Somnote (Page 2 of 2)

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Chloral Hydrate is a Schedule IV drug.

Abuse

Chloral hydrate may be habit forming.

Dependence

Symptoms of Chloral Hydrate dependence are similar to those of chronic alcoholism. Sudden withdrawal of the drug from physically dependent persons may cause delirium tremens and hallucinations. For this reason, Chloral Hydrate should be withdrawn slowly.

OVERDOSAGE

Chloral Hydrate overdosage produces symptoms which are similar to those of barbiturate overdosage and may include coma, hypotension, hypothermia, respiratory depression and cardiac arrhythmias. Miosis, vomiting, areflexia, and muscle flaccidity may also occur. Esophageal stricture, gastric necrosis and perforation, and gastrointestinal hemorrhage have also been reported. Hepatic and Renal function may be impaired and may result in transient jaundice and/or albuminuria. Death may result from respiratory failure or hypertension. Ingestion of 4 grams of Chloral Hydrate has caused death, although some patients have survived the ingestion of as much as 30 grams of the drug. Treatment of Chloral Hydrate intoxication consists of general supportive therapy including maintenance of an adequate airway, assisted respiration, oxygen administration, and maintaining body temperature and circulation. Gastric lavage may be done following oral overdosage if an endotracheal tube with cuff inflated is in place to prevent aspiration of vomitus. Peritoneal dialysis or hemodialysis may be beneficial.

DOSAGE AND ADMINISTRATION

The usual hypnotic dose of Chloral Hydrate for adults is 500 mg to 1 gram 15 to 30 minutes before retiring. The usual sedative dosage is 250 mg 3 times daily after meals. When Choral Hydrate is administered in the management of alcohol withdrawal symptoms, the usual dosage is 500 mg to 1 gram repeated at 6-hour intervals if needed. Generally, single doses or daily dosage for adults should not exceed 2 grams.

HOW SUPPLIED

Somnote® Capsules are supplied as gray, oval-shaped softgel capsules, imprinted “B-080″. Available in unit dose packaging 50 capsules (5 × 10), NDC 51991-080-51, and bottles containing 50 capsules, NDC 51991-080-52.

Store at 25°C (77°F); excursions permitted to 15°-30°C(59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Manufactured by:
G. Pohl Boskamp GmbH & Co.
Hohenlockstedt, Germany

Distributed By:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

REV. 5/09 Rx Only

PRINCIPAL DISPLAY PANEL — 50 Capsule Bottle

Breckenridge Pharmaceutical, Inc.

NDC 51991-080-52

Somnote®
(Chloral Hydrate Capsules, USP)

500 mg

Rx Only

50 Capsules

New Appearance

PRINCIPAL DISPLAY PANEL -- 50 Capsule Bottle
(click image for full-size original)
SOMNOTE
chloral hydrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-080
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chloral Hydrate (Chloral) Chloral Hydrate 500 mg
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol 400
Gelatin
Glycerin
Sorbitol
Mannitol
Titanium Dioxide
Ferric Oxide Red
Product Characteristics
Color GRAY Score no score
Shape OVAL Size 15mm
Flavor Imprint Code B080
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-080-52 50 CAPSULE in 1 BOTTLE None
2 NDC:51991-080-51 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51991-080-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2001 08/31/2014
Labeler — Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
G Pohl BoskampGmbH & Co 315881672 MANUFACTURE (51991-080)

Revised: 12/2012 Breckenridge Pharmaceutical, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.