Ranitidine Hcl (ranitidine HCl)

Although USP currently states that potency of ranitidine hydrochloride preparations should be expressed both in terms of the salt and the base (''active moiety''), dosage currently is expressed in terms of the base.

Because geriatric patients are more likely to have decreased renal function, caution should be exercised in dosage selection, and it may be useful to monitor renal function. (See Cautions: Geriatric Precautions.)

In patients with creatinine clearances less than 50 mL/minute, the manufacturer recommends an oral ranitidine dosage of 150 mg once every 24 hours and an IM or IV (intermittent slow infusion or direct injection) dosage of 50 mg every 18-24 hours; the administration of ranitidine as a continuous IV infusion has not been evaluated in patients with impaired renal function. Dosage intervals may be decreased cautiously from every 24 hours to every 12 hours or less, if necessary. Because hemodialysis reduces serum ranitidine concentrations, the dosage regimen should be adjusted so that a scheduled dose of ranitidine is administered at the end of dialysis.

Ranitidine hydrochloride usually is administered orally. The drug also may be given by IM or slow IV injection or by intermittent or continuous slow IV infusion in hospitalized patients with pathologic hypersecretory conditions or intractable duodenal ulcer, or when oral therapy is not feasible. In addition, ranitidine hydrochloride may be given by intermittent slow IV injection or intermittent infusion for the treatment of duodenal ulcer in children 1 month to 16 years of age, and by intermittent slow IV injection, intermittent infusion, or continuous slow IV infusion to decrease gastric pH in neonates younger than 1 month of age receiving extracorporeal membrane oxygenation (ECMO). Because of the risk of inducing bradycardia , the recommended rates of IV administration should not be exceeded. Antacids may be administered concomitantly as necessary for relief of pain.

The 1-g pharmacy bulk package of ranitidine hydrochloride is not intended for direct IV infusion; doses of the drug from the bulk package must be further diluted in a compatible IV solution prior to administration.

Ranitidine hydrochloride 150 and 300 mg tablets should be stored at 15-30degreesC in tight, light-resistant containers in a dry place; the cap should be replaced securely each time the container is opened. Ranitidine hydrochloride tablets for self-medication should be stored at 20-25degreesC. The oral solution should be stored in a tight, light-resistant container at 4-25degreesC. USP states that the oral solution should be stored below 25degreesC and freezing should be avoided. The individually foil-packaged effervescent tablets should be stored at 2-30degreesC. Ranitidine hydrochloride injection should be stored at a temperature of 4-25degreesC and protected from light but may be exposed to temperatures up to 30degreesC. Commercially available ranitidine injection in 0.45% sodium chloride should be stored at 2-25degreesC and protected from light. Brief exposure to temperatures up to 40degreesC will not adversely affect stability of the injections, but freezing should be avoided; in addition, darkening of the undiluted injection will not affect potency.

Ranitidine hydrochloride injection is stable for up to 48 hours at room temperature when added to or diluted with most IV solutions (e.g., 0.9% sodium chloride, 5 or 10% dextrose, lactated Ringer's, 5% sodium bicarbonate). The commercially available IV infusion solution of the drug in 0.45% sodium chloride is provided in containers fabricated from a specially formulated, nonplasticized, thermoplastic copolyester (CR3). Water can permeate from inside the container into the overwrap in amounts insufficient to substantially affect the solution. Solutions in contact with the plastic can leach out some of its chemical components in very small amounts within the expiration period of the injection; however, safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers. Additives should not be introduced into the injection container of the commercially available diluted solution of the drug. The commercially available IV infusion solution of the drug in 0.45% sodium chloride is stable through the expiration date noted on the container when stored as recommended. When the pharmacy bulk package is used, infusion solutions of ranitidine hydrochloride should be prepared within 24 hours after the vial is first entered; any drug remaining in the bulk package after this period should be discarded.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rats and rabbits using oral ranitidine dosages up to 160 times the usual human oral dosage have not revealed evidence of harm to the fetus. There are no adequate and controlled studies to date using ranitidine in pregnant women, and the drug should be used during pregnancy only when clearly needed. Women who are pregnant or nursing should seek the advice of a health professional before using ranitidine for self-medication.

Since ranitidine is distributed into milk, the drug should be used with caution in nursing women.

No enhanced messaging available.