Description
Oritavancin injection is used to treat acute bacterial skin and skin structure infections (ABSSSI). Oritavancin belongs to the group of medicines known as antibiotics. It works by killing bacteria or preventing their growth. Oritavancin will not work for colds, flu, or other virus infections.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of oritavancin injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oritavancin injection in the elderly. However, elderly patients are more sensitive to the effects of oritavancin injection than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Heparin
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cholera Vaccine, Live
- Warfarin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to glycopeptides (eg, dalbavancin, telavancin, vancomycin) or
- Osteomyelitis (bone infection)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1 hour.
Precautions
It is very important that your doctor will check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine together with warfarin may increase the risk of bleeding. If you use warfarin, tell your doctor right away if you have bleeding gums, dizziness, nosebleeds, red or black, tarry stools, red or dark brown urine, trouble breathing, or are coughing up blood.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
You should not receive a heparin injection if you have received oritavancin within the past 120 hours (5 days). Receiving these medicines together may affect the results of some tests.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.
This medicine may cause infusion-related reactions that can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a cough, difficulty with swallowing, dizziness, a fast heartbeat, trouble breathing, swelling in your face or hands, a fever, chills, itching or hives, or a feeling of warmth or redness on your upper body with this medicine.
This medicine may cause diarrhea, and in some cases it can be severe. It may also occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without checking with your doctor. If mild diarrhea continues or gets worse or you have questions, check with your doctor.
Tell your doctor right away if you have bone pain. This may be a symptom of a bone infection (osteomyelitis).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
- Accumulation of pus
- changes in skin color
- dry, red, hot, or irritated skin
- fast, pounding, or irregular heartbeat or pulse
- fever
- pain, swelling, or tenderness in the skin
- swollen, red, tender area of infection
Less common
- Anxiety
- black, tarry stools
- blistering, peeling, or loosening of the skin
- blurred vision
- chest pain or tightness
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- difficulty in moving
- dizziness
- headache
- hives, itching skin, or rash
- increase in bone pain
- increased hunger
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back, side, or stomach pain
- muscle aches, cramps, pains, or stiffness
- nervousness
- nightmares
- noisy breathing
- painful or difficult urination
- pale skin
- red, irritated eyes
- redness or soreness of the skin
- seizures
- shakiness
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the eyelids, face, lips, hands, feet, ankles, or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Stomach cramps or tenderness
- watery and severe diarrhea, which may also be bloody
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Hard lump, pain, redness, or pale skin at the site of injection
- nausea or vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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