Usage
This combination medication is primarily prescribed for the treatment of hemorrhoids (piles) and anal fissures. It is also used to alleviate pain and inflammation following hemorrhoid surgery and in cases of mild proctitis. It can also be used to prepare the nasal mucosa for surgery or endoscopy.
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Pharmacological Classification: This is a combination product containing a corticosteroid (beclometasone), a local anesthetic (lidocaine), and a decongestant (phenylephrine).
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Mechanism of Action: Beclometasone reduces inflammation and itching. Lidocaine provides local pain relief by blocking nerve signals. Phenylephrine constricts blood vessels, reducing swelling and congestion.
Alternate Names
No alternate names are listed in the provided sources. Brand names may vary by region.
- Brand Names: Proctosedyl, No Pile Cream, StayHappi Cream (and other regional variations). A lidocaine/phenylephrine combination is marketed as Lidocaine and Phenylephrine Topical Solution.
How It Works
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Pharmacodynamics: Beclometasone exerts its anti-inflammatory action by binding to glucocorticoid receptors, inhibiting inflammatory mediators. Lidocaine blocks voltage-gated sodium channels, preventing nerve impulse transmission. Phenylephrine activates alpha-adrenergic receptors, causing vasoconstriction.
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Pharmacokinetics: Beclometasone is minimally absorbed systemically when applied topically. Lidocaine is absorbed through mucous membranes, with the rate dependent on application site, dosage, and duration. Phenylephrine’s absorption is limited when applied topically.
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Mode of Action: The combination provides synergistic relief by targeting different aspects of anorectal inflammation and pain.
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Elimination Pathways: Limited information is available on the specific metabolic and elimination pathways of this combination when applied topically. Systemically administered beclometasone is metabolized by CYP3A4. Systemically administered phenylephrine is metabolized by monoamine oxidase (MAO). Systemically administered lidocaine is metabolized in the liver.
Dosage
Standard Dosage
Adults:
Apply a small quantity to the affected area two to three times daily, or before and after each bowel movement. Use the provided applicator for internal hemorrhoids.
Children:
This combination is generally not recommended for children under 12 years of age. For children 12 years and older, the adult dosage may be followed. However, pediatric use should be under strict medical supervision. One source states that this drug combination is not safe for children.
Special Cases:
- Elderly Patients: No specific dosage adjustments are mentioned, but caution is advised due to potential age-related changes in drug metabolism.
- Patients with Renal Impairment: No specific adjustments. Exercise caution in patients with severe renal disease.
- Patients with Hepatic Dysfunction: No specific dose adjustments. Use with caution in patients with severe liver disease.
- Patients with Comorbid Conditions: Use with caution in patients with diabetes, hypertension, glaucoma, or thyroid problems.
Clinical Use Cases
- Intubation: For nasal application before nasal intubation. Spray up to 8 sprays in total.
- Surgical Procedures: Used before anorectal surgery.
- Mechanical Ventilation: Not typically used.
- Intensive Care Unit (ICU) Use: No specific dosage guidelines provided.
- Emergency Situations: Not typically used.
Dosage Adjustments:
Dosage adjustments should be made based on individual patient response and clinical condition. For nasal application, the number of sprays can be increased to two sprays in each nostril. If using the combination rectally, the number of daily applications can be reduced to two if sufficient pain and inflammation relief is achieved.
Side Effects
Common Side Effects
- Burning sensation
- Itching
- Redness
- Irritation at the application site
- Dryness at the application site
- Sneezing (with nasal application)
- Sore throat, hoarse voice (with nasal application)
- Unpleasant taste or smell (with nasal application)
- Dry or sore nose, nosebleeds (with nasal application)
- Constipation
Rare but Serious Side Effects
- Allergic reactions
- Skin thinning or inflammation (with prolonged use)
Long-Term Effects
- Thinning of perianal skin (with prolonged topical use)
- Systemic effects of corticosteroids (with prolonged or excessive use)
Adverse Drug Reactions (ADR)
- Severe allergic reactions (rare)
- Adrenal suppression (with prolonged systemic absorption)
Contraindications
- Hypersensitivity to any of the components
- Viral, fungal, or bacterial skin infections at the application site
- Tuberculosis of the skin
- Perianal ulcers or open wounds
- Children under four years old (or, from other sources, under twelve years old)
- Pregnancy and breastfeeding (caution advised)
- Hypovolemia
- Severe hypertension
- Acute ischemic heart disease
- Complete heart block
- Thyrotoxicosis
- Glaucoma
- Urinary retention
- Concomitant use of sympathomimetic drugs or MAO inhibitors
Drug Interactions
- Other corticosteroids: Increased risk of systemic side effects.
