Deferiprone Capsules 500mg Taj Pharma

1. WHAT IS DEFERIPRONE

Deferiprone binds to iron and removes it from the bloodstream.

Deferiprone is used to treat iron overload caused by blood transfusions in people with certain hereditary red blood cell disorders (thalassemia syndrome).

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

Important Information

Both men and women using deferiprone should use effective birth control to prevent pregnancy. Women should keep using birth control for at least 6 months after the last dose. Men should keep using birth control for at least 3 months after the last dose.

Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, skin sores, or sores in your mouth and throat.

  1. BEFORE TAKING THIS MEDICINE

You should not use deferiprone if you are allergic to it.

Tell your doctor if you have ever had:

It is not known whether this medicine will harm an unborn baby. Both men and women using this medicine should use effective birth control to prevent pregnancy.

  • If you are a woman,you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
  • If you are a man,use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using deferiprone.

You should not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Deferiprone is not approved for use by anyone younger than 18 years old.

  1. HOW SHOULD I TAKE DEFERIPRONE

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Deferiprone is usually taken 3 times per day. Take the first daily dose each morning, the second dose at mid-day, and the third dose in the evening.

Measure liquid medicine (oral solution) carefully. Use only the dose-measuring cup provided with the oral solution. Drink all of the medicine in the measuring cup. Then add about 1 tablespoon of water to the cup, swirl gently and drink. Hand-wash the measuring cup after each use.

Take with food if deferiprone upsets your stomach.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Deferiprone doses are based on weight. Your dose needs may change if you gain or lose weight.

Store deferiprone tablets or liquid in the original container at room temperature. Protect from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Throw away any liquid medicine not used within 35 days after you first opened the bottle.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking deferiprone?

Do not use other iron chelating medicines such as deferasirox (Exjade) or deferoxamine (Desferal), unless your doctor has told you to.

  1. DEFERIPRONE SIDE EFFECTS

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

Serious and sometimes fatal infections may occur during treatment with deferiprone. Stop using deferiprone and call your doctor right away if you have signs of infection such as:

  • fever, chills, body aches;
  • flu symptoms;
  • skin sores; or
  • sores in your mouth and throat.

Further doses may be delayed until your infection clears up.

Deferiprone may cause your urine to turn a reddish-brown color. This side effect is usually not harmful. Call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • nauseavomiting, stomach pain;
  • infections;
  • joint pain; or
  • abnormal liver function tests.

Deferiprone dosing information

Usual Adult Dose for Thalassemia:

Initial dose: 25 mg/kg, orally, 3 times a day (total daily dose: 75 mg/kg)
Maximum dose: 33 mg/kg, orally, 3 times a day (total daily dose: 99 mg/kg)
Comments:
-Round dose to the nearest 250 mg (half tablet).
-Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).
-Approval based on reduction in serum ferritin; there are no trials showing a direct treatment benefit (e.g. improved symptoms, functioning, or survival).
-Safety and efficacy have not been established for transfusional iron overload with other chronic anemias.
Use: Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Initial dose: 25 mg/kg, orally, 3 times a day (total daily dose: 75 mg/kg)
Maximum dose: 33 mg/kg, orally, 3 times a day (total daily dose: 99 mg/kg)
Comments:
-Round dose to the nearest 250 mg (half tablet).
-Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).
-Approval based on reduction in serum ferritin; there are no trials showing a direct treatment benefit (e.g. improved symptoms, functioning, or survival).
-Safety and efficacy have not been established for transfusional iron overload with other chronic anemias.
Use: Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

What other drugs will affect deferiprone?

If you take any of the following medicines, take your deferiprone dose 4 hours before or 4 hours after you take the other medicine:

  • an antiacid that contains aluminum;
  • a medicine or supplement that contains iron (including ferric citrate, FeosolFergonFerrocite, Hemocyte, and others; or
  • vitamin or mineral supplements that contain iron or zinc.

Avoid taking an herbal supplement containing milk thistle.

Other drugs may affect deferiprone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
MajorHighly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
ModerateModerately clinically significant. Usually avoid combinations; use it only under special circumstances.
MinorMinimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
UnknownNo interaction information available.

 

Deferiprone alcohol/food interactions

There is 1 alcohol/food interaction with deferiprone

Deferiprone disease interactions

There are 2 disease interactions with deferiprone which include:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store oral solution in original carton to protect from light; use contents within 35 days after first opening bottle; discard any remaining solution after 35 days.

5. PHARMACOLOGICAL PROPERTIES:

Iron-chelating agent with affinity for ferric ion (iron III); binds to ferric ion and forms a 3:1 (deferiprone:iron) complex which is excreted in the urine. Has a lower affinity for other metals such as copper, aluminum, and zinc.
5.1 Pharmacokinetics Properties:
Absorption
Rapid
Distribution
1.6 L/kg (in thalassemia patients)
Metabolism
Primarily by UGT 1A6; major metabolite (3-O-glucuronide) lacks iron-binding capacity
Excretion
Urine (75% to 90%; primarily as metabolite)
Time to Peak
1-2 hours
Half-Life Elimination
2 hours
  1. FURTHER INFORMATION

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.

Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com