Calcipotriene/betamethasone Susp

Calcipotriene is a synthetic analog of vitamin D3. It regulates cell proliferation and differentiation, inhibiting keratinocyte proliferation and promoting their differentiation, which helps normalize abnormal cell growth in psoriasis. Betamethasone dipropionate is a high-potency corticosteroid. It exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Skin breakdown where the medication is used
Change in skin color
Change in eyesight

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

* Itching

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have elevated calcium levels in your blood.
If you currently have a skin infection.
If the skin where you will be applying this medication is thinning.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use. If you are undergoing light therapy, notify your doctor to avoid any potential interactions.

When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and consult with your doctor if you have any concerns.

To minimize the risk of severe side effects, use this medication only as directed by your doctor. Do not exceed the recommended dosage, frequency, or duration of treatment, as this may increase the likelihood of adverse reactions.

You may be more susceptible to sunburn while using this medication. To protect yourself, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when outdoors.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and monitor your eye health accordingly.

When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area to prevent potential harm to your baby.

• Other topical corticosteroids (increased risk of systemic effects)
• Other vitamin D analogs (increased risk of hypercalcemia)

• Skin irritation
• Burning
• Itching
• Erythema
• Folliculitis
• Skin atrophy
• Striae
• Telangiectasias
• Acneiform eruptions
• Perioral dermatitis
• Secondary infection
• Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
• Hyperglycemia
• Glucosuria
• Symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, fatigue, confusion)

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown teratogenic effects with high doses of both calcipotriene and betamethasone. This medication should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether calcipotriene or betamethasone are excreted in human milk following topical application. Systemic absorption is low, but caution should be exercised when administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.

Safety and effectiveness in pediatric patients under 12 years of age have not been established. Children may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Adrenal suppression and Cushing's syndrome have been reported in children receiving topical corticosteroids. Use with caution and for the shortest duration possible in adolescents 12 years and older.

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, elderly patients may have thinner skin and be more susceptible to skin atrophy and other local side effects. Use with caution and monitor for adverse reactions.

• This combination product is highly effective for plaque psoriasis but should be used judiciously due to the potent corticosteroid component.
• Advise patients to apply a thin layer only to affected areas and to wash hands thoroughly after application to avoid accidental transfer to sensitive areas like the face or eyes.
• Emphasize the importance of not exceeding the recommended dose (60g/week) or duration (4 weeks) to minimize the risk of systemic side effects (HPA axis suppression, hypercalcemia).
• Educate patients about signs of skin atrophy (thinning, bruising, stretch marks) and systemic effects, and to report them promptly.
• Consider alternative or rotational therapies for long-term management to reduce cumulative corticosteroid exposure.

• Topical corticosteroids (e.g., clobetasol, fluocinonide)
• Topical vitamin D analogs (e.g., calcipotriene, calcitriol)
• Topical retinoids (e.g., tazarotene)
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
• Coal tar
• Anthralin
• Phototherapy (UVB, PUVA)
• Systemic therapies for severe psoriasis (e.g., methotrexate, cyclosporine, biologics, oral retinoids, apremilast)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.