Zienem Uses

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What is Zienem?

Treating infections caused by certain bacteria.

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

Zienem indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Treatment: The activity of Zienem 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. Zienem is indicated for the treatment of the following infections due to susceptible organisms: Intra-abdominal infections; lower respiratory tract and gynecological infections; septicemia; genitourinary tract, bone and joint, and skin and soft tissue infections; infective endocarditis.

Zienem 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 Zienem.

Zienem 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 Zienem. However, many strains of methicillin-resistant Staphylococci are resistant to Imipenem (Zienem).

Zienem is not indicated for the treatment of meningitis.

Prophylaxis: Zienem is also indicated for the prevention of certain post-operative 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 Zienem?

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use Zienem 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 Zienem.

Zienem description

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

It also contains sodium bicarbonate as buffer.

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

Imipenem (Zienem) (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 (Zienem) 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.

Zienem dosage

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Zienem is available as IV infusion.

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

The total daily dosage and route of administration of Zienem 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 Zienem 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 (Zienem) and Cilastatin (Zienem) are cleared from the circulation during hemodialysis. The patient should receive Zienem 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, Zienem IV is recommended only when the benefit outweighs the potential risk of seizures.

Currently, there are inadequate data to recommend use of Zienem 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 Zienem 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).

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

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

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

Zienem 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 Zienem 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 Zienem IV when reconstituted with selected infusion solutions and stored at room temperature or under refrigeration.

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

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

Zienem interactions

See also:
What other drugs will affect Zienem?

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

Also see Stability, Zienem IV under Storage.

Case reports in the literature have shown that co-administration of carbapenems, including Imipenem (Zienem), 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: Zienem IV is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. Zienem IV can be administered, however, into an IV system through which a lactate solution is being infused.

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

Zienem side effects

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What are the possible side effects of Zienem?

Imipenem (Zienem)/Cilastatin (Zienem) injection (Zienem) is generally well tolerated. The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely, related to Imipenem (Zienem)/Cilastatin (Zienem) injection (Zienem) 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 (Zienem)/Cilastatin (Zienem) injection (Zienem) 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.

Zienem contraindications

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

Do not use Imipenem (Zienem) and Cilastatin (Zienem) 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 (Zienem) and Cilastatin (Zienem), 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.

Zienem (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 Zienem 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 Zienem:

Cilastatin/Imipenem


Unit description / dosage (Manufacturer)Price, USD
Zienem Imipenem 500mg, Cilastin Na 500mg VIAL / 1$ 21.03

List of Zienem substitutes (brand and generic names):

Tienam 1 Bottle (Merck Sharp & Dohme)
Tienam 20 mL x 1's (Merck Sharp & Dohme)
Tienam 120 mL x 1's (Merck Sharp & Dohme)$ 32.52
Tienam infusion 1's (Merck Sharp & Dohme)
Tienam infusion / vial 1's (Merck Sharp & Dohme)$ 38.48
Injectable; Injection; Cilastatin Sodium 250 mg; Imipenem Monohydrate 250 mg (Merck sharp & dohme)
Injectable; Injection; Cilastatin Sodium 500 mg; Imipenem Monohydrate 500 mg (Merck sharp & dohme)
Tilam 1's
Timipen 1 g x 1's (Interbat)$ 29.76
V Penum Injection (Intas Pharmaceuticals Ltd)$ 7.56
Vericare Injection (Veritaz Healthcare Ltd)$ 21.92
Vonem Imipenem 0.5 g, Cilastatin 0.5g. VIAL / 1 (Acekinetics Healthcare Pvt Ltd)$ 26.19
1's (Acekinetics Healthcare Pvt Ltd)$ 26.19
Vonem 500+500 Injection (Acekinetics Healthcare Pvt Ltd)$ 0.02
Younam 1's
Yungpenem 10 Bottle
Injectable; Injection; Cilastatin Sodium; Imipenem 250 mg (MSD Pharmaceuticals Pvt. Ltd.)
Injectable; Injection; Cilastatin Sodium; Imipenem 500 mg (MSD Pharmaceuticals Pvt. Ltd.)
Zienam Cilastatin sodium 500 mg, Imipenem 500 mg. VIAL / 1 (MSD Pharmaceuticals Pvt. Ltd.)$ 21.03
1's (MSD Pharmaceuticals Pvt. Ltd.)$ 21.03
Zienam 500+500 Injection (MSD Pharmaceuticals Pvt. Ltd.)$ 0.02
ZIENAM 500MG/500MG INJECTION 1 vial / 20 ML injection each (MSD Pharmaceuticals Pvt. Ltd.)$ 28.21
ZIENAM MONOVIAL 250MG/250MG INJECTION 1 vial / 1 ml injection each (Msd Pharmaceuticals Private Ltd)$ 26.86
Zienam Monovial 250 mg/250 mg Injection (MSD Pharmaceuticals Pvt Ltd)$ 26.86
ZILONEM 500MG/500MG INJECTION 1 vial / 1 injection each (Orchid Chemicals & Pharmaceuticals Ltd)$ 16.67
Zilonem 500 mg/500 mg Injection (Orchid Chemicals & Pharmaceuticals Ltd)$ 16.67
Zimilast inj 1 g 1's (Zifam India)

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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