Cyclobenzaprine Hydrochloride
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Questions & Answers
Question
This medication loses it effectiveness fast, so you have to increase your dose not very long after first taking it. I wouldn’t recommend this for long-term use for this reason. I was prescribed Flexeril for muscle spasms, but it eventually stopped working unless I don’t take in for several weeks.
Side Effects & Adverse Reactions
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride 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 with MAO inhibitors is contraindicated (see CONTRAINDICATIONS). 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 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 and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS, Drug Interactions).
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 WARNINGS, below, and ADVERSE REACTIONS).
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
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 tablets, USP 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 tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
History
There is currently no drug history available for this drug.
Other Information
Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C20H21N•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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. 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 tablets, USP are supplied as 7.5 mg tablets for oral administration.
Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.
Sources
Cyclobenzaprine Hydrochloride Manufacturers
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Direct Rx
![Cyclobenzaprine Hydrochloride Tablet, Film Coated [Direct Rx]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cyclobenzaprine Hydrochloride | Direct Rx
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Preferred Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Preferred Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Preferred Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Preferred Pharmaceuticals, Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Northwind Pharmaceuticals, Llc
Cyclobenzaprine Hydrochloride | Northwind Pharmaceuticals, Llc
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Blenheim Pharmacal, Inc.
Cyclobenzaprine Hydrochloride | Blenheim Pharmacal, Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and PRECAUTIONS Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Direct Rx
Cyclobenzaprine Hydrochloride | Rite Aid
adults: chew 1 or 2 tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician -
Proficient Rx Lp
Cyclobenzaprine Hydrochloride | Mylan Pharmaceuticals Inc.
Disulfiram should never be administered until the patient has abstained from alcohol for at least 12 hours.
Initial Dosage ScheduleIn the first phase of treatment, a maximum of 500 mg daily is given in a single dose for 1 to 2 weeks. Although usually taken in the morning, disulfiram may be taken on retiring by patients who experience a sedative effect. Alternatively, to minimize, or eliminate, the sedative effect, dosage may be adjusted downward.
Maintenance RegimenThe average maintenance dose is 250 mg daily (range, 125 mg to 500 mg), it should not exceed 500 mg daily.
Note:Occasionally patients, while seemingly on adequate maintenance doses of disulfiram, report that they are able to drink alcoholic beverages with impunity and without any symptomatology. All appearances to the contrary, such patients must be presumed to be disposing of their tablets in some manner without actually taking them. Until such patients have been observed reliably taking their daily disulfiram tablets (preferably crushed and well mixed with liquid), it cannot be concluded that disulfiram is ineffective.
Duration of TherapyThe daily, uninterrupted administration of disulfiram must be continued until the patient is fully recovered socially and a basis for permanent self-control is established. Depending on the individual patient, maintenance therapy may be required for months or even years.
Trial with AlcoholDuring early experience with disulfiram, it was thought advisable for each patient to have at least one supervised alcohol-drug reaction. More recently, the test reaction has been largely abandoned. Furthermore, such a test reaction should never be administered to a patient over 50 years of age. A clear, detailed and convincing description of the reaction is felt to be sufficient in most cases.
However, where a test reaction is deemed necessary, the suggested procedure is as follows:
After the first 1 to 2 weeks’ therapy with 500 mg daily, a drink of 15 mL (1/2 oz) of 100 proof whiskey, or equivalent, is taken slowly. This test dose of alcoholic beverage may be repeated once only, so that the total dose does not exceed 30 mL (1 oz) of whiskey. Once a reaction develops, no more alcohol should be consumed. Such tests should be carried out only when the patient is hospitalized, or comparable supervision and facilities, including oxygen, are available.
Management of Disulfiram-Alcohol ReactionIn severe reactions, whether caused by an excessive test dose or by the patient’s unsupervised ingestion of alcohol, supportive measures to restore blood pressure and treat shock should be instituted. Other recommendations include: oxygen, carbogen (95% oxygen and 5% carbon dioxide), vitamin C intravenously in massive doses (1 g) and ephedrine sulfate. Antihistamines have also been used intravenously. Potassium levels should be monitored, particularly in patients on digitalis, since hypokalemia has been reported.
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Direct Rx
Cyclobenzaprine Hydrochloride | Direct Rx
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a
day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Northwind Pharmaceuticals, Llc
Cyclobenzaprine Hydrochloride | Provision Medical
spray over cleaned affected area 1 to 3 times daily if bandaged, let dry first -
Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
Total dose should not exceed 32 g per day, over all affected joints. (2.3) Voltaren Gel should be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. (2)
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.
