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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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Rx News

Clomid (clomiphene citrate) 50mg x30s Tabs

Clomid (clomiphene citrate) 50mg x30s Tabs
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Price: $69.00
Product ID : clomid_50mgx30s
Manufacturer: AVENTIS PHARMA
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Clomid 50mg x30s Tabs $69.00
Clomiphene generic 50mg x30s Tabs $38.04
Min/Max Order: 1 / 3

Description

What is clomiphene? (Clomid?)

Clomiphene stimulates the release of hormones necessary for ovulation to occur.

Clomiphene is used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient.

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

Important information about clomiphene

Use caution when driving, operating machinery, or performing other hazardous activities. Clomiphene may cause blurred vision or other visual side effects during or shortly after therapy. Notify your doctor immediately if you develop any visual side effects and use caution when performing hazardous activities, especially under conditions of variable lighting.

Clomiphene may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Who should not take clomiphene?

Do not take clomiphene without first talking to your doctor if you;

  • might be pregnant;

  • have a thyroid problem or another endocrine disorder;

  • have undiagnosed vaginal bleeding;

  • have endometriosis or endometrial carcinoma;

  • have uterine fibroids;

  • have liver disease;

  • have ovarian cysts or ovarian enlargement not due to polycystic ovarian syndrome; or

  • have any other serious or chronic medical illness.

You may not be able to take clomiphene, or you may require a lower dose or special monitoring if you have any of the conditions listed above.

Do not take clomiphene if you are pregnant. Clomiphene is in the FDA pregnancy category X. This means that it is known to cause birth defects. It is not known whether clomiphene pass into breast milk. Do not take clomiphene without first talking to your doctor if you are breast-feeding a baby.

How should I take clomiphene?

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

Take each dose with a full glass of water.

Clomiphene is usually taken in 5 day cycles. Follow your doctor's instructions.

Store clomiphene at room temperature, away from direct light, moisture, and heat.

What happens if I miss a dose?

Contact your doctor if you miss a dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an overdose include nausea, vomiting, flushing, blurred vision, visual spots or flashes, and abdominal pain.

What should I avoid while taking clomiphene?

Use caution when driving, operating machinery, or performing other hazardous activities. Clomiphene may cause blurred vision or other visual side effects during or shortly after therapy. Notify your doctor immediately if you develop any visual side effects and use caution when performing hazardous activities, especially under conditions of variable lighting.

Usual Adult Dose for Ovulation Induction

50 mg orally once a day for 5 days. Therapy should be initiated on or near the 5th day of the menstrual cycle, but may be started at any time in patients without recent uterine bleeding.

If ovulation occurs and pregnancy is not achieved, up to 2 additional courses of clomiphene 50 mg orally once a day for 5 days may be administered. Each subsequent course may be started as early as 30 days after the previous course and after pregnancy has been excluded.

Most patients ovulate following the first course of therapy. However, if the patient fails to ovulate, a second course of 100 mg/day for 5 days may be given as early as 30 days following the initial course. A third course of 100 mg/day for 5 days may be given after 30 days, if necessary.

Treatments beyond three cycles of clomiphene, dosages greater than 100 mg once a day, and/or course durations beyond 5 days are not recommended by the manufacturer. However, successful pregnancies and term deliveries have been reported in women receiving up to 200 mg/day for 5 days, or extended 10-day course of therapy, or consecutive cycles of treatment beyond the 3 recommended by the manufacturer.

Usual Adult Dose for Lactation Suppression

50 to 100 mg orally once a day for 5 days. Generally, one course of therapy is sufficient.

Usual Adult Dose for Oligospermia

25 to 100 mg orally once a day. Therapy is generally given over a period of several months.

Renal Dose Adjustments

Dosage reductions are not recommended for patients with renal dysfunction during short term clomiphene therapy. Dosage reductions are also not recommended for patients with renal dysfunction during long term clomiphene therapy. However, the half-life of clomiphene may be prolonged with chronic therapy and patients with renal dysfunction should be monitored for patient response and tolerance.

Liver Dose Adjustments

Clomiphene is contraindicated in patients with liver disease or a history of liver dysfunction

Clomiphene side effects

Stop taking clomiphene and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving clomiphene. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;

  • flushing;

  • nausea, vomiting, or diarrhea;

  • breast tenderness or discomfort;

  • blurred vision or other visual disturbances;

  • headache; or

  • abnormal uterine bleeding.

Clomiphene may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect clomiphene?

There are no known interactions between clomiphene and other medicines. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

  • Your pharmacist has additional information about clomiphene written for health professionals that you may read.

What does my medication look like?

Clomiphene is available with a prescription generically and under the brand names Clomid and Serophene. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Clomid 50 mg - round, white, scored tablets

  • Serophene 50 mg - white, scored tablets

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