PREVACID Delayed-release capsule / Delayed-release tablet (2020)

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Cardinal Health

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1. Indications and Usage

1.1 Treatment of Active Duodenal Ulcer PREVACID and PREVACID SoluTab are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical ...

2. Dosage and Administration

2.1 Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily Eradication ...

3. Dosage Forms and Strengths

PREVACID delayed-release capsules: 15 mg strength is an opaque, pink and green capsule imprinted with TAP and PREVACID 15. 30 mg strength is an opaque, pink and black capsule imprinted with TAP and PREVACID ...

4. Contraindications

PREVACID and PREVACID SoluTab are contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, ...

5. Warnings and Precautions

5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with PREVACID or PREVACID SoluTab does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

Additional adverse experiences have been reported since PREVACID and PREVACID SoluTab have been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID or PREVACID SoluTab ...

7. Drug Interactions

Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PREVACID or PREVACID SoluTab and instructions for preventing ...

8.1. Pregnancy

Risk Summary Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (see Data). In animal reproduction ...

8.2. Lactation

Risk Summary There is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. However, lansoprazole and its metabolites ...

8.4. Pediatric Use

PREVACID was not effective in pediatric patients with symptomatic GERD one month to less than one year of age in a multicenter, double-blind, placebo controlled study. Therefore, safety and effectiveness ...

8.5. Geriatric Use

Of the total number of patients (n=21,486) in clinical studies of PREVACID, 16% of patients were aged 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness ...

8.6. Hepatic Impairment

In patients with various degrees of chronic hepatic impairment the exposure to lansoprazole was increased compared to healthy subjects with normal hepatic function [see Clinical Pharmacology (12.3)] ...

10. Overdosage

Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of PREVACID with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg in rats ...

11. Description

The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] ...

12.1. Mechanism of Action

Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase enzyme system at the secretory ...

12.2. Pharmacodynamics

Antisecretory Activity After oral administration, lansoprazole was shown to significantly decrease the basal acid output and significantly increase the mean gastric pH and percent of time the gastric pH ...

12.3. Pharmacokinetics

Absorption PREVACID and PREVACID SoluTab contain an enteric-coated granule formulation of lansoprazole (because lansoprazole is acid-labile), so that absorption of lansoprazole begins only after the granules ...

12.4. Microbiology

Microbiology Lansoprazole, clarithromycin and/or amoxicillin have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections [see Indications and ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In two 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m²) basis of a 50 ...

14. Clinical Studies

14.1 Duodenal Ulcer In a U.S. multi-center, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of PREVACID once daily) study of 284 patients with endoscopically documented duodenal ulcer, ...

16.1. How Supplied

PREVACID SoluTab delayed-release orally disintegrating tablets, 15 mg, are white to yellowish white, round uncoated tablets containing orange to dark brown speckles, with 15 debossed on one side of the ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients to: Acute Interstitial Nephritis: To call their healthcare provider if they ...