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phenylephrine/witch hazel topical (Preparation H Cooling Gel)

 

Classes: Gastrointestinal Agents, Other

Dosing and uses of Preparation H Cooling Gel (phenylephrine/witch hazel topical)

 

Adult dosage forms and strengths

phenylephrine/witch hazeL

topical geL

  • 0.25%/50%

 

Hemorrhoids

Apply gel externally to clean, dry hemorrhoidal area

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

 

Administration

Puncture foil seal using the top end of the tube’s cap when using for the first time

Apply gel externally

 

Pediatric dosage forms and strengths

phenylephrine/witch hazeL

topical geL

  • 0.25%/50%

 

Hemorrhoids

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

12 years or older: Apply gel externally to clean, dry hemorrhoidal area

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

 

Administration

Puncture foil seal using the top end of the tube’s cap when using for the first time

Apply gel externally

 

Preparation H Cooling Gel (phenylephrine/witch hazel topical) adverse (side) effects

Frequency not defined

There are no adverse reactions reported with the usage of this product

If ingested, witch hazel can cause nausea, vomiting, or liver damage

 

Warnings

Contraindications

Hypersensitivity to phenylephrine, witch hazel, or inactive components

Oral use

 

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

This product should not be placed in the rectum using a mechanical device or fingers

 

Pregnancy and 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.

 

Pharmacology of Preparation H Cooling Gel (phenylephrine/witch hazel topical)

Mechanism of action

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

Witch Hazel: Astringent, anti-inflammatory, styptic