Cyclobenzaprine Hydrochloride (Page 4 of 4)

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 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 are yellow-orange, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘87’ on one side and plain on other side.
Bottles of 100 NDC 65862-190-01
Bottles of 500 NDC 65862-190-05
Bottles of 1,000 NDC 65862-190-99
Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are butterscotch yellow, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘32’ on one side and plain on other side.
Bottles of 100 NDC 65862-191-01
Bottles of 500 NDC 65862-191-05
Bottles of 1,000 NDC 65862-191-99
STORAGE
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 032, India
Revised: 09/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Tablet Bottle)

NDC 65862-190-01
Cyclobenzaprine Hydrochloride Tablets, USP
5 mg
Rx only 100 Tablets AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Tablet Bottle)

NDC 65862-191-01
Cyclobenzaprine Hydrochloride Tablets, USP
10 mg
Rx only 100 Tablets AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (100 Tablet Bottle)
(click image for full-size original)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-190
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
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW (Yellow to Orange) Score no score
Shape PENTAGON (5 sided) (Biconvex) Size 7mm
Flavor Imprint Code D;87
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-190-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-190-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-190-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078643 09/26/2008
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-191
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (Butterscotch Yellow) Score no score
Shape PENTAGON (5 sided) (Biconvex) Size 7mm
Flavor Imprint Code D;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-191-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-191-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-191-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078643 09/26/2008
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-190), ANALYSIS (65862-191), MANUFACTURE (65862-190), MANUFACTURE (65862-191)

Revised: 11/2021 Aurobindo Pharma Limited

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