Acid Reducer

Name: Acid Reducer

Package/Label Principal Display Panel

Compare to Zantac 150® active ingredient

H E B®

Ranitidine Tablets, 150 mg

Acid Reducer

Maximum Strength

One Tablet Prevents and Relieves:

Heartburn Associated with Acid Indigestion and Sour Stomach

ACTUAL SIZE

65 TABLETS (65 Doses)

GLUTEN FREE

Acid Reducer 
ranitidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-507
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color BROWN (Beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L852
Contains     
Packaging
# Item Code Package Description
1 NDC:37808-507-09 1 BOTTLE in 1 CARTON
1 65 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091429 11/30/2015
Labeler - H E B (007924756)
Revised: 11/2015   H E B

For the Consumer

Applies to ranitidine: oral solution, oral tablets and tablets for, oral tablets effervescent for solution, parenteral injection, parenteral injection for iv infusion only

Side effects include:

Oral or parenteral therapy: Headache, sometimes severe.

IM therapy: Transient pain at injection site.

IV therapy: Transient local burning or itching.

For Healthcare Professionals

Applies to ranitidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent

General

The most commonly reported side effect for IM administration was injection site pain, and the most commonly reported side effects with IV administration were localized pain and burning.[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Abdominal discomfort/pain, constipation, nausea, vomiting
Very rare (less than 0.01%): Acute pancreatitis, diarrhea[Ref]

Abdominal pain, constipation, and nausea tended to improve with continued treatment.[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hypotension, chest pain, arrhythmia, bradycardia, atrioventricular block, tachycardia, premature ventricular beats
Very rare (less than 0.01%): Asystole, vasculitis[Ref]

Bradycardia, atrioventricular block, tachycardia, and asystole have occurred in H2 receptor antagonists.[Ref]

Psychiatric

Rare (0.01% to 0.1%): Insomnia, reversible mental confusion, agitation, depression, hallucinations
Frequency not reported: Loss of libido[Ref]

Nervous system

Headache may be related to administration of treatment.[Ref]

Rare (0.01% to 0.1%): Dizziness, somnolence, vertigo, reversible involuntary movement disorders
Very rare (less than 0.01%): Headache/severe headache[Ref]

Dermatologic

Rare (0.01% to 0.1%): Urticaria, angioneurotic edema, skin rash
Very rare (less than 0.01%): Erythema multiforme, alopecia[Ref]

Musculoskeletal

Very rare (less than 0.01%): Musculoskeletal symptoms, arthralgia, myalgia[Ref]

Hepatic

Rare (0.01% to 0.1%): Transient and reversible changes in liver function tests, increased ALT levels
Very rare (less than 0.01%): Hepatocellular/hepatocanalicular/mixed hepatitis with/without jaundice[Ref]

Hepatitis with/without jaundice were usually reversible.

ALT levels increased to at least 2 times the pretreatment levels in patients receiving high IV doses for at least 5 days.[Ref]

Other

Rare (0.01% to 0.1%): Fever, malaise
Frequency not reported: Death[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Very rare (less than 0.01%): Anaphylactic shock/anaphylaxis[Ref]

Anaphylactic shock occurred after administration of a single dose.[Ref]

Renal

Rare (0.01% to 0.1%): Elevation in serum creatinine
Very rare (less than 0.01%): Acute interstitial nephritis[Ref]

Elevation in serum creatinine was usually slight, and typically normalized with continued treatment.[Ref]

Respiratory

Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Dyspnea, pneumonia[Ref]

Ocular

Rare (0.01% to 0.1%): Reversible blurred vision[Ref]

Hematologic

Very rare (less than 0.01%): Blood count changes, leukopenia, thrombocytopenia, granulocytopenia, agranulocytosis, pancytopenia, marrow hypoplasia/aplasia
Frequency not reported: Aplastic anemia, immune hemolytic anemia/acquired immune hemolytic anemia, eosinophilia[Ref]

Leukopenia, granulocytopenia, and thrombocytopenia were usually reversible.[Ref]

