Bulpol Smoking Patches

Description

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

Uses and Indications

This drug is indicated for smoking cessation in adults who smoke 10 or fewer cigarettes per day. For these individuals, the recommended regimen begins with STEP 2 (14 mg) for a duration of 6 weeks, followed by STEP 3 (7 mg) for an additional 2 weeks. This gradual reduction in nicotine levels is designed to enhance the likelihood of successfully quitting smoking.

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

Dosage and Administration

For the initial treatment phase, healthcare professionals should apply one 21 mg patch daily for a duration of six weeks. Following this period, the dosage should be adjusted to one 14 mg patch daily for the subsequent two weeks. In the final phase of the treatment, one 7 mg patch should be applied daily for weeks nine and ten.

The patches should be applied to clean, dry, and hairless skin on the upper body or outer arm. It is important to rotate the application site with each new patch to minimize skin irritation. The patch should be pressed firmly in place for at least 10 seconds to ensure proper adhesion.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should consult a healthcare professional prior to use if they are currently using a non-nicotine stop smoking drug or are taking prescription medications for depression or asthma, as dosage adjustments may be necessary.

Additionally, this product must be kept out of reach of children and pets. Used patches contain sufficient nicotine to pose a poisoning risk. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

If a patient is pregnant or breastfeeding, the use of this medicine should only occur under the guidance of a healthcare provider. It is important to note that smoking poses significant risks to the child, and patients are encouraged to attempt cessation without the use of nicotine replacement therapies. While this medicine is considered to be safer than smoking, the potential risks to the child associated with its use are not fully understood.

This medicine must be kept out of reach of children and pets, as used patches contain sufficient nicotine to pose a poisoning risk. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted. Patients should retain the pouch for proper disposal of used patches. Used patches should be disposed of by folding the sticky ends together and placing them in the pouch to prevent accidental exposure.

Prior to use, patients should consult with a healthcare professional if they are currently using a non-nicotine smoking cessation product or are taking prescription medications for conditions such as depression or asthma. Adjustments to the prescribed dosage may be necessary to ensure safety and efficacy.

Side Effects

Patients using this medicine should be aware of specific warnings related to pregnancy and breastfeeding. It is advised that this medicine be used only under the guidance of a healthcare provider during these periods. Smoking poses significant risks to the child, and patients are encouraged to attempt cessation without the use of nicotine replacement therapies. While this medicine is considered to be safer than smoking, the full extent of its risks to the child remains undetermined. Therefore, careful consideration and consultation with a healthcare professional are essential for pregnant or breastfeeding patients.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking a non-nicotine smoking cessation agent or a prescription medication for depression or asthma. The potential for interaction necessitates careful consideration, as dosage adjustments may be required for the prescription medication to ensure safety and efficacy. Monitoring for any adverse effects or changes in therapeutic response is advised during concurrent use.

Packaging & NDC

Below are the non-prescription pack sizes of Bulpol Smoking Patches (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept away from this medication, as used patches contain sufficient nicotine to pose a poisoning risk to children and pets. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is essential. It is crucial for healthcare professionals to advise caregivers on the importance of storing this product securely out of reach of children and pets to prevent accidental exposure.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should only use this medicine under the guidance of their healthcare provider. It is important to note that smoking during pregnancy can significantly harm fetal development. Patients are encouraged to attempt cessation of smoking without the use of nicotine replacement therapies, as these may pose additional risks.

While this medicine is considered to be safer than smoking, the full extent of its risks to the fetus is not completely understood. Therefore, healthcare providers should carefully weigh the potential benefits and risks when prescribing this medication to pregnant patients or those planning to become pregnant.

Lactation

Lactating mothers are advised to use this medicine only under the guidance of their healthcare provider. While this medicine is believed to be safer than smoking, the risks to breastfed infants are not fully understood. It is important for lactating mothers to be aware that smoking can seriously harm their child, and efforts should be made to stop smoking without the use of nicotine replacement therapies.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

Nonclinical Toxicology

The risks to the child from this medicine are not fully known. It is acknowledged that smoking can seriously harm the child; however, this medicine is believed to be safer than smoking.

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 and pets. It is important to emphasize that used patches contain sufficient nicotine to pose a poisoning risk to children and pets. In the event that a patch is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Additionally, healthcare providers should instruct patients on the proper disposal of used patches. Patients should be informed to save the pouch provided for patch disposal. They should fold the sticky ends of the used patches together and place them in the pouch before disposing of it to ensure safety.

Storage and Handling

Used patches should be stored by folding the sticky ends together and placing them back in the saved pouch for proper disposal. To dispose of used patches, the same method should be employed: fold the sticky ends together and place them in the pouch.

For application, one new patch should be applied every 24 hours to skin that is dry, clean, and hairless.

Additional Clinical Information

Patients should apply one new patch every 24 hours to dry, clean, and hairless skin. The recommended dosing schedule includes one 21 mg patch per day for Weeks 1-6, one 14 mg patch per day for Weeks 7-8, and one 7 mg patch per day for Weeks 9-10.

Clinicians should counsel patients on the importance of consulting a healthcare provider if they are pregnant or breastfeeding before using this medication. Patients are advised to attempt to quit smoking without nicotine replacement therapy, as smoking can significantly harm their child. Additionally, patients should seek medical advice if they are using non-nicotine smoking cessation drugs or prescription medications for depression or asthma, as dosage adjustments may be necessary. It is crucial to keep the patches out of reach of children and pets, as used patches contain enough nicotine to be harmful. In case of accidental ingestion, immediate medical assistance should be sought. Patients should also be instructed to use the provided pouch for the safe disposal of used patches by folding the sticky ends together before placing them inside.

Drug Information (PDF)

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

View product document (PDF)