Skelebenz

Skelebenz is a skeletal muscle relaxant and a central nervous system (CNS) depressant. Skelebenz 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.

Skelebenz 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.

Skelebenz extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

Skelebenz extended-release capsules has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.

Skelebenz (Skelebenz) is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Skelebenz is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Skelebenz may also be used for other purposes not listed in this medication guide.

The recommended adult dose for most patients is one (1) Skelebenz extended-release 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) Skelebenz extended-release 30 mg capsule taken once daily or as two (2) Skelebenz extended-release 15 mg capsules taken once daily.

It is recommended that doses be taken at approximately the same time each day.

Use of Skelebenz extended-release capsules for periods longer than two or three weeks is not recommended.

Dosage Considerations for Special Patient Populations: Skelebenz extended-release capsules should not be used in the elderly or in patients with impaired hepatic function.

See also:
What is the most important information I should know about Skelebenz?

• Hypersensitivity to any component of this product.
• Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation.
• Hyperpyretic crisis seizures and deaths have occurred in patients receiving Skelebenz (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.
• During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block conduction disturbances, or congestive heart failure.
• Hyperthyroidism.

Use Skelebenz extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Skelebenz extended-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Skelebenz extended-release capsules whole. Do not break, crush, or chew before swallowing.
• Skelebenz extended-release capsules works best if it is taken at the same time each day.
• Do not suddenly stop taking Skelebenz extended-release capsules without checking with your doctor.
• If you miss a dose of Skelebenz 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 Skelebenz extended-release capsules.

Skelebenz is used along with physical therapy and rest to relieve pain, stiffness or discomfort caused by muscle injury.

See also:
What other drugs will affect Skelebenz?

Plasma concentration may be increased with the use of cimetidine, diltiazem, disulfiram, methylphenidate, ritonavir, and verapamil. Side-effects are increased by adrenaline, amiodarone, general anesthetics, SSRIs, antihistamines, antimuscarinics, antipsychotics, anxiolytics and hypnotics, clozapine, disopyramide, diuretics, flecainide, MAOIs, moclobemide, moxifloxacin, nefopam, nicorandil, noradrenaline, phenothiazine, pimozide, procainamide, propafenone, quinidine, selegiline, sibutramine, sotalol, terfenadine, thioridazine, and tramadol. Effects of adrenergic neurone blockers, clonidine, barbiturates, nitrates, and primidone are reduced while effects of baclofen, opioid analgesics, and thyroid hormones are enhanced with concomitant use of Skelebenz. Carbamazepine and rifampicin may increase metabolism of Skelebenz. Effects may be antagonized by oestrogens. Avoid use with brimonidine, entacapone, artemether with lumefantrine, or sibutramine. CNS effects may be enhanced by other CNS depressants.

See also:
What are the possible side effects of Skelebenz?

The most common adverse reactions in the two 14-day clinical efficacy trials and in the 7-day repeat-dose pharmacokinetic study are presented in Tables 5 and 6, respectively.

Table 5: Incidence of the Most Common Adverse Reactions Occurring in ≥ 3% of

Subjects in Any Treatment Group in the Two Phase 3, Double-Blind

Skelebenz Extended-Release Capsules Trials

Table 6: Incidence of the Most Common Adverse Reactions

Occurring in ≥ 3% of Subjects in Any Treatment Group

in the Seven-Day Pharmacokinetic Study of Skelebenz

Hydrochloride Extended-Release Capsules

In a postmarketing surveillance program (7607 patients treated with Skelebenz 10 mg TID), the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:

Table 7: Most Common Adverse Reactions from Postmarketing Surveillance Program

Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg TID tablet:

Body as a Whole: Syncope; malaise.

Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.

Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice, and cholestasis.

Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash. Musculoskeletal: Local weakness.

Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia.

Skin: Sweating.

Special Senses: Ageusia; tinnitus.

Urogenital: Urinary frequency and/or retention.

Causal Relationship Unknown

Other reactions, reported rarely for Skelebenz under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:

Body as a Whole: Chest pain; edema.

Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.

Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.

Endocrine: Inappropriate ADH syndrome.

Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.

Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss.

Musculoskeletal: Myalgia.

Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.

Respiratory: Dyspnea.

Skin: Photosensitization; alopecia.

Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.