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LumaSon
Overview
What is LumaSon?
Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable
suspension, for intravenous or intravesical use is used to prepare
the ultrasound contrast agent. The single-patient use kit contains
the following three items:
1) one clear glass 10 mL vial containing 25 mg of lyophilized powder
lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with
a blue flip-cap
2) one
prefilled syringe containing 5 mL Sodium Chloride 0.9% Injection,
USP (Diluent)
3) one
Mini-Spike
Each vial
is formulated as a 25 mg sterile, pyrogen-free lyophilized powder
containing 24.56 mg of polyethylene glycol 4000, 0.19 mg of distearoylphosphatidyl-choline
(DSPC), 0.19 mg of dipalmitoylphosphatidylglycerol sodium (DPPG-Na)
and 0.04 mg of palmitic acid. The headspace of each vial contains
6.07 mg/mL (± 2 %) sulfur hexafluoride, SF, or 60.7 mg per vial.
Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride
Injection is sterile, nonpyrogenic, preservative free containing 9
mg sodium chloride per mL.
Upon reconstitution with 5mL diluent, Lumason is a milky white, homogeneous
suspension containing sulfur hexafluoride lipid-type A microspheres.
The suspension is isotonic and has a pH of 4.5 to 7.5.
The sulfur hexafluoride lipid
microspheres are composed of SF gas in the
core surrounded by an outer shell monolayer of phospholipids consisting
DSPC and DPPG-Na with palmitic acid as a stabilizer.
Sulfur hexafluoride has a molecular weight
of 145.9 and the following chemical structure:
1,2-Ditearoyl-glycero-3-phosphocholine
(DSPC), with empirical formula CHNOP, has a molecular weight
of 790.6 and the following chemical structure:
1,2-Dipalmitoyl--glycero-3-phospho--glycerol sodium
(DPPG-Na), with empirical formula CHNaOP, has a molecular weight
of 745 and the following chemical structure:
Each milliliter of reconstituted
Lumason suspension contains 1.5 to 5.6 x10 microspheres, 68 mcg SF (12 mcL), 0.038
mg DSPC, 0.038 mg DPPG-Na, 4.91 mg polyethylene glycol 4000 and 0.008
mg palmitic acid. The sulphur hexafluoride associated with the microspheres
suspension is 45 mcg/mL. Fifteen to twenty three percent of the total
lipids in the suspension are associated with the microspheres.
The sulfur hexafluoride lipid
microsphere characteristics are listed in Table 2:
What does LumaSon look like?
What are the available doses of LumaSon?
For injectable suspension: Lumason
is supplied as a 3-part single-patient use kit comprised of:
Following reconstitution,
Lumason is a homogeneous, milky white suspension containing1.5 to
5.6 x10 microspheres/mL with 45 mcg/mL
of sulfur hexafluoride.
What should I talk to my health care provider before I take LumaSon?
How should I use LumaSon?
Echocardiography
Lumason is indicated
for use in adult patients with suboptimal echocardiograms to opacify
the left ventricular chamber and to improve the delineation of the
left ventricular endocardial border.
Ultrasonography
of the Liver
Lumason is indicated for
use with ultrasound of the liver in adult and pediatric patients to
characterize focal liver lesions.
Ultrasonography
of the Urinary Tract
Lumason is indicated for
use in ultrasonography of the urinary tract in pediatric patients
for the evaluation of suspected or known vesicoureteral reflux.
Do not administer Lumason by intra-arterial
injection .
What interacts with LumaSon?
Sorry No Records found
What are the warnings of LumaSon?
Sorry No Records found
What are the precautions of LumaSon?
Sorry No Records found
What are the side effects of LumaSon?
Sorry No records found
What should I look out for while using LumaSon?
p77135301460167984
Lumason is contraindicated
in patients with:
p54194301460166158
Serious cardiopulmonary reactions, including fatalities, have occurred
uncommonly during or following the injection of ultrasound contrast
agents, including sulfur hexafluoride lipid microspheres . Most serious reactions occur within 30 minutes of administration .
What might happen if I take too much LumaSon?
Sorry No Records found
How should I store and handle LumaSon?
Store oxcarbazepine oral suspension, USP in the original container. Shake well before using.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Store oxcarbazepine oral suspension, USP in the original container. Shake well before using.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners. Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners. Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners. Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners. Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners. Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners. Gabapentin capsules, USP are supplied as follows:100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Brands listed are trademarks of their respective owners.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Within the blood, the acoustic impedance
of Lumason microspheres is lower than that of the surrounding non-aqueous
tissue. Therefore, an ultrasound beam is reflected from the interface
between the microspheres and the surrounding tissue. The reflected
ultrasound signal provides a visual image that shows a contrast between
the blood and the surrounding tissues.
