ranitidine hydrochloride

ranitidine hydrochloride

Apo-Ranitidine (CA), Gavilast (UK), Ranitil (UK), Rantek (UK), Zantac, Zantac 75, Zantac EFFERdose

Pharmacologic class: Histamine₂-receptor antagonist

Therapeutic class: Antiulcer drug

Pregnancy risk category B

Action

Reduces gastric acid secretion and increases gastric mucus and bicarbonate production, creating a protective coating on gastric mucosa

Availability

Capsules (liquid-filled): 150 mg, 300 mg

Solution for injection: 25 mg/ml in 2-, 6-, and 40-ml vials

Solution for injection (pre-mixed): 50 mg/50 ml in 0.45% sodium chloride

Syrup: 15 mg/ml

Tablets: 150 mg, 300 mg

Tablets (effervescent): 150 mg

⊘Indications and dosages

➣ Active duodenal ulcer

Adults: 150 mg or 10 ml P.O. b.i.d., or 300 mg or 20 ml P.O. daily, or 50 mg I.V. or I.M. q 6 to 8 hours

➣ To maintain healing of duodenal ulcers

Adults: 150 mg or 10 ml P.O.

➣ Benign gastric ulcer

Adults: 150 mg or 10 ml P.O. b.i.d. For maintenance, 150 mg or 10 ml P.O. or 50 mg I.V. or I.M. q 6 to 8 hours.

➣ Active duodenal and gastric ulcers

Children ages 1 month to 16 years: 2 to 4 mg/kg/day P.O., up to a maximum of 300 mg/day

➣ To maintain healing of duodenal and gastric ulcers

Children ages 1 month to 16 years: 2 to 4 mg/kg/day P.O., up to a maximum of 150 mg/day

➣ Erosive esophagitis

Adults: 150 mg or 10 ml P.O. q.i.d.

Children ages 1 month to 16 years: 5 to 10 mg/kg P.O. daily in two divided doses

➣ Gastroesophageal reflux disease

Adults: 150 mg or 10 ml P.O. b.i.d.

Children ages 1 month to 16 years: 5 to 10 mg/kg P.O. daily in two divided doses

➣ Pathologic hypersecretory conditions, including Zollinger-Ellison syndrome

Adults: 150 mg or 10 ml P.O. b.i.d., adjusted according to patient's needs. In severe cases, up to 6 g/day may be needed. Continue therapy as long as indicated.

➣ Hospitalized patients with pathologic hypersecretory conditions, including Zollinger-Ellison syndrome; intractable duodenal ulcers; patients who can't receive oral drugs

Adults: 50 mg I.M. q 6 to 8 hours, or 50 mg intermittent I.V. bolus q 6 to 8 hours, or 50 mg intermittent I.V. infusion q 6 to 8 hours.

Children ages 1 month to 16 years: 2 to 4 mg/kg/day I.V. in divided doses q 6 to 8 hours, up to a maximum of 50 mg q 6 to 8 hours

Dosage adjustment

• Renal or hepatic impairment
• Debilitated patients

Off-label uses

• Asthma
• GI hemorrhage
• Helicobacter pylori infection
• Short-bowel syndrome
• Immunosuppression reversal
• Psoriasis
• Aspiration pneumonitis prophylaxis

Contraindications

• Hypersensitivity to drug or its components
• Alcohol intolerance (with some oral products)
• History of acute porphyria

Precautions

Use cautiously in:
• renal or hepatic impairment, heart rhythm disturbances, phenylketonuria (effervescent tablets)
• elderly patients
• pregnant or breastfeeding patients.

Administration

• For intermittent I.V. bolus injection, dilute in normal saline solution or other compatible solution to a concentration not exceeding 2.5 mg/ml. Inject no faster than 4 ml/minute (5 minutes).
• For continuous I.V. infusion in patients with Zollinger-Ellison syndrome, add to dextrose 5% in water (D₅W) or other compatible solution; dilute to a concentration not exceeding 2.5 mg/ml, and start infusion at 1 mg/kg/hour. After 4 hours, if measured gastric acid output exceeds 10 mEq/hour or symptoms occur, increase dosage in increments of 0.5 mg/kg/hour, and remeasure acid output.
• Give P.O. doses with or without food. Give once-daily dose at bedtime.
• For intermittent I.V. infusion, dilute in D₅W or other compatible solution to a concentration not exceeding 0.5 mg/ml. Infuse no faster than 7 ml/minute (15 to 20 minutes).
• Be aware that premixed Zantac solution of 50 mg in half-normal saline solution (50 ml) doesn't require dilution. Infuse over 15 to 20 minutes.
• Know that I.V. form may be added to total parenteral nutrition solutions.
• Inject I.M. undiluted deep into large muscle.

Route	Onset	Peak	Duration
P.O.	Unknown	1-3 hr	8-12 hr
I.V., I.M.	Unknown	15 min	8-12 hr

Adverse reactions

CNS: headache, agitation, anxiety

GI: nausea, vomiting, diarrhea, constipation, abdominal discomfort or pain

Hematologic: reversible granulocytopenia and thrombocytopenia

Hepatic: hepatitis

Skin: rash

Other: pain at I.M. injection site, burning or itching at I.V. site, hypersensitivity reaction

Interactions

Drug-drug. Antacids: decreased ranitidine absorption

Propantheline: delayed ranitidine absorption and increased peak blood level

Drug-diagnostic tests. Creatinine: slight elevation

Hepatic enzymes: increased levels

Urine protein tests using Multistix: false-negative results

Drug-herbs. Yerba maté: decreased drug clearance

Drug-behaviors. Smoking: decreased ranitidine effects

Patient monitoring

• Assess vital signs.
• Monitor CBC and liver function tests.

Patient teaching

• Tell patient he may take oral drug with or without food. Advise him to take once-daily prescription drug at bedtime.
• Instruct patient to dissolve EFFERdose in 6 to 8 oz of water before taking.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Tell patient smoking may decrease drug effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.