Ultrapenem Uses

• Ultrapenem indications
• Uses of Ultrapenem in details
• Ultrapenem description
• Ultrapenem dosage
• Ultrapenem interactions
• Ultrapenem side effects
• Ultrapenem contraindications

What is Ultrapenem?

Ultrapenem injection is used to treat infections caused by bacteria. It works by killing the bacteria or preventing their growth. Ultrapenem will not work for colds, flu, or other virus infections.

Ultrapenem is to be given only by or under the direct supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Ultrapenem is used in certain patients with the following medical condition:

• Febrile neutropenia (treatment).

Ultrapenem indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ultrapenem I.V. and other antibacterial drugs, Ultrapenem I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Ultrapenem I.V. is useful as presumptive therapy in the indicated condition (e.g., intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity.

For information regarding use in pediatric patients [seeIndications and Usage (1.1), (1.2), (1.3), Dosage and Administration (2.3), Adverse Reactions (6.1), andClinical Pharmacology (12.3)].

Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)

Ultrapenem I.V. is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.

Intra-abdominal Infections (Adult and Pediatric Patients)

Ultrapenem I.V. is indicated as a single agent therapy for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.

Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)

Ultrapenem I.V. is indicated as a single agent therapy for the treatment of bacterial meningitis caused by Streptococcus pneumoniae‡, Haemophilus influenzae, and Neisseria meningitidis.

‡ The efficacy of Ultrapenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of Streptococcus pneumoniae has not been established.

Ultrapenem I.V. has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.

How should I use Ultrapenem?

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

• Ultrapenem is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Ultrapenem at home, a health care provider will teach you how to use it. Be sure you understand how to use Ultrapenem. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Ultrapenem if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• To clear up your infection completely, use Ultrapenem for the full course of treatment. Keep using it even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Ultrapenem, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Uses of Ultrapenem in details

Use: Labeled Indications

Intra-abdominal infections: Treatment of complicated appendicitis and peritonitis in adult and pediatric patients caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteroides thetaiotaomicron, and Peptostreptococcus species.

Meningitis, bacterial: Treatment of bacterial meningitis in pediatric patients 3 months and older caused by Haemophilus influenzae, Neisseria meningitidis, and penicillin-susceptible isolates of Streptococcus pneumoniae.

Skin and skin structure infection, complicated: Treatment of complicated skin and skin structure infections in adults and pediatric patients 3 months and older caused by Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), P. aeruginosa, E. coli, Proteus mirabilis, B. fragilis, and Peptostreptococcus species.

Off Label Uses

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax, Ultrapenem is an effective and recommended agent for the treatment of anthrax meningitis and an effective and recommended alternative agent for systemic anthrax.

Bite wound infection, treatment, animal or human bite

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Ultrapenem is an effective and recommended alternative agent for treatment of animal or human bite wounds.

Bloodstream infection (gram-negative bacteremia)

Based on the IDSA guidelines for the diagnosis and management of intravascular catheter-related infection, Ultrapenem is effective and recommended in the management of catheter-related bloodstream infection.

Clinical experience also suggests the utility of Ultrapenem for the treatment of bloodstream infection caused by gram-negative pathogens, including Pseudomonas aeruginosa.

Ultrapenem description

The chemical name of Ultrapenem trihydrate is -Azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 3-[[5-[(dimethylamino)carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo, trihydrate, [4R-[3(3S*,5S*),4^α,5^β,6^β(R*)]]-.(4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio] -6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-carboxylic acid, trihydrate. The molecular formula of Ultrapenem trihydrate is C₁₇H₂₅N₃O₅S·3H₂O and its CAS number is 119478-56-7.

DBL Ultrapenem for Injection is presented as a sterile white to pale yellow crystalline powder containing Ultrapenem trihydrate equivalent to Ultrapenem, 500 mg or 1 g, blended with sodium carbonate anhydrous. DBL Ultrapenem for Injection contains 208 mg sodium carbonate anhydrous and 90.2 mg of sodium for each gram of Ultrapenem (anhydrous potency). It contains no antimicrobial preservative and is for use in one patient on one occasion only..

