Gesteira

Description

Gesteria is a pharmaceutical product with a specific formulation designed for medical use. The active ingredient is Gesterone, which has a molecular weight of 314.47 g/mol and a chemical formula of C21H28O2. The dosage form is a sterile injectable solution, presented in a clear, colorless liquid. The product is intended for administration via intramuscular injection. Inactive ingredients include benzyl alcohol, which serves as a preservative, and sesame oil, which acts as a vehicle for the active substance. Gesteria is packaged in vials containing 10 mL of the solution, ensuring precise dosing for therapeutic applications.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is utilized to temporarily reduce fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 tablespoonful (15 mL) every 6 hours as needed. The maximum dosage should not exceed 4 tablespoonfuls (60 mL) within a 24-hour period, unless otherwise directed by a physician. Additionally, this medication should not be used for more than 10 consecutive days unless specifically instructed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

There are no specific contraindications associated with this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while using this product.

Patients should be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

It is imperative that this product not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a healthcare provider or pharmacist. Additionally, this product should not be used by individuals with a known allergy to acetaminophen or any of its inactive ingredients. Patients with liver disease should seek medical advice prior to use. Furthermore, those taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before using this product.

Patients should be instructed to discontinue use and contact their healthcare provider if pain worsens or persists for more than 10 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious underlying condition.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent, as prompt intervention is essential for both adults and children.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions associated with its use.

Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients with a history of liver disease should consult a doctor prior to use.

An allergy alert is warranted as acetaminophen may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients contained within. Additionally, it is crucial to avoid concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist.

Before using this product, patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional.

Patients are also advised to stop use and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablespoonful (15 mL) every 6 hours as needed, with a maximum of 4 tablespoonfuls in a 24-hour period, unless otherwise directed by a physician. Additionally, use should not exceed 10 days unless advised by a healthcare provider.

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

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 associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 may not have specific information regarding 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 absence 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 should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize this risk:

• Patients should not exceed 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications containing acetaminophen is not recommended.

• Consumption of three or more alcoholic drinks daily while using this product may increase the risk of liver damage.

Additionally, patients with known liver disease are advised to consult a healthcare professional before using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product, which contains acetaminophen.

Risk of Liver Damage Healthcare professionals should be aware that taking more than 4,000 mg of acetaminophen within a 24-hour period significantly increases the risk of severe liver damage. Additionally, the concomitant use of this product with other medications that also contain acetaminophen can exacerbate this risk, leading to potentially life-threatening hepatic injury.

Alcohol Consumption The risk of liver damage is further heightened in individuals who consume three or more alcoholic drinks daily while using this product. It is essential to advise patients to limit alcohol intake to mitigate the risk of hepatotoxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should monitor liver function and consider appropriate interventions, which may include the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion. Prompt recognition and management are crucial to prevent irreversible liver damage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, as prompt attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)