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Desoxyn

(methamphetamine hydrochloride)

Desoxyn (methamphetamine hydrochloride); CII

Full Prescribing Information DailyMed Drug Information

Summary

Desoxyn is methamphetamine hydrochloride, a short-acting immediate-release amphetamine tablet approved for ADHD in patients 6 years of age and older. It is pharmacologically an amphetamine and offers no labeled advantage over conventional amphetamine products, while carrying the same boxed warning and a far larger diversion problem. The brand no longer exists. Schedule II; generic only, from three labelers.

Forms & Strengths

  • Tablets: 5 mg

Dosing

  • Age: ADHD: ≥ 6 y/o; no adult and no other pediatric indication is carried
  • Onset: 30 to 60 min
  • Duration: 4 to 6 hours
  • Initial Dose: 5 mg once or twice daily
  • Titration: 5 mg every 7 days
  • Max Dose: 25 mg/day; the label gives a recommended range of 20 to 25 mg daily rather than an absolute ceiling
  • Considerations: Avoid dosing late in the evening because of insomnia. Acidifying agents lower and alkalinizing agents raise blood levels; the label directs dose adjustment by clinical response.

Pharmacology

  • Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
  • Delivery / Release: Immediate-release tablet
  • Metabolism: Hepatic hydroxylation, N-dealkylation and deamination, with at least seven urinary metabolites including active amphetamine. Half-life 4 to 5 hours; excretion is pH dependent and alkaline urine lengthens it
  • Pharmacogenomics: no genotype-based adjustment labeled; CYP2D6 inhibitors raise exposure, so start lower
  • Class Positioning: an amphetamine with an added N-methyl group, raising lipophilicity and central penetration, which is also what makes it more reinforcing
  • Against Adderall, a lower ceiling (20-25 against 40 mg/day) and no claimed advantage; against Vyvanse, built to blunt a rapid rise, it sits at the opposite end of that axis

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o
  • No obesity indication. Methamphetamine historically carried a short-term exogenous obesity indication. No currently marketed label carries it, and it should not be prescribed for weight management

Off-Label Uses

  • None established. No off-label pediatric use is supported by graded evidence.
  • Where the evidence was looked for and not found: AHRQ CER 267 contains no methamphetamine result, so nothing grades it against methylphenidate, the amphetamine salts or a non-stimulant. (AHRQ 2024)
  • Narcolepsy (ICD-10: G47.4x): other amphetamines carry it; this one does not. Insufficient. Use a labeled agent.

Contraindications & Warnings

  • Boxed Warning: ABUSE, MISUSE, AND ADDICTION. High potential for abuse and misuse, which can lead to substance use disorder including addiction; overdose and death, with risk increased at higher doses or by snorting or injection. Assess each patient's risk before prescribing, educate patient and family on the risks and on proper storage and disposal, and reassess risk and monitor throughout treatment.
  • Contraindicated:
    • Known hypersensitivity to amphetamine or tablet components
    • MAOI use, current or within 14 days, including linezolid and IV methylene blue
  • Use with caution (Warnings, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
    • Hypertension; BP rises about 2 to 4 mm Hg and HR about 3 to 6 bpm
    • Psychotic or bipolar disorder; new psychosis or mania in 0.1% against 0% on placebo
    • Prior seizure or EEG abnormality; the convulsive threshold may fall, and discontinue if a seizure occurs
    • Tics or Tourette's syndrome; peripheral vasculopathy including Raynaud phenomenon
    • Serotonergic drugs or CYP2D6 inhibitors; diabetes, where insulin needs may change
  • Substance use history in the patient or household is a strong reason to choose a non-controlled agent such as Strattera or Qelbree.
  • Screen before starting (label section 2.1 plus the boxed-warning duty):
    • Cardiac history, family history of sudden death or arrhythmia, and exam; ECG only if positive
    • Tic history; mania risk from past depression or family suicide, bipolar disorder or depression
    • Abuse risk in the patient, diversion risk in the household, and who else has access
    • Whether it can be stored locked; baseline height, weight, BP, HR

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not prescribe within 14 days.
  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol): serotonin syndrome. Start lower; stop both drugs if it occurs.
  • CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, quinidine): raise exposure and serotonin syndrome risk. Start lower or choose an alternative.
  • Urinary pH agents: alkalinizers (bicarbonate, antacids) raise exposure and the label says avoid; acidifiers (ascorbic acid, fruit juice) lower efficacy. Adjust by response.
  • Tricyclic antidepressants: sustained rise in brain d-amphetamine with potentiated cardiovascular effects. Monitor; adjust or switch.
  • Laboratory interference: amphetamines interfere with urinary steroid assays and produce positive amphetamine urine drug screens. Document that for the family in advance.

Administration

  • Give orally once daily, or in two divided doses daily.
  • Avoid administration late in the evening because of insomnia.
  • No food restriction; doses are whole multiples of 5 mg, so splitting is unnecessary.
  • If a dose is missed, skip it rather than giving it late; do not double up.
  • Store in a safe place, preferably locked; never give it to anyone else, and dispose of unused drug.
  • No conversion ratio is published against any other amphetamine. Switching means restarting titration at the new drug's own starting dose.

