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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 2017
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 2017
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 type of glycerin suppository, which is a medication designed to help relieve constipation. It comes in a jar containing 100 suppositories, making it easy to use when you need assistance with bowel movements. Glycerin works by drawing water into the intestines, which helps to soften the stool and promote a bowel movement.

It's important to use Avedana as directed and not to rely on laxative products for more than one week without consulting a doctor. This ensures that you use the medication safely and effectively.

Uses

You should only use laxative products for a short period, specifically no longer than one week, unless your doctor advises otherwise. This is important to ensure your health and safety while using these medications.

It's reassuring to know that there are no teratogenic effects (which means they do not cause birth defects) associated with these laxatives. Additionally, there are no nonteratogenic effects noted, indicating that these products are generally safe when used as directed. Always consult with your healthcare provider if you have any questions or concerns about using laxatives.

Dosage and Administration

If you or your child is using this medication, here’s how to take it properly. For adults and children aged 6 years and older, you should insert one suppository (a small, solid medication designed to be inserted into the rectum) once a day, or follow your doctor’s specific instructions. If your child is between 2 and 6 years old, make sure to use the child-specific suppositories. For children under 2 years, it’s important to consult a doctor before use.

To use the suppository, insert it well up into the rectum and hold it in place for about 15 minutes. You don’t need to wait for the suppository to melt for it to work effectively. Following these steps will help ensure that the medication works as intended.

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

When using this medication, it's important to remember that it is intended for rectal use only. You should consult your doctor before using it if you experience any abdominal pain, nausea, or vomiting. Additionally, if you notice a sudden change in your bowel habits that lasts more than two weeks, it's crucial to seek medical advice. These precautions can help ensure your safety and well-being while using the product.

Warnings and Precautions

This medication is intended for rectal use only. It’s important to follow this guideline to ensure your safety and the effectiveness of the treatment.

If you accidentally swallow the medication, seek emergency medical help or contact a Poison Control Center immediately. Additionally, you should stop using the medication and call your doctor if you experience abdominal pain, nausea, vomiting, or if you notice a sudden change in your bowel habits that lasts more than two weeks. Always consult with your healthcare provider before starting this medication if you have any of these symptoms.

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 if you are unsure, 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. Remember, timely intervention can make a significant difference.

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, which are specially formulated for their age group. If your child is under 2 years old, it's best to consult with a doctor before administering any medication.

For older children, specifically those 6 years and older, the recommended dosage is one suppository per day, or as directed by your healthcare provider. Always ensure you follow these age-specific recommendations to keep your child safe and healthy.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests is essential to ensure your kidneys are managing medications effectively.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider a reduced dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

You can feel confident that there are no specific storage or handling instructions for this product or device. This means you don’t need to worry about special temperature ranges or conditions for keeping it safe. Just ensure that you handle it with care, as you would with any medical product, to maintain its integrity and effectiveness. If you have any questions about its use or safety, don’t hesitate to reach out for more information.

Additional Information

No further information is available.

FAQ

What is Avedana?

Avedana is a brand of glycerin suppositories available in a jar containing 100 units.

How should I use Avedana?

For adults and children 6 years and over, insert 1 suppository into the rectum once a day or as directed by a doctor.

What should I do if I have abdominal pain or nausea before using Avedana?

You should ask a doctor before using Avedana if you have abdominal pain, nausea, vomiting, or a sudden change in bowel habits lasting over 2 weeks.

Can children use Avedana?

Children aged 2 to under 6 years should use child suppositories, while those under 2 years should consult a doctor.

How do I administer Avedana?

Insert 1 suppository well up into the rectum and retain it for 15 minutes.

Are there any warnings for using Avedana?

Yes, Avedana is for rectal use only. If swallowed, seek emergency medical help or contact a Poison Control Center immediately.

What should I do if I am pregnant or breastfeeding?

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

Are there any contraindications for Avedana?

No specific contraindications are listed for Avedana.

Can I use Avedana for more than a week?

Do not use Avedana for longer than 1 week unless directed by a doctor.

What if I have kidney problems?

If you have renal impairment, dosage adjustments may be necessary, and renal function tests should be monitored regularly.

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 100 units. Each suppository is formulated with glycerin as the active ingredient, designed for rectal administration. The product is intended for use as a laxative to relieve occasional constipation. The packaging ensures the integrity and stability of the suppositories, facilitating ease of use and storage.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug. However, healthcare providers should exercise caution and provide guidance on the appropriate duration of use.

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is one suppository per day, or as directed by a healthcare professional. For children aged 2 to under 6 years, it is advised to use child-specific suppositories. In the case of children under 2 years of age, consultation with a healthcare provider is necessary before administration.

The administration method involves inserting one suppository well up into the rectum. It is important for the patient to retain the suppository for a minimum of 15 minutes to ensure effective action. Notably, the suppository does not need to melt in order to produce a laxative effect.

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 this route of administration to ensure patient safety and efficacy of the treatment.

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

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

Side Effects

For rectal use only. Patients should be advised to consult a doctor prior to use if they experience abdominal pain, nausea, vomiting, or a sudden change in bowel habits that persists for more than two weeks. These symptoms may indicate underlying conditions that require medical evaluation before proceeding with treatment.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring 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. In patients aged 6 years and older, the recommended dosage is 1 suppository per day or as directed by a healthcare professional.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 patients 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 standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Additionally, healthcare providers should encourage patients to consult with their doctor before using the medication if they experience any of the following symptoms: abdominal pain, nausea, vomiting, or a sudden change in bowel habits that lasts longer than two weeks. This precaution is essential to ensure the safe and effective use of 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.