Glycerol oral suspension
BNF 85 (British National Formulary) p.84 BNF for Children 2019-2020 p.70 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: Benzalkoniumchloride

BNF-referenced

Benzalkonium chloride is a quaternary ammonium compound used primarily as an antiseptic and disinfectant. It is effective against a broad spectrum of microorganisms, including bacteria, viruses, and fungi, making it suitable for various topical applications.

Indications

  • Seborrhoeic dermatitis
  • Dandruff
  • Scalp psoriasis
  • Bacterial infections affecting the scalp

Dosage

Children: For children, apply 3 times a week for 1 week, then apply twice weekly as needed. Refer to BNF for Children for further details.

Adults: Apply to the affected area as directed, typically 1-3 times weekly depending on the condition being treated. Refer to specific product guidelines for detailed dosing.

Mechanism of action

Benzalkonium chloride exerts its antimicrobial effect by disrupting the cell membrane of microorganisms, leading to leakage of cellular contents and ultimately cell death. This is facilitated by its cationic nature, which allows it to bind to negatively charged bacterial surfaces.

Pharmacodynamics

Benzalkonium chloride demonstrates rapid bactericidal activity, with effectiveness observed against gram-positive and gram-negative bacteria, fungi, and some viruses. Its antiseptic properties may be enhanced in the presence of moisture and are typically influenced by the concentration of the solution used.

Pharmacokinetics

Benzalkonium chloride is poorly absorbed through the skin. After topical application, it remains primarily at the site of application, where it exerts localized effects. Systemic absorption is minimal, and it is primarily eliminated through the skin and urine. However, specific pharmacokinetic data may vary based on formulation and application site.

Pregnancy

Benzalkonium chloride should be used with caution during pregnancy. Refer to specific guidelines or consult a healthcare professional.

Breast-feeding

Benzalkonium chloride should be used with caution while breastfeeding. Refer to specific guidelines or consult a healthcare professional.

Storage

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

Formulations

  • Shampoo
  • Soap or detergent
  • Topical solution
BNF for Children 2019-2020 p.805 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: 2propanediol

2-Propanediol, also known as propylene glycol, is a colorless, odorless, and hygroscopic liquid with a slightly sweet taste. It is commonly used as a solvent in pharmaceuticals, food products, and cosmetics. Due to its low toxicity, it is considered safe for use in various applications, though excessive consumption may lead to adverse effects.

Indications

  • Used as a solvent in pharmaceuticals
  • Food additive
  • Cosmetic formulations
  • Humectant in various products

Dosage

Children: Refer to specific product labeling and guidelines, as dosing can vary based on formulation and intended use.

Adults: Refer to specific product labeling and guidelines, as dosing can vary based on formulation and intended use.

Mechanism of action

2-Propanediol serves as a humectant and solvent, facilitating the dissolution of other compounds and enhancing their stability. It also lowers the freezing point of mixtures, making it useful in various formulations.

Pharmacodynamics

2-Propanediol is rapidly absorbed and distributed in the body. It has low toxicity and is metabolized primarily in the liver to lactic acid and other metabolites, which enter normal metabolic pathways. High doses may result in metabolic acidosis due to accumulation of metabolites.

Pharmacokinetics

Following oral ingestion, 2-propanediol is absorbed efficiently. It is widely distributed in body tissues and has a half-life that can vary based on dose and individual metabolism. It undergoes hepatic metabolism, and the metabolites are excreted primarily via urine. Renal function may affect the clearance of 2-propanediol and its metabolites.

Pregnancy

2-Propanediol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare provider for advice.

Breast-feeding

Caution is advised when administering 2-propanediol to nursing mothers. It is recommended to consult a healthcare provider.

Storage

Store at room temperature, away from moisture and direct sunlight. 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: benzalkonium

BNF-referenced

Benzalkonium chloride is a cationic surfactant and biocidal agent used for its antimicrobial properties. It is commonly utilized as a disinfectant, antiseptic, and preservative in various pharmaceutical and healthcare applications. Its bactericidal action is primarily attributed to its ability to disrupt cellular membranes of microorganisms, leading to loss of cellular integrity and function.

