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Medicines > pregnancy : Category C or Limited data

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generic:
None (4) · Bisoprolol (1) · Dexmethylphenidate (1) · Duloxetine (1) · Haloperidol (1) · Metoprolol (1) · Mixed amphetamine salts (1) · Nebivolol (1) · Prazosin (1) · Propranolol (1) · Sodium Oxybate (1)
brand:
Adderall, Adderall XR, Mydayis (1) · Bystolic (1) · Cymbalta, Drizalma Sprinkle, Irenka, Yentreve (1) · Focalin, Focalin XR (1) · Haldol, Serenace, Haldol Decanoate (1) · Inderal (1) · Kisunla (1) · Leqembi (1) · Lopressor (tartrate), Toprol XL (succinate) (1) · Minipress (1) · Qelbree (1) · Vraylar (1) · Xyrem; Xywav (lower-sodium formulation with Ca/Mg/K salts) (1) · Zebeta (1)
classes:
Alpha-1 Adrenergic Antagonist (1) · Amphetamine (1) · Anti-amyloid beta (Aβ) monoclonal antibody (2) · Antidepressant (1) · Antiemetic (1) · Anxiolytic (1) · Atypical antipsychotic (1) · Beta Blocker (4) · Cardioselective (β1) (2) · Cardioselective (β1) + vasodilator (1) · CNS stimulant (1) · D2/D3/5HT1A partial agonist (1) · GABAB Agonist; Endogenous GHB receptor agonist (1) · NDRI (1) · Non-selective (1) · non-stimulant ADHD agent (1) · Psychostimulant (2) · Selective norepinephrine reuptake inhibitor (NRI) with 5HT1A partial agonism (1) · SNRI (1) · targets protofibrils (1) · targets pyroglutamated Aβ in plaques (1) · Typical antipsychotic (1)
mechanism:
None (3) · Agonist at the metabotropic GABAB receptor and the endogenous γ-hydroxybutyrate (GHB) receptor. Produces deep sleep with increased slow-wave architecture, suppression of REM intrusion, and cataplexy reduction. (1) · Cardioselective β1-adrenergic antagonist. Selectivity is dose-dependent and partially lost at higher doses. (1) · High-affinity D2 receptor antagonist (1) · Highly β1-selective adrenergic antagonist. Greater selectivity than metoprolol or atenolol. (1) · Non-selective competitive antagonist at β1 and β2 adrenergic receptors. Lipophilic; significant blood–brain barrier penetration, accounting for its CNS effects. (1) · Norepinephrine–dopamine reuptake inhibition (DAT, NET), d-threo enantiomer of methylphenidate (1) · Selective alpha-1 adrenergic receptor antagonist. Lowers peripheral vascular resistance via vasodilation; in the CNS, blunts noradrenergic hyperarousal thought to drive trauma-related nightmares. (1) · Selective NET inhibitor (no significant DAT activity, distinguishes from amphetamine/methylphenidate). Also: 5HT1A receptor partial agonism, 5HT2B and 5HT7 receptor antagonism. The serotonergic actions may underlie better tolerability and possibly different efficacy spectrum than atomoxetine. (1) · Serotonin–norepinephrine reuptake inhibition (balanced) (1) · TAAR1 agonism, VMAT2 substrate, DAT/NET reverse transport, net release of dopamine and norepinephrine (1) · The d-enantiomer is a highly β1-selective antagonist; the l-enantiomer triggers endothelial nitric-oxide–mediated vasodilation. Unique among beta blockers for this NO mechanism. (1)
uses:
