Elastyn Uses

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What is Elastyn?

Treating infections caused by certain bacteria.

Elastyn is a carbapenem antibiotic. It kills bacteria by blocking growth of the bacteria's cell wall.

Elastyn indications

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Treatment: The activity of Elastyn against an unusually broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic and mixed aerobic/anaerobic infections, as well as initial therapy prior to the identification of the causative organisms. Elastyn is indicated for the treatment of the following infections due to susceptible organisms: Intra-abdominal infections; lower respiratory tract infections; gynecological infections; septicemia; genitourinary tract infections; bone and joint infections; skin and soft tissue infections; endocarditis.

Elastyn is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by fecal flora or flora originating from the vagina, skin and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, cephalosporins and penicillins. However, Bacteroides fragilis is usually susceptible to Elastyn.

Elastyn has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime and ceftriaxone. Similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment with Elastyn.

Elastyn is not indicated for the treatment of meningitis.

Prophylaxis: Elastyn is also indicated for the prevention of certain postoperative infections in patients undergoing contaminated or potentially contaminated surgical procedures or where the occurrence of postoperative infection could be especially serious.

How should I use Elastyn?

Use Elastyn as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Elastyn.

Elastyn description

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Each vial of powder for injection contains Imipenem (Elastyn) equivalent to anhydrous Imipenem (Elastyn) 500 mg and Cilastatin (Elastyn) sodium equivalent to anhydrous Cilastatin (Elastyn) 500 mg.

It also contains sodium bicarbonate as buffer.

Elastyn is a sterile formulation of Imipenem (Elastyn) (a thienamycin antibiotic) and Cilastatin (Elastyn) sodium (the inhibitor of the renal dipeptidase, dehydropeptidase l). Imipenem (Elastyn) and Cilastatin (Elastyn) combination is a potent broad spectrum antibacterial for intravenous administration.

Imipenem (Elastyn) (N-formimidoylthienamycin) is a derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid. It has a molecular weight of 299.37 and an empirical formula of C12H17N3O4S.

Cilastatin (Elastyn) sodium is the sodium salt of a derivatized heptenoic acid. It is chemically designated as sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It has a molecular weight of 380.43 and an empirical formula of C16H25N2O5SNa.

Elastyn dosage

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Elastyn is available as IV infusion.

The dosage recommendations for Elastyn represent the quantity of Imipenem (Elastyn) to be administered. An equivalent amount of Cilastatin (Elastyn) is also present.

The total daily dosage and route of administration of Elastyn should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function and body weight.

IV Infusion: Treatment: Adults with Normal Renal Function: Doses cited in Table 1 are based on a patient with normal renal function (CrCl >70 mL/min/1.73 m2) and a body weight of ≥70 kg.

A reduction in dose must be made for a patient with a CrCl ≤70 mL/min/1.73 m2 and/or a body weight <70 kg. The reduction for body weight is especially important for patients with much lower body weights and/or moderate/severe renal insufficiency.

When the 500-mg dose is used in patients with CrCl 6-20 mL/min/1.73 m2, there may be an increased risk of seizures.

Patients with CrCl ≤5 mL/min/1.73 m2 should not receive Elastyn IV unless hemodialysis is instituted within 48 hrs.

Hemodialysis: When treating patients with CrCl ≤5 mL/min/1.73 m2 who are undergoing hemodialysis, use the dosage recommendations for patients with CrCl 6-20 mL/min/1.73 m2.

Both Imipenem (Elastyn) and Cilastatin (Elastyn) are cleared from the circulation during hemodialysis. The patient should receive Elastyn IV after hemodialysis and at 12-hr intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, Elastyn IV is recommended only when the benefit outweighs the potential risk of seizures.

Currently, there are inadequate data to recommend use of Elastyn IV for patients on peritoneal dialysis.

Renal status of elderly patients may not be accurately portrayed by measurement of BUN or creatinine alone. Determination of CrCl is suggested to provide guidance for dosing in such patients.