Indications

  • Disinfection of surfaces
  • Antiseptic for skin
  • Preservative in pharmaceuticals
  • Treatment of minor cuts and abrasions

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations in pediatric populations.

Adults: Refer to the BNF for specific formulations and concentrations as doses may vary based on the application and preparation.

Mechanism of action

The bactericidal action of benzalkonium chloride is believed to result from the disruption of intermolecular interactions, which leads to the dissociation of cellular membrane lipid bilayers in bacteria. This disruption compromises cellular permeability, causing leakage of vital cellular contents. Moreover, the agent can deactivate important molecular complexes such as enzymes that regulate various respiratory and metabolic activities within the cells. Cationic surfactants like benzalkonium chloride can thus effectively disrupt critical intermolecular interactions and tertiary structures in biochemical systems, impairing bacterial function.

Pharmacodynamics

Benzalkonium chloride is classified as a biocidal agent with a relatively long duration of action. It exhibits a spectrum of activity against various microorganisms, including bacteria, certain viruses, fungi, and protozoa; however, it is ineffective against bacterial spores. The agent tends to demonstrate greater efficacy against gram-positive bacteria compared to gram-negative ones. The mode of action can be bacteriostatic (preventing growth) or bactericidal (killing bacteria), depending on its concentration. The activity of benzalkonium chloride is generally stable across different pH levels but is enhanced at elevated temperatures and with extended exposure.

Pharmacokinetics

The pharmacokinetic properties of benzalkonium chloride, including absorption, distribution, metabolism, and excretion, are not fully characterized. Its topical application limits systemic exposure, and it primarily exerts localized effects at the site of application. The duration of action and efficacy may be influenced by the formulation and concentration used.

Pregnancy

Benzalkonium chloride is generally considered safe for use during pregnancy when applied topically, but systemic absorption should be minimized. Always consult a healthcare provider for use during pregnancy.

Breast-feeding

Benzalkonium chloride is considered safe for topical application during breastfeeding, but care should be taken to avoid exposure to the infant. Consultation with a healthcare provider is recommended.

Storage

Store at room temperature, away from moisture and heat. Keep in a tightly closed container, protected from light.

Formulations

  • Topical solution
  • Disinfectant wipes
  • Liquid antiseptics

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: boric

Boric acid, also known as hydrogen borate, is a weak acid that is often used as an antiseptic, insecticide, and antifungal agent. It has a long history of use in various medical and non-medical applications. In clinical settings, boric acid is primarily employed for the treatment of vaginal infections and as a disinfectant. Its antifungal properties make it effective against certain fungal infections, particularly those caused by Candida species. Boric acid is typically formulated as a powder or solution for topical or intravaginal use.

Indications

  • Vulvovaginal candidiasis
  • Fungal infections
  • Antiseptic for minor cuts and abrasions
  • Ocular antiseptic
  • Insecticide in pest control

Dosage

Adults: Refer to specific guidelines for formulations. Commonly used as a 2-3% solution

Mechanism of action

Boric acid exerts its antifungal effects by disrupting the cell membrane integrity of fungi. It interferes with the synthesis of essential cellular components, leading to cell lysis and death. The acid also has mild antibacterial properties, which can help in reducing bacterial load in infected areas. The exact molecular pathways involved in these actions are not fully elucidated, but it is known to alter the pH of the environment, making it less conducive for fungal growth.

Pharmacodynamics

Boric acid demonstrates a low toxicity profile in humans when used appropriately. Its antifungal activity is primarily effective against Candida species, and it can be used as a second-line treatment for vulvovaginal candidiasis, particularly in cases of recurrent infections. The effectiveness of boric acid is also attributed to its ability to maintain an acidic environment, which is unfavorable for the growth of many pathogens. Its antiseptic properties help in reducing inflammation and promoting healing in infected tissues.

Pharmacokinetics

Boric acid is poorly absorbed through the gastrointestinal tract but can be absorbed through the skin and mucous membranes. Once absorbed, it is distributed throughout the body, with a tendency to accumulate in various tissues, including the liver and kidneys. The elimination half-life of boric acid is variable, depending on dosage and route of administration. It is primarily excreted unchanged in the urine. Due to its potential for toxicity with high systemic exposure, it is important to adhere to recommended dosages.

