Epoprostenol Sodium

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Overview

What is Epoprostenol Sodium?

Epoprostenol sodium for injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of epoprostenol sodium for injection contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol, 3.76 mg glycine, 2.93 mg sodium chloride, and 50 mg mannitol. Sodium hydroxide may have been added to adjust pH.

Epoprostenol (PGI, PGX, prostacyclin), a metabolite of arachidonic acid, is a naturally occurring prostaglandin with potent vasodilatory activity and inhibitory activity of platelet aggregation.

Epoprostenol is (5Z,9α,11α,13,15)-6,9-epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid.

Epoprostenol sodium has a molecular weight of 374.45 and a molecular formula of CHNaO. The structural formula is:

Epoprostenol sodium for injection is a white to off-white powder that must be reconstituted with STERILE DILUENT for epoprostenol sodium for injection. STERILE DILUENT for epoprostenol sodium for injection is supplied in glass vials containing 50 mL of 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust pH), and Water for Injection, USP.

The reconstituted solution of epoprostenol sodium for injection has a pH of 11.0 to 11.8 and is increasingly unstable at a lower pH.

What does Epoprostenol Sodium look like?

What are the available doses of Epoprostenol Sodium?

For injection: 0.5 mg or 1.5 mg epoprostenol freeze-dried powder in a single dose vial for reconstitution with the supplied diluent. ()

What should I talk to my health care provider before I take Epoprostenol Sodium?

How should I use Epoprostenol Sodium?

Epoprostenol sodium for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%).

Each vial is for single dose only; discard any unused diluent or unused reconstituted solution.

Select a concentration for the solution of epoprostenol sodium for injection that is compatible with the infusion pump being used with respect to minimum and maximum flow rates, reservoir capacity, and the infusion pump criteria listed below .

Using aseptic technique, reconstitute epoprostenol sodium for injection only with STERILE DILUENT for epoprostenol sodium for injection. Table 1 gives directions for preparing several different concentrations of epoprostenol sodium for injection. See Table 2 for storage and administration time limits for the reconstituted epoprostenol sodium for injection.

What interacts with Epoprostenol Sodium?

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What are the warnings of Epoprostenol Sodium?

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What are the precautions of Epoprostenol Sodium?

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What are the side effects of Epoprostenol Sodium?

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What should I look out for while using Epoprostenol Sodium?

Epoprostenol is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction .

Epoprostenol is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients.

What might happen if I take too much Epoprostenol Sodium?

Signs and Symptoms

Hypoxemia, hypotension, and respiratory arrest leading to death have been reported in clinical practice following overdosage of epoprostenol.

Excessive doses of epoprostenol were associated with flushing, headache, hypotension, tachycardia, nausea, vomiting, and diarrhea during clinical trials.

One patient with PAH/SSD accidentally received 50 mL of an unspecified concentration of epoprostenol. The patient vomited and became unconscious with an initially unrecordable blood pressure. Epoprostenol was discontinued and the patient regained consciousness within seconds.

Single intravenous doses of epoprostenol at 10 and 50 mg/kg (2,703 and 27,027 times the recommended acute phase human dose based on body surface area) were lethal to mice and rats, respectively. Symptoms of acute toxicity were hypoactivity, ataxia, loss of righting reflex, deep slow breathing, and hypothermia.

Treatment

Discontinue or reduce dose of epoprostenol.

How should I store and handle Epoprostenol Sodium?

Store at 20º - 25° C (68º - 77º F).Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Clorazepate Dipotassium Tablets, USP are available as tablets containing 15 mg of clorazepate dipotassium, USP.The 15 mg tablets are white round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows: bottles of 3, 6, 10 and 12 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Epoprostenol has 2 major pharmacological actions: (1) direct vasodilation of pulmonary and systemic arterial vascular beds, and (2) inhibition of platelet aggregation.

Non-Clinical Toxicology

Epoprostenol is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction .

Epoprostenol is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients.

With potassium supplements and potassium-sparing diuretics:

With lithium:

With antacids:

Gold:

Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors):

The antihypertensive effect of ACE inhibitors, including fosinopril may be attenuated by NSAIDs.

Agents that inhibit mTOR:

Dual Blockade of the Renin-Angiotensin System (RAS):

Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid use of aliskiren with fosinopril in patients with renal impairment (GFR <60 ml/min).

Other:

In a pharmacokinetic interaction study with warfarin, bioavailability parameters, the degree of protein binding, and the anticoagulant effect (measured by prothrombin time) of warfarin were not significantly changed.

If the patient develops pulmonary edema during initiation with epoprostenol, discontinue therapy and do not readminister. Consider the possibility of associated pulmonary veno-occlusive disease in such patients.

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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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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

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