Meropenem Auro Pharma Dosage

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Dosage of Meropenem Auro Pharma in details

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Meropenem Auro Pharma Dosage

Generic name: Meropenem Auro Pharma 1g in 30mL

Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Adult Patients

The recommended dose of Meropenem Auro Pharma I.V. is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P.aeruginosa, a dose of 1 gram every 8 hours is recommended.

Meropenem Auro Pharma I.V. should be administered by intravenous infusion over approximately 15 minutes to 30 minutes. Doses of 1 gram may also be administered as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes.

Use in Adult Patients with Renal Impairment

Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less.

When only serum creatinine is available, the following formula (Cockcroft and Gault equation)5 may be used to estimate creatinine clearance.

Males: Creatinine Clearance (mL/min) =

Weight (kg) x (140 - age)

72 x serum creatinine (mg/dL)

Females: 0.85 x above value

Recommended Meropenem Auro Pharma I.V. Dosage Schedule for Adult Patients with Renal Impairment

Creatinine Clearance (mL/min)

Dose (dependent on type of infection)

Dosing Interval

Greater than 50

Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal)

Every 8 hours

Greater than 25-50

Recommended dose

Every 12 hours

10-25

One-half recommended dose

Every 12 hours

Less than 10

One-half recommended dose

Every 24 hours

There is inadequate information regarding the use of Meropenem Auro Pharma I.V. in patients on hemodialysis or peritoneal dialysis.

Use in Pediatric Patients

Pediatric Patients 3 Months of Age and Older

For pediatric patients 3 months of age and older, the Meropenem Auro Pharma I.V. dose is 10 mg/kg, 20 mg/kg or 40 mg/kg every 8 hours (maximum dose is 2 grams every 8 hours), depending on the type of infection (complicated skin and skin structure, intra-abdominal or meningitis). See dosing table below. Pediatric patients weighing over 50 kg should be administered Meropenem Auro Pharma I.V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 gram every 8 hours for intra-abdominal infections and 2 grams every 8 hours for meningitis. Meropenem Auro Pharma I.V. should be given as intravenous infusion over approximately 15 minutes to 30 minutes or as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes.

There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 grams) bolus dose.

Recommended Meropenem Auro Pharma I.V. Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function

Type of Infection

Dose (mg/kg)

Up to a Maximum Dose

Dosing Interval

Complicated skin and skin structure

10

500 mg

Every 8 hours

Intra-abdominal

20

1 gram

Every 8 hours

Meningitis

40

2 grams

Every 8 hours

There is no experience in pediatric patients with renal impairment.

When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended.

Pediatric Patients Less Than 3 Months of Age

For pediatric patients (with normal renal function) less than 3 months of age, with intra-abdominal infections, the Meropenem Auro Pharma I.V. dose is based on gestational age (GA) and postnatal age (PNA). See dosing table below. Meropenem Auro Pharma I.V. should be given as intravenous infusion over 30 minutes.

Recommended Meropenem Auro Pharma I.V. Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-Abdominal Infections and Normal Renal Function

Age Group

Dose (mg/kg)

Dose Interval

Infants less than 32 weeks GA and PNA less than 2 weeks

20

Every 12 hours

Infants less than 32 weeks GA and PNA 2 weeks and older

20

Every 8 hours

Infants 32 weeks and older GA and PNA less than 2 weeks

20

Every 8 hours

Infants 32 weeks and older GA and PNA 2 weeks and older

30

Every 8 hours

There is no experience in pediatric patients with renal impairment.

Preparation of Solution

For

Intravenous Bolus Administration

Constitute injection vials (500 mg and 1 gram) with sterile Water for Injection. Shake to dissolve and let stand until clear.

Vial Size

Amount of Diluent Added (mL)

Approximate Withdrawable Volume

(mL)

Approximate Average Concentration (mg/mL)

500 mg

10

10

50

1 gram

20

20

50

For Infusion

Infusion vials (500 mg and 1 gram) may be directly constituted with a compatible infusion fluid. Alternatively, an injection vial may be constituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid.

WARNING: Do not use flexible container in series connections.

Compatibility

Compatibility of Meropenem Auro Pharma I.V. with other drugs has not been established. Meropenem Auro Pharma I.V. should not be mixed with or physically added to solutions containing other drugs.

Stability and Storage

Freshly prepared solutions of Meropenem Auro Pharma I.V. should be used. However, constituted solutions of Meropenem Auro Pharma I.V. maintain satisfactory potency under the conditions described below. Solutions of intravenous Meropenem Auro Pharma I.V. should not be frozen.

Intravenous Bolus Administration

Meropenem Auro Pharma I.V. injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem Auro Pharma I.V.) may be stored for up to 3 hours at up to 25oC (77oF) or for 13 hours at up to 5oC (41oF).

Intravenous Infusion Administration

Solutions prepared for infusion (Meropenem Auro Pharma I.V. concentrations ranging from 1 mg/mL to 20 mg/mL) constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25oC (77oF) or 15 hours at up to 5oC (41oF).

Solutions prepared for infusion (Meropenem Auro Pharma I.V. concentrations ranging from 1 mg/mL to 20 mg/mL) constituted with Dextrose Injection 5% should be used immediately.

NOTE:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

More about Meropenem Auro Pharma (Meropenem Auro Pharma)

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What other drugs will affect Meropenem Auro Pharma?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Meropenem Auro Pharma, especially:

This list is not complete. Other drugs may interact with Meropenem Auro Pharma, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Meropenem Auro Pharma interactions

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Probenecid competes with Meropenem Auro Pharma for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of Meropenem Auro Pharma. As the potency and duration of action of Meropenem Auro Pharma dosed without probenecid are adequate, the co-administration of probenecid with Meropenem Auro Pharma is not recommended.

The potential effect of Meropenem Auro Pharma on the protein-binding of other drugs or metabolism has not been studied. The protein binding of Meropenem Auro Pharma is low (approximately 2%) and, therefore, no interactions with other compounds based on displacement from plasma proteins would be expected.

Meropenem Auro Pharma may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.

Meropenem Auro Pharma has been administered concomitantly with other medications without adverse pharmacological interactions. However, no specific data regarding potential drug interactions is available (apart from probenecid as previous;y mentioned).

Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100% decrease in valproic acid levels in about 2 days. Due to the rapid onset and the extent of the decrease, co-administration of Meropenem Auro Pharma in patients stabilised on valproic acid is not considered to be manageable and therefore should be avoided.

Oral Anticoagulants:

Simultaneous administration of antibiotics with warfarin may augment its anticoagulant effects. There have been many reports of increases in the anticoagulant effects of orally administered anticoagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in international normalised ratio (INR) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anticoagulant agent.

Incompatibilities: Meropenem Auro Pharma must not be mixed with other medicinal products except those mentioned in Cautions for Usage.


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References

  1. DailyMed. "MEROPENEM: 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. "YOP6PX0BAO: 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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