Rx Item-Amrix cyclobenzaprine 15mg Cap 60 by Teva Pharma

Clinical Information
Gen. Code and Des.
62177 cyclobenzaprine HCl ORAL CAP ER 24H 15 MG
GCN and Des.
97959 cyclobenzaprine HCl ORAL CAP ER 24H 15 MG
Strength
15MG ER
Dose Form
CAPSULE, EXT RELEASE 24 HR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
12200400 CENTRALLY ACTING SKELETAL MUSCLE RELAXNT
Active Ingredients
1678 cyclobenzaprine HCl 6202239
Inactive Ingredients
10141 red dye
10143 yellow dye
2549 gelatin 9000708
2598 sucrose 57501




AMRIX- cyclobenzaprine hydrochloride capsule, extended release
Cephalon, Inc.
DESCRIPTION
AMRIX is skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in AMRIX extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is white, crystalline tricyclic amine salt with the empirical formula C20 H21 N?HCl and molecular weight of 311.9. It has melting point of 217?C, and pKa of 8.47 at 25?C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H -dibenzo[a,d cyclohepten-5-ylidene)-N,N -dimethyl-1-propanamine hydrochloride
Mechanism of Action
Cyclobenzaprine relieves skeletal muscle spasm of local origin without interfering with muscle function

INDICATIONS AND USAGE
AMRIX? (cyclobenzaprine hydrochloride extended-release capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.
DOSAGE AND ADMINISTRATION
The recommended adult dose for most patients is one AMRIX 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one AMRIX 30 mg capsule taken once daily or as two AMRIX 15 mg capsules taken once daily
Use of AMRIX for periods longer than two or three weeks is not recommended
3 DOSAGE FORMS AND STRENGTHS
Extended-release capsules in the following strengths:
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15 mg: Capsules are orange/orange and are embossed in blue ink with ?15 mg? on the body, and Cephalon ?C? logo, ?Cephalon,? and dashed band on the cap.
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30 mg: Capsules are blue/red and are embossed in white ink with ?30 mg? on the body, and Cephalon ?C? logo, ?Cephalon,? and dashed band on the cap.
CONTRAINDICATIONS
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Hypersensitivity to any component of this product. These adverse reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling or pruritus. Discontinue AMRIX if hypersensitivity reaction is suspected.
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Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.
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During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
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Hyperthyroidism.

Amrix 15mg Cap 60 by Teva Pharma
NDC No.63459-0700-60 UPC/GTIN No.3-63459-70060-1 MPN 70060 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

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Teva Pharmaceuticals USA/Brand

CYCLOBENZAPRINE HCL ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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