Cyclobenzaprine Hydrochloride (Page 4 of 4)

Gastrointestinal Decontamination

All patients suspected of an overdose with cyclobenzaprine hydrochloride should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated.

Cardiovascular

A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose. Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation (as needed), should be instituted for patients with dysrhythmias and/or QRS widening. A pH >7.60 or a pCO2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

CNS

In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center.

PSYCHIATRIC FOLLOW-UP

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

PEDIATRIC MANAGEMENT

The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

HOW SUPPLIED

Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed “2631” on one side and debossed “V” on the reverse side, supplied in bottles of 10, 100, 500 and 1000.

Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed “2632” on one side and debossed “V” on the reverse side, supplied in bottles of 10, 90, 100, 180, 270, 500, 1000 and 5000.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

This product was Manufactured for:


QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8181950
Rev 4/13R4

PRINCIPAL DISPLAY PANEL

NDC 68258-7013-XX

NDC 68258-7013-08

NDC 68258-7013-XX
(click image for full-size original)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-7013(NDC:0603-3078)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
FD&C RED NO. 40
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 2631;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-7013-8 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077797 02/28/2007
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (68258-7013), repack (68258-7013)

Revised: 08/2013 Dispensing Solutions, Inc.

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