Omadacycline is prescribed to treat community-acquired bacterial pneumonia (CABP) and skin & soft tissue infections of bacterial origin in adult patients.
Omadacycline is a new tetracycline broad-spectrum antibacterial agent effective against a wide range of microorganisms such as anaerobes, Gram-positive, Gram-negative, atypical and specific drug-resistant strains.
Omadacycline works by binding to specific cellular components and disrupts the protein synthesis of the bacteria, thereby controlling its growth. It is also effective against tetracycline resistant micro-organisms.
Omadacycline should not be used in patients-
If there is an allergy to omadacycline and other tetracyclines
Pregnant and breastfeeding women
Children below 18 years of age
Who undergo treatment to correct infertility (Male & Female)
With a present history of Clostridium difficile associated diarrhea (CDAD)
The doctor can choose the dosing schedule based on the type and the severity of the bacterial infections.
The dose of omadacycline for treating community-acquired bacterial pneumonia and acute bacterial skin structure and skin infections are as follows-
Treatment Option 1: On day one an initial dose of 200 mg of omadacycline intravenous (IV) infusion given once followed by 100 mg IV maintenance dose once a day for 7 to 14 days.
Treatment Option 2: On day one an initial dose of 100 mg of omadacycline IV given twice followed by a maintenance dose of 300 mg orally once daily for 7 to 14 days.
Alternate dosing option for treating acute skin structure and skin infections-
On the first and second day take 450 mg of omadacycline once a day followed by 300 mg orally once daily as maintenance dose for 7 to 14 days.
No dose adjustment or modification of omadacycline is required to treat patients with a history of kidney or liver disease.
The use of omadacycline requires doctors approval and must be prescribed only after the confirmation of infection to avoid tolerance or the development of drug-resistant bacteria.
Omadacycline is available in injection and tablet form.
Injection should be given intravenously (IV) into the vein slowly for over 60 minutes for 200 mg IV and 30 minutes for 100 mg IV infusion.
Always use a separate IV line for giving the omadacycline injection. If the same IV line is used flush well with either 0.9% sodium chloride or 5 % dextrose depending on the solution that is used for the dilution.
Tablets should be taken with sufficient amount of water at least 4 hours before food.
Do not take any food, dairy products, ulcer healing agents, multivitamins, and drinks except water for at least 2 to 4 hours after taking omadacycline tablets.
Omadacycline powder should be mixed with sterile water for injection and must be further diluted with the required volume of 0.9% sodium chloride solution or 5% dextrose. The mixture can be gently inverted for proper mixing.
The vial mixed with sterile water and the diluted solution of omadacycline should be visually inspected for the presence of any visible matter or cloudy appearance before injecting. If such things are found, do not use and discard the solution immediately.
Women of childbearing age living with active male partners must check their pregnancy status before initiating omadacycline therapy. Omadacycline can cause permanent teeth discoloration, enamel hypoplasia (thin or deficient enamel formation), and decreased bone growth in unborn babies.
Breastfeeding mothers who are treated with omadacycline should be advised not to breastfeed their babies during the treatment and wait for at least four days from the last dose to re-start.
Patients given omadacycline should be carefully observed for symptoms and signs of Clostridium difficile associated diarrhea (CDAD) such as watery or bloody stools with or without stomach pain and fever.
If CDAD is suspected or confirmed discontinue the treatment with omadacycline and provide proper medical attention with fluid or electrolyte management, protein supplements, and antibacterial medications for treating Clostridium infection.
In severe cases of CDAD, an opinion with a surgeon for a surgical evaluation should also be sought.
Monitoring for symptoms and signs of increased pressure in the brain, kidney or liver damage, pancreatitis is necessary during omadacycline therapy. Discontinue the treatment permanently if such serious side effects occur and treat the patients appropriately with proper medical care.
Patients should be strictly advised to avoid or minimize the exposure to direct sunlight, tanning beds, and treatment with Ultraviolet A or B (UV A/B) radiations. Patients moving outdoors must wear protective clothing and should apply sunscreen with the highest sun protection factor (SPF) to avoid sunburn.
Older patients with one or more additional diseases must be carefully monitored as there is a high risk of death while treating with omadacycline.
Gastrointestinal: Nausea, vomiting, loose stools, the presence of blood in stools, stomach pain, indigestion
Nervous system: Fever, headache, inability to sleep, pressure difference in the brain, taste disturbances, abnormal tiredness, vertigo
Skin: Itching, rashes, skin redness, pain and swelling at the injection site, excess sweating
Lab abnormalities: Abnormal levels of bilirubin, creatinine, liver enzymes, red blood cells, platelets
Others: Fungal infections, throat pain
Women of reproductive potential who are prescribed omadacycline should be advised to use effective contraception during the treatment to avoid unwanted pregnancy and harm to the unborn.
Women must be advised to consult the doctor immediately if they become pregnant during the omadacycline therapy.
Men and women wishing to have a child in future must utilize sperm or egg bank services before starting omadacycline treatment as their fertility status are affected during treatment.
The refrigerated diluted solution of omadacycline should be allowed to come to room temperature by keeping it in a vertical position for at least 60 minutes before injecting into the patient.
Patients taking blood thinners must reduce the dose and be carefully monitored while taking omadacycline as there is a possibility of increased risk of bleeding.
Iron-containing preparations and antacids containing aluminum, magnesium, calcium or bismuth should not be taken along with omadacycline tablets as it may affect the concentration of omadacycline resulting in treatment failure or drug-resistant bacteria.
The doctor must be informed by the patients before prescribing omadacycline if they are taking or have plans to take any prescription drugs, Over-The-Counter products, or herbal supplements to avoid unwanted side effects that could occur due to the drug combinations.
Store the vials and tablets of omadacycline at a room temperature of 20°C to 25°C.
Omadacycline diluted solution should be used within 24 hours if stored at room temperature and can be used up to 48 hours if stored in a refrigerator (2°C to 8°C).
Do not shake or keep in the freezer.
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