FOCALIN 20mg. Tablets.

$360.00$945.00

in stock
SKU: FOCALIN-20

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Description

FORMULATION:

Dexmethylphenidate Hydrochloride 20mg.

 

 

BOXED WARNING

DOSAGE & INDICATIONS

 

For the treatment of attention-deficit hyperactivity disorder (ADHD).
Oral dosage (immediate-release formulations; e.g., Focalin)
Adults

Initially, 2.5 mg PO twice daily for those not currently taking methylphenidate. When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the oral daily dose of racemic methylphenidate. May adjust dose at weekly intervals in 2.5 to 5 mg increments. Max: 20 mg/day (10 mg PO twice daily). If paradoxical aggravation of symptoms or other adverse reactions occur, the dosage should be reduced, or, if necessary, discontinued. If improvement is not observed after appropriate dosage adjustment over a 1-month period, discontinue the drug.

Children and Adolescents 6 years and older

Initially, 2.5 mg PO twice daily, with doses given at least 4 hours apart. When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the total daily dose of racemic methylphenidate (for example, if the patient is currently receiving methylphenidate 10 mg PO twice daily, begin with dexmethylphenidate 5 mg PO twice daily). May titrate daily dose in 2.5 to 5 mg increments at weekly intervals. Max: 20 mg/day per FDA-approved labeling; however, some experts recommend a maximum dose of 50 mg/day. If no improvement within 1 month, discontinue dexmethylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Oral dosage (extended-release formulations; e.g., Focalin XR)
Adults

Initially, 10 mg PO once daily in the morning if not currently taking methylphenidate or dexmethylphenidate. When converting from immediate-release dexmethylphenidate to extended-release dexmethylphenidate, give the total daily dexmethylphenidate dose once daily in the morning. When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the oral daily dose of racemic methylphenidate given once daily in the morning. Adjust dose at weekly intervals in 10 mg increments if needed. Max: 40 mg/day. If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or if necessary, discontinued. If improvement is not observed after appropriate dosage adjustment over a 1-month period, discontinue the drug.

Children and Adolescents 6 years and older

Initially, 5 mg PO once daily in the morning if not currently taking methylphenidate or dexmethylphenidate. When converting from immediate-release dexmethylphenidate to extended-release dexmethylphenidate, give the total daily dexmethylphenidate dose once daily in the morning (for example, if the patient is currently receiving immediate-release dexmethylphenidate 10 mg PO twice daily, then begin with extended-release dexmethylphenidate 20 mg PO once daily). When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the total daily dose of racemic methylphenidate, given once daily in the morning (for example, if the patient is currently receiving extended-release methylphenidate 20 mg PO once daily, they should begin with extended-release dexmethylphenidate 10 mg PO once daily). May titrate daily dose in 5 mg increments at weekly intervals. Max: 30 mg/day per FDA-approved labeling; however, some experts recommend a maximum dose of 50 mg/day. If no improvement within 1 month, discontinue dexmethylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

MAXIMUM DOSAGE

Adults

20 mg/day PO immediate-release formulation; 40 mg/day PO extended-release formulation.

Geriatric

20 mg/day PO immediate-release formulation; 40 mg/day PO extended-release formulation.

Adolescents

20 mg/day PO immediate-release formulation and 30 mg/day PO extended-release formulation (FDA-approved labeling); however, up to 50 mg/day PO has been used off-label (both formulations).

Children

6 years and older: 20 mg/day PO immediate-release formulation and 30 mg/day PO extended-release formulation (FDA-approved labeling); however, up to 50 mg/day PO has been used off-label (both formulations).
5 years and younger: Safety an efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

DOSING CONSIDERATIONS

Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; use with caution, as dexmethylphenidate is metabolized by the liver.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

ADMINISTRATION

Oral Administration
Oral Solid Formulations

A MedGuide is available which informs patients about the cardiac and psychiatric risks associated with use, and should be provided by the authorized dispenser to each patient receiving a prescription.
Immediate-release tablets: Administer twice daily, with doses at least 4 hours apart. Depending on the patient’s needs, twice-daily dosages may be administered in the morning and around noon. Individualized timing of the midday dose may be necessary. May be administered with or without food.
Once-daily extended-release capsules: Administer once daily in the morning. May be administered without regard to meals and swallowed whole with the aid of liquids. Do NOT crush, chew, or cut in half. If swallowing is difficult, the capsule may be opened and the contents gently sprinkled on one tablespoon of cold applesauce (not warm- warm applesauce could change the characteristics of the medication) and swallowed. The capsule contents (beads) should not be crushed or chewed. Prepare the sprinkle dose just prior to administration (do not store for future use). Drinking some fluids (e.g., water, milk or juice), should follow the intake of the sprinkles with applesauce.

STORAGE

Focalin:
– Protect from light
– Protect from moisture
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Focalin XR:
– Store at controlled room temperature (between 68 and 77 degrees F)

Additional information

months

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Tablets

90 tablets, 180 tablets, 270 tablets

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