loratadine reference
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(loratadine · DailyMed)
Registered Tanzania · TMDA

Clarityne

Lactose Monohydrate 71.3 mg/6 mL,Loratadine 10 mg/6 mL,Magnesium Stearate 0.7 mg/6 mL,Maize starch 18.0 mg/6 mL,Purified Water. q.s q.s

TAN 24 HM 0345 Oral tablet 10 respiratory system INN generic

What it does

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

Commonly used for: lactose intolerance, as a filler in tablets and capsules

Read more in plain English ↓

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

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Registration & product details

Registration no.
TAN 24 HM 0345
Registration date
2024-09-27
Expiry date
2029-09-26
Status
Registered/Compliant
Active ingredient
Lactose Monohydrate 71.3 mg/6 mL,Loratadine 10 mg/6 mL,Magnesium Stearate 0.7 mg/6 mL,Maize starch 18.0 mg/6 mL,Purified Water. q.s q.s
Dosage form
Oral tablet
Strength
10
Pack size
-
Therapeutic class
-
ATC class (WHO)
R06AX - Other antihistamines for systemic use
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
28889
Manufacturer / MAH
Bayer
Applicant / LTR
Bayer East Africa Ltd
Country of origin
GERMANY
Manufacturer location
Salegaster Ch 1, 06803 Bitterfeld-Wolfen, Germany

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:41:17 · updated 2026-10-22 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 lactose

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

What it treats

  • lactose intolerance
  • as a filler in tablets and capsules

How it works

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

Who it's for

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

Cautions

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

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

About loratadine

Loratadine is an antihistamine that helps relieve allergy symptoms.

What it treats

  • seasonal allergies (hay fever)
  • chronic hives (urticaria)

How it works

It blocks the action of histamine, a substance in the body that causes allergic symptoms.

Who it's for

It is suitable for adults and children over the age of 2 who have allergies.

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 purified

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

What it treats

  • various medical conditions

How it works

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

Who it's for

People who need medications with safe and effective ingredients.

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

About starch

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

What it treats

  • energy source
  • dietary supplement

How it works

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

Who it's for

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

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

Clinical monograph: Loratadine

BNF-referenced

Loratadine is a second-generation antihistamine used primarily for the symptomatic relief of allergic conditions such as seasonal allergic rhinitis and chronic idiopathic urticaria. It is known for its low sedative effects, making it suitable for individuals who need to avoid drowsiness while managing allergy symptoms.

Indications

  • Seasonal allergic rhinitis
  • Chronic idiopathic urticaria

Dosage

Children: Child 6–11 years: 30 mg twice daily. Child 12–17 years: 120 mg once daily for seasonal allergic rhinitis or 180 mg once daily for chronic idiopathic urticaria.

Adults: 120 mg once daily for seasonal allergic rhinitis or chronic idiopathic urticaria. Alternatively, 180 mg once daily may be prescribed depending on clinical judgement.

Mechanism of action

Loratadine exerts its effects by binding to H1 histamine receptors, which are found on various cell types, including epithelial, endothelial, and smooth muscle cells. It acts as an 'inverse agonist', stabilizing the inactive form of the H1 receptor and thereby preventing the actions of histamine, which is a key mediator in allergic responses. This mechanism effectively reduces the severity of symptoms associated with allergies.

Pharmacodynamics

Loratadine is selective for peripheral H1 receptors and does not significantly penetrate the central nervous system, resulting in minimal sedation and CNS depression. This pharmacodynamic profile helps to avoid common side effects associated with first-generation antihistamines, such as drowsiness and impaired psychomotor function.

Pharmacokinetics

Loratadine is well-absorbed after oral administration and undergoes extensive hepatic metabolism, primarily via cytochrome P450 enzymes. It has a long half-life, allowing for once-daily dosing. The drug is mainly excreted through urine and bile, with a small percentage eliminated unchanged. Dose adjustments may be necessary in individuals with renal impairment.

