Tranquilyn

Attention Deficit Hyperactivity Disorder (ADHD)

Tranquilyn (Tranquilyn HCl, USP) Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Tranquilyn in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who met DSM-IV criteria for ADHD.

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.

Need For Comprehensive Treatment Program

Tranquilyn is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use

The effectiveness of Tranquilyn for long-term use, i.e., for more than 3 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Tranquilyn for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Tranquilyn is administered once daily in the morning, before breakfast.

Tranquilyn may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed. Patients should be advised to avoid alcohol while taking Tranquilyn.

Dosage should be individualized according to the needs and responses of the patient.

Initial Treatment

The recommended starting dose of Tranquilyn is 20 mg once daily. Dosage may be adjusted in weekly 10-20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended.

Maintenance/Extended Treatment

There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Tranquilyn. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Tranquilyn for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Dose Reduction And Discontinuation

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Tranquilyn is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Tranquilyn is also used to treat narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Tranquilyn works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. Tranquilyn is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Tranquilyn is available only with your doctor's prescription.

Administer orally once daily. As the effect has been shown to be present 12 hrs after dosing, Tranquilyn should be taken once daily in the morning.

Tranquilyn should be swallowed whole with the aid of liquids and must not be chewed, divided, or crushed. It may be administered with or without food.

Patients New to Tranquilyn: The recommended starting dose of Tranquilyn for patients who are not currently taking Tranquilyn or stimulants other than Tranquilyn is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults.

Patients Currently Using Tranquilyn: The recommended dose of Tranquilyn for patients who are currently taking Tranquilyn twice daily or 3 times daily, at doses of 10-60 mg/day, is provided as follows: Recommended Dose Conversion from Tranquilyn Regimens to Tranquilyn: Tranquilyn 5 mg twice daily or 3 times daily: Tranquilyn 18 mg every morning; Tranquilyn 10 mg twice daily or 3 times daily: Tranquilyn 36 mg; Tranquilyn 15 mg twice daily or 3 times daily: Tranquilyn 54 mg every morning; Tranquilyn 20 mg twice daily or 3 times daily: Tranquilyn 72 mg every morning.

Clinical judgement should be used when selecting the dose for patients currently taking Tranquilyn in other regimens.

Dose Titration: Dosage should be individualized according to the needs and responses of the patient. Doses may be increased in 18-mg increments at weekly intervals. Daily dosages above 54 mg in children, 72 mg in adolescents and 108 mg in adults have not been studied and are not recommended.

Maintenance/Extended Treatment: The long-term use of Tranquilyn has not been systematically evaluated in controlled trials. The physician who elects to use Tranquilyn for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy.

Dose Reduction and Discontinuation: If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or if necessary, Tranquilyn should be discontinued.

Children <6 years: Use of Tranquilyn in patients <6 years has not been studied in controlled trials. Tranquilyn should not be used in patients <6 years.

Elderly: Use of Tranquilyn in elderly patients >65 years has not been studied in controlled trials.

See also:
What is the most important information I should know about Tranquilyn?

Agitation

Tranquilyn is contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms.

Hypersensitivity To Tranquilyn Or Other Excipients

Tranquilyn is contraindicated in patients known to be hypersensitive to Tranquilyn or other components of the product.

Tranquilyn contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Glaucoma

Tranquilyn is contraindicated in patients with glaucoma.

Tics

Tranquilyn is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.

Monoamine Oxidase Inhibitors

Tranquilyn is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Hypertension And Other Cardiovascular Conditions

Tranquilyn is contraindicated in patients with severe hypertension, angina pectoris, cardiac arrhythmias, heart failure, recent myocardial infarction, hyperthyroidism or thyrotoxicosis.

Halogenated Anesthetics

There is a risk of sudden blood pressure increase during surgery. If surgery is planned, Tranquilyn should not be taken on the day of the surgery.

