No

Histamine H₂ Antagonist

Short-term treatment of active duodenal ulcers and benign gastric ulcers; long-term prophylaxis of duodenal ulcer and gastric hypersecretory states, gastroesophageal reflux, recurrent postoperative ulcer, upper GI bleeding, prevention of acid-aspiration pneumonitis during surgery, and prevention of stress-induced ulcers; causes fewer interactions than cimetidine

B

Hypersensitivity to ranitidine or any component

Use with caution in children <12 years of age; use with caution in patients with liver and renal impairment; dosage modification required in patients with renal impairment; long-term therapy may cause vitamin B₁₂ deficiency

1% to 10%:

Central nervous system: Dizziness, sedation, malaise, headache, drowsiness

Dermatologic: Rash

Gastrointestinal: Constipation, nausea, vomiting, diarrhea

<1%: Gynecomastia, hepatitis, arthralgia, bradycardia, tachycardia, fever, confusion, thrombocytopenia, neutropenia, agranulocytosis, bronchospasm

Symptoms of overdose include muscular tremors, vomiting, rapid respiration, renal failure, CNS depression

Treatment is primarily symptomatic and supportive

CYP2D6 and 3A3/4 enzyme inhibitor

Decreased toxicity of atropine

Increased toxicity of cyclosporine (increased serum creatinine), gentamicin (neuromuscular blockade), glipizide, glyburide, midazolam (increased concentrations), metoprolol, pentoxifylline, phenytoin, quinidine

Ranitidine injection should be stored at 4°C to 30°C and protected from light; injection solution is a clear, colorless to yellow solution; slight darkening does not affect potency

Prepared bags: 2 days

Premixed bags: Manufacturer expiration dating and out of overwrap stability: 15 days

Stability of prepared bags at refrigeration temperature (4°C): 10 days

Solution for I.V. infusion in NS or D₅W is stable for 30 days when frozen; I.V. form is incompatible with amphotericin B, clindamycin, diazepam (same syringe), hetastarch (Y-line), hydroxyzine (same syringe), midazolam (same syringe), pentobarbital (same syringe), phenobarbital (same syringe)

Competitive inhibition of histamine at H₂-receptors of the gastric parietal cells, which inhibits gastric acid secretion, gastric volume and hydrogen ion concentration reduced

Absorption: Oral: 50% to 60%

Distribution: Minimally penetrates the blood-brain barrier; appears in breast milk

Protein binding: 15%

Metabolism: In the liver (<10%)

Half-life: Children 3.5-16 years: 1.8-2 hours; Adults: 2-2.5 hours; End-stage renal disease: 6-9 hours

Time to peak serum concentration: Oral: Within 1-3 hours and persisting for 8 hours

Elimination: 30% (oral) / 70% (I.V.) eliminated as unchanged drug in the urine and feces

Giving oral dose at 6 PM may be better than 10 PM bedtime, the highest acid production usually starts at approximately 7 PM, thus giving at 6 PM controls acid secretion better

Oral: 1.25-2.5 mg/kg/dose every 12 hours; maximum: 300 mg/day

I.M., I.V.: 0.75-1.5 mg/kg/dose every 6-8 hours, maximum daily dose: 400 mg

Continuous infusion: 0.1-0.25 mg/kg/hour (preferred for stress ulcer prophylaxis in patients with concurrent maintenance I.V.s or TPNs)

Adults:

Short-term treatment of ulceration: 150 mg/dose twice daily or 300 mg at bedtime

Prophylaxis of recurrent duodenal ulcer: Oral: 150 mg at bedtime

Gastric hypersecretory conditions:

Oral: 150 mg twice daily, up to 600mg/day

I.M., I.V.: 50 mg/dose every 6-8 hours (dose not to exceed 400 mg/day)

I.V.: 50 mg/dose IVPB every 6-8 hours (dose not to exceed 400 mg/day)

or

Continuous I.V. infusion: Initial: 50 mg IVPB, followed by 6.25 mg/hour titrated to gastric pH >4.0 for prophylaxis or >7.0 for treatment; continuous I.V. infusion is preferred in patients with active bleeding

Gastric hypersecretory conditions: Doses up to 2.5 mg/kg/hour (220 mg/hour) have been used

Dosing adjustment in renal impairment:

Cl_cr 10-50 mL/minute: Administer at 75% of normal dose or administer every 18-24 hours

Cl_cr <10 mL/minute: Administer at 50% of normal dose or administer every 18-24 hours

