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Histamine dihydrochloride

From Wikidoc - Reading time: 5 min

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Histamine dihydrochloride is a OTC granule that is FDA approved for the treatment of symptoms associated with allergic reactions and Helps support healthy respiratory system. Common adverse reactions include breathing difficulties, chills, cough, diarrhoea, flushing, headaches.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Helps support healthy respiratory system and alleviates symptoms associated with allergic reactions

Dosage

  • Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
  • Children: Take three granules and follow adult directions.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Histamine dihydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Histamine dihydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

Children: Take three granules and follow adult directions.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Histamine dihydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Histamine dihydrochloride in pediatric patients.

Contraindications

  • Condition1

Warnings

  • If pregnant or breastfeeding, ask a health professional before use.
  • Keep out of reach of children.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

breathing difficulties, chills, cough, diarrhoea, flushing, headaches

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Histamine dihydrochloride in the drug label.

Drug Interactions

There is limited information regarding Histamine dihydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • If pregnant or breastfeeding, ask a health professional before use.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Histamine dihydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Histamine dihydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Histamine dihydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Histamine dihydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Histamine dihydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Histamine dihydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Histamine dihydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Histamine dihydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Histamine dihydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Histamine dihydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Histamine dihydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Histamine dihydrochloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Histamine dihydrochloride in the drug label.

Overdosage

  • In case of overdose, get medical help or contact a Poison Control Center right away.

Pharmacology

Template:Px
Histamine dihydrochloride
Systematic (IUPAC) name
2-(1H-imidazol-5-yl)ethanamine dihydrochloride
Identifiers
CAS number 56-92-8
ATC code L03AX14
PubChem 11309913
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 184.067 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

Approved for use in the EU (2008) and Israel (2011)

Routes Subcutaneous injection

Mechanism of Action

Structure

Active Ingredient
  • HISTAMINUM HYDROCHLORICUM (Histamine hydrochloride) 15CH GR
  • HISTAMINUM HYDROCHLORICUM (Histamine hydrochloride) 200K GR
  • HISTAMINUM HYDROCHLORICUM (Histamine hydrochloride) 30K GR
  • HISTAMINUM HYDROCHLORICUM (Histamine hydrochloride) 5CH GR
  • HISTAMINUM HYDROCHLORICUM (Histamine hydrochloride) 6CH GR
  • HISTAMINUM HYDROCHLORICUM (Histamine hydrochloride) 9CH GR
Inactive Ingredients
  • Lactose,
  • sucrose.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Histamine dihydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Histamine dihydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Histamine dihydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Histamine dihydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Histamine dihydrochloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Histamine dihydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

This image is provided by the National Library of Medicine.

UNDA

Do not use if label perforation is broken

Homeopathic Remedy

NDC : 62106-5986-4

HISTAMINUM HYDROCHLORICUM

Histamine hydrochloride

140 granules

Indications

Helps support healthy respiratory system and alleviates symptoms associated with allergic reactions

Ingrediendts and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Histamine dihydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

QUESTIONS? 1-888-737-6925.

Precautions with Alcohol

  • Alcohol-Histamine dihydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • HISTAMINUM HYDROCHLORICUM®[1]

Look-Alike Drug Names

There is limited information regarding Histamine dihydrochloride 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.

  1. ↑ "Histamine hydrochloride".
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