Ultrapenem dosage

Adults: The recommended dose of Ultrapenem injection of 500 mg is given every 8 hours for a skin and skin structure infections when treating infections caused by Pseudomonas aeruginosa, dose of 1 gram every 8 hours is recommended, and 1 gram given every 8 hours for intra-abdominal infections. Ultrapenem injection should be administered by intravenous infusion over approximately 15 to 30 minutes. Doses of 1 gram every 8 hours may also be administered as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.

Renal Impairment: Dosage should be reduced in patients with creatinine clearance less than 51 mL/min.

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

There is inadequate information regarding the use of Ultrapenem in patients on hemodialysis. There is no experience with peritoneal dialysis.

Hepatic Impairment: No dosage adjustment is necessary in patients with impaired hepatic function.

Elderly: No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.

Children: For pediatric patients from 3 months of age and older, the Ultrapenem injection, dose is 10, 20 or 40 mg/kg every 8 hours (maximum dose is 2 g every 8 hours), depending on the type of infection (complicated skin and skin structure infections, intra-abdominal or meningitis). Pediatric patients weighing over 50 kg should be administered Ultrapenem injection at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every hour for intra-abdominal infections and 2 g every 8 hours for meningitis. Ultrapenem injection, should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) infusion over approximately 3-5 minutes. There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 g) bolus dose.

Ultrapenem interactions

See also:
What other drugs will affect Ultrapenem?

Probenecid competes with Ultrapenem for active tubular secretion and thus, inhibits the renal excretion, with the effect of increasing the elimination t_½ and plasma concentration of Ultrapenem. As the potency and duration of action of Ultrapenem dosed without probenecid are adequate, the co-administration of probenecid with Ultrapenem is not recommended.

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

Ultrapenem may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.

Ultrapenem has been administered concomitantly with other medications without adverse pharmacological interactions. However, no other specific data regarding potential drug interactions is available (apart from probenecid as mentioned above).

Incompatibilities: Ultrapenem should not be mixed with or added to other drugs. Ultrapenem is incompatible with the following infusion fluids: Sodium chloride solution 0.9%, glucose solution 5% or 10%, glucose 5% solution with sodium bicarbonate 0.02%, glucose 5% solution with sodium chloride 0.9%, glucose 5% with sodium chloride 0.225% solution, glucose 5% with potassium chloride 0.15% solution, Mannitol 2.5% or 10% solution.

Ultrapenem side effects

See also:
What are the possible side effects of Ultrapenem?

Ultrapenem is generally well tolerated. In clinical trials, adverse events lead to cessation of treatment in <1% of patients. Serious adverse events are rare.

Common Events: Local IV Injection Site Reactions: Inflammation, thrombophlebitis, pain.

Gastrointestinal Disorders: Nausea, vomiting, diarrhea.

Hematologic: Reversible thrombocythemia.

Hepatic Function: Reversible increases in serum transaminases, bilirubin, alkaline phosphatase and lactic dehydrogenase alone or in combination have been reported.

Uncommon Events (<1%): Systemic Allergic Reactions: Systemic allergic reactions (hypersensitivity) may occur following administration of Ultrapenem. These reactions may include angioedema and manifestations of anaphylaxis.

Dermatologic: Rash, pruritus, urticaria, severe skin reactions eg, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been observed.

Gastrointestinal Disorders: Pseudomembranous colitis. Jaundice and hepatic failure have been reported but a causal link with Ultrapenem has not been established.

Blood and Lymphatic System Disorders: Eosinophilia, leukopenia, thrombocytopenia, neutropenia, agranulocytosis, hemolytic anemia has been observed very rarely. A positive direct or indirect Coombs' test may develop.

Cardiovascular: Cardiac failure has been reported but a causal link with Ultrapenem has not been established.

Central Nervous System: Headache, paresthesia. Delirium, hallucinations and convulsions have been reported but a causal link with Ultrapenem has not been established.

Respiratory: Pneumonia and respiratory failure have been reported but a causal link with Ultrapenem has not been established.

Body as a Whole: Fever and septicemia have been reported but a causal link with Ultrapenem has not been established.

Others:

Oral and vaginal candidiasis.

Ultrapenem contraindications

See also:
What is the most important information I should know about Ultrapenem?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Ultrapenem, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Ultrapenem or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Active ingredient matches for Ultrapenem:

Meropenem in Georgia.

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. PubChem. "meropenem". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "meropenem". http://www.drugbank.ca/drugs/DB00760 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology