"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
Gris Peg Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of the hands/feet, mental/mood changes (e.g., confusion, trouble doing normal activities), sunburn-like rash, hearing changes, butterfly-shaped facial rash (around the nose and cheeks), joint/muscle pain.
Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark/frothy urine, change in the amount of urine, signs of infection (e.g., fever, persistent sore throat).
Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Gris Peg (griseofulvin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking griseofulvin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain blood disorder (porphyria), severe liver disease (liver failure).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: lupus.
This drug may make you dizzy or less alert. Do not engage in activities requiring alertness such as driving or using machinery until you know how this drug affects you and that you can safely perform these activities.
Avoid alcoholic beverages while you are taking this drug unless your doctor gives permission. Drinking alcohol during treatment with this drug could result in a fast heartbeat and flushing of the skin.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss delaying griseofulvin treatment. Use of reliable form(s) of birth control is recommended during treatment and for 1 month after the drug is stopped. If you are planning to become pregnant within 1 month after treatment, the manufacturer recommends avoiding this drug. (See also Drug Interactions.)
The effects of this drug on human sperm are unknown. However, based on animal cell studies, the manufacturer recommends waiting for a period of time after completing griseofulvin treatment before trying to father a child. Discuss the risks and benefits with your doctor, and ask how long to wait after your last dose before trying to father a child.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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