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Tonmya
cyclobenzaprine
Adult Dosing .
Dosage forms: SL TAB: 2.8 mg
fibromyalgia
- [5.6 mg SL qhs]
- Start: 2.8 mg SL qhs x14 days; Max: 5.6 mg/day; Info: max 2.8 mg/day in elderly patients; do not cut/crush/chew/swallow SL tab; avoid food/drink >15min after admin.
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A: max 2.8 mg/day; Child-Pugh Class B or C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- MAO inhibitor use w/in 14 days
- pregnancy 1st trimester
- elderly patients (ER form)
- hepatic impairment, Child-Pugh Class B-C (IR form)
- hepatic impairment (ER form)
- MI, acute recovery
- cardiac conduction disturbance
- arrhythmia
- heart block
- CHF
- hyperthyroidism
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: patients of childbearing potential
- caution: elderly patients (IR form)
- caution: hepatic impairment, Child-Pugh Class A (IR form)
- caution: seizure disorder
- caution: urinary retention
- caution: glaucoma, angle-closure
- caution: IOP incr.
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: smoking habit change
- caution: environmental temperature, high
Drug Interactions .
Overview
cyclobenzaprine
muscle relaxant
- CYP1A2 substrate
- anticholinergic effects
- CNS depression
- lowers seizure threshold
- serotonergic effects
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- isocarboxazid
- phenelzine
- potassium chloride
- potassium citrate
- rasagiline
- safinamide
- selegiline
- selegiline transdermal
- tranylcypromine
Avoid/Use Alternative
- 5-HTP
- aclidinium inhaled
- aldesleukin
- alfentanil
- almotriptan
- amifampridine
- amitriptyline
- amoxapine
- amphetamine
- benztropine
- black cohosh
- bromocriptine
- buprenorphine
- buspirone
- butalbital
- butorphanol
- carbamazepine
- citalopram
- clomipramine
- clonidine
- clozapine
- cocaine
- codeine
- desipramine
- desvenlafaxine
- dexmethylphenidate
- dextroamphetamine
- dextromethorphan
- dihydrocodeine
- dihydroergotamine
- doxepin
- doxepin topical
- doxylamine
- duloxetine
- eletriptan
- eluxadoline
- ergotamine
- escitalopram
- ethanol
- fenfluramine
- fentanyl
- fluoxetine
- fluvoxamine
- frovatriptan
- gepirone
- glucagon
- glycopyrronium topical
- granisetron
- hydrocodone
- hydromorphone
- imipramine
- iohexol
- isoniazid
- kava
- kratom
- lasmiditan
- levomilnacipran
- levorphanol
- linezolid
- lisdexamfetamine
- lithium
- meperidine
- metaxalone
- methadone
- methamphetamine
- methylene blue oral
- methylergonovine
- methylphenidate
- metoclopramide
- midazolam
- milnacipran
- mirtazapine
- morphine
- nalbuphine
- naratriptan
- nefazodone
- nortriptyline
- oliceridine
- ondansetron
- opium
- oxybate
- oxycodone
- oxymorphone
- palonosetron
- paroxetine
- pentazocine
- pramlintide
- procarbazine
- promethazine
- protriptyline
- remifentanil
- revefenacin inhaled
- rivastigmine
- rizatriptan
- ropeginterferon alfa-2b
- SAMe
- sertraline
- sofpironium topical
- St. John's wort
- sufentanil
- sumatriptan
- tapentadol
- thalidomide
- tramadol
- trazodone
- trimethobenzamide
- trimipramine
- venlafaxine
- vilazodone
- vortioxetine
- yohimbe
- ziprasidone
- zolmitriptan
- zuranolone
Monitor/Modify Tx
- alprazolam
- bupropion
- chlorpromazine
- clobazam
- clonazepam
- clorazepate
- daridorexant
- desflurane
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- droperidol
- ephedra
- esketamine
- eszopiclone
- etomidate
- fluphenazine
- flurazepam
- gabapentin
- gabapentin enacarbil
- hydroxyzine
- ifosfamide
- iopamidol
- ketamine
- lemborexant
- lorazepam
- methylene blue injection
- nelarabine
- olanzapine
- opicapone
- oxazepam
- oxybutynin
- pentobarbital
- perphenazine
- phenobarbital
- pregabalin
- primidone
- propofol
- quazepam
- remimazolam
- sevoflurane
- suvorexant
- thioridazine
- thiothixene
- triazolam
- zaleplon
- ziconotide
- zolpidem
Caution Advised
- aceclidine ophthalmic
- acetazolamide
- allopurinol
- alosetron
- amantadine
- apomorphine
- apraclonidine ophthalmic
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- atropine
- atropine ophthalmic
- baclofen
- baclofen intrathecal
- barium
- belladonna alkaloids
- bethanechol
- botulinum toxin
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- brompheniramine
- busulfan
