phenylephrine/cocoa butter rectal (OTC)

Brand and Other Names:Preparation H Suppository
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

phenylephrine/cocoa butter

rectal ointment

  • 0.25%/85.39%
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Hemorrhoids

Insert 1 suppository rectally

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

Administration

Detach 1 suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

1) hold suppository with rounded end up

2) carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"

3) slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository

4) remove exposed suppository from wrapper

5) insert 1 suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement

Dosage Forms & Strengths

phenylephrine/cocoa butter

rectal ointment

  • 0.25%/85.39%
more...

Hemorrhoids

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

12 years or older: Insert 1 suppository rectally

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

Administration

Detach 1 suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

1) hold suppository with rounded end up

2) carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"

3) slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository

4) remove exposed suppository from wrapper

5) insert 1 suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement

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Adverse Effects

Frequency Not Defined

Allergic reaction

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Warnings

Contraindications

Hypersensitivity

Cautions

For rectal 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

Cocoa butter: Provides moisturizing and lubricating effects

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Images

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