Fixed-dose combination
Amphetamine and Dextroamphetamine is a fixed-dose combination medicine indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. MedsAcross supplies Amphetamine and Dextroamphetamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
Source: US FDA prescribing information
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
Source: US FDA prescribing information
Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 12 years of age is 30 mg once daily. Adults: 20 mg once daily in the morning. Pediatric patients (ages 6 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. Adults with severe renal impairment: 15 mg once daily in the morning. Patients with end stage renal disease (ESRD): Not recommended.
Source: US FDA prescribing information
ADDERALL XR administration is contraindicated in patients: known to be hypersensitive to amphetamine, or other components of ADDERALL XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products. taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis. Known hypersensitivity or idiosyncrasy to amphetamine. During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI).
Source: US FDA prescribing information
Boxed warning (abuse, misuse, and addiction adderall xr ®): has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse at appropriate intervals. Psychiatric Adverse Reactions: Prior to initiating ADDERALL XR, screen patients for risk factors for developing a manic episode.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction Risks to Patients with Serious Cardiac Disease Increased Blood Pressure and Heart Rate Psychiatric Adverse Reactions Long-Term Suppression of Growth in Pediatric Patients Seizures Peripheral Vasculopathy, including Raynaud’s Phenomenon Serotonin Syndrome Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Pediatric patients ages 6 to 12: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. Pediatric patients ages 13 to 17: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
Source: US FDA prescribing information
Alkalinizing agents (GI antacids and urinary): These agents increase blood levels of amphetamine. Acidifying agents (GI and urinary): These agents reduce blood levels of amphetamine.
Source: US FDA prescribing information
Store at room temperature, 20 to 25ºC (68 to 77ºF). Excursions permitted to 15 to 30ºC (59 to 86ºF).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
54 presentations of Amphetamine and Dextroamphetamine, sorted by availability.
6 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 19 January 1960 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 54 presentations of Amphetamine and Dextroamphetamine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 6 brand names for Amphetamine and Dextroamphetamine, including Adderall, Adderall XR, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII, Mixed Salts of a Single Entity Amphetamine Product XR, Mixed Salts of a Single-Entity Amphetamine Product, Mydayis.
Yes. The US FDA first approved Amphetamine and Dextroamphetamine on 19 January 1960, according to Drugs@FDA.
No listed presentation of Amphetamine and Dextroamphetamine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.