CEVIMELINE HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Advagen Pharma Ltd

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome. Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Produkt oppsummering:

Cevimeline hydrochloride capsules 30 mg are available as opaque white cap printed ‘˄’ in black and white opaque body printed ‘A20’in black containing white to off white powder. They are supplied as follows: Bottles of 30, NDC 72888-118-30 Bottles of 100, NDC 72888-118-01 Bottles of 500, NDC 72888-118-05 Bottles of 1,000, NDC 72888-118-00 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Distributed By: Advagen Pharma Ltd., 666 Plainsboro Road, Suite 605 Plainsboro, NJ 08536, USA. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India. Rev.01, 12/2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CEVIMELINE HYDROCHLORIDE- CEVIMELINE HYDROCHLORIDE CAPSULE
ADVAGEN PHARMA LTD
----------
CEVIMELINE HYDROCHLORIDE CAPSULES 30MG
RX ONLY
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.½ 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. Cevimeline hydrochloride is available as 30 mg
capsules for oral
administration. Inactive ingredients include lactose monohydrate,
hydroxypropyl
cellulose, and magnesium stearate, gelatin, titanium dioxide, sodium
lauryl sulphate,
shellac, propylene glycol, black iron oxide and potassium hydroxide.
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.
_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
10
17
2
o
max
max
<20% bound to human plasma proteins. This suggests that cevimeline is
extensively
bound to tissues; however, the specific binding sites are unknown.
Metabolism: Isozym