RITALIN 10mg. Tablets.

$360.00$945.00

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SKU: RITA-10

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Description

FORMULATION:

Methylphenidate hydrochloride 10mg.

 

 

BOXED WARNING

DOSAGE & INDICATIONS

 

For the treatment of attention-deficit hyperactivity disorder (ADHD).
For once-daily product dosing.
Oral dosage (extended-release once-daily tablets; e.g., Concerta)
Adults up to 65 years not currently taking methylphenidate

Initially, 18 to 36 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adults up to 65 years currently taking 10 to 15 mg/day methylphenidate

Initially, 18 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adults up to 65 years currently taking 20 to 30 mg/day methylphenidate

Initially, 36 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adults up to 65 years currently taking 30 to 45 mg/day methylphenidate

Initially, 54 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adults up to 65 years currently taking 40 to 60 mg/day methylphenidate

72 mg PO once daily in the morning. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older not currently taking methylphenidate

Initially, 18 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. A 27-mg tablet is available for prescribers who wish to utilize a dosage between 18 to 36 mg. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older currently taking 10 to 15 mg/day methylphenidate

Initially, 18 mg PO once daily in the morning. Titrate dose by 18 mg increments at weekly intervals as needed. A 27-mg tablet is available for patients who may benefit from a dosage between 18 to 36 mg. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older currently taking 20 to 30 mg/day methylphenidate

Initially, 36 mg PO once daily in the morning. Titrate dose by 18 mg increments at weekly intervals as needed. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older currently taking 30 to 45 mg/day methylphenidate

Initially, 54 mg PO once daily in the morning. Titrate dose by 18 mg increments at weekly intervals as needed and as clinically appropriate. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adolescents currently taking 40 to 60 mg/day methylphenidate

Initially, 72 mg PO once daily in the morning. While the FDA-approved maximum dosage is 72 mg/day (not to exceed 2 mg/kg/day), some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Titrate dosage by 18 mg increments no more frequently than weekly intervals as clinically appropriate. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate 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 once-daily capsules; e.g., Metadate CD)
Adults not currently taking methylphenidate

Initially, 20 mg PO once daily in the morning. When in the judgment of the clinician a lower dosage is indicated for initial treatment, it is recommended that patients begin treatment with an immediate-release product first. Dose may be increased by 10 to 20 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adults currently taking other dosage forms of methylphenidate

Initially, 20 mg PO once daily in the morning. Alternatively, give an equivalent total daily dosage as the previous methylphenidate product PO once daily, rounded to the closest available capsule size. For example, patients already taking 10 mg of immediate-release methylphenidate twice daily (20 mg/day) should start with 20 mg Metadate CD once daily; those taking 20 mg twice daily (40 mg/day) should start with 40 mg Metadate CD once daily. Dose may be increased by 10 to 20 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older not currently taking methylphenidate

Initially, 20 mg PO once daily in the morning. Dose may be increased by 10 to 20 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day for patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older currently taking other dosage forms of methylphenidate

Initially, 20 mg PO once daily in the morning. Alternatively, give no more than the equivalent total daily dose of the previous methylphenidate product, rounded to the nearest available capsule size, PO once daily. For example, patients already taking 10 mg of immediate-release methylphenidate twice daily (20 mg/day) should start with 20 mg Metadate CD once daily; those taking 20 mg twice daily (40 mg/day) could start with 40 mg Metadate CD once daily. Dose may be increased by 10 to 20 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day for patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate 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 once-daily capsules; e.g., Ritalin LA)
Adults not currently taking methylphenidate

Initially, 20 mg PO once daily in the morning. If a lower initial dose is desired, patients may begin treatment with 10 mg PO once daily. Dose may be increased by 10 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Adults currently taking other dosage forms of methylphenidate

Initially, give no more than the total daily dosage of the previous methylphenidate product PO once daily in the morning. Dose may be increased by 10 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older not currently taking methylphenidate

Initially, 20 mg PO once daily in the morning. If a lower initial dose is desired, 10 mg PO once daily may be used. Dose may be increased by 10 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older currently taking other dosage forms of methylphenidate

Initially, give no more than the total daily dosage of the previous methylphenidate product PO once daily in the morning. For example, patients already taking 10 mg of immediate-release methylphenidate twice daily (20 mg/day) should start with 20 mg Ritalin LA once daily; those taking 20 mg of extended-release methylphenidate once daily (20 mg/day) should also start with 20 mg of Ritalin LA once daily. Dose may be increased by 10 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate 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 once-daily capsules; e.g., Aptensio XR)
Children and Adolescents 6 years and older

Initially, 10 mg PO once daily in the morning. Dose may be increased by 10 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts have recommended doses up to 100 mg/day of other methylphenidate formulations in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate 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 once-daily chewable tablets; e.g., QuilliChew ER)
Children and Adolescents 6 years and older

