Registered Tanzania · TMDA

Betanex S

Calcipotriol/ combinations

TAN 23 HM 0327 Ointment 50/0.5 mcg dermatologicals

What it does

Calcipotriol is a topical medication used to treat skin conditions. It helps to reduce the growth of skin cells and alleviate symptoms.

Commonly used for: psoriasis, plaque psoriasis

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

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Registration & product details

Registration no.
TAN 23 HM 0327
Registration date
2023-08-17
Expiry date
2028-08-16
Status
Registered/Compliant
Active ingredient
Calcipotriol/ combinations
Dosage form
Ointment
Strength
50/0.5 mcg
Pack size
-
Therapeutic class
-
ATC class (WHO)
D05AX - Other antipsoriatics for topical use
Drug group
DERMATOLOGICALS
RxNorm RxCUI
29365
Manufacturer / MAH
-
Country of origin
-

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:52:03 · updated 2026-09-17 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 calcipotriol

Calcipotriol is a topical medication used to treat skin conditions. It helps to reduce the growth of skin cells and alleviate symptoms.

What it treats

  • psoriasis
  • plaque psoriasis

How it works

Calcipotriol works by slowing down the production of skin cells, which helps to decrease scaling and redness.

Who it's for

This medication is suitable for adults and children over a certain age with psoriasis.

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

About combinations

Combinations refer to medicines that contain multiple active ingredients to treat various conditions.

What it treats

  • high blood pressure (hypertension)
  • pain relief
  • allergy symptoms
  • cold and flu symptoms

How it works

These medicines work by combining different ingredients that target specific symptoms or conditions to provide better relief.

Who it's for

These medicines are for adults and children, depending on the specific combination and formulation.

Cautions

  • • Always check with a healthcare provider if you are taking other medications.
  • • Be aware of allergies to any ingredients in the combination.

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

Clinical monograph: Calcipotriol

BNF-referenced

Calcipotriol is a synthetic derivative of vitamin D used primarily in the treatment of psoriasis, particularly plaque psoriasis. It works by modulating skin cell growth and differentiation, thereby reducing the rapid turnover of skin cells that characterizes psoriasis. The drug is available in various topical forms, including ointments and scalp solutions, and is typically applied directly to the affected areas of the skin.

Indications

  • Plaque psoriasis
  • Mild to moderate plaque psoriasis
  • Scalp psoriasis

Dosage

Children: For children aged 6–11 years, apply twice daily, with a maximum total calcipotriol of 2.5 mg in any one week. For children aged 12–17 years, apply twice daily, not exceeding 3.75 mg in any one week.

Adults: Apply calcipotriol ointment or scalp solution to the affected areas twice daily. Maximum total calcipotriol dosage should not exceed 5 mg per week.

Mechanism of action

Calcipotriol binds to vitamin D receptors in skin cells, leading to the regulation of gene expression involved in cell proliferation and differentiation. This action promotes the normal maturation of keratinocytes and reduces hyperproliferation, which is a hallmark of psoriatic lesions. Additionally, it exhibits anti-inflammatory properties, further aiding in the management of psoriasis.

Pharmacodynamics

Calcipotriol has a dose-dependent effect on keratinocyte proliferation and differentiation. It decreases the production of pro-inflammatory cytokines and chemokines, which are elevated in psoriasis. The therapeutic effects are typically observed within a few weeks of treatment, with optimal results often seen after sustained use. Side effects may include local skin irritation and an increased risk of hypercalcemia, especially if used excessively.

Pharmacokinetics

When applied topically, calcipotriol is minimally absorbed through intact skin. Systemic absorption can occur, particularly when applied to large areas or under occlusion. The half-life of calcipotriol is approximately 1.5 hours in systemic circulation, but its effects persist due to its action on skin cells. The drug is metabolized primarily in the liver, with metabolites excreted through urine and feces.

Contra-indications

  • Calcium metabolism disorders
  • Erythrodermic exfoliative psoriasis
  • Generalised pustular psoriasis
  • Do not apply under occlusion

Adverse effects

  • Skin reactions
  • Hypercalcaemia
  • Hypercalciuria
  • Photosensitivity reactions
  • Increased risk of infection

Interactions

  • Acitretin

Precautions

  • Avoid excessive exposure to sunlight
  • Avoid broken or inflamed skin
  • Caution in patients with renal impairment
  • Caution in patients with hepatic impairment

Pregnancy

Manufacturers advise avoidance unless essential.

Breast-feeding

No information available.

Storage

Store in a cool, dry place away from light.

Formulations

  • Calcipotriol 50 micrograms/g ointment
  • Calcipotriol scalp solution
BNF for Children 2019-2020 p.795 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: combinations

Combinations refer to pharmaceutical formulations that contain two or more active ingredients, often used to enhance therapeutic efficacy, minimize side effects, or provide treatment for multiple conditions simultaneously. Such combinations may include various classes of drugs, such as antibiotics, antihypertensives, or analgesics, tailored to the specific needs of a patient.

Indications

  • Hypertension
  • Diabetes mellitus
  • HIV/AIDS
  • Tuberculosis
  • Chronic pain management
  • Respiratory conditions
  • Cardiovascular diseases

Dosage

Children: Refer to specific combination formulations for dosing information, as it will vary based on the active ingredients and the condition being treated.

Adults: Refer to specific combination formulations for dosing information, as it will vary based on the active ingredients and the condition being treated.

Mechanism of action

The mechanism of action of drug combinations can vary significantly based on the specific drugs involved. Generally, combinations may work synergistically, where the combined effect is greater than the sum of individual effects. For example, in antimicrobial therapy, one drug may inhibit bacterial cell wall synthesis while another interferes with protein synthesis, leading to enhanced bacterial killing.

Pharmacodynamics

Pharmacodynamics of combinations often involves the interaction between the active ingredients and their targets within the body, which may include receptors, enzymes, or cellular pathways. The therapeutic effects can be additive, synergistic, or antagonistic, depending on the pharmacological profiles of the individual components. This can lead to improved outcomes, such as increased efficacy or reduced resistance in cases of infections.

Pharmacokinetics

Pharmacokinetics of drug combinations can be complex, as each component may have its own absorption, distribution, metabolism, and excretion (ADME) characteristics. The presence of multiple active ingredients may alter these processes, such as through pharmacokinetic interactions that affect the plasma concentration of the drugs. Factors such as bioavailability, half-life, and clearance rates must be considered when determining the appropriate dosing regimen for a combination therapy.

Pregnancy

Consult healthcare provider before use, as safety varies depending on specific components of the combination.

Breast-feeding

Consult healthcare provider before use, as safety varies depending on specific components of the combination.

Storage

Store in a cool, dry place away from direct sunlight. Refrigeration may be required for certain formulations.

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: Calcipotriol

PubChem CID 5288783

Molecular formula: C27H40O3

Mechanism of action

The precise mechanism of calcipotriol in remitting psoriasis is not well-understood, however, it has been shown to have comparable affinity with calcitriol for the Vitamin D receptor while being less than 1% the activity in regulating calcium metabolism. The Vitamin D receptor (VDR) belongs to the steroid/thyroid receptor superfamily, and is found on the cells of many different tissues including the thyroid, bone, kindney, and T cells of the immune system. T cells are known to play a role in psoriasis and are believed to undergo modulation of gene expression with binding of calcipotriol to the VDR. This modulation is thought to affect gene products related to cell differentiation and proliferation.

Pharmacodynamics

Calcipotriene is a synthetic analog of vitamin D. In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin.

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.