Flexor 5 Tablet
Cyclobenzaprine Hydrochloride
5mg
Incepta Pharmaceuticals Ltd.
| Pack size | 100's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 2.00 AED |
Available as:
Indications
Flexor 5 Tablet is used for:
Fibromyalgia, Muscle spasm
Adult Dose
Oral
Painful muscle spasms associated with musculoskeletal conditions
Adult: 5 mg tid, may increase to 10 mg tid if needed.
Treatment should not last more than 2-3 weeks.
Max: 60 mg.
Child Dose
Muscle Spasm
Oral
<15 years: Safety and efficacy not established
>15 years: 5 mg PO q8hr; may increase dose to 10 mg PO q8hr PRN
Renal Dose
Administration
Contra Indications
Hypersensitivity to drug or formulation components
Hyperthyroidism
During the acute recovery phase of myocardial infarction and in patients with arrhythmia, heart block or conduction disturbances, or congestive heart failure
Concomitant use or within 14 days of discontinuing MAO inhibitors
Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors
Precautions
Use caution in urinary retention, narrow-angle glaucoma or IOP, or concomitant use of other anticholinergic drugs
May cause drowsiness/dizziness; do not ingest alcohol or other CNS depressants; may impair the ability to operate heavy machinery
May take with food to avoid stomach upset
Serotonin syndrome is reported when coadministered with other drugs that increase serotonin (eg, SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors
Not effective for the treatment of spasticity associated with cerebral/spinal cord disease or for pediatric cerebral palsy
Elderly patients may be more prone to adverse effects and require dose/frequency reduction
Use immediate release with caution in hepatic impairment; the extended-release form not recommended with hepatic impairment
Pregnancy-Lactation
Pregnancy
Available data from case reports with use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
In rats, decreased pup body weight and survival was noted at cyclobenzaprine doses ?10 mg/kg/day (approximately >3 times maximum recommended human dose (MRHD) of 30 mg/day), when administered orally during pregnancy and lactation
Lactation
There are no data on presence of drug in either human or animal milk, the effects on a breastfed infant, or effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition.
Interactions
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 cyclobenzaprine. Carbamazepine and rifampicin may increase metabolism of cyclobenzaprine. 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.
Contraindicated (4)
isocarboxazid
phenelzine
safinamide
tranylcypromine
Adverse Effects
Side effects of Cyclobenzaprine Hydrochloride :
>10%
Drowsiness (up to 39% immediate-release),Dry mouth (21-32%),Dizziness (3-11%)
1-10%
Pharyngitis (1-3%),Headache (1-5%),Fatigue (6%),Palpitations (6%),Bad taste in mouth (1-6%),Indigestion (4%),Blurred vision (3%),Constipation (1-3%),Asthenia (1-3%),Confusion (1-3%),Nausea (1-3%),Nervousness (1-3%)
<1%
Arrhythmia,Hypotension,Palpitation,Syncope,Tachycardia,Vasodilation,Cardiac dysrhythmia (rare),Cholestasis (rare),Hepatitis,Jaundice,Anaphylaxis (rare),Immune hypersensitivity reaction
Mechanism of Action
Cyclobenzaprine, a centrally-acting skeletal muscle relaxant, is structurally related to tricyclic antidepressants, thus they share similar properties. It acts on the brain stem, decreasing tonic-somatic motor activities influencing both the ? and ? motor systems. It is used as an adjunct in the symptomatic treatment of painful muscle spasms associated with musculoskeletal conditions.
Note
Flexor 5 5mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Cyclobenzaprine Hydrochloride. Flexor 5 is availble in Bangladesh.
Farmaco BD drug index information on Flexor 5 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.