Initially, 20 mg PO once daily in the morning. Dose may be titrated up or down in increments of 10 mg, 15 mg, or 20 mg at weekly intervals. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. FDA-approved Maximum: 60 mg/day PO; however, some experts have recommended doses up to 100 mg/day of other methylphenidate formulations in patients weighing more than 50 kg. If switching from another methylphenidate product, discontinue that treatment and titrate with QuilliChew ER as previously described; do not substitute QuilliChew ER for other methylphenidate products on a mg-for-mg basis. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate 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 once-daily suspension; e.g., Quillivant XR)
Children and Adolescents 6 years and older

Initially, 20 mg PO once daily in the morning. Dose may be increased by 10 to 20 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts have recommended doses up to 100 mg/day of other methylphenidate formulations in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate 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 orally disintegrating tablets; e.g., Cotempla XR-ODT)
Children and Adolescents 6 years and older

Initially, 17.3 mg PO once daily in the morning; take consistently with or without food. Dose may be increased by 8.6 to 17.3 mg increments at weekly intervals. FDA-approved Max: 51.8 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Transdermal dosage (transdermal system; e.g., Daytrana)
Children and Adolescents 6 years and older

Initially, apply a 10 mg/9-hour patch topically once daily in the morning, 2 hours before an effect is needed, regardless of previous methylphenidate therapy. If response is not maximized after 1 week, titrate to the next available patch strength in weekly intervals. The suggested upward titration schedule is Week 1: apply 10 mg/9-hour patch once daily; Week 2: apply 15 mg/9-hour patch once daily; Week 3: apply 20 mg/9-hour patch once daily; Week 4: apply 30 mg/9-hour patch once daily. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. Maximum: 30 mg/9-hour patch once daily. In clinical trials, there was no additional benefit of increasing the patch dose from 20 mg/9-hours to 30 mg/9-hours. Remove the patch 9 hours after application or may remove earlier if late day side effects appear and shorter duration of effect is desired.

Oral dosage (immediate-release preparations, e.g., Ritalin, Methylin, Methylin oral solution, Methylin chewable tablets)
Adults

Average effective dose is 20 to 30 mg/day PO divided and given in 2 to 3 divided doses 30 to 45 minutes before meals. Range: 10 to 60 mg/day PO. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 pm.

Children and Adolescents 6 years and older

Initially, 5 mg PO twice daily before breakfast and lunch. Dose may be increased by 5 to 10 mg/day at weekly intervals; some patients may require dosing up to 3 times daily (administer last dose of day before 6 pm to limit sleep interference). Max: 60 mg/day per FDA-approved labeling; however, some experts state that doses up to 100 mg/day may be needed in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children 3 to 5 years†

The National Institute of Mental Health’s Preschool ADHD Treatment Study (PATS) provides clinical guidance for children with ADHD 3 to 5 years of age. In the PATS, the initial dose of immediate-release methylphenidate was 1.25 mg PO 3 times daily. Doses were increased gradually up to a maximum of 10 mg PO 3 times daily to reach optimum therapeutic response. The mean optimal total daily dose was 14.2 +/- 8.1 mg (0.7 +/- 0.4 mg/kg/day). Max: 30 mg/day. In all cases, treatment should start with a low dose and be titrated upward slowly. Use lowest effective dose. Higher doses have lead to social withdrawal in some children. Behavior therapy, parental training, and a structured preschool environment are considered first line treatment for preschool-aged children with ADHD; lack of significant improvement with such modalities may warrant the addition of methylphenidate.

Oral dosage (extended-release tablets, e.g., Ritalin SR, Metadate ER, Methylin ER)
Adults

The extended-release (ER) tablets have a duration of action of approximately 8 hours. Use in place of immediate-release (IR) tablets when the 8-hour dosage of these ER tablets corresponds to the previously titrated 8-hour dosage of the IR tablets. Max: 20 mg PO 3 times daily. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

Children and Adolescents 6 years and older

The extended-release (ER) tablets have a duration of action of approximately 8 hours. Use in place of immediate-release (IR) tablets when the 8-hour dosage of the ER tablets corresponds to the previously titrated 8-hour dosage of the IR tablets. Alternatively, some experts recommend an initial dose of 10 mg PO once daily. Ritalin SR may be administered once or twice daily. Max: 60 mg/day per FDA-approved labeling; however, some experts state that doses up to 100 mg/day may be needed in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.

For the treatment of narcolepsy.
Oral dosage (immediate-release formulations; e.g., Ritalin, Methylin)
Adults

Average dose 20 to 30 mg/day; range 10 to 60 mg/day PO in 2 to 3 divided doses, 30 to 45 minutes before meals. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children and Adolescents 6 years and older

Initially, 5 mg PO twice daily before breakfast and lunch. May increase by 5 to 10 mg/day PO at weekly intervals. Max: 60 mg/day.