Prophylaxis: Adults: For prophylaxis against post-surgical infections in adults, 1000 mg Elastyn IV should be given IV on induction of anesthesia and 1000 mg 3 hrs later. For high-risk (eg, colorectal) surgery, 2 additional 500-mg doses can be given at 8 and 16 hrs after induction.

There are insufficient data on which to base a dosage recommendation for prophylaxis in patients with a CrCl ≤70 mL/min/1.73 m2.

Treatment: Children ≥3 months: For children and infants, the following dosage schedule is recommended: Children ≥40 kg body weight should receive adult doses. Children and infants <40 kg body weight should receive 15 mg/kg at 6-hr intervals. The total daily dose should not exceed 2 g.

Clinical data are insufficient to recommend dosing for children <3 months or pediatric patients with impaired renal function (serum creatinine >2 mg/dL).

Elastyn is not recommended for the therapy of meningitis. If meningitis is suspected, an appropriate antibiotic should be used.

Elastyn may be used in children with sepsis as long as they are not suspected of having meningitis.

Reconstitution: Elastyn for IV infusion is supplied as a sterile powder in vials containing 500 mg Imipenem (Elastyn) equivalent and 500 mg cilastin equivalent.

Elastyn IV is buffered with sodium bicarbonate to provide solutions in the pH range of 6.5-8.5. There is no significant change in pH when solutions are prepared and used as directed.

Sterile powder Elastyn should be reconstituted as shown in Table 3. It should be shaken until a clear solution is obtained. Variations of color, from colorless to yellow, do not affect the potency of the product.

Stability: Table 4 shows the stability period for Elastyn IV when reconstituted with selected infusion solutions and stored at room temperature or under refrigeration.

Caution: Elastyn IV is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. Elastyn IV can be administered, however, into an IV system through which a lactate solution is being infused.

Elastyn IV should not be mixed with or physically added to other antibiotics.

Elastyn interactions

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What other drugs will affect Elastyn?

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Generalized seizures have been reported in patients who received ganciclovir and Elastyn IV. These drugs should not be used concomitantly unless the potential benefits outweigh the risks.

Also see Stability, Elastyn IV under Storage.

Case reports in the literature have shown that co-administration of carbapenems, including Imipenem (Elastyn), to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus, decreasing the serum concentrations of valproic acid.

Incompatibilities: Caution: Elastyn IV is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. Elastyn IV can be administered, however, into an IV system through which a lactate solution is being infused.

Elastyn IV should not be mixed with or physically added to other antibiotics.

Elastyn side effects

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What are the possible side effects of Elastyn?

Imipenem (Elastyn)/Cilastatin (Elastyn) injection (Elastyn) is generally well tolerated. The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely, related to Imipenem (Elastyn)/Cilastatin (Elastyn) injection (Elastyn) were nausea (2%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), seizures (0.4%), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), somnolence (0.2%).

Additional adverse systemic clinical reactions reported as possibly, probably, or definitely drug related occurring in less than 0.2% of the patients or reported since the drug was marketed are listed within each body system in order of decreasing severity: Gastrointestinal: Pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment), hemorrhagic colitis, hepatitis, jaundice, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth and/or tongue, heartburn, pharyngeal pain, increased salivation.

Hematologic: Pancytopenia, bone marrow depression, thrombocytopenia, neutropenia, leukopenia, hemolytic anemia.

CNS: Encephalopathy, tremor, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances including hallucinations.

Special Senses: Hearing loss, tinnitus, taste perversion.

Respiratory: Chest discomfort, dyspnea, hyperventilation, thoracic spine pain.

Cardiovascular: Palpitations, tachycardia.

Skin: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioneureticedema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae.

Body as a Whole: Polyarthralgia, asthenia/weakness, drug fever.

Renal: Acute renal failure; oliguria/anuria, polyuria, urine discoloration. The role of Imipenem (Elastyn)/Cilastatin (Elastyn) injection (Elastyn) in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.

Elastyn contraindications

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What is the most important information I should know about Elastyn?

