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Epoprostenol Sodium (Flolan)

Trade Name : FLOLAN

GlaxoSmithKline LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 0.5 mg/1

EPOPROSTENOL SODIUM Prostacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]

Delivery Process

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Epoprostenol Sodium (Flolan) which is also known as FLOLAN and Manufactured by GlaxoSmithKline LLC. It is available in strength of 0.5 mg/1 per ml. Read more

Epoprostenol Sodium (Flolan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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%).
  • FLOLAN is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Studies establishing effectiveness included predominantly (97%) patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). ()
  • No data
  • 2.2n- 2.3
  • 2.2n- 5.2
  • For injection: 0.5 mg or 1.5 mg of epoprostenol, freeze-dried powder in a single-dose vial for reconstitution with the supplied diluent.
  • For injection: 0.5 mg or 1.5 mg of epoprostenol freeze-dried powder in a single-dose vial for reconstitution with the supplied diluent. ()
  • 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.
  • No data
  • The most common adverse reactions are dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting, and are generally associated with vasodilation. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or n
  • No data
  • 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 50u00a0mg/kg (2,703 and 27,027u00a0times 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.
  • 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 0.5u00a0mg (500,000u00a0ng) or 1.5u00a0mg (1,500,000u00a0ng) epoprostenol, 3.76u00a0mg glycine, 50u00a0mg mannitol, and 2.93u00a0mg 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,9u03b1,11u03b1,13,15)-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 50u00a0mL of 94u00a0mg glycine, 73.3u00a0mg 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.
  • No data
  • Longu2011term studies in animals have not been performed to evaluate carcinogenic potential. A micronucleus test in rats revealed no evidence of mutagenicity. The Ames test and DNA elution tests were also negative, although the instability of epoprostenol makes the significance of these tests uncertain.
  • In a fertility/postnatal development study, epoprostenol sodium was administered subcutaneously to female rats for 2 weeks prior to mating through weaning and to male rats for 60 days prior to and through mating at an adult toxic dose of up to 100 mcg/kg/day (600 mcg/m/day, 2.5 times the MRHD based on body surface area). There was no effect on fertility in female or male rats.
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Advise patients:
  • Trademark is owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • FLL:9PI
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0517-00
  • Arrayn- FLOLANn
  • Arrayn- (epoprostenol sodium)
  • Arrayn- for Injection
  • Arrayn- 0.5 mg/vial (500,000 ng/vial)
  • Must be reconstituted. For intravenous infusion after dilution.
  • Note: Use only STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN for reconstitution and dilution.
  • R only
  • Single-Use Vial
  • Each vial contains epoprostenol sodium equivalent to 0.5 mg (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.
  • Usual Dose:
  • Store at 15 and 25 C (59 to 77F).
  • Do not accept if plastic overseal is missing or not securely fitted.
  • GlaxoSmithKline
  • RTP, NC 27709
  • Rev. 4/16
  • 10000000140666
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0519-00
  • Arrayn- FLOLANn
  • Arrayn- (epoprostenol sodium)
  • Arrayn- for Injection
  • Arrayn- 1.5 mg/vial (1,500,000 ng/vial)
  • Must be reconstituted. For intravenous infusion after dilution.
  • Note: Use only STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN for reconstitution and dilution.
  • R only
  • Single-Use Vial
  • Each vial contains epoprostenol sodium equivalent to 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.
  • Usual Dose:
  • Store at 15 and 25 C (59 to 77F).
  • Do not accept if plastic overseal is missing or not securely fitted.
  • GlaxoSmithKline
  • RTP, NC 27709
  • Rev. 4/16
  • 10000000140667
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0518-00
  • Arrayn- STERILE DILUENT for FLOLANn
  • Contains drug diluent for use only with FLOLAN (epoprostenol sodium) for Injection.
  • Each vial contains 94 mg Glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust Ph), AND Water for Injection, USP.
  • For reconstitution information see package insert for FLOLAN (epoprostenol sodium) for Injection.
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F).
  • DO NOT FREEZE.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in England
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0857-02
  • Arrayn- pH 12 Sterile Diluent for FLOLANn
  • Use only with FLOLAN (epoprostenol sodium) for Injection
  • Single-Use Vial.
  • Discard Unused Portion
  • 50 Ml
  • Rx only
  • For reconstitution information see package insert for FLOLAN (epoprostenol sodium) for Injection.
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F).
  • DO NOT FREEZE.
  • Do not accept if plastic overseal is missing or not securely fitted.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in England

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