Oral dosage (extended-release tablets; e.g., Ritalin SR, Metadate ER)
Adults, Adolescents, and Children 6 years and older

The extended-release (ER) tablets have a duration of action of approximately 8 hours. Therefore, use in place of immediate-release (IR) tablets when the 8-hour dosage of the ER tablets corresponds to the previously titrated 8-hour dosage of the IR tablets. Max: 60 mg/day.

For the treatment of major depression† or post-stroke depression refractory to other therapies.
NOTE: The use of stimulants for the treatment of depressive disorders is usually limited to treatment-refractory cases or when standard medical therapies are not tolerated. Stimulants may aggravate coexisting anxiety or agitation in depressed patients.
Oral dose (immediate-release tablets)
Adults

Initially, 2.5 mg PO twice daily administered in the morning and at noon; increase by 2.5—5 mg PO every 2 or 3 days as tolerated, until the desired response is achieved. Roughly 50% of patients appear to respond to treatment.

Geriatric

Initially, 2.5 mg PO twice daily administered in the morning and at noon; increase by 2.5—5 mg PO every 2 or 3 days as tolerated, until the desired response is achieved. Dosage in elderly patients with post-stroke depression has ranged from 15—40 mg/day PO after dosage titration for a mean of 15 days. Roughly 50% of patients appear to respond to treatment.

†Indicates off-label use

MAXIMUM DOSAGE

Adults

72 mg/day PO.

Geriatric

72 mg/day PO.

Adolescents

72 mg/day (Max: 2 mg/kg/day) PO for Concerta (FDA-approved labeling) and 60 mg/day PO for all other oral formulations excluding Cotempla XR-ODT (FDA-approved labeling); 51.8 mg/day PO for Cotempla XR-ODT; however, doses up to 100 to 108 mg/day PO have been used in patients weighing more than 50 kg for some formulations. For the transdermal patch, 30 mg/9-hour patch per day is the maximum.

Children

6 to 12 years: 54 mg/day PO for Concerta (FDA-approved labeling) and 60 mg/day PO for all other oral formulations excluding Cotempla XR-ODT (FDA-approved labeling); 51.8 mg/day PO for Cotempla XR-ODT; however, doses up to 100 to 108 mg/day PO have been used in patients weighing more than 50 kg. For the transdermal patch, 30 mg/9-hour patch per day is the maximum.
3 to 5 years: Safety and efficacy have not been established. Maximum doses have not been adequately studied; however The Preschool ADHD Treatment Study (PATS) has suggested immediate-release doses up to 30 mg/day PO.
1 to 2 years: Safety and 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.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Renal clearance is not an important predictor of methylphenidate clearance.

ADMINISTRATION

Oral Administration
Oral Solid Formulations

Methylin chewable tablets: Administer with at least 8 ounces of fluid to avoid choking.
Immediate-release dosage forms (Ritalin, Methylin, Metadate, generic equivalents): Administer 30 to 45 minutes before meals. Depending on the patient’s needs, twice-daily dosages may be administered in the morning and around noon. Individualized timing of the midday dose is usually necessary, as determined by the loss of positive drug effect which occurs in a range of 2 to 6 hours after the morning dose.
Extended-release tablets (Ritalin SR, Metadate ER, generic methylphenidate ER): May be administered without regard to meals. Administer whole; do not cut, crush, or chew. Administer the last dose of the day several hours before bedtime. Extended-release tablets may be used when the determined 8 hour dose of immediate-release methylphenidate tablets equals the 8 hour dosage of the extended-release tablets.
Once-daily extended-release tablets (Concerta): May be administered without regard to meals. Administer whole; do not cut, crush, or chew. The biologically inert portion of this tablet may appear intact in the stool; this is normal.
Once-daily extended-release capsules (Metadate CD, Ritalin LA, Aptensio XR): May be administered without regard to meals; however, the manufacturer of Aptensio XR recommends that patients establish a routine pattern with regard to meals. Administer with an adequate amount of fluid. Do not cut, crush, or chew. If swallowing is difficult, the capsule may be opened and the contents gently sprinkled on one tablespoon of applesauce and swallowed immediately. The capsule contents (beads) should not be crushed or chewed. Instruct the patient to drink fluids (e.g., water, milk, or juice) after the intake of the sprinkles with applesauce.
Once-daily extended-release chewable tablets (QuilliChew ER): Administer once daily in the morning with or without food. The 10 mg and 15 mg doses can be achieved by breaking in half the scored 20 mg and 30 mg tablets, respectively.
Once-daily extended-release orally disintegrating tablets (Cotempla XR-ODT): Administer once daily in the morning consistently either with or without food. Do not remove tablet from the blister pack until just prior to dosing; use dry hands when opening the blister pack. Remove the tablet by peeling back the foil; do not push the tablet through the foil. Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing. No liquid is needed to take the tablet.

