Formula H

Description

No relevant information regarding the Description for SPL code 34089-3 is present in the provided text.

Uses and Indications

This drug is indicated for the relief of hemorrhoids. It is designed to alleviate the discomfort and symptoms associated with this condition.

Dosage and Administration

The medication should be applied to the affected area up to six times daily or following each bowel movement. It is important to ensure that the area is clean and dry before application. A thin layer of the product should be gently massaged into the skin until fully absorbed. Healthcare professionals should advise patients to wash their hands thoroughly after application to avoid unintentional contact with other areas of the body or with other individuals.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to plants of the Asteraceae/Compositae/Daisy family due to the potential for hypersensitivity reactions. In such cases, discontinuation of use is advised.

Additionally, this product should not come into contact with the eyes, as this may lead to irritation or adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Individuals with known allergies to plants belonging to the Asteraceae/Compositae/Daisy family should refrain from using this product. Hypersensitivity reactions, including allergic responses, have been reported; therefore, if any signs of allergy occur, the use of the product should be discontinued immediately.

Healthcare professionals should advise patients to stop using the product and seek medical advice if any of the following conditions arise: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, in the event of any bleeding, it is crucial to consult a healthcare provider promptly.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. In the event of bleeding, it is imperative to seek medical attention promptly.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Formula H (glycerin 25%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no stated safety concerns or contraindications related to pregnancy. Additionally, no dosage modifications for pregnant individuals are mentioned, and the insert does not include any special precautions regarding use during this period. Healthcare professionals should consider the absence of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for guiding treatment decisions and ensuring patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified hypersensitivity reactions, including allergy, as a reported event. In cases of hypersensitivity, it is recommended that the use of the product be discontinued.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they have a known allergy to plants of the Asteraceae/Compositae/Daisy family, as hypersensitivity reactions, including allergies, may occur. In such cases, patients should discontinue use and consult a healthcare professional.

Healthcare providers should counsel patients to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be advised to consult a doctor promptly in the event of any bleeding.

It is important to remind patients to avoid getting the product into their eyes while using it.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered via rectal and topical routes. Patients are advised to apply the treatment to the affected area up to six times daily or following each bowel movement.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Formula H, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)