Total dose should not exceed 32 g per day, over all affected joints.
Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel. -
Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Rxchange Co.
Cyclobenzaprine Hydrochloride | Rxchange Co.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Living Well Remedies, Llc
Directions: Before bedtime, spray 6 times directly into mouth under your tongue. Take additional doses (6 sprays) as needed throughout the night.
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Rebel Distributors
Cyclobenzaprine Hydrochloride | Rebel Distributors
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Rebel Distributors
Cyclobenzaprine Hydrochloride | Rebel Distributors
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Blenheim Pharmacal, Inc.
Cyclobenzaprine Hydrochloride | Blenheim Pharmacal, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Kaiser Foundation Hospitals
Cyclobenzaprine Hydrochloride | Kaiser Foundation Hospitals
For most patients, the recommended dose of Cyclobenzaprine HCl tablets 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 HCl tablets for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Contract Pharmacy Services-pa
Cyclobenzaprine Hydrochloride | Contract Pharmacy Services-pa
For most patients, the recommended dose of Cyclobenzaprine HCl tablets 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 HCl tablets for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Physicians Total Care, Inc.
Cyclobenzaprine Hydrochloride | Physicians Total Care, Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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State Of Florida Doh Central Pharmacy
Cyclobenzaprine Hydrochloride | State Of Florida Doh Central Pharmacy
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Mckesson Packaging Services Business Unit Of Mckesson Corporation
Cyclobenzaprine Hydrochloride | Mckesson Packaging Services Business Unit Of Mckesson Corporation
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Keltman Pharmaceuticals Inc.
Cyclobenzaprine Hydrochloride | Keltman Pharmaceuticals Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (SeeINDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (seePRECAUTIONS, Impaired Hepatic Function, andUse in the Elderly).
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Amneal Pharmaceuticals
Cyclobenzaprine Hydrochloride | Woonsocket Prescription Center,incorporated
take with a glass of wateradults and children 12 years and over
take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Stat Rx Usa Llc
Cyclobenzaprine Hydrochloride | Stat Rx Usa Llc
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Redpharm Drug Inc.
Cyclobenzaprine Hydrochloride | Redpharm Drug Inc.
For most patients, the recommended dose of Cyclobenzaprine HCl 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Redpharm Drug Inc.
Cyclobenzaprine Hydrochloride | Redpharm Drug Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Bryant Ranch Prepack
Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see ). INDICATIONS AND USAGE
Less frequent dosing should be considered for hepatically impaired or elderly patients (see . PRECAUTIONS, Impaired Hepatic Function, andUse in the Elderly)
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Redpharm Drug Inc.
Cyclobenzaprine Hydrochloride | Redpharm Drug Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Pd-rx Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Pd-rx Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Pd-rx Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Pd-rx Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Stat Rx Usa Llc
Cyclobenzaprine Hydrochloride | Stat Rx Usa Llc
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Pd-rx Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Pd-rx Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS: Impaired Hepatic Function, and Use in the Elderly).
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Stat Rx Usa Llc
Cyclobenzaprine Hydrochloride | Stat Rx Usa Llc
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (SeeINDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (seePRECAUTIONS, Impaired Hepatic Function, andUse in the Elderly).
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Cyclobenzaprine Hydrochloride | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Breckenridge Pharmaceutical, Inc.
Cyclobenzaprine Hydrochloride | Breckenridge Pharmaceutical, Inc.
For most patients, the recommended dose of Cyclobenzaprine HCl tablets 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 HCl tablets for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Cyclobenzaprine Hydrochloride | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (SeeINDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (seePRECAUTIONS, Impaired Hepatic Function, andUse in the Elderly).
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Camber Pharmaceuticals
Cyclobenzaprine Hydrochloride | Camber Pharmaceuticals
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Mckesson Contract Packaging
Cyclobenzaprine Hydrochloride | Mckesson Contract Packaging
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Major Pharmaceuticals
Cyclobenzaprine Hydrochloride | Major Pharmaceuticals
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (SeeINDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (seePRECAUTIONS, Impaired Hepatic Function, andUse in the Elderly).
