amrix
Pharmaranks rates Amrix 2.8/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Amrix (Cyclobenzaprine Hydrochloride) is a muscle relaxant used to treat Muscle Cramp, Muscle Rigidity, Muscle Spasticity, Myositis.
Cyclobenzaprine Hydrochloride · by Teva
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Cyclobenzaprine Hydrochloride
- Drug class
- Muscle Relaxant
- Form
- Capsule, extended release
- Strength
- Cyclobenzaprine Hydrochloride 15MG · Cyclobenzaprine Hydrochloride 30MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- muscle cramp, muscle rigidity, muscle spasticity
- Manufacturer
- Teva
- Half-life
- about 18 hours (range roughly 8 to 37 hours) for the standard immediate-release tablet in typical adults (how long it stays in your system)
- What the pharmacy pays
- ~$0.63 for 30 — not your price
- FDA application
- NDA021777
What is Amrix?
From the FDA label:Cyclobenzaprine hydrochloride is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20 H 21 N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a 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, and has the following structural formula: Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: diethyl phthalate NF, ethylcellulose NF (Ethocel Standard 10 Premium), gelatin, Opadry ® Clear YS-1-7006, sugar spheres NF (20-25 mesh), and titanium dioxide. Cyclobenzaprine hydrochloride extended-release 15 mg capsules also contain D&C yellow #10, FD&C green #3, and FD&C red #40. Cyclobenzaprine hydrochloride extended-release 30…
How to use
The recommended adult dose for most patients is one (1) cyclobenzaprine hydrochloride extended-release 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) cyclobenzaprine hydrochloride extended-release 30 mg capsule taken once daily or as two (2) cyclobenzaprine hydrochloride extended-release 15 mg capsules taken once daily. It is recommended that doses be taken at approximately the same time each day. Use of cyclobenzaprine hydrochloride extended-release capsules for periods longer than two or three weeks is not recommended [see Indications and Usage (1) ]. Instruct patients to swallow cyclobenzaprine hydrochloride extended-release capsules intact. Alternatively, the contents of the cyclobenzaprine hydrochloride extended-release capsule may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to: Sprinkle the contents of the capsule onto a tablespoon of applesauce and consume immediately without chewing. Rinse the mouth to ensure all of the contents have been swallowed. Discard any unused portion of the cyclobenzaprine hydrochloride extended-release capsules after the contents have been sprinkled on applesauce. Recommended adult dose for most…
Side effects
The following clinically significant reactions are described in greater detail, in other sections. Serotonin Syndrome [see Warnings and Precautions ( 5.1 )] Adverse Cardiovascular Effects [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥3% in any treatment group and greater than placebo): dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to cyclobenzaprine hydrochloride extended-release capsules in 253 patients in 2 clinical trials. Cyclobenzaprine hydrochloride extended-release capsules were studied in two double-blind, parallel-group, placebo-controlled, active-controlled trials of identical design [see Clinical Studies ( 14 )] . The study population was composed of patients with muscle spasms associated with acute painful musculoskeletal conditions. Patients received 15 mg or 30 mg of cyclobenzaprine hydrochloride extended-release…
Warnings
Important safety information
Serotonin syndrome has been reported with cyclobenzaprine when used in combination with other serotonergic drugs ( 5.1 ) Cyclobenzaprine is structurally related to tricyclic antidepressants which have been reported to produce adverse cardiovascular effects or CNS depressant effects ( 5.2 ) Use in the elderly is not recommended ( 5.3 ) Use in patients with hepatic impairment is not recommended ( 5.4 ) Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and in patients taking anticholinergic medications ( 5.5 ) 5.1 Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of cyclobenzaprine hydrochloride extended-release capsules with MAO inhibitors is contraindicated [see Contraindications ( 4 )]. Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with cyclobenzaprine hydrochloride extended-release capsules and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with cyclobenzaprine hydrochloride extended-release capsules and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases. 5.2 Tricyclic Antidepressant-like Effects Cyclobenzaprine is structurally related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke [see Contraindications ( 4 )]. Cyclobenzaprine hydrochloride extended-release capsules may enhance the effects of alcohol, barbiturates, and other CNS depressants. Some of the more serious central nervous system (CNS) reactions noted with the tricyclic antidepressants have occurred in short-term studies of cyclobenzaprine for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm. If clinically significant CNS symptoms develop, consider discontinuation of cyclobenzaprine hydrochloride extended-release capsules. 5.3 Use in the Elderly As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma half-life following administration of cyclobenzaprine hydrochloride extended-release capsules in elderly subjects as compared to young adults, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in the elderly [see Clinical Pharmacology ( 12.3 )]. 5.4 Use in Patients with Hepatic Impairment As a result of two-fold higher cyclobenzaprine plasma levels in subjects with mild hepatic impairment, as compared to healthy subjects, following administration of immediate-release cyclobenzaprine and because there is limited dosing flexibility with cyclobenzaprine hydrochloride extended-release capsules, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in patients with mild, moderate, or severe hepatic impairment [see Clinical Pharmacology ( 12.3 )]. 5.5 Atropine-like Action Because of its atropine-like action, cyclobenzaprine hydrochloride extended-release capsules should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication. 5.5 Atropine-like Action Because of its atropine-like action, cyclobenzaprine hydrochloride extended-release capsules should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
