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Important safety information

Important Safety Information

COMPOUNDED SEMAGLUTIDE is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

27 kg/m² or greater (overweight or obesity)

Limitations of Use:

• Co-administration with other COMPOUNDED SEMAGLUTIDE-containing products or any GLP-1 receptor agonist is not recommended.
• The safety and efficacy of coadministration with other products for weight management have not been established.

• COMPOUNDED SEMAGLUTIDE has not been studied in patients with a history of pancreatitis.

   

WARNING: RISK OF THYROID C-CELL TUMORS

• In rodents, semaglutide causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

• Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.

   

Do not take COMPOUNDED SEMAGLUTIDE if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Are allergic to semaglutide or any other GLP-1 drug or any of its inactive ingredients.

• Have a history of suicidal attempts or active suicidal ideation.

   

WARNINGS AND PRECAUTIONS:

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Gallbladder issues have been observed in clinical trials. Clinical follow-up is needed if cholelithiasis is suspected.
• Hypoglycemia: The use of insulin secretagogues or insulin may increase the risk of hypoglycemia, including severe cases. Adjust the dose of insulin secretagogues or insulin accordingly.
• Acute Kidney Injury: Monitor renal function when starting or escalating doses in patients reporting severe gastrointestinal side effects.
• Hypersensitivity Reactions: Anaphylaxis and angioedema have been reported post-marketing. Discontinue if suspected.
• Pregnancy: Semaglutide may cause fetal harm. Discontinue immediately upon pregnancy recognition.
• Diabetic Retinopathy Complications: Monitor patients with a history of diabetic retinopathy.
• Heart Rate Increase: Monitor heart rate periodically.

• Suicidal Behavior and Ideation: Monitor for signs of depression or suicidal thoughts. Discontinue if these symptoms develop.

   

Side Effects: Most common side effects (incidence ≥ 5%) include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Fatigue
• Dyspepsia (indigestion)
• Dizziness
• Abdominal distension
• GERD (gastroesophageal reflux disease)

• Headache

   

Drug Interactions: COMPOUNDED SEMAGLUTIDE delays gastric emptying, which may impact the absorption of oral medications. Use with caution.

Important safety information

Important Safety Information

COMPOUNDED SEMAGLUTIDE is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

27 kg/m² or greater (overweight or obesity)

Limitations of Use:

• Co-administration with other COMPOUNDED SEMAGLUTIDE-containing products or any GLP-1 receptor agonist is not recommended.
• The safety and efficacy of coadministration with other products for weight management have not been established.

• COMPOUNDED SEMAGLUTIDE has not been studied in patients with a history of pancreatitis.

   

WARNING: RISK OF THYROID C-CELL TUMORS

• In rodents, semaglutide causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

• Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.

   

Do not take COMPOUNDED SEMAGLUTIDE if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Are allergic to semaglutide or any other GLP-1 drug or any of its inactive ingredients.

• Have a history of suicidal attempts or active suicidal ideation.

   

WARNINGS AND PRECAUTIONS:

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Gallbladder issues have been observed in clinical trials. Clinical follow-up is needed if cholelithiasis is suspected.
• Hypoglycemia: The use of insulin secretagogues or insulin may increase the risk of hypoglycemia, including severe cases. Adjust the dose of insulin secretagogues or insulin accordingly.
• Acute Kidney Injury: Monitor renal function when starting or escalating doses in patients reporting severe gastrointestinal side effects.
• Hypersensitivity Reactions: Anaphylaxis and angioedema have been reported post-marketing. Discontinue if suspected.
• Pregnancy: Semaglutide may cause fetal harm. Discontinue immediately upon pregnancy recognition.
• Diabetic Retinopathy Complications: Monitor patients with a history of diabetic retinopathy.
• Heart Rate Increase: Monitor heart rate periodically.

• Suicidal Behavior and Ideation: Monitor for signs of depression or suicidal thoughts. Discontinue if these symptoms develop.

   

Side Effects: Most common side effects (incidence ≥ 5%) include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Fatigue
• Dyspepsia (indigestion)
• Dizziness
• Abdominal distension
• GERD (gastroesophageal reflux disease)

• Headache

   

Drug Interactions: COMPOUNDED SEMAGLUTIDE delays gastric emptying, which may impact the absorption of oral medications. Use with caution.

