Kuvan Oral Tablet 100Mg Drug Medication Dosage Information
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Kuvan: Oral tablet (100mg)

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What is this Medicine?

SAPROPTERIN (SAP roe TER in) works to lower phenylalanine levels in the blood. It is used with a special diet to treat phenylketonuria. This medicine is not a cure.

In-Depth Information

KUVAN 100mg Tablet

NDC: 681350300
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Phenylketonuria (PKU)

Storage Information
Protect from moisture
Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
KUVAN 100mg Tablet

Reported Side Effects for KUVAN 100mg Tablet

Hyperactivity Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Stuffy Nose Incidence:
4.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Runny Nose Incidence:
11.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
15.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


Learning More About
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