FLEXERIL Tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Flexeril.
Summary product information
Route of Administration Dosage Form / Strength All Non-Medicinal Ingredients Oral 10 mg Tablets Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Lactose monohydrate, Magnesium Stearate, partially ...
Indications and clinical use
Flexeril (cyclobenzaprine hydrochloride) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Flexeril should be ...
Contraindications
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the ...
Warnings and precautions
General Tricyclic Antidepressant-like Effects Cyclobenzaprine is structurally related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. Tricyclic antidepressants have been reported ...
Adverse reactions
The following adverse reactions have been reported with cyclobenzaprine hydrochloride tablets: <u>Most frequent:</u> Drowsiness (39%), dry mouth (27%), dizziness (11%). <u>Less frequent:</u> Increased ...
Drug interactions
<b>Serious Drug Interactions:</b> Cyclobenzaprine may have life-threatening interactions with MAO inhibitors (see also CONTRAINDICATIONS). Postmarketing cases of serotonin syndrome have been reported during ...
Dosage and administration
Dosing Considerations Cyclobenzaprine hydrochloride is not recommended for periods longer than two or three weeks (see INDICATIONS AND CLINICAL USE). Reduced (e.g. less frequent) dosing should be considered ...
Overdosage
Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; hospital monitoring is required as soon as possible. Monitor patients for an extended period after ingestion as delayed ...
Action and clinical pharmacology
Controlled clinical studies show that cyclobenzaprine hydrochloride improves the signs and symptoms of skeletal muscle spasm. Mechanism of Action Cyclobenzaprine relieves skeletal muscle spasm of local ...
Storage and stability
Store at room temperature between 15°-30°C in tightly sealed containers. Protect from heat.
Dosage forms, composition and packaging
Composition <u>Each 10 mg tablet contains:</u> Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Lactose monohydrate, Magnesium Stearate, Partially pregelatinized maize Starch, titanium dioxide, polyethylene ...
Pharmaceutical information
Drug Substance <u>Chemical Name:</u> 3-(5H-Dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1 propanamine hydrochloride. N,N-dimethyl-5H dibenzo[a,d]cyclohepten-Δ<sup>5</sup>,γ-propylamine hydrochloride. ...
Detailed pharmacology
Non-clinical Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine ...
Clinical trials
Comparative Bioavailability Study A randomized, single-dose, blinded, standard 2-way crossover comparative bioavailability study was conducted under fasting conditions on healthy male volunteers (N=28). ...
Toxicology
Non-clinical Acute Toxicity Oral LD<sub>50</sub> values were approximately 338 mg/kg in mice and 425 mg/kg in rats (27 and 69 times the MRHD on mg/m² basis respectively). Signs of drug effects were similar ...
Marketing authorization holder
ORIMED Pharma Inc., 1310, rue Nobel, Boucherville, Québec, J4B 5H3
Submission control number
233015
Date of revision
January 07, 2020
References
1. Product Monograph for Flexeril, Frosst Division of Merck Frosst Canada Inc. Kirkland, Quebec, March 8, 1988. 2. Product Monograph for pms-CYCLOBENZAPRINE, Pharmascience Inc. Montreal, Quebec. Date of ...
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
