DRUG ABUSE AND DEPENDENCE
Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine 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. 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 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 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 2 or 3 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 are available in the following strengths and package sizes:
5 mg (Orange, round, film-coated tablets, debossed with “TL 211” on one side and plain on the other side)
Bottles of 100’s NDC 59746-211-06
Bottles of 1000’s NDC 59746-211-10
7.5 mg (White, round, film coated tablets, debossed with “C 735” on one side and plain on the other side)
Bottles of 30’s NDC 59746-735-30
Bottles of 100’s NDC 59746-735-01
Bottles of 1000’s NDC 59746-735-10
10 mg (Yellow, round, film-coated tablets, debossed with “TL 177” on one side and plain on the other side)
Bottles of 100’s NDC 59746-177-06
Bottles of 1000’s NDC 59746-177-10
Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.
Rev. # 04/2017
PACKAGE LABEL.
NDC 59746-177 -06
Cyclobenzaprine Hydrochloride Tablets, USP
10 mg
CADISTA™
100 Tablets
Rx Only
Each film-coated tablet contains: Cyclobenzaprine hydrochloride, USP 10 mg
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep container tightly closed.
Keep this and all medication out of the reach of children.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Usual Adult Dosage: See accompanying prescribing information.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev # 01/17
NDC 59746-735-30
Cyclobenzaprine Hydrochloride Tablets, USP
7.5 mg
CADISTA™
30 Tablets
Rx only
Rev # 12/16
Each film-coated tablet contains: Cyclobenzaprine Hydrochloride, USP 7.5 mg
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep container tightly closed.
Keep this and all medication out of the reach of children.
Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature].
Usual Adult dosage: See accompanying prescribing information.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA
NDC 59746-211 -06
Cyclobenzaprine Hydrochloride Tablets, USP
5 mg
CADISTA™
100 Tablets
Rx only
Each film-coated tablet contains: Cyclobenzaprine hydrochloride, USP 5 mg
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep container tightly closed.
Keep this and all medication out of the reach of children.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Usual Adult Dosage: See accompanying prescribing information.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev.# 01/17
| CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated |
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| CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated |
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| CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated |
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Revised: 11/2017 Jubilant Cadista Pharmaceuticals Inc.
