The following Structured Product Label (SPL) was submitted to the FDA by Alivio Medical Products, Llc for the product Cyclobenzaprine Hydrochloride (NDC 69512-541). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, storage and handling, clinical pharmacology, indications & usage, contraindications, warnings, precautions, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Each film-coated tablet contains:
Cyclobenzaprine Hydrichloride, USP 10 mg
Usual Adult Dosage:
See package outsert for dosage information
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical
formula C20H21N-HCl and a molecular weight of 311.9.
This container is not intended for household use.
Dispense contents with a child-resistant closure
(as required) and in tight, light-resistant container
as defined in the USP.
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]. KEEP THIS
AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
CLINICAL PHARMACOLOGY
Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle
function. It is ineffective in muscle spasm due to central nervous system disease.
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets,USP are indicated as an adjunct to rest and physical therapy for
relief of muscle spasm associated with acute, painful muscoskeletal conditions.
CONTRAINDICATIONS
Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO)
inhibitors or within 14 days after their discontinuation.
WARNINGS
Serotonin Syndrome. The development of a potentially life-threatening serotonin syndrome has been
reported with Cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective
serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic
antidepressants (TCAs), tramadol, bupropion, meperidine, verapimal,, or (MAO) inhibitors.
PRECAUTIONS
General. Because of its atropine - like action, cyclobenzaprine hydrochloride should be sued with caution
in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and
in patients taking anticholinergic medication.
ADVERSE REACTIONS
Incidence of most common adverse reactions in the 2 double-blind, placebo controlled - 5 mg studies
(incidence of >3% on cyclobenzaprine hydrochloride 5 mg
DRUG ABUSE AND DEPENDENCE
Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be
considered when cyclobenzaprine hydrochloride 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 hydrochloride.
DOSAGE AND ADMINISTRATION
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets, USP is 5 mg three
times a day.
HOW SUPPLIED
Cyclobenzaprine hydrochloride tablets, USP 5 mg are supplied as butterscotch yellow-colored, capsule-
shaped, film-coated convex tablets, debossed with "AN40" on one side and plain on the other side.
Copy Of Label (Cyclo Label)
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