Important Safety Information

Important Safety Information

Tirzepatide is a dual GIP/GLP-1 receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

27 kg/m² or greater (overweight or obesity)

Limitations of Use:

• Co-administration with other GIP/GLP-1 receptor agonists or any similar compounds is not recommended.
• The safety and efficacy of tirzepatide for weight management have not been established in combination with other products.
• Tirzepatide has not been studied in patients with a history of pancreatitis.

WARNING: RISK OF THYROID C-CELL TUMORS

• In animal studies, tirzepatide has caused thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. The relevance of these findings to humans remains uncertain.
• Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients on the potential risk of MTC and the symptoms of thyroid tumors.

Do not take tirzepatide if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Are allergic to tirzepatide or any of its inactive ingredients.
• Have a history of suicidal attempts or active suicidal ideation.

WARNINGS AND PRECAUTIONS

• Acute Pancreatitis: Discontinue tirzepatide promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Gallbladder disease has been observed in clinical trials. Clinical follow-up and further studies are indicated if gallbladder issues are suspected.
• Hypoglycemia: Concomitant use with insulin or insulin secretagogues may increase the risk of hypoglycemia. Dose adjustments of insulin or insulin secretagogues may be necessary.
• Acute Kidney Injury: Monitor renal function when initiating or increasing doses in patients reporting severe gastrointestinal side effects.
• Hypersensitivity Reactions: Discontinue tirzepatide if hypersensitivity reactions such as anaphylaxis or angioedema occur and seek medical attention.
• Pregnancy: Tirzepatide may cause fetal harm. Discontinue the medication immediately upon recognizing pregnancy.
• Diabetic Retinopathy Complications: Patients with a history of diabetic retinopathy should be monitored closely.
• Heart Rate Increase: Monitor heart rate periodically.
• Suicidal Behavior and Ideation: Monitor for symptoms of depression or suicidal thoughts and discontinue if these symptoms develop.

Side Effects Most common side effects (incidence ≥ 5%) include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Fatigue
• Dyspepsia (indigestion)
• Dizziness
• Abdominal distension
• Gastroesophageal reflux disease (GERD)
• Headache

Drug Interactions Tirzepatide delays gastric emptying and may impact the absorption of oral medications. Use with caution.

Use in Specific Populations

• Pregnancy: May cause fetal harm. Discontinue tirzepatide as soon as pregnancy is detected.
• Females and Males of Reproductive Potential: Discontinue tirzepatide at least 2 months before a planned pregnancy due to its long half-life.

Reporting Adverse Reactions To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Important Safety Information

Important Safety Information

Tirzepatide is a dual GIP/GLP-1 receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

27 kg/m² or greater (overweight or obesity)

Limitations of Use:

• Co-administration with other GIP/GLP-1 receptor agonists or any similar compounds is not recommended.
• The safety and efficacy of tirzepatide for weight management have not been established in combination with other products.
• Tirzepatide has not been studied in patients with a history of pancreatitis.

WARNING: RISK OF THYROID C-CELL TUMORS

• In animal studies, tirzepatide has caused thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. The relevance of these findings to humans remains uncertain.
• Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients on the potential risk of MTC and the symptoms of thyroid tumors.

Do not take tirzepatide if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Are allergic to tirzepatide or any of its inactive ingredients.
• Have a history of suicidal attempts or active suicidal ideation.

WARNINGS AND PRECAUTIONS

• Acute Pancreatitis: Discontinue tirzepatide promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Gallbladder disease has been observed in clinical trials. Clinical follow-up and further studies are indicated if gallbladder issues are suspected.
• Hypoglycemia: Concomitant use with insulin or insulin secretagogues may increase the risk of hypoglycemia. Dose adjustments of insulin or insulin secretagogues may be necessary.
• Acute Kidney Injury: Monitor renal function when initiating or increasing doses in patients reporting severe gastrointestinal side effects.
• Hypersensitivity Reactions: Discontinue tirzepatide if hypersensitivity reactions such as anaphylaxis or angioedema occur and seek medical attention.
• Pregnancy: Tirzepatide may cause fetal harm. Discontinue the medication immediately upon recognizing pregnancy.
• Diabetic Retinopathy Complications: Patients with a history of diabetic retinopathy should be monitored closely.
• Heart Rate Increase: Monitor heart rate periodically.
• Suicidal Behavior and Ideation: Monitor for symptoms of depression or suicidal thoughts and discontinue if these symptoms develop.

