Cyproheptadine hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Cyproheptadine hydrochloride is an antihistamine that is FDA approved for the treatment of allergic conjunctivitis, perennial and seasonal allergic rhinitis, dermatographic urticaria, hypersensitivity reaction, to blood or plasma; or mild allergic skin manifestations, urticaria due to cold and vasomotor rhinitis.. Common adverse reactions include increased appetite, weight gain, abdominal discomfort, diarrhea, nausea, vomiting, xerostomia, central nervous system depression and somnolence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Perennial and seasonal allergic rhinitis
- Vasomotor rhinitis
- Allergic conjunctivitis due to inhalant allergens and foods
- Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
- Amelioration of allergic reactions to blood or plasma
- Cold urticaria
- Dermatographism
Dosage
- The total daily dose for adults should not exceed 0.5 mg/kg/day.
- The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg a day.
- An occasional patient may require as much as 32 mg a day for adequate relief.
- It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cyproheptadine hydrochloride in adult patients.
Non–Guideline-Supported Use
- Loss of appetite
- Migraine
- Pruritus
- Schizophrenia
- Spasticity - Spinal cord injury
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Age 2 to 6 years
- The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m2).
- The usual dose is 2 mg (1/2 tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day.
Age 7 to 14 years
- The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cyproheptadine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cyproheptadine hydrochloride in pediatric patients.
Contraindications
Newborn or Premature Infants
This drug should not be used in newborn or premature infants.
Nursing Mothers
Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
Other Conditions
- Hypersensitivity to cyproheptadine and other drugs of similar chemical structure.
- Monoamine oxidase inhibitor therapy
- Angle-closure glaucoma
- Stenosing peptic ulcer
- Symptomatic prostatic hypertrophy
- Bladder neck obstruction
- Pyloroduodenal obstruction
- Elderly, debilitated patients
Warnings
Pediatric Patients
- Overdosage of antihistamines, particularly in infants and young children, may produce hallucinations, central nervous system depression, convulsions, respiratory and cardiac arrest, and death. Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation.
CNS Depressants
- Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.
Activities Requiring Mental Alertness
Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
Adverse Reactions
Clinical Trials Experience
Adverse reactions which have been reported with the use of antihistamines are as follows:
Central Nervous System
- Sedation and sleepiness (often transient)
- Dizziness
- Disturbed coordination
- Confusion
- Restlessness
- Excitation
- Nervousness
- Tremor
- Irritability
- Insomnia
- Paresthesias
- Neuritis
- Convulsions
- Euphoria
- Hallucinations
- Hysteria
- Faintness
Integumentary
- Allergic manifestation of rash and edema
- Excessive perspiration
- Urticaria
- Photosensitivity
Special Senses
- Acute labyrinthitis
- Blurred vision
- Diplopia
- Vertigo
- Tinnitus
Cardiovascular
- Hypotension
- Palpitation
- Tachycardia
- Extrasystoles
- Anaphylactic shock
Hematologic
- Hemolytic anemia
- Leukopenia
- Agranulocytosis
- Thrombocytopenia
Digestive System
- Cholestasis
- Hepatic failure
- Hepatitis
- Hepatic function abnormality
- Dryness of mouth
- Epigastric distress
- Anorexia
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Jaundice
Genitourinary
- Urinary frequency
- Difficult urination
- Urinary retention
- Early menses
Respiratory
- Dryness of nose and throat
- Thickening of bronchial secretions
- Tightness of chest and wheezing
- Nasal stuffiness
Miscellaneous
- Fatigue
- Chills
- Headache
- Increased appetite/weight gain
Postmarketing Experience
There is limited information regarding Cyproheptadine hydrochloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Cyproheptadine hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cyproheptadine hydrochloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cyproheptadine hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cyproheptadine hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cyproheptadine hydrochloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Cyproheptadine hydrochloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Cyproheptadine hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Cyproheptadine hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cyproheptadine hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cyproheptadine hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cyproheptadine hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cyproheptadine hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cyproheptadine hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Cyproheptadine hydrochloride Administration in the drug label.
Monitoring
There is limited information regarding Cyproheptadine hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Cyproheptadine hydrochloride and IV administrations.
Overdosage
There is limited information regarding Cyproheptadine hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cyproheptadine hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Cyproheptadine hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Cyproheptadine hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Cyproheptadine hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Cyproheptadine hydrochloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Cyproheptadine hydrochloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cyproheptadine hydrochloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cyproheptadine hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Cyproheptadine hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cyproheptadine hydrochloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cyproheptadine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cyproheptadine hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cyproheptadine hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.