- cannabidiol
- cannabis
- carbinoxamine
- cariprazine
- carisoprodol
- cenobamate
- cetirizine
- cevimeline
- chamomile, German
- chlophedianol
- chlorambucil
- chlordiazepoxide
- chlorpheniramine
- chlorzoxazone
- cisapride
- clemastine
- clidinium
- cyclopentolate ophthalmic
- cyproheptadine
- dantrolene
- darifenacin
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- dicyclomine
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- disopyramide
- domperidone
- donepezil
- doxazosin
- dronabinol
- efavirenz
- entacapone
- entrectinib
- erenumab
- erythromycin
- eslicarbazepine acetate
- estazolam
- ethanol (in some formulations)
- ethosuximide
- felbamate
- fesoterodine
- flavoxate
- flibanserin
- foslevodopa
- fosphenytoin
- galantamine
- ganaxolone
- glofitamab
- glycopyrrolate
- glycopyrrolate inhaled
- guanfacine
- haloperidol
- homatropine
- hydrochlorothiazide
- hydroxychloroquine
- hyoscyamine
- iloperidone
- ipratropium inhaled
- ipratropium nasal
- isoflurane
- lacosamide
- lamotrigine
- levetiracetam
- levocetirizine
- levodopa
- linvoseltamab
- lofexidine
- loperamide
- loxapine
- lumateperone
- lurasidone
- magnesium citrate
- meclizine
- melatonin
- meprobamate
- methacholine inhaled
- methocarbamol
- methohexital
- methscopolamine
- methsuximide
- methyldopa
- metyrapone
- metyrosine
- mexiletine
- mirabegron
- mitotane
- molindone
- mosunetuzumab
- mycophenolate mofetil
- naltrexone
- neostigmine
- orphenadrine
- oxcarbazepine
- paliperidone
- passion flower
- perampanel
- pheniramine
- phenytoin
- pilocarpine
- pilocarpine ophthalmic
- pimozide
- polyethylene glycol
- polyethylene glycol/electrolytes
- potassium acid phosphate
- potassium gluconate
- potassium phosphate
- pramipexole
- procainamide
- prochlorperazine
- pyridostigmine
- pyrilamine
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ramelteon
- repotrectinib
- risperidone
- ritonavir
- ropinirole
- rotigotine transdermal
- rufinamide
- scopolamine
- selinexor
- sodium picosulfate
- solifenacin
- stiripentol
- sulfate bowel prep
- tasimelteon
- temazepam
- tetrabenazine
- thiotepa
- tiagabine
- tiotropium inhaled
- tizanidine
- tolcapone
- tolterodine
- topiramate
- treosulfan
- trifluoperazine
- trihexyphenidyl
- triprolidine
- tropicamide ophthalmic
- trospium
- umeclidinium inhaled
- valbenazine
- valerian
- valproic acid
- vibegron
- vigabatrin
- viloxazine
- zonisamide
Adverse Reactions .
Serious Reactions
- seizures
- cardiac conduction disturbance
- arrhythmia
- MI
- stroke
- heat stroke
- hypersensitivity rxn
- anaphylaxis
- psychosis
Common Reactions
- drowsiness
- xerostomia
- dizziness
- somnolence
- fatigue
- dyspepsia
- headache
- constipation
- nausea
- taste changes
- blurred vision
- nervousness
- confusion
- hypoesthesia, oral (SL tab form)
- oral discomfort (SL tab form)
- paresthesia, oral (SL tab form)
- aphthous ulcer (SL tab form)
- photosensitivity
Safety/Monitoring .
Monitoring Parameters
pregnancy test before tx start
Look/Sound-Alike Drug Names
cyclobenzaprine confused with: cetirizine; chlorproMAZINE; cyproheptadine; phenazopyridine
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 1st trimester, weigh risk/benefit in 2nd and 3rd trimesters; risk of fetal harm not expected based on limited human data; possible risk of neural tube defects if used w/in 2wk of conception or during 1st trimester based on conflicting animal data
Pregnancy Reporting
report pregnancy to Tonix Medicines, Inc. Adverse Event reporting line at 1-888-869-7633
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x2wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; inadequate human data available to assess risk of infant harm, though drug excreted into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 1A2, 2D6 (minor), 3A4 substrate
Excretion: urine primarily; Half-life: 18h (PO route, IR form), 32h (ER form), 36h (SL route)
Subclass: Fibromyalgia
Mechanism of Action
exact mechanism of action unknown; influences gamma and alpha motor neurons, reducing tonic somatic motor activity (centrally-acting muscle relaxant); antagonizes serotonin 5-HT2A, alpha-1 adrenergic, histamine H1, and M1 muscarinic acetylcholine receptors
Formulary .
No Formulary Selected
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