Hemorrhoidal Ointment (phenylephrine HCl/shark liver oil/mineral oil/wh.petrolatum)
Rectal Local Vasoconstrictors Rectal Ointment (GRAM)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Phenylephrine hydrochloride, synthetic sympathomimetic amine, is a vasoconstrictor.
USES: This medication is used to temporarily relieve swelling, burning, pain, and itching caused by hemorrhoids. It contains phenylephrine, which belongs to a class of drugs known as sympathomimetic amines. It works by temporarily narrowing the blood vessels in the area.
This effect decreases swelling and discomfort. Some products may also contain substances (such as cocoa butter, hard fat, mineral oil, shark liver oil) that form a protective barrier to prevent too much irritating contact with stool. Do not use this product in children 12 years or younger without talking with the doctor.
Generic name: phenylephrine HCl/shark liver oil/mineral oil/wh.petrolatum
Pronunciation: (FEN-il-EF-rin)
Drug class: Rectal Local Vasoconstrictors
Therapeutic class: Anorectal Preparations
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Hemorrhoidal Ointment
Indications
The following indications are listed for Hemorrhoidal Ointment:
- Hemorrhoids
- Proctitis
- Pruritus Ani
- Rectal Pain
Also known as: Proctalgia, Rectitis.
Dosing
To produce decongestion of the conjunctiva, 1 or 2 drops of a 0.12-0.25% ophthalmic solution of phenylephrine hydrochloride may be applied topically to the conjunctiva every 3-4 hours (up to 4 times daily for self-medication) as needed. Vasoconstriction for diagnosis of ocular congestion or to improve visualization of ocular blood vessels in sickle-cell disease may be achieved by application of 1 or 2 drops of a 2.5% solution. In the ''blanching test'', congestion probably is caused by conjunctivitis rather than iridocyclitis if the drug produces perilimbal blanching in the congested eye. A 2.5 or 10% solution of the drug may also be administered prior to surgery to produce mydriasis and aid in controlling hemorrhage. (See Phenylephrine Hydrochloride 52:24.)
To produce nasal decongestion in adults and children 12 years of age or older, the usual dosage is 2 or 3 drops, 1-3 sprays, or 1-3 metered sprays instilled in each nostril. In cases of extreme nasal congestion in adults, a 1% solution may be used initially. To produce nasal decongestion in children 6-12 years of age, 2 or 3 drops or 1 or 2 sprays of a 0.25% solution may be instilled in each nostril. Doses of the drug as drops or spray may be repeated in 4 hours if needed. Phenylephrine nasal solutions should not be used for self-medication for longer than 3 days; if symptoms persist, the drug should be discontinued and a physician consulted. Intranasal application of phenylephrine should generally be used for no longer than 3-5 days.
For use with local anesthetics, phenylephrine hydrochloride may be used in concentrations of 1:2500 to 1:20,000.
Phenylephrine hydrochloride ophthalmic solutions are applied topically to the conjunctiva. Digital pressure should be applied on the lacrimal sac for 1-2 minutes following topical instillation of ophthalmic solutions to minimize drainage into the nose and throat and reduce the risk of absorption and systemic reactions. Excess solution around the eye should be removed with a tissue.
For intranasal applications, phenylephrine may be administered in solution as drops or spray. Vicks Sinex(R) (with mist spray nozzle) nasal solution is administered by nasal inhalation using a special nasal inhaler that produces metered droplet sprays. Care must be taken to avoid contamination of the dropper, inhaler, or spray. Except in young children in whom sprays are difficult to use, nasal sprays may be preferable to drops because of the lesser risk of swallowing the drug and resultant systemic absorption. Drops should be applied to the dependent (lower) nostril, with the patient in a lateral head-low position. The patient should remain in the same position for 5 minutes, then the solution should be applied to the other nostril in a similar manner. Alternatively, drops may be instilled when the patient is reclining with the head tilted back as far as possible. Sprays should be delivered or pumped (Vicks Sinex(R) metered spray) into each nostril with the patient's head erect so that excess solution is not released. The nose should be blown thoroughly 3-5 minutes later. Prior to initial use of the metered sprays, the nasal inhaler must be primed by depressing the pump firmly several times. To minimize the risk of spreading infections, droppers, inhalers, and spray dispensers should not be used by more than one person, and tips of the dispensers, inhalers, or droppers should be rinsed with hot water following use.
Phenylephrine nasal solutions also may be applied to a tampon or nasal pack for insertion into nasal passages. However, this method of application should be restricted to use in diagnostic or surgical procedures performed under medical supervision because mechanical injury may occur.
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No dosing information is available for this tab.
Drug interactions
When applied topically to the conjunctiva (especially in concentrations of 2.5% or greater), phenylephrine hydrochloride must be administered under careful supervision and in reduced dosage if used within 21 days after the patient has received a monoamine oxidase (MAO) inhibitor because potentiation of the pressor effects of phenylephrine may result. Nasal solutions containing phenylephrine must not be given to a patient receiving an MAO inhibitor. The pressor response to phenylephrine may also be potentiated if a tricyclic antidepressant is administered concomitantly.
