SILENOR Tablet (2023)
Βιβλιογραφική αναφορά
Συγγραφείς
Currax Pharmaceuticals LLC
Λέξεις κλειδιά
42847-103 42847-106
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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Indications and Usage
SILENOR is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.
2. Dosage and Administration
The dose of SILENOR should be individualized. 2.1. Dosing in Adults The recommended dose of SILENOR for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically ...
3. Dosage Forms and Strengths
SILENOR is an immediate-release, oval-shaped, tablet for oral administration available in strengths of 3 mg and 6 mg. The tablets are blue (3 mg) or green (6 mg) and are debossed with 3 or 6, respectively, ...
4. Contraindications
4.1. Hypersensitivity SILENOR is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. 4.2. Co-administration with Monoamine ...
5. Warnings and Precautions
5.1. Need to Evaluate for Comorbid Diagnoses Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated ...
6. Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of labeling: Abnormal thinking and behavioral changes <em>[see Warnings and Precautions (5.2)]</em>. Suicide risk ...
6.1. Clinical Trials Experience
The pre-marketing development program for SILENOR included doxepin HCl exposures in 1017 subjects (580 insomnia patients and 437 healthy subjects) from 12 studies conducted in the United States. 863 of ...
7. Drug Interactions
7.1. Cytochrome P450 Isozymes SILENOR is primarily metabolized by hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9. Inhibitors of these isozymes may increase ...
8. Use in Specific Populations
8.7. Use in Patients with Sleep Apnea SILENOR has not been studied in patients with obstructive sleep apnea. Since hypnotics have the capacity to depress respiratory drive, precautions should be taken ...
8.1. Pregnancy
Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage <em>(see Data)</em>. There are risks ...
8.2. Lactation
Risk Summary Data from the published literature report the presence of doxepin and nordoxepin in human milk. There are reports of excess sedation, respiratory depression, poor sucking and swallowing, and ...
8.3. Females and Males of Reproductive Potential
Infertility Based on results from animal fertility studies conducted in rats, doxepin may reduce fertility in females and males of reproductive potential <em>[see Nonclinical Toxicology (13.1)]</em>. It ...
8.4. Pediatric Use
The safety and effectiveness of SILENOR in pediatric patients have not been evaluated.
8.5. Geriatric Use
A total of 362 subjects who were ≥65 years and 86 subjects who were ≥75 years received SILENOR in controlled clinical studies. No overall differences in safety or effectiveness were observed between these ...
8.6. Hepatic Impairment
Patients with hepatic impairment may display higher doxepin concentrations than healthy individuals. Initiate SILENOR treatment with 3 mg in patients with hepatic impairment and monitor closely for adverse ...
9.1. Controlled Substance
Doxepin is not a controlled substance.
9.2. Abuse
Doxepin is not associated with abuse potential in animals or in humans. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs ...
9.3. Dependence
In a brief assessment of adverse events observed during discontinuation of doxepin following chronic administration, no symptoms indicative of a withdrawal syndrome were observed. Thus, doxepin does not ...
10. Overdosage
Doxepin is routinely administered for indications other than insomnia at doses 10- to 50-fold higher than the highest recommended dose of SILENOR. The signs and symptoms associated with doxepin use at ...
11. Description
SILENOR (doxepin) is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6mg of doxepin, respectively. ...
12.1. Mechanism of Action
The mechanism of action of doxepin in sleep maintenance is unclear; however, doxepins effect could be mediated through antagonism of the H<sub>1</sub> receptor.
12.2. Pharmacodynamics
Doxepin has high binding affinity to the H<sub>1</sub> receptor (Ki<1 nM). Cardiac Electrophysiology In a thorough QTc prolongation clinical study in healthy subjects, doxepin had no effect on QT intervals ...
12.3. Pharmacokinetics
Absorption The median time to peak concentrations (T<sub>max</sub>) of doxepin occurred at 3.5 hours postdose after oral administration of a 6 mg dose to fasted healthy subjects. Peak plasma concentrations ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis No evidence of carcinogenic potential was observed when doxepin was administered orally to hemizygous Tg.rasH2 mice for 26 weeks at doses of 25, 50, 75, and 100 mg/kg/day. Mutagenesis Doxepin ...
14. Clinical Studies
14.1. Controlled Clinical Trials The efficacy of SILENOR for improving sleep maintenance was supported by six randomized, double-blind studies up to 3 months in duration that included 1,423 subjects, 18 ...
16.1. How Supplied
SILENOR 3 mg tablets are oval shaped, blue, identified with debossed markings of 3 on one side and SP on the other, and are supplied as: NDC 42847-103-30 Bottle of 30 SILENOR 6 mg tablets are oval ...
16.2. Storage and Handling
Store at controlled room temperature 20°-25°C (68°-77°F), protected from light.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Sleep-driving and Other Complex Behaviors There have been reports of people getting out of bed after taking a hypnotic and ...