Agrylin

DRUG DESCRIPTION

Name: AGRYLIN® (anagrelide hydrochloride)
Dosage Form:
0.5 mg capsules for oral administration
Active Ingredient: AGRYLIN®
Capsules contain 0.5 mg of anagrelide base (as anagrelide hydrochloride).
Inactive Ingredients:
Anhydrous Lactose NF, Crospovidone NF, Lactose Monohydrate NF, Magnesium stearate NF, Microcrystalline cellulose NF, Povidone USP.
Pharmacological Classification:
Platelet-reducing agent.
Chemical Name:
6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one monohydrochloride monohydrate.
Molecular formula:
C10H7Cl2N3O•HCl•H2O
Molecular weight:
310.55 Structural formula:

AGRYLIN® (anagrelide hydrochloride) Structural Formula Illustration

Appearance: Off-white powder
Solubility:

Water??????????????????.. Very slightly soluble
Dimethyl Sulfoxide???????? Sparingly soluble
Dimethylformamide??????... Sparingly soluble

What are the possible side effects of anagrelide (Agrylin)?

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 have a serious side effect such as:

  • dry cough, wheezing, night sweats;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • fast, pounding, or uneven heartbeats;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...

Read All Potential Side Effects and See Pictures of Agrylin »

What are the precautions when taking anagrelide (Agrylin)?

Before taking anagrelide, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart attack, heart failure, irregular heartbeat), lung problems, kidney problems, liver problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure...

Read All Potential Precautions of Agrylin »


Agrylin Consumer (continued)

SIDE EFFECTS: Headache, diarrhea, weakness, nausea, and dizziness may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding/bruising, black stools, swelling of the ankles/feet, rapid/difficult breathing, fainting, stomach/abdominal pain, unusual tiredness, change in the amount of urine, pink/bloody urine, vomit that looks like coffee grounds.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, confusion/mental changes, fast/irregular/pounding heartbeat, slurred speech, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 anagrelide, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart attack, heart failure, irregular heartbeat), lung problems, kidney problems, liver problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication is not recommended for use during pregnancy because of possible harm to the unborn baby. Discuss the risk and benefits with your doctor. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Agrylin Patient Information Including Side Effects

Brand Names: Agrylin

Generic Name: anagrelide (Pronunciation: an AH gre lide)

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

What is anagrelide (Agrylin)?

Anagrelide lowers the number of blood clotting cells (platelets) in the body, which helps prevent blood clots from forming.

Anagrelide is used to treat a condition called thrombocythemia (also called thrombocytosis). Thrombocythemia is a blood cell disorder in which too many platelet cells are produced, causing bleeding or blood-clotting problems.

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

What are the possible side effects of anagrelide (Agrylin)?

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 have a serious side effect such as:

  • dry cough, wheezing, night sweats;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • fast, pounding, or uneven heartbeats;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever, chills, flu symptoms;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • seizure (convulsions);
  • feeling like you might pass out;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • easy bruising or bleeding, unusual weakness; or
  • blood in your urine, painful or difficult urination.

Less serious side effects may include:

  • dizziness, mild headache;
  • mild rash or itching;
  • constipation, diarrhea, gas;
  • loss of appetite, mild nausea or stomach pain;
  • numbness or tingly feeling in your hands or feet;
  • sore throat, runny or stuffy nose, nosebleed;
  • muscle or joint pain;
  • sleep problems (insomnia); or
  • blurred vision, ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about anagrelide (Agrylin)?

You should not use this medication if you are allergic to anagrelide, or if you have moderate to severe liver or kidney disease.

Before you take anagrelide, tell your doctor if you have heart disease, kidney disease, or liver disease.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled appointments. Tell any doctor or dentist who treats you that you are taking anagrelide, especially if you need to have any type of surgery.

Do not stop taking this medication without first talking to your doctor. Stopping suddenly can make your condition worse very quickly.

Call your doctor at once if you have a serious side effect such as dry cough, trouble breathing, swelling, fast or pounding heartbeats, chest pain, sudden numbness or weakness, confusion, problems with speech or balance, severe stomach pain, seizure, fainting, blood in your urine or stools, easy bruising or bleeding, or unusual weakness.

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