RANITIDINE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Preferred Pharmaceuticals Inc.

INN (Tên quốc tế):

RANITIDINE HYDROCHLORIDE

Thành phần:

RANITIDINE 300 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Ranitidine tablets USP are indicated in: Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis. Ranitidine tablets USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

Tóm tắt sản phẩm:

Ranitidine tablets USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51” engraved on one side and “300” on the other side. They are available in bottles of; 14 NDC #68788-6382-1 30 NDC #68788-6382-3 60 NDC #68788-6382-6 90 NDC #68788-6382-9 100 NDC #68788-6382-0

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

RANITIDINE- RANITIDINE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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RANITIDINE TABLETS USP, 150 MG AND 300 MG
PRESCRIBING INFORMATION
DESCRIPTION
The active ingredient in ranitidine tablets USP 150 mg and 300 mg is
ranitidine hydrochloride (HCl),
USP, a histamine H -receptor antagonist. Chemically it is
N[2-[[[5-[(dimethylamino)methyl]-2-
furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl.
It has the following structure:
The empirical formula is C
H N O S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl USP is a white to pale yellow, granular substance that
is soluble in water. It has a
slightly bitter taste and sulfur like odor.
Each ranitidine tablet USP 150 mg for oral administration contains 168
mg of ranitidine HCl USP
equivalent to 150 mg of ranitidine. Each tablet also contains the
inactive ingredients microcrystalline
cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium
stearate, FD&C Red # 40
Aluminum Lake, hypromellose, titanium dioxide, triacetin.
Each ranitidine tablet USP 300 mg for oral administration contains 336
mg of ranitidine HCl USP
equivalent to 300 mg of ranitidine. Each tablet also contains the
inactive ingredients microcrystalline
cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium
stearate, FD&C Red # 40
Aluminum Lake, hypromellose, titanium dioxide, triacetin.
CLINICAL PHARMACOLOGY
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the histamine H -receptors,
including receptors on the gastric cells. Ranitidine does not lower
serum Ca++ in hypercalcemic states.
Ranitidine is not an anticholinergic agent.
PHARMACOKINETICS :
ABS ORPTION:
Ranitidine is 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, p