Prior to treating patients with Obesin, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Obesin use.
Obesin may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.
Obesin should be taken as follows:
The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years.
The recommended dose is Obesin 12.5 mg daily.
Patients taking ADDERALL XR may be switched to Obesin at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Obesin and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, Obesin aspartate monohydrate, and Obesin sulfate extended-release capsules) is also referred to as mixed salts of a single-entity Obesin product extended-release capsules (MAS ER).
Table 1: Equivalent Doses of Obesin and ADDERALL XR (Mixed Salts of a Single-Entity Obesin Product) Extended-Release Capsules
|Obesin||3.1 mg||6.3 mg||9.4 mg||12.5 mg||15.7 mg||18.8 mg|
|Obesin extended-release orally disintegrating tablets|
|ADDERALL XR||5 mg||10 mg||15 mg||20 mg||25 mg||30 mg|
|Mixed salts of a single-entity Obesin product extended-release capsules (MAS ER)|
If switching from any other Obesin products, discontinue that treatment, and titrate with Obesin using the titration schedule.
Do not substitute for other Obesin products on a milligram-per-milligram basis because of different Obesin base compositions and differing pharmacokinetic profiles.
Agents that alter urinary pH can impact urinary excretion and alter blood levels of Obesin. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Obesin dosage accordingly.
Obesin 3.1 mg Obesin Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)
Obesin 6.3 mg Obesin Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)
Obesin 9.4 mg Obesin Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)
Obesin 12.5 mg Obesin Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)
Obesin 15.7 mg Obesin Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)
Obesin 18.8 mg Obesin Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)
Obesin 3.1 mg Extended Release
Obesin 6.3 mg Extended Release
Obesin 9.4 mg Extended Release
Obesin 12.5 mg Extended Release
Obesin 15.7 mg Extended Release
Obesin 18.8 mg Extended Release
Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)
Store Obesin blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-XXX-XXX-XXXX.
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Obesin at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Obesin with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Obesin in the household trash.
Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016
Do not take Obesin if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days.
Before taking Obesin, tell your doctor if you are taking any of the following medicines:
insulin or another medicine to treat diabetes;
guanethidine (Ismelin) or reserpine (Diutensin-R);
doxazosin (Cardura), terazosin (Hytrin), prazosin (Minipress), or guanadrel(Hylorel);
a tricyclic antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil), clomipramine (Anafranil), protriptyline (Vivactil), or desipramine (Norpramin)
a phenothiazine such as chlorpromazine (Thorazine);
lithium (Lithobid, Lithonate, Eskalith, others); or
You may not be able to take Obesin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with Obesin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
Table 2: Drugs having clinically important interactions with amphetamines.
|MAO Inhibitors (MAOI)|
|Clinical Impact||MAOI antidepressants slow Obesin metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.|
|Intervention||Do not administer Obesin during or within 14 days following the administration of MAOI.|
|Examples||selegiline, isocarboxazid, phenelzine, tranylcypromine|
|Clinical Impact||Increase blood levels and potentiate the action of Obesin.|
|Intervention||Co-administration of Obesin and gastrointestinal alkalinizing agents should be avoided.|
|Examples||Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate). Urinary alkalinizing agents (e.g. acetazolamide, some thiazides).|
|Clinical Impact||Lower blood levels and efficacy of amphetamines.|
|Intervention||Increase dose based on clinical response.|
|Examples||Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid). Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).|
|Clinical Impact||May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Obesin in the brain; cardiovascular effects can be potentiated.|
|Intervention||Monitor frequently and adjust or use alternative therapy based on clinical response.|
|Proton Pump Inhibitors|
|Clinical Impact||Time to maximum concentration (Tmax) of Obesin is increased compared to when administered alone.|
|Intervention||Monitor patients for changes in clinical effect and adjust therapy based on clinical response.|
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
Obesin contains Amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).
Obesin, is a CNS stimulant that contains Amphetamine which has a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.
Signs and symptoms of Obesin abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death.
To reduce the abuse of Obesin, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Obesin use.
Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Obesin.
Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Obesin. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
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Information checked by Dr. Sachin Kumar, MD Pharmacology