R-Gene 10 (Intravenous)

Arginine injection is used to check how well the pituitary gland is working. It helps the pituitary gland produce growth hormone to diagnose certain conditions.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor monitor you closely to ensure that this medicine is working correctly and to look for any unwanted effects.

Your growth hormone levels usually rise when you are pregnant or taking birth control pills, which can influence the results of the test procedure. Talk to your doctor if you have any concerns about this before receiving this medicine.

In deciding to use a diagnostic test, you and your doctor must consider any risks of the test against the benefits it will provide. Other factors may also affect test results. For this test, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There is no information on whether the risk of arginine-induced side effects is higher in children. However, due to the potential toxicity of this medication, it should be used with great caution. Recommended doses must not be exceeded, and the patient should be closely monitored during treatment.

Geriatric

While appropriate studies on how age affects the effects of arginine injection have not been conducted in older adults, no specific problems related to older age have been documented so far.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all; however, in some cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. When receiving this diagnostic test, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their possible significance and are not necessarily all-inclusive.

It is generally not recommended to receive this diagnostic test with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amiloride
• Spironolactone
• Triamterene

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this diagnostic test. Be sure to inform your doctor if you have any other medical problems, especially:

• Electrolyte imbalance—This should be corrected first before receiving this medicine.

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

Check with your doctor or nurse right away if any of the following side effects occur:

Rare

• Redness or discoloration of the skin
• Swelling of the hands and face

Incidence not known

• Blood in the urine
• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Hives, itching, skin rash
• Pain or redness at the injection site
• Pale skin at the injection site
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Tightness in the chest
• Unusual tiredness or weakness

Get emergency help right away if you experience any of the following symptoms of overdose:

Symptoms of overdose

• Confusion
• Deep or fast breathing with dizziness
• Drowsiness
• Muscle tremors
• Numbness of the feet, hands, and around the mouth
• Rapid, deep breathing
• Restlessness
• Stomach cramps

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also have ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Headache
• Nausea
• Numbness
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• R-Gene 10

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Solution

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle must stay in place for at least 30 minutes.

The test is usually given in the morning, after at least 30 minutes of bed rest. You will be advised not to take any food or water the night before the test and during the test procedure. Care should be taken to lessen nervousness and distress, especially in children.

You may have to repeat this test 1 day after the results of the first one showed a deficiency in the function of your pituitary gland.