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Avedana Glycerin

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This product has been discontinued

Active ingredient
Glycerin 2 g
Other brand names
Dosage form
Suppository
Route
Rectal
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
January 4, 2024
Active ingredient
Glycerin 2 g
Other brand names
Dosage form
Suppository
Route
Rectal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
January 4, 2024
Manufacturer
Unipack LLC
Registration number
M007
NDC root
43749-440

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Drug Overview

Avedana is a product that comes in the form of glycerin suppositories, which are designed to help relieve constipation. These suppositories work by drawing water into the intestines, which helps to soften the stool and promote bowel movements.

Typically, Avedana is used for short-term relief of constipation, and it is important to follow the guidance of a healthcare professional regarding its use, especially if you find yourself needing to use laxatives for more than a week.

Uses

It's important to use laxative products responsibly. You should not use them for more than one week unless your doctor specifically tells you to do so. This guideline helps ensure your safety and the effectiveness of the treatment.

Fortunately, there are no concerns regarding teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which are harmful effects that do not affect fetal development) associated with these laxatives. Always consult with your healthcare provider if you have any questions or concerns about using these products.

Dosage and Administration

For adults and children aged 6 years and older, you should insert one suppository (a small, solid medication designed to be placed in the rectum) well into the rectum and hold it in place for 15 minutes. It's important to note that the suppository does not need to melt in order to work effectively as a laxative (a medication that helps relieve constipation). You should not use more than one suppository in a day unless your doctor advises otherwise.

If you have a child between the ages of 2 and under 6 years, make sure to use the specially formulated Child Suppositories. For children under 2 years old, it’s best to consult with a doctor before administering any medication. Always follow the guidance provided by your healthcare professional to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of some warnings and considerations when using this medication. It is intended for rectal use only. Before using it, you should consult your doctor if you experience stomach pain, nausea, or vomiting, or if you notice a sudden change in your bowel habits that lasts more than two weeks. These symptoms could indicate a more serious condition that requires medical attention.

Warnings and Precautions

This medication is intended for rectal use only, so please ensure you follow this guideline carefully. If you accidentally swallow it, seek emergency medical help or contact a Poison Control Center immediately.

Before using this medication, it's important to consult your doctor if you experience any of the following: stomach pain, nausea, vomiting, or a sudden change in your bowel habits that lasts more than two weeks. If you notice any of these symptoms while using the medication, stop taking it and reach out to your healthcare provider for further advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health after taking medication.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When it comes to using this medication for children, it's important to follow specific guidelines. For children aged 2 to under 6 years, you should use Child Suppositories. If your child is under 2 years old, it's best to consult a doctor before use.

For adults and children aged 6 years and older, you can insert one suppository well into the rectum and have them retain it for 15 minutes. The suppository does not need to melt to work effectively. Remember, do not exceed one suppository in a day unless directed by a doctor. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your situation. They can help determine the best course of action based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

It appears that there is no specific storage or handling information provided for the product or device. This means you don't need to worry about particular temperature ranges or special handling instructions. However, it's always a good practice to keep any medical product in a clean, dry place and to follow any general safety guidelines that may apply.

If you have any questions or concerns about the product's use or safety, please consult your healthcare provider for more detailed information.

Additional Information

No further information is available.

FAQ

What is Avedana?

Avedana is a glycerin suppository product available in a 25 count jar.

How should I use Avedana?

For adults and children 6 years and over, insert 1 suppository well into the rectum and retain for 15 minutes. Do not exceed 1 suppository daily unless directed by a doctor.

Can children use Avedana?

Children aged 2 to under 6 years should use Child Suppositories, while for children under 2 years, you should ask a doctor.

Are there any warnings for Avedana?

Avedana is for rectal use only. You should ask a doctor before use if you have stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting over 2 weeks.

What should I do if I accidentally swallow Avedana?

If swallowed, get medical help or contact a Poison Control Center right away.

Is Avedana safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Avedana.

Are there any contraindications for Avedana?

There are no contraindications listed for Avedana.

Can I use Avedana for longer than a week?

You should not use laxative products like Avedana for longer than 1 week unless directed by a doctor.

Are there any known drug interactions with Avedana?

No specific drug interactions are mentioned for Avedana.

Packaging Info

Below are the non-prescription pack sizes of Avedana Glycerin (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Avedana Glycerin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Avedana Glycerin Suppositories are presented in a jar containing 25 units. These suppositories are formulated to provide a reliable method for rectal administration. The product is designed to facilitate bowel movements by drawing water into the intestines, thereby softening stool and promoting evacuation.

Uses and Indications

This drug is indicated for the short-term relief of constipation. It is recommended that laxative products not be used for longer than one week unless directed by a healthcare professional.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is to insert one suppository well into the rectum and retain it for a minimum of 15 minutes. The suppository does not need to melt in order to produce a laxative effect. It is important not to exceed one suppository per day unless otherwise directed by a healthcare professional.

For children aged 2 to under 6 years, it is advised to use Child Suppositories specifically formulated for this age group.

For children under 2 years of age, consultation with a healthcare provider is recommended prior to administration.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For rectal use only. It is imperative that healthcare professionals emphasize the appropriate administration route to prevent misuse and potential complications.

In the event of accidental ingestion, immediate medical assistance is required. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay.

Healthcare providers should advise patients to discontinue use and consult a physician if they experience any of the following symptoms: stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than two weeks. These symptoms may indicate underlying conditions that require further evaluation and management.

Side Effects

Patients should be aware that the product is intended for rectal use only.

Before using this product, it is advised that patients consult a healthcare professional if they experience any of the following conditions: stomach pain, nausea, vomiting, or a sudden change in bowel habits that persists for more than two weeks. These symptoms may indicate underlying health issues that require medical evaluation prior to the use of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Avedana Glycerin (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Avedana Glycerin.
Details

Pediatric Use

Pediatric patients aged 2 to under 6 years should use Child Suppositories. For infants and children under 2 years, it is advised to consult a doctor before use.

For children aged 6 years and older, the recommended dosage is to insert 1 suppository well into the rectum and retain it for 15 minutes. The suppository does not need to melt to produce a laxative effect. It is important not to exceed 1 suppository daily or to use it beyond the directions provided by a healthcare professional.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Avedana Glycerin, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.