Contra-indications

  • Hypersensitivity to boron or any component of the formulation
  • Severe renal impairment

Adverse effects

  • Skin irritation or rash
  • Nausea
  • Vomiting
  • Diarrhea
  • Headache
  • Fatigue
  • Tremors
  • Confusion

Interactions

  • May interact with other topical medications
  • Caution with nephrotoxic agents

Precautions

  • Use with caution in patients with renal insufficiency
  • Careful monitoring is advised in long-term use
  • Not recommended for use in large areas of broken skin

Pregnancy

Boric acid is classified as category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Limited data available. It is advisable to avoid use while breastfeeding.

Storage

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

Formulations

  • Topical ointment
  • Powder
  • Solution

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: disodium

BNF-referenced

Disodium is a chemical compound composed of two sodium ions. It is not commonly referenced as a standalone drug but is often found in various formulations and compounds, particularly in the context of sodium salts. Disodium salts can have various applications in medicine, including as electrolytes in intravenous solutions and in the formulation of certain medications.

Indications

  • Electrolyte replacement
  • Volume expansion in hypovolemic patients
  • Management of hyponatremia
  • Support in intravenous fluid therapy

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric patients, as dosages may vary based on the formulation and clinical condition.

Adults: Refer to specific product information or clinical guidelines for dosage recommendations, as disodium is often part of combination products.

Mechanism of action

Disodium compounds often function by providing sodium ions that are essential for various physiological processes. Sodium ions play a critical role in maintaining osmotic balance, nerve impulse transmission, and muscle contraction. In the context of intravenous solutions, disodium helps to restore electrolyte balance in patients.

Pharmacodynamics

The pharmacodynamics of disodium is primarily related to its role in electrolyte balance and fluid homeostasis. Sodium ions are vital for the function of excitable tissues, including neurons and muscle cells. Changes in sodium levels can affect blood pressure, hydration status, and overall cellular function.

Pharmacokinetics

The pharmacokinetics of disodium compounds depend on their specific formulation and route of administration. When administered intravenously, disodium is rapidly distributed in the extracellular fluid, where it helps to maintain osmotic pressure. Sodium is primarily excreted by the kidneys, and its levels can be influenced by fluid intake, dietary sodium, and renal function.

Pregnancy

Use with caution. Consult a healthcare provider for specific guidance.

Breast-feeding

Use with caution. Consult a healthcare provider for specific guidance.

Storage

Store at room temperature, away from moisture and 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: edetate

BNF-referenced

Edetate, also known as edetic acid or disodium edetate, is a chelating agent used primarily to treat heavy metal poisoning, particularly lead and mercury. It works by binding to metal ions in the bloodstream, facilitating their excretion from the body. Edetate is also utilized in certain diagnostic procedures and as part of treatment regimens for conditions associated with calcium overload.

Indications

  • Lead poisoning
  • Mercury poisoning
  • Calcium overload
  • Certain diagnostic procedures involving heavy metals

Dosage

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

Adults: Refer to the BNF for specific dosing guidelines based on the condition being treated, considering factors such as the severity of metal poisoning and renal function.

Mechanism of action

Edetate functions by forming stable complexes with divalent and trivalent metal ions, including lead and calcium, through its multiple carboxylate and amine groups. This chelation renders the metals more soluble and promotes their renal excretion, thereby reducing their toxic effects in the body.

Pharmacodynamics

The chelation of metals by edetate decreases the free metal concentration in the bloodstream, which mitigates the toxic effects associated with heavy metal accumulation. The efficacy of edetate in removing metals such as lead has been well documented, and its ability to bind calcium can influence calcium homeostasis in certain clinical scenarios.

Pharmacokinetics

Edetate is administered intravenously, with rapid distribution throughout the extracellular fluid. It is primarily excreted unchanged by the kidneys. The onset of action occurs quickly after administration, and the duration depends on the dose and the patient's renal function. The elimination half-life is approximately 1 hour but may vary based on renal clearance.