For ultrasonography of
the urinary tract in pediatric patients, the intravesically administered
Lumason microspheres increase signal intensity of fluids within the
urethra, bladder, ureters, and renal pelvis.
Non-Clinical Toxicology
p77135301460167984Lumason is contraindicated in patients with:
p54194301460166158
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres . Most serious reactions occur within 30 minutes of administration .
Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.
Coadministration of mycophenolate mofetil (1 g) and acyclovir (800 mg) to 12 healthy volunteers resulted in no significant change in MPA AUC and C. However, MPAG and acyclovir plasma AUCs were increased 10.6 % and 21.9 %, respectively. Because MPAG plasma concentrations are increased in the presence of renal impairment, as are acyclovir concentrations, the potential exists for mycophenolate and acyclovir or its prodrug (e.g, valacyclovir) to compete for tubular secretion, further increasing the concentrations of both drugs.
Absorption of a single dose of mycophenolate mofetil (2 g) was decreased when administered to ten rheumatoid arthritis patients also taking MaaloxTC (10 mL qid). The Cand AUC(0 to 24h) for MPA were 33 % and 17 % lower, respectively, than when mycophenolate mofetil was administered alone under fasting conditions. Mycophenolate mofetil may be administered to patients who are also taking antacids containing magnesium and aluminum hydroxides; however, it is recommended that mycophenolate mofetil and the antacid not be administered simultaneously.
Coadministration of PPIs (e.g., lansoprazole, pantoprazole) in single doses to healthy volunteers and multiple doses to transplant patients receiving mycophenolate mofetil has been reported to reduce the exposure to mycophenolic acid (MPA). An approximate reduction of 30 to 70% in the C and 25% to 35% in the AUC of MPA has been observed, possibly due to a decrease in MPA solubility at an increased gastric pH. The clinical impact of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PPIs and mycophenolate mofetil. Because clinical relevance has not been established, PPIs should be used with caution when coadministered to transplant patients being treated with mycophenolate mofetil.
Following single-dose administration of 1.5 g mycophenolate mofetil to 12 healthy volunteers pretreated with 4 g tid of cholestyramine for 4 days, MPA AUC decreased approximately 40 %. This decrease is consistent with interruption of enterohepatic recirculation which may be due to binding of recirculating MPAG with cholestyramine in the intestine. Some degree of enterohepatic recirculation is also anticipated following intravenous administration of mycophenolate mofetil. Therefore, mycophenolate mofetil is not recommended to be given with cholestyramine or other agents that may interfere with enterohepatic recirculation.
Cyclosporine (Sandimmune) pharmacokinetics (at doses of 275 to 415 mg/day) were unaffected by single and multiple doses of 1.5 g bid of mycophenolate mofetil in 10 stable renal transplant patients. The mean (±SD) AUC and C of cyclosporine after 14 days of multiple doses of mycophenolate mofetil were 3290 (±822) ng•h/mL and 753 (±161) ng/mL, respectively, compared to 3245 (±1088) ng•h/mL and 700 (±246) ng/mL, respectively, 1 week before administration of mycophenolate mofetil.
Cyclosporine A interferes with MPA enterohepatic recirculation. In renal transplant patients, mean MPA exposure (AUC) was approximately 30 to 50 % greater when mycophenolate mofetil is administered without cyclosporine compared with when mycophenolate mofetil is coadministered with cyclosporine. This interaction is due to cyclosporine inhibition of multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract, thereby preventing the excretion of MPAG into the bile that would lead to enterohepatic recirculation of MPA. This information should be taken into consideration when MMF is used without cyclosporine; changes in MPA exposure should be expected when switching patients from cyclosporine A to one of the immunosuppressants which do not interfere with MPA's enterohepatic cycle (e.g., tacrolimus; belatacept).
Concommitant administration of telmisartan and mycophenolate mofetil resulted in an approximately 30% decrease in mycophenolic acid (MPA) concentrations. Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Following single-dose administration to 12 stable renal transplant patients, no pharmacokinetic interaction was observed between mycophenolate mofetil (1.5 g) and intravenous ganciclovir (5 mg/kg). Mean (±SD) ganciclovir AUC and C (n=10) were 54.3 (±19) mcg•h/mL and 11.5 (±1.8) mcg/mL, respectively, after coadministration of the two drugs, compared to 51 (±17) mcg•h/mL and 10.6 (±2) mcg/mL, respectively, after administration of intravenous ganciclovir alone. The mean (±SD) AUC and C of MPA (n=12) after coadministration were 80.9 (±21.6) mcg•h/mL and 27.8 (±13.9) mcg/mL, respectively, compared to values of 80.3 (±16.4) mcg•h/mL and 30.9 (±11.2) mcg/mL, respectively, after administration of mycophenolate mofetil alone. Because MPAG plasma concentrations are increased in the presence of renal impairment, as are ganciclovir concentrations, the two drugs will compete for tubular secretion and thus further increases in concentrations of both drugs may occur. In patients with renal impairment in which MMF and ganciclovir or its prodrug (eg, valganciclovir) are coadministered, patients should be monitored carefully.
