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Cyclobenzaprine Hydrochloride (Cyclobenzaprine Hydrochloride)

Trade Name : Cyclobenzaprine Hydrochloride

Amneal Pharmaceuticals of New York LLC

CAPSULE, EXTENDED RELEASE

Strength 15 mg/1

CYCLOBENZAPRINE HYDROCHLORIDE Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cyclobenzaprine Hydrochloride (Cyclobenzaprine Hydrochloride) which is also known as Cyclobenzaprine Hydrochloride and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 15 mg/1 per ml. Read more

Cyclobenzaprine Hydrochloride (Cyclobenzaprine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cyclobenzaprine hydrochloride extended-release capsules areu00a0indicated 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 are a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. ()
  • Limitations of Use:
  • Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to 2 or 3 weeks) ()
  • Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity or cerebral palsy n
  • The recommended adult dose for most patients is one (1) cyclobenzaprine hydrochloride 15 mg extended-release capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) cyclobenzaprine hydrochlorideu00a030 mg extended-release capsule taken once daily or as two (2) cyclobenzaprine hydrochlorideu00a015 mg extended-release capsules taken once daily.
  • Instruct patients to swallow cyclobenzaprine hydrochloride extended-releaseu00a0capsules intact. Alternatively, the contents of the cyclobenzaprine hydrochloride extended-releaseu00a0capsule 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:
  • Recommended adult dose for most patients is 15 mg taken once daily.u00a0 Some patients may require 30 mg taken once dailyu00a0n
  • Recommended to take doses at approximately same time each day n
  • Instruct patients to swallow cyclobenzaprine hydrochloride extended-releaseu00a0capsules intact or to sprinkle capsule contents on a tablespoon of applesauce and swallow immediately without chewing ()
  • Use for periods longer than 2 or 3 weeks is not recommended n
  • Extended-release capsules in the following strengths:
  • Extended-release capsules:u00a015 mg and 30 mg n
  • No data
  • Hypersensitivity to any component of this product n
  • Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation n
  • During acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure n
  • Hyperthyroidism n
  • No data
  • Serotonin syndrome has been reported with cyclobenzaprine when used in combination with other serotonergic drugs ()
  • Cyclobenzaprine is structurally related to tricyclic antidepressants which have been reported to produce adverse cardiovascular effects or CNS depressant effects ()
  • Use in the elderly is not recommended ()
  • Use in patients with hepatic impairment is not recommended ()
  • Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and in patients taking anticholinergic medications ()
  • The following clinically significant reactions are described in greater detail, in other sections.
  • Most common adverse reactions (incidence u22653% in any treatment group and greater than placebo):u00a0 dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence () u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Based on its structural similarity to tricyclic antidepressants, cyclobenzaprine hydrochloride extended-releaseu00a0may have life-threatening interactions with MAO inhibitors , 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 inhibitorsu00a0n
  • MAO Inhibitors: Life-threatening interactions may occur (, )
  • Serotonergic Drugs: Serotonin syndrome has been reported (, )
  • CNS Depressants: Effects of alcohol, barbiturates, and other CNS depressants may be enhanced (, )
  • Tramadol: Seizure risk may be enhanced ()
  • Guanethidine: Antihypertensive effect may be blocked ()
  • No data
  • Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride extended-releaseu00a0is administered, even though they have not been reported to occur with this drug.u00a0 Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise.u00a0 These are not indicative of addiction.
  • No data
  • Cyclobenzaprine hydrochlorideu00a0is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochlorideu00a0extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula CHNu00b7HCl and a molecular weight of 311.9.u00a0 It has a melting point of 217u00b0C, and a pK of 8.47 at 25u00b0C.u00a0 It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents.u00a0 If aqueous solutions are made alkaline, the free base separates.u00a0 Cyclobenzaprine hydrochlorideu00a0is designated chemically as 3-(-dibenzo[] cyclohepten-5-ylidene)--dimethyl-1-propanamine hydrochloride, and has the following structural formula:
  • Cyclobenzaprine hydrochlorideu00a0extended-release capsules for oral administration are supplied in 15 mgu00a0and 30 mg strengths.u00a0 Cyclobenzaprine hydrochloride extended-releaseu00a0capsules contain the following inactive ingredients:u00a0 diethyl phthalate NF, ethylcellulose NF (Ethocel Standard 10 Premium), gelatin, Opadry Clear YS-1-7006, sugar spheres NF (20 to 25 mesh), and titanium dioxide. Cyclobenzaprine hydrochlorideu00a015 mg extended-release capsules also contain D&C yellow #10, FD&C green #3, and FD&C red #40.u00a0 Cyclobenzaprine hydrochlorideu00a030 mg extended-release capsules also contain FD&C blue #1, FD&C blue #2, FD&C red #40, and FD&C yellow #6.
  • No data
  • No data
  • Efficacy was assessed in two double-blind, parallel-group, active-controlled, placebo-controlled studies of identical design of cyclobenzaprine hydrochloride extended-release capsules,u00a015 mg and 30 mg taken once daily, between 6:00 and 7:00 PM, cyclobenzaprine 10 mg three times a day, or placebo for 14 days in patients with muscle spasms associated with acute painful musculoskeletal conditions.
