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Cyproheptadine

R06A - Antihistamines for systemic use ATC R06AX02 Small molecule approved 1961 Oral Natural product

JFDA label: Periactin

Mechanism of Action

A potent antihistamine and serotonin antagonist with anticholinergic effects; competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract (Paton 1985).

Indications

Approved

  • Allergic conditions

Off-label

  • Decreased appetite secondary to chronic disease
  • Episodic migraine prevention (pediatrics)
  • Serotonin syndrome (adults)
  • Spasticity associated with spinal cord damage
  • serotonin syndrome (pediatrics)

Contraindications

Source: Lexicomp

  • Use in newborn or premature infants or breast-feeding mothers Absolute
  • angle-closure glaucoma Absolute
  • bladder neck obstruction Absolute
  • elderly, debilitated patients Absolute
  • hypersensitivity to cyproheptadine or any component of the formulation Absolute
  • monoamine oxidase inhibitor therapy Absolute
  • pyloroduodenal obstruction Absolute
  • stenosing peptic ulcer Absolute
  • symptomatic prostatic hypertrophy Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (4)

Not Known Extrasystoles · hypotension · palpitations · tachycardia

Nervous system disorders (20)

Not Known Ataxia · chills · confusion · dizziness · drowsiness · euphoria · excitement · fatigue · hallucination · headache · hysteria · insomnia · irritability · nervousness · neuritis · paresthesia · restlessness · sedation · seizure · vertigo

Hepatobiliary disorders (3)

Not Known Hepatic failure · hepatitis · jaundice

Renal and urinary disorders (3)

Not Known Difficulty in micturition · urinary frequency · urinary retention

Blood and lymphatic system disorders (4)

Not Known Agranulocytosis · hemolytic anemia · leukopenia · thrombocytopenia

Immune system disorders (3)

Not Known Anaphylactic shock · angioedema · hypersensitivity reaction

Gastrointestinal disorders (9)

Not Known Abdominal pain · anorexia · cholestasis · constipation · diarrhea · increased appetite · nausea · vomiting · xerostomia

Skin and subcutaneous tissue disorders (4)

Not Known Diaphoresis · skin photosensitivity · skin rash · urticaria

Musculoskeletal and connective tissue disorders (1)

Not Known Tremor

Eye disorders (2)

Not Known Blurred vision · diplopia

Ear and labyrinth disorders (2)

Not Known Labyrinthitis (acute) · tinnitus

Respiratory, thoracic and mediastinal disorders (3)

Not Known Nasal congestion · pharyngitis · thickening of bronchial secretions

Dosing

Source: Lexicomp

Allergic conditions: Oral: Initial: 4 mg 3 times daily; maintenance: 4 to 20 mg daily in divided doses; maximum: 0.5 mg/kg/day; some patients may require up to 32 mg/day for adequate control of symptoms Decreased appetite secondary to chronic disease (off-label use): Oral: Initial: 2 mg 4 times per day for one week, then 4 mg 4 times per day (Homnick 2004; Homnick 2005) Serotonin syndrome (off-label use): Oral: Initial: 12 mg followed by 2 mg every 2 hours or 4 to 8 mg every 6 hours as needed for symptom control (Boyer 2005; Sun-Edelstein 2008) Spasticity associated with spinal cord damage (off-label use): Oral: Initial: 2 to 4 mg every 8 hours; maximum: 8 mg every 8 hours (Barbeau 1982; Wainberg 1990)
(For additional information see "Cyproheptadine: Pediatric drug information") Allergic conditions: Children 2 to 6 years: Oral: Usual dose: 0.25 mg/kg/day or 8 mg/m2/day in 2 to 3 divided doses or 2 mg 2 or 3 times daily; maximum: 12 mg/day Children ≥7 years and Adolescents ≤14 years: Oral: Usual dose: 4 mg 2 or 3 times daily; maximum: 16 mg/day Adolescents >14 years: Oral: Refer to adult dosing Episodic migraine preventions (off-label use): Children ≥3 years and Adolescents: Oral: Usual dose: 0.2 to 0.4 mg/kg/day divided twice daily; maximum: 0.5 mg/kg/day (Lewis 2004a; Lewis 2004b)
Refer to adult dosing. Initiate therapy at the lower end of the dosage range.
No dosage adjustment provided in manufacturer’s labeling. However, elimination is diminished in renal insufficiency.
No dosage adjustment provided in manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

CNS depression

May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Disease-related concerns:

Cardiovascular disease

Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).

Increased intraocular pressure

Use with caution in patients with increased intraocular pressure.

Respiratory disease

Use with caution in patients with asthma or other chronic breathing disorders.