Do not use Imipenem (Elastyn) and Cilastatin (Elastyn) if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

Before using Imipenem (Elastyn) and Cilastatin (Elastyn), tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.

Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Elastyn (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Elastyn into a vein and do not inject Primaxin IV into a muscle.

Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.



Active ingredient matches for Elastyn:

Cilastatin/Imipenem in Indonesia.


Unit description / dosage (Manufacturer)Price, USD
Elastyn 1 g x 1's$ 27.90

List of Elastyn substitutes (brand and generic names):

Emperem Imipenem 500 mg, cilastatin500 mg. INJ / 1 (RSM Lifecare)$ 15.36
Flaminem Imipenem 500mg, Cilastin500mg VIAL / 1$ 15.28
Flaminim Imipenem 0.5 g, Cilastatin 0.5g. VIAL / 1 (Flamingo Pharmaceutical)$ 15.28
1's (Flamingo Pharmaceutical)$ 15.28
Flaminim 500+500 Injection (Flamingo Pharmaceutical)$ 0.01
Flaminim Imipenem 500mg, Cilastin500mg VIAL / 1 (Flamingo Pharmaceutical)$ 15.28
Genem 1's
GLIMAXIN 500MG/500MG INJECTION 1 vial / 1 injection each (Gland Pharma Limited)$ 15.42
Glimaxin 500 mg/500 mg Injection (Gland Pharma Limited)$ 15.42
Injectable; Injection; Cilastatin 500 mg; Imipenem 500 mg
I Nem 250+250 Injection (Glenmark Pharmaceuticals Ltd.)$ 7.83
I Nem 250mg/250mg Injection (Glenmark Pharmaceuticals Ltd.)$ 8.94
I-Nem Imipenem 250mg, Cilastatin 250mg VIAL / 1 (Glenmark (Critica))$ 7.83
I-Nem Imipenem 500mg, Cilastatin 500mg VIAL / 1 (Glenmark (Critica))$ 15.78
I-Nem Imipenem 250mg, Cilastin250mg VIAL / 1 (Glenmark (Critica))$ 7.83
I-Nem Imipenem 500mg, Cilastin500mg VIAL / 1 (Glenmark (Critica))$ 15.78
1's (Glenmark (Critica))$ 14.46
I-NEM 250 MG/250 MG INJECTION 1 vial / 1 injection each (Glenmark (Critica))$ 8.94
I-NEM 500 MG/500 MG INJECTION 1 vial / 1 injection each (Glenmark (Critica))$ 20.72
I-Nem Imipenem 250mg, Cilastin250mg VIAL / 1 (Glenmark (Critica))$ 7.83
I-Nem Imipenem 500mg, Cilastin500mg VIAL / 1 (Glenmark (Critica))$ 15.78
I-Nem Imipenem 250mg, Cilastatin 250mg VIAL / 1 (Glenmark (Critica))$ 7.83
I-Nem Imipenem 500mg, Cilastatin 500mg VIAL / 1 (Glenmark (Critica))$ 15.78
Icl Imipenem 250 mg, Cilastatin250 mg. INJ / 1 (Excella)$ 16.27
ICL 1000000IU INJECTION 1 vial / 1 injection each (Excella)$ 9.52
ICL 2000000IU INJECTION 1 vial / 1 injection each (Excella)$ 16.93
ICL 3000000IU INJECTION 1 vial / 1 injection each (Excella)$ 26.75
Icl 1000000IU Injection (Excella)$ 9.52
Icl 2000000IU Injection (Excella)$ 16.93
Icl 3000000IU Injection (Excella)$ 26.75
Im-Cil 1 Bottle
Im-Cila Imipenem 500 mg, Cilastatin500 mg VIAL / 1$ 15.65
Im-Cila Imipenem 250 mg, Cilastatin250 mg. VIAL / 1$ 8.46
Ime-Cila Imipenem 500mg, Cilastin500mg IV-VIAL / 1 (AHPL)$ 15.65

References

  1. DailyMed. "CILASTATIN SODIUM; IMIPENEM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "CILASTATIN SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "Cilastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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