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DOSAGE AND ADMINISTRATION
General Instruction For Use
Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of guanfacine release. Do not administer with high fat meals, due to increased exposure.
Take INTUNIV orally once daily, either in the morning or evening, at approximately the same time each day. Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week.
In monotherapy clinical trials, there was dose-and exposure-related clinical improvement as well as risks for several clinically significant adverse reactions (hypotension, bradycardia, sedative events). To balance the exposure-related potential benefits and risks, the recommended target dose range depending on clinical response and tolerability for INTUNIV® is 0.05-0.12 mg/kg/day (total daily dose between 1-7 mg. (See Table 1).
Table 1: Recommended Target Dose Range for Therapy
|Weight||Target dose range (0.05 - 0.12 mg/kg/day)|
|25-33.9 kg||2-3 mg/day|
|34-41.4 kg||2-4 mg/day|
|41.5-49.4 kg||3-5 mg/day|
|49.5-58.4 kg||3-6 mg/day|
|58.5-91 kg||4-7 mg/day|
|> 91 kg||5-7 mg/day|
|Doses above 4 mg/day have not been evaluated in children (ages 6-12 years) and doses above 7 mg/day have not been evaluated in adolescents (ages 13-17 years)|
In the adjunctive trial which evaluated INTUNIV® treatment with psychostimulants, the majority of patients reached optimal doses in the 0.05-0.12 mg/kg/day range. Doses above 4 mg/day have not been studied in adjunctive trials.
Periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Switching From Immediate-Release Guanfacine To INTUNIV®
If switching from immediate-release guanfacine, discontinue that treatment, and titrate with INTUNIV® following above recommended schedule.
Do not substitute for immediate-release guanfacine tablets on a milligram-per-milligram basis, because of differing pharmacokinetic profiles. INTUNIV® has significantly reduced Cmax (60% lower), bioavailability (43% lower), and a delayed Tmax (3 hours later) compared to those of the same dose of immediate-release guanfacine [see CLINICAL PHARMACOLOGY].
When discontinuing INTUNIV, taper the daily dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension.
When reinitiating patients to the previous maintenance dose after two or more missed consecutive doses, consider titration based on patient tolerability.
Dosage Adjustment With Concomitant Use Of Strong CYP3A4 Inhibitors Or Inducers
Dosage adjustments for INTUNIV® are recommended with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole), or CYP3A4 inducers (e.g., carbamazepine) (Table 2) [see DRUG INTERACTIONS].
Table 2: INTUNIV® Dosage Adjustments for
Patients Taking Concomitant CYP3A4 Inhibitors or Inducers
|Starting INTUNIV® while currently on a CYP3A4 modulator||Continuing INTUNIV® while adding a CYP3A4 modulator||Continuing INTUNIV® while stopping a CYP3A4 modulator|
|CYP3A4 Strong Inhibitors||Decrease INTUNIV® dosage to half the recommended level. (see Table 1)||Decrease INTUNIV® dosage to half the recommended level. (see Table 1)||Increase INTUNIV® dosage to recommended level. (see Table 1)|
|CYP3A4 Strong Inducers||Consider increasing INTUNIV® dosage up to double the recommended level. (see Table 1)||Consider increasing INTUNIV® dosage up to double the recommended level over 1 to 2 weeks. (see Table 1)||Decrease INTUNIV® dosage to recommended level over 1 to 2 weeks. (see Table 1)|
Dosage Forms And Strengths
1 mg, 2 mg, 3 mg and 4 mg extended-release tablets
Storage And Handling
INTUNIV® is supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets in 100 count bottles.
|1 mg||2 mg||3 mg||4 mg|
|Debossment (top/bottom)||503 / 1 mg||503 / 2 mg||503 / 3 mg||503 / 4 mg|
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature.
Manufactured for Shire US Inc., Wayne, PA 19087. Revised: 11/2014
Last reviewed on RxList: 12/4/2014
This monograph has been modified to include the generic and brand name in many instances.
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