Usage
- Betamethasone + Calcipotriol is prescribed for the topical treatment of stable plaque psoriasis vulgaris in adults. Specifically, it’s indicated for scalp and mild to moderate non-scalp plaque psoriasis.
- Pharmacological Classification: This is a combination product containing a Vitamin D analog (Calcipotriol) and a corticosteroid (Betamethasone). Therefore, it falls under the classifications of antipsoriatics and corticosteroids.
- Mechanism of Action: Calcipotriol, a synthetic vitamin D3 analog, inhibits keratinocyte proliferation and promotes keratinocyte differentiation. Betamethasone dipropionate, a synthetic corticosteroid, provides anti-inflammatory, antipruritic, and vasoconstrictive actions.
Alternate Names
- Calcipotriol/betamethasone dipropionate.
- Brand Names: Dovobet, Daivobet, Taclonex, Enstilar (foam).
How It Works
- Pharmacodynamics: Calcipotriol binds to the vitamin D receptor, modulating keratinocyte proliferation and differentiation. Betamethasone exerts its anti-inflammatory effects through glucocorticoid receptor binding, ultimately inhibiting inflammatory mediators.
- Pharmacokinetics: Topical application leads to minimal systemic absorption of both drugs when used as directed. Less than 1% of calcipotriol and betamethasone are absorbed through normal skin.
- Mode of Action: The combination acts synergistically. Calcipotriol targets the underlying hyperproliferation and abnormal differentiation of keratinocytes, while betamethasone reduces inflammation and itching.
- Receptor Binding: Calcipotriol binds to Vitamin D receptors. Betamethasone binds to glucocorticoid receptors.
- Elimination Pathways: Primarily hepatic metabolism for both drugs. Calcipotriol metabolites are mainly excreted via feces, while betamethasone is primarily excreted in urine.
Dosage
Standard Dosage
Adults:
- Apply once daily to affected areas.
- Maximum daily dose: 15 grams.
- Maximum weekly dose: 100 grams.
- Treat up to a maximum of 30% of body surface area.
- Scalp psoriasis: Treat for up to 4 weeks.
- Non-scalp psoriasis: Treat for up to 8 weeks. Treatment can be continued or restarted after medical review.
Children: Not recommended for use in patients under 18 years of age. Data in adolescents aged 12-17 are available but pose no recommendation on posology.
Special Cases:
- Elderly Patients: No specific dosage adjustments are indicated, but caution is advisable due to potential age-related changes in skin integrity and drug metabolism.
- Patients with Renal Impairment: No dosage adjustment is formally recommended, though safety and efficacy haven’t been fully evaluated in patients with severe renal impairment. Monitor renal function during treatment.
- Patients with Hepatic Dysfunction: No dosage adjustment is formally recommended, though safety and efficacy haven’t been fully evaluated in patients with severe hepatic impairment.
- Patients with Comorbid Conditions: Caution in patients with diabetes mellitus due to potential for betamethasone-induced hyperglycemia. Monitor blood glucose levels as needed.
Clinical Use Cases
- Intubation: Not applicable.
- Surgical Procedures: Not applicable.
- Mechanical Ventilation: Not applicable.
- Intensive Care Unit (ICU) Use: Not applicable.
- Emergency Situations: Not applicable.
Side Effects
Common Side Effects
- Pruritus, burning sensation, skin irritation, erythema, dry skin.
Rare but Serious Side Effects
- Hypercalcemia (especially with overuse), Cushing’s syndrome (with prolonged or excessive use), adrenal suppression, skin atrophy, folliculitis, pustular psoriasis (upon abrupt discontinuation after prolonged use), hypersensitivity reactions (including angioedema and facial edema).
Long-Term Effects
- Skin atrophy, striae, telangiectasia, and other cutaneous changes with prolonged high-dose or inappropriate use.
Contraindications
- Hypersensitivity to any of the components.
- Disorders of calcium metabolism.
- Erythrodermic, exfoliative, and pustular psoriasis.
- Viral, fungal, bacterial, or parasitic skin infections.
- Tuberculosis or syphilis of the skin.
- Rosacea, acne vulgaris.
- Perioral dermatitis.
Drug Interactions
- Concurrent use with other topical corticosteroids should be avoided due to the risk of additive systemic effects.
- UV radiation can exacerbate the effects of calcipotriol, increasing the risk of skin cancer. Patients should avoid excessive sun exposure and tanning beds.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C. Topical use during pregnancy only if the potential benefit outweighs the risk to the fetus.
- It is unknown if betamethasone/calcipotriol is excreted in breast milk. Caution advised when used in lactating mothers. Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.
Drug Profile Summary
- Mechanism of Action: Calcipotriol normalizes keratinocyte proliferation and differentiation. Betamethasone provides anti-inflammatory, antipruritic, and vasoconstrictive effects.
- Side Effects: Pruritus, burning, irritation, dry skin (common); Hypercalcemia, Cushing’s syndrome, skin atrophy (rare but serious).
- Contraindications: Hypersensitivity, calcium disorders, erythrodermic psoriasis, infections.
- Drug Interactions: Other topical corticosteroids, UV radiation.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Apply 15g daily, max 100g weekly.
- Monitoring Parameters: Serum calcium, especially with prolonged or high-dose use, signs of adrenal suppression with long term use.
Popular Combinations
- This medication already represents a combination therapy. Generally, it is not combined with other topical agents applied to the same area due to the potential for increased side effects.
Precautions
- Avoid application to face, axillae, groin, genitals, or areas with thin skin.
- Avoid occlusion, which can increase systemic absorption.
- Wash hands after application.
- Caution with concomitant UV therapy.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Betamethasone + Calcipotriol?
A: Apply once daily, not exceeding 15 grams per day or 100 grams per week. Do not apply to more than 30% of the body surface area.
Q2: Can this combination be used on the face?
A: No, it should be avoided on the face, axillae, groin, or areas with thin skin due to increased risk of local side effects like skin atrophy.
Q3: What are the main side effects?
A: Common side effects include pruritus, burning, irritation, and dry skin. Rarely, more serious effects like hypercalcemia, Cushing’s syndrome, or skin atrophy can occur.
Q4: Is it safe to use during pregnancy or breastfeeding?
A: Use with caution during pregnancy and breastfeeding only if potential benefits outweigh risks. It is unknown if the drugs are excreted in breastmilk.
Q5: Can this be used with other topical steroids?
A: No, avoid concurrent use of other topical steroids on the same treatment areas as this can increase the risk of systemic side effects.
Q6: How long can a patient use this medication?
A: Initial treatment is generally for up to 4 weeks for scalp psoriasis and up to 8 weeks for other areas. Further courses may be considered after medical review if needed.
Q7: What should I do if a patient develops hypercalcemia?
A: Discontinue the medication and monitor serum calcium levels until normalized. Manage the hypercalcemia appropriately as needed.
Q8: Are there any drug interactions I should be aware of?
A: Concurrent use with other topical corticosteroids should be avoided. Patients should also avoid excessive exposure to natural or artificial sunlight, including UV therapy.
Q9: What should I do if psoriasis does not improve within the recommended treatment duration?
A: Reassess the diagnosis and consider alternative therapies.
Q10: How does Calcipotriol work differently from Betamethasone in treating psoriasis?
A: Calcipotriol addresses the abnormal keratinocyte proliferation and differentiation, while betamethasone reduces inflammation and itching. The combination of both provides synergistic efficacy.
