phenylephrine/pramoxine/glycerin/petrolatum rectal (OTC)

Brand and Other Names:Preparation H Cream Maximum Strength Pain Relief
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

phenylephrine/pramoxine/glycerin/petrolatum

rectal ointment

  • 0.25%/1%/14.4%/15%
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Hemorrhoids

Apply to cleansed area externally 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: 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/pramoxine/glycerin/petrolatum

rectal ointment

  • 0.25%/1%/14.4%/15%
more...

Hemorrhoids

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

12 years or older: Apply to cleansed area externally 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: 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, caution with heart disease, hypertension, hyperthyroidism, diabetes, or prostatic hypertrophy

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

Discontinue if bleeding, allergic reaction, redness, irritation, swelling, pain, or other symptoms develop or increase

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

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

Pramoxine: Local anesthetic for temporary pain relief

Glycerin: Hyperosmotic laxative; attracts water into stool and elicits bowel movement

Petrolatum: Provides moisturizing and lubricating effects

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