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Symproic
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Overview
What is Symproic?
SYMPROIC (naldemedine), an opioid antagonist,
contains naldemedine tosylate as the active ingredient.
The chemical name for naldemedine
tosylate is: 17-(cyclopropylmethyl)-6,7-didehydro-4,5α-epoxy-3,6,14-trihydroxy-N-[2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl]morphinan-7-carboxamide
4-methylbenzenesulfonic acid.
The structural formula is:
The empirical formula
for naldemedine tosylate is CHNOCHOS
and the molecular weight is 742.84.
Naldemedine tosylate is a white to light
tan powder, soluble in dimethylsulfoxide and methanol, slightly soluble
in alcohol and water, and independent of pH.
SYMPROIC (naldemedine) tablets for oral use
contain 0.2 mg naldemedine (equivalent to 0.26 mg of naldemedine tosylate).
What should I talk to my health care provider before I take Symproic?
How should I use Symproic?
P5
SYMPROIC is indicated for the
treatment of opioid-induced constipation (OIC) in adult patients with
chronic non-cancer pain, including patients with chronic pain related
to prior cancer or its treatment who do not require frequent (e.g.,
weekly) opioid dosage escalation.
Alteration of analgesic dosing regimen prior to initiating
SYMPROIC is not required
Patients receiving opioids for less than 4 weeks may be
less responsive to SYMPROIC
Discontinue SYMPROIC if treatment with the opioid pain medication
is also discontinued
What interacts with Symproic?
Sorry No Records found
What are the warnings of Symproic?
Sorry No Records found
What are the precautions of Symproic?
Sorry No Records found
What are the side effects of Symproic?
Sorry No records found
What should I look out for while using Symproic?
SYMPROIC is contraindicated in:
What might happen if I take too much Symproic?
Single doses of naldemedine up to 100 mg (500 times the recommended
dose) and multiple doses of up to 30 mg (150 times the recommended
dose) for 10 days have been administered to healthy subjects in clinical
studies. Dose-dependent increases in gastrointestinal-related adverse
reactions, including abdominal pain, diarrhea, and nausea, were observed.
Single doses of naldemedine up
to 3 mg (15 times the recommended dose) and multiple doses of 0.4
mg (twice the recommended dose) for 28 days have been administered
to patients with OIC in clinical studies. Dose-dependent increases
in gastrointestinal-related adverse reactions, including abdominal
pain, diarrhea, nausea, and vomiting, were observed. Also, chills,
hyperhidrosis, and dizziness were reported more frequently at 1 and
3 mg doses and hyperhidrosis at the 0.4 mg dose.
No antidote for naldemedine is known. Hemodialysis
is not an effective means to remove naldemedine from the blood .
How should I store and handle Symproic?
Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F).Protect from light.Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F).Protect from light.SYMPROIC is supplied
as 0.2 mg naldemedine tablets in:Store SYMPROIC in light
resistant container at 20°C to 25°C (68°F to 77°F); excursions permitted
to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].SYMPROIC is supplied
as 0.2 mg naldemedine tablets in:Store SYMPROIC in light
resistant container at 20°C to 25°C (68°F to 77°F); excursions permitted
to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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Clinical Information
Chemical Structure
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Clinical Pharmacology
Naldemedine is an opioid antagonist with binding affinities
for mu-, delta-, and kappa-opioid receptors. Naldemedine functions
as a peripherally-acting mu-opioid receptor antagonist in tissues
such as the gastrointestinal tract, thereby decreasing the constipating
effects of opioids.
Naldemedine is a derivative of naltrexone to which a side chain has
been added that increases the molecular weight and the polar surface
area, thereby reducing its ability to cross the blood-brain barrier
(BBB).
Naldemedine
is also a substrate of the P-glycoprotein (P-gp) efflux transporter.
Based on these properties, the CNS penetration of naldemedine is
expected to be negligible at the recommended dose levels, limiting
the potential for interference with centrally-mediated opioid analgesia.
Non-Clinical Toxicology
SYMPROIC is contraindicated in:
Careful observation is required when amantadine is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine.
Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson’s disease, however, it is not known if other phenothiazines produce a similar response. Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson’s disease. It is not known which of the components of triamterene and hydrochlorothiazide capsules contributed to the observation or if related drugs produce a similar response.
Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%.
The concurrent use of amantadine with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine.
Cases of gastrointestinal perforation have been reported with use
of another peripherally acting opioid antagonist in patients with
conditions that may be associated with localized or diffuse reduction
of structural integrity in the wall of the gastrointestinal tract
(e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease,
infiltrative gastrointestinal tract malignancies, or peritoneal metastases).
Take into account the overall risk-benefit profile when using SYMPROIC
in patients with these conditions or other conditions which might
result in impaired integrity of the gastrointestinal tract wall (e.g.,
Crohn’s disease). Monitor for the development of severe, persistent,
or worsening abdominal pain; discontinue SYMPROIC in patients who
develop this symptom .
Serious and important adverse reactions described elsewhere
in labeling include:
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Clonazepam Description
Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake.
Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:
C15H10ClN3O3 M.W. 315.72
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Tips
Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib).
228 major drug interactions (854 brand and generic names)
210 moderate drug interactions (691 brand and generic names)
2 minor drug interactions (4 brand and generic names)
Show all medications in the database that may interact with Imbruvica (ibrutinib).
