Cyclobenzaprine Hydrochloride 30 mg Capsule, Extended Release
Other active recalls for Cyclobenzaprine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Muscle Relaxant class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- It's a muscle relaxant prescribed to help ease muscle spasms, pain, and stiffness from acute musculoskeletal injuries — like a back strain or a pulled muscle. It's meant to be used...
- What is cyclobenzaprine actually used for?
- Yes, drowsiness is one of the most common side effects — it's real and can be significant. You should not drive, operate heavy machinery, or do anything that requires sharp focus u...
- Will this make me really drowsy? Can I drive?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $2.06 | $206.29 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride 30 mg 00093-1921-06 | Teva | 60 capsules | $0.893 | AB | Availability likely | — |
| Cyclobenzaprine Hydrochloride 30 mg 00115-1437-13 | Amneal | 60 capsules | $0.893 | AB | Availability likely | — |
| Cyclobenzaprine Hydrochloride 30 mg 24979-0036-04 | Upsher-Smith | 60 capsules | $0.893 | AB | Availability likely | — |
| Amrix 30 mg 63459-0701-60 | Cephalon, | 60 capsules | $66.567 | AB | Availability likely | — |
| Cyclobenzaprine Hydrochloride 30 mgthis 33342-0273-12 | Macleods | 10 capsules | — | AB | FDA listed | — |
| Cyclobenzaprine Hydrochloride 30 mg 70518-4174-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Cyclobenzaprine Hydrochloride 30 mg 70518-4523-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Cyclobenzaprine Hydrochloride 30 mg 71205-0858-00 | Proficient | 100 capsules | — | AB | FDA listed | — |
| Cyclobenzaprine Hydrochloride 30 mg 71335-2696-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Cyclobenzaprine Hydrochloride 30 mg 76420-0896-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 33342-0273-09 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-273-09) | 2024-07-22 | Active |
| 33342-0273-12 You're viewing this | 10 BLISTER PACK in 1 CARTON (33342-273-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK | 2024-07-22 | Active |
Pack size FAQ
What quantity is in NDC 33342-0273-12?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Cyclobenzaprine hydrochloride extended-release capsules are 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. Limitations of Use: • Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. • Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
Cyclobenzaprine hydrochloride extended-release capsules are a muscle relaxant 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. ( 1 ) Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
( 1 ) Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION 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 patients is 15 mg taken once daily. Some patients may require 30 mg taken once daily ( 2 ) • Recommended to take doses at approximately same time each day ( 2 ) • Instruct patients to swallow cyclobenzaprine hydrochloride extended-release capsules intact or to sprinkle capsule contents on a tablespoon of applesauce and swallow immediately without chewing ( 2 ) • Use for periods longer than 2 or 3 weeks is not recommended ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Extended-release capsules in the following strengths: • 15 mg: Size ‘4’ capsule, containing white to off white pellets, having orange cap, orange body with ‘T39’ imprinted on the cap and ‘15 mg’ imprinted on the body with black ink. • 30 mg: Size ‘4’ capsule, containing white to off white pellets, having orange cap, Blue body with ‘T40’ imprinted on the cap and ‘30 mg’ imprinted on the body with white ink. • Extended-release capsules: 15 and 30 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 )
5.1Serotonin 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.
5.2Tricyclic 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.
5.3Use 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 )].
5.4Use 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 )] .
5.5Atropine-like Action Because of its atropine-like action, cyclobenzaprine hydrochloride extended-release capsules should be used with…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 capsules taken orally once daily, cyclobenzaprine immediate-release (IR) 10 mg three times a day, or placebo for 14 days. The most common adverse reactions (incidence ≥3% in any treatment group and greater than placebo) were dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence ( see Table 1).
