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Drug overview for ALVOX HP (tazarotene/niacinamide):
Generic name: TAZAROTENE/NIACINAMIDE
Drug class: Acne Products
Therapeutic class: Dermatological
Tazarotene is a synthetic acetylenic retinoid.
No enhanced Uses information available for this drug.
Generic name: TAZAROTENE/NIACINAMIDE
Drug class: Acne Products
Therapeutic class: Dermatological
Tazarotene is a synthetic acetylenic retinoid.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ALVOX HP (tazarotene/niacinamide) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for ALVOX HP (tazarotene/niacinamide):
Application of tazarotene cream or gel may cause a transient feeling of pruritus, burning, or stinging. (See Cautions: Precautions and Contraindications.) If irritation is excessive, tazarotene should be discontinued temporarily until the integrity of the skin is restored, or dosing of the drug should be reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate; tazarotene therapy may be resumed, or the drug concentration or frequency of application increased, as therapy with the drug becomes more tolerable. Frequency of dosing, therapeutic response, and skin tolerance should be monitored carefully during tazarotene therapy.
The efficacy of reduced dosing frequencies (i.e., less than once daily) has not been established.
Safe use of tazarotene gel over more than 20% of body surface area has not been established.
The efficacy of reduced dosing frequencies (i.e., less than once daily) has not been established.
Safe use of tazarotene gel over more than 20% of body surface area has not been established.
Tazarotene is applied topically to the skin as a 0.05 or 0.1% cream or gel.
Patients should be instructed carefully regarding proper use of the drug. (See Cautions: Precautions and Contraindications.) Occlusive dressings or wrappings should not be used with tazarotene cream or gel, and hands should be washed after applying the drug (unless the hands are being treated for psoriasis). Patients should be advised not to use tazarotene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked redness, peeling, or discomfort.
Patients should be instructed carefully regarding proper use of the drug. (See Cautions: Precautions and Contraindications.) Occlusive dressings or wrappings should not be used with tazarotene cream or gel, and hands should be washed after applying the drug (unless the hands are being treated for psoriasis). Patients should be advised not to use tazarotene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked redness, peeling, or discomfort.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ALVOX HP (tazarotene/niacinamide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ALVOX HP (tazarotene/niacinamide):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
| Sunburn |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Skin photosensitivity |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ALVOX HP (tazarotene/niacinamide):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Severe erythema Severe pruritus Skin fissure |
None. |
| Rare/Very Rare |
|---|
|
Blistering skin Dyschromia Skin photosensitivity |
There are 12 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Erythema Localized edema Pruritus of skin Skin irritation Stinging of skin |
Cheilitis Contact dermatitis |
| Rare/Very Rare |
|---|
|
Exfoliative dermatitis Pain Skin rash |
The following precautions are available for ALVOX HP (tazarotene/niacinamide):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered orally to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:28.) Single instances of known retinoid malformations (e.g., spina bifida, hydrocephaly, heart anomalies) have been reported in some species of animals (e.g., rabbits) followingtopical administration of tazarotene during gestation. Abnormal early embryonic development (e.g., decreased litter size, decreased number of live fetuses, decreased fetal body weights) was observed in animals receiving oral tazarotene in dosages 3.4
times the systemic exposure (AUC0-24 h) in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 11 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 6.7
times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area. Developmental delays, teratogenic effects, and postimplantation fetal loss also have been reported in animals receiving oral tazarotene in dosages 1.1-26
or 0.7-13 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream (over 35% of body surface area) or gel (over 20% of body surface area), respectively, 3.5-85
times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream (over 15% of body surface area), or 2.1-52 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1%
cream (over 15% of body surface area). Systemic exposure to tazarotene depends on the extent of body surface area treated. In patients treated topically over sufficient body surface area (over 35 or 20% of body surface area when used as a cream or gel, respectively, in psoriasis patients), systemic exposure to tazarotene could be of the same magnitude as in these orally treated animals.
Although systemic exposure anticipated in the treatment of the face alone may be less as a result of the more limited area of application of the drug, it is not known what level of exposure produces teratogenic effects in humans. There are no adequate and controlled studies to date using tazarotene topical cream or gel in pregnant women. The manufacturer states that the 8 women in clinical trials who were inadvertently exposed to tazarotene during pregnancy subsequently delivered healthy infants.
The importance of these findings is unknown because the exact timing and extent of exposure to the drug in relation to gestation are uncertain. However, tazarotene is contraindicated in women who are or may become pregnant or who intend to become pregnant during treatment. Women of childbearing potential should be warned of the potential risk and should use adequate birth-control measures during treatment with tazarotene.
If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the drug should be discontinued and the patient informed of the potential risks to the fetus. A negative result on a reliable blood pregnancy test (i.e., having a sensitivity of at least 50 mIU/mL for human chorionic gonadotropin (hCG)) should be obtained within 2 weeks prior to beginning tazarotene therapy and therapy should begin during the next normal menstrual period.
times the systemic exposure (AUC0-24 h) in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 11 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 6.7
times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area. Developmental delays, teratogenic effects, and postimplantation fetal loss also have been reported in animals receiving oral tazarotene in dosages 1.1-26
or 0.7-13 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream (over 35% of body surface area) or gel (over 20% of body surface area), respectively, 3.5-85
times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream (over 15% of body surface area), or 2.1-52 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1%
cream (over 15% of body surface area). Systemic exposure to tazarotene depends on the extent of body surface area treated. In patients treated topically over sufficient body surface area (over 35 or 20% of body surface area when used as a cream or gel, respectively, in psoriasis patients), systemic exposure to tazarotene could be of the same magnitude as in these orally treated animals.
Although systemic exposure anticipated in the treatment of the face alone may be less as a result of the more limited area of application of the drug, it is not known what level of exposure produces teratogenic effects in humans. There are no adequate and controlled studies to date using tazarotene topical cream or gel in pregnant women. The manufacturer states that the 8 women in clinical trials who were inadvertently exposed to tazarotene during pregnancy subsequently delivered healthy infants.
The importance of these findings is unknown because the exact timing and extent of exposure to the drug in relation to gestation are uncertain. However, tazarotene is contraindicated in women who are or may become pregnant or who intend to become pregnant during treatment. Women of childbearing potential should be warned of the potential risk and should use adequate birth-control measures during treatment with tazarotene.
If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the drug should be discontinued and the patient informed of the potential risks to the fetus. A negative result on a reliable blood pregnancy test (i.e., having a sensitivity of at least 50 mIU/mL for human chorionic gonadotropin (hCG)) should be obtained within 2 weeks prior to beginning tazarotene therapy and therapy should begin during the next normal menstrual period.
It is not known if topically applied tazarotene is distributed into human milk, but the drug appears to distribute into milk following topical application in lactating animals. The manufacturer states that caution should be exercised when tazarotene is administered to a nursing woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ALVOX HP (tazarotene/niacinamide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALVOX HP (tazarotene/niacinamide)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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