phenylephrine/mineral oil/petrolatum rectal (Preparation H Ointment)
Classes: Gastrointestinal Agents, Other
Dosing and uses of Preparation H Ointment (phenylephrine/mineral oil/petrolatum rectal)
Adult dosage forms and 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
Pediatric dosage forms and 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
Preparation H Ointment (phenylephrine/mineral oil/petrolatum rectal) adverse (side) effects
Frequency not defined
Allergic reaction
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
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 Ointment (phenylephrine/mineral oil/petrolatum rectal)
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