CitraNatal DHA

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CitraNatal DHA
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Disclaimer

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Black Box Warning

Accidental Overdose
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Overview

CitraNatal DHA is a multi-vitamin/mineral that is FDA approved for the {{{indicationType}}} of improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include allergic reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Improving Nutritional status of Women
  • Dosing Information
  • CitraNatal® DHA is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
  • One tablet and one soft gel daily or as directed by a physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of CitraNatal DHA in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Accidental Overdose
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
  • Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Precautions

  • Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions

Clinical Trials Experience

  • Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of CitraNatal DHA in the drug label.

Drug Interactions

There is limited information regarding CitraNatal DHA Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of CitraNatal DHA during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of CitraNatal DHA with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of CitraNatal DHA with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of CitraNatal DHA with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of CitraNatal DHA in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of CitraNatal DHA in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of CitraNatal DHA in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of CitraNatal DHA in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of CitraNatal DHA in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Management

Chronic Overdose

There is limited information regarding Chronic Overdose of CitraNatal DHA in the drug label.

Pharmacology

There is limited information regarding CitraNatal DHA Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding CitraNatal DHA Mechanism of Action in the drug label.

Structure

  • CitraNatal® DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of CitraNatal DHA in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of CitraNatal DHA in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of CitraNatal DHA in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of CitraNatal DHA in the drug label.

How Supplied

  • Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30.
  • To report a serious adverse event or obtain product information, call (210) 696-8400.
  • Please consult your health care provider with any dietary concerns.
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.
  • NOTICE: Contact with moisture can discolor or erode the tablet.

Storage

There is limited information regarding CitraNatal DHA 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 Patient Counseling Information of CitraNatal DHA in the drug label.

Precautions with Alcohol

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

Brand Names

  • CitraNatal DHA®[1]

Look-Alike Drug Names

There is limited information regarding CitraNatal DHA 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. ↑ [dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5027852-b374-10e4-7acd-42f9ada83f81 "CITRANATAL DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium"] Check |url= value (help).


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