RANITIDINE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)

متاح من:

Blenheim Pharmacal, Inc.

INN (الاسم الدولي):

RANITIDINE HYDROCHLORIDE

تركيب:

RANITIDINE 150 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Ranitidine Tablets, USP are indicated in: - Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. - The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). - Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. - Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out

ملخص المنتج:

Ranitidine Tablets, USP 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are supplied as orange, round, biconvex aqueous film-coated tablets debossed “IP 253” on one side and plain on the reverse.  They are available as follows: Bottles of 60:              NDC 53746-253-60 Bottles of 100:            NDC 53746-253-01 Bottles of 180:            NDC 53746-253-18 Bottles of 500:            NDC 53746-253-05 Bottles of 1000:          NDC 53746-253-10 Ranitidine Tablets, USP 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are supplied as yellow, capsule-shaped aqueous film-coated tablets debossed “IP 254” on one side and plain on the reverse.  They are available as follows: Bottles of 30:              NDC 53746-254-30 Bottles of 100:            NDC 53746-254-01 Bottles of 250:            NDC 53746-254-02 Bottles of 500:            NDC 53746-254-05 Bottles of 1000:          NDC 53746-254-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light resistant container as defined in the USP.  Protect from light. Replace cap securely after each opening.  

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RANITIDINE- RANITIDINE TABLET
BLENHEIM PHARMACAL, INC.
----------
RANITIDINE TABLETS, USP
RX ONLY
CLINICAL PHARMACOLOGY
Ranitidine Tablets, USP are a competitive, reversible inhibitor of the
action of histamine at the
histamine H
-receptors, including receptors on the gastric cells. Ranitidine
Tablets, USP do not lower
serum Ca
in hypercalcemic states. Ranitidine Tablets, USP are not an
anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP are 50%
absorbed after oral administration,
compared to an intravenous (IV) injection with mean peak levels of 440
to 545 ng/mL occurring 2 to 3
hours after a 150-mg dose. Absorption is not significantly impaired by
the administration of food or
antacids. Propantheline slightly delays and increases peak blood
levels of ranitidine, probably by
delaying gastric emptying and transit time. In one study, simultaneous
administration of high-potency
antacid (150 mmol) in fasting subjects has been reported to decrease
the absorption of Ranitidine
Tablets, USP.
_DISTRIBUTION:_ The volume of distribution is about 1.4 L/kg. Serum
protein binding averages 15%.
_METABOLISM: _In humans, the N-oxide is the principal metabolite in
the urine; however, this amounts to
<4% of the dose. Other metabolites are the S-oxide (1%) and the
desmethyl ranitidine (1%). The
remainder of the administered dose is found in the stool. Studies in
patients with hepatic dysfunction
(compensated cirrhosis) indicate that there are minor, but clinically
insignificant, alterations in ranitidine
half-life, distribution, clearance, and bioavailability.
_EXCRETION:_ The principal route of excretion is the urine, with
approximately 30% of the orally
administered dose collected in the urine as unchanged drug in 24
hours. Renal clearance is about 410
mL/min, indicating active tubular excretion. The elimination half-life
is 2.5 to 3 hours. Four patients
with clinically significant renal function impairment (creatinine
clearance 25 to 35 mL/min) administered
50 mg of ranitidine intravenously had an ave