Está en la página 1de 6

Skelebenz Tablets Product Information

Skelebenz (Cyclobenzaprine HCl) is a skeletal muscle relaxant which relieves muscle spasm of local origin and associated pain in acute musculoskeletal conditions without interfering with muscle function. Skelebenz Tablets for oral administration are supplied in 15 mg strengths.

Name of Drug
Skelebenz. This medication is also referred to as Cyclobenzaprine Tablets.

Manufacturer of Skelebenz Tablets (Cyclobenzaprine Tablets)


Sun Pharmaceutical Industries Ltd. Website: www.sunpharma.com

Active Pharmaceutical Ingredients


The active ingredient in Skelebenz Tablets is Cyclobenzaprine Hydrochloride. Cyclobenzaprine Hydrochloride (Cyclobenzaprine HCl) is a white, crystalline tricyclic amine salt.

What is Cyclobenzaprine Tablets (Skelebenz Tablets) Used For


Skelebenz (Cyclobenzaprine HCl) is used along with proper 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. Cyclobenzaprine Tablets should be used only for short periods (up to two or three weeks)

Skelebenz Tablets Dosage


The recommended adult dose for most patients is one Skelebenz (Cyclobenzaprine Hydrochloride) 15 mg Tablet taken once daily. Some patients may require up to 30 mg/day. It is recommended that doses be taken at approximately the same time each day. Use of Cyclobenzaprine Tablets for periods longer than two or three weeks is not recommended.

Contraindications of Skelebenz Tablets


Skelebenz Tablets are contraindicated in patients with a history of hypersensitivity to Cyclobenzaprine Hydrochloride or any other ingredients of Skelebenz Tablets. It is also contraindicated in the following cases:

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

Drug Class and Mechanism


Cyclobenzaprine acts primarily within the central nervous system at the brain stem as opposed to the spinal cord level, although an overlapping action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma and alpha motor systems.

Missed Dose
If you miss a dose of Cyclobenzaprine Tablets, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your dose at thescheduled time. Do not double a dose to make up for a missed dose.

Storage Instructions for Cyclobenzaprine Tablets (Skelebenz)


Store Skelebenz Tablets between 59F and 86F (15C and 30 C) in well-closed containers.. Keep Cyclobenzaprine Tablets out of the reach of children and away from pets.

Warnings and Precautions when using Cyclobenzaprine Tablets


Before using Cyclobenzaprine Tablets (Skelebenz Tablets) please inform your doctor all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.Skelebenz is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. Short term studies have shown that 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.Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. Skelebenz may enhance the effects of alcohol,

barbiturates, and other CNS depressants. Use of Cyclobenzaprine Tablets (Skelebenz Tablets) is not recommended in subjects with mild, moderate or severe hepatic impairment. As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma half life following administration of Skelebenz Tablets in elderly subjects as compared to young adults, use of Skelebenz is not recommended in elderly. Skelebenz should be used with caution in patients with a history of urinary retention, angleclosure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.

Possible Side Effects of Cyclobenzaprine Tablets (Skelebenz) Tablets


The most common side effects of Cyclobenzaprine Tablets (occurring in 3% or more patients) were dry mouth, dizziness, fatigue, somnolence, constipation Nausea and Dyspepsia. The most common adverse reactions reported most frequently in a postmarketing surveillance program were drowsiness, dry mouth, and dizziness. Side effects 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.

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.

Methylprednisolone (Mepresso)
> Indications > Dosage > Overdosage > Contraindications > Special Precautions > Adverse Drug Reactions > Drug Interactions > Food Interaction > Lab Interference > Pregnancy Category (US FDA) > Mechanism of Action > CIMS Class > ATC Classification