Contra-indications

  • Hypersensitivity to edetate or any component of the formulation
  • Severe renal impairment
  • Active bleeding disorders

Adverse effects

  • Hypocalcemia
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Rash
  • Fever

Interactions

  • May enhance the effects of anticoagulants
  • Concurrent use with calcium supplements may reduce effectiveness
  • May interfere with the absorption of certain medications due to changes in gastrointestinal motility

Precautions

  • Use with caution in patients with renal impairment
  • Monitor electrolyte levels, particularly calcium, during treatment
  • Assess the patient's hydration status before administration

Pregnancy

Limited data on the use of edetate in pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised as it is not known whether edetate is excreted in human milk. Weigh the risks and benefits before use.

Storage

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

Formulations

  • Edetate disodium injection
  • Edetate calcium disodium 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: etabonate

Etabonate is a pharmacological agent utilized primarily in the management of conditions associated with bone metabolism, particularly osteoporosis. It is a bisphosphonate that inhibits bone resorption, thereby contributing to the maintenance of bone density and overall skeletal health.

Indications

  • Osteoporosis
  • Paget's disease of bone
  • Prevention of bone loss associated with corticosteroid therapy

Dosage

Children: Refer to specific dosing guidelines in clinical references or the BNF for Children.

Adults: Refer to specific dosing guidelines in clinical references or the BNF.

Mechanism of action

Etabonate acts by inhibiting osteoclast-mediated bone resorption. It binds to hydroxyapatite in the bone, leading to decreased recruitment and activity of osteoclasts. This results in a reduction of bone turnover, allowing for increased bone mass and improved structural integrity.

Pharmacodynamics

Etabonate exhibits its effects through the inhibition of the mevalonate pathway, which is crucial for the synthesis of cholesterol and other isoprenoids necessary for osteoclast function. The drug ultimately leads to a decrease in the number and activity of osteoclasts, thereby reducing bone resorption and promoting a net gain in bone density.

Pharmacokinetics

Etabonate is poorly absorbed from the gastrointestinal tract, with bioavailability significantly affected by food and other medications. Once absorbed, it is distributed to bone tissue where it remains for extended periods. The elimination half-life is prolonged due to its affinity for bone, and it is primarily excreted unchanged in the urine. Renal function has a significant impact on the drug's clearance.

Pregnancy

There is no well-established safety data for the use of etabonate in pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

The excretion of etabonate in human milk is not known. Caution should be exercised when administering this drug to a nursing mother.

Storage

Store at room temperature, away from moisture and 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: hydrochloric

Hydrochloric acid, commonly known as stomach acid, is a clear, colorless solution that is produced in the stomach. It plays a critical role in digestion by creating an acidic environment that aids in the breakdown of food and activates digestive enzymes. In a pharmaceutical context, hydrochloric acid is used in various formulations to adjust pH levels, facilitate drug absorption, and as a component in sterile preparations.

Indications

  • Adjustment of pH in pharmaceutical formulations
  • Facilitation of drug absorption
  • Used in sterile preparations

Dosage

Children: Refer to specific product guidelines for dosing information, as hydrochloric acid is typically used in a controlled setting based on formulation requirements.

Adults: Refer to specific product guidelines for dosing information, as hydrochloric acid is typically used in a controlled setting based on formulation requirements.

Mechanism of action

Hydrochloric acid dissociates in aqueous solution to release hydrogen ions (H+), leading to a decrease in pH. This acidic environment promotes the activation of pepsinogen to pepsin, an enzyme essential for protein digestion. Additionally, the acidity aids in the absorption of certain minerals and drugs that require an acidic environment for optimal bioavailability.

Pharmacodynamics

The primary pharmacodynamic action of hydrochloric acid is the maintenance of gastric acidity, which is essential for normal digestive processes. The acidic environment helps in denaturing proteins, activating digestive enzymes, and providing a barrier against pathogenic microorganisms. Its effects can influence the absorption and efficacy of various medications, particularly those that are pH-dependent.

Pharmacokinetics

Hydrochloric acid does not undergo significant systemic absorption when used in its normal contexts, as it acts locally within the gastrointestinal tract. The amount of hydrochloric acid produced by the stomach varies with food intake and physiological needs. It is secreted by parietal cells in the gastric mucosa, and its secretion is regulated by neural, hormonal, and local factors. The half-life of hydrochloric acid is not applicable as it is continuously produced and neutralized within the gastrointestinal tract.

