Taclonex Suspension 60gm

Calcipotriene is a synthetic vitamin D3 analog that regulates cell proliferation and differentiation. It is believed to inhibit keratinocyte proliferation and promote their differentiation, thereby normalizing abnormal cell growth in psoriatic skin. Betamethasone dipropionate is a high-potency synthetic corticosteroid. It exerts anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Serious Side Effects: Seek Medical Help Immediately

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

Allergic reaction symptoms, 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 fainting
+ 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 unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

* Itching

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact 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 alongside your other treatments and health issues. 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. If you are undergoing light therapy, it is crucial to discuss this with 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. It is vital to follow your doctor's instructions regarding dosage and frequency of application, as using more than prescribed or for an extended period may increase the risk of severe side effects.

You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear that provide adequate sun protection.

This medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor. If you are a parent or caregiver of a child using this medication, it is essential to use it with caution, as children may be more prone to certain side effects.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, and your doctor will discuss this with you. If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of using this medication. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area.

• Other topical corticosteroids (increased risk of HPA axis suppression)
• Other topical vitamin D analogs (increased risk of hypercalcemia)

• Increased thirst
• Frequent urination
• Muscle weakness
• Bone pain
• Confusion
• Fatigue
• Nausea
• Vomiting
• Weight loss
• Dizziness
• Blurred vision
• Skin thinning
• Easy bruising
• Stretch marks
• Acne-like eruptions

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown teratogenic effects with both calcipotriene and betamethasone.

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. Avoid applying to the breast area to prevent direct infant exposure.

Safety and effectiveness have not been established in pediatric patients under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids and calcipotriene due to a larger skin surface area to body weight ratio. HPA axis suppression and hypercalcemia have been reported in pediatric patients using topical corticosteroids and calcipotriene. Use in adolescents (12-17 years) should be with caution and limited duration.

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, due to potential for increased systemic absorption in patients with compromised skin barrier or extensive use, monitor for systemic effects (HPA axis suppression, hypercalcemia).

• Taclonex Suspension is specifically formulated for scalp and body psoriasis; it is not for use on the face, groin, or axillae due to increased risk of skin atrophy and other side effects in these sensitive areas.
• Patients should be instructed to shake the bottle well before each use.
• The maximum recommended weekly dose is 60 grams; exceeding this dose increases the risk of systemic side effects like HPA axis suppression and hypercalcemia.
• Advise patients to wash their hands thoroughly after applying the medication to avoid accidental transfer to eyes or other sensitive areas.
• Avoid concomitant use of other topical corticosteroids or vitamin D analogs unless specifically directed by a healthcare provider.
• Prolonged use, especially on large surface areas or under occlusion, can increase systemic absorption and the risk of adverse effects.

• Other topical corticosteroids (e.g., clobetasol, fluocinonide)
• Other topical vitamin D analogs (e.g., calcitriol)
• Topical retinoids (e.g., tazarotene)
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
• Phototherapy (UVB, PUVA)
• Systemic agents (e.g., methotrexate, cyclosporine, apremilast, biologics like adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, brodalumab)
• Excimer laser

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 overdose, including the medication taken, the amount, and the time it occurred.