Somatropin
Precautions
See also Side Effects section.
Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or to lonapegsomatropin; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol or metacresol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, eye problems (such as diabetic retinopathy), recent major surgery/injury, breathing problems, diabetes or family history of diabetes, obesity, kidney disease, cancer/tumor (especially of the head/neck), thyroid problems, back problems (scoliosis).
If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
When this medication is given to newborns, mix with sterile water for injection that does not contain a preservative. A preservative (benzyl alcohol) which may be found in the liquid used to mix this product can rarely cause serious problems (sometimes death), if given by injection to an infant during the first months of life. The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor right away should they occur.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially effects on blood sugar, or swelling ankles/feet.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Side Effects
Headache, nausea, vomiting, tiredness, muscle pain, or weakness may occur. If these symptoms continue or become bothersome, inform your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, development of a limp, unusual tiredness, unusual/unexplained weight gain, cold intolerance, fast/slow heartbeat, ear pain/itching, hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in thirst or urination, swelling hands/ankles/feet, change in the appearance or size of any mole, severe stomach/abdominal pain.
Get medical help right away if you have any very serious side effects, including: vision problems/changes, seizure, severe headache.
Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( such as sleep apnea, lung infections, lung disease). Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment. Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction. Tell the doctor right away if these signs occur. Also report any signs of lung infection, such as fever, cough, or trouble breathing.
Somatropin may increase your risk of getting a tumor or cancer. Discuss the details and the risks and benefits of this medication with your doctor.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/severe swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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