Contra-indications

  • Acute porphyrias

Adverse effects

  • Dizziness
  • Drowsiness
  • Headache
  • Nausea
  • Fatigue
  • Abdominal pain
  • Aggression
  • Agitation
  • Angioedema
  • Appetite increased
  • Arthralgia
  • Depression
  • Dyspnoea
  • Hallucination
  • Hepatitis
  • Myalgia
  • Oedema
  • Palpitations
  • Paraesthesia
  • Seizure
  • Skin reactions
  • Suicidal ideation
  • Syncope
  • Tachycardia
  • Taste altered
  • Tremor
  • Urinary disorders
  • Vertigo
  • Vision disorders
  • Vomiting
  • Weight increased

Interactions

  • Other antihistamines

Precautions

  • Patients and their carers should be advised that drowsiness can occur and may affect performance of skilled tasks such as cycling or driving.
  • Avoid in patients with renal impairment if eGFR is less than 10 mL/minute/1.73 m2.

Pregnancy

Most manufacturers of antihistamines advise avoiding their use during pregnancy; however, there is no evidence of teratogenicity.

Breast-feeding

Most antihistamines are present in breast milk in varying amounts; although not known to be harmful, most manufacturers advise avoiding their use in mothers who are breast-feeding.

Storage

Store at room temperature, away from excessive heat and moisture.

Formulations

  • Oral suspension
  • Oral solution
  • Tablet
BNF 85 (British National Formulary) p.326 BNF for Children 2019-2020 p.200 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: lactose

BNF-referenced

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

Indications

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

Dosage

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

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

Mechanism of action

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

Pharmacodynamics

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

Pharmacokinetics

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

Adverse effects

  • Bloating
  • Diarrhea
  • Abdominal pain
  • Flatulence

Precautions

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

Pregnancy

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

Breast-feeding

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

Storage

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

Formulations

  • Powder
  • Granules
  • Tablets
  • Syrup

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

Clinical monograph: 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: purified

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

Dosage

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

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

Mechanism of action

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

Pharmacodynamics

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

Pharmacokinetics

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

Pregnancy

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

Breast-feeding

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

Storage

Store in a cool, dry place, away from light and moisture, and keep out of reach of children.

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

Clinical monograph: starch

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

Indications

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

Dosage

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

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

Mechanism of action

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

Pharmacodynamics

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

Pharmacokinetics

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

Adverse effects

  • Allergic reactions
  • Gastrointestinal discomfort
  • Diarrhea
  • Constipation

Precautions

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

Pregnancy

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

Breast-feeding

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

Storage

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

Formulations

  • Powder
  • Granules
  • Tablets
  • Suspensions

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

Molecular reference: lactose

PubChem CID 6134

Molecular formula: C12H22O11

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

Molecular reference: Loratadine

PubChem CID 3957

Molecular formula: C22H23ClN2O2

Mechanism of action

Histamine release is a key mediator in allergic rhinitis and urticaria. As a result, loratadine exerts it's effect by targeting H1 histamine receptors. Loratadine binds to H1 histamine receptors found on the surface of epithelial cells, endothelial cells, eosinophils, neutrophils, airway cells, and vascular smooth muscle cells among others. H1 histamine receptors fall under the wider umbrella of G-protein coupled receptors, and exist in a state of equilibrium between the active and inactive forms. Histamine binding to the H1-receptor facilitates cross linking between transmembrane domains III and V, stabilizing the active form of the receptor. On the other hand, antihistamines bind to a different site on the H1 receptor favouring the inactive form. Hence, loratadine can more accurately be classified as an "inverse agonist" as opposed to a "histamine antagonist", and can prevent or reduce the severity of histamine mediated symptoms. All of the available H1 receptor antagonists are reversible, competitive inhibitors of the interaction of histamine with H1 receptors. /H1 Receptor Antagonists/ H1 antagonists inhibit most responses of smooth muscle to histamine. /H1 Antagonists Receptors/ Within the vascular tree, the H1 antagonists inhibit both the vasoconstrictor effects of histamine and, to a degree, the more rapid vasodilator effects that are mediated by H1 receptors on endothelial cells. /H1 Receptor Antagonists/ H1 antagonists strongly block the action of histamine that results in increased capillary permeability and formation of edema and wheal. /H1 Receptor Antagonists/ For more Mechanism of Action (Complete) data for LORATADINE (6 total), please visit the HSDB record page.

Pharmacodynamics

Like other 2nd generation antihistamines, loratadine is selective for peripheral H1 receptors. Loratadine does not penetrate effectively into the central nervous system and has poor affinity for CNS H1-receptors. These qualities result in a lack of CNS depressant effects such as drowsiness, sedation, and impaired psychomotor function.

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.