Brand Names:

• Vaprisol

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Cardiovascular Agent

Uses of This Medicine:

Conivaptan is used to treat euvolemic hyponatremia (a condition where there is not enough sodium in your blood but with a normal blood volume). Sodium is a chemical that the body needs to be able to function well. Even if there is a normal blood volume, but with a low sodium level, it can still be a danger to your health. Conivaptan works by maintaining the right amount of sodium that the body needs .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of conivaptan in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of conivaptan in the elderly .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clarithromycin
• Indinavir
• Itraconazole
• Ketoconazole
• Ritonavir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypovolemic hyponatremia (low blood sodium with low blood volume)—This medicine should NOT be used in patients with this condition .

• Heart disease (e.g., congestive heart failure)—Use with caution. This medicine may make the condition worse .

• Liver disease or
• Kidney disease—Use with caution. These conditions may increase the concentration of conivaptan in your blood .

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. Make sure that the infusion site be changed every 24 hours to prevent irritation. If you still have the needle placed on the same site after 24 hours, tell your doctor or nurse .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For treatment of euvolemic hyponatremia:
    • Adults—At first, 20 milligrams (mg) administered over 30 minutes. Then, another 20 mg infused continuously for 24 hours. After the initial day of treatment, conivaptan may be given for another 1 to 3 days in a continuous infusion of 20 mg per day. All doses of conivaptan are diluted prior to injection into a vein. Your doctor may increase the dose if needed.
    • Children—Use and dose must be determined by your doctor .

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it .

If your symptoms do not improve within a few days or if they become worse, check with your doctor .

You should not use any of the following medicines while you are using conivaptan :

• Clarithromycin (e.g., Biaxin®).
• Indinavir (e.g., Crixivan®).
• Itraconazole (e.g., Sporanox®).
• Ketoconazole (e.g., Nizoral®).
• Ritonavir (e.g., Norvir®) .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More Common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

bloating or swelling of face, arms, hands, lower legs, ankles, or feet

blurred vision

decreased urine

dizziness

dry mouth

headache

increased thirst

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

nervousness

numbness or tingling in hands, feet, or lips

pounding in the ears

rapid weight gain

seizures

shortness of breath

slow or fast heartbeat

tingling of hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Less Common

Abdominal pain

bladder pain

bloody or cloudy urine

bluish color

change in consciousness

changes in skin color

chest pain

cold sweats

confusion

cool pale skin

cough

decreased urination

depression

difficult, burning, or painful urination

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

drowsiness

fainting

fear

fever or chills

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

increase in amount of urine

increase in heart rate

increased hunger

increased urination

loss of consciousness

lower back or side pain

mental changes

muscle spasms [tetany] or twitching

nightmares

pale skin

problems in urination

rapid breathing

shakiness

sleeplessness

slurred speech

sneezing

sore mouth or tongue

sore throat

sunken eyes

sweating

swelling of foot or leg

tenderness

thirst

tightness in chest

trembling

trouble sleeping

troubled breathing with exertion

unable to sleep

unusual bleeding or bruising

wheezing

white patches in mouth and/or on tongue

wrinkled skin

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Diarrhea

Less Common

Difficulty having a bowel movement (stool)

flushing

redness of skin

unusually warm skin

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