CEVIMELINE HYDROCHLORIDE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

CEVIMELINE HYDROCHLORIDE (UNII: P81Q6V85NP) (CEVIMELINE - UNII:K9V0CDQ56E)

Beszerezhető a:

Ingenus Pharmaceuticals NJ, LLC

INN (nemzetközi neve):

CEVIMELINE HYDROCHLORIDE

Összetétel:

CEVIMELINE HYDROCHLORIDE 30 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CEVIMELINE HYDROCHLORIDE- CEVIMELINE HYDROCHLORIDE CAPSULE
INGENUS PHARMACEUTICALS NJ, LLC
----------
CEVIMELINE HYDROCHLORIDE CAPSULES
DESCRIPTION
Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3,
5’ -[1,3] oxathiolane} hydrochloride,
hydrate (2:1). Its empirical formula is C
H NOS.HCl.1/2 H O, and its structural formula is:
Cevimeline has a molecular weight of 244.79. It is a white to off
white crystalline powder with a
melting point range of 201 to 203°C. It is freely soluble in alcohol
and chloroform, very soluble in
water, and virtually insoluble in ether. The pH of a 1% solution
ranges from 4.6 to 5.6. Inactive
ingredients include lactose monohydrate, hydroxypropyl cellulose, and
magnesium stearate.
Empty capsule shell consists of Titanium Dioxide and Gelatin. Ink used
in the imprint is Black SW-9049
which contains Shellac, Dehydrated alcohol, Isopropyl Alcohol, Butyl
Alcohol, Propylene Glycol,
Purified Water, Strong Ammonia Solution, Potassium Hydroxide, and
Black Iron Oxide.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS:_
Cevimeline is a cholinergic agonist which binds to muscarinic
receptors. Muscarinic agonists in
sufficient dosage can increase secretion of exocrine glands, such as
salivary and sweat glands and
increase tone of the smooth muscle in the gastrointestinal and urinary
tracts.
10
17
2
_PHARMACOKINETICS_
Absorption: After administration of a single 30 mg capsule, cevimeline
was rapidly absorbed with a
mean time to peak concentration of 1.5 to 2 hours. No accumulation of
active drug or its metabolites was
observed following multiple dose administration. When administered
with food, there is a decrease in
the rate of absorption, with a fasting T
of 1.53 hours and a T
of 2.86 hours after a meal; the peak
concentration is reduced by 17.3%. Single oral doses across the
clinical dose range are dose
proportional.
_Distribution:_ Cevimeline has a volume of distribution of
approximately 6L/kg and is <20% bound to
human plasma proteins. This suggests that cevimeline is extensively
bound t