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This document provides essential safety information and warnings for individuals considering the use of somatropin injections such as Omnitrope. It is crucial to understand the potential risks and necessary precautions. Always consult your healthcare provider if you have questions or concerns regarding this medication.

• Increased Mortality Risk in Critical Illness: Avoid using somatropin if you are critically ill due to open heart or abdominal surgery, severe injuries, or significant respiratory issues, as it may raise the risk of death in these scenarios.

• Risks in Children with Prader-Willi Syndrome: Somatropin is not recommended for children with Prader-Willi syndrome who are obese or have respiratory issues such as blocked airways or sleep apnea, as it may lead to sudden death. Ensure weight management and monitor for respiratory symptoms if treatment is necessary.

• Severe Allergic Reactions: Be aware of the potential for severe allergic reactions, including anaphylaxis. Seek immediate medical attention if you experience dizziness, breathing difficulties, or swelling around the face following administration.

• Cancer Concerns: Do not use somatropin if you or your child has active tumors. Those with a history of cancer should be closely monitored, as the medication can potentially increase the risk of new cancer development.

• Blood Sugar and Diabetes: Monitor blood sugar levels regularly, as somatropin may cause elevated blood sugar or increase the risk of diabetes, particularly in individuals with obesity, Turner syndrome, or a family history of diabetes.

• Intracranial Hypertension: Some individuals may experience high blood pressure in the brain, leading to symptoms like headaches or vision changes. These typically appear within eight weeks of starting treatment and may resolve upon discontinuation or dose reduction.

• Fluid Retention: Somatropin can cause fluid retention, leading to swelling in the limbs and possibly conditions like carpal tunnel syndrome. Report any such symptoms to your healthcare provider.

• Low Cortisol Levels: The medication may reduce cortisol levels, especially in individuals taking steroid hormones. Be vigilant if you or your child is in this category.

• Bone Growth Issues in Children: Rapidly growing children may experience a slipped thigh bone. If your child reports knee or hip pain or begins limping, contact a healthcare provider promptly.

• Pancreatitis Risk: Rare cases of pancreatitis have occurred. If you experience severe stomach pain that radiates to the back, along with nausea or vomiting, discontinue use immediately and seek medical help.

Contraindications: Do not use somatropin if you have:

• A short-term, critical illness from surgery or serious injuries.
• Active cancer.
• Severe eye damage due to diabetes.
• Prader-Willi syndrome with severe obesity or serious breathing issues.
• Children who have completed their growth phase.

Always discuss with your healthcare provider before starting somatropin if you have any contraindications or are part of a vulnerable group.

When taking this medication, some common side effects you might experience include headaches, nausea, vomiting, tiredness, muscle pain, and weakness. These symptoms are generally mild, but if they persist or worsen, it's advisable to consult your healthcare provider. Additionally, some users report bruising, leg pain, and swelling in the arms and legs. While these are typically not severe, monitoring them is important.

In some cases, more serious side effects can occur. These include persistent nausea or vomiting, unusual tiredness, unexplained weight gain, cold intolerance, irregular heartbeat, joint pain, and changes in thirst or urination. If you notice any of these, reaching out to your healthcare provider promptly is crucial. Swelling of the hands, ankles, or feet and changes in moles should also be reported right away.

There are rare but potentially severe side effects that require immediate medical attention. These include vision changes, seizures, severe headaches, and signs of lung or breathing problems, particularly in children with Prader-Willi syndrome. Symptoms such as heavy snoring or irregular breathing during sleep, fever, cough, or trouble breathing need urgent evaluation.

A rare but very serious allergic reaction could manifest as a rash, severe swelling, dizziness, or difficulty breathing. If any of these occur, seek emergency medical help immediately. While the risk of developing a tumor or cancer may increase with this medication, discussing these risks with your healthcare provider can help you make informed decisions. Always report any unlisted side effects to your healthcare provider to ensure your safety.