Trade Name: Cyclobenzaprine Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/1

Storage and handling

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

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula Cn n n Hn n n Nu2022HCl and a molecular weight of 311.9. It has a melting point of 217u00b0C, and a pKn n n of 8.47 at 25u00b0C. 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 hydrochloride, USP is designated chemically as 3-(n n n u2013dibenzo[n n n ]cyclohepten-5-ylidene)-n n n , n n n -dimethyl-1-propanamine hydrochloride, and has the following structural formula:n nn
  • Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration.
  • Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration.
  • Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red).
  • Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).
  • Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease.
  • Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. 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 brain stem as opposed to spinal cord levels, although its 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 (u03b3) and alpha (u03b1) motor systems.
  • Pharmacological studies in animals showed 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.
  • Cyclobenzaprine hydrochloride tablets USP 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, limitation of motion, and restriction in activities of daily living.
  • Cyclobenzaprine hydrochloride n n n .n nn
  • cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
  • Hypersensitivity to any component of this product.
  • 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.
  • Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
  • Hyperthyroidism.
  • Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see n n n , below, and n n n ).n nn
  • Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.
  • Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.
  • No data
  • Incidence of most common adverse reactions in the 2 double-blindu2021, placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine hydrochloride tablets, 5 mg):
  • Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.
  • The following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine hydrochloride tablets, 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
  • The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:
  • u2021 n n n n
  • Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were 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 post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet:
  • Body as a Whole:
  • Cardiovascular:
  • Digestive:
  • Hypersensitivity:
  • Musculoskeletal:
  • Nervous System and Psychiatric:
  • Skin:
  • Special Senses:
  • Urogenital:
  • Causal Relationship Unknown
  • Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:
  • Body as a whole:
  • Cardiovascular:
  • Digestive:
  • Endocrine:
  • Hematic and Lymphatic:
  • Metabolic, Nutritional and Immune:
  • Musculoskeletal:
  • Nervous System and Psychiatric:
  • Respiratory:
  • Skin:
  • Urogenital:
  • Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.
  • Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride. Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose.n n n Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible. The acute oral LD50 of cyclobenzaprine hydrochloride is approximately 338 and 425 mg/kg in mice and rats, respectively.n nn
  • For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets USP is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets USP for periods longer than two or three weeks is not recommended. (see n n n ).n nn
  • Less frequent dosing should be considered for hepatically impaired or elderly patients (see n n n , n n n n n ).n nn
  • Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with u2018 n u2019 on one side and u201c n u201d on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with u2018 n u2019 on one side and u201c n u201d on other. The two dosage strengths are supplied as follows:n
  • NDC 66267-775-04 BOTTLES OF 04
  • NDC 66267-775-06 BOTTLES OF 06
  • NDC 66267-775-07 BOTTLES OF 07
  • NDC 66267-775-01 BOTTLES OF 10
  • NDC 66267-775-03 BOTTLES OF 30
  • STORAGEn n nStore at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].n
  • Rx Onlyn n
  • Manufactured by:n n nInvaGen Pharmaceuticals, Inc.n n nHauppauge, NY 11788n
  • Rev: 01/12
  • Barcode:n n n283-01-2012n
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Cyclobenzaprine Hydrochloride (Cyclobenzaprine Hydrochloride) which is also known as Cyclobenzaprine Hydrochloride and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 10 mg/1.

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.

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