Ziconotide (Prialt)

Trade Name : Prialt

Jazz Pharmaceuticals, Inc.

INJECTION, SOLUTION

Strength 100 ug/mL

ZICONOTIDE ACETATE N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC]

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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 Ziconotide (Prialt) which is also known as Prialt and Manufactured by Jazz Pharmaceuticals, Inc.. It is available in strength of 100 ug/mL per ml. Read more

Ziconotide (Prialt) 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

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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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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
  • PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.
  • WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS
  • See full prescribing information for complete boxed warning
  • Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Do not treat patients with a pre-existing history of psychosis with PRIALT
  • PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.
  • PRIALT (ziconotide) solution, intrathecal infusion is an N-type calcium channel antagonist indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. ()
  • PRIALT is a non-opioid and non-NSAID analgesic agent used for the management of severe and chronic pain. Administer PRIALT intrathecally by or under the direction of a physician experienced in the technique of intrathecal administration and who is familiar with the drug and device labeling. ()
  • PRIALT (ziconotide) solution, intrathecal infusion is supplied as a 25 mcg/mL concentration in single-use 20 mL glass vials and as a 100 mcg/mL concentration in single-use glass vials containing 1 mL or 5 mL of solution.
  • Intrathecal solution ():
  • No data
  • No data
  • u00a0The most frequently reported adverse reactions (u2265 25%) in clinical trials were dizziness, nausea, confusional state, nystagmus ()
  • u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at (800) 890-3098 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Formal PK drug-drug interaction studies have not been performed with PRIALT. As ziconotide is a peptide, it is expected to be completely degraded by endopeptidases and exopeptidases (Phase I hydrolytic enzymes) widely located throughout the body, and not by other Phase I biotransformation processes (including the cytochrome P450 system) or by Phase II conjugation reactions. Thus, intrathecal administration, low plasma ziconotide concentrations, and metabolism by ubiquitous peptidases make metabolic interactions of other drugs with ziconotide unlikely. Further, as ziconotide is not highly bound in plasma (approximately 50%) and has low plasma exposure following intrathecal administration, clinically relevant plasma protein displacement reactions involving ziconotide and co-administered medications are unlikely.
  • Over 90% of patients treated with intrathecal PRIALT used systemic opiates and in the slow titration study, 98% of patients received opioids.
  • The combination of PRIALT with intrathecal opiates has not been studied in placebo-controlled clinical trials and is not recommended.
  • Almost all patients in the PRIALT clinical trials received concomitant non-intrathecal medication. Most patients received several concomitant drugs, including antidepressants (66%), anxiolytics (52%), antiepileptics (47%), neuroleptics (46%), and sedatives (34%). The use of drugs with CNS-depressant activities may be associated with an increased incidence of CNS adverse reactions such as dizziness and confusion [].
  • Pregnancy:
  • Nursing Mothers:
  • Pediatric Use:
  • Geriatric Use:
  • The maximum recommended intrathecal PRIALT dose is 19.2 mcg/day. The maximum intrathecal dose of PRIALT in clinical trials was 912 mcg/day. In some patients who received intrathecal doses greater than the maximum recommended dose, exaggerated pharmacological effects (e.g., ataxia, nystagmus, dizziness, stupor, unresponsiveness, spinal myoclonus, confusion, sedation, hypotension, word-finding difficulties, garbled speech, nausea, and vomiting) were observed. There was no indication of respiratory depression. Overdoses may occur due to pump programming errors or incorrect drug concentration preparations. In these cases, patients were observed and ziconotide was either temporarily discontinued or permanently withdrawn. Most patients recovered within 24 hours after withdrawal of drug. In the event of an overdose, elimination of ziconotide from CSF would be expected to remain constant (CSF t=4.6u00a0hours). Therefore, within 24 hours of stopping therapy, the ziconotide CSF concentration should be less than 5% of peak levels.