Use Tranquilyn system as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tranquilyn system comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tranquilyn system refilled.
• Do not remove the patch from the pouch until you are ready to apply it.
• Do NOT use the patch if the pouch seal is open or damaged or if the patch is cut or damaged in any way.
• Do NOT apply the patch to skin that is oily, damaged, or irritated, or skin that has lotion or powder on it. Do NOT apply to an open wound or cut skin.
• Do NOT apply the patch to the waistline or anywhere that tight clothing may rub it or cause it to fall off.
• Apply the patch 2 hours before the effect is needed, unless your doctor tells you otherwise.
• Gently wash and completely dry the application area before you apply the patch. Open the pouch. Remove the protective liner from the patch. Apply the patch to a clean, dry area on the hip. Hold it in place for 30 seconds. Be sure the edges are firmly attached to the skin. Choose a new area on the opposite hip each day when you apply the patch.
• Wash your hands immediately after handling Tranquilyn system.
• Remove the patch 9 hours after it is applied, unless your doctor tells you otherwise.
• Remove the patch slowly. If the patch is difficult to remove, apply an oil-based product (eg, petroleum jelly, mineral oil) to the patch edges, gently working it underneath the edges. Oil or lotion may be used to remove any glue that remains on the skin after the patch has been removed.
• After removing the used patch, fold it in half with the sticky sides together. Throw the patch away in a container with a lid. You may also ask your doctor or pharmacist for other ways to dispose of Tranquilyn system. Be sure it is out of the reach of children and away from pets.
• Do NOT flush the pouches or protective liners down the toilet. Throw these items away in a container with a lid, out of the reach of children and away from pets.
• If the patch falls off during the day, be sure you know when and how the patch came off. Choose a different site on the same hip and apply a new patch. Remove the patch at the regularly scheduled time.
• Do not wear the patch any longer than 9 hours in a 24-hour period.
• Use the administration chart that comes with Tranquilyn system to monitor the date and time that you apply and remove the patch. Also record how you dispose of it.
• Throw away any unused patches as soon as they are no longer needed. Remove the patches from the pouch and remove the protective liners. Fold the patches in half with the sticky sides together. Throw the patches away in a container with a lid, or ask your doctor or pharmacist for other ways to properly dispose of Tranquilyn system. Be sure they are out of the reach of children and away from pets. Wash your hands after throwing away Tranquilyn system.
• If you miss a dose of Tranquilyn system, apply the missed patch if you remember that day, then remove the patch at the regularly scheduled time. If it is close to the time that you would regularly remove the patch or if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule the next day. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tranquilyn system.

This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Tranquilyn belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

How to use Tranquilyn transdermal

Read the Medication Guide provided by your pharmacist before you start using Tranquilyn and each time you get a refill. Read and follow all directions in the Patient Information Leaflet. Learn how to properly use, store, and discard the patches. If you have any questions, ask your doctor or pharmacist.

Apply this medication to the skin as directed by your doctor, usually once daily in the morning, 2 hours before you need the effects of this drug. Then remove the patch as directed by your doctor, usually 9 hours later. Applying this medication late in the day may cause trouble sleeping (insomnia). If you apply this patch in the early morning and still have trouble sleeping, your doctor may direct you to remove the patch within less than 9 hours. Carefully follow your doctor's instructions.

This medication should be applied to a clean, dry area of skin on the hip. Before applying the patch, gently wash, rinse, and dry the application area. Do not apply to cut or irritated skin. Remove the patch from the pouch and apply right away as directed. Do not cut the patch. When using a new patch the next day, apply to an area of skin on the other hip to avoid irritation. Do not apply a heating pad or other heat to the patch area since this may increase the risk of side effects. Bathing, swimming, or showering may affect how well the patch stays on the skin. If the patch does not stick properly or falls off, replace with a new patch at another site. Remove the new patch at your usual time, usually 9 hours after applying the first patch.

After removing the patch, fold it in half with the sticky sides together and throw it away as directed. Do not touch the sticky side with your fingers. Wash your hands after applying or removing the patch.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

When used for a long time, this medication may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition does not improve or if it worsens.

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What other drugs will affect Tranquilyn?

Tranquilyn is metabolized primarily by de-esterification (nonmicrosomal hydrolytic esterases) to ritalinic acid and not through oxidative pathways.

The effects of gastrointestinal pH alterations on the absorption of Tranquilyn from Tranquilyn have not been studied. Since the modified release characteristics of Tranquilyn are pH dependent, the coadministration of antacids or acid suppressants could alter the release of Tranquilyn.

