Telavancin hydrochloride
What is Telavancin hydrochloride?[edit | edit source]
- Telavancin hydrochloride (VIBATIV) is a lipoglycopeptide antibacterial drug used to treat adults with certain types of germs (bacteria).
What are the uses of this medicine?[edit | edit source]
This medicine is used alone, or with other medicines, to treat adults with certain types of germs (bacteria) that cause:
- Serious skin infections
- Hospital-Acquired Bacterial Pneumonia (HABP)
- Ventilator-Associated Bacterial Pneumonia (VABP)
How does this medicine work?[edit | edit source]
- Like vancomycin, telavancin binds tightly to the D-alanyl-D-alanine residue of cell wall precursors, thereby interfering with bacterial cell wall synthesis.
- In addition, the lipophilic moiety of telavancin may interact with the lipid bilayer in the bacterial cell membrane, thereby compromising the integrity of cell membrane and causing cell membrane depolarization.
- This novel mechanism of action may contribute to telavancin's rapid bactericidal activity and its improved activity over vancomycin against some antibiotic resistance gram-positive bacteria.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients:
- with known hypersensitivity to telavancin
What drug interactions can this medicine cause?[edit | edit source]
- Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.
Is this medicine FDA approved?[edit | edit source]
- FDA approved this drug in the year of 2013.
How should this medicine be used?[edit | edit source]
Recommended Dosage: Complicated Skin and Skin Structure Infections:
- The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥18 years of age by intravenous infusion once every 24 hours for 7 to 14 days.
Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP)ː
- The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥18 years of age by intravenous infusion once every 24 hours for 7 to 21 days.
- Dosage adjustment in patients with renal impairment.
Administration
- VIBATIV is given by your healthcare provider through a needle placed into your vein (IV infusion) slowly over 1 hour, 1 time each day, for 7 to 21 days.
- Do not stop receiving VIBATIV unless your healthcare provider tells you to, even if you feel better.
- Your healthcare provider will do blood tests before you start and while you receive VIBATIV.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Single-use vials containing either 250 or 750 mg telavancin.
This medicine is available in fallowing brand namesː
- VIBATIV
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
VIBATIV may cause serious side effects, including:
- Increased risk of death
- New or worsening kidney problems
- VIBATIV may harm your unborn baby
- Serious allergic reactions
- Infusion-related reactions
- Problems with the electrical system of your heart (QTc prolongation)
What special precautions should I follow?[edit | edit source]
- Decreased efficacy among patients treated for skin and skin structure infections with moderate/severe pre-existing renal impairment. Consider these data when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min.
- Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.
- VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome”-like reactions including: flushing of the upper body, urticaria, pruritus, or rash. Stopping or slowing the infusion may result in cessation of these reactions.
- Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Prescribing VIBATIV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval.
- Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.
What to do in case of emergency/overdose?[edit | edit source]
Management of overdosage:
- In the event of overdosage, VIBATIV should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function.
- No information is available on the use of hemodialysis to treat an overdosage.
- The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study.
- However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdosage is unknown.
Can this medicine be used in pregnancy?[edit | edit source]
- There are no data on VIBATIV use in pregnant women.
- There is a pregnancy registry that monitors pregnancy outcomes in women exposed to VIBATIV during pregnancy.
- Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the VIBATIV pregnancy registry by calling 1-855-MED-THRX (1-855-633-8479).
Can this medicine be used in children?[edit | edit source]
- The safety and effectiveness of VIBATIV in pediatric patients has not been studied.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- Active ingredient: telavancin hydrochloride
- Inactive ingredients: hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin), mannitol, sodium hydroxide and hydrochloric acid
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured for: Theravance, Inc. South San Francisco
What should I know about storage and disposal of this medication?[edit | edit source]
- Store original packages at refrigerated temperatures of 2 to 8°C (35 to 46 °F).
- Excursions to ambient temperatures (up to 25 °C (77 °F)) are acceptable.
- Avoid excessive heat.
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