  • There is no known antidote to ziconotide. General medical supportive measures should be administered to patients who receive an overdose until the exaggerated pharmacological effects of the drug have resolved. Treatment for an overdose is hospitalization, when needed, and symptom-related supportive care. Ziconotide does not bind to opiate receptors and its pharmacological effects are not blocked by opioid antagonists.
  • In the event of an inadvertent intravenous or epidural administration, adverse reactions could include severe hypotension, which can be treated with a recumbent posture and blood pressure support as required. The half-life of PRIALT in serum is 1.3 hours.
  • PRIALT contains ziconotide, a synthetic equivalent of a naturally occurring conopeptide found in the piscivorous marine snail, Ziconotide is a 25u00a0amino acid, polybasic peptide containing three disulfide bridges with a molecular weight of 2639u00a0daltons and a molecular formula of CHNOS. Theu00a0amino acid sequence and disulfide bridging pattern are given below:
  • Ziconotide is a hydrophilic molecule that is freely soluble in water and is practically insoluble in methyl t-butyl ether.
  • PRIALT is formulated as a sterile, preservative-free, isotonic solution for intrathecal administration using an appropriate microinfusion device []. Each 1 or 5 mL vial of PRIALT (100 mcg/mL) respectively contains 100 or 500 mcg of ziconotide acetate, and the 20 mL vial of PRIALT (25 mcg/mL) contains 500 mcg of ziconotide acetate, with L-methionine and sodium chloride as excipients at pH 4.0u20135.0. Each vial is intended for single use only, either undiluted or after dilution to the appropriate concentration with 0.9% Sodium Chloride Injection, USP (preservative free).
  • No data
  • No carcinogenicity studies have been conducted in animals.
  • Ziconotide was negative in the in vitro bacterial reverse mutation assay, in vitro mouse lymphoma assay, in vivo mouse micronucleus assay, and in the in vitro Syrian hamster embryo (SHE) cell transformation assay.
  • Ziconotide did not affect male fertility in rats when administered as a continuous intravenous infusion at a dose of up to 10 mg/kg/day when administered for approximately 8 weeks, including a 28-day pre-mating period, or female fertility at a dose of 3 mg/kg/day when administered for approximately 6 weeks, including a 14-day pre-mating period. Estimated exposures for the male and female rats were approximately 6500-fold and 1700-fold higher, respectively, than the expected exposure resulting from the maximum recommended human daily intrathecal dose of 0.8 mcg/hr (19.2 mcg/day) based on plasma exposure.
  • Female fertility in rats was significantly affected following continuous intravenous infusion at a dose of 10 mg/kg/day. Significant reductions in corpora lutea, implantation sites, and number of live fetuses were observed.
  • The efficacy of intrathecal PRIALT in the management of severe chronic pain was studied in three double-blind, placebo-controlled, multicenter studies in a total of 457 patients (268u00a0PRIALT, 189 placebo) using two different titration schedules. The slow titration schedule tested dose increases 2 to 3 times per week with a maximum dose of 19.2 mcg/day (0.8 mcg/hr) at 21 days. The fast titration schedule used daily increases up to a maximum dose of 57.6u00a0mcg/day (2.4 mcg/hr) in 5 to 6 days but resulted in less tolerability and substantially more frequent adverse events.
  • A randomized, double-blind, placebo-controlled study of PRIALT was conducted in adult patients with severe chronic pain not adequately controlled with intrathecally delivered analgesics including morphine, bupivacaine and/or clonidine; or who were intolerant to analgesics and/or systemic analgesics using the 21-day slow titration schedule. All prior intrathecal medications were discontinued over a one to three week period, and patients were maintained on a stable regimen of non-intrathecal analgesics, including opiates, for at least 7u00a0days prior to randomization. Dosing with PRIALT was started at 2.4 mcg/day (0.1 mcg/hr) and the dose was increased by 2.4 mcg/day (0.1 mcg/hr) two to three times/week (minimum titration interval 24 hours) to a maximum dose of 19.2 mcg/day (0.8 mcg/hr) as needed for management of pain. The final mean dose at the end of the trial at 21 days was 6.9 mcg/day (0.29 mcg/hr).