Tranquilyn may decrease the effectiveness of drugs used to treat hypertension. Because of possible effects on blood pressure, Tranquilyn should be used cautiously with pressor agents.

As an inhibitor of dopamine reuptake, Tranquilyn may be associated with pharmacodynamic interactions when coadministered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) as well as dopamine antagonists (antipsychotics, e.g., haloperidol).

Case reports suggest a potential interaction of Tranquilyn with coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine) but pharmacokinetic interactions were not confirmed when explored at higher sample sizes. Downward dose adjustment of these drugs may be required when given concomitantly with Tranquilyn. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant Tranquilyn.

Tranquilyn is not metabolized by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on Tranquilyn pharmacokinetics. Conversely, the d- and l- enantiomers of Tranquilyn did not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.

Tranquilyn coadministration did not increase plasma concentrations of the CYP2D6 substrate desipramine.

An interaction with the anticoagulant ethylbiscoumacetate in 4 subjects was not confirmed in a subsequent study with a higher sample size (n=12).

Other specific drug-drug interaction studies with Tranquilyn have not been performed in vivo.

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What are the possible side effects of Tranquilyn?

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Tranquilyn hydrochloride based on the comprehensive assessment of the available adverse event information. A causal relationship with Tranquilyn hydrochloride usually cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trial Data: Double-Blind Data: Adverse Drug Reactions Reported at ≥1% Frequency: Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations.

Pediatric patients: The safety of Tranquilyn was evaluated in 639 pediatric patients (children and adolescents) with ADHD who participated in 4 placebo-controlled, double-blind clinical trials. Three (3) of the studies were conducted in children aged 6-12 years: 2 were cross-over studies in which patients received Tranquilyn (doses of either 18, 36 or 54 mg/day), immediate-release Tranquilyn and placebo for each of 7 days. The 3rd study was a parallel group comparison in which patients were randomised to Tranquilyn (doses of either 18, 36 or 54 mg/day), immediate-release Tranquilyn or placebo for 28 days. In a 4th study, adolescents aged 13-18 years, receiving Tranquilyn doses of 18, 36, 54 or 72 mg/day were randomised into a 2-week placebo-controlled, double-blind phase following an open-label 4 weeks titration phase. The information presented as mentioned was derived from pooled data.

Adverse Drug Reactions (ADRs) reported by ≥1% of Tranquilyn-treated subjects in these trials are shown as follows.

The majority of ADRs were mild to moderate in severity.

Adults: The safety of Tranquilyn was evaluated in 905 adult patients with ADHD who participated in 3 placebo-controlled, double-blind clinical trials. The information presented in this section was derived from pooled data.

Adverse reactions reported by ≥1% of Tranquilyn-treated adult patients in these trials are shown as follows.

The majority of ADRs were mild to moderate in severity.

Open-Label Data - Adverse Drug Reactions Reported at ≥1% Frequency: The safety of Tranquilyn was evaluated in 3,782 pediatric and adult patients with ADHD who participated in 12 open-label clinical trials. The information presented in this section was derived from pooled data.

Adverse reactions reported by ≥1% of Tranquilyn-treated subjects in these trials and not listed in Tables 3 and 4 are shown as follows.

The majority of ADRs were mild to moderate in severity.

Double-Blind and Open-Label Data - Adverse Drug Reactions Reported at <1% Frequency: Additional adverse reactions that occurred in <1% of Tranquilyn-treated pediatric and adult patients in the double-blind and open-label clinical datasets are listed as follows.

The majority of ADRs were mild to moderate in severity.

Post-Marketing Data: Adverse reactions identified during post-marketing experience with Tranquilyn are included in Table 7. The frequencies are provided according to the following convention: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare:<1/10,000, including isolated reports.

In Table 7, ADRs are presented by frequency category based on incidence in clinical trials, when known.

Tranquilyn HCl is d,l(racemic)methylα-phenyl-2-piperidineacetate HCl. Its empirical formula is C₁₄H₁₉NO₂·HCl.

Tranquilyn HCl is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77.

Tranquilyn also contains the following excipients: Butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, isopropyl alcohol, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide and triacetin.