CYCLOBENZAPRINE HYDROCHLORIDE (Page 3 of 3)

DRUG ABUSE AND DEPENDENCE

Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine HCl is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.

OVERDOSAGE

Although rare, deaths may occur from overdosage with cyclobenzaprine HCl. Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose. As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible. The acute oral LD50 of cyclobenzaprine HCl is approximately 338 and 425 mg/kg in mice and rats, respectively.

Manifestations

The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia. Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations. Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity.

Other potential effects of overdosage include any of the symptoms listed under ADVERSE REACTIONS.

Management

General

As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.

In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. Monitoring of plasma drug levels should not guide management of the patient. Dialysis is probably of no value because of low plasma concentrations of the drug.

Gastrointestinal Decontamination

All patients suspected of an overdose with cyclobenzaprine HCl 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 & ADMINISTRATION

For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl 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).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-440-54

MFG: 0591-5658-10

Cyclobenzaprine Hydrochloride 10 MG

15 Tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains cyclobenzaprine HCL, USP…10 mg

Dosage: See accompanying prescribing information

Store at 68 to 77 degrees F.

Keep out of the reach of children.

Medicatin guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by Watson Laboratories, Inc Corona, CA 92880 Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-440-54
(click image for full-size original)

NDC: 51655-440-52

MFG: 0591-5658-10

Cyclobenzaprine Hydrochloride 10 MG

30Tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains cyclobenzaprine HCL, USP…10 mg

Dosage: See accompanying prescribing information

Store at 68 to 77 degrees F.

Keep out of the reach of children.

Medicatin guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by Watson Laboratories, Inc Corona, CA 92880 Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-440-52
(click image for full-size original)
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-440(NDC:0591-5658)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 10 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code DAN;5658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-440-54 15 TABLET in 1 BOTTLE, DISPENSING None
2 NDC:51655-440-52 30 TABLET in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071611 11/24/2014
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-440)

Revised: 04/2015 Northwind Pharmaceuticals, LLC

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