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Brand Name :
Preparation H Ointment
Synonyms :
phenylephrine/mineral oil/petrolatum rectal
Class :
Gastrointestinal agents, others
Brand Name :
Preparation H Ointment
Synonyms :
phenylephrine/mineral oil/petrolatum rectal
Class :
Gastrointestinal agents, others
Dosage forms and strengths
phenylephrine/mineral oil/petrolatum
rectal ointment
(0.25%/14%/71.9%)
Dosage forms and strengths
phenylephrine/mineral oil/petrolatum
rectal ointment
(0.25%/14%/71.9%)
Refer adult dosing
Actions and Spectrum
Action:
Vasoconstriction: phenylephrine causes constriction of blood vessels, particularly those in the rectal area. This helps to reduce swelling and inflammation, providing relief from conditions such as hemorrhoids.
Spectrum: phenylephrine is primarily used for its vasoconstrictive properties in the rectal area. However, when combined with other substances in a rectal preparation, such as mineral oil and petrolatum, the spectrum expands to include additional benefits:
Lubrication: mineral oil and petrolatum act as lubricants. When combined with phenylephrine, they help to ease the passage of stool during bowel movements, reducing discomfort and potential irritation in the rectal area.
Moisturizing and Protection: mineral oil and petrolatum also have moisturizing properties that can help soothe dry or irritated skin in the rectal area. They form a protective barrier that helps to prevent further irritation or damage.
Frequency not defined
Allergic reaction
Black Box Warning:
serious adverse reactions in some cases
These reactions may include severe allergic reactions, respiratory distress, and cardiovascular complications.
Contraindication/Caution:
Hypersensitivity: The drug should not be used in individuals with known hypersensitivity or allergic reactions to any of its components. Allergic reactions may manifest as skin rash, itching, swelling, or difficulty breathing. Immediate medical attention should be sought if such reactions occur.
Gastrointestinal Obstruction: The drug is contraindicated in individuals with a known or suspected gastrointestinal obstruction. The use of this medication in such cases may worsen the obstruction or lead to bowel perforation. Prompt medical evaluation is necessary if symptoms of obstruction, such as severe abdominal pain, bloating, or vomiting, occur.
Rectal Bleeding: Administration of this drug is contraindicated in patients experiencing rectal bleeding. The use of this medication in the presence of active bleeding can obscure the underlying cause and delay appropriate diagnosis and treatment.
Inflammatory Bowel Disease: Patients with inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, should avoid using this drug. The presence of active inflammation in the gastrointestinal tract can increase the risk of complications, including worsening of the disease or the development of infections.
Recent Rectal or Colorectal Surgery: Individuals who have undergone recent rectal or colorectal surgery should not use this drug.
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
phenylephrine, mineral oil, and petrolatum are commonly used in rectal preparations, providing pharmacological effects through their distinct mechanisms of action.
Pharmacodynamics:
phenylephrine: phenylephrine is a sympathomimetic agent that acts as a selective alpha-1 adrenergic receptor agonist. Upon rectal administration, The drugactivates alpha-1 adrenergic receptors located in the smooth muscles of blood vessels, leading to vasoconstriction. This vasoconstrictive effect results in decreased blood flow to the affected area, thereby reducing inflammation, edema, and congestion. Additionally, phenylephrine’s vasoconstrictive action can help alleviate symptoms associated with hemorrhoids and other rectal conditions.
mineral Oil: When administered rectally, mineral oil acts as a lubricant, forming a protective film on the mucosal surfaces of the rectum. This lubricating action facilitates smoother bowel movements and helps relieve constipation. By reducing friction between the stool and the rectal walls, mineral oil eases the passage of fecal matter, promoting regular bowel movements.
petrolatum: It possesses emollient properties and is widely used for its protective and moisturizing effects on the skin. When applied rectally, petrolatum acts as a lubricant and forms a protective barrier on the rectal mucosa. This barrier helps reduce irritation, inflammation, and discomfort associated with certain rectal conditions. Furthermore, petrolatum’s occlusive properties help retain moisture and promote the healing of damaged tissues.
Pharmacokinetics:
Absorption
Upon rectal administration, the phenylephrine/mineral oil/petrolatum preparation is expected to undergo absorption through the rectal mucosa. The absorption process involves the drug crossing the epithelial barrier and entering the systemic circulation.
Distribution
phenylephrine and its associated components are likely to distribute throughout the body via systemic circulation. Distribution may occur to various tissues and organs, including target sites responsible for the desired therapeutic effects. The extent of distribution depends on factors such as lipophilicity, protein binding, and tissue permeability.
Metabolism
The metabolism of drug primarily take place in liver, where enzymes such as cytochrome P450s catalyze biotransformation reactions. phenylephrine may undergo oxidative metabolism, leading to the formation of metabolites that may exhibit altered pharmacological properties compared to the parent drug.
Excretion and elimination
The metabolites and any unmetabolized drug are eliminated from the body through excretion. The primary route of excretion for phenylephrine and its metabolites is through renal clearance. Unabsorbed components may also be eliminated through fecal excretion.
Administration:
To utilize in the lower anal canal, follow these steps: Remove the protective cover from the dispensing cap and connect the cap to the tube.
For intrarectal use:
Remove the cover from the applicator and attach it to the ointment tube. Ensure the applicator is well lubricated, then gently insert it into the rectum. Remember to clean the applicator after each use and place the cover back on.
Patient information leaflet
Generic Name: phenylephrine/mineral oil/petrolatum rectal
Why do we use phenylephrine/mineral oil/petrolatum rectal ?
Hemorrhoids: phenylephrine/mineral oil/petrolatum rectal is commonly employed in the management of hemorrhoids, which are swollen blood vessels in the rectal area. The phenylephrine component acts as a vasoconstrictor, reducing blood flow to the affected area and alleviating the associated symptoms such as itching, swelling, and discomfort. The mineral oil and petrolatum constituents help to soften the stools and facilitate smoother bowel movements, reducing strain during defecation.
Anal Fissures: This medication is also utilized in the treatment of anal fissures, Additionally, the mineral oil and petrolatum components act as lubricants, easing bowel movements and reducing friction on the anal fissures.
Rectal Irritation: phenylephrine/mineral oil/petrolatum rectal can be beneficial in managing rectal irritation caused by various factors, including diarrhea, constipation, and excessive wiping. The vasoconstrictor properties of phenylephrine help to reduce inflammation and irritation, while the mineral oil and petrolatum components provide a protective barrier, soothing the affected area and promoting healing.
Post-Rectal Surgery: Following certain rectal surgeries, such as hemorrhoidectomy or anal fistula repair, It helps reduce swelling, discomfort, and inflammation in the postoperative period, while the mineral oil and petrolatum constituents prevent dryness and promote tissue repair.
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