Ranitidine

Ranitidine is a prescription drug used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. Ranitidine is also used to treat certain stomach and throat problems such as erosive esophagitis, gastroesophageal reflux disease or GERD, and Zollinger-Ellison syndrome. It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn’t go away, stomach pain, heartburn, and difficulty swallowing.  Ranitidine belongs to a class of drugs known as H2 blockers.

In April 2020, the U.S. Food and Drug Administration (FDA) requested manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market.

Other details, if available

Dosages of Ranitidine

Adult and pediatric dosages:

Injection solution

• 25 mg/mL

Syrup

• 15 mg/mL

Tablet

• 75 mg
• 150 mg
• 300 mg

Dosage Considerations -- Should Be Given As Follows:

Adult Dosage Considerations

Gastroesophageal Reflux Disease

• 150 mg orally every 12 hours or 50 mg intramuscular/intravenously every 6-8 hours

Gastric Ulcer, Benign

• Treatment: 150 mg orally every 6 hours or 50 mg intermuscular/intravenously every 6-8 hours intermittent bolus or infusion; alternatively, 6.25 mg/hours intravenously by continuous infusion
• Maintenance of healing: 150 mg orally every 12 hours

Hypersecretory Conditions

• 150 mg orally every 12 hours, up to 6 g/day used
• Parenteral: 50 mg (2 mL) intramuscularly or intermittent intravenous bolus or infusion every 6-8 hours, not to exceed 400 mg/day; alternatively, 6.25 mg/hour continuous infusion

Dosing Considerations

More frequent doses may be necessary, individualize dosage, and continue as long as indicated; dosages up to 6 g/day have been used for severe disease.

Zollinger-Ellison syndrome: Start intravenous infusion at 1 mg/kg/hour, then adjust upward in 0.5 mg/kg/hour increments according to gastric acid output (not to exceed 2.5 mg/kg/hour or 220 mg/hour.

Stress Ulcer Prophylaxis (Off-label)

• 150 mg orally or nasogastric every 12 hours
• 50 mg (2 mL) intramuscular or intermittent intravenous bolus or infusion every 6-8 hours, not to exceed 400 mg/day; alternatively, 6.25 mg/hour continuous infusion

Dosing Modifications

• Renal impairment (Creatinine clearance less than 50 mL/min): 50 mg intravenously/intramuscular every 18 to 24 hours or 150 mg orally once daily
• Hepatic impairment: Dosage adjustment not necessary

Pediatric Dosage Considerations

Active Duodenal/Gastric Ulcer

• Treatment: 4-8 mg/kg orally every 12 hours; not to exceed 300 mg/day
• Maintenance: 2-4 mg/kg orally once daily; not to exceed 150 mg/day
• Parenteral: 2-4 mg/kg/day intravenously divided every 6-8 hours; not to exceed 50 mg/dose or 200 mg/day

Gastroesophageal Reflux Disease (GERD)

Children: 1 month - 16 years

• 5-10 mg/kg/day orally divided every 12 hours; not to exceed 300 mg/day
• Parenteral (Off-label): 2-4 mg/kg/day intravenously divided every 6-8 hours; not to exceed 50 mg/dose or 200 mg/day; alternatively, infusion at 1mg/kg/dose once followed by continuous infusion of 0.08-0.17 mg/kg/hour or 2-4 mg/kg/day

Erosive Esophagitis

Children: 1 month - 16 years

• 5-10 mg/kg/day orally divided every 12 hours; not to exceed 300 mg/day
• Parenteral (Off-label): 2-4 mg/kg/day intravenously divided every 6-8 hours; not to exceed 200 mg/day; alternatively, 1mg/kg/dose once followed by continuous infusion of 0.08-0.17 mg/kg/hour or 2-4 mg/kg/day

Neonates (Off-label)

Term Neonates (less than 29 days)

• 2-4 mg/kg/day orally divided every 8-12 hours or 2 mg/kg/day intravenously divided every 8 hours

Prophylaxis against dexamethasone associated ulceration: 0.031-1.25 mg/kg/hour during dexamethasone therapy to maintain gastric pH greater than 4

Prophylaxis against stress ulceration: 2 mg/kg every 12 hours or 1.5 mg/kg intravenously every 8 hours; alternatively, 2 mg/kg over 10 min, followed by continuous infusion of 0.083 mg/kg/hour

Side effects of Ranitidine include:

• headache
• abdominal pain
• agitation
• hair loss
• confusion
• constipation
• diarrhea
• dizziness
• hypersensitivity reaction
• nausea
• vomiting
• anemia
• necrotizing inflammation of the small intestine and colon in fetus or newborn

Rare side effects of Ranitidine include:

• pancreatitis
• deficiency of platelets in the blood
• reduction of all blood cells
• lowered white blood cells
• acquired immune hemolytic anemia
• joint pain
• muscle pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

There are no severe interactions with Ranitidine.

Serious Interactions of Ranitidine include:

• atazanavir
• dasatinib
• delavirdine
• erlotinib
• itraconazole
• ivacaftor
• ketoconazole
• mesalamine
• pazopanib
• ponatinib
• risedronate

Ranitidine has moderate interactions with at least 51 different drugs.

Mild Interactions of ranitidine include:

• alendronate
• blessed thistle
• ceftibuten
• cyanocobalamin
• devil's claw
• ethotoin
• etravirine
• fosphenytoin
• hydrochlorothiazide
• midodrine
• miglitol
• phenytoin
• phytoestrogens
• propantheline
• sulfamethoxalone
• triamterene
• triazolam
• verapamil

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

Symptom relieve does not rule out presence of gastric malignancy.

This medication contains ranitidine. Do not take ranitidine if you are allergic to ranitidine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to ranitidine or components of the formulation

Effects of Drug Abuse

• None.

Short-Term Effects

• Symptom relieve does not rule out presence of gastric malignancy
• See also "What Are Side Effects Associated with Using Ranitidine?”

Long-Term Effects

• Prolonged treatment may lead to B12 malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (younger than 30 years)
• See also "What Are Side Effects Associated with Using Ranitidine?”

Cautions

• If gastroesophageal reflux disease does not respond adequately in 6-8 weeks, do not increase dosage; prescribe proton pump inhibitor instead
• Prolonged treatment may lead to B12 malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (younger than 30 years)
• Use caution in renal impairment; adjust dosage
• Use caution in hepatic impairment
• Elevation of ALT levels reported with higher doses (greater than 100 mg) or prolonged IV therapy (longer than 5 days); monitor for ALT levels for the remainder of treatment
• Avoid in patients with acute porphyria; may precipitate attack
• Symptom relieve does not rule out presence of gastric malignancy
• Reversible state of confusion reported with use (linked to age over 50 years and renal or hepatic impairment); clears within 3-4 days after discontinuation

Pregnancy and Lactation with Ranitidine

• Use of ranitidine in pregnancy may be acceptable
• Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk
• Ranitidine transfers into breast milk
• Discontinue use of ranitidine if lactating and use caution