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Bryant Ranch Prepack
Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see ). INDICATIONS AND USAGE
Less frequent dosing should be considered for hepatically impaired or elderly patients (see , and ). PRECAUTIONS,Impaired Hepatic FunctionUse in the Elderly
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Unit Dose Services
Cyclobenzaprine Hydrochloride | Unit Dose Services
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see ). INDICATIONS AND USAGE
Less frequent dosing should be considered for hepatically impaired or elderly patients (see , and ). PRECAUTIONS,Impaired Hepatic FunctionUse in the Elderly
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of Cyclobenzaprine HCl tablets 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 HCl tablets for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Jubilant Cadista Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Jubilant Cadista Pharmaceuticals, Inc.
For most patients, the recommended dose of Cyclobenzaprine Hydrochloride tablets 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 for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Qualitest Pharmaceuticals
Cyclobenzaprine Hydrochloride | Qualitest Pharmaceuticals
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Kle 2, Inc.
Cyclobenzaprine Hydrochloride | Mylan Pharmaceuticals Inc.
2.1 EpilepsyDivalproex sodium delayed-release capsules are administered orally. As divalproex sodium dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected [see Drug Interactions (7.2)].
Complex Partial SeizuresFor adults and children 10 years of age or older.
Monotherapy (Initial Therapy)Divalproex sodium delayed-release capsules have not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.
Conversion to MonotherapyPatients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
Concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks. This reduction may be started at initiation of divalproex sodium therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction. The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency.
Adjunctive TherapyDivalproex sodium delayed-release capsules may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. If the total daily dose exceeds 250 mg, it should be given in divided doses.
In a study of adjunctive therapy for complex partial seizures in which patients were receiving either carbamazepine or phenytoin in addition to valproate, no adjustment of carbamazepine or phenytoin dosage was needed [see Clinical Studies (14)]. However, since valproate may interact with these or other concurrently administered AEDs as well as other drugs, periodic plasma concentration determinations of concomitant AEDs are recommended during the early course of therapy [see Drug Interactions (7)].
Simple and Complex Absence SeizuresThe recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. The maximum recommended dosage is 60 mg/kg/day. If the total daily dose exceeds 250 mg, it should be given in divided doses.
A good correlation has not been established between daily dose, serum concentrations, and therapeutic effect. However, therapeutic valproate serum concentrations for most patients with absence seizures are considered to range from 50 to 100 mcg/mL. Some patients may be controlled with lower or higher serum concentrations [see Clinical Pharmacology (12.3)].
As the divalproex sodium dosage is titrated upward, blood concentrations of phenobarbital and/or phenytoin may be affected [see Drug Interactions (7.2)].
Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
In epileptic patients previously receiving valproic acid therapy, divalproex sodium delayed-release capsules should be initiated at the same daily dose and dosing schedule. After the patient is stabilized on divalproex sodium delayed-release capsules, a dosing schedule of 2 or 3 times a day may be elected in selected patients.
2.2 General Dosing Advice Dosing in Elderly PatientsDue to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients. Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence. The ultimate therapeutic dose should be achieved on the basis of both tolerability and clinical response [see Warnings and Precautions (5.14), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
Dose Related Adverse ReactionsThe frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia) may be dose related. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males) [see Warnings and Precautions (5.8)].The benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.
G.I. IrritationPatients who experience G.I. irritation may benefit from administration of the drug with food or by slowly building up the dose from an initial low level.
Administration of Sprinkle CapsulesDivalproex sodium delayed-release capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoonful) of soft food such as applesauce or pudding. The drug/food mixture should be swallowed immediately (avoid chewing) and not stored for future use. Each capsule is oversized to allow ease of opening.
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Mutual Pharmaceutical
Cyclobenzaprine Hydrochloride | Mutual Pharmaceutical
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Watson Laboratories, Inc.
Cyclobenzaprine Hydrochloride | Watson Laboratories, Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Golden State Medical Supply, Inc.
Cyclobenzaprine Hydrochloride | Golden State Medical Supply, Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Clinical Solutions Wholesale
Cyclobenzaprine Hydrochloride | Clinical Solutions Wholesale
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Dispensing Solutions, Inc.
Cyclobenzaprine Hydrochloride | Dispensing Solutions, Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Pd-rx Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Pd-rx Pharmaceuticals, Inc.
For most patients, the recommended dose of Cyclobenzaprine HCl tablets 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 HCl tablets for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Pliva Inc.
Cyclobenzaprine Hydrochloride | Pliva Inc.