Available Brands

Related Information

ACTO-PRED ALPRED ANPRED ARICORT-M AVPRED BIOLONE CARTIPRED CECORT DEPOCORT DEPOMAX See more brands

See related methylprednisolone information CIMS Abbreviation Index MIMS Abbreviation Index Indications Dosage Listed in Dosage. Adult: PO Anti-inflammatory or immunosuppressive Initial: 2-60 mg/day in 1-4 divided doses, then reduce slowly to maintain adequate clinical response. IV Status asthmaticus As Na succinate: Loading dose: 2 mg/kg, then 0.5-1 mg/kg 6 hrly for up to 5 days. Acute spinal cord injury As Na succinate: 30 mg/kg, followed in 45 mins by a continuous infusion of 5.4 mg/kg/hr for 23 hr. Lupus nephritis As Na succinate: High-dose "pulse" therapy: 1 g/day for 3 days. Aplastic anaemia As Na succinate: 1 mg/kg/day or 40 mg/day (whichever dose is higher) for 4 days. Thereafter, change to PO and continue until day 10 or till symptoms of serum sickness resolve, then rapidly reduce over approx 2 wk. Pneumocystis (carinii) jiroveci pneumonia in patients with AIDS As Na succinate: 30 mg twice daily for 5 days, then 30 mg once daily for 5 days, then 15 mg once daily for 11 days. Lifethreatening shock As Na succinate: Initial: 30 mg/kg, repeat 4-6 hrly if needed. IV/IM Anti-inflammatory or immunosuppresive As Na succinate: 10-40 mg via IV inj, may repeat via IV/IM inj at intervals based on clinical response. Up to 30 mg/kg may be used if needed; may repeat 4-6 hrly for 48 hr. IM Anti-inflammatory or immunosuppressive As Na succinate: 10-80 once daily. As acetate: 10-80 mg every 1-2 wkly. Intra-articular Anti-inflammatory or immunosuppresive As acetate: Large joints: 20-80 mg; Small joints: 4-10 mg. Give doses 1-5 wkly. Intralesional Anti-inflammatory or immunosuppressive As acetate: 20-60 mg 1-5 wkly. Topical

Corticosteroid-responsive dermatoses As 0.1% aceponate oint/cream/lotion: Apply once daily for <12 wk. Click to view methylprednisolone Dosage by Indications Overdosage For action to be taken in the event of accidental overdose ... click to view methylprednisolone Serious infections except septic shock or tuberculous meningitis; viral, fungal and tubercular skin lesions; admin of live virus vaccines. Preparations containing benzyl alcohol preservative are contraindicated in infants.

Contraindications

Special Precautions Children and adolescents (possible irreversible growth retardation), elderly (monitoring required on long-term treatment). Frequent monitoring if history of tuberculosis (or X-ray changes), hypertension, recent MI (rupture reported), CHF, liver and renal failure (associated with fluid retention), DM including family history (glucose regulation altered), osteoporosis especially post-menopausal women (associated with increased bone loss and osteoporotic fractures), glaucoma including family history (risk of increased intraocular pressure), corneal perforation, severe affective disorders (particularly if history of steroid-induced psychosis), epilepsy, GI disease (perforation risk), thyroid disease (changes in thyroid status may necessitate dosage adjustments ), history of steroid myopathy. Pregnancy and lactation. Avoid abrupt withdrawal after a prolonged period of use. When applied topically to large areas, broken skin, or under occlusive dressings, may cause systemic effects. Adverse Drug Reactions Oedema, hypertension, arrhythmia; CNS, endocrine, metabolic and GI effects; hirsutism, acne, skin atrophy, bruising, hyperpigmentation; transient leukocytosis; arthralgia, muscle weakness, osteoporosis, fractures, cataracts, glaucoma; infections, hypersensitivity reactions, avascular necrosis, secondary malignancy, intractable hiccups. Decreases effect of anticholinesterases in myasthenia gravis. May decrease the hypoglycaemic effects of antidiabetic agents. Decreases serum concentrations of salicylates. Increased hypokalemic effects of potassium-depleting diuretics (thiazides or furosemide), amphotericin B, bronchodilator therapy with xanthines or 2 agonists. Increase incidence of GI bleeding and ulceration with NSAIDs. May increase the anticoagulant effects of warfarin. Decreased levels/effects with CYP3A4 inducers (aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins). Increased levels/effects with CYP3A4 inhibitors (azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors,

Drug Interactions

quinidine, telithromycin, and verapamil). May decrease the effects of vaccines (dead organism) or increase the risk of vaccinal infection (live organism). Antacids and bile sequestrants may decrease the absorption of corticosteroids, separate admin by 2 hr. Increased risk of myopathy with neuromuscular-blocking agents, tendinopathies with fluoroquinolones. Food Interaction For caution against potential drug-food interactions ... click to view methylprednisolone For caution against possible drug interference in lab test results ... click to view methylprednisolone

Lab Interference

Pregnancy Category (US FDA) Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Mechanism of Action CIMS Class ATC Classification For details of the mechanism of action, pharmacology and pharmacokinetics and toxicology ... click to view methylprednisolone Corticosteroid Hormones / Topical Corticosteroids D10AA02 - methylprednisolone ; Belongs to the class of topical corticosteroids used in the treatment of acne. H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations. D07AA01 - methylprednisolone ; Belongs to the class of weak (group I) corticosteroids. Used in the treatment of dermatological diseases.

También podría gustarte