Table 1: Incidence of the Most Common Adverse Reactions Occurring in ≥ 3% of Patients in any Treatment Group* and Greater Than Placebo in the Two Phase 3, Double-Blind Cyclobenzaprine Hydrochloride Extended-Release Capsules Trials Placebo Cyclobenzaprine Hydrochloride Extended-Release Capsules 15 mg Cyclobenzaprine Hydrochloride Extended-Release Capsules 30 mg N=128 N=127 N=126 Dry mouth 2% 6% 14% Dizziness 2% 3% 6% Fatigue 2% 3% 3% Constipation 0% 1% 3% Somnolence 0% 1% 2% Nausea 1% 3% 3% Dyspepsia 1% 0% 4% *cyclobenzaprine hydrochloride extended-release capsules 15 mg QD, cyclobenzaprine hydrochloride extended-release capsules 30 mg QD, or cyclobenzaprine IR tablets TID
6.2Postmarketing Experience The following adverse reactions have been reported in clinical studies or postmarketing experience with cyclobenzaprine hydrochloride extended-release capsules, cyclobenzaprine IR, or tricyclic drugs. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In a postmarketing surveillance program of cyclobenzaprine IR, the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness and adverse reactions reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.
The following adverse reactions have been reported in postmarketing experience (cyclobenzaprine hydrochloride extended-release capsules or cyclobenzaprine IR), in clinical studies of cyclobenzaprine IR (incidence <1%), or in postmarketing experience with other tricyclic drugs: Body as a Whole: Syncope; malaise; chest pain; edema. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension; hypertension; myocardial infarction; heart block; stroke. Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice, and cholestasis; paralytic ileus, tongue discoloration; stomatitis; parotid swelling.
Endocrine: Inappropriate…
🔄 Drug Interactions ▾
7 DRUG 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 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from case reports with cyclobenzaprine hydrochloride extended-release capsules use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In rats, decreased pup body weight and survival was noted at cyclobenzaprine doses ≥10 mg/kg/day (approximately ≥3 times the maximum recommended human dose (MRHD) of 30 mg/day), when administered orally during pregnancy and lactation ( see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No adverse embryofetal effects were reported following oral administration of cyclobenzaprine during organogenesis to mice and rabbits at maternal doses up to 20 mg/kg/day (approximately 3 and 15 times the MRHD, respectively, on a mg/m2 basis).
Maternal toxicity characterized by decreased body weight gain was observed only in mice at the highest tested dose of 20 mg/kg/day. Decreased pup body weight and survival were reported in a prenatal and postnatal study where pregnant rats were treated orally with cyclobenzaprine during pregnancy and lactation with maternal doses of 10 and 20 mg/kg/day (approximately 3 and 6 times the MRHD on a mg/m 2 basis). Maternal toxicity, characterized by a decreased body weight gain, was observed only at the highest tested dose of 20 mg/kg/day.
8.2Lactation Risk Summary There are no data on the presence of cyclobenzaprine in either human or animal milk, the effects on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cyclobenzaprine hydrochloride extended-release capsules and any potential adverse effects on the breastfed child from cyclobenzaprine hydrochloride extended-release capsules or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of cyclobenzaprine hydrochloride extended-release capsules have not been studied in pediatric patients.
8.5Geriatric Use Clinical studies of cyclobenzaprine hydrochloride extended-release capsules did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of cyclobenzaprine hydrochloride extended-release capsules in the elderly population. The plasma concentration and half-life of cyclobenzaprine are substantially increased in the elderly when compared to the general patient population. Accordingly, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in the elderly [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )].
8.6Hepatic Impairment The use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in patients with mild, moderate, or severe hepatic impairment [see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )].
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from case reports with cyclobenzaprine hydrochloride extended-release capsules use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In rats, decreased pup body weight and survival was noted at cyclobenzaprine doses ≥10 mg/kg/day (approximately ≥3 times the maximum recommended human dose (MRHD) of 30 mg/day), when administered orally during pregnancy and lactation ( see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No adverse embryofetal effects were reported following oral administration of cyclobenzaprine during organogenesis to mice and rabbits at maternal doses up to 20 mg/kg/day (approximately 3 and 15 times the MRHD, respectively, on a mg/m2 basis).
