Tonalgen (Tonalgen) is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.
Tonalgen is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.
Tonalgen may also be used for other purposes not listed in this medication guide.
Tonalgen indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Tonalgen® (Tonalgen hydrochloride extended-release capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.
Limitations of Use:
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Tonalgen 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.
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Tonalgen has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
How should I use Tonalgen?
Use Tonalgen extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Tonalgen extended-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Tonalgen extended-release capsules whole. Do not break, crush, or chew before swallowing.
Tonalgen extended-release capsules works best if it is taken at the same time each day.
Do not suddenly stop taking Tonalgen extended-release capsules without checking with your doctor.
If you miss a dose of Tonalgen extended-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tonalgen extended-release capsules.
Uses of Tonalgen in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Tonalgen is used along with physical therapy and rest to relieve pain, stiffness or discomfort caused by muscle injury.
Tonalgen description
Tonalgen is a skeletal muscle relaxant and a central nervous system (CNS) depressant. Tonalgen acts on the locus coeruleus where it results in increased norepinephrine release, potentially through the gamma fibers which innervate and inhibit the alpha motor neurons in the ventral horn of the spinal cord. It is structurally similar to Amitriptyline, differing by only one double bond.
Tonalgen dosage
Tonalgen Dosage
Generic name: Tonalgen HYDROCHLORIDE 15mg
Dosage form: capsule, extended release
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The recommended adult dose for most patients is one (1) Tonalgen 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) Tonalgen 30 mg capsule taken once daily or as two (2) Tonalgen 15 mg capsules taken once daily.
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It is recommended that doses be taken at approximately the same time each day.
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Use of Tonalgen for periods longer than two or three weeks is not recommended.
Instruct patients to swallow Tonalgen capsules intact. Alternatively, the contents of the Tonalgen capsule may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:
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Sprinkle the contents of the capsule onto a tablespoon of applesauce and consume immediately without chewing.
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Rinse the mouth to ensure all of the contents have been swallowed.
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Discard any unused portion of the Tonalgen capsules after the contents have been sprinkled on applesauce.
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Tonalgen extended-release capsules
Tonalgen
Tonalgen (Advanced Reading)
Other brands: Tonalgen, Fexmid, Comfort Pac with Tonalgen
Based on its structural similarity to tricyclic antidepressants, Tonalgen may have life-threatening interactions with MAO inhibitors, may enhance the effects of alcohol, barbiturates, and other CNS depressants, may enhance the seizure risk in patients taking tramadol, or may block the antihypertensive action of guanethidine and similarly acting compounds.
Postmarketing cases of serotonin syndrome have been reported during combined use of Tonalgen and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.
Drug Abuse And Dependence
Dependence
Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when Tonalgen is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.
Most Common Adverse Reactions in the Tonalgen Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to Tonalgen in 253 patients in 2 clinical trials. Tonalgen was studied in two double-blind, parallel-group, placebo-controlled, active-controlled trials of identical design. The study population was composed of patients with muscle spasms associated with acute painful musculoskeletal conditions. Patients received 15 mg or 30 mg of Tonalgen taken orally once daily, Tonalgen immediate-release (IR) 10 mg three times a day, or placebo for 14 days.
The most common adverse reactions (incidence ≥ 3% in any treatment group and greater than placebo) were dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence.
Table 1: Incidence of the Most Common Adverse Reactions Occurring in ≥ 3% of Patients in any Treatment Group* and Greater Than Placebo in the Two Phase 3, Double-Blind Tonalgen Trials
Placebo
N=128
Tonalgen 15 mg
N=127
Tonalgen 30 mg
N=126
Dry mouth
2%
6%
14%
Dizziness
2%
3%
6%
Fatigue
2%
3%
3%
Constipation
0%
1%
3%
Somnolence
0%
1%
2%
Nausea
1%
3%
3%
Dyspepsia
1%
0%
4%
*Tonalgen 15 mg QD, Tonalgen 30 mg QD, or Tonalgen IR tablets TID
Additional Adverse Reactions from Clinical Studies and Postmarketing Experience
The following adverse reactions have been reported in clinical studies or postmarketing experience with Tonalgen, Tonalgen IR, or tricyclic drugs. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In a postmarketing surveillance program of Tonalgen IR, the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness and adverse reactions reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.
The following adverse reactions have been reported in postmarketing experience (Tonalgen or Tonalgen IR), in clinical studies of Tonalgen IR (incidence < 1%), or in postmarketing experience with other tricyclic drugs:
Body as a Whole: Syncope; malaise; chest pain; edema.
Do not take Tonalgen if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take Tonalgen before the MAO inhibitor has cleared from your body.
You should not take Tonalgen if you have recently had a heart attack, or if you have a heart rhythm disorder, congestive heart failure, heart block, or an overactive thyroid.
Tonalgen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol, which can increase some of the side effects of Tonalgen.
The results of a survey conducted on ndrugs.com for Tonalgen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tonalgen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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1 consumer reported age
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%
> 60
1
100.0%
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