ADHD in children (6+), adolescents, and adults (FDA-approved 2021 for pediatric, 2022 for adult) (1) · Alzheimer disease (MCI or mild dementia stage), FDA-approved July 2024 (1) · Alzheimer disease (MCI or mild dementia stage); FDA accelerated approval Jan 2023 → traditional approval July 2023 (1) · Depression, anxiety, neuropathic pain, fibromyalgia, chronic musculoskeletal pain (1) · Schizophrenia (FDA-approved 2015). Acute manic or mixed episodes of bipolar I disorder. Bipolar I depression (FDA-approved 2019). Adjunctive treatment of major depressive disorder (FDA-approved Dec 2022). (1) · Schizophrenia, acute psychosis, agitation, delirium, Tourette syndrome, severe nausea (1) · '"`UNIQ--vote-00000150-QINU`"', '"`UNIQ--vote-00000151-QINU`"' (1) · '"`UNIQ--vote-000004F5-QINU`"', '"`UNIQ--vote-000004F6-QINU`"', '"`UNIQ--vote-000004F7-QINU`"', '"`UNIQ--vote-000004F8-QINU`"', '"`UNIQ--vote-000004F9-QINU`"' (1) · '"`UNIQ--vote-00000562-QINU`"', '"`UNIQ--vote-00000563-QINU`"', '"`UNIQ--vote-00000564-QINU`"', '"`UNIQ--vote-00000565-QINU`"', '"`UNIQ--vote-00000566-QINU`"' (1) · '"`UNIQ--vote-0000059D-QINU`"' (1) · '"`UNIQ--vote-000005D0-QINU`"', '"`UNIQ--vote-000005D1-QINU`"', '"`UNIQ--vote-000005D2-QINU`"' (1) · '"`UNIQ--vote-000005E7-QINU`"', '"`UNIQ--vote-000005E8-QINU`"', '"`UNIQ--vote-000005E9-QINU`"', '"`UNIQ--vote-000005EA-QINU`"', '"`UNIQ--vote-000005EB-QINU`"' (1) · '"`UNIQ--vote-00000636-QINU`"', '"`UNIQ--vote-00000637-QINU`"', '"`UNIQ--vote-00000638-QINU`"' (1) · '"`UNIQ--vote-00000717-QINU`"', '"`UNIQ--vote-00000718-QINU`"', '"`UNIQ--vote-00000719-QINU`"' (1)
starting dose:
None (3) · 1 mg at bedtime (PTSD nightmares); 1 mg BID–TID (HTN) (1) · 10 mg/kg IV every 2 weeks (1) · 10–40 mg (situational anxiety); 40 mg BID (HTN) (1) · 2.25 g at bedtime + 2.25 g 2.5–4 h later; titrate weekly to 6–9 g/night total (1) · 2.5 mg IR, 5 mg XR, or 12.5mg Mydayis (1) · 2.5–5 mg daily (HTN); 1.25 mg daily (HFrEF, slow titration) (1) · 25–50 mg BID (tartrate); 25–100 mg daily (succinate); 12.5 mg daily in HFrEF (1) · 5 mg daily (1) · 700 mg IV q4w × 3 doses, then 1400 mg IV q4w; may discontinue when amyloid PET shows clearance (1) · Pediatric 6-11: 100 mg PO daily, titrate weekly to max 400 mg. Adolescent 12-17: 200 mg, max 400 mg. Adult: 200 mg, max 600 mg. (1) · Schizophrenia: 1.5 mg PO daily, increase to 1.5-6 mg as tolerated. Bipolar mania: 1.5 mg, may increase to 3-6 mg. Bipolar depression: 1.5 mg daily for 14 days, then 3 mg. MDD adjunct: 1.5 mg, may increase to 3 mg. (1)
preparations:
None (3) · 0.5 g/mL oral solution (1) · 1, 2, 5 mg caps (1) · 1.5 mg, 3 mg, 4.5 mg, 6 mg capsules (1) · 10, 20, 40, 60, 80 mg tabs; 60/80/120/160 mg ER caps; 1 mg/mL IV (1) · 100 mg, 150 mg, 200 mg extended-release capsules (can be sprinkled on food) (1) · 2.5, 5, 10, 20 mg tabs (1) · 200 mg/2 mL, 500 mg/5 mL vials for IV infusion (1) · 350 mg/20 mL vial for IV infusion (1) · 5, 10 mg tabs (1) · IR tabs 5, 7.5, 10, 12.5, 15, 20, 30 mg; XR caps 5, 10, 15, 20, 25, 30 mg; Mydayis caps 12.5, 25, 37.5, 50 mg (1) · Tartrate: 25, 50, 100 mg tabs; 1 mg/mL IV. Succinate ER: 25, 50, 100, 200 mg. (1)
