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Acitretin (Acitretin)

Trade Name : Acitretin

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 10 mg/1

ACITRETIN Retinoid [EPC],Retinoids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acitretin (Acitretin) which is also known as Acitretin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Acitretin (Acitretin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • CONTRAINDICATIONS AND WARNINGS: Pregnancy
  • Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected.
  • Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification.
  • Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. These doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m comparison.
  • Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae.
  • Acitretin should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity.
  • Because of the teratogenicity of acitretin, a program called the , ake ction to revent regnancy, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after itsu00a0discontinuation. The program requirements are described below and program materials are available at www.tevagenerics.com/acitretin or may be requested by calling 1-855-850-2138 (see also section).
  • Arrayn- Important Information for Women of Childbearing Potential
  • Acitretin should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
  • Females of reproductive potential must not be given a prescription for acitretin until pregnancy is excluded. Acitretin is contraindicated in females of reproductive potential n
  • Effective forms of contraception include both primary and secondary forms of contraception. Primary forms of contraception include: tubal ligation, partneru2019s vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical hormonal birth control products. Secondary forms of contraception include condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a spermicide), and vaginal sponges (contains spermicide).
  • Any birth control method can fail. Therefore, it is critically important that women of childbearing potential use 2 effective forms of contraception (birth control) simultaneously. It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin preparations. Microdosed u201cminipillu201d progestin preparations are not recommended for use with acitretin. Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. Johnu2019s wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. Johnu2019s wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. Johnu2019s wort (see ).
  • Arrayn- Important Information for Males Taking Acitretin
  • Patients should not donate blood during and for at least 3 years following therapy with acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.
  • There have been 25 cases of reported conception when the male partner was taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome).
  • No data
  • Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is:
  • CHO M.W. 326.43
  • Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate.
  • The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze.
  • Meets USP Dissolution Test 2
  • The mechanism of action of acitretin is unknown.
  • In 2 double-blind, placebo-controlled trials, acitretin was administered once daily to subjects with severe psoriasis (e.g., covering at least 10% to 20% of the body surface area). At 8 weeks (see Table 1) subjects treated in Trial A with 50 mg of acitretin per day showed significant improvements ( u2264 0.05) relative to baseline and to placebo in the physicianu2019s global evaluation and in the mean ratings of severity of psoriasis (scaling, thickness, and erythema). In Trial B, differences from baseline and from placebo were statistically significant ( u2264 0.05) for all variables at both the 25-mg and 50-mg doses; it should be noted for Trial B that no statistical adjustment for multiplicity was carried out.
  • A subset of 141 subjects from both pivotal Trials A and B continued to receive acitretin in an open fashion for up to 24 weeks. At the end of the treatment period, all efficacy variables, as indicated in Table 2, were significantly improved ( u2264 0.01) from baseline, including extent of psoriasis, mean ratings of psoriasis severity, and physicianu2019s global evaluation.
  • All efficacy variables improved significantly in a subset of 55 subjects from Trial A treated for a second, 6-month maintenance course of therapy (for a total of 12 months of treatment); a small subset of subjects (n = 4) from Trial A continued to improve after a third 6-month course of therapy (for a total of 18 months of treatment).
  • Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed u2014 Acitretin Capsules can cause severe birth defects).
  • Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.
  • Pregnancy Category X
  • (See boxed CONTRAINDICATIONS AND WARNINGS.)
  • Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed , , ; and ).
  • An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see , ).
  • Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see ).
  • Acitretin is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids.
  • (See also boxed .)
  • A description of the materials is provided below. The main goals of the materials are to explain the program requirements, to reinforce the educational messages, and to assess program effectiveness.
  • The booklet includes:
  • Information for Patients
  • (n
  • Patients should be instructed to read the Medication Guide supplied as required by law when acitretin capsules are dispensed.
  • Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of acitretin resemble those of the hypervitaminosis A syndrome.
  • In the event of acute overdosage, acitretin must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A (e.g., headache and vertigo). The acute oral toxicity (LD) of acitretin in both mice and rats was greater than 4,000 mg per kg.
  • In one reported case of overdose, a 32-year-old male with Darieru2019s disease took 21 x 25-mg capsules (525-mg single dose). He vomited several hours later but experienced no other ill effects.
  • All female patients of childbearing potential
  • 1) Have a pregnancy test at the time of overdose; 2) Be counseled as per the boxed and sections regarding birth defects and contraceptive use for at least 3 yearsu2019 duration after the overdose.
  • There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with acitretin capsules. A number of the more common side effects are dose-related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Therapy with acitretin capsules should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patientu2019s response to initial treatment. Relapses may be treated as outlined for initial therapy.
  • When acitretin capsules are used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patientu2019s individual response (see ).
  • Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the U.S.; for information, call 1-888-838-2872.
  • Information for Pharmacists
  • Acitretin capsules must only be dispensed in no more than a monthly supply. An acitretin capsules Medication Guide must be given to the patient each time acitretin capsules are dispensed, as required by law.
  • Acitretin Capsules USP are available as follows:
  • 10 mg: Two-piece hard gelatin capsule with light green opaque cap and white opaque body filled with yellow powder, imprinted in black ink with TEVA on the cap and 1135 on the body, available in bottles of 30 capsules (NDC 0093-1135-56).
  • 17.5 mg: Two-piece hard gelatin capsule with yellow opaque cap and yellow opaque body filled with yellow powder, imprinted in black ink with TEVA on the cap and 1138 on the body, available in bottles of 30 capsules (NDC 0093-1138-56).
  • 25 mg: Two-piece hard gelatin capsule with light green opaque cap and yellow opaque body filled with yellow powder, imprinted in black ink with TEVA on the cap and 1136 on the body, available in bottles of 30 capsules (NDC 0093-1136-56).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).
  • PROTECT FROM LIGHT.
  • AVOID EXPOSURE TO HIGH TEMPERATURES AND HUMIDITY AFTER THE BOTTLE IS OPENED.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • 1.n- Arch Dermatol Res n- 2.n- Lancet n- 3.n- Dermatology n- 4.n- Dermatologica n- 5.n- Andrologian n- 6.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. C 10/2017
  • Arrayn- To be completed by the patient* and signed by her prescriber
  • *Must also be initialed by the parent or guardian of a minor patient (under age 18)
  • Read each item below and initial in the space provided to show that you understand each item. n
  • _____________________________________________________________
  • (Patientu2019s name)
  • I have received a copy of the T.A.P.P. brochure. My prescriber has answered all my questions about acitretin capsules. I understand that it is my responsibility to follow my doctoru2019s instructions, and not to get pregnant during treatment with acitretin capsules or for at least 3 years after I stop taking acitretin capsules.
  • I now authorize my prescriber, ___________________________________________________, to begin my treatment with acitretin capsules.
  • Patient signature: ________________________________________
  • Date: ___________________
  • Parent/guardian signature (if under age 18): ____________________
  • Date: ___________________
  • Please print: Patient name and address: _______________________________________________________________
  • _______________________________________________________________
  • Telephone: ______________________________________________________
  • I have fully explained to the patient, _______________________________________________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with acitretin capsules and have answered those questions to the best of my ability.
  • Prescriber signature: _______________________________________
  • Date: __________________
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. B 10/2017
  • This Medication Guide has been approved by the U.S. Food and Drug Administration Rev. D 10/2017
  • No data
  • No data
  • No data

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