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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

PROPECIA (finasteride) 1mg x30s Tablets

PROPECIA (finasteride) 1mg x30s Tablets
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Price: $55.00
Product ID : propecia_1x30s
Manufacturer: MERCK SHARP DOHME
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Min/Max Order: 1 / 10

Description

PROPECIA (finasteride) 1mg Tablets

Patient Education - English

  • Generic Name: finasteride
  • Pronounced: fih NAH steh ride
  • Brand Names: Propecia, Proscar

What is the most important information I should know about finasteride?

 

Finasteride should never be taken by a woman or a child. Finasteride can be absorbed through the skin, and women or children should not be permitted to handle finasteride tablets.

Before taking finasteride, tell your doctor if you have ever had an allergic reaction to this medication, or to a similar medicine called dutasteride (Avodart).

Although finasteride is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Finasteride tablets should not be handled by a woman who is pregnant or who may become pregnant.

If a woman accidentally comes into contact with this medication from a broken or crushed tablet, wash the area with soap and water right away.

Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

What is finasteride?

Finasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Finasteride is used to treat male pattern hair loss in men. It is also used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Finasteride may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking finasteride?

 

Finasteride should never be taken by a woman or a child. Finasteride can be absorbed through the skin, and women or children should not be permitted to handle finasteride tablets.

Before taking finasteride, tell your doctor if you have ever had an allergic reaction to this medication, or to a similar medicine called dutasteride (Avodart). Also tell your doctor if you have:

  • liver disease, or abnormal liver enzyme tests;
  • prostate cancer;
  • a bladder muscle disorder;
  • stricture of your urethra; or
  • if you are unable to urinate.

Although finasteride is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Finasteride tablets should not be handled by a woman who is pregnant or who may become pregnant.

If a woman accidentally comes into contact with this medication from a broken or crushed tablet, wash the area with soap and water right away.

How should I take finasteride?

 

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Finasteride can be taken with or without food.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your doctor will also test your prostate specific antigen (PSA) to check for prostate cancer. Do not miss any scheduled appointments.

It is important to use finasteride regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store this medication at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

 

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of finasteride is not expected to produce life-threatening symptoms.

What should I avoid while taking finasteride?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using finasteride.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What are the possible side effects of finasteride?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

Less serious side effects may include:

  • feeling like you might pass out;
  • swelling in your hands or feet;
  • pain in the testicles;
  • impotence, loss of interest in sex, or trouble having an orgasm;
  • abnormal ejaculation;
  • swelling or tenderness in your breasts;
  • dizziness, weakness;
  • headache;
  • runny nose; or
  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect finasteride?

There may be other drugs that can interact with finasteride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about finasteride.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Pill Pictures

Propecia (finasteride) 1 mg

Propecia (finasteride) 1 mg

Propecia Dosage and Administration

The recommended dosage is 1 mg orally once a day.

Propecia may be administered with or without meals.

In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.

How is Propecia Supplied

No. 6642 — Propecia tablets, 1 mg, are tan, octagonal, film-coated convex tablets with “stylized P” logo on one side and Propecia on the other. They are supplied as follows:

NDC 0006-0071-31 unit of use bottles of 30 (with desiccant)

NDC 0006-0071-61 PROPAK®3 - carton of 3 unit of use bottles of 30 (with desiccant)

NDC 0006-0071-54 PROPAK unit of use bottle of 90 (with desiccant)

Registered trademark of MERCK & CO., Inc.

Storage and Handling

Store at room temperature, 15-30°C (59-86°F). Keep container closed and protect from moisture.

Women should not handle crushed or broken Propecia tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. (See WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; and PRECAUTIONS, Information for Patients and Pregnancy.)

Distributed by:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Issued May 2007

9636003

US Patent No.: 5,547,957

US Patent No.: 5,571,817

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