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tazarotene
Overview
What is Fabior?
FABIOR (tazarotene) Foam, 0.1% contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical use only.
Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The structural formula is represented below:
Molecular Formula: CHNOS Molecular Weight: 351.46
Tazarotene is a pale yellow to yellow substance. FABIOR Foam contains tazarotene, 1 mg/g, in aqueous-based white to off-white foam vehicle consisting of butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. FABIOR Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.
What does Fabior look like?
What are the available doses of Fabior?
0.1%, white to off-white foam
What should I talk to my health care provider before I take Fabior?
How should I use Fabior?
FABIOR (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.
FABIOR Foam is for topical use only. FABIOR Foam is not for oral, ophthalmic, or intravaginal use.
FABIOR Foam should be applied once daily in the evening after washing with a mild cleanser and fully drying the affected area. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears. Avoid the eyes, lips, and mucous membranes. Wash hands after application.
Patients may use moisturizer as needed.
If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides. Treatment should be discontinued if irritation persists.
What interacts with Fabior?
Sorry No Records found
What are the warnings of Fabior?
Sorry No Records found
What are the precautions of Fabior?
Sorry No Records found
What are the side effects of Fabior?
Sorry No records found
What should I look out for while using Fabior?
FABIOR Foam is contraindicated in pregnancy.
FABIOR Foam may cause fetal harm when administered to a pregnant woman.
[see Use in Specific Populations (8.1)].
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus
[see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
What might happen if I take too much Fabior?
Excessive topical application of FABIOR Foam may lead to marked redness, peeling, or discomfort. Management of accidental ingestion or excessive application to the skin should be as clinically indicated.
How should I store and handle Fabior?
How Supplied:FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:50-g aluminum can NDC 0145-0020-03100-g aluminum can NDC 0145-0020-02Storage and Handling:How Supplied:FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:50-g aluminum can NDC 0145-0020-03100-g aluminum can NDC 0145-0020-02Storage and Handling:How Supplied:FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:50-g aluminum can NDC 0145-0020-03100-g aluminum can NDC 0145-0020-02Storage and Handling:How Supplied:FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:50-g aluminum can NDC 0145-0020-03100-g aluminum can NDC 0145-0020-02Storage and Handling:How Supplied:FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:50-g aluminum can NDC 0145-0020-03100-g aluminum can NDC 0145-0020-02Storage and Handling:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Tazarotene is a retinoid prodrug that is converted to its active form, the cognate carboxylic acid of tazarotene, by rapid deesterification in animals and man. Tazarotenic acid binds to all 3 members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ but shows relative selectivity for RARβ and RARγ and may modify gene expression. The clinical significance of these findings is unknown.
The mechanism of tazarotene action in acne vulgaris is not defined. However, the basis of tazarotene's therapeutic effect in acne may be due to its anti-hyperproliferative, normalizing-of-differentiation and anti-inflammatory effects. Tazarotene inhibited corneocyte accumulation in rhino mouse skin and cross-linked envelope formation in cultured human keratinocytes. The clinical significance of these findings is unknown.
Non-Clinical Toxicology
FABIOR Foam is contraindicated in pregnancy.FABIOR Foam may cause fetal harm when administered to a pregnant woman.
[see Use in Specific Populations (8.1)].
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus
[see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
Since cilostazol is extensively metabolized by cytochrome P-450 isoenzymes, caution should be exercised when cilostazol is coadministered with inhibitors of CYP3A4 such as ketoconazole and erythromycin or inhibitors of CYP2C19 such as omeprazole. Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of cilostazol among patients concurrently treated with diltiazem, an inhibitor of CYP3A4 (see , ). Cilostazol does not, however, appear to cause increased blood levels of drugs metabolized by CYP3A4, as it had no effect on lovastatin, a drug with metabolism very sensitive to CYP3A4 inhibition.
Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans .
There were 5 reported pregnancies in subjects who participated in clinical trials for topical tazarotene foam. One of the subjects was found to have been treated with topical tazarotene for 25 days, 2 were treated with vehicle foam, and the other 2 did not receive either tazarotene foam or vehicle foam. The subjects were discontinued from the trials when their pregnancy was reported. The one pregnant woman who was inadvertently exposed to topical tazarotene during the clinical trial delivered a full-term healthy infant.
Females of Childbearing Potential:
Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene foam is used. The possibility of pregnancy should be considered in females of child-bearing potential at the time of institution of therapy.
A negative serum or urine result for pregnancy test having a sensitivity down to at least 25 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to therapy with FABIOR Foam, which should begin during a normal menstrual period for females of childbearing potential. Advise patients of the need to use an effective method of contraception to avoid pregnancy .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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