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ZANTAC

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Overview

What is ZANTAC?

The active ingredient in ZANTAC 150 Tablets and ZANTAC 300 Tablets 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 CHNOS•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 sulfur-like odor.

Each ZANTAC 150 Tablet for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin, and yellow iron oxide.

Each ZANTAC 300 Tablet for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.



What does ZANTAC look like?



What are the available doses of ZANTAC?

Sorry No records found.

What should I talk to my health care provider before I take ZANTAC?

Sorry No records found

How should I use ZANTAC?

ZANTAC 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.

The current recommended adult oral dosage of ZANTAC for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated (see Clinical Trials: ). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).


What interacts with ZANTAC?

ZANTAC is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).



What are the warnings of ZANTAC?

Sorry No Records found


What are the precautions of ZANTAC?

General:

Laboratory Tests:

False-positive tests for urine protein with MULTISTIX may occur during therapy with ZANTAC, and therefore testing with sulfosalicylic acid is recommended.

Drug Interactions:

Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

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Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

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Carcinogenesis, Mutagenesis, Impairment of Fertility:

There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.

Ranitidine was not mutagenic in standard bacterial tests () for mutagenicity at concentrations up to the maximum recommended for these assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.

Pregnancy:

Teratogenic Effects:

Nursing Mothers:

Ranitidine is secreted in human milk. Caution should be exercised when ZANTAC is administered to a nursing mother.

Pediatric Use:

The safety and effectiveness of ZANTAC have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of ZANTAC in this age-group is supported by adequate and well-controlled trials in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature (see CLINICAL PHARMACOLOGY: Pediatrics and DOSAGE AND ADMINISTRATION: Pediatric Use).

Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.

Safety and effectiveness in neonates (aged younger than 1 month) have not been established (see CLINICAL PHARMACOLOGY: Pediatrics).

Geriatric Use:

Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of ZANTAC, for which there were subgroup analyses, 4,197 were aged 65 and older, while 899 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients with Impaired Renal Function).

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What are the side effects of ZANTAC?

The following have been reported as events in clinical trials or in the routine management of patients treated with ZANTAC. The relationship to therapy with ZANTAC has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ZANTAC.

Central Nervous System:

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular:

As with other H-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal:

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic:

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.

Musculoskeletal:

Rare reports of arthralgias and myalgias.

Hematologic:

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine:

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ZANTAC and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ZANTAC has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving ZANTAC, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.

Integumentary:

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory:

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (HRAs) compared with patients who had stopped HRA treatment, with an observed adjusted relative risk of 1.63 (95% CI: 1.07–2.48). However, a causal relationship between use of HRAs and pneumonia has not been established.

Other:

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.


What should I look out for while using ZANTAC?

ZANTAC is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).


What might happen if I take too much ZANTAC?

There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Studies in dogs receiving dosages of ZANTAC in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD values in mice and rats were 77 and 83 mg/kg, respectively.


How should I store and handle ZANTAC?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.ZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PIZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with “ZANTAC 150” on one side and “Glaxo” on the other. They are available in bottles of 60 (NDC 0173-0344-42) tablets.ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with “ZANTAC 300” on one side and “Glaxo” on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.Store between 15° and 30°C (59° and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.GlaxoSmithKlineResearch Triangle Park, NC 27709ZANTAC is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license.MULTISTIX is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.©2016 the GSK group of companies. All rights reserved.August 2016ZNT:9PI


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Absorption:

Distribution:

Metabolism:

Excretion:

Geriatrics:

Pediatrics:

Plasma clearance measured in 2 neonatal patients (aged younger than 1 month) was considerably lower (3 mL/min/kg) than children or adults and is likely due to reduced renal function observed in this population (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION: Pediatric Use).

Non-Clinical Toxicology
ZANTAC is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).

Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.









Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.





























General:

The following have been reported as events in clinical trials or in the routine management of patients treated with ZANTAC. The relationship to therapy with ZANTAC has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ZANTAC.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).