Genitourinary

Very rare (less than 0.01%): Reversible impotence, breast symptoms/conditions, galactorrhea[Ref]

Endocrine

Very rare (less than 0.01%): Gynecomastia[Ref]

Metabolic

Postmarketing reports: Acute porphyria[Ref]

Local

Frequency not reported: Injection site pain, transient localized burning or itching[Ref]

Some side effects of Acid Reducer may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Ranitidine Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Animal models have failed to reveal evidence of impaired fertility or fetal harm. It is unknown whether use of gastric-suppressing drugs are associated with childhood allergy and asthma. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Ranitidine Breastfeeding Warnings

This drug is known to increase prolactin levels. There are no data on galactorrhea and/or adverse effects with breastfeeding.

Caution is recommended. Excreted into human milk: Yes

Ranitidine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Although interpatient variability exists, the dose of ranitidine in breastmilk is less than the dose used in newborn infants. Maternal ranitidine would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Drug Levels

Maternal Levels. Six women with established lactation who were 6 to 10 days postpartum were given a single dose of 150 mg of ranitidine orally. Average milk levels were 1.28, 1.42 and 1.02 mg/L at 2, 4 and 8 hours, respectively, after the dose; however, there was great interpatient variability in both peak levels and the time of the peak.[1]

After 5 oral doses of ranitidine 150 mg every 12 hours in a 54-day postpartum woman, the highest measured milk level occurred 5.5 hours after the 5th dose and was 2.6 mg/L. The estimated half-life in milk was 2.9 hours.[2]

Using the average peak milk level data from these 2 papers, an exclusively breastfed infant would receive an estimated maximum of 300 mcg/kg daily with a maternal dosage of 150 mg daily. This dosage is 20% of the dosage used intravenously in newborn infants for stress ulcer prophylaxis.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

One 54-day-old breastfed infant had no observable adverse effects after maternal ingestion of ranitidine 150 mg every 12 hours for 2 days.[2]

Effects on Lactation and Breastmilk

Histamine H2-receptor blockade is known to stimulate prolactin secretion.[3] Ranitidine in intravenous doses over 100 mg or during long-term oral use have increased serum prolactin in some studies,[4][5][6] but no reports of galactorrhea or effects on breastfeeding women were found as of the revision date. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Cimetidine, Famotidine, Nizatidine, Omeprazole, Pantoprazole, Sucralfate

References

1. Riley AJ, Crowley P, Harrison C. Transfer of ranitidine to biological fluids: milk and semen. In: Misiewicz JJ, Wormsley KG, eds. The clinical use of ranitidine. Oxford: Medicine Publishing Foundation, 1982:78-81.

2. Kearns GL, McConnell RF Jr, Trang JM et al. Appearance of ranitidine in breast milk following multiple dosing. Clin Pharm. 1985;4:322-4. PMID: 4039999

3. Knigge UP. Histaminergic regulation of prolactin secretion. Dan Med Bull. 1990;37:109-24. PMID: 2188799

4. Perret G, Hugues JN, Louchahi M et al. Effect of a short-term oral administration of cimetidine and ranitidine on the basal and thyrotropin-releasing hormone-stimulated serum concentrations of prolactin, thyrotropin and thyroid hormones in healthy volunteers. A double-blind cross-over study. Pharmacology. 1986;32:101-8. PMID: 3081918

5. Delitala G, Devilla L, Pende A et al. Effects of the H2 receptor antagonist ranitidine on anterior pituitary hormone secretion in man. Eur J Clin Pharmacol. 1982;22:207-11. PMID: 6125393

6. Knigge U, Wollesen F, Dejgarrd A et al. Comparison between dose-responses of prolactin, thyroid stimulating hormone and growth hormone to two different histamine H-2 receptor antagonists in normal men. Clin Endocrinol (Oxf). 1981;15:585-92. PMID: 6276054

Ranitidine Identification

Substance Name

Ranitidine

CAS Registry Number

66357-35-5

Drug Class

Anti-Ulcer Agents

Histamine H2 Antagonists

Administrative Information

LactMed Record Number

384

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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