What is Tevapenem?
Tevapenem injection is used to treat infections caused by bacteria. It works by killing the bacteria or preventing their growth. Tevapenem will not work for colds, flu, or other virus infections.
Tevapenem 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, Tevapenem is used in certain patients with the following medical condition:
- Febrile neutropenia (treatment).
Tevapenem indications
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tevapenem I.V. and other antibacterial drugs, Tevapenem 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.
Tevapenem 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)
Tevapenem 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)
Tevapenem 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)
Tevapenem 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 Tevapenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of Streptococcus pneumoniae has not been established.
Tevapenem I.V. has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
How should I use Tevapenem?
Use Tevapenem as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tevapenem is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Tevapenem at home, a health care provider will teach you how to use it. Be sure you understand how to use Tevapenem. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Tevapenem if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- To clear up your infection completely, use Tevapenem 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 Tevapenem, 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 Tevapenem.
Uses of Tevapenem 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, Tevapenem 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), Tevapenem 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, Tevapenem is effective and recommended in the management of catheter-related bloodstream infection.
Clinical experience also suggests the utility of Tevapenem for the treatment of bloodstream infection caused by gram-negative pathogens, including Pseudomonas aeruginosa.
Tevapenem description
The chemical name of Tevapenem 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*),4α,5β,6β(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 Tevapenem trihydrate is C17H25N3O5S·3H2O and its CAS number is 119478-56-7.
DBL Tevapenem for Injection is presented as a sterile white to pale yellow crystalline powder containing Tevapenem trihydrate equivalent to Tevapenem, 500 mg or 1 g, blended with sodium carbonate anhydrous. DBL Tevapenem for Injection contains 208 mg sodium carbonate anhydrous and 90.2 mg of sodium for each gram of Tevapenem (anhydrous potency). It contains no antimicrobial preservative and is for use in one patient on one occasion only..
Tevapenem dosage
Adults: The recommended dose of Tevapenem 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. Tevapenem 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 Tevapenem 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 Tevapenem 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 Tevapenem 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. Tevapenem 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.
Tevapenem interactions
See also:
What other drugs will affect Tevapenem?
Probenecid competes with Tevapenem for active tubular secretion and thus, inhibits the renal excretion, with the effect of increasing the elimination t½ and plasma concentration of Tevapenem. As the potency and duration of action of Tevapenem dosed without probenecid are adequate, the co-administration of probenecid with Tevapenem is not recommended.
The potential effect of the Tevapenem on the protein-binding of other drugs or metabolism has not been studied. The protein-binding of Tevapenem is low (approximately 2%) and therefore, no interactions with other compounds based on displacement from plasma proteins would be expected.
Tevapenem may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.
Tevapenem 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: Tevapenem should not be mixed with or added to other drugs. Tevapenem 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.
Tevapenem side effects
See also:
What are the possible side effects of Tevapenem?
Tevapenem 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 Tevapenem. 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 Tevapenem 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 Tevapenem has not been established.
Central Nervous System: Headache, paresthesia. Delirium, hallucinations and convulsions have been reported but a causal link with Tevapenem has not been established.
Respiratory: Pneumonia and respiratory failure have been reported but a causal link with Tevapenem has not been established.
Body as a Whole: Fever and septicemia have been reported but a causal link with Tevapenem has not been established.
Others:
Oral and vaginal candidiasis.
Tevapenem contraindications
See also:
What is the most important information I should know about Tevapenem?
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 Tevapenem, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Tevapenem 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 Tevapenem:
Meropenem in Bulgaria.
