"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
Chloroptic Consumer (continued)
Temporary blurred vision, burning, stinging, or redness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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: vision changes/problems.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 Chloroptic (chloramphenicol) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using chloramphenicol, 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: an eye infection due to a virus (e.g., herpes, varicella), another type of eye infection (e.g., tuberculosis, fungus), history of a bad reaction to chloramphenicol.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, anemia (low red blood cells), radiation therapy.
After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.
During pregnancy, this medication should be used only when clearly needed. This medication should not be used near or at the time of delivery due to possible harm to the newborn (gray baby syndrome). Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Additional Chloroptic Information
- Chloroptic Drug Interactions Center: chloramphenicol opht
- Chloroptic Side Effects Center
- Chloroptic Overview including Precautions
- Chloroptic FDA Approved Prescribing Information including Dosage
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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