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(gefitinib) Tablets, 250 mg
IRESSA® (gefitinib tablets) contain 250 mg of gefitinib and are available as brown film-coated tablets for daily oral administration.
Gefitinib is an anilinoquinazoline with the chemical name 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-4-morpholin) propoxy] and the following structural formula:
It has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 and is a white-colored powder. Gefitinib is a free base. The molecule has pKas of 5.4 and 7.2 and therefore ionizes progressively in solution as the pH falls. Gefitinib can be defined as sparingly soluble at pH 1, but is practically insoluble above pH 7, with the solubility dropping sharply between pH 4 and pH 6. In non-aqueous solvents, gefitinib is freely soluble in glacial acetic acid and dimethylsulphoxide, soluble in pyridine, sparingly soluble in tetrahydrofuran, and slightly soluble in methanol, ethanol (99.5%), ethyl acetate, propan-2-ol and acetonitrile.
The inactive ingredients of IRESSA (getfitinib) tablets are: Tablet core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate and magnesium stearate. Coating: Hypromellose, polyethylene glycol 300, titanium dioxide, red ferric oxide and yellow ferric oxide.
What are the possible side effects of gefitinib (Iressa)?
If you experience any of the following serious side effects from gefitinib, contact your doctor immediately:
- an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- lung problems (difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);
- severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or
- eye pain or irritation.
Other, less serious side effects may be more likely to occur. Continue taking gefitinib and talk to your doctor if you...
What are the precautions when taking getfitinib (Iressa)?
Before taking this medication, 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease (e.g., pulmonary fibrosis), severe kidney disease, eye problems, stomach/intestinal ulcers, other stomach/intestinal problems (such as diverticulitis, blockage, bowel disease), smoking, cancer that has spread to the bowels.
Gefitinib is not recommended for use during pregnancy. It may cause harm to an unborn baby. Consult your doctor for more details.
It is not known whether this drug passes...
Last reviewed on RxList: 10/2/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Iressa Information
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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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