Ortedrine Dosage

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Dosage of Ortedrine in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Pre-Treatment Screening

Prior to treating patients with Ortedrine, 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 Ortedrine use.

Dosing Considerations For All Patients

Ortedrine may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.

Ortedrine should be taken as follows:

  • The tablet should remain in the blister pack until the patient is ready to take it.
  • The patient or caregiver should use dry hands to open the blister.
  • Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
  • As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
  • The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
  • The tablet will disintegrate in saliva so that it can be swallowed.

Pediatric Patients

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.

Adults

The recommended dose is Ortedrine 12.5 mg daily.

Switching From Other Ortedrine Products

Patients taking ADDERALL XR may be switched to Ortedrine at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Ortedrine and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, Ortedrine aspartate monohydrate, and Ortedrine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity Ortedrine product extended-release capsules (MAS ER).

Table 1: Equivalent Doses of Ortedrine and ADDERALL XR (Mixed Salts of a Single-Entity Ortedrine Product) Extended-Release Capsules

Ortedrine 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.7 mg 18.8 mg
Ortedrine 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 Ortedrine product extended-release capsules (MAS ER)

If switching from any other Ortedrine products, discontinue that treatment, and titrate with Ortedrine using the titration schedule.

Do not substitute for other Ortedrine products on a milligram-per-milligram basis because of different Ortedrine base compositions and differing pharmacokinetic profiles.

Dosage Modifications Due To Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of Ortedrine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Ortedrine dosage accordingly.

How supplied

Dosage Forms And Strengths

Ortedrine 3.1 mg Ortedrine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)

Ortedrine 6.3 mg Ortedrine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)

Ortedrine 9.4 mg Ortedrine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)

Ortedrine 12.5 mg Ortedrine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)

Ortedrine 15.7 mg Ortedrine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)

Ortedrine 18.8 mg Ortedrine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)

Storage And Handling

Ortedrine 3.1 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30

Ortedrine 6.3 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30

Ortedrine 9.4 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30

Ortedrine 12.5 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30

Ortedrine 15.7 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30

Ortedrine 18.8 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30

Storage

Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)

Store Ortedrine 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.

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Ortedrine 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 Ortedrine 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 Ortedrine in the household trash.

Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016

What other drugs will affect Ortedrine?

Do not take Ortedrine 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 Ortedrine, 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

  • haloperidol (Haldol).

You may not be able to take Ortedrine, 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 Ortedrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Ortedrine interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Ortedrine, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Drugs Having Clinically Important Interactions With Amphetamines

Table 2: Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow Ortedrine 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 Ortedrine during or within 14 days following the administration of MAOI.
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine
Alkalinizing Agents
Clinical Impact Increase blood levels and potentiate the action of Ortedrine.
Intervention Co-administration of Ortedrine and gastrointestinal alkalinizing agents should be avoided.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate). Urinary alkalinizing agents (e.g. acetazolamide, some thiazides).
Acidifying Agents
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).
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Ortedrine in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.
Examples desipramine, protriptyline
Proton Pump Inhibitors
Clinical Impact Time to maximum concentration (Tmax) of Ortedrine is increased compared to when administered alone.
Intervention Monitor patients for changes in clinical effect and adjust therapy based on clinical response.
Example omeprazole

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Drug Abuse And Dependence

Controlled Substance

Ortedrine contains Amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).

Abuse

Ortedrine, 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 Ortedrine 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 Ortedrine, 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 Ortedrine use.

Dependence

Tolerance

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 Ortedrine.

Dependence

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 Ortedrine. 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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References

  1. DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. MeSH. "Dopamine Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Amphetamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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