Oral Liquid Formulations

Immediate-release oral solution (Methylin)
Measure methylphenidate dosage with an oral syringe or calibrated measuring device.
Administer 30 to 45 minutes before meals in divided doses 2 to 3 times daily. Twice-daily dosages may be administered in the morning and around noon. Individualized timing of the midday dose is usually necessary, as determined by the loss of positive drug effect which occurs 2 to 6 hours after the morning dose. Administer the last dose of the day prior to 6 p.m.

Once-daily extended-release oral suspension (Quillivant XR)
Vigorously shake the bottle of suspension for a minimum of 10 seconds.
Measure dosage with the calibrated oral dosing dispenser provided.
Administer in the morning without regard to meals.

Reconstitution of once-daily extended-release oral suspension (Quillivant XR)
Review the manufacturer’s reconstitution instructions for the particular product and package size.
Prior to reconstitution, tap the bottle several times to loosen the powder.
To prepare the suspension, add the specified amount of water to the bottle, fully insert the bottle adapter into the bottle neck, replace the cap, and vigorously shake the bottle for at least 10 seconds.
Storage: Store reconstituted suspension at 77 degrees F; dispense in original packaging (bottle in container). The reconstituted suspension is stable for 4 months from date of reconstitution.

Topical Administration
Transdermal Patch Formulations

Daytrana transdermal system:
Patch should be applied 2 hours before the effect is needed.
Do not cut or trim patch.
Apply patch immediately after opening the pouch and removing protective liner. Do not use if pouch seal is broken. Do not touch the adhesive side of the patch during application to avoid absorption of methylphenidate. Wash hands immediately if adhesive side of the patch is touched. Discard the patch if difficulty is encountered in separating the patch from the release liner, or if tearing or other damage occurs. Discard patch if adhesive containing medication has transferred to the liner during removal of the patch from the liner.
Place on a dry, clean area of the hip and hold in place for 30 seconds with the palm of the hand. Do not apply to oily, damaged, or irritated skin. Do not apply topical preparations to the application site immediately prior to patch application. Avoid the waistline area where the patch could be rubbed by clothing.
Applications sites should be alternated from one hip to the next each day, avoiding sites where a patch was recently placed, when possible.
Instruct patient on proper application and disposal of patch. Adherence of the patch may be affected by showering, bathing, or swimming. The carton contains an administration chart that can help the patient monitor application and removal time, which the patient and/or caregiver should be encouraged to use. If a patch was removed without the caregiver’s knowledge, or if a patch is missing from the tray, the caregiver should be encouraged to ask the child when and how the patch was removed.
Avoid exposing the application site to hair dryers, heating pads, electric blankets, heated water beds, or other direct external heat sources. The rate and extent of absorption of methylphenidate are significantly increased during application of heat to the patch during use. Temperature-dependent increases in absorption may be greater than 2-fold, potentially resulting in overdose.
Do not apply or re-apply the patch with dressings, tape, or adhesives. If the patch is not fully adhered to the skin during application or wear time, discard the patch according to disposal instructions and apply a new patch.
The total daily wear time should not exceed 9 hours, regardless of patch replacement.
Patches should be peeled off slowly. Patch removal may be aided by applying an oil-based product (i.e., petroleum jelly, mineral oil, olive oil) to the patch edges and gently working the oil underneath the edges of the patch.
Disposal: Instruct patient and/or caregiver to fold used patches, so that the adhesive side of the patch adheres to itself, and then flush it down the toilet or dispose of in an appropriate lidded container. If the patient stops using the prescription, each unused patch should be removed from its pouch, separated from the protective liner, folded onto itself, and flushed down the toilet or disposed of in an appropriate lidded container. Do not flush pouch and protective liner down the toilet. Instead, dispose of them in an appropriate container with a lid.

STORAGE

Generic:
– Protect from moisture
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Aptensio XR:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Concerta:
– Avoid excessive humidity
– Protect from moisture
– Store at controlled room temperature (between 68 and 77 degrees F)
Daytrana:
– Do not freeze
– Do not refrigerate
– Product should be used within 2 months after opening
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
– Store unused product in foil pouch
Metadate CD:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Metadate ER:
– Protect from moisture
– Store solution at 68 to 77 degrees F, excursions permitted to 59 to 86 degrees F
Methylin:
– Store at controlled room temperature (between 68 and 77 degrees F)
QuilliChew ER:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
QUILLIVANT XR:
– Store and dispense in original container
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Ritalin:
– Protect from light
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Ritalin LA:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Ritalin SR:
– Protect from moisture
– Store solution at 68 to 77 degrees F, excursions permitted to 59 to 86 degrees F

Additional information

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Tablets

90 tablets, 180 tablets, 270 tablets

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