fda max:
None (3) · 10 mg/kg q2w (1) · 1400 mg q4w (1) · 20 mg/d (1) · 40 mg/d (2) · 400 mg/d (1) · 400 mg/d (pediatric); 600 mg/d (adult) (1) · 6 mg/d (psychosis/mania); 3 mg/d (depression adjunct) (1) · 640 mg/d (HTN); 240 mg/d (migraine) (1) · 9 g/night (1) · XR = 40 or 60 mg/d; IR = 40 or 60 mg/d'"`UNIQ--ref-00000567-QINU`"' (1)
routes:
IM (1) · IV (3) · IV infusion (60 min) every 2 weeks; outpatient or infusion-center setting (1) · IV infusion every 4 weeks (1) · Oral (11) · Oral (must be taken in bed; effects within minutes) (1)
onset:
15–30 min (fasting) (1) · 1–2 h (2) · 1–2 h (PO), immediate (IV) (1) · 1–2 h (PO); immediate (IV) (1) · 30–60 min (1) · 30–90 min (1) · ADHD symptom improvement reported within 1-2 weeks (faster than atomoxetine which takes 4-6 weeks) (1) · Amyloid PET clearance within months; cognitive benefit over 18 months (1) · IR: 30–60 min; XR: 1–2 h to peak effect (1) · Mood: 2–4 weeks. Pain: often within 1–2 weeks. (1) · PO 1–2 h; IM 30–60 min; IV 5–20 min (1) · Slowing of cognitive decline over 18 months (modest effect, ~27% relative slowing) (1) · Weeks for psychosis/mood efficacy (1)
duration:
12–24 h (oral); decanoate IM 3–4 weeks (1) · 24 h (2) · 6–12 h (IR); 24 h (ER) (1) · 6–12 h (tartrate); 24 h (succinate) (1) · 6–8 h (1) · Chronic daily dosing (1) · Daily dosing (1) · Daily dosing; active metabolites with very long half-lives (up to 1-3 weeks) (1) · IR 4–6 h; XR 10–12 h; Mydayis 14–16 h (1) · IR 4–6 h; XR 8–12 h (1) · Ongoing dosing (1) · Treatment can be discontinued upon achieving amyloid clearance (1) · ~3 h per dose (twice-nightly schedule required) (1)
halflife:
14–26 h (oral); ~3 weeks (decanoate) (1) · 2.2 h (IR parent); ~3 h (XR parent) (1) · 2–3 h (1) · 30–60 min (1) · 3–6 h (1) · 3–7 h (1) · 9–12 h (1) · Cariprazine ~2-4 d; major active metabolites desmethyl-cariprazine (DCAR) ~1-3 weeks → 'oral depot' effect with delayed steady-state and reduced effect of missed doses (1) · D-amphetamine ~10 h; L-amphetamine ~13 h (adults) (1) · ~10 h (CYP2D6 extensive metabolizers); up to 31 h (poor metabolizers) (1) · ~12 hours (1) · ~12.1 days (1) · ~5-7 days (1) · ~7 hours (1)
bioavailability:
100% (IV) (2) · Adequate oral bioavailability (1) · Adequate oral bioavailability with extended-release formulation (1) · ~12% (extensive metabolizers); ~96% (poor metabolizers) (1) · ~22–25% (1) · ~25% (extensive hepatic first-pass) (1) · ~25% (high first-pass) (1) · ~50% (1) · ~50% (highly variable) (1) · ~60% (1) · ~60–70% (oral) (1) · ~75–90% (oral) (1) · ~90% (low first-pass) (1)
pregnancy: (Click arrow to add another value)
legal:
Rx (1) · Rx, '''not a controlled substance''' (no DEA scheduling) (1) · Rx-only (2) · Rx-only in US (5) · Rx; ARIA monitoring required (1) · Rx; REMS-like program for ARIA monitoring (1) · Schedule II (2) · Schedule III; REMS-restricted (Schedule I if outside the pharmaceutical channel, same molecule as illicit GHB) (1)

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