Thyroid dysfunction

Use with caution in patients with thyroid dysfunction. Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Elderly

Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

Pediatric

Antihistamines may cause excitation in young children.

Pregnancy & Lactation

Pregnancy

FDA category B

Adverse events were observed in some animal reproduction studies. Per the product labeling, an increased risk of congenital abnormalities was not observed following maternal use of cyproheptadine during the first, second, or third trimesters in two studies of pregnant women; however the possibility of harm cannot be ruled out. Although cyproheptadine is approved for the treatment of allergic conditions such as rhinitis and uritcaria, other agents are preferred for use in pregnant women (Scadding 2008; Wallace 2008; Zuberbier 2014). Antihistamines are not recommended for treatment of pruritus associated with intrahepatic cholestasis in pregnancy (Ambros-Rudolph 2011; Kremer 2014).

Lactation

Contraindicated

Use while breast-feeding is contraindicated by the manufacturer. It is not known if cyproheptadine is excreted into breast milk. Premature infants and newborns have a higher risk of intolerance to antihistamines. In general, if a nursing infant is exposed to a first generation antihistamine via breast milk, they should be monitored for irritability or drowsiness. When treatment is needed in breast-feeding women, second generation antihistamines are preferred (Butler 2014). Antihistamines may d

Chemistry & Properties

2D structure
FormulaC21H21N
Molecular weight287.41 g/mol
IUPAC name1-methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine
CAS129-03-3
PubChem CID2913
InChIKeyJJCFRYNCJDLXIK-UHFFFAOYSA-N
logP4.7 (XLogP 4.7)
Polar surface area3.24 Ų
H-bond acceptors / donors1 / 0
Drug-likeness (QED)0.58
Lipinski violations0
SMILESCN1CCC(=C2c3ccccc3C=Cc3ccccc32)CC1

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantYes

Enzyme interactions

EnzymeRoleDetail
CYP1A2Substrate
CYP2B6Substrate
CYP2C19Substrate
CYP2D6Inhibitor
CYP3A4Substrate

Receptor binding (top 30)

TargetActionAffinity
HISTAMINE H1 (HRH1) Binding pKi 10.2
H1 receptor (HRH1) Antagonist pKi 10.2
H1 Binding pKi 9.0
5-HT2B (HTR2B) Binding pKi 8.7
5-HT2A (HTR2A) Binding pKi 8.5
H2 Binding pKi 8.3
5-HT2C (HTR2C) Binding pKi 8.2
Cholinergic, muscarinic M5 (CHRM5) Binding pKi 8.1
DOPAMINE D3 (DRD3) Binding pKi 8.1
Cholinergic, muscarinic M2 (CHRM2) Binding pKi 7.9
Cholinergic, muscarinic M3 (CHRM3) Binding pKi 7.9
Cholinergic, muscarinic M4 (CHRM4) Binding pKi 7.9
Cholinergic, muscarinic M1 (CHRM1) Binding pKi 7.8
&alpha;1B-adrenoceptor (ADRA1B) Antagonist pKi 7.6
DOPAMINE D1 (DRD1) Binding pKi 7.5

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OCT1 (Inhibitor)P-gp (Inhibitor)MDR1 (Substrate)P-gp (Substrate)

Drug–drug interactions (100+, DDInter)

Interacting drugSeverityManagement
Dextropropoxyphene major
Potassium chloride major
Potassium citrate major
Sodium oxybate major
Topiramate major
Zonisamide major
Acetylcholine moderate
Aclidinium moderate
Acrivastine moderate
Alfentanil moderate
Alimemazine moderate
Alprazolam moderate
Amantadine moderate
Amitriptyline moderate
Amobarbital moderate
Amoxapine moderate
Apomorphine moderate
Apraclonidine moderate
Aripiprazole moderate
Asenapine moderate
Atropine moderate
Azatadine moderate
Azelastine (nasal) moderate
Baclofen moderate
Belladonna moderate
Benzatropine moderate
Benzhydrocodone moderate
Biperiden moderate
Botulinum Toxin Type B moderate
Botulinum toxin type A moderate
Brexanolone moderate
Brexpiprazole moderate
Brimonidine (ophthalmic) moderate
Brimonidine (topical) moderate
Brivaracetam moderate
Bromocriptine moderate
Brompheniramine moderate
Buprenorphine moderate
Buspirone moderate
Butabarbital moderate

Showing 40 of 100+.

Registered Products (1)

BrandForm / strengthPackAgentCitizen (JOD)
Periactin Tablet 4 mg 20 tab Adatco Drug Store 1.100