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FLOLAN

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Overview

What is FLOLAN?

FLOLAN (epoprostenol sodium) for injection is sterile sodium salt that is a white or off-white powder formulated for intravenous (IV) administration. Each vial of FLOLAN 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, 50 mg mannitol, and 2.93 mg sodium chloride. 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. The chemical name of 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:

FLOLAN must be reconstituted with either STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN.

STERILE DILUENT for FLOLAN is supplied in glass vials and pH 12 STERILE DILUENT for FLOLAN is supplied in plastic vials each containing 50 mL of 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust pH), and Water for Injection. The stability of reconstituted solutions of FLOLAN is pH-dependent, and is greater at higher pH.



What does FLOLAN look like?



What are the available doses of FLOLAN?

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

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

How should I use FLOLAN?

FLOLAN 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 use only; discard any unused diluent or unused reconstituted solution.

Select a concentration for the solution of FLOLAN 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 FLOLAN only with STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN. Table 1 gives directions for preparing several different concentrations of FLOLAN. See Table 2 for storage and administration time limits for the reconstituted FLOLAN.


What interacts with FLOLAN?

Sorry No Records found


What are the warnings of FLOLAN?

Sorry No Records found


What are the precautions of FLOLAN?

Sorry No Records found


What are the side effects of FLOLAN?

Sorry No records found


What should I look out for while using FLOLAN?

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

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


What might happen if I take too much FLOLAN?

Signs and Symptoms

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

Excessive doses of FLOLAN 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 FLOLAN. The patient vomited and became unconscious with an initially unrecordable blood pressure. FLOLAN was discontinued and the patient regained consciousness within seconds.

Single intravenous doses of FLOLAN 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 FLOLAN.


How should I store and handle FLOLAN?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60)Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Manufactured for Distributed By:Major Pharmaceuticals17177 N Laurel Park Dr., Suite 233Livonia, MI 48152REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBERRev 03/17210082


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Clinical Information

Chemical Structure

No Image found
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
FLOLAN is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction .

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

Drug Interactions:





Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see ).

Should lidocaine and prilocaine cream, 2.5%/2.5% be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

If the patient develops pulmonary edema during initiation with FLOLAN, 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

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Interactions

Interactions

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