Velosulin BR

Insulin (human) is a prescription medication used to control hyperglycemia (high blood sugar) in patients with diabetes mellitus.

Insulin (human) is a naturally occurring hormone produced by the pancreas. Insulin helps move sugar from the blood into other tissues that use it for energy.

This medication comes in solution and suspension for injection and inhalational forms. The dose and frequency of administration will depend on many factors, including diet, lifestyle, and other conditions you have.

The most common side effect of insulin (human) is hypoglycemia (low blood sugar).                                                                                  

Hypoglycemia related to insulin can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how insulin (human) affects you.

Insulin (human) is a prescription medication used to control hyperglycemia (high blood sugar) in patients with diabetes mellitus.

Inhalational:

Inhalational formulations are administered immediately before meals.

Injectable:

Injectable formulations are administered several times daily, depending on your condition and meal times.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Insulin (human). See the “Insulin (human) Precautions” section.

The most common side effect of insulin (human) is hypoglycemia, which can include the following symptoms:

• Sweating
• Dizziness
• Palpitation
• Tremor
• Hunger
• Restlessness
• Tingling in the hands, feet, lips, or tongue
• Lightheadedness
• Decreased concentration
• Headache
• Drowsiness
• Sleep disturbances
• Anxiety
• Blurred vision
• Slurred speech
• Depressed mood
• Irritability
• Abnormal behavior
• Unsteady movement
• Personality changes

This is not a complete list of insulin (human) side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines alter glucose metabolism and may require insulin dose adjustment or close monitoring. Especially tell your doctor if you take:

• Angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• Certain cholesterol-lowering medications such as fenofibrate (Antara, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), and niacin (Niacor, Niaspan, in Advicor)
• Clonidine (Catapres, Catapres-TTS, in Clorpres)
• Danazol
• Digoxin (Digitek, Lanoxin)
• Disopyramide (Norpace, Norpace CR)
• Diuretics
• Fuoxetine (Prozac, Sarafem, in Symbyax)
• Hormone replacement therapy
• Isoniazid (INH, Nydrazid)
• Lithium (Eskalith, Lithobid)
• Medications for asthma and colds
• Medications for mental illness
• Medications for nausea
• Monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl) and Tranylcypromine (Parnate)
• Octreotide (Sandostatin)
• Oral contraceptives (birth control pills)
• Oral medications for diabetes such as pioglitazone (Actos, in Actoplus Met and others) and rosiglitazone (Avandia, in Avandamet and others)
• Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); Pentamidine (NebuPent, Pentam)
• Reserpine
• Salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic)
• Somatropin (Nutropin, Serostim, others)
• Sulfa antibiotics
• Thyroid medications

This is not a complete list of insulin (human) drug interactions. Ask your doctor or pharmacist for more information.

Inhalational:

Serious side effects have been reported with inhalations insulin (human) including the following:

Hypoglycemia. Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia.

• Sweating
• Dizziness
• Palpitation
• Tremor
• Hunger
• Restlessness
• Tingling in the hands, feet, lips, or tongue
• Lightheadedness
• Decreased concentration
• Headache
• Drowsiness
• Sleep disturbances
• Anxiety
• Blurred vision
• Slurred speech
• Depressed mood
• Irritability
• Abnormal behavior
• Unsteady movement
• Personality changes

Dry mouth

Decreased respiratory function

Cough

Shortness of breath

Injectable:

Serious side effects have been reported with injectable insulin (human) including the following:

Hypoglycemia. Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia.

• Sweating
• Dizziness
• Palpitation
• Tremor
• Hunger
• Restlessness
• Tingling in the hands, feet, lips, or tongue
• Lightheadedness
• Decreased concentration
• Headache
• Drowsiness
• Sleep disturbances
• Anxiety
• Blurred vision
• Slurred speech
• Depressed mood
• Irritability
• Abnormal behavior
• Unsteady movement
• Personality changes

Peripheral edema

Weight gain

Local redness and itching at the site of injection

Hypoglycemia related to insulin can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how insulin (human) affects you.

Do not take insulin (human) if you:

• are allergic to insulin (human) or to any of its ingredients
• are experiencing hypoglycemia

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of insulin (human), there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking insulin (human), tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to insulin (human) or to any of its ingredients
• have nerve damage related to diabetes mellitus
• have heart failure or other heart disease
• have liver disease
• have kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Insulin falls into category B. There are no well-done studies that have been done in humans or animals with insulin (human). Extensive literature demonstrates that blood glucose control is important during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Insulin (human) is naturally present in human breast milk. No adverse reactions have been associated with infant exposure to insulin in human breast milk. Glucose control supports lactation. 

Use insulin (human) exactly as prescribed.

This medication comes in solution and suspension for injection and inhalational forms. The dose and frequency of administration will depend on many factors, including diet, lifestyle, and other conditions you have.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your level of physical activity
• your meal times and eating habits

If you take too much insulin (human), call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Inhalational:

• Unopened cartridges or blister packs of insulin (human) for inhalation should be stored in the refrigerator.
• Opened cartridges or blister packs of insulin (human) for inhalation may be stored out of the refrigerator, as long as it is kept cool (below 86°F) and away from heat and light. Opened cartridges or blister packs must be discarded after 10 days.

Injectable:

• Unopened vials of insulin (human) for injection should be stored in the refrigerator.
• Opened bottles of insulin (human) for injection may be stored out of the refrigerator, as long as it is kept cool (below 86°F) and away from heat and light. Opened vials must be discarded after 31 days.

Inhalational:

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

See full prescribing information for complete boxed warning.

Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA.

AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD.

Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients