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FDA Drug Import News

Import Rules Regarding Personal Medicine Orders:

Current FDA policy is not a law or a regulation, but serves as guidance for FDA personnel.

The importation of certain unapproved prescription medications for personal use may be allowed in some circumstances where these factors apply:


    1). The Drug is for personal use and is a 3-month supply or less and not for resale or commercialization.

    2). If no drug commercialization or drug promotion to U.S. residents by pharmacy companies involved in the distribution of the necessary drug exists.

    3). If an individual seeking to import the drug affirms in writing, that it is for the patient's private use and provides the name and address of the licensed American physician responsible for treatment.

    4). Provides evidence that the drug is for continuation of a treatment begun in a foreign country.

    5). The intended use is for a serious condition for which effective treatment may not be available domestically.

    6). If the product is not considered to represent an unreasonable health issue.

    7). Overnite FedEx shipments require copy of your identification and the prescription.

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Ergamisol (levamisole)

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Product ID : ergamisol
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Description

What is Ergamisol (levamisole)?

Levamisole is a cancer (antineoplastic) medication. Levamisole interferes with the growth of cancer cells and slows their growth and spread in the body.

Levamisole is used in the treatment of colon cancer.

Levamisole may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ergamisol (levamisole)?

Serious side effects have been reported with the use of levamisole including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function or blood problems (fever or chills; or signs of infection); nervous system problems (confusion or loss of consciousness, extreme fatigue, memory loss, muscle weakness, numbness or tingling; seizure, speech disturbances); and others. Talk to your doctor about the possible side effects from treatment with levamisole.

What should I discuss with my healthcare provider before taking Ergamisol (levamisole)?

Do not use levamisole without first talking to your doctor if you have

  • liver disease;
  • a seizure disorder;

  • a bleeding or blood clotting disorder; or

  • poor bone marrow function.

The use of levamisole may be dangerous if you have any of the conditions listed above.

How should I use Ergamisol (levamisole)?

Take levamisole exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose by mouth with a full glass of water.

Your doctor will determine the correct amount and frequency of treatment with levamisole depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor may want you to have blood tests and other medical evaluations during treatment with levamisole to monitor progress and side effects.

Your healthcare provider will store levamisole as directed by the manufacturer. If you are storing levamisole at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of levamisole.

What happens if I overdose?

If for any reason an overdose of levamisole is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a levamisole overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Ergamisol (levamisole)?

Levamisole can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with levamisole. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Alcohol should be avoided or used with caution while taking levamisole. Flushing, nausea, vomiting, headache, swelling, and rashes have occurred when alcohol has been used during treatment with levamisole.

Ergamisol (levamisole) side effects

If you experience any of the following serious side effects from levamisole, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  • decreased bone marrow function or blood problems (extreme fatigue; or fever, chills, or signs of infection); or

  • nervous system problems (confusion or loss of consciousness, extreme fatigue, memory loss, muscle weakness, numbness or tingling; seizure, speech disturbances).

Other, less serious side effects may be more likely to occur. Continue taking levamisole and talk to your doctor if you experience:

  • nausea, vomiting, or loss of appetite;

  • diarrhea;

  • sores in the mouth or on the lips; or

  • rash and itching.

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with levamisole.

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