Hemodialysis: Slightly dialyzable (5% to 20%)

Dosing adjustment/comments in hepatic disease: Unchanged

AST, ALT, serum creatinine; when used to prevent stress-related GI bleeding, measure the intragastric pH and try to maintain pH >4; signs and symptoms of peptic ulcer disease, occult blood with GI bleeding, monitor renal function to correct dose; monitor for side effects

False-positive urine protein using Multistix®, gastric acid secretion test, skin test allergen extracts, serum creatinine and serum transaminase concentrations, urine protein test

May cause drowsiness or dizziness

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine; concurrent use with diazepam may reduce diazepam's effectiveness

No information available to require special precautions

No effects or complications reported

Take exactly as directed (at meals and bedtime); do not increase dose - may take several days before you notice relief. If antacids are approved by prescriber, allow 1 hour between antacid and ranitidine. Avoid OTC medications, especially cold or cough medication and aspirin or anything containing aspirin. Follow diet as prescriber recommends. You may experience constipation or diarrhea (request assistance from prescriber); nausea or vomiting (frequent small meals, frequent mouth care, sucking lozenges, or chewing gum may help); impotence or loss of libido (reversible when drug is discontinued); drowsiness, dizziness, or fatigue (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report skin rash, fever, sore throat, tarry stools, changes in CNS, muscle or joint pain, yellowing of skin or eyes, and change in color of urine or stool.

I.M. solution does not need to be diluted before use; monitor creatinine clearance for renal impairment; observe caution in patients with renal function impairment and hepatic function impairment

Capsule (GELdose™): 150 mg, 300 mg

Granules, effervescent (EFFERdose™): 150 mg

Infusion, preservative free, in NaCl 0.45%: 1 mg/mL (50 mL)

Injection: 25 mg/mL (2 mL, 10 mL, 40 mL)

Syrup (peppermint flavor): 15 mg/mL (473 mL)

Tablet: 75 mg [OTC]; 150 mg, 300 mg

Tablet, effervescent (EFFERdose™): 150 mg

Balestrazzi P, Gregori G, Bernasconi S, et al, "Bradycardia and Neurologic Disorders Associated With Ranitidine in a Child," Am J Dis Child, 1985, 139(5):442.

Blumer JL, Rothstein FC, Kaplan BS, et al, "Pharmacokinetic Determination of Ranitidine Pharmacodynamics in Pediatric Ulcer Disease," J Pediatr, 1985, 107(2):301-6.

Eddleston JM, Booker PD, and Green JR, "Use of Ranitidine in Children Undergoing Cardiopulmonary Bypass," Crit Care Med, 1989, 17(1):26-9.

Fontana M, Massironi E, Rossi A, et al, "Ranitidine Pharmacokinetics in Newborn Infants," Arch Dis Child, 1993, 68(5 Spec No):602-3.

Lehmann AB, "Reversible Chorea Due to Ranitidine and Cimetidine," Lancet, 1988, 2(8603):158.

Lopez-Herce J, Albajara L, Codoceo R, et al, "Ranitidine Prophylaxis in Acute Gastric Mucosal Damage in Critically Ill Pediatric Patients," Crit Care Med, 1988, 16(6):591-93.

Miralles ES, Nunez M, del Olmo N, et al, "Ranitidine-Related Toxic Epidermal Necrolysis in a Patient With Idiopathic Thrombocytopenic Purpura," J Am Acad Dermatol, 1995, 32(1):133-4.

Morris DL, Markham SJ, Beechey A, et al, "Ranitidine-Bolus or Infusion Prophylaxis for Stress Ulcer," Crit Care Med, 1988, 16(3):229-32.

Ohsawa T, Masuhara K, and Hirata W, "Reversal of Ranitidine-Induced Hypergastrinemia by Cimetidine," Ann Pharmacother, 1994, 28(11):1303.

Roberts CJ, "Clinical Pharmacokinetics of Ranitidine," Clin Pharmacokinet, 1984, 9(3):211-21.

Romaguera C, Grimalt F, and Vilaplana J, "Epidemic of Occupational Contact Dermatitis From Ranitidine," Contact Dermatitis, 1988, 18(3):177-8.

Souza Lima MA, "Hepatitis Associated With Ranitidine," Ann Intern Med, 1984, 101(2):207-8.

Todd P, Norris P, Hawk JL, et al, "Ranitidine-Induced Photosensitivity," Clin Exp Dermatol, 1995, 20(2):146-8.