Orbactiv 400mg Sol For Inj, 3 Vials

Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive bacteria. It inhibits bacterial cell wall synthesis by binding to the D-Ala-D-Ala terminus of peptidoglycan precursors, thereby inhibiting transglycosylation (polymerization) and transpeptidation (cross-linking). Additionally, it disrupts bacterial membrane integrity, leading to depolarization, increased permeability, and cell death.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Infusion-related reactions, such as:
+ Flushing
+ Rash on the face, neck, trunk, or arms
+ Back pain
+ Chest pain
+ Chills
+ Shakiness
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps. This could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD), which may occur during or after antibiotic treatment.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:

Headache
Irritation at the injection site
Diarrhea
Upset stomach
Vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as prolonged use may increase the risk of a second infection.

After completing treatment with this drug, do not receive heparin intravenously for at least 120 hours (5 days), as this may interfere with the effectiveness of heparin. Additionally, this medication may impact the accuracy of certain laboratory tests used to monitor heparin's efficacy. Be sure to discuss this with your doctor.

Clinical studies have reported cases of severe bone infections in patients treated with this medication. If you experience any bone pain, promptly notify your doctor.

This drug may also affect the results of other laboratory tests. Therefore, it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• Warfarin (Oritavancin can falsely prolong aPTT, PT, and INR for up to 24 hours, and ACT for up to 12 hours. If co-administration is necessary, consider alternative coagulation tests not affected by Oritavancin, such as Factor Xa activity assays, or collect blood samples for coagulation testing prior to Oritavancin infusion.)
• Heparin (Oritavancin can falsely prolong aPTT and ACT. Avoid concomitant use of unfractionated heparin for 5 days after Oritavancin administration due to interference with aPTT monitoring. If heparin is required, consider alternative anticoagulants or alternative coagulation tests.)

• Rash
• Hives
• Itching
• Swelling of face/lips/tongue/throat
• Difficulty breathing
• Dizziness
• Fainting
• Flushing
• Severe diarrhea
• Abdominal pain
• Fever
• New or worsening signs of infection

Category C. There are no adequate and well-controlled studies of Oritavancin in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether Oritavancin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established.

No overall differences in safety or effectiveness were observed between elderly subjects (65 years and older) and younger subjects. No dosage adjustment is necessary based on age.

• Oritavancin is a single-dose IV antibiotic, which can be advantageous for patient adherence and outpatient treatment of ABSSSI.
• It has a very long half-life (approx. 10 days), meaning its effects persist for an extended period after a single dose.
• Be aware of the interference with common coagulation tests (aPTT, PT/INR, ACT) for up to 5 days post-infusion. This is an assay interference, not an actual effect on coagulation. If coagulation monitoring is critical, use alternative tests (e.g., Factor Xa activity) or collect samples before Oritavancin administration.
• Ensure proper infusion rate (over 3 hours) to minimize infusion-related reactions.
• Confirm the infection is caused by susceptible Gram-positive organisms before administration.

• Dalbavancin (another single-dose lipoglycopeptide)
• Telavancin (lipoglycopeptide)
• Vancomycin (glycopeptide)
• Linezolid (oxazolidinone)
• Daptomycin (lipopeptide)
• Ceftaroline (cephalosporin)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may have additional patient information leaflets, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.