- Other topical anesthetics: Additive effects.
- Other decongestants: Additive effects.
- Antiarrhythmic drugs (e.g., tocainide): Increased risk of lidocaine toxicity.
- Quinuprisin/dalfoprisin: Increased risk of ventricular arrhythmias.
- Guanethedine, reserpine, digitalis, methyldopa: Potential for interaction with phenylephrine.
- Propranolol: Increased risk of myocardial depression with lidocaine.
Pregnancy and Breastfeeding
Use with caution during pregnancy and breastfeeding. The safety has not been fully established. Topical beclometasone is considered safe during pregnancy and breastfeeding. However, the safety profiles of topical lidocaine and topical phenylephrine during these periods are less clear. If the benefits of using the combination product outweigh the risks, it may be considered.
Drug Profile Summary
- Mechanism of Action: Combines anti-inflammatory, anesthetic, and decongestant actions.
- Side Effects: Burning, itching, redness, irritation, dryness, sneezing, sore throat.
- Contraindications: Hypersensitivity, skin infections, pregnancy/breastfeeding (caution).
- Drug Interactions: Other corticosteroids, anesthetics, decongestants.
- Pregnancy & Breastfeeding: Use with caution; safety not fully established.
- Dosage: Adults: Apply a small quantity 2-3 times/day or before/after bowel movement.
- Monitoring Parameters: Monitor for local skin reactions, signs of infection, blood pressure (with phenylephrine).
Popular Combinations
This medication is typically used as a standalone combination product. Combining with other anorectal medications should be done with caution and under medical supervision.
Precautions
- General Precautions: Perform a thorough patient history, including allergies, medical conditions, and current medications.
- Specific Populations: Use cautiously in pregnant/breastfeeding women, children, and the elderly.
- Lifestyle Considerations: Limit alcohol intake, as it can worsen constipation.
FAQs (Frequently Asked Questions)
A: Apply a small amount to the affected area 2-3 times daily, or before and after bowel movements. Use the applicator for internal hemorrhoids. For nasal application, use up to 8 total sprays.
Q2: Can this combination be used during pregnancy or breastfeeding?
A: It should be used with caution. Consult a physician to assess the benefits and risks.
Q3: What are the common side effects?
A: Burning, itching, redness, irritation, dryness at the application site.
Q4: Are there any serious side effects?
A: Rare but serious side effects include allergic reactions and skin thinning with prolonged topical use.
Q5: What are the contraindications to using this combination?
A: Hypersensitivity, local skin infections, pregnancy/breastfeeding (use with caution).
Q6: Can this medication interact with other drugs?
A: Yes, it can interact with other corticosteroids, topical anesthetics, and decongestants. It can also interact with certain antiarrhythmic drugs.
Q7: How should this medication be stored?
A: Store at room temperature, away from direct sunlight and moisture.
Q8: What should I do if I miss a dose?
A: Apply the missed dose as soon as you remember, unless it’s almost time for the next dose. Do not apply extra medication to catch up.
Q9: How long can I use this combination product?
A: It is best to use this medication for the duration prescribed by your physician. Using the combination product long-term should be avoided unless advised by a doctor.
Q10: Can it be used for other conditions besides hemorrhoids and anal fissures?
A: It is sometimes used to prepare the nasal passages before surgical procedures. It can also be used to facilitate the removal of foreign bodies from the nose.