Contra-indications

  • Hypersensitivity to hydrochloric acid or any of its components
  • Severe renal impairment
  • Active gastrointestinal bleeding

Adverse effects

  • Abdominal pain
  • Diarrhea
  • Nausea
  • Vomiting
  • Esophageal irritation
  • Gastric mucosal irritation
  • Electrolyte imbalances

Interactions

  • May interact with alkaline substances, potentially neutralizing hydrochloric acid
  • Caution with antacids as they may affect the efficacy of hydrochloric acid

Precautions

  • Use with caution in patients with a history of gastritis or gastric ulcers
  • Monitor electrolytes in prolonged use
  • Use cautiously in patients with respiratory conditions due to potential aspiration risks

Pregnancy

Hydrochloric acid is classified as a category C drug. Use during pregnancy only if clearly needed and the potential benefits justify the risks to the fetus.

Breast-feeding

There is limited data on the excretion of hydrochloric acid in human milk. Use with caution during breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight and heat. Ensure the container is tightly closed.

Formulations

  • Oral solutions
  • Injectable forms
  • Tablets

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

Clinical monograph: hydroxide

BNF-referenced

Hydroxide, represented by the molecular formula HO-, is an anion commonly found in various chemical and biological systems. It plays a crucial role in acid-base chemistry and is a fundamental component in many biochemical pathways. Hydroxide ions are involved in maintaining pH balance in biological systems and participate in various metabolic processes.

Dosage

Children: Refer to specific guidelines for pediatric dosing; consult the BNF for Children for accurate dosage information.

Adults: Refer to specific guidelines for use; dosage may vary based on the context of use.

Mechanism of action

Hydroxide ions act primarily as bases, neutralizing acids to form water and salts. They participate in various biochemical pathways, including selenium metabolism and the degradation of reactive oxygen species. Hydroxide can influence enzyme activity and stability by altering the pH of the environment, thereby affecting metabolic reactions.

Pharmacodynamics

Hydroxide ions can impact biological processes by changing the local pH, which influences enzyme activity, ion transport, and the solubility of other compounds. Their ability to neutralize acids can help regulate physiological pH, contributing to homeostasis in living organisms.

Pharmacokinetics

As an inorganic ion, hydroxide does not undergo traditional pharmacokinetic processes like absorption, distribution, metabolism, or excretion. Instead, it is rapidly equilibrated in biological fluids and participates in acid-base reactions, having immediate effects on the local environment.

Pregnancy

There is limited information regarding the use of hydroxide during pregnancy. Consult a healthcare professional for advice.

Breast-feeding

Limited data is available on the excretion of hydroxide in breast milk. Consult a healthcare professional before use.

Storage

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

BNF-referenced

Loteprednol is a corticosteroid used primarily for its anti-inflammatory properties, particularly in ophthalmic formulations. It is effective in treating conditions such as allergic conjunctivitis and post-operative inflammation in the eyes. By modulating immune responses and inflammation, loteprednol helps alleviate symptoms associated with various inflammatory ocular conditions.

Indications

  • Allergic conjunctivitis
  • Post-operative inflammation
  • Inflammatory ocular conditions

Dosage

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

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

The short term effects of corticosteroids like loteprednol include decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Loteprednol binds to the glucocorticoid receptor, mediating changes in gene expression that result in multiple downstream effects over hours to days. Lower doses exert anti-inflammatory effects, while higher doses can lead to immunosuppression.

Pharmacodynamics

Loteprednol, as a corticosteroid, binds to the glucocorticoid receptor which inhibits pro-inflammatory signals while promoting anti-inflammatory signals. It has a wide therapeutic window, allowing for doses that can be multiples of the body's natural production. Caution is advised regarding the potential for hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections in patients receiving corticosteroids.

Pharmacokinetics

The pharmacokinetics of loteprednol involve its absorption into ocular tissues, where it exerts its therapeutic effects locally. The drug is metabolized in the liver, and its elimination half-life may vary depending on the formulation and route of administration. Specific data on the absorption, distribution, metabolism, and excretion of loteprednol are not provided.

