Nilandron

DRUG DESCRIPTION

NILANDRON® tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione with the following structural formula:

NILANDRON® (nilutamide) Structural Formula Illustration

Nilutamide is a microcrystalline, white to practically white powder with a molecular weight of 317.25.

Its molecular formula is C12H10F3N3O4.

It is freely soluble in ethyl acetate, acetone, chloroform, ethyl alcohol, dichloromethane, and methanol. It is slightly soluble in water [ < 0.1% W/V at 25°C (77°F)]. It melts between 153°C and 156°C (307.4°F and 312.8°F).

Each NILANDRON tablet contains 150 mg of nilutamide. Other ingredients in NILANDRON (nilutamide) tablets are corn starch, lactose, povidone, docusate sodium, magnesium stearate, and talc.

What are the possible side effects of nilutamide (Nilandron)?

If you experience any of the following serious side effects, stop taking nilutamide, and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives),
  • shortness of breath, cough, chest pain, or fever;
  • liver damage (yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, or unexplained flulike symptoms).

Other less serious...

Read All Potential Side Effects and See Pictures of Nilandron »

What are the precautions when taking nilutamide (Nilandron)?

Before taking nilutamide, 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 (such as asthma, chronic obstructive pulmonary disease-COPD, emphysema), liver problems.

This drug may rarely make you dizzy, drowsy, or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. You may also develop intolerance to alcohol while taking this medication. Avoid alcoholic beverages...

Read All Potential Precautions of Nilandron »


Nilandron Consumer (continued)

SIDE EFFECTS: See also Warning section.

Because nilutamide may be used with other medications, the side effects may be due to any one medicine or the combination of medications. Hot flashes, sweating, dizziness, loss of sexual interest/ability, vision changes (such as difficulty seeing when moving into the dark or light, changes in color vision), stomach pain, constipation, nausea, signs of alcohol intolerance (such as flushing, tiredness) dry skin, increased sensitivity to touch/pain, and loss of body hair 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.

Rarely, nilutamide has caused severe (sometimes fatal) liver problems. Seek immediate medical attention if you develop symptoms of liver problems (such as loss of appetite, persistent nausea/vomiting/stomach pain, severe tiredness, dark urine, yellowing eyes/skin). Liver problems can happen at any time while taking nilutamide, but they occur most often during the first 3-4 months of treatment. Your doctor will tell you whether to stop or continue nilutamide. Your doctor will monitor your liver function with blood tests before you start and while you are taking nilutamide. Keep all medical and laboratory appointments.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

PRECAUTIONS: Before taking nilutamide, 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 (such as asthma, chronic obstructive pulmonary disease-COPD, emphysema), liver problems.

This drug may rarely make you dizzy, drowsy, or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. You may also develop intolerance to alcohol while taking this medication. Avoid alcoholic beverages while taking this medication.

Nilutamide should not be used in women. Women who are pregnant should avoid touching or accidentally taking this medication. It may harm an unborn baby. Consult your doctor for more information.

It is not known whether this drug passes into breast milk. Women who are breast-feeding should avoid touching or accidentally taking this medication. Consult your doctor for more information.


Nilandron Patient Information Including Side Effects

Brand Names: Nilandron

Generic Name: nilutamide (Pronunciation: nih LUTE ah mide)

  • What is nilutamide (Nilandron)?
  • What are the possible side effects of nilutamide (Nilandron)?
  • What is the most important information I should know about nilutamide (Nilandron)?
  • What should I discuss with my healthcare provider before taking nilutamide (Nilandron)?
  • How should I take nilutamide (Nilandron)?
  • What happens if I miss a dose (Nilandron)?
  • What happens if I overdose (Nilandron)?
  • What should I avoid while taking nilutamide (Nilandron)?
  • What other drugs will affect nilutamide (Nilandron)?
  • Where can I get more information?

What is nilutamide (Nilandron)?

Nilutamide is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones).

Nilutamide is used in the treatment of prostate cancer.

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

What are the possible side effects of nilutamide (Nilandron)?

If you experience any of the following serious side effects, stop taking nilutamide, and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives),
  • shortness of breath, cough, chest pain, or fever;
  • liver damage (yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, or unexplained flulike symptoms).

Other less serious side effects may be more likely to occur. Continue to take nilutamide and talk to your doctor if you experience

  • hot flashes,
  • dizziness,
  • constipation,
  • nausea or vomiting,
  • skin rash,
  • loss of appetite,
  • decreased libido,
  • impotence, or
  • poor visual adaptation to darkness or other changes in vision.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nilutamide (Nilandron)?

Call your doctor immediately if you develop yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, unexplained "flu-like" symptoms, difficulty breathing, shortness of breath, cough, chest pain, or fever.

Alcohol may cause facial flushing, dizziness, and other symptoms in approximately 5% of patients when used during treatment with nilutamide. Do not drink alcohol if you experience any of these symptoms.

Nilutamide may cause a delay in your ability to see in the dark after being in a lighted area. Use caution when driving at night, when entering into a tunnel, and in other similar situations. Tinted glasses may alleviate this side effect.

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