Data from FDA - Curated by EPG Health - Last updated 20 December 2016
CONTRAINDICATIONS Hypersensitivity to any component of this product.
Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation.
Hyperpyretic crisis seizures, and
PRECAUTIONS General Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with
Cyclobenzaprine hydrochloride should be used with
Information for Patients Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may
In the elderly, the frequency and
In elderly patients, cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and
In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in
Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the
At oral doses of up to 10 times the human dose, cyclobenzaprine did not
Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose.
Pregnancy Category B:
Reproduction studies have been performed in
There are, however,
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers It is not known whether this drug is excreted in human milk.
Use in the Elderly
PHARMACOLOGY, Pharmacokinetics, Elderly).
The elderly may also be more at risk for CNS
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
The following list of
The overall incidence of
The incidence of these
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 HCl 10 mg Surveillance Progam With Cyclobenzaprine HCl 10 mg Drowsiness 39 % 16 % Dry Mouth 27 % 7 % Dizziness 11 % 3 % Among the less frequent
Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.
Digestive: Vomiting; anorexia; diarrhea; gastrointestinal
Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.
Urogenital: Urinary frequency and/or retention.
Causal Relationship Unknown Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where
Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.
Digestive: Paralytic ileus, tongue
Hematic and Lymphatic: Purpura; bone marrow
Metabolic, Nutritional and Immune: Elevation and lowering of
Skin: Photosensitization; alopecia.
DOSAGE AND ADMINISTRATION For most patients,
Based on individual patient response,
Use of cyclobenzaprine hydrochloride for periods longer than two or
(see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically
|Date Last Revised||15-07-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||PD-Rx Pharmaceuticals, Inc.|