Acitretin (Soriatane)

Trade Name : SORIATANE

Stiefel Laboratories 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 (Soriatane) which is also known as SORIATANE and Manufactured by Stiefel Laboratories Inc. It is available in strength of 10 mg/1 per ml. Read more

Acitretin (Soriatane) 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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CONTRAINDICATIONS AND WARNINGS: Pregnancy
SORIATANE 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. SORIATANE 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 SORIATANE 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.
SORIATANE 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 SORIATANE, a program called the program, Pregnancy Prevention Actively Required During and After Treatment, 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 its discontinuation. The program requirements are described below and program materials are available at or may be requested by calling 1-888-784-3335 (1-888-STIEFEL) (see also section).
Arrayn- Important Information for Women of Childbearing Potential:
SORIATANE 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 SORIATANE until pregnancy is excluded. SORIATANE is contraindicated in females of reproductive potential n
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).
Arrayn- For All Patients:

SORIATANE (acitretin), a retinoid, is available in 10-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 powder with a molecular weight of 326.44. The structural formula is:
Each capsule contains acitretin, black monogramming ink, gelatin, maltodextrin (a mixture of polysaccharides), microcrystalline cellulose, and sodium ascorbate.
Gelatin capsule shells contain gelatin, iron oxide (yellow, black, and red), and titanium dioxide. They may also contain benzyl alcohol, carboxymethylcellulose sodium, edetate calcium disodium.

The mechanism of action of SORIATANE is unknown.

In 2 double-blind, placebo-controlled trials, SORIATANE 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 SORIATANE per day showed significant improvements ( u22640.05) 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 (u22640.05) 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.
P
The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physician's global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a 7-point scale (0 = none, 1 = trace, 2 = mild, 3 = mild-moderate, 4 = moderate, 5 = moderate-severe, 6 = severe).
A subset of 141 subjects from both pivotal Trials A and B continued to receive SORIATANE 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 ( u22640.01) from baseline, including extent of psoriasis, mean ratings of psoriasis severity, and physicianu2019s global evaluation.
P
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).

SORIATANE is indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, SORIATANE should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, SORIATANE 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 CONTRAINDICATIONS AND WARNINGS u2014 SORIATANE 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.

See boxed CONTRAINDICATIONS AND WARNINGS.
SORIATANE is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed n , n , and PRECAUTIONS).
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with SORIATANE is also contraindicated (see n ).
Since both SORIATANE and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see n ).
SORIATANE is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids.

(See also boxed CONTRAINDICATIONS AND WARNINGS.)

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:
The program also includes a voluntary patient survey for women of childbearing potential to assess the effectiveness of the SORIATANE Pregnancy Prevention Program Program materials are available at www.soriatane.com or may be requested by calling 1-888-784-3335 (1-888-STIEFEL).

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 SORIATANE resemble those of the hypervitaminosis A syndrome.

In the event of acute overdosage, SORIATANE 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 CONTRAINDICATIONS AND WARNINGS and PRECAUTIONS 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 SORIATANE. 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 SORIATANE 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 SORIATANE is used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patientu2019s individual response (see PRECAUTIONS: General).
Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call Stiefel at 1-888-784-3335 (1-888-STIEFEL).
SORIATANE must only be dispensed in no more than a monthly supply. A SORIATANE Medication Guide must be given to the patient each time SORIATANE is dispensed, as required by law.

Brown and white capsules, 10 mg, imprinted u201cA-10 mgu201d; bottles of 30 (NDC 0145-0090-25).
Brown and yellow capsules, 25 mg, imprinted u201cA-25 mgu201d; bottles of 30 (NDC 0145-0091-25).
Store between 15u00b0 and 25u00b0C (59u00b0 and 77u00b0F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

1.n- Arch Dermatol Res
2.n- Lancet
3.n- Dermatology
4.n- Dermatologica
5.n- Andrologia
6.

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)
1.
INITIAL: ___________
2.
INITIAL: ___________
3.
INITIAL: ___________
4. n- at the same time.
INITIAL: ___________
5.
INITIAL: ___________
6.
INITIAL: ___________
7.
INITIAL: ___________
8.
INITIAL: ___________
9.
INITIAL: ___________
10. n- sure
INITIAL: ___________
11.
INITIAL: ___________
12.
INITIAL: ___________
13.
INITIAL: ___________
14.
INITIAL: ___________
15.
INITIAL: ___________
u00a0I have received a copy of the Do Your P.A.R.T. brochure. My prescriber has answered all my questions about SORIATANE. I understand that it is my responsibility to follow my doctoru2019s instructions, and not to get pregnant during treatment with SORIATANE or for at least 3 years after I stop taking SORIATANE.
I now authorize my prescriber, ______________________________________________________, to begin my treatment with SORIATANE.
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 SORIATANE and have answered those questions to the best of my ability.
Prescriber signature: _______________________________________
Date: __________________n
SRN:8PIn

This Medication Guide has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0Revised: 09/2017

NDC 0145-0090-25
SORIATANEn
(acitretin) Capsules
10 mg
30 Capsules
R only
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT
Made in Austria
u00a92016 Stiefel Laboratories, Inc.

NDC 0145-0091-25
SORIATANEn
(acitretin) Capsules
25 mg
30 Capsules
R only
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT
Made in Austria
u00a92016 Stiefel Laboratories, Inc.

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Acitretin (Soriatane)

Trade Name : SORIATANE

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Acitretin (Soriatane)

Trade Name : SORIATANE

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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