RANITIDINE- ranitidine syrup

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Ranitidine Syrup (Ranitidine Oral Solution USP) is 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 is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).

Povzetek izdelek:

Ranitidine Syrup (Ranitidine Oral Solution USP), a clear, pale yellow, spearmint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per 1 mL of oral solution (75 mg/5 mL) supplied in: NDC 68788-7101-4: 16 fl oz (473 mL) bottle Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

RANITIDINE- RANITIDINE SYRUP
PREFERRED PHARMACEUTICALS INC.
----------
RANITIDINE SYRUP
(RANITIDINE ORAL SOLUTION USP)
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution
USP) 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 is a white to pale yellow, granular substance that is
soluble in water. It has a slightly
bitter taste and sulfurlike odor.
Each 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains
16.8 mg of ranitidine HCl
equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral
Solution USP) also contains the
inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose,
methylparaben, purified water,
sodium chloride, sodium saccharin, spearmint flavor, sucrose and may
contain monobasic sodium
phosphate.
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. The oral solution is
bioequivalent to the tablets. 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.
DIS TRIBUTION
The volume of distribution is about 1.4 L/kg. Ser