Stratuscare Adult Glycerin

Description

STRATUSCARE is a laxative formulation intended for adult use, presented in the form of suppositories. Each package contains 50 suppositories. The product is distributed by STRATUS PHARMACEUTICALS INC. The presence of glycerin serves as an active ingredient. It is imperative 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.

Limitations of Use: 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 carefully insert one suppository well into the rectum. 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. It is important not to exceed one suppository per day unless otherwise directed by a healthcare professional.

The use of this product is not recommended for children under 6 years of age.

Contraindications

Laxative products are contraindicated for use beyond one week unless directed by a healthcare professional. Prolonged use may lead to dependency or other complications.

Patients should discontinue use and consult a physician if rectal bleeding occurs or if there is a failure to have a bowel movement after using the laxative, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

For rectal use only, this product may cause rectal discomfort or a burning sensation. Healthcare professionals should advise patients to consult a physician prior to use if they experience abdominal pain, nausea, or vomiting, or if there is a sudden change in bowel habits lasting more than two weeks.

Patients should be instructed to discontinue use and seek medical advice if they experience rectal bleeding or if they do not have a bowel movement after using a laxative, as these symptoms may indicate a serious underlying condition. It is important to note that laxative products should not be used for longer than one week unless specifically directed by a healthcare provider.

Additionally, this product must be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1212.

Side Effects

Patients using this product should be aware of several important warnings and adverse reactions associated with its use. This product is intended for rectal use only and may cause rectal discomfort or a burning sensation.

Before using this product, patients are advised to consult a doctor if they experience abdominal pain, nausea, or vomiting, or if there is a sudden change in bowel habits lasting more than two weeks.

Patients should discontinue use and seek medical advice if they experience rectal bleeding or fail to have a bowel movement after using the laxative, as these symptoms may indicate a serious condition. It is also important to note that laxative products should not be used for longer than one week unless directed by a healthcare professional.

Additional considerations include the recommendation for pregnant or breastfeeding individuals to consult a doctor prior to use. Furthermore, 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 advised.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 years and older, the recommended administration involves carefully inserting one suppository well into the rectum. Caution is advised to ensure proper use in this age group.

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 potential adverse effects or changes in efficacy, 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers 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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the 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 at 1-800-222-1212.

Patients should be informed not to use laxative products for longer than one week unless directed by a healthcare professional. It is important to counsel patients to stop using the product and consult a doctor if they experience rectal bleeding or if they do not have a bowel movement after using the laxative, as these symptoms may indicate a serious condition.

Additionally, healthcare providers should encourage patients to ask a doctor before using the laxative if they have any of the following conditions: abdominal pain, nausea, or vomiting, or if they have experienced a sudden change in bowel habits lasting more than two weeks. This precaution helps ensure the safe and effective use of the medication.

Storage and Handling

Glycerin suppositories are supplied in a container that must be kept tightly closed to maintain product integrity. They should be stored at room temperature, within a temperature range of 15°C to 30°C (59°F to 86°F). Proper storage conditions are essential to ensure the effectiveness and safety of the product.

Additional Clinical Information

The route of administration for the medication is rectal. For adults and children aged 6 years and older, one suppository should be carefully inserted into the rectum. It is noted that the suppository does not need to melt completely to elicit a laxative effect, typically resulting in a bowel movement within 15 minutes to 1 hour. Clinicians should advise patients not to exceed one suppository daily unless directed by a physician. The use of this medication is not recommended for children under 6 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)