Betamethasone and calcipotriene topical

Name: Betamethasone and calcipotriene topical

What should I discuss with my healthcare provider before using betamethasone and calcipotriene?

You should not use this medicine if you are allergic to betamethasone or calcipotriene.

To make sure this medicine is safe for you, tell your doctor if you have:

  • high levels of calcium in your blood (hypercalcemia);

  • a history of kidney stones;

  • liver or kidney disease;

  • severe forms of psoriasis (with pus, skin peeling, severe redness);

  • a skin infection; or

  • if you are receiving UV light treatments (phototherapy).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether betamethasone and calcipotriene topical passes into breast milk or if it could harm a nursing baby. Do not apply this medicine to your breasts if you are breast-feeding a baby.

Do not use this medicine on a child without a doctor's advice. Children can absorb larger amounts of steroid medicine through the skin and may be more likely to have side effects. Steroid medicine can also affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Betamethasone and calcipotriene topical is not approved for use by anyone younger than 12 years old.

Betamethasone and calcipotriene side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Tell your doctor if you have:

  • weight gain (especially in your face or your upper back and torso);

  • slow wound healing, thinning skin, increased body hair;

  • irregular menstrual periods, changes in sexual function; or

  • muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Stop using the medicine and call your doctor at once if you have:

  • severe burning or irritation where the medicine was applied;

  • redness or crusting around your hair follicles;

  • pus, swelling, redness, increased itching, or other signs of skin infection;

  • high levels of calcium in your blood--constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling; or

  • signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

  • skin dryness, itching, burning, or irritation;

  • mild rash; or

  • changes in skin color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Betamethasone and calcipotriene dosing information

Usual Adult Dose for Psoriasis:

Topical ointment:
Psoriasis vulgaris: Apply to the affected areas once a day for up to 4 weeks. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended.

Topical suspension:
Plaque psoriasis of the scalp and body: Apply to the affected areas once a day for up to 8 weeks; treatment may be discontinued earlier if cleared. The maximum weekly dose should not exceed 100 g.

For Healthcare Professionals

Applies to betamethasone / calcipotriene topical: topical foam, topical ointment, topical suspension

Dermatologic

Common (1% to 10%): Ointment: Pruritus (up to 7.2%), psoriasis (up to 3.4%), skin atrophy (up to 1.9%), folliculitis (up to 1.4%), skin depigmentation (1.4%), scaly rash (1.2%), hand dermatitis (1%); Suspension: Pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), folliculitis (up to 1.2%)
Uncommon (0.1% to 1%): Ointment: Erythema (up to 1%), skin irritation (0.4%), papular rash (greater than 0.1% and less than 1%), pustular rash (greater than 0.1% and less than 1%), skin hypopigmentation (greater than 0.1% and less than 1%), telangiectasia (0.1%), skin hyperpigmentation (0.1%); Suspension: Acne (greater than 0.1% and less than 1%), exacerbation of psoriasis (greater than 0.1% and less than 1%), rash (greater than 0.1% and less than 1%), pustular rash (greater than 0.1% and less than 1%)
Rare (less than 0.1%): Ointment: Serious flare-up of psoriasis (at least 1 case)
Postmarketing reports: Ointment: Pustular psoriasis[Ref]

Nervous system

Common (1% to 10%): Ointment: Headache (2.8%)[Ref]

Metabolic

Frequency not reported: Hypercalcemia, hypercalciuria[Ref]

Endocrine

Frequency not reported: Adrenal suppression; Ointment: Hypothalamic-pituitary-adrenal axis suppression[Ref]

Hypersensitivity

Frequency not reported: Allergic contact dermatitis

Respiratory

Common (1% to 10%): Ointment: Nasopharyngitis (2.3%)
Uncommon (0.1% to 1%): Ointment: Influenza (0.9%), upper respiratory tract infection (0.8%)[Ref]

Other

Common (1% to 10%): Ointment: Burning sensation (up to 1.4%); Suspension: Burning sensation of skin (1%)
Uncommon (0.1% to 1%): Ointment: Pain (0.3%)
Postmarketing reports: Ointment: Rebound effect[Ref]

Hematologic

Common (1% to 10%): Ointment: Ecchymosis (1%)[Ref]

Local

Uncommon (0.1% to 1%): Ointment: Application site pruritus (0.5%)[Ref]

Ocular

Uncommon (0.1% to 1%): Suspension: Eye irritation (greater than 0.1% and less than 1%)[Ref]

Some side effects of betamethasone / calcipotriene topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Precautions

Betamethasone-calcipotriene topical should not be applied to the face, axilla, or groin. It should not be used if skin atrophy is present at the treatment site. It is not for oral, ophthalmic, or intravaginal use.

Hypercalcemia and hypercalciuria have been reported with betamethasone-calcipotriene topical. If either occurs, treatment should be discontinued until parameters of calcium metabolism normalize.

Safety and effectiveness have not been established in patients with known or suspected disorders of calcium metabolism.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes can result from systemic absorption of topical corticosteroids. HPA axis suppression may occur during treatment or upon withdrawal of the topical corticosteroid. Use of more potent steroids, use over large surface areas, prolonged use, use under occlusion, use on altered skin barrier, and liver failure may predispose patients using a topical corticosteroid to HPA axis suppression. A cosyntropin stimulation test may be useful in the periodic evaluation of patients for HPA axis suppression. If HPA axis suppression develops, the use of betamethasone-calcipotriene topical should be modified (e.g., attempt to withdraw drug, reduce application frequency, or substitute less potent steroid).

Local side effects may be more likely with occlusive use, prolonged use, or use of higher potency corticosteroids.

Safety and effectiveness have not been established in patients with erythrodermic, exfoliative, or pustular psoriasis.

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, betamethasone-calcipotriene topical should be discontinued until the infection has been adequately treated.

If skin irritation develops, betamethasone-calcipotriene topical ointment should be discontinued and appropriate therapy started.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age). Due to a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic adverse effects when treated with a topical medication.

Betamethasone / calcipotriene topical Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

It is unknown if there is sufficient systemic absorption with topically administered betamethasone or calcipotriene to have detectable quantities in human milk. Betamethasone-calcipotriene topical suspension should not be used on the breast when nursing.

(web3)