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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Dispensing Solutions, Inc.
Cyclobenzaprine Hydrochloride | Dispensing Solutions, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a
day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Ranbaxy Pharmaceuticals Inc
Cyclobenzaprine Hydrochloride | Ranbaxy Pharmaceuticals Inc
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Lake Erie Medical Dba Quality Care Product Llc
Cyclobenzaprine Hydrochloride | Lake Erie Medical Dba Quality Care Product Llc
DOSAGE AND ADMINISTRATION
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Pharmaceutica North America, Inc.
Cyclobenzaprine Hydrochloride | Pharmaceutica North America, Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Dispensing Solutions, Inc.
Cyclobenzaprine Hydrochloride | Dispensing Solutions, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Lake Erie Medical Dba Quality Care Products Llc
Cyclobenzaprine Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc
For most patients, the recommended dose of Cyclobenzaprine HCl tablets 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 HCl tablets for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Medvantx, Inc.
Cyclobenzaprine Hydrochloride | Medvantx, Inc.
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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Liberty Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Liberty Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Clinical Solutions Wholesale
Cyclobenzaprine Hydrochloride | Clinical Solutions Wholesale
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Cima Labs Inc
Cyclobenzaprine Hydrochloride | Cima Labs Inc
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).
Dosage Considerations for Special Patient Populations: Cyclobenzaprine hydrochloride extended-release capsules should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Cyclobenzaprine Hydrochloride | Teva Parenteral Medicines, Inc.
2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic ChemotherapyOndansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.
Adults
The recommended adult intravenous dosage of ondansetron hydrochloride is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology12.2]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron hydrochloride.
Pediatrics
For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron hydrochloride is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2,12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron hydrochloride. The drug should be infused intravenously over 15 minutes.
2.2 Prevention of Postoperative Nausea and VomitingOndansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Adults
The recommended adult intravenous dosage of ondansetron hydrochloride is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
Pediatrics
For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron hydrochloride.
2.3 Stability and HandlingAfter dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.
2.4 Dosage Adjustment for Patients with Impaired Hepatic FunctionIn patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].
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Unit Dose Services
Cyclobenzaprine Hydrochloride | Unit Dose Services
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see ). INDICATIONS AND USAGE
Less frequent dosing should be considered for hepatically impaired or elderly patients (see , and ). PRECAUTIONS,Impaired Hepatic FunctionUse in the Elderly
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Aurobindo Pharma Limited
Cyclobenzaprine Hydrochloride | Aurobindo Pharma Limited
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets are 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 for periods longer than two or three weeks are not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly). -
New Horizon Rx Group, Llc
Cyclobenzaprine Hydrochloride | New Horizon Rx Group, Llc
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Aidarex Pharmaceuticals Llc
Cyclobenzaprine Hydrochloride | Aidarex Pharmaceuticals Llc
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a
day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Aidarex Pharmaceuticals Llc
Cyclobenzaprine Hydrochloride | Aidarex Pharmaceuticals Llc
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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American Health Packaging
Cyclobenzaprine Hydrochloride | American Health Packaging
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Cyclobenzaprine Hydrochloride | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS: Impaired Hepatic Function, and Use in the Elderly).
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Direct Rx
Cyclobenzaprine Hydrochloride | Value Merchandisers Company, Inc.
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years: ask a doctor -
Blenheim Pharmacal, Inc.
Cyclobenzaprine Hydrochloride | Bluepoint Laboratories
2.1 AsthmaMontelukast sodium tablets should be taken once daily in the evening. The following dose is recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and OlderFor prevention of EIB, a single 10 mg dose of montelukast sodium tablets should be taken at least 2 hours before exercise. An additional dose of montelukast sodium tablets should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium tablets daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium tablets for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Allergic RhinitisFor allergic rhinitis, montelukast sodium tablets should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.
The following dose for the treatment of symptoms of seasonal allergic rhinitis is recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following dose for the treatment of symptoms of perennial allergic rhinitis is recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
2.4 Asthma and Allergic RhinitisPatients with both asthma and allergic rhinitis should take only one montelukast sodium tablet dose daily in the evening.
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Mylan Pharmaceuticals Inc.
