Sp Pharma

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

Paracetamol tablets are indicated for the relief of mild to moderate pain, including headache, toothache, sore throat, backache, and period pain. Additionally, these tablets are utilized to reduce fever and alleviate discomfort associated with feverish colds.

There are no teratogenic or nonteratogenic effects associated with the use of paracetamol tablets.

Dosage and Administration

For patients aged 12 years and older, the recommended dosage is 1 to 2 tablets taken every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period. It is advised that the tablets be taken with water to facilitate swallowing.

For pediatric patients aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 4 tablets in a 24-hour period. Similar to the adult dosage, the tablet should be taken with water.

Healthcare professionals should ensure that patients adhere to the specified dosing intervals and maximum daily limits to avoid potential overdose.

Contraindications

Use of this product is contraindicated in situations where it may be accessible to children, as it should be kept away from their reach to prevent accidental ingestion or misuse. No other specific contraindications have been identified.

Warnings and Precautions

Patients should consult with their healthcare provider prior to using paracetamol tablets if they have a history of liver or kidney issues, or if they are currently taking warfarin or other anticoagulant medications. These conditions may increase the risk of adverse effects associated with paracetamol.

Paracetamol tablets are contraindicated in individuals with a known allergy to paracetamol or those who are concurrently using other medications that contain paracetamol. It is essential to avoid exceeding the recommended dosage to prevent potential toxicity.

This medication is not recommended for children under the age of 6 years. Healthcare professionals should exercise caution when considering the use of paracetamol in this population.

Patients are advised to discontinue the use of paracetamol and seek medical attention if symptoms persist for more than 48 hours or if they experience any serious adverse effects, including but not limited to allergic skin reactions, shortness of breath, or wheezing. Prompt evaluation by a healthcare provider is crucial in these situations to ensure patient safety and appropriate management.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include allergic skin reactions, shortness of breath, and wheezing. These reactions warrant immediate medical attention and should be reported to a healthcare provider.

In addition to the serious reactions, it is crucial for patients to be aware that the medication should not be taken by individuals who are allergic to paracetamol, as this could lead to severe allergic responses.

Healthcare professionals should monitor patients for these adverse reactions and provide guidance on the appropriate steps to take should they occur.

Drug Interactions

Patients taking warfarin or other anticoagulants should consult their healthcare provider prior to using paracetamol. The concomitant use of paracetamol with these medications may increase the risk of bleeding due to potential pharmacodynamic interactions. Monitoring of coagulation parameters is advisable to ensure patient safety and to adjust dosages as necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients below 6 years of age may not be suitable candidates for this preparation. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 4 tablets in a 24-hour period. Care should be taken to adhere to the dosing guidelines to ensure safety and efficacy in this age group.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

Pregnant patients or those planning to become pregnant should consult their healthcare provider before using paracetamol tablets. While paracetamol is commonly used for pain relief and fever reduction, its safety during pregnancy has not been fully established. There is no specific risk category provided for paracetamol in pregnancy; however, caution is advised.

Patients should be aware that paracetamol is contraindicated in individuals with a known allergy to the drug. Additionally, this preparation is not suitable for children under 6 years of age. If symptoms persist for more than 48 hours or if any serious adverse effects occur, such as allergic skin reactions, shortness of breath, or wheezing, patients should discontinue use and seek medical attention promptly.

It is essential to store paracetamol tablets below 25°C and keep them out of reach of children to prevent accidental ingestion.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment and to monitor renal status throughout the course of therapy. In patients with reduced kidney function, the potential for altered drug clearance may necessitate modifications to the standard dosing regimen to avoid toxicity. Healthcare professionals should remain vigilant for any signs of adverse effects and adjust treatment as needed based on individual patient circumstances.

Hepatic Impairment

Patients with hepatic impairment should consult their healthcare provider prior to using paracetamol tablets, particularly if they have existing liver or kidney problems. It is essential for healthcare professionals to evaluate the patient's liver function and consider potential dosage adjustments or monitoring requirements based on the severity of the hepatic impairment. Careful assessment is necessary to ensure the safe use of paracetamol in this population, as compromised liver function may affect the metabolism and clearance of the medication.

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 the patient 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 supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult poison control centers for additional guidance on management strategies.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects. Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided 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 or misuse. It is essential to emphasize the importance of proper storage and handling to ensure the safety of young children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product below 25°C to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable environment to prevent degradation.

Additional Clinical Information

The medication is administered orally. For patients aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period. For pediatric patients aged 6 to 11 years, the dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 4 tablets in a 24-hour period. 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 Sp Pharma, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)