Side Effects

  • Common: palpitation, dizziness, insomnia, tremor, headache, bowel change, dry mouth, unpleasant taste, restlessness, overstimulation, dysphoria or euphoria, elevated blood pressure, tachycardia.
  • Serious:
    • Abuse, misuse and addiction, per the boxed warning; reassess at every visit and refill.
    • Sudden death, myocardial infarction and stroke with serious cardiac disease; avoid use. Fatal cardiorespiratory arrest, mostly with abuse.
    • New psychosis or mania, including with no prior history; consider discontinuing.
    • Growth suppression; interrupt if a child is not growing as expected.
    • Peripheral vasculopathy, rarely with digital ulceration; reduce or stop.
    • Seizure; discontinue. Serotonin syndrome; stop both drugs and treat supportively.
    • New or worsening tics; rhabdomyolysis; intestinal ischemia; Stevens-Johnson syndrome; angioedema; prolonged erections.
    • Overdose: tachyarrhythmias, blood pressure extremes, vasospasm, agitation, hallucinations, seizures, stroke, coma, hyperthermia. Not dialyzable.

Monitoring & Labs

  • Abuse, misuse and diversion: at every visit and refill: adherence, pill count, who has access at home, locked storage confirmed, and a PDMP check per state requirement.
  • Why: a boxed-warning obligation, and four or five 5 mg tablets a day is the easiest supply here to divert unnoticed.
  • Cardiovascular: BP and HR at baseline, each dose change, and every 6 months; investigate exertional chest pain or syncope promptly.
  • Growth: height, weight and BMI charted at baseline and every 6 months; interrupt in a child not growing or gaining as expected.
  • Appetite and sleep: every visit; the label warns against evening dosing.
  • Psychiatric, tics and digits: psychosis, mania, aggression and hostility at every visit and each dose increase; ask about tics and examine the digits.
  • Laboratory: none routinely; recheck glucose control in diabetes after starting or changing dose.

Discontinuation & Taper

  • No taper is specified in the label, and an immediate-release stimulant at therapeutic doses can be stopped without one.
  • Physical dependence is labelled, with withdrawal after abrupt stop or reduction: dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
  • That statement is more explicit than the amphetamine-salts labels carry; step down over a week or two after prolonged higher-dose use.
  • Tolerance is also labelled; escalating dose requirements call for reassessment of diagnosis, adherence and misuse, not an automatic increase.
  • Discontinue for a seizure, suspected serotonin syndrome, unresolving psychosis or mania, or digital ulceration.
  • Drug holidays suit appetite or growth as the limiting problem; dispose of unused drug.

Pregnancy & Lactation

  • Pregnancy: Decades of data have not identified a drug-associated risk of major birth defects or miscarriage; background risk is 2% to 4% and 15% to 20%.
  • Pregnancy, clinical: amphetamines vasoconstrict and reduce placental perfusion; premature delivery, low birth weight and neonatal withdrawal are reported.
  • Neonate: monitor for feeding difficulty, irritability, agitation and drowsiness.
  • Lactation: the label does not recommend breastfeeding, and no published experience exists with therapeutic methamphetamine while nursing, so prefer an alternate drug. (LactMed 2026)
  • Lactation, illicit use: peak milk levels of 160 and 610 mcg/L in two women; withhold breastfeeding 48 hours after use, or 24 hours after a negative urine screen. (LactMed 2026)
  • Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org. Named in this label.

Counseling Points

  • Counsel the family on:

    • What this medicine is, plainly and first: the same molecule as the street drug, at a small fraction of the non-medical dose, taken orally rather than smoked or injected.
    • That route is most of the difference in what a drug does, and why you chose it over a conventional amphetamine.
    • Locked storage in the label's terms: a safe place, preferably locked, never given to anyone else, unused tablets disposed of properly.
    • Counting tablets at each refill, yours as well as theirs; routine for this drug, not suspicion of the child.
    • No dose late in the evening; largest meal at breakfast and in the evening for midday appetite suppression.
    • Positive urine amphetamine screens at sports physicals or employment testing. Give them something in writing first.

  • Advise them to call for:

    • Chest pain, fainting, or a racing heart that does not settle.
    • New hallucinations, or suspicious, fearful or grandiose thinking.
    • Any seizure; agitation with sweating, shivering, twitching or fever, which can be serotonin syndrome.
    • Numbness or colour change in the fingers or toes; a rash with fever or blistering; a new tic; weight loss; a painful erection lasting hours.
    • Tablets going missing, running out early, or anyone in the household asking for them. Say explicitly that this is a phone call.

References

  1. DailyMed. Methamphetamine hydrochloride tablets, for oral use, CII, prescribing information. Hikma Pharmaceuticals USA Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90c02ac6-e5e2-4c97-8c68-81e4e389a195
  2. DailyMed. Methamphetamine hydrochloride tablet. Dr. Reddy's Laboratories Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6
  3. DailyMed. Methamphetamine hydrochloride tablet. Mayne Pharma Commercial LLC. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f31f580f-1f08-4a0f-b078-0b9e3308f712
  4. openFDA. NDC Directory, generic_name methamphetamine, all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methamphetamine%22&limit=1000
  5. AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
  6. LactMed. Methamphetamine. Drugs and Lactation Database, NICHD. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501612/
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