R-GENE® 10 (arginine HCl) | Pfizer Medical Information - US

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

R-GENE® 10 Quick Finder

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INDICATIONS AND USAGE

R-Gene® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can...

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DOSAGE AND ADMINISTRATION

Adult Dosage

The recommended adult dose is 30 g arginine hydrochloride (300 mL of R-Gene® 10) administered by...

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CONTRAINDICATIONS

The administration of R-Gene® 10 is contraindicated in persons having known hypersensitivity to any ingredient in this product.

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WARNINGS

There have been reports of overdosage of R-Gene® 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE® 10 INTO PEDIATRIC...

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ADVERSE REACTIONS

Adverse reactions associated with 1670 infusions in premarketing studies were as follows:

Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous...

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OVERDOSAGE

An overdosage may cause a transient metabolic acidosis with hyperventilation, which could lead to death (see "WARNINGS"). In most cases the acidosis will self-compensate and the base...

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DESCRIPTION

Each 100 mL of R-Gene® 10 (Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP (equivalent to a 10%...

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CLINICAL PHARMACOLOGY

Intravenous infusion of R-Gene® 10 often induces a pronounced rise in the plasma level of human growth hormone (HGH) in subjects with intact pituitary function. This rise is...

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HOW SUPPLIED

R-Gene® 10 is supplied as a 30 g/300 mL (0.1 g/mL) fill in 500 mL glass containers.

Preservative Free: Discard any unused portion.

NDC 0009-0436-01...

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For Intravenous Use

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Report Adverse Event

Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.