VAPRISOL DEXTROSE IN PLASTIC CONTAINER

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Overview

What is VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

Conivaptan hydrochloride is chemically [1,1'-biphenyl]-2-carboxamide, -[4-[(4,5-dihydro-2-methylimidazo[4,5-][1]benzazepin-6(1)-yl)carbonyl]phenyl]-, monohydrochloride, having a molecular weight of 535.04 and molecular formula CHNO∙HCl. The structural formula of conivaptan hydrochloride is:

Conivaptan hydrochloride is a white to off-white or pale orange-white powder that is very slightly soluble in water (0.15 mg/mL at 23° C). Conivaptan hydrochloride injection is supplied as a sterile premixed solution with dextrose in a flexible plastic container.

Each container contains a clear, colorless, sterile, non-pyrogenic solution of conivaptan hydrochloride in dextrose injection for intravenous use. Each 100 mL, single-use premixed INTRAVIA Container contains 20 mg of conivaptan hydrochloride and 5 g of Dextrose Hydrous, USP. Lactic Acid, USP is added for pH adjustment to pH 3.4 to 3.8. The flexible plastic container is fabricated from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain of the chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to affect the premixed solution significantly.

What does VAPRISOL DEXTROSE IN PLASTIC CONTAINER look like?

What are the available doses of VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

Intravenous injection solution: conivaptan hydrochloride 20 mg/100 mL premixed in 5% Dextrose in flexible plastic containers.

What should I talk to my health care provider before I take VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

How should I use VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

VAPRISOL is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.

VAPRISOL is for intravenous use only.

VAPRISOL is for use in hospitalized patients only.

Administer VAPRISOL through large veins and change of the infusion site every 24 hours to minimize the risk of vascular irritation .

Initiate with a loading dose of 20 mg VAPRISOL administered intravenously over 30 minutes.

Follow the loading dose with 20 mg VAPRISOL administered in a continuous intravenous infusion over 24 hours. After the initial day of treatment, administer VAPRISOL for an additional 1 to 3 days in a continuous infusion of 20 mg/day. If serum sodium is not rising at the desired rate, VAPRISOL may be titrated upward to a maximum dose of 40 mg daily, administered in a continuous intravenous infusion over 24 hours.

The total duration of infusion of VAPRISOL (after the loading dose) should not exceed four days.

Patients receiving VAPRISOL must have frequent monitoring of serum sodium and volume status .

What interacts with VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

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What are the warnings of VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

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What are the precautions of VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

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What are the side effects of VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

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What should I look out for while using VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

Hypovolemic hyponatremia ().

Coadministration with potent CYP3A inhibitors (, , ).

Anuria: no benefit can be expected ().

What might happen if I take too much VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

Although no data on overdosage in humans are available, VAPRISOL has been administered as a 20 mg loading dose on Day 1 followed by continuous infusion of 80 mg/day for 4 days in hyponatremia patients and up to 120 mg/day for 2 days in CHF patients. No new toxicities were identified at these higher doses, but adverse events related to the pharmacologic activity of VAPRISOL, e.g. hypotension and thirst, occurred more frequently at these higher doses.

In case of overdose, based on expected exaggerated pharmacological activity, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is recommended.

How should I store and handle VAPRISOL DEXTROSE IN PLASTIC CONTAINER?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.VAPRISOL (conivaptan hydrochloride) Injection is supplied as a single-use, premixed solution, containing 20 mg of conivaptan hydrochloride in 5% Dextrose in 100 mL INTRAVIA Plastic Containers. VAPRISOL in INTRAVIA Plastic Containers should be stored at 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light until ready to use. VAPRISOL (conivaptan hydrochloride) Injection is supplied as a single-use, premixed solution, containing 20 mg of conivaptan hydrochloride in 5% Dextrose in 100 mL INTRAVIA Plastic Containers. VAPRISOL in INTRAVIA Plastic Containers should be stored at 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light until ready to use.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Conivaptan hydrochloride is a dual arginine vasopressin (AVP) antagonist with nanomolar affinity for human V and V receptors in vitro. The level of AVP in circulating blood is critical for the regulation of water and electrolyte balance and is usually elevated in both euvolemic and hypervolemic hyponatremia. The AVP effect is mediated through V receptors, which are functionally coupled to aquaporin channels in the apical membrane of the collecting ducts of the kidney. These receptors help to maintain plasma osmolality within the normal range. The predominant pharmacodynamic effect of conivaptan hydrochloride in the treatment of hyponatremia is through its V antagonism of AVP in the renal collecting ducts, an effect that results in aquaresis, or excretion of free water.

Non-Clinical Toxicology

Hypovolemic hyponatremia ().

Coadministration with potent CYP3A inhibitors (, , ).

Anuria: no benefit can be expected ().

Flecainide acetate has been administered to patients receiving preparations or without adverse effects. During administration of multiple oral doses of flecainide acetate to healthy subjects stabilized on a maintenance dose of , a 13% to 19% increase in plasma levels occurred at six hours postdose.

In a study involving healthy subjects receiving flecainide acetate and concurrently, plasma flecainide levels were increased about 20% and levels were increased about 30% compared to control values. In this formal interaction study, flecainide acetate and were each found to have negative inotropic effects; when the drugs were administered together, the effects were additive. The effects of concomitant administration of flecainide acetate and on the PR interval were less than additive. In flecainide acetate clinical trials, patients who were receiving concurrently did not experience an increased incidence of side effects. Nevertheless, the possibility of additive negative inotropic effects of and flecainide should be recognized.

Flecainide is not extensively bound to plasma proteins. studies with several drugs which may be administered concomitantly showed that the extent of flecainide binding to human plasma proteins is either unchanged or only slightly less. Consequently, interactions with other drugs which are highly protein bound (e.g., ) would not be expected. Flecainide acetate has been used in a large number of patients receiving without apparent interaction. Limited data in patients receiving known enzyme inducers (, , ) indicate only a 30% increase in the rate of flecainide elimination. In healthy subjects receiving (1 gm daily) for one week, plasma flecainide levels increased by about 30% and half-life increased by about 10%.

When is added to flecainide therapy, plasma flecainide levels may increase two-fold or more in some patients, if flecainide dosage is not reduced. (See).

Drugs that inhibit cytochrome P450IID6, such as , might increase the plasma concentrations of flecainide in patients that are on chronic flecainide therapy; especially if these patients are extensive metabolizers.

There has been little experience with the coadministration of flecainide acetate and either or . Because both of these drugs have negative inotropic properties and the effects of coadministration with flecainide acetate are unknown, neither nor should be administered concurrently with flecainide unless, in the judgment of the physician, the benefits of this combination outweigh the risks. There has been too little experience with the coadministration of flecainide acetate with or to recommend concomitant use.

The amount of safety data on the use of VAPRISOL in patients with hypervolemic hyponatremia associated with heart failure is limited. VAPRISOL should be used to raise serum sodium in such patients only after consideration of other treatment options .

The following adverse reactions are discussed elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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