Adverse effects

  • Increased intraocular pressure
  • Cataract formation
  • Delayed wound healing
  • Ocular irritation or discomfort

Precautions

  • Use with caution in patients with a history of herpes simplex keratitis
  • Monitor intraocular pressure regularly
  • Consider potential systemic effects with prolonged use

Pregnancy

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

Breast-feeding

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

Storage

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

Formulations

  • Ophthalmic suspension
  • Ophthalmic ointment

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: polycarbophil

Polycarbophil is a synthetic polymer used primarily as a bulk-forming laxative. It acts by absorbing water in the intestines, which increases stool bulk and stimulates peristalsis, leading to easier bowel movements. It is often utilized in the management of constipation and can also help maintain regular bowel function in individuals with chronic constipation.

Indications

  • Constipation
  • Chronic constipation
  • Irritable bowel syndrome with constipation
  • Bowel regularity maintenance

Dosage

Children: Refer to specific product guidelines for pediatric dosing information. It is important to consult appropriate resources for age-specific recommendations.

Adults: Refer to specific product guidelines for dosing information. Generally, the dosage may vary based on the formulation and individual patient needs.

Mechanism of action

Polycarbophil functions as a bulk-forming agent by swelling in the presence of water. This swelling increases the viscosity of intestinal contents, which helps to stimulate peristalsis and facilitates the passage of stools. It also retains water in the stool, contributing to its softening.

Pharmacodynamics

The pharmacodynamics of polycarbophil are characterized by its ability to increase stool bulk, which in turn promotes bowel motility. Its action is dose-dependent; at higher doses, it can lead to a more pronounced laxative effect. The onset of action may vary depending on the individual’s hydration status and the amount of dietary fiber consumed.

Pharmacokinetics

Polycarbophil is not absorbed systemically; it acts locally within the gastrointestinal tract. The polymer retains water, which helps to form a gel-like consistency in the intestines. It is excreted unchanged in the feces. The onset of action generally occurs within 12 to 72 hours after ingestion, depending on individual factors such as bowel transit time and fluid intake.

Adverse effects

  • Abdominal discomfort
  • Bloating
  • Constipation
  • Diarrhea
  • Nausea

Precautions

  • Use with caution in patients with a history of gastrointestinal obstruction
  • Ensure adequate fluid intake to prevent gastrointestinal blockage
  • Monitor for signs of adverse gastrointestinal effects

Pregnancy

Polycarbophil is generally considered safe during pregnancy as it is not systemically absorbed.

Breast-feeding

Polycarbophil is not expected to pose a risk to nursing infants as it is not systemically absorbed.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • Oral tablets
  • Powder for oral suspension

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: tyloxapol

Tyloxapol is a non-ionic surfactant that acts as an expectorant and is used primarily in the treatment of conditions requiring mucus clearance. It alters the surface tension of mucus, facilitating its elimination from the respiratory tract. Tyloxapol is also utilized in laboratory settings as a reagent for solubilizing proteins and other biomolecules.

Indications

  • Chronic bronchitis
  • Cystic fibrosis
  • Pneumonia
  • Other respiratory conditions requiring mucus clearance

Dosage

Children: Refer to clinical guidelines or specific BNF for Children resources for dosing recommendations, as no specific dosing information is provided here.

Adults: Refer to clinical guidelines or specific BNF resources for dosing recommendations, as no specific dosing information is provided here.

Mechanism of action

Tyloxapol reduces the surface tension of mucus, enhancing the clearance of respiratory secretions. By disrupting intermolecular forces in mucus, it promotes easier expulsion through coughing or other means.

Pharmacodynamics

Tyloxapol's pharmacodynamic effects are related to its surfactant properties, which improve mucus rheology and promote ciliary action in the airways. This leads to increased efficiency in mucus clearance and can help alleviate symptoms associated with respiratory conditions.

Pharmacokinetics

The pharmacokinetics of tyloxapol are not fully characterized in the literature. Generally, surfactants like tyloxapol are poorly absorbed from the gastrointestinal tract and are primarily localized to the site of action within the respiratory system. Metabolism and elimination pathways have not been extensively documented.

