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
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
|
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.
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.
https://medlibrary.org/lib/rx/meds/cyclobenzaprine-hydrochloride-17/page/4/