Novydrine Dosage

• Dosage of Novydrine in details
• Novydrine interactions
• Novydrine reviews

Dosage of Novydrine in details

Pre-Treatment Screening

Prior to treating patients with Novydrine, 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 Novydrine use.

Dosing Considerations For All Patients

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

Novydrine 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 Novydrine 12.5 mg daily.

Switching From Other Novydrine Products

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

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

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

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

Do not substitute for other Novydrine products on a milligram-per-milligram basis because of different Novydrine 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 Novydrine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Novydrine dosage accordingly.

How supplied

Dosage Forms And Strengths

Novydrine 3.1 mg Novydrine Extended Release

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

Novydrine 6.3 mg Novydrine Extended Release

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

Novydrine 9.4 mg Novydrine Extended Release

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

Novydrine 12.5 mg Novydrine Extended Release

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

Novydrine 15.7 mg Novydrine Extended Release

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

Novydrine 18.8 mg Novydrine Extended Release

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

Storage And Handling

Novydrine 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

Novydrine 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

Novydrine 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

Novydrine 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

Novydrine 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

Novydrine 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 Novydrine 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 Novydrine 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 Novydrine 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 Novydrine in the household trash.

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

What other drugs will affect Novydrine?

Do not take Novydrine 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 Novydrine, 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 Novydrine, 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 Novydrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Novydrine interactions

Drugs Having Clinically Important Interactions With Amphetamines

Table 2: Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)
Clinical Impact	MAOI antidepressants slow Novydrine 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 Novydrine 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 Novydrine.
Intervention	Co-administration of Novydrine 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-Novydrine 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 Novydrine 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

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

Abuse

Novydrine, 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 Novydrine 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 Novydrine, 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 Novydrine 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 Novydrine.

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 Novydrine. 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.

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).

Reviews

The results of a survey conducted on ndrugs.com for Novydrine are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Novydrine. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology