Linezolid Hikma Dosage

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Dosage of Linezolid Hikma 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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General Dosage And Administration

The recommended dosage for Linezolid Hikma formulations for the treatment of infections is described in Table 1.

Table 1:Dosage Guidelines for Linezolid Hikma

Infection* Dosage and Route of Administration Recommended Duration of Treatment (consecutive days)
Pediatric Patients† (Birth through 11 Years of Age) Adults and Adolescents (12 Years and Older)
Nosocomial pneumonia 10 mg/kg intravenously or oral‡ every 8 hours 600 mg intravenously or oral‡ every 12 hours 10 to 14
Community-acquired pneumonia, including concurrent bacteremia
Complicated skin and skin structure infections
Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 10 mg/kg intravenously or oral‡ every 8 hours 600 mg intravenously or oral‡ every 12 hours 14 to 28
Uncomplicated skin and skin structure infections less than 5 yrs: 10 mg/kg oral‡ every 8 hours 5-11 yrs: 10 mg/kg oral‡ every 12 hours Adults: 400 mg oral‡ every 12 hours Adolescents: 600 mg oral‡ every 12 hours 10 to 14
*Due to the designated pathogens

Neonates less than 7 days : Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic Linezolid Hikma clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life.

Oral dosing using either Linezolid Hikma Tablets or Linezolid Hikma for

Oral Suspension.

No dose adjustment is necessary when switching from intravenous to oral administration.

Intravenous Administration

Linezolid Hikma I.V. Injection is supplied in single-use, ready-to-use infusion bags.

Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired. Keep the infusion bags in the overwrap until ready to use. Store at room temperature. Protect from freezing. Linezolid Hikma I.V. Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

Linezolid Hikma I.V. Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous infusion bag in series connections. Additives should not be introduced into this solution. If Linezolid Hikma I.V. Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each product.

If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Linezolid Hikma I.V. Injection with an infusion solution compatible with Linezolid Hikma I.V. Injection and with any other drug(s) administered via this common line.

Compatibilities

Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer's Injection, USP.

Incompatibilities

Physical incompatibilities resulted when Linezolid Hikma I.V. Injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when Linezolid Hikma I.V. Injection was combined with ceftriaxone sodium.

Constitution Of

Oral Suspension

Linezolid Hikma for

Oral Suspension is supplied as a powder/granule for constitution. Gently tap bottle to loosen powder. Add a total of 123 mL distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After constitution, each 5 mL of the suspension contains 100 mg of Linezolid Hikma. Before using, gently mix by inverting the bottle 3 to 5 times. Do not shake. Store constituted suspension at room temperature. Use within 21 days after constitution.

How supplied

Dosage Forms And Strengths

Linezolid Hikma I.V. Injection: 100-mL (200 mg Linezolid Hikma), 200-mL (400 mg Linezolid Hikma) and 300-mL (600 mg Linezolid Hikma) single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free.

Linezolid Hikma 600 mg Tablet:

white, capsule-shaped, film-coated tablet printed with “Linezolid Hikma 600 mg”

white, capsule-shaped, film-coated tablet debossed with “ZYV” on one side and “600” on the other

Linezolid Hikma for

Oral Suspension: dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of Linezolid Hikma per each 5 mL.

Storage And Handling

Injection

Linezolid Hikma I.V. Injection is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free. The infusion bags are available in the following package sizes:

100 mL bag (200 mg Linezolid Hikma) NDC 0009-5137-01

100 mL bag (200 mg Linezolid Hikma) x 10 NDC 0009-5137-04

200 mL bag (400 mg Linezolid Hikma) NDC 0009-5139-01

300 mL bag (600 mg Linezolid Hikma) NDC 0009-5140-01

300 mL bag (600 mg Linezolid Hikma) 10 NDC 0009-5140-04

Tablets

Linezolid Hikma Tablets are available as follows:

600 mg (white, capsule-shaped, film-coated tablets printed with “Linezolid Hikma 600 mg”)

100 tablets in HDPE bottle NDC 0009-5135-01

20 tablets in HDPE bottle NDC 0009-5135-02

Unit dose packages of 30 tablets NDC 0009-5135-03

600 mg (white, capsule-shaped, film-coated tablets debossed with “ZYV” on one side and “600” on the other)

20 tablets in HDPE bottle NDC 0009-5138-02

Unit dose packages of 30 tablets NDC 0009-5138-03

Oral Suspension

Linezolid Hikma for

Oral Suspension

is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of Linezolid Hikma per each 5 mL. Linezolid Hikma for

Oral Suspension is supplied as follows:

100 mg/5 mL in 240-mL glass bottles NDC 0009-5136-01

Storage

Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.

Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc., NY, NY 10017. Revised: Jul 2015

What other drugs will affect Linezolid Hikma?

During your treatment with Linezolid Hikma, do not start or stop using any other medications unless your doctor tells you to.

If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.

Many other drugs can interact with Linezolid Hikma, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Linezolid Hikma 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 Linezolid Hikma, 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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Drugs Metabolized by Cytochrome P-450: Linezolid Hikma is not detectably metabolised by the cytochrome P-450 (CYP) enzyme system and it does not induce or inhibit the activities of clinically significant human CYP isoforms (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). Therefore, no CYP450-induced drug interactions are expected with Linezolid Hikma. Drugs eg, warfarin and phenytoin, which are CYP2C9 substrates, may be given with Linezolid Hikma without changes in dosage regimen.

Antibiotics: The pharmacokinetics of Linezolid Hikma were not altered when administered together with either aztreonam or gentamicin. The effect of rifampin on the pharmacokinetics of Linezolid Hikma was studied in 16 healthy adult male volunteers administered Linezolid Hikma 600 mg twice daily for 2.5 days with and without rifampin 600 mg once daily for 8 days. Rifampin decreased the Linezolid Hikma Cmax and AUC by a mean 21% (90% CI, 15, 27) and a mean 32% (90% CI, 27, 37) respectively. The mechanism of this interaction and its clinical significance are unknown.

Monoamine Oxidase Inhibition: Linezolid Hikma is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid Hikma has the potential for interaction with adrenergic and serotonergic agents.

Adrenergic Agents: A significant pressor response has been observed in normal adult subjects receiving Linezolid Hikma and tyramine doses of >100 mg. Therefore, patients receiving Linezolid Hikma need to avoid consuming large amounts of foods or beverages with high tyramine content (eg, mature cheese, yeast extracts, undistilled alcoholic beverages and fermented soya bean products eg, soy sauce).

A reversible enhancement of the pressor response of either pseudoephedrine HCl (PSE) or phenylpropanolamine HCl (PPA) is observed when Linezolid Hikma is administered to healthy normotensive subjects. A similar study has not been conducted in hypertensive patients. The interaction studies conducted in normotensive subjects evaluated the blood pressure and heart rate effects of placebo, PPA or PSE alone, Linezolid Hikma alone, and the combination of steady-state Linezolid Hikma (600 mg every 12 hrs for 3 days) with 2 doses of PPA (25 mg) or PSE (60 mg) given 4 hrs apart. Heart rate was not affected by any of the treatments.

Blood pressure was increased with both combination treatments. Maximum blood pressure levels were seen 2-3 hrs after the 2nd dose of PPA or PSE and returned to baseline 2-3 hrs after peak. The results of the PPA study follow, showing the mean (and range) maximum systolic blood pressure in mm Hg: Placebo=121 (103-158); Linezolid Hikma alone=120 (107-135); PPA alone=125 (106-139); PPA with Linezolid Hikma=147 (129-176). The results from the PSE study were similar to those in the PPA study. The mean maximum increase in systolic blood pressure over baseline was 32 mm Hg (range: 20-52 mm Hg) and 38 mm Hg (range: 18-79 mm Hg) during co-administration of Linezolid Hikma with pseudoephedrine or phenylpropanolamine, respectively. Initial doses of adrenergic agents eg, dopamine or dopamine agonists, should be reduced and titrated to achieve the desired response.

Serotonergic Agents: The potential drug-drug interaction with dextromethorphan was studied in healthy volunteers. Subjects were administered dextromethorphan (two 20-mg doses given 4 hrs apart) with or without Linezolid Hikma. No serotonin syndrome effects (confusion, delirium, restlessness, tremors, blushing, diaphoresis, hyperpyrexia) have been observed in normal subjects receiving Linezolid Hikma and dextromethorphan. The effects of other serotonin re-uptake inhibitors have not been studied. However, very rare spontaneous reports of serotonin syndrome with co-administration of Linezolid Hikma and serotonergic agents have been reported.

Incompatibilities: Injection: Additives should not be introduced into this solution. If Linezolid Hikma is to be given concomitantly with other drugs, each drug should be given separately in accordance with its own directions for use. Similarly, if the same IV line is to be used for sequential infusion of several drugs, the line should be flushed prior to and following Linezolid Hikma administration with a compatible infusion solution.

Linezolid Hikma solution for infusion is known to be physically incompatible with the following compounds: Amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium and sulfamethoxazole/trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.

Compatible Infusion Solutions: 5% dextrose injection; 0.9% sodium chloride injection; lactated ringer's injection (Hartmann's solution for injection).


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References

  1. DailyMed. "LINEZOLID: 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. FDA/SPL Indexing Data. "ISQ9I6J12J: 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).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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