  • Using a 100 mm Visual Analog Scale of Pain Intensity (VASPI) where 100 mm represented the worst possible pain, mean baseline pain scores were 81 in both the PRIALT and placebo groups. The primary efficacy variable was the mean percent change in the VASPI score from baseline to day 21. In the intent-to-treat efficacy analysis, there was a statistically significant difference between groups in the mean percent change in VASPI score from baseline with the PRIALT group having a 12% mean improvement at Week 3 compared to a 5% mean improvement in the placebo group. The 95% confidence interval for the treatment difference (PRIALTu2013placebo) was 0.4%, 13%.
  • The effect of intrathecal PRIALT on pain was variable over the time period of treatment for some patients. Patients exhibited various degrees of improvement in pain after three weeks of treatment compared with baseline pain assessment. Figure 1 depicts the fraction of patients by their degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 30%, are also included at every level of improvement below 30%. Patients who did not have a VASPI score recorded at Week 3 (Study days 17u201323, inclusive) were assigned 0% improvement. The improvement in the proportion of u201cresponders,u201d defined as having a u2265 30% improvement from baseline in VASPI, was 16% in the PRIALT group compared to 12% in the placebo group, for a net difference of 4%. The use of non-intrathecal opioids decreased by 24% in the PRIALT group and by 17% in the placebo group.
  • Figure 1: Patients Achieving Various Levels of Pain Relief from Baseline to Week 3
  • No data
  • For use only in the Medtronic SynchroMed II Infusion System and CADD-Micro Ambulatory Infusion Pump.
  • Distributed by:
  • Jazz Pharmaceuticals, Inc.Palo Alto, CA 94304
  • u00a9 2013 Jazz Pharmaceuticals
  • PRIALT is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries
  • SynchroMed is a registered trademark of Medtronic, Inc.
  • U.S. Patent Nos. 5,364,842; 5,795,864; and 5,891,849
  • Carton - 20 mL
  • u00a0
  • NDC 18860-723-10
  • Principal Display Panel
  • Rx ONLYu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a020 mL
  • Arrayn- Prialt
  • For Intrathecal Infusion Only with a Microinfusion Pump
  • 500 mcg/20 mL
  • For pump priming, initial & maintenance dosing
  • Sterile Solution Preservative-Free
  • Left Side Panel
  • 500 mcg/20 mL
  • Arrayn- Prialt
  • NDC 18860-723-10
  • Store under refrigeration2-8u00b0C (36-46u00b0F) Protect from light
  • DO NOT FREEZE
  • Each 1 mL of Prialt contains25 mcg ziconotide acetate in an aqueous isotonic vehiclecontaining 9.0 mg sodiumchloride and 0.05 mg L-meth-ionine buffered with sodiumhydroxide/hydrochloric acid toan approximate pH of 4.5 u00b1 0.5.
  • See package insertfor full prescribinginformation.
  • Sterile SolutionPreservative-Free
  • For IntrathecalInfusion Only with aMicroinfusion Pump
  • Right Side Panel
  • 500 mcg/20 mL
  • Arrayn- Prialt
  • For use in the MedtronicSynchroMed EL,SynchroMed II InfusionSystem, and CADD-MicroExternal MicroinfusionDevice and Catheter
  • See package insertfor full prescribinginformation.
  • Sterile SolutionPreservative-Free
  • SynchroMed is a registeredtrademark of Medtronic, Inc.
  • PRIALT is a registered trademark ofJazz Pharmaceuticals plc or its subsidiaries
  • u00a9 2013 Jazz Pharmaceuticals
  • International Limited
  • Back Panel
  • 500 mcg/20 mL
  • See bottom panelfor Lot Number and Expiration Date.
  • Distributed by Jazz Pharmaceuticals, Inc.Palo Alto, CA 94304
  • Carton - 20 mL - Sample
  • u00a0
  • NDC 18860-723-05
  • Principal Display Panel
  • Rx ONLYu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a020 mL
  • PROFESSIONAL SAMPLE NOT FOR SALE
  • Arrayn- Prialt
  • For Intrathecal Infusion Only with a Microinfusion Pump
  • 500 mcg/20 mL
  • For pump priming, initial & maintenance dosing
  • Sterile Solution Preservative-Free
  • Carton - 1 mL
  • u00a0
  • NDC 18860-720-10
  • Principal Display Panel
  • Rx ONLYu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01 mL
  • Arrayn- Prialt
  • For Intrathecal Infusion Only with a Microinfusion Pump
  • 100 mcg/1 mL
  • DO NOT USE for pump priming
  • Sterile Solution Preservative-Free
  • Carton - 5 mL
  • u00a0
  • NDC 18860-722-10
  • Principal Display Panel
  • Rx ONLYu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05 mL
  • Arrayn- Prialt
  • For Intrathecal Infusion Only with a Microinfusion Pump
  • 500 mcg/5 mL
  • DO NOT USE for pump priming
  • Sterile Solution Preservative-Free

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