8,240 Clinical Drug Overviews
17-Alpha Hydroxyprogesterone Caproate
Intramuscular synthetic progestogen (C21 steroid) historically used for prevention of recurrent spontaneous preterm birth (sPTB) in singleton gestations with a prior sPTB. The landmark MFMU Network PREIS trial (Meis et al., NEJM 2003) demonstrated a 34% relative risk reduction in PTB <37 weeks, forming the basis of FDA accelerated approval of Makena (AMAG Pharmaceuticals) in 2011. However, the adequately powered PROLONG trial (Blackwell et al., 2019), conducted in a broader international population, failed to replicate efficacy on either primary or secondary outcomes. The 2021 EPPPIC individual patient data meta-analysis (Lancet) further confirmed no significant benefit on neonatal composite outcomes for 17-OHPC IM. Following an FDA advisory committee vote in 2019 and a formal benefit-risk reassessment, the FDA withdrew approval of Makena in April 2023 — the first withdrawal of an obstetric drug under the accelerated approval pathway. Current ACOG guidance (Practice Bulletin 234, reaffirmed 2023) and SMFM no longer recommend 17-OHPC IM as a standard strategy for sPTB prevention. Vaginal progesterone (90 mg gel or 200 mg micronized capsule) remains the preferred option for asymptomatic patients with a singleton pregnancy and sonographic short cervix (≤25 mm) at 16–24 weeks, supported by individual patient data meta-analyses (IPDMA, Romero et al., 2018).
Progestogen; synthetic C21 pregnane steroid; 17α-hydroxyprogesterone ester; progestin (IM depot formulation)
8-HOUR BAYER
Comprehensive clinical and safety monograph for 8-HOUR BAYER (8-HOUR BAYER).
ORAL
8-MOP
Comprehensive clinical and safety monograph for 8-MOP (8-MOP).
A-HYDROCORT
Comprehensive clinical and safety monograph for A-HYDROCORT (A-HYDROCORT).
INJECTION
A-METHAPRED
Comprehensive clinical and safety monograph for A-METHAPRED (A-METHAPRED).
A-POXIDE
Comprehensive clinical and safety monograph for A-POXIDE (A-POXIDE).
A.P.L.
Comprehensive clinical and safety monograph for A.P.L. (A.P.L.).
A/T/S
Comprehensive clinical and safety monograph for A/T/S (A/T/S).
TOPICAL
ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
Trimethoprim/sulfamethoxazole increases lamivudine exposure Severe acute exacerbations of hepatitis B have been reported upon discontinuation.
NRTI
ABACAVIR AND LAMIVUDINE
ABACAVIR SULFATE
Comprehensive clinical and safety monograph for ABACAVIR SULFATE (ABACAVIR SULFATE).
ABACAVIR SULFATE AND LAMIVUDINE
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
Other bone marrow suppressants may have additive effects Can cause severe myelosuppression and myopathy.
ABACAVIR SULFATE; LAMIVUDINE
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
ABACAVIR; LAMIVUDINE
ABELCET
Comprehensive clinical and safety monograph for ABELCET (ABELCET).
ABEMACICLIB
Comprehensive clinical and safety monograph for ABEMACICLIB (ABEMACICLIB).
Therapeutic Agent
ABILIFY
Comprehensive clinical and safety monograph for ABILIFY (ABILIFY).
ORAL, INTRAMUSCULAR
ABILIFY ASIMTUFII
Comprehensive clinical and safety monograph for ABILIFY ASIMTUFII (ABILIFY ASIMTUFII).
INTRAMUSCULAR
ABILIFY MAINTENA KIT
Comprehensive clinical and safety monograph for ABILIFY MAINTENA KIT (ABILIFY MAINTENA KIT).
ABILIFY MYCITE KIT
Comprehensive clinical and safety monograph for ABILIFY MYCITE KIT (ABILIFY MYCITE KIT).
ABIRATERONE ACETATE
Comprehensive clinical and safety monograph for ABIRATERONE ACETATE (ABIRATERONE ACETATE).
ABITREXATE
Comprehensive clinical and safety monograph for ABITREXATE (ABITREXATE).
ABLAVAR
Comprehensive clinical and safety monograph for ABLAVAR (ABLAVAR).
INTRAVENOUS
ABLYSINOL
Comprehensive clinical and safety monograph for ABLYSINOL (ABLYSINOL).
INTRA-ARTERIAL
ABRAXANE
Comprehensive clinical and safety monograph for ABRAXANE (ABRAXANE).
ABREVA
Comprehensive clinical and safety monograph for ABREVA (ABREVA).
ABRILADA
Comprehensive clinical and safety monograph for ABRILADA (ABRILADA).
ABSORICA
Comprehensive clinical and safety monograph for ABSORICA (ABSORICA).
ABSORICA LD
Comprehensive clinical and safety monograph for ABSORICA LD (ABSORICA LD).
ABSTRAL
Comprehensive clinical and safety monograph for ABSTRAL (ABSTRAL).
SUBLINGUAL
ACALABRUTINIB
Comprehensive clinical and safety monograph for ACALABRUTINIB (ACALABRUTINIB).
ACAMPROSATE CALCIUM
Comprehensive clinical and safety monograph for ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM).
ACANYA
Comprehensive clinical and safety monograph for ACANYA (ACANYA).
ACARBOSE
Comprehensive clinical and safety monograph for ACARBOSE (ACARBOSE).
ACCOLATE
Comprehensive clinical and safety monograph for ACCOLATE (ACCOLATE).
ACCRETROPIN
Comprehensive clinical and safety monograph for ACCRETROPIN (ACCRETROPIN).
ACCRUFER
Comprehensive clinical and safety monograph for ACCRUFER (ACCRUFER).
ACCUNEB
Comprehensive clinical and safety monograph for ACCUNEB (ACCUNEB).
INHALATION
ACCUPRIL
Comprehensive clinical and safety monograph for ACCUPRIL (ACCUPRIL).
ACCURBRON
Comprehensive clinical and safety monograph for ACCURBRON (ACCURBRON).
ACCURETIC
Comprehensive clinical and safety monograph for ACCURETIC (ACCURETIC).
ACCUTANE
Comprehensive clinical and safety monograph for ACCUTANE (ACCUTANE).
ACEBUTOLOL HYDROCHLORIDE
Comprehensive clinical and safety monograph for ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL HYDROCHLORIDE).
ACEON
Comprehensive clinical and safety monograph for ACEON (ACEON).
ACEPHEN
Comprehensive clinical and safety monograph for ACEPHEN (ACEPHEN).
RECTAL
ACETADOTE
Comprehensive clinical and safety monograph for ACETADOTE (ACETADOTE).
ACETAMINOPHEN
Comprehensive clinical and safety monograph for ACETAMINOPHEN (ACETAMINOPHEN).
ORAL, INTRAVENOUS, RECTAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
CNS depressants including alcohol and benzodiazepines increase sedation risk Life-threatening respiratory depression may occur especially in CYP2D6 ultra-rapid metabolizers.
Opioid Agonist
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