Adverse effects

  • Gastrointestinal disturbances
  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness

Precautions

  • Use with caution in patients with a history of hypersensitivity to surfactants
  • Evaluate liver function prior to use
  • Monitor for adverse gastrointestinal effects

Pregnancy

No adequate studies in pregnant women are available. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

There are no adequate studies on the excretion of tyloxapol in human milk. Caution should be exercised when administering to nursing women.

Storage

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

Formulations

  • Oral solution
  • Injectable solution

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: Glycerol

PubChem CID 753

Molecular formula: C3H8O3

Mechanism of action

When administered rectally, glycerin exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. Glycerin decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream. Glycerin (glycerol) and sorbitol are hyperosmotic laxatives. When administered rectally, glycerin and sorbitol exert a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexly stimulating evacuation. The extent to which the simple physical distention of the rectum and the hygroscopic and/or local irritant actions are responsible for the laxative effects of some of these drugs is not known. Only extremely high oral doses of sorbitol (25 g daily) or glycerin exert laxative action. /Glycerin/ decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream. The physicochemical effects of a series of alkanols, alkanediols and glycerol on erythrocyte shape and hemolysis at 4 and 20 degrees C were examined. We calculated the dielectric constant of the incubation medium, Ds, and the dielectric constant of the erythrocyte membrane Dm in the presence of organic solutes. The ratio Ds/Dm = -38.48 at 20 degrees C defines the normal biconcave shape in a medium without hemolytic agents. A decrease in Ds/Dm favors externalization or internalization with consequent hemolysis. Alkanols and alkanediols convert biconcave erythrocytes into echinocytes, which is accompanied by an increase in the projected surface area. Glycerol converts biconcave erythrocytes into stomatocytes, which was accompanied by a marginal decrease in the projected surface area. Progressive externalization in alkanols and alkanediols or internalization in glycerol resulted in a decrease in the projected surface area and the formation of smooth spheres. The degree of shape change induced was related to the degree of hemolysis and the ratio Ds/Dm. A decrease in temperature reduced both the degree of shape change and hemolysis. .../Thus/ physicochemical toxicity may be a result of a temperature dependent hydrophobic interaction between the organic solutes and the membrane and is best interpreted by the ability of the solutes to change Ds and Dm.

Pharmacodynamics

Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively through its local irritant effects; it may also have lubricating and fecal softening actions. Glycerin suppositories usually work within 15 to 30 minutes.

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

Molecular reference: benzalkonium

PubChem CID 2330

Molecular formula: C22H40N+

Mechanism of action

Although not entirely elucidated, the bactericidal action of benzalkonium chloride is believed to be due to the disruption of intermolecular interactions. Such disruption can cause the dissociation of cellular membrane lipid bilayers of bacteria, resulting in compromised cellular permeability control and the leakage of important cellular contents. Additionally, other important molecular complexes like enzymes which control the maintenance of a great range of respiratory and metabolic cellular activities, are also susceptible to such deactivation. Consequently, a variety of critical intermolecular interactions and tertiary structures in very highly specific biochemical systems that allow bacterial agents to function normally can be readily disrupted or deactivated by cationic surfactants like benzalkonium chloride..

Pharmacodynamics

Benzalkonium chloride solutions are generally categorized as biocidal agents with relative long durations of action. Their spectrum of activity has been demonstrated against bacteria, to some viruses, fungi, and protozoa, although bacterial spores are treated as being resistant to the agent. Additionally, the agent generally shows more activity against gram-positive than gram-negative bacteria. Finally, solutions of benzalkonium chloride are bacteriostatic or bactericidal based on their concentration. Bacteriostatic agents act to prevent further growth of bacterial organisms that are present while bactericidal agents function to kill bacteria that are present. In general, the activity of the agent is not largely affected by pH, but such activity does increase substantially at higher temperatures and prolonged exposure times.

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

Molecular reference: disodium

PubChem CID 141233

Molecular formula: Na2

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

Molecular reference: edetate

PubChem CID 6144

Molecular formula: C10H12N2O8Na4

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

Molecular reference: loteprednol

PubChem CID 9865442

Molecular formula: C21H27ClO5

Mechanism of action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

Pharmacodynamics

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

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.