List of Tevapenem substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Talmor (India) | |
| Talmor 1000 mg Injection (Talent Healthcare) | $ 0.01 |
| Tisopenum (Georgia) | |
| Tripenem (Indonesia) | |
| Tripenem 0.5 g x 1's (Dexa Medica) | $ 24.55 |
| Tripenem 1 g x 1's (Dexa Medica) | $ 45.32 |
| Tripenem 1 (Vietnam) | |
| Tripenem 1 1 g x 1 Bottle | |
| TROYPENEM | |
| TROYPENEM 1000 MG INJECTION 1 vial / 1 injection each (Troikaa Pharmaceuticals Ltd) | $ 6.78 |
| TROYPENEM 500 MG INJECTION 1 vial / 1 injection each (Troikaa Pharmaceuticals Ltd) | $ 3.01 |
| Troypenem 1000mg Injection (Troikaa Pharmaceuticals Ltd) | $ 6.78 |
| Troypenem 500mg Injection (Troikaa Pharmaceuticals Ltd) | $ 3.01 |
| U Life | |
| U Life 250 mg Injection (Uniword Marketing (P) Ltd) | $ 7.23 |
| U Life 1000 mg Injection (Uniword Marketing (P) Ltd) | $ 0.02 |
| U Life 500 mg Injection (Uniword Marketing (P) Ltd) | $ 0.01 |
| ULTIBLAST | |
| Ultrapenem (Georgia) | |
| V-Nem (India) | |
| V-Nem 1g AMP / 1 (Veliko) | $ 22.89 |
| V-Penum (India) | |
| V-Penum 500mg POWD / 1 (Intas) | $ 7.82 |
| V-PENUM 500MG/500MG INJECTION 1 vial / 1 injection each (Intas) | $ 8.61 |
| V-PENUM INJECTION 1 vial / 1 injection each (Intas) | $ 5.74 |
| VALUPENEM | |
| VALUPENEM 1000MG INJECTION 1 vial / 2 ML injection each (Abbott India Ltd) | $ 9.63 |
| Valupenem 1gm Injection (Abbott India Ltd) | $ 4.81 |
| Varnem | |
| Varnem 1000mg Injection (Varenyam Healthcare Pvt Ltd) | $ 7.59 |
| Varnem 500mg Injection (Varenyam Healthcare Pvt Ltd) | $ 4.01 |
| VENCER | |
| VENCER 1000MG INJECTION 1 vial / 10 ML injection each (Unimark) | $ 26.39 |
| VENCER 125MG INJECTION 1 vial / 1 injection each (Unimark) | $ 2.71 |
| VENCER 500MG INJECTION 1 vial / 1 injection each (Unimark) | $ 11.24 |
| Vencer 125mg Injection (Unimark) | $ 2.71 |
| Vencer 500mg Injection (Unimark) | $ 11.24 |
| Veropen (India) | |
| Veropen 1g POWD / 1 (Ventus) | |
| Veropen 125mg POWD / 1 (Ventus) | |
| VERPENEM | |
| VERPENEM 1000MG INJECTION 1 vial / 1 injection each (Karnataka Antibiotics & Pharmaceuticals Ltd) | $ 19.88 |
| VERPENEM 500MG INJECTION 1 vial / 1 injection each (Karnataka Antibiotics & Pharmaceuticals Ltd) | $ 7.70 |
| Verpenem 500mg Injection (Karnataka Antibiotics & Pharmaceuticals Ltd) | $ 7.70 |
| Vhpenem-1g (Vietnam) | |
| Vhpenem-1g 1 g x 1 Bottle | |
| Vilipen (Colombia) | |
| VINEM (India) | |
| Vivem (India) | |
| Vivem 500mg VIAL / 1 (Intas) | |
| Vivem 1000mg VIAL / 1 (Intas) | |
| VIVEM 1000MG INJECTION 1 vial / 1 injection each (Intas) | $ 27.86 |
| VIVEM 500MG INJECTION 1 vial / 5 ML injection each (Intas) | $ 16.39 |
| Vivem 1000mg Injection (Intas) | $ 27.86 |
| Vivem 500mg Injection (Intas) | $ 3.28 |
| VIVEM PLUS | |
| VIVEM PLUS 1000MG INJECTION 1 vial / 1 GM injection each (Intas Pharmaceuticals Ltd) | $ 10.32 |
See 1239 substitutes for Tevapenem | |
References
- 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).
- PubChem. "meropenem". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "meropenem". http://www.drugbank.ca/drugs/DB00760 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Tevapenem are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tevapenem. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
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Information checked by Dr. Sachin Kumar, MD Pharmacology