Maternal toxicity characterized by decreased body weight gain was observed only in mice at the highest tested dose of 20 mg/kg/day. Decreased pup body weight and survival were reported in a prenatal and postnatal study where pregnant rats were treated orally with cyclobenzaprine during pregnancy and lactation with maternal doses of 10 and 20 mg/kg/day (approximately 3 and 6 times the MRHD on a mg/m 2 basis). Maternal toxicity, characterized by a decreased body weight gain, was observed only at the highest tested dose of 20 mg/kg/day.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of cyclobenzaprine hydrochloride extended-release capsules have not been studied in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of cyclobenzaprine hydrochloride extended-release capsules did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of cyclobenzaprine hydrochloride extended-release capsules in the elderly population. The plasma concentration and half-life of cyclobenzaprine are substantially increased in the elderly when compared to the general patient population. Accordingly, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in the elderly [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )].
🆘 Overdosage ▾
10 OVERDOSAGE 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 information on treatment. In order to protect against the rare but potentially critical symptoms described above, obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line, and initiate gastric decontamination.
Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. Monitoring of plasma drug levels should not guide management of the patient.
Dialysis is probably of no value because of low plasma concentrations of the drug. Gastrointestinal Decontamination All patients suspected of an overdose with cyclobenzaprine hydrochloride extended-release capsules should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal.
If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated. Cardiovascular A maximal limb-lead QRS duration of 0.10 seconds may be the best indication of the severity of the overdose. Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation (as needed), should be instituted for patients with dysrhythmias and/or QRS widening.
A pH >7.60 or a pCO2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium, or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).
CNS In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center.
Psychiatric Follow-Up Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate. Pediatric Management The principles of management of child and adult overdosage are similar.
It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cyclobenzaprine relieves skeletal muscle spasm of local origin without interfering with muscle function. Cyclobenzaprine has not been shown to be effective in muscle spasm due to central nervous system disease. In animal models, cyclobenzaprine reduced or abolished skeletal muscle hyperactivity.
Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at the brain stem as opposed to the spinal cord level, although an overlapping action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems.
Pharmacological studies in animals demonstrated a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. Cyclobenzaprine caused slight to moderate increase in heart rate in animals.
12.3Pharmacokinetics Absorption Following single-dose administration of cyclobenzaprine hydrochloride extended-release capsules 15 mg and 30 mg in healthy adult subjects (n=15), C max , AUC 0-168h and AUC 0-∞ increased in an approximately dose-proportional manner from 15 mg to 30 mg. The time to peak plasma cyclobenzaprine concentration (T max ) was 7 to 8 hours for both doses of cyclobenzaprine hydrochloride extended-release capsules. A food effect study conducted in healthy adult subjects (n=15) utilizing a single dose of cyclobenzaprine hydrochloride extended-release capsules 30 mg demonstrated a statistically significant increase in bioavailability when cyclobenzaprine hydrochloride extended-release capsules 30 mg was given with food relative to the fasted state.
There was a 35% increase in peak plasma cyclobenzaprine concentration (C max ) and a 20% increase in exposure (AUC 0-168h and AUC 0-∞ ) in the presence of food. No effect, however, was noted in T max or the shape of the mean plasma cyclobenzaprine concentration versus time profile. Cyclobenzaprine in plasma was first detectable in both the fed and fasted states at 1.5 hours.
When the contents of cyclobenzaprine hydrochloride extended-release capsules were administered by sprinkling on applesauce, it was found to be bioequivalent to the same dose when administered as an intact capsule. In a multiple-dose study utilizing cyclobenzaprine hydrochloride extended-release capsules 30 mg administered once daily for 7 days in a group of healthy adult subjects (n=35), a 2.5-fold accumulation of plasma cyclobenzaprine levels was noted at steady-state. Metabolism and Excretion Cyclobenzaprine is extensively metabolized and is excreted primarily as glucuronides via the kidney.
Cytochromes P-450 3A4, 1A2, and, to a lesser extent, 2D6, mediate N-demethylation, one of the oxidative pathways for cyclobenzaprine. Cyclobenzaprine has an elimination half-life of 32 hours (range 8-37 hours; n=18); plasma clearance is
0.7L/min following single-dose administration of cyclobenzaprine hydrochloride extended-release capsules. Special Populations Elderly Although there were no notable differences in C max or T max , cyclobenzaprine plasma AUC is increased by 40% and the plasma half-life of cyclobenzaprine is prolonged in elderly subjects greater than 65 years of age (50 hours) after dosing with cyclobenzaprine hydrochloride extended-release capsules compared to younger subjects 18 to 45 years of age (32 hours). Pharmacokinetic characteristics of cyclobenzaprine following multiple-dose administration of cyclobenzaprine hydrochloride extended-release capsules in the elderly were not evaluated.
Hepatic Impairment In a pharmacokinetic study of immediate-release cyclobenzap…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cyclobenzaprine relieves skeletal muscle spasm of local origin without interfering with muscle function. Cyclobenzaprine has not been shown to be effective in muscle spasm due to central nervous system disease. In animal models, cyclobenzaprine reduced or abolished skeletal muscle hyperactivity.
Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at the brain stem as opposed to the spinal cord level, although an overlapping action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems.
Pharmacological studies in animals demonstrated a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. Cyclobenzaprine caused slight to moderate increase in heart rate in animals.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Cyclobenzaprine hydrochloride extended-release capsules USP are available in 15 mg and 30 mg strengths, packaged in bottles of 60 capsules and blister of 10 capsules. Cyclobenzaprine hydrochloride extended-release 15 mg capsules are orange cap, orange body with ‘T39’ imprinted on the cap and ‘15 mg’ imprinted on the body with black ink. Bottle of 60 capsules NDC 33342-272-09 Carton of 100 capsules (10 x 10 unit-dose) NDC 33342-272-12 Cyclobenzaprine hydrochloride extended-release 30 mg capsules are orange cap, Blue body with ‘T40’ imprinted on the cap and ‘30 mg’ imprinted on the body with white ink.
Bottle of 60 capsules NDC 33342-273-09 Carton of 100 capsules (10 x 10 unit-dose) NDC 33342-273-12
16.2Storage and Handling Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Cyclobenzaprine hydrochloride USP 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 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-(5 H -dibenzo[ a,d ] cyclohepten-5-ylidene)- N,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride extended-release capsules USP for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules USP contain the following inactive ingredients: sugar spheres, hypromellose, colloidal silicon dioxide, ethyl cellulose. In addition, the capsule shell consists of gelatin, sodium lauryl sulphate, titanium dioxide, FD & C Red 40.
Also, 15 mg strength capsules contain FD & C Green 3 and D & C Yellow 10 and 30 mg strength capsules contain FD & C Yellow 6 and FD & C Blue 1. USP Dissolution Test pending structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). • Instruct patients to swallow cyclobenzaprine hydrochloride extended-release capsules intact or to sprinkle capsule contents on a tablespoon of applesauce and swallow immediately without chewing. • Advise patients to stop taking cyclobenzaprine hydrochloride extended-release capsules and to notify their physician right away if they experience symptoms of an allergic reaction, such as difficulty breathing, hives, swelling of face or tongue, or itching. • Advise patients that cyclobenzaprine hydrochloride extended-release capsules should not be taken with MAO inhibitors or within 14 days after their discontinuation. • Caution patients about the risk of serotonin syndrome with concomitant use of cyclobenzaprine hydrochloride extended-release capsules and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.
Advise patients of the signs and symptoms of serotonin syndrome [see Warnings and Precautions ( 5.1 )] and instruct patients to seek medical care immediately if they experience these symptoms. • Advise patients to stop taking cyclobenzaprine hydrochloride extended-release capsules and to notify their physician right away if they experience arrhythmias or tachycardia. • Advise patients that cyclobenzaprine hydrochloride extended-release capsules may enhance the impairment effects of alcohol. These effects may also be seen if cyclobenzaprine hydrochloride extended-release capsules are taken with other CNS depressants. • Caution patients about operating an automobile or other hazardous machinery until it is reasonably certain that cyclobenzaprine hydrochloride extended-release capsules therapy will not adversely affect their ability to engage in such activities. • Advise patients to take cyclobenzaprine hydrochloride extended-release capsules at approximately the same time each day.
Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA Rev.
08/2024