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Sapropterin dihydrochloride

Latest prescription information about Sapropterin dihydrochloride. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Sapropterin dihydrochloride
Pronunciation : SAP-roe-TER-in
Therapeutic Classification : Miscellaneous
Trade Name(s): 
International- Kuvan.
Why it is prescribed (Indications) : 
This medication is a synthetic preparation of the tetrahydrobiopterin (BH4), prescribed for phenylketonuria.  
When it is not to be taken (Contraindications): 
Hypersensitivity.

Pregnancy Category :

A B C D X
Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Dosage & When it is to be taken : 
Adult- PO- The recommended starting dose is 10 mg/kg/day taken once daily. The dose may be increased upto 20 mg/kg/day.
How it should be taken : 
It comes as a tablet to take by mouth, with food.
Warnings and Precautions : 
* Caution should be exercised in patients with history of liver or kidney impairment, fever, poor nutrition, loss of appetite, any allergy, who are taking other medications, especially in children less than 4 years old, during pregnancy and breastfeeding.
* It may cause dizziness, do not drive a car or operate machinery while taking this medication.
* Follow the diet program as directed by your healthcare provider.
Side Effects : 
Most Serious Effects - Stomach inflammation, spinal cord injury, infection, testicular cancer and urinary tract infection.
Most Common - Headache, diarrhea, abdominal pain, upper respiratory tract infection, throat pain, vomiting, and nausea.
Miscellaneous - Dizziness, gastrointestinal bleeding, post-procedural bleeding, irritability, heart attack, over stimulation, respiratory failure, swelling in the extremities, joint pain, increased urination, and agitation.
Other Precautions : 
* Avoid excess dosage.
Storage Conditions : 
Store it at room temperature (20° to 25°C), and in an airtight container. Protect from moisture.

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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