SORIATANE Capsule (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Stiefel Laboratories Inc

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

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 ...

Storage and Handling

Store between 15° and 25°C (59° and 77°F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

1. Description

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 ...

2. Clinical Pharmacology

The mechanism of action of SORIATANE is unknown. Pharmacokinetics Absorption Oral absorption of acitretin is optimal when given with food. For this reason, acitretin was given with food in all of the following ...

3. Indications and Usage

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 ...

4. Contraindications

Pregnancy 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 ...

5. Warnings

(See also boxed CONTRAINDICATIONS AND WARNINGS.) Hepatotoxicity: Of the 525 subjects treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered ...

6. Precautions

A description of the Do Your P.A.R.T. materials is provided below. The main goals of the materials are to explain the program requirements, to reinforce the educational messages, and to assess ...

6.2. Information for Patients

(See Medication Guide for all patients and Patient Agreement/Informed Consent for Female Patients at end of professional labeling). Patients should be instructed to read the Medication Guide supplied ...

6.4. Drug Interactions

Ethanol Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and CLINICAL PHARMACOLOGY: Pharmacokinetics). ...

6.5. Drug/Laboratory Test Interactions

Laboratory Tests If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment. Blood ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A carcinogenesis study of acitretin in Wistar rats, at doses up to 2 mg per kg per day administered 7 days per week for 104 weeks, has been completed. There were no neoplastic lesions observed ...

6.7. Pregnancy

Teratogenic Effects (see boxed CONTRAINDICATIONS AND WARNINGS). In a study in which acitretin was administered to male rats only at a dosage of 5 mg per kg per day for 10 weeks (approximate duration ...

6.9. Nursing Mothers

Studies on lactating rats have shown that etretinate is excreted in the milk. There is one prospective case report where acitretin is reported to be excreted in human milk. Therefore, nursing mothers should ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. No clinical trials have been conducted in pediatric subjects. Ossification of interosseous ligaments and tendons of the extremities, ...

6.11. Geriatric Use

Clinical trials of SORIATANE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

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 ...

9. Overdosage

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 (LD50 ...

10. Dosage and Administration

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 ...

11. How Supplied

Brown and white capsules, 10 mg, imprinted A-10 mg; bottles of 30 (NDC 0145-0090-25). Brown and yellow capsules, 25 mg, imprinted A-25 mg; bottles of 30 (NDC 0145-0091-25).

13. Clinical Studies

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 ...

14. References

Berbis Ph, et al.: Arch Dermatol Res (1988) 280:388-389. Maier H, Honigsmann H: Concentration of etretinate in plasma and subcutaneous fat after long-term acitretin. Lancet 348:1107, ...