OXSORALEN-ULTRA Capsule (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

0187-0650

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

CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION. Methoxsalen with ultraviolet (UV) radiation should be used only by physicians who ...

1. Description

Oxsoralen-Ultra (methoxsalen capsules, USP) contains 10 mg methoxsalen (8-methoxsalen). Methoxsalen occurs as white to pale yellow crystals and can be obtained naturally from seeds of Ammi majus ...

2. Clinical Pharmacology

The combination treatment regimen of psoralen (P) and ultraviolet radiation of 320-400 nm wavelength commonly referred to as UVA is known by the acronym PUVA. Skin reactivity to UVA (320-400 nm) radiation ...

3. Indications and Usage

Photochemotherapy (methoxsalen with long-wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and ...

4. Contraindications

A. Patients exhibiting idiosyncratic reactions to psoralen compounds. B. Patients possessing a specific history of light-sensitive disease states should not initiate methoxsalen therapy except under special ...

5. Warnings

General A. Skin burning Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are exceeded. B. Carcinogenicity ...

6.1. General

General Applicable to psoriasis treatment Before methoxsalen ingestion: Patients must not sunbathe during the 24 hours prior to methoxsalen ingestion and UV exposure. The presence of a sunburn ...

6.2. Information for Patients

See accompanying Patient Package Insert.

6.3. Laboratory Tests

Patients should have an ophthalmologic examination prior to start of therapy, and thence yearly. Patients should have routine laboratory tests prior to the start of therapy and at regular periods thereafter ...

6.4. Drug Interactions

See WARNINGS GENERAL.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

See WARNINGS GENERAL.

6.7. Pregnancy

Animal reproduction studies have not been conducted with methoxsalen. It is also not known whether methoxsalen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, either methoxsalen ingestion or nursing should be discontinued.

6.10. Pediatric Use

Safety in children has not been established. Potential hazards of long-term therapy include the possibilities of carcinogenicity and cataractogenicity as described in the WARNINGS GENERAL section as well ...

6.11. Geriatric Use

Clinical studies with Oxsoralen-Ultra capsules did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects responded differently from younger subjects. Other reported ...

7. Adverse Reactions

A. Methoxsalen The most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients. This effect may be minimized or avoided by instructing the patient ...

9. Overdosage

In the event of methoxsalen overdosage, induce emesis and keep the patient in a darkened room for at least 24 hours. Emesis is most beneficial within the first 2 to 3 hours after ingestion of methoxsalen, ...

10. Dosage and Administration

CAUTION: Oxsoralen-Ultra represents a new dose form of methoxsalen. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous ...

11. How Supplied

Oxsoralen-Ultra Capsules, each containing 10 mg of methoxsalen (8-methoxypsoralen) are available in green soft gelatin capsules in white plastic bottles of 50 (NDC 0187-0650-42), with VRX imprinted on ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

14. References

Levins, P.C., Gange, R.W., Momtaz-T,K., Parrish, J.A., and Fitzpatrick, T.B.: A New Liquid Formulation of 8-Methoxypsoralen: Bioactivity and Effect of Diet: JID, 82, No. 2, pp. 185-187 (1984) and ...