Vonem Dosage

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Dosage of Vonem in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Vonem is available as IV infusion.

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

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

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

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

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

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

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

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

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

What other drugs will affect Vonem?

Tell your doctor about all other medications you use, especially:

This list is not complete and other drugs may interact with Imipenem (Vonem) and Cilastatin (Vonem). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Vonem interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Vonem, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Generalized seizures have been reported in patients who received ganciclovir and Vonem IV. These drugs should not be used concomitantly unless the potential benefits outweigh the risks.

Also see Stability, Vonem IV under Storage.

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

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


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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. FDA/SPL Indexing Data. "Q20IM7HE75: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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