Who should not take Amrix
Hypersensitivity to any component of this product. Adverse reactions may include anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue cyclobenzaprine hydrochloride extended-release capsules if a hypersensitivity reaction is suspected. 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. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism. Hypersensitivity to any component of this product ( 4 ) Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation ( 4 ) During acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure ( 4 ) Hyperthyroidism ( 4 )
Overdose — what happens if you take too much
Clinical Presentation Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride extended-release capsules. 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 most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia. Less frequent symptoms include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations. Rare but potentially critical symptoms of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, cases of neuroleptic malignant syndrome and rhabdomyolysis have been reported. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity. Other potential effects of overdosage include any of the symptoms listed under Adverse Reactions ( 6 ) . Treatment of Overdose General As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Based on its structural similarity to tricyclic antidepressants, cyclobenzaprine hydrochloride extended-release capsules may have life-threatening interactions with MAO inhibitors [see Contraindications ( 4 )], may enhance the effects of alcohol, barbiturates, and other CNS depressants, may enhance the seizure risk in patients taking tramadol, or may block the antihypertensive action of guanethidine and similarly acting compounds. Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors [see Warnings and Precautions ( 5.1 )]. MAO Inhibitors: Life-threatening interactions may occur ( 4 , 7 ) Serotonergic Drugs: Serotonin syndrome has been reported ( 5.1 , 7 ) CNS Depressants: Effects of alcohol, barbiturates, and other CNS depressants may be enhanced ( 5.2 , 7 ) Tramadol: Seizure risk may be enhanced ( 7 ) Guanethidine: Antihypertensive effect may be blocked ( 7 )
How long does Cyclobenzaprine Hydrochloride stay in your body?
The elimination half-life of cyclobenzaprine hydrochloride is about 18 hours (range roughly 8 to 37 hours) for the standard immediate-release tablet in typical adults — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Half-life varies by formulation and population: it is longer with the extended-release capsule (about 32 hours) and in adults over 65 (up to about 50 hours), and hepatic impairment roughly doubles drug exposure; no active metabolite with a materially longer half-life is described.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CYCLOBENZAPRINE HYDROCHLORIDE tablet (DailyMed FDA label).
Drug class
How this class works, per Cyclobenzaprine - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Amrix ranks — best-rated muscle relaxant for:
Dosage forms
Capsule, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Amrix treat?
- Amrix (Cyclobenzaprine Hydrochloride) may be used to treat muscle cramp, muscle rigidity, muscle spasticity, myositis, pain, spasm, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Amrix work?
- Amrix is a muscle relaxant. Most muscle relaxants work in the brain and spinal cord rather than on the muscle itself: they damp down the overactive nerve signals and reflexes that keep muscles tense, easing spasms and tightness. Some specialized agents instead act directly on muscle calcium release.
- How is Amrix rated?
- pharmaranks gives Amrix a composite score of 2.8 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Amrix cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.63 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Amrix?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Amrix. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Amrix?
- Amrix is marketed by Teva. You can see Teva's full profile, rating, and other products on pharmaranks.
- Is Amrix a brand-name or generic drug?
- Amrix is a brand-name product with the active ingredient Cyclobenzaprine Hydrochloride.
- Is Amrix available over the counter?
- No. Amrix is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Amrix come in?
- Amrix is currently marketed as capsule, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Amrix?
- Amrix is classified as muscle relaxant, per the FDA's Established Pharmacologic Class.
- Is Amrix FDA-registered?
- Amrix is on record with the U.S. FDA under application number NDA021777. You can verify this on its official FDA label.
- Has Amrix been recalled by the FDA?
- Amrix has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Amrix safe?
- There's no single safe-or-not verdict. pharmaranks gives Amrix a recall-safety score of 56/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Amrix?
- Amrix's side effects are taken directly from its FDA label. From the label: The following clinically significant reactions are described in greater detail, in other sections. Serotonin Syndrome [see Warnings and Precautions ( 5.1 )] Adverse Cardiovascular Effects [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥3% in any treatment group and g… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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amrix
56/100