ZONALON Cream (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Mylan Pharmaceuticals 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

1. Description

Zonalon (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents ...

2. Clinical Pharmacology

Although doxepin HCl does have H1 and H2 histamine receptor blocking actions, the exact mechanism by which doxepin exerts its antipruritic effect is unknown. Zonalon Cream can produce ...

3. Indications and Usage

Zonalon Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)

4. Contraindications

Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Zonalon Cream application, the use of Zonalon Cream is contraindicated in ...

5. Warnings

Drowsiness occurs in over 20% of patients treated with Zonalon Cream, especially in patients receiving treatment to greater than 10% of their body surface area. Patients should be warned about the possibility ...

6.1. General

Drowsiness Since drowsiness may occur with the use of Zonalon Cream, patients should be warned of the possibility and cautioned against driving a car or operating dangerous machinery while using this drug. ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, mutagenesis, and impairment of fertility studies have not been conducted with doxepin hydrochloride.

6.7. Pregnancy

Reproduction studies have been performed in which doxepin was orally administered to rats and rabbits at doses up to 0.6 and 1.2 times, respectively, the estimated exposure to doxepin that results from ...

6.9. Nursing Mothers

Doxepin is excreted in human milk after oral administration. It is possible that doxepin may also be excreted in human milk following topical application of Zonalon Cream. One case has been reported of ...

6.10. Pediatric Use

The use of Zonalon Cream in pediatric patients is not recommended. Safe conditions for use of Zonalon Cream in children have not been established. One case has been reported of a 2.5-year-old child who ...

6.11. Geriatric Use

Clinical studies of Zonalon Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...

7. Adverse Reactions

Controlled Clinical Trials Systemic Adverse Effects In controlled clinical trials of patients treated with Zonalon Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred ...

9. Overdosage

Deaths may occur from overdosage with this class of drugs. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. ...

10. Dosage and Administration

A thin film of Zonalon Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Zonalon Cream ...

11. How Supplied

ZONALON Cream is available containing 50 mg of doxepin hydrochloride, USP equivalent to 44.3 mg of doxepin. ZONALON Cream, 5% is a soft white cream available as follows: NDC 0378-8123-30 carton containing ...

12. Storage and Handling

Store below 27°C (80°F).