cyclobenzaprine hydrochloride

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cyclobenzaprine hydrochloride

Amrix, Apo-Cyclobenzaprine (CA), Dom-Cyclobenzaprine (CA), Fexmid, Flexeril, Novo-Cycloprine (CA) PHL-Cyclobenzaprine (CA), PMS-Cyclobenzaprine (CA), Ratio-Cyclobenzaprine (CA), Riva-Cyclobenzaprine (CA)

Pharmacologic class: Autonomic nervous system drug

Therapeutic class: Skeletal muscle relaxant (centrally acting)

Pregnancy risk category B

Action

Unclear. Thought to act primarily at brain stem (and to a lesser extent at spinal cord level) to relieve skeletal muscle spasms of local origin without altering muscle function.

Availability

Capsules (extended-release): 15 mg, 30 mg

Tablets: 5 mg, 7.5 mg, 10 mg

Indications and dosages

Adjunct to rest and physical therapy to relieve muscle spasm associated with acute, painful musculoskeletal conditions

Adults: 5 mg P.O. t.i.d. (immediate-release tablet). May increase to 10 mg P.O. t.i.d. (immediate-release tablet) as needed. Or, 15 mg (extended-release capsule) P.O. daily; some patients may need up to 30 mg/day, given as one 30-mg (extended-release capsule) P.O. daily or two 15-mg (extended-release capsules) P.O. daily.

Contraindications

• Hypersensitivity to drug

• Acute recovery phase after myocardial infarction (MI)

• Heart failure

• Arrhythmias

• Hyperthyroidism

• MAO inhibitor use within past 14 days

Precautions

Use cautiously in:

• cardiovascular disease, closed-angle glaucoma, hepatic impairment, increased intraocular pressure, urinary retention

• elderly patients

• pregnant or breastfeeding patients

• children younger than age 15.

Administration

Don't give within 14 days of MAO inhibitor. Drug interaction may cause hypertensive crisis and severe seizures.

• Give extended-release capsule at approximately the same time each day.

• Know that drug shouldn't be used for more than 3 weeks.

• Be aware that drug may not be first-line agent for elderly patients because of its anticholinergic effects.

Adverse reactions

CNS: dizziness, drowsiness, syncope, confusion, fatigue, headache, nervousness, decreased mental acuity, irritability, weakness, insomnia, depression, disorientation, delusions, peripheral neuropathy, abnormal gait, Bell's palsy, EEG changes, extrapyramidal symptoms, cerebrovascular accident

CV: vasodilation, tachycardia, chest pain, hypotension, MI, heart block

EENT: blurred vision

GI: nausea, constipation, dyspepsia, swollen parotid glands, mouth inflammation, discolored tongue, dry mouth, paralytic ileus

GU: galactorrhea, urinary retention, urinary frequency, gynecomastia, testicular swelling, libido changes, erectile dysfunction

Hematologic: purpura, eosinophilia, bone marrow depression, leukopenia, thrombocytopenia

Metabolic: hyperglycemia, hypoglycemia, syndrome of inappropriate diuretic hormone secretion

Musculoskeletal: muscle ache

Respiratory: dyspnea

Skin: photosensitization, alopecia, angioedema

Other: unpleasant taste, weight gain or loss, edema

Interactions

Drug-drug. Anticholinergics, anti-cholinergic-like drugs (including anti-depressants, antihistamines, disopyramide, haloperidol, phenothiazines): additive anticholinergic effects

Antihistamines, CNS depressants, opioids, sedative-hypnotics: additive CNS depression

Guanadrel, guanethidine: reduction in or blockage of these drugs' actions

MAO inhibitors: hyperpyretic crisis, seizures, death

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Assess for adverse CNS effects, such as drowsiness, dizziness, and decreased mental acuity.

• Monitor patient for evidence of drug interactions, especially when giving drug with CNS depressants.

Patient teaching

• Tell patient to take extended-release capsule at approximately the same time each day.

• Tell patient that drug may cause dry mouth.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.

• Advise patient not to use alcohol, sedatives, pain medications, over-the-counter preparations, or herbs without consulting prescriber.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, herbs, and behaviors mentioned above.

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References in periodicals archive ?
The annual brand sales in the US for Tevaa[euro](tm)s Actiq drug are USD173m, while for Amrix they are around USD125m and stand at USD1.1bn for Provigil, the company added.
The Actiq and Amrix brands make annual sales in the US of USD173m and USD125m respectively, Teva said.
Pharmaceutical company Watson Pharmaceuticals Inc (NYSE:WPI) revealed on Monday that it has introduced the authorised generic version of AMRIX 15 mg and 30 mg, in the market.
AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is approved for use along with rest and physical therapy to help control muscle spasm associated with acute, painful musculoskeletal conditions, added Watson Pharmaceuticals Inc.
Pursuant to the non-exclusive sales agent agreement, Anesta manufactures and supplies Watson with all dosage strengths of generic AMRIX.
Watson markets and distributes generic AMRIX in the U S on behalf of Anesta and will receive payments based on sales of the product.
For the 12 months ending 31 March 2011, AMRIX had sales of about USD125m (EUR88.1m), according to IMS Health data.
According to the company, Cyclobenzaprine HCl ER Capsules are the generic version of Cephalon's Amrix Capsules, a muscle relaxant.
Annual sales in the United States for Provigil and Amrix are around $1.1 billion and $125 million, respectively.
Cyclobenzaprine HCl ER Capsules are the generic version of Cephalon's (NASDAQ: CEPH) Amrix Capsules, a muscle relaxant.
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