Stratuscare Glycerin Laxative Pediatric

Description

STRATUSCARE is a laxative formulation specifically designed for infants and children, available in the form of suppositories. Each package contains 25 suppositories, and the product is distributed by STRATUS PHARMACEUTICALS INC. The active ingredient in STRATUSCARE is glycerin. It is important to note that the product should not be used if the inner seal is broken or missing.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within ¼ to 1 hour of administration.

Dosage and Administration

For children aged 2 to under 6 years, one suppository should be carefully inserted into the child's rectum. It is important to note that the suppository does not need to melt completely to achieve the desired laxative effect. Typically, a bowel movement is expected within 15 minutes to 1 hour following administration. Healthcare professionals should advise that the dosage should not exceed one suppository per day unless otherwise directed by a physician.

For children under 2 years of age, it is essential to consult a doctor prior to administration.

Contraindications

The use of laxative products is contraindicated for periods exceeding one week unless directed by a healthcare professional. Prolonged use may lead to potential complications, including dependency or altered bowel function.

Warnings and Precautions

For rectal use only, this product may cause rectal discomfort or a burning sensation. Healthcare professionals should advise caregivers to consult a physician prior to use if the child presents with abdominal pain, nausea, vomiting, or a sudden change in bowel habits lasting more than two weeks.

In the event of rectal bleeding or if the child does not have a bowel movement after using the laxative, it is imperative to discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition.

This product must be kept out of the reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1212.

Laxative products should not be used for longer than one week unless specifically directed by a healthcare professional. Regular monitoring of the child's response to treatment is recommended to ensure safety and efficacy.

Side Effects

Patients using this product may experience adverse reactions, which can include rectal discomfort or a burning sensation, particularly with rectal use. It is important to note that this product is intended for rectal administration only.

In clinical practice, caregivers are advised to consult a physician prior to use if the child has abdominal pain, nausea, vomiting, or a sudden change in bowel habits lasting more than two weeks. Should a child experience rectal bleeding or fail to have a bowel movement after using the laxative, it is crucial to discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition.

The use of laxative products should not exceed one week unless directed by a healthcare professional. Additionally, this product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1212) is recommended.

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 Stratuscare Glycerin Laxative Pediatric (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For rectal use only. Prior to administration, healthcare professionals should advise caregivers to consult a doctor if the child presents with abdominal pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 2 weeks. If rectal bleeding occurs or if the child does not have a bowel movement after using the laxative, caregivers should discontinue use and seek medical advice, as these may indicate a serious condition.

Laxative products should not be used for longer than 1 week unless directed by a physician. It is essential to keep this product out of the reach of children. In the event of accidental ingestion, medical help should be sought immediately or the Poison Control Center contacted at 1-800-222-1212.

For dosing, children aged 2 to under 6 years should have one suppository carefully inserted into the rectum. The suppository does not need to melt completely to be effective and typically induces a bowel movement within 15 minutes to 1 hour. Caregivers should not exceed one suppository daily unless otherwise directed by a healthcare provider. For children under 2 years of age, consultation with a doctor is required before use.

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, given the lack of targeted data for this population.

Pregnancy

Stratuscare Glycerin Laxative Pediatric does not provide specific information regarding its use during pregnancy. There are no contraindications noted for pregnant patients, nor are there any identified risks to the fetus associated with the use of this product. Additionally, the prescribing information does not outline any special precautions or dosage modifications for pregnant individuals. As such, healthcare professionals should exercise clinical judgment when considering the use of this laxative in pregnant patients, taking into account the lack of data on safety and efficacy in this population.

Lactation

There is no specific information regarding the use of Stratuscare Glycerin Laxative Pediatric in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this medication. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1212.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1212.

Patients should be informed that laxative products should not be used for longer than one week unless directed by a healthcare professional. It is important to emphasize that if a child experiences rectal bleeding or does not have a bowel movement after using a laxative, they should stop use and consult a doctor, as these symptoms may indicate a serious condition.

Additionally, healthcare providers should encourage patients to consult a doctor before using this product if their child has any of the following conditions: abdominal pain, nausea, or vomiting, or if there has been a sudden change in bowel habits lasting more than two weeks.

Storage and Handling

Glycerin suppositories are supplied in a package configuration that includes NDC numbers relevant to the product. These suppositories should be stored at room temperature, specifically within a temperature range of 15°C to 30°C (59°F to 86°F). It is essential to ensure that the storage environment maintains these temperature conditions to preserve the integrity and efficacy of the product. No special handling requirements are noted for the storage of glycerin suppositories.

Additional Clinical Information

The route of administration for the medication is rectal. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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