Cyclobenzaprine Hydrochloride (Page 3 of 4)

Use in the Elderly

The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly). The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions. For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed. In such patients cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.

ADVERSE REACTIONS

Incidence of most common adverse reactions in the 2 double-blind3 , placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine hydrochloride 5 mg):

Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo
N=464 N=249 N=469
Drowsiness 29% 38% 10%
Dry Mouth 21% 32% 7%
Fatigue 6% 6% 3%
Headache 5% 5% 8%

Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.
The following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine hydrochloride 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
The adverse reactions reported most frequently with cyclobenzaprine hydrochloride 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:3 Note: Cyclobenzaprine hydrochloride 10 mg data are from one clinical trial. Cyclobenzaprine hydrochloride 5 mg and placebo data are from two studies.

Clinical Studies With Cyclobenzaprine Hydrochloride 10 mg Surveillance Program With Cyclobenzaprine Hydrochloride 10 mg
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 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, serotonin syndrome.
Skin:
Sweating.
Special Senses:
Ageusia; tinnitus.
Urogenital:
Urinary frequency and/or retention.
Causal Relationship Unknown
Other reactions, reported rarely for cyclobenzaprine hydrochloride 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.

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. 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 hydrochloride is approximately 338 and 425 mg/kg in mice and rats, respectively.

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