Cyclobenzaprine Hydrochloride | Mylan Specialty
2.1 Initial TreatmentEMSAM should be applied to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh or the outer surface of the upper arm once every 24 hours. The recommended starting dose and target dose for EMSAM is 6 mg per 24 hours. EMSAM has been systematically evaluated and shown to be effective in a dose range of 6 mg per 24 hours to 12 mg per 24 hours. However, the trials were not designed to assess if higher doses are more effective than the lowest effective dose of 6 mg per 24 hours. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur in dose increments of 3 mg per 24 hours (up to a maximum dose of 12 mg per 24 hours) at intervals of no less than 2 weeks. Full antidepressant effect may be delayed.
Patients should be informed that tyramine-rich foods and beverages should be avoided beginning on the first day of EMSAM 9 mg per 24 hours or 12 mg per 24 hours treatment and should continue to be avoided for 2 weeks after a dose reduction to EMSAM 6 mg per 24 hours or following the discontinuation of EMSAM 9 mg per 24 hours or 12 mg per 24 hours [see Warnings and Precautions (5.3)].
2.2 Maintenance TreatmentIt is generally agreed that episodes of depression require several months or longer of sustained pharmacologic therapy. Maintenance of efficacy in depressed patients on therapy with EMSAM at a dose of 6 mg per 24 hours after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial [see Indications and Usage (1) and Clinical Studies (14.1)].
The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Dietary Modifications Required for Patients Taking EMSAM 9 mg per 24 hours and 12 mg per 24 hoursEMSAM (selegiline transdermal system) contains a monoamine oxidase inhibitor (MAOI). MAOIs including EMSAM combined with a high tyramine diet may cause a hypertensive crisis. A hypertensive crisis can be a life-threatening condition [see Warnings and Precautions (5.3)].
The foods and beverages listed in Table 5 should be avoided beginning on the first day of EMSAM 9 mg per 24 hours or 12 mg per 24 hours treatment, and should continue to be avoided for 2 weeks after a dose reduction to EMSAM 6 mg per 24 hours or following the discontinuation of EMSAM 9 mg per 24 hours or 12 mg per 24 hours [see Drug Interactions (7.2)].
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Pd-rx Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Cardinal Health
Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid, USP given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regard less of age) is up to 1 mg daily. Resistant cases may require larger doses.
When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.
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State Of Florida Doh Central Pharmacy
Cyclobenzaprine Hydrochloride | State Of Florida Doh Central Pharmacy
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets are 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 for periods longer than two or three weeks are not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly). -
State Of Florida Doh Central Pharmacy
Cyclobenzaprine Hydrochloride | State Of Florida Doh Central Pharmacy
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Mylan Institutional Inc.
Cyclobenzaprine Hydrochloride | Mylan Institutional Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS: Impaired Hepatic Function, and Use in the Elderly).
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Proficient Rx Lp
Cyclobenzaprine Hydrochloride | Proficient Rx Lp
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Legacy Pharmaceutical Packaging
Cyclobenzaprine Hydrochloride | Legacy Pharmaceutical Packaging
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Readymeds
Cyclobenzaprine Hydrochloride | Readymeds
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Northwind Pharmaceuticals
Cyclobenzaprine Hydrochloride | Northwind Pharmaceuticals
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Lake Erie Medical Dba Quality Care Products Llc
Cyclobenzaprine Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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American Health Packaging
Cyclobenzaprine Hydrochloride | American Health Packaging
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and PRECAUTIONS Use in the Elderly).
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Proficient Rx Lp
Cyclobenzaprine Hydrochloride | Proficient Rx Lp
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 INDICATIONS AND USAGE). Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and PRECAUTIONS Use in the Elderly).
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Proficient Rx Lp
Cyclobenzaprine Hydrochloride | Proficient Rx Lp
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a
day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Aphena Pharma Solutions – Tennessee, Llc
Cyclobenzaprine Hydrochloride | Aphena Pharma Solutions - Tennessee, Llc
For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Kvk-tech, Inc.
Cyclobenzaprine Hydrochloride | Woonsocket Prescription Center,incorporated
do not take more than directed adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor -
Pd-rx Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | West-ward Pharmaceuticals Corp.
2.1 Important Dosing and Administration InformationIn selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.
Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally. Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of Digoxin Injection should be injected into a single site. For pediatric patients, see the full prescribing information for pediatric digoxin injection (not available from West-Ward) for specific recommendations.
Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of Digoxin Injection with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.
Digoxin Injection can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended.
If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid overadministration of digoxin.
Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and Precautions (5.4)].
2.2 Loading Dosing Regimen in Adult Patients Table 1. Recommended Digoxin Injection Loading Dose mcg = microgram Age Total IV Loading Dose (mcg/kg)
Administer half the total loading dose initially,
then ¼ the loading dose every 6-8 hours twice Adult patients 8-12 2.3 Maintenance Dosing in Adult PatientsThe maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].
The recommended starting maintenance dose in adult patients with normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
Table 2. Recommended Starting Digoxin Injection Maintenance Dosage in Adult Patients mcg = microgram Age Total Intravenous Maintenance Dose,
mcg/kg/day
(given once daily) Adult patients 2.4-3.6Table 3 provides the recommended (once daily) maintenance dose for adult patients according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):
Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100
(% Daily Loss = 14 + Creatinine clearance/5)Reduce the dose of digoxin in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.
Table 3. Recommended Maintenance Dose (in micrograms given once daily) of Digoxin Injection in Adult Patients by Lean Body Weight and by Renal Function a For adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.
GFR (mL/min/1.73 m2) = (k x Height)/Scr
b If no loading dose administered
c The doses listed assume average body composition. Corrected
Creatinine Clearancea Lean Body Weightc Number of Days
Before Steady
State Achievedb kg 40 50 60 70 80 90 100 10 mL/min 64 80 96 112 128 144 160 19 20 mL/min 72 90 108 126 144 162 180 16 30 mL/min 80 100 120 140 160 180 200 14 40 mL/min 88 110 132 154 176 198 220 13 50 mL/min 96 120 144 168 192 216 240 12 60 mL/min 104 130 156 182 208 234 260 11 70 mL/min 112 140 168 196 224 252 280 10 80 mL/min 120 150 180 210 240 270 300 9 90 mL/min 128 160 192 224 256 288 320 8 100 mL/min 136 170 204 238 272 306 340 7 2.4 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood LevelsMonitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.
Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the digoxin dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting digoxin and correct post-treatment values by the reported baseline level.
Obtain serum digoxin concentrations just before the next scheduled digoxin dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
2.5 Switching from Intravenous Digoxin to Oral DigoxinWhen switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 4).
Table 4. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous Digoxin Absolute Bioavailability Equivalent Doses (mcg) Digoxin Tablets 60-80% 62.5 125 250 500 Digoxin Intravenous Injection 100% 50 100 200 400 -
Preferred Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Preferred Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Preferred Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Preferred Pharmaceuticals, Inc.
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Avpak
Cyclobenzaprine Hydrochloride | Avpak
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Preferred Pharmaceuticals, Inc.
Cyclobenzaprine Hydrochloride | Professional Disposables International, Inc.
For the preparation of the skin prior to surgery
clean the treatment area remove applicator apply to the operative site prior to surgery allow to dryFor use as a first aid antiseptic
clean the treatment area apply a small amount of this product on the treatment area 1-3 times daily as directed may be covered with a sterile bandage if bandaged, let dry before applying bandage to prevent possible irritation -
Cardinal Health
Cyclobenzaprine Hydrochloride | Cardinal Health
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 for periods longer than 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS: Impaired Hepatic Function, and Use in the Elderly).
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Proficient Rx Lp
Cyclobenzaprine Hydrochloride | Proficient Rx Lp
For most patients, the recommended dose of cyclobenzaprine hydrochloride 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 for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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State Of Florida Doh Central Pharmacy
Cyclobenzaprine Hydrochloride | State Of Florida Doh Central Pharmacy
For most patients, the recommended dose of Cyclobenzaprine Hydrochloride tablets 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 for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Medsource Pharmaceuticals
Cyclobenzaprine Hydrochloride | Medsource Pharmaceuticals
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Solubiomix
Cyclobenzaprine Hydrochloride | Select Brand Dist.
shake well before using do not take more than 6 doses in any 24-hour period measure only with the dosing cup provided keep dosing cup with product mL= milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use -
Medsource Pharmaceuticals
Cyclobenzaprine Hydrochloride | Medsource Pharmaceuticals
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Remedyrepack Inc.
Cyclobenzaprine Hydrochloride | Remedyrepack Inc.
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 INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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![Cyclobenzaprine Hydrochloride Tablet [Northwind Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=239ba279-9ac2-4edc-8e0b-697e16951986&name=hyd0g-0000-01.jpg)
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