  • There were significant differences in the primary efficacy analysis, the patientu2019s rating of medication helpfulness, between the cyclobenzaprine hydrochloride extended-release capsules,u00a015 mg group and the placebo group at Days 4 and 14 in one study and between the cyclobenzaprine hydrochloride extended-release capsules,u00a030 mg group and the placebo group at Day 4 in the second study.
  • Table 2: Patientsu2019 Rating of Medication Helpfulness - Study 1*
  • *Percentages are rounded to the nearest whole percent.
  • Table 3: Patientsu2019 Rating of Medication Helpfulness - Study 2*
  • *Percentages are rounded to the nearest whole percent.
  • In addition, one of the two studies demonstrated significant differences between the cyclobenzaprine hydrochloride extended-release capsules,u00a030u00a0mg group and the placebo group in terms of patient-rated relief from local pain due to muscle spasm at Day 4 and Day 8, in patient-rated restriction of movement at Day 4 and Day 8, and in patient-rated global impression of change at Day 4, Day 8, and Day 14.
  • In both studies, there were no significant treatment differences between the cyclobenzaprine hydrochloride extended-releaseu00a0treatment groups and the placebo group in physician's global assessment, patient-rated restriction in activities of daily living, or quality of nighttime sleep.
  • No data
  • See FDA-approved patient labeling (Patient Information).
  • Manufactured By:n n Vandalia, OH 45377
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 05-2019-01
  • Cyclobenzaprine Hydrochloriden n- Extended-Release Capsules
  • What are cyclobenzaprine hydrochloride extended-release capsules?
  • Cyclobenzaprine hydrochloride extended-release capsules are a prescription medicine used along with rest and physical therapy to help treat muscle spasm due to acute, painful musculoskeletal problems.
  • Cyclobenzaprine hydrochloride extended-release capsules should only be used for up to 2 or 3 weeks. It is not known if cyclobenzaprine hydrochloride extended-release capsules are effective when used for longer periods.
  • It is not known if cyclobenzaprine hydrochloride extended-release capsules are safe and effective in children.
  • Do not take cyclobenzaprine hydrochloride extended-release capsules if you:
  • Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.
  • Before taking cyclobenzaprine hydrochloride extended-release capsules, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take
  • Especially tell your healthcare provider if you take:
  • Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider or pharmacist when you get a new medicine.
  • How should I take cyclobenzaprine hydrochloride extended-release capsules?
  • What should I avoid while taking cyclobenzaprine hydrochloride extended-release capsules?
  • You should not drink alcohol until you know how cyclobenzaprine hydrochloride extended-release capsules affect you. Taking cyclobenzaprine hydrochloride extended-release capsules with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times.
  • Do not drive, operate machinery, or do other dangerous activities until you know how cyclobenzaprine hydrochloride extended-release capsules affect you.
  • What are the possible side effects of cyclobenzaprine hydrochloride extended-release capsules?
  • Cyclobenzaprine hydrochloride extended-release capsulesn- may cause serious side effects, including:
  • The most common side effects of cyclobenzaprine hydrochloride extended-release capsules n- include:
  • These are not all the possible side effects of cyclobenzaprine hydrochloride extended-release capsules.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store cyclobenzaprine hydrochloride extended-release capsules?
  • General information about the safe and effective use of cyclobenzaprine hydrochloride extended-release capsules.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cyclobenzaprine hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give cyclobenzaprine hydrochloride extended-release capsules to other people, even if they have the same symptoms you have. It may harm them.
  • You can ask your pharmacist or healthcare provider for information about cyclobenzaprine hydrochloride extended-release capsules that is written for healthcare professionals.
  • What are the ingredients in cyclobenzaprine hydrochloride extended-release capsules?
  • Active Ingredient:
  • Inactive Ingredients:
  • Cyclobenzaprine hydrochloride 15 mg extended-release capsules
  • Cyclobenzaprine hydrochloride 30 mg extended-release capsules
  • Distributed by:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Manufactured By:Amneal Pharmaceuticals LLCu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n Bridgewater, NJ 08807u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Vandalia, OH 45377n
  • Revised: 05-2019
  • For more information, go to www.amneal.com or call toll-free 1-877-835-5472.
  • This Patient Information has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Revised: May 2019
  • INSTRUCTIONS FOR USECyclobenzaprine Hydrochloriden- Array
  • Read this Instructions for Use before you prepare your first dose of cyclobenzaprine hydrochloride extended-release capsules mixed with applesauce using the capsule sprinkle method, each time you get a refill, and as needed. There may be new information. Ask your healthcare provider or pharmacist if you have any questions about how to mix or give a dose of cyclobenzaprine hydrochloride extended-release capsules using the capsule sprinkle method.
  • Important Information:
  • Preparing a dose of n- cyclobenzaprine hydrochloride extended-release capsulesn- using the capsule sprinkle method.
  • Before you prepare a dose of cyclobenzaprine hydrochloride extended-release capsules mixed with applesauce using the capsule sprinkle method, gather the following supplies:
  • How should I store cyclobenzaprine hydrochloride extended-release capsules?
  • Keep cyclobenzaprine hydrochloride extended-release capsules and all medicines out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Issued: May 2019
  • No data
  • No data

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