LEVSIN SL- hyoscyamine sulfate tablet, orally disintegrating

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)

Dostupno od:

Alaven Pharmaceutical LLC

INN (International ime):

HYOSCYAMINE SULFATE

Sastav:

HYOSCYAMINE SULFATE 0.125 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Levsin® /SL is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Levsin® /SL is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce ri

Proizvod sažetak:

Levsin® /SL tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other. Store at controlled room temperature 20°- 25°C (68° - 77°F); excursions permitted to 15°- 30°C (59°- 86°F). Please refer to current USP. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN Also available as: Levsin®    Dosage    Strength Package Size NDC Tablets    0.125mg 100 68220-112-10 Tablets    0.125mg 500 68220-112-50 Sub-lingual Tablets    0.125mg 100 68220-113-10 Sub-lingual Tablets    0.125mg 500 68220-113-50 Elixir    0.125mg/5 mL Pint 0091-4532-16 Drops    0.125mg/mL 15mL 0091-4538-15 Injection    0.5mg/mL Box of 5-1mL 0091-1536-05 Levbid® extended-    0.375mg 100 68220-115-10 release tablets    0.375mg 500 68220-115-50 Manufactured for: ALAVEN® PHARMACEUTICAL LLC Marietta, GA 30067 Or call toll free 1-888-317-0001

Status autorizacije:

unapproved drug other

Svojstava lijeka

LEVSIN SL- HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING
ALAVEN PHARMACEUTICAL LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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LEVSIN /SLTABLETS
(HYOSCYAMINE SULFATE TABLETS USP)
RX ONLY
500364 113 Rev. 02/08
DESCRIPTION
Levsin /SL tablets (hyoscyamine sulfate tablets USP) contain 0.125 mg
hyoscyamine sulfate formulated
for sublingual administration. However, the tablets may be chewed or
taken orally.
Each tablet also contains as inactive ingredients: FD&C blue #1,
lactose monohydrate, magnesium
stearate, mannitol, starch and stearic acid.
CLINICAL PHARMACOLOGY
Levsin /SL inhibits specifically the actions of acetylcholine on
structures innervated by postganglionic
cholinergic nerves and on smooth muscles that respond to acetylcholine
but lack cholinergic
innervation. These peripheral cholinergic receptors are present in the
autonomic effector cells of the
smooth muscle, cardiac muscle, the sinoatrial node, the
atrioventricular node, and the exocrine glands.
At therapeutic doses, it is completely devoid of any action on
autonomic ganglia. Levsin /SL inhibits
gastrointestinal propulsive motility and decreases gastric acid
secretion. Levsin /SL also controls
excessive pharyngeal, tracheal and bronchial secretions.
Levsin /SL is absorbed totally and completely by sublingual
administration as well as oral
administration. Once absorbed, Levsin /SL disappears rapidly from the
blood and is distributed
throughout the entire body. The half-life of Levsin /SL is 2 to 3½
hours. Levsin /SL is partly
hydrolyzed to tropic acid and tropine but the majority of the drug is
excreted in the urine unchanged
within the first 12 hours. Only traces of this drug are found in
breast milk. Levsin /SL passes the blood
brain barrier and the placental barrier. The tablets can be taken
orally with the same pharmacological
®
®
Levsin /SL is one of the principal anticholinergic/antispasmo