phenylephrine/mineral oil/petrolatum rectal (OTC)

Brand and Other Names:Preparation H Ointment
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Sections

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

phenylephrine/mineral oil/petrolatum

rectal ointment

  • 0.25%/14%/71.9%

Hemorrhoids

Apply externally to cleansed hemorrhoidal area or in the lower portion of the anal canal

May apply up to 4 times/day, especially at night, in the morning, or after bowel movement that may exacerbate hemorrhoid(s)

Administration

For application in the lower anal canal, remove cover from dispensing cap and attach dispensing cap to tube

Intrarectal use: Intrarectal use: Remove cover from applicator and attach applicator to ointment tube, lubricate applicator well and gently insert applicator into rectum; clean applicator after each use and replace cover

Dosage Forms & Strengths

phenylephrine/mineral oil/petrolatum

rectal ointment

  • 0.25%/14%/71.9%

Hemorrhoids

<12 years: Use is dependent on patient and if benefit outweighs risk

12 years or older: Apply externally to cleansed hemorrhoidal area or in the lower portion of the anal canal

May apply up to 4 times/day, especially at night, in the morning, or after bowel movement that may exacerbate hemorrhoid(s)

Administration

For application in the lower anal canal, remove cover from dispensing cap and attach dispensing cap to tube

Intrarectal use: Intrarectal use: Remove cover from applicator and attach applicator to ointment tube, lubricate applicator well and gently insert applicator into rectum; clean applicator after each use and replace cover

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Adverse Effects

Frequency Not Defined

Allergic reaction

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Warnings

Contraindications

Hypersensitivity

Cautions

For external use only

Contains phenylephrine, ask healthcare professional if experiencing heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland

Discontinue and contact physician if hemorrhoids worsen or do not improve within 7 days

Discontinue and ask doctor if symptom being treated does not subside, experience, bleeding, allergic reaction, redness, irritation, swelling, pain, or other symptoms develop or increase

If currently taking prescription drug for high blood pressure or depression consult healthcare professional

Do not exceed recommended daily dose unless directed by a doctor

Do not put into the rectum by using fingers or any mechanical device or applicator

Keep out of reach of children; if swallowed, get medical help or contact a poison control center right away

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Pregnancy & Lactation

Pregnancy

Ask healthcare professional before use

Lactation

Ask healthcare professional before use

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Phenylephrine: Alpha adrenergic agonist; elicits localized vasoconstriction and decreases inflammation

Mineral oil: Emollient; softens stool in colon by retarding colonic absorption of fecal water

Petrolatum: Provides moisturizing and lubricating effects

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Hemorrhoidal (phenylephrine-mineral oil-petrolatum) rectal
-
0.25-14-74.9 % ointment
Hemorrhoidal (phenylephrine-mineral oil-petrolatum) rectal
-
0.25-14-74.9 % ointment

Copyright © 2010 First DataBank, Inc.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.