Concomitant administration of phenylephrine with cycloplegic antimuscarinic drugs such as atropine sulfate, cyclopentolate hydrochloride, homatropine hydrobromide, or scopolamine hydrobromide produces increased mydriatic effects.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Agents That Affect Catecholamines/Iobenguane I 123
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Many compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells.(1)
CLINICAL EFFECTS: Compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with imaging completed with iobenguane.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Discuss the use of agents that affect catecholamines. Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores prior to imaging with iobenguane. Before imaging with iobenguane, discontinue agents that affect catecholamines for at least 5 biological half-lives, as clinically tolerated.(1)
DISCUSSION: Many agents may reduce catecholamine uptake or deplete catecholamine stores.(1) Examples include: - CNS stimulants or amphetamines (e.g. cocaine, methylphenidate, dextroamphetamine) - norepinephrine and dopamine reuptake inhibitors (e.g. phentermine) - norepinephrine and serotonin reuptake inhibitors (e.g. tramadol) - monoamine oxidase inhibitors (e.g. phenelzine, linezolid) - central monoamine depleting drugs (e.g. reserpine) - non-select beta adrenergic blocking drugs (e.g. labetalol) - alpha agonists or alpha/beta agonists (e.g. pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline) - tricyclic antidepressants or norepinephrine reuptake inhibitors (e.g. amitriptyline, bupropion, duloxetine, mirtazapine, venlafaxine) - botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine (e.g. ephedra, ma huang, St. John's Wort, yohimbine)
Agents That Affect Catecholamines/Iobenguane I 131
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Many compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells.(1)
CLINICAL EFFECTS: Compounds that reduce catecholamine uptake or that deplete catecholamine stores may impact the dosimetry calculations or effectiveness of iobenguane.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Discuss the use of agents that affect catecholamines. Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores for at least 5 half-lives before administration of either the dosimetry or a therapeutic dose of iobenguane. Do not administer these drugs until at least 7 days after each iobenguane dose.(1)
DISCUSSION: Many agents may reduce catecholamine uptake or deplete catecholamine stores.(1) Examples include: - CNS stimulants or amphetamines (e.g. cocaine, methylphenidate, dextroamphetamine) - norepinephrine and dopamine reuptake inhibitors (e.g. phentermine) - norepinephrine and serotonin reuptake inhibitors (e.g. tramadol) - monoamine oxidase inhibitors (e.g. phenelzine, linezolid) - central monoamine depleting drugs (e.g. reserpine) - non-select beta adrenergic blocking drugs (e.g. labetalol) - alpha agonists or alpha/beta agonists (e.g. pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline) - tricyclic antidepressants or norepinephrine reuptake inhibitors (e.g. amitriptyline, bupropion, duloxetine, mirtazapine, venlafaxine) - botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine (e.g. ephedra, ma huang, St. John's Wort, yohimbine) - calcium channel blockers
Moderate Interaction: Assess the risk to the patient and take action as needed.
Sympathomimetics (DIRECT, MIXED-ACTING)/Methyldopa
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Unknown.
CLINICAL EFFECTS: The pressor response to sympathomimetics may be increased.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Start with low doses of sympathomimetics and monitor blood pressure of patients during concurrent administration of sympathomimetics and methyldopa.
DISCUSSION: The pressor response to sympathomimetics has been reported to be increased during methyldopa administration. In addition to increased duration of pressor response, severe hypertension has been reported.
Sympathomimetics/Rauwolfia Alkaloids
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Reserpine depletes catecholamine stores within the peripheral vascular adrenergic nerve endings, thus indirect acting sympathomimetics are unable to trigger the release of catecholamines. The reserpine-induced catecholamine release increases sensitivity to the effects of direct acting sympathomimetics.
CLINICAL EFFECTS: Increased effects of direct acting sympathomimetics. Decreased effects of indirect acting sympathomimetics. Mixed acting sympathomimetics will show effects based on the predominance of either direct or indirect activity.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: If these agents are administered concurrently, monitor blood pressure. The dose of the sympathomimetic may need to be adjusted.
DISCUSSION: This interaction has been well documented in animal studies and human case reports have confirmed the interaction. Reserpine has been shown to decrease the response to epinephrine administered for hypotension. Reserpine has also been shown to decrease the effectiveness of ophthalmic epinephrine, a direct acting sympathomimetic. Ophthalmic phenylephrine has been shown to decrease the hypotensive effects of reserpine.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Benign prostatic hyperplasia
- Cardiac arrhythmia
- Coronary artery disease
- Hypertension
- Hyperthyroidism
- Nervousness
Adverse reactions
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Rare or Very Rare
- Cardiac arrhythmia
- Dizziness
- Headache disorder
- Hyperhidrosis
- Insomnia
- Nervousness
- Pallor
- Tachycardia
- Tremor
Rare or Very Rare
- Rectal irritation
Precautions
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No enhanced messaging available.
Animal reproduction studies have not been performed with phenylephrine. It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia. (See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed.
Since it is not known whether phenylephrine is distributed into milk, the drug should be used with caution in nursing women.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Hemorrhoids | ||
| K64.0 | ICD10CM | First degree hemorrhoids |
| K64.8 | ICD10CM | Other hemorrhoids |
| K64.9 | ICD10CM | Unspecified hemorrhoids |
| O22.4 | ICD10CM | Hemorrhoids in pregnancy |
| O22.40 | ICD10CM | Hemorrhoids in pregnancy, unspecified trimester |
| O22.41 | ICD10CM | Hemorrhoids in pregnancy, first trimester |
| O22.42 | ICD10CM | Hemorrhoids in pregnancy, second trimester |
| O22.43 | ICD10CM | Hemorrhoids in pregnancy, third trimester |
| O87.2 | ICD10CM | Hemorrhoids in the puerperium |
| Proctitis | ||
| K62.7 | ICD10CM | Radiation proctitis |
| K62.89 | ICD10CM | Other specified diseases of anus and rectum |
| Pruritus ani | ||
| L29.0 | ICD10CM | Pruritus ani |
| L29.3 | ICD10CM | Anogenital pruritus, unspecified |
| Rectal pain | ||
| K62.89 | ICD10CM | Other specified diseases of anus and rectum |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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