Somatropin, e-coli derived (subcutaneous route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin in children.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin in the elderly. However, elderly patients are more sensitive to the effects of somatropin and are more likely to have unwanted effects, which may require an adjustment in the dose for patients receiving somatropin.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Insulin Aspart, Recombinant

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to benzyl alcohol or
• Allergy to metacresol or
• Brain tumor or
• Cancer, active or
• Closed epiphyses (normal bone growth stopped) in children or
• Diabetic retinopathy (eye condition) or
• Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems (eg, sleep apnea) or
• Severe illness after surgery or major medical emergency (eg, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.

• Cancer, history of or
• Hypoadrenalism (adrenal glands produce low hormone levels) or
• Hypothyroidism (underactive thyroid gland) or
• Otitis media (ear infection) in children, history of or
• Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.

• Diabetes, or a family history of—Use with caution. May prevent insulin or other drugs for diabetes from working properly.

• Turner syndrome—Use with caution. May increase risk of having serious problems (eg, pancreas, thyroid, or heart and blood vessel problems, ear or hearing disorders, diabetes, increased pressure in the head, and bone problems including dislocation in the hip bone or scoliosis).

More common

• Bleeding gums
• bloating or swelling of the face, arms, hands, ankles, lower legs, or feet
• burning, numbness, pain, or tingling in all fingers except the smallest finger
• coughing up blood
• difficulty with breathing or swallowing
• difficulty with moving
• dizziness
• increased menstrual flow or vaginal bleeding
• muscle pain or stiffness
• nosebleeds
• not able to move
• pain, swelling, or redness in the joints
• prolonged bleeding from cuts
• rapid weight gain
• red or black, tarry stools
• red or dark brown urine
• tingling of the hands or feet
• unusual weight gain or loss

Rare

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blurred vision
• bone pain
• change in personality
• change in the ability to see colors, especially blue or yellow
• changes in vision
• chills
• confusion
• constipation
• curved spine
• darkened urine
• dry mouth
• fast heartbeat
• fever
• flushed, dry skin
• fracture
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• indigestion
• limp pain in the hip or knee
• loss of appetite
• loss of consciousness
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• problems with walking or talking
• seizures
• stomachache
• sweating
• tumor
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Incidence not known

• Chest tightness
• cough
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin lesions
• unexplained weight loss

Symptoms of overdose

• Arm or leg pain
• backache
• excessive sweating
• extreme weakness
• increase in hand and foot size
• increased volume of pale, diluted urine
• stop in menstruation

More common

• Large, flat, blue, or purplish patches in the skin
• unusually warm skin

Rare

• Swelling of the breasts or breast soreness in both females and males