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ZORYVE is a brand name for Roflumilast, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Plaque Psoriasis ZORYVE® (roflumilast cream, 0.3%) is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older. ZORYVE® (roflumilast foam, 0.3%) is indicated for topical treatment of plaque psoriasis of the scalp and body…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Apply ZORYVE to affected areas once daily. 3 Pharmacokinetics, Special Populations and Conditions). 4 Administration Apply ZORYVE topically once a day to affected areas of skin and rub in completely.
Wash hands after application unless hands are being treated. If deemed medically necessary to use during breastfeeding, use ZORYVE on the smallest area of skin for the shortest duration possible. 2 Breastfeeding). ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use (see 7 WARNINGS AND PRECAUTIONS, General).
5 Missed Dose Advise patients if they forget to use ZORYVE as directed that they may skip the missed application and go back to their regular schedule the following day. 5 OVERDOSE There are no data from clinical trials regarding signs and symptoms of overdose of ZORYVE.
If surplus ZORYVE has been applied, the excess should be wiped off. ZORYVE® (roflumilast) Page 6 of 41 Protected B / Protégé B For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
3% are diarrhea, nausea, and headache. 15% are headache and nausea. 3% are nasopharyngitis, nausea, and headache. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 3% or vehicle once daily for 8 weeks. 3% for subjects treated with vehicle. The adverse reactions reported by ≥1% of patients treated with ZORYVE in clinical trials are listed in Table 2.
3% for up to 64 weeks in open-label extension studies, the adverse reaction profile was similar to that observed in vehicle-controlled studies. 4% of patients treated with ZORYVE cream). 3% in open-label studies of 2- and 24-weeks duration.
1 Clinical Trials by Indication). 3% In two multicenter, randomized, double-blind, vehicle-controlled trials, 734 subjects (of which 12 were aged 12 to 17 years of age, and 82 were 65 years of age or older) with plaque psoriasis of the scalp and body were treated with ZORYVE foam or vehicle foam once daily for 8 weeks.
6% for subjects treated with vehicle. The adverse reactions reported by ≥1% of patients treated with ZORYVE in clinical trials are listed in Table 3. 7% of patients treated with ZORYVE). Seven adolescent patients were treated with ZORYVE foam in an open-label study of 8 weeks duration.
1 Clinical Trials by ZORYVE® (roflumilast) Page 11 of 41 Protected B / Protégé B Indication). 15% or vehicle once daily for 4 weeks. 1% for subjects treated with vehicle cream. The adverse reactions reported by ≥1% of patients treated with ZORYVE in clinical trials are listed in Table 4.
, General). 5 Missed Dose Advise patients if they forget to use ZORYVE as directed that they may skip the missed application and go back to their regular schedule the following day. 5 OVERDOSE There are no data from clinical trials regarding signs and symptoms of overdose of ZORYVE.
If surplus ZORYVE has been applied, the excess should be wiped off. ZORYVE® (roflumilast) Page 6 of 41 Protected B / Protégé B For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
3% roflumilast (w/w) in a white to off-white cream and is supplied in 5-g (physician sample) and 60-g aluminum tubes. 3% roflumilast (w/w) in a white to off-white foam and is supplied in 25-g (physician sample) and 60-g pressurized aluminum cans.
7 WARNINGS AND PRECAUTIONS General ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). 15%) of white to off-white cream ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol, diethylene glycol monoethyl ether, hexylene glycol, isopropyl palmitate, methylparaben, propylparaben, purified water, sodium hydroxide, and white petrolatum.
Hydrochloric acid may have been added to adjust pH. 3%) of white to off-white foam ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol, diethylene glycol monoethyl ether, hexylene glycol, isopropyl palmitate, methylparaben, propylparaben, purified water, sodium hydroxide, and white petrolatum.
Hydrochloric acid may have been added to adjust pH. ZORYVE foam is dispensed from an aluminum can pressurized with propellant (butane, isobutane, and propane). 8 times human exposure to unbound roflumilast and roflumilast N-oxide, respectively, when roflumilast was administered orally).
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Roflumilast in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
15% administered daily or twice weekly for up to 56 weeks in an open-label extension trial, the adverse reaction profile was similar to that observed in vehicle-controlled trials. 15% in this age group included 406 patients aged 6 to 17 years from two […]
However, a human spermatogenesis study investigated reproductive safety of 500-mcg oral roflumilast in healthy male volunteers. No adverse treatment effects were found on parameters of the male reproductive system including reproductive hormones (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
1 Pregnant Women ZORYVE should not be used during labor and delivery. There are no human studies that have investigated effects of ZORYVE on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice.
There are no adequate and well controlled studies of oral or topical roflumilast in pregnant women. The potential risk for humans is unknown. Studies of oral roflumilast in animals have shown reproductive toxicity at doses above the human recommended dose (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
2 Breastfeeding ZORYVE should only be used by a breastfeeding mother if deemed medically necessary, considering a potential risk to the baby. To minimize potential exposure to the breastfed infant via breast milk, use ZORYVE on the smallest area of skin and for the shortest duration possible while breastfeeding.
Advise breastfeeding women not to apply ZORYVE directly to the nipple or areola to avoid direct infant exposure. There is no information regarding the presence of topically administered roflumilast in human milk, the effects on the breastfed infant, or the effects on milk production.
Oral roflumilast and/or its metabolites are excreted into the milk of lactating rats. Excretion of roflumilast and/or its metabolites into human milk is probable. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZORYVE and any potential adverse effects on the breastfed infant from ZORYVE or from the underlying maternal condition.
3% for pediatric use primarily from extrapolation of data generated from adult patients. 3 Pharmacokinetics). 3% in the treatment of plaque psoriasis for pediatric patients below the age of 12 years. 3 Pharmacokinetics). Pediatrics (<6 […]