The round, blue (or light blue) pill debossed with “U27” is Dextroamphetamine-Amphetamine 10 mg (mixed amphetamine salts), manufactured by Aurobindo Pharma / Aurolife Pharma. It is a generic immediate-release formulation of Adderall 10 mg. Classified as a Schedule II (C-II) controlled substance in the United States, it carries a high potential for abuse, dependence, and diversion.
Pill Identification
Attribute – Specification
- Imprint – U27
- Reverse Side – Plain / scored or double-scored
- Active Ingredient – Mixed Amphetamine Salts (10 mg total): Dextroamphetamine Sulfate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate (approx. 3:1 d- to l-isomer ratio)
- Color – Light blue to blue
- Shape – Round
- Release Type – Immediate-Release (IR)
- Manufacturer – Aurobindo Pharma USA / Aurolife Pharma LLC
- Drug Class – Central Nervous System (CNS) Stimulant / Phenethylamine
- DEA Schedule – Schedule II (C-II)
Mechanism of Action
Mixed amphetamine salts act as sympathomimetic amines that increase monoaminergic neurotransmission in the central nervous system:
- Neurotransmitter Release: Amphetamines enter presynaptic neurons primarily via dopamine active transporters (DAT) and norepinephrine transporters (NET). Once inside, they inhibit the vesicular monoamine transporter 2 (VMAT2), causing monoamines (dopamine and norepinephrine) to leak from storage vesicles into the cytoplasm.
- Transporter Reversal: The elevated cytoplasmic concentrations trigger reverse transport via DAT and NET, causing non-vesicular release of dopamine and norepinephrine directly into the synaptic cleft.
- Reuptake Inhibition & MAO Inhibition: Amphetamines also competitively inhibit DAT and NET reuptake and, to a lesser extent, inhibit monoamine oxidase (MAO) breakdown of neurotransmitters.
- Clinical Effect: Enhanced activity in the prefrontal cortex improves attention span, impulse control, executive functioning, and wakefulness. Peak blood concentrations typically occur within 2 to 3 hours, with therapeutic effects lasting 4 to 6 hours.
Indications and Dosage
- Attention Deficit Hyperactivity Disorder (ADHD):
- Adults: Standard starting dosage is typically 5 mg to 10 mg once or twice daily, taken upon waking. Daily doses can be titrated in 5 mg increments at weekly intervals, usually up to 40 mg/day (rarely higher).
- Pediatrics (6 years and older): Typically started at 5 mg once or twice daily, titrated weekly by 5 mg up to a standard maximum of 30 mg/day.
- Narcolepsy:
- Adults: Starting dose of 10 mg/day, adjusted in weekly increments of 10 mg up to a maximum of 60 mg/day in divided doses.
- Administration:
- Take orally with or without food. Avoid taking late in the afternoon or evening due to potential insomnia.
- Acidic foods/beverages (e.g., fruit juices, vitamin C, citrus) can reduce GI absorption, while urinary alkalinizers (e.g., sodium bicarbonate/antacids) increase absorption and prolong drug half-life.
Side Effects
Common Side Effects
- Decreased appetite, anorexia, and weight loss
- Insomnia, sleep disruption, and restlessness
- Dry mouth (xerostomia) and unpleasant taste
- Headaches, dizziness, and mild tremors
- Palpitations, increased heart rate (tachycardia), and mild blood pressure elevation
- Gastrointestinal distress (nausea, constipation, or diarrhea)
Serious Adverse Reactions
- Cardiovascular Events: Severe hypertension, arrhythmias, myocardial infarction, and sudden cardiac death (particularly in patients with pre-existing heart defects).
- Psychiatric Manifestations: New or worsening psychosis, mania, extreme aggression, paranoia, or suicidal ideation.
- Peripheral Vasculopathy: Raynaud’s phenomenon, digital ulceration, and paresthesias in fingers and toes.
- Serotonin Syndrome: If combined with other serotonergic agents (SSRIs, SNRIs, triptans).
- Growth Suppression: Temporary retardation of linear growth and weight gain in pediatric patients with long-term use.
Precautions and Drug Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Absolute contraindication. Do not administer during or within 14 days of taking MAOIs (e.g., selegiline, phenelzine, linezolid) due to the risk of severe hypertensive crisis and intracranial hemorrhage.
- Cardiovascular Pre-screening: Thorough cardiac evaluation (including family history of sudden cardiac death or arrhythmias) is advised prior to starting therapy.
- Contraindications: Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma, history of agitated states, or known hypersensitivity to sympathomimetic amines.
- Pregnancy & Nursing: Amphetamines cross the placenta and pass into breast milk. Use during pregnancy is associated with increased risk of premature delivery and low birth weight.
Critical Warnings (FDA Boxed Warnings)
- Abuse, Misuse, and Addiction: Dextroamphetamine-amphetamine carries a high risk of abuse and physical dependence. Misuse can result in severe cardiovascular toxicity, psychosis, addiction, overdose, and death.
- Cardiovascular Risk: CNS stimulants can cause sudden unexplained death in patients with pre-existing structural cardiac abnormalities or other serious heart problems. Regular monitoring of blood pressure and pulse rate is required throughout treatment.