CEVIMELINE- cevimeline hydrochloride capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bionpharma Inc

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Cevimeline hydrochloride capsules are 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.

Ringkasan produk:

Cevimeline hydrochloride capsules are available as white, hard gelatin capsules with white opaque cap and white opaque body filled with white to off-white powder blend. The capsule is printed with CH in black ink on the body. It is supplied in child-resistant bottles of: 100 capsules (NDC 69452-316-20) Store 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]. Dispense in tight containers. Keep this and all drugs out of the reach of children. Distributed by: Bionpharma Inc. Princeton, NJ 08540 MADE IN INDIA Revised: 9/2023 FDA-04 948026810

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CEVIMELINE- CEVIMELINE HYDROCHLORIDE CAPSULE
BIONPHARMA INC
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CEVIMELINE HYDROCHLORIDE CAPSULES
RX ONLY
DESCRIPTION
Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3,
5’ -[1,3] oxathiolane}
hydrochloride, hydrate (2:1). Its molecular formula is C
H
NOS•HCl•½ H
O, and its
structural formula is:
Cevimeline hydrochloride, USP has a molecular weight of 244.79. It is
a white to off white
crystalline powder with a melting point range of 201°C and 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.
Each capsule for oral administration contains 30 mg of cevimeline
hydrochloride, USP.
Inactive ingredients include hydroxypropyl cellulose, lactose
monohydrate, and
magnesium stearate. The capsule shell is composed of gelatin, and
titanium dioxide. The
capsules are printed with black ink composed of black iron oxide,
potassium hydroxide,
propylene glycol, shellac, and strong ammonia solution.
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 hours 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%
10
17
2
max
max
bound to human plasma proteins. This suggests that cevime