CEVIMELINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cevimeline Hydrochloride (UNII: P81Q6V85NP) (CEVIMELINE - UNII:K9V0CDQ56E)

Available from:

Rising Pharma Holdings, Inc.

INN (International Name):

Cevimeline Hydrochloride

Composition:

CEVIMELINE HYDROCHLORIDE ANHYDROUS 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Cevimeline Hydrochloride Capsules, 30 mg are available as white, hard gelatin capsules containing 30 mg of Cevimeline Hydrochloride. Cevimeline Hydrochloride Capsules are size 3 hard gelatin capsules with an opaque white cap and body. Cevimeline Hydrochloride capsules are imprinted with P 657 on both cap and body in black ink. Cevimeline Hydrochloride is supplied in child resistant bottles of: 100 capsules (NDC: 16571-657-10) Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004 Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Rx only Revised 03/20 551601 PIR65710-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEVIMELINE HYDROCHLORIDE - CEVIMELINE HYDROCHLORIDE CAPSULE
RISING PHARMA HOLDINGS, INC.
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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.
_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
10
17
2
max
max
human plasma proteins. This suggests that cevimeline is extensively
bo