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warnings
WARNINGS Cyclobenzaprine hydrochloride extended-release is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short-term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS, below, and ADVERSE REACTIONS ). Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. Cyclobenzaprine hydrochloride extended-release may enhance the effects of alcohol, barbiturates, and other CNS depressants. As a result of a 2-fold higher cyclobenzaprine plasma levels in subjects with mild hepatic impairment, as compared to healthy subjects, following administration of immediate-release cyclobenzaprine and because there is limited dosing flexibility with cyclobenzaprine hydrochloride extended-release capsules, use of cyclobenzaprine hydrochloride extended-release is not recommended in subjects with mild, moderate or severe hepatic impairment. As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma half-life following administration of cyclobenzaprine hydrochloride extended-release capsules in elderly subjects as compared to young adults, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in elderly.
ADVERSE REACTIONS The most common adverse reactions in the two 14-day clinical efficacy trials and in the 7-day repeat-dose pharmacokinetic study are presented in Tables 5 and 6, respectively. Table 5: Incidence of the Most Common Adverse Reactions Occurring in ≥ 3% of Subjects in Any Treatment Group in the Two Phase 3, Double-Bline Cyclobenzaprine Hydrochloride Extended-release Capsules Trials Cyclobenzaprine Hydrochloride Extended- release 15 mg N = 127 Cyclobenzaprine Hydrochloride Extended- release 30 mg N = 126 Placebo N = 128 Dry mouth 6% 14% 2% Dizziness 3% 6% 2% Fatigue 3% 3% 2% Constipation 1% 3% 0% Somnolence 1% 2% 0% Nausea 3% 3% 1% Dyspepsia 0% 4% 1% Table 6: Incidence of the Most Common Adverse Reactions Occurring in ≥ 3% of Subjects in Any Treatment Group in the 7-Day Pharmacokinetic Study of Cyclobenzaprine Hydrochloride Extended-release Capsules Cyclobenzaprine Hydrochloride Extended-release 30 mg N = 36 Somnolence 100% Dry mouth 58% Headache NOS 17% Dizziness 19% Vision blurred 3% Nausea 8% Dysgeusia 6% Palpitations 6% Tremor 6% Dry throat 8% Acne NOS 6% Disturbance in attention 6% Insomnia 0% In a post-marketing surveillance program (7,607 patients treated with cyclobenzaprine 10 mg TID), the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies: Table 7: Most Common Adverse Reactions From Post-marketing Surveillance Program Clinical Studies Cyclobenzaprine 10 mg TID Surveillance Program Cyclobenzaprine 10 mg TID Drowsiness 39% 16% Dry mouth 27% 7% Dizziness 11% 3% Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg TID tablet: Body as a Whole : Syncope; malaise. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension. Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice, and cholestasis. Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash. Musculoskeletal: Local weakness. Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia. Skin: Sweating. Special Senses: Ageusia; tinnitus. Urogenital: Urinary frequency and/or retention. Causal Relationship Unknown Other reactions, reported rarely for cyclobenzaprine under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians: Body as a Whole: Chest pain; edema. Cardiovascular: Hypertension; myocardial infarction; heart block; stroke. Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling. Endocrine: Inappropriate ADH syndrome. Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia. Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss. Musculoskeletal: Myalgia. Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms. Respiratory: Dyspnea. Skin: Photosensitization; alopecia. Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.