Dosage of Raphetamine in details
Raphetamine Dosage
Generic name: Raphetamine 2.5mg in 1mL
Dosage form: suspension, extended release
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2.1 Important Information Prior to Initiating Treatment
Prior to treating children, adolescents, and adults with CNS stimulants, including Raphetamine, 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 Raphetamine use.
2.2 General Dosing Information
Raphetamine should be orally administered once daily in the morning with or without food. The dose should be individualized according to the needs and responses of the patient. Before administering the dose, shake the bottle of Raphetamine.
In children 6 years of age and older, start with 2.5 mg or 5 mg once daily in the morning. The dose may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days up to a maximum dose of 20 mg per day.
Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of Raphetamine, and adjust dosage as needed.
2.3 Switching from other Raphetamine Products
If switching from other Raphetamine products, discontinue that treatment, and titrate with Raphetamine using the above titration schedule.
Do not substitute for other Raphetamine products on a milligram-per-milligram basis, because of different Raphetamine base compositions and differing pharmacokinetic profiles.
2.4 Dosage Modifications due to Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of Raphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Raphetamine dosage accordingly.
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- Other brands: Evekeo, Raphetamine
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What other drugs will affect Raphetamine?
Do not take Raphetamine 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 Raphetamine, tell your doctor if you are taking any of the following medicines:
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insulin or another medicine to treat diabetes;
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guanethidine (Ismelin) or reserpine (Diutensin-R);
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doxazosin (Cardura), terazosin (Hytrin), prazosin (Minipress), or guanadrel(Hylorel);
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a tricyclic antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil), clomipramine (Anafranil), protriptyline (Vivactil), or desipramine (Norpramin)
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a phenothiazine such as chlorpromazine (Thorazine);
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lithium (Lithobid, Lithonate, Eskalith, others); or
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haloperidol (Haldol).
You may not be able to take Raphetamine, 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 Raphetamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
Raphetamine interactions
Drugs Having Clinically Important Interactions With Amphetamines
Table 5: Drugs having clinically important interactions with amphetamines.
| MAO Inhibitors (MAOI) | |
| Clinical Impact | MAOI antidepressants slow Raphetamine 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 Raphetamine 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 Raphetamine. |
| Intervention | Co-administration of Raphetamine 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). |
| Tricyclic Antidepressants | |
| Clinical Impact | May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Raphetamine 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 Raphetamine 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
Raphetamine contains Amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).
Abuse
Raphetamine, is a CNS stimulant that contains Amphetamine which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.
Signs and symptoms of Raphetamine 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 Raphetamine, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Raphetamine 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 Raphetamine.
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 Raphetamine. 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
- 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).
- MeSH. "Dopamine Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- 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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