A study of coadministration of mycophenolate mofetil (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.20 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) was conducted in 18 women with psoriasis over 3 consecutive menstrual cycles. Mean AUC was similar for ethinylestradiol and 3-keto desogestrel; however, mean levonorgestrel AUC significantly decreased by about 15 %. There was large inter-patient variability (%CV in the range of 60 % to 70 %) in the data, especially for ethinylestradiol. Mean serum levels of LH, FSH and progesterone were not significantly affected. Mycophenolate mofetil may not have any influence on the ovulation-suppressing action of the studied oral contraceptives. It is recommended to coadminister mycophenolate mofetil with hormonal contraceptives (eg, birth control pill, transdermal patch, vaginal ring, injection, and implant) with caution and additional barrier contraceptive methods must be used (see ).
Concomitant administration of sevelamer and mycophenolate mofetil in adult and pediatric patients decreased the mean MPA C and AUC by 36 % and 26 % respectively. This data suggest that sevelamer and other calcium free phosphate binders should not be administered simultaneously with mycophenolate mofetil. Alternatively, it is recommended that sevelamer and other calcium free phosphate binders preferentially could be given 2 hours after mycophenolate mofetil intake to minimize the impact on the absorption of MPA.
Following single-dose administration of mycophenolate mofetil (1.5 g) to 12 healthy male volunteers on day 8 of a 10 day course of trimethoprim 160 mg/sulfamethoxazole 800 mg administered bid, no effect on the bioavailability of MPA was observed. The mean (±SD) AUC and C of MPA after concomitant administration were 75.2 (±19.8) mcg•h/mL and 34 (±6.6) mcg/mL, respectively, compared to 79.2 (±27.9) mcg•h/mL and 34.2 (±10.7) mcg/mL, respectively, after administration of mycophenolate mofetil alone.
Following single-dose administration of mycophenolate mofetil (1 g) to 11 healthy volunteers on day 4 of a 5 day course of a combination of norfloxacin and metronidazole, the mean MPA AUC was significantly reduced by 33 % compared to the administration of mycophenolate mofetil alone (p< 0.05). Therefore, mycophenolate mofetil is not recommended to be given with the combination of norfloxacin and metronidazole. There was no significant effect on mean MPA AUC when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately. The mean (±SD) MPA AUC after coadministration of mycophenolate mofetil with norfloxacin or metronidazole separately was 48.3 (±24) mcg·h/mL and 42.7 (±23) mcg·h/mL, respectively, compared with 56.2 (±24) mcg·h/mL after administration of mycophenolate mofetil alone.
A total of 64 mycophenolate mofetil -treated renal transplant recipients received either oral ciprofloxacin 500 mg bid or amoxicillin plus clavulanic acid 375 mg tid for 7 or at least 14 days. Approximately 50 % reductions in median trough MPA concentrations (pre-dose) from baseline (mycophenolate mofetil alone) were observed in 3 days following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid. These reductions in trough MPA concentrations tended to diminish within 14 days of antibiotic therapy and ceased within 3 days after discontinuation of antibiotics. The postulated mechanism for this interaction is an antibiotic-induced reduction in glucuronidase-possessing enteric organisms leading to a decrease in enterohepatic recirculation of MPA. The change in trough level may not accurately represent changes in overall MPA exposure; therefore, clinical relevance of these observations is unclear.
In a single heart-lung transplant patient, after correction for dose, a 67 % decrease in MPA exposure (AUC) has been observed with concomitant administration of mycophenolate mofetil and rifampin. Therefore, mycophenolate mofetil is not recommended to be given with rifampin concomitantly unless the benefit outweighs the risk.
The measured value for renal clearance of MPAG indicates removal occurs by renal tubular secretion as well as glomerular filtration. Consistent with this, coadministration of probenecid, a known inhibitor of tubular secretion, with mycophenolate mofetil in monkeys results in a 3-fold increase in plasma MPAG AUC and a 2-fold increase in plasma MPA AUC. Thus, other drugs known to undergo renal tubular secretion may compete with MPAG and thereby raise plasma concentrations of MPAG or the other drug undergoing tubular secretion.
Drugs that alter the gastrointestinal flora may interact with mycophenolate mofetil by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption.
During treatment with mycophenolate mofetil, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective (see ). Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination.
Serious cardiopulmonary reactions, including fatalities have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including Lumason. These reactions typically occurred within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias). Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Lumason administration and monitor all patients for acute reactions.
The reported reactions that may follow the administration of ultrasound contrast agents include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions.
The following serious adverse reactions are discussed elsewhere in the labeling:
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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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. 315.72Tips
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