Side Effects Most common side effects (incidence ≥ 5%) include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Fatigue
• Dyspepsia (indigestion)
• Dizziness
• Abdominal distension
• Gastroesophageal reflux disease (GERD)
• Headache

Drug Interactions Tirzepatide delays gastric emptying and may impact the absorption of oral medications. Use with caution.

Use in Specific Populations

• Pregnancy: May cause fetal harm. Discontinue tirzepatide as soon as pregnancy is detected.
• Females and Males of Reproductive Potential: Discontinue tirzepatide at least 2 months before a planned pregnancy due to its long half-life.

Reporting Adverse Reactions To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Important safety information

Do not take Sildenafil (generic Viagra) if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
• are allergic to Sildenafil, as contained in Sildenafil and REVATIO, or any of the ingredients in Sildenafil

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate medical help

Sildenafil can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis
• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Sildenafil and call your healthcare provider right away if you have any sudden vision loss
• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Sildenafil and contact a doctor right away

Before you take Sildenafil, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
• have had heart surgery within the last 6 months
• have pulmonary hypertension
• have had a stroke
• have low blood pressure, or high blood pressure that is not controlled
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours
• have problems with your blood cells such as sickle call anemia, multiple myeloma, or leukemia
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including an eye problem called NAION
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis have any other medical conditions
  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil may affect the way other medicines work, and other medicines may affect the way Sildenafil works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators such as Adempas (riociguat)
• medicines called alpha-blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosinmesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Sildenafil with alpha-blockers can lead to a drop in blood pressure or to fainting
• medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase), or atazanavir sulfate (Reyataz)
• some types of oral antifungal medicines, such as ketoconazole (Nizoral) and itraconazole (Sporanox)
• some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
• other medicines that treat high blood pressure
• other medicines or treatments for ED
• Sildenafil contains Sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil should not be used with REVATIO or with other PAH treatments containing Sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])
  

Sildenafil does not protect against sexually transmitted diseases, including HIV.


The most common side effects of Sildenafil: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

Sildenafil (generic Viagra) is prescription medicine used to treat erectile dysfunction (ED).

Sildenafil is not for women or children.

Important safety information

Do not take Sildenafil (generic Viagra) if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
• are allergic to Sildenafil, as contained in Sildenafil and REVATIO, or any of the ingredients in Sildenafil

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate medical help

Sildenafil can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis
• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Sildenafil and call your healthcare provider right away if you have any sudden vision loss
• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Sildenafil and contact a doctor right away

Before you take Sildenafil, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
• have had heart surgery within the last 6 months
• have pulmonary hypertension
• have had a stroke
• have low blood pressure, or high blood pressure that is not controlled
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours
• have problems with your blood cells such as sickle call anemia, multiple myeloma, or leukemia
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including an eye problem called NAION
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis have any other medical conditions
  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil may affect the way other medicines work, and other medicines may affect the way Sildenafil works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators such as Adempas (riociguat)
• medicines called alpha-blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosinmesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Sildenafil with alpha-blockers can lead to a drop in blood pressure or to fainting
• medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase), or atazanavir sulfate (Reyataz)
• some types of oral antifungal medicines, such as ketoconazole (Nizoral) and itraconazole (Sporanox)
• some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
• other medicines that treat high blood pressure
• other medicines or treatments for ED
• Sildenafil contains Sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil should not be used with REVATIO or with other PAH treatments containing Sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])
  

Sildenafil does not protect against sexually transmitted diseases, including HIV.


The most common side effects of Sildenafil: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

Sildenafil (generic Viagra) is prescription medicine used to treat erectile dysfunction (ED).

Sildenafil is not for women or children.