Berlthyrox

Uses

What is Berlthyrox® (levothyroxine) used for?

Levothyroxine is a thyroid hormone. It works by replacing thyroid hormone when your body does not make enough on its own.

Berlthyrox® is commonly used for treating low thyroid hormone levels and certain types of goiters. It is also used with surgery and other medicines for managing certain types of thyroid cancer.

It may be used for other conditions as determined by your doctor.

How should I take Berlthyrox® (levothyroxine)?

How do I store Berlthyrox® (levothyroxine)?

Berlthyrox® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Berlthyrox® in the bathroom or the freezer. There may be different brands of Berlthyrox® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Berlthyrox® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Berlthyrox® (levothyroxine)?

Levothyroxine should not be used to treat obesity or weight problems. Dangerous side effects or death can occur from the misuse of levothyroxine, especially if you are taking any other weight-loss medications or appetite suppressants.

Since thyroid hormone occurs naturally in the body, almost anyone can take levothyroxine. However, you may not be able to take this medication if you have certain medical conditions.

Is it safe during pregnancy or breastfeeding?

Pregnancy

Levothyroxine is not expected to harm an unborn baby. If you become pregnant while taking this medicine, do not stop taking the medicine without your doctor’s advice. Having low thyroid hormone levels during pregnancy could harm both mother and baby. Your dose needs may be different during pregnancy.

Breastfeeding

Levothyroxine can pass into breast milk, but it is not expected to be harmful to a nursing baby. Do not use this medication without telling your doctor if you are breastfeeding a baby. Your dose needs may be different while you are nursing.

Side effects

What side effects can occur from Berlthyrox® (levothyroxine)?

Seek medical attention right away if any of these severe side effects occur:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; flushing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness)
• Changes in appetite
• Changes in menstrual periods
• Chest pain
• Diarrhea
• Excessive sweating
• Fast or irregular heartbeat
• Fever
• Heat intolerance
• Joint pain
• Leg cramps
• Mental or mood changes (e.g., anxiety, irritability, nervousness)
• Muscle weakness
• Seizures
• Severe or persistent headache or fatigue
• Shortness of breath
• Stomach cramps
• Tremors
• Trouble sleeping
• Unusual weight gain or weight loss
• Vomiting
• Wheezing

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Berlthyrox® (levothyroxine)?

Levothyroxine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Berlthyrox® (levothyroxine)?

Berlthyrox® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Berlthyrox® (levothyroxine)?

Berlthyrox® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

To make sure levothyroxine is safe for you, tell your doctor if you have:

• A thyroid disorder (thyrotoxicosis)
• Heart disease, coronary artery disease, or a history of blood clots
• Diabetes
• Anemia (lack of red blood cells)
• Osteoporosis, or low bone mineral density
• Problems with your pituitary gland
• Food or drug allergies
• An untreated or uncontrolled adrenal gland disorder
• A heart attack, or any symptoms of a heart attack (chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling)

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Berlthyrox® (levothyroxine).

What is the dose of Berlthyrox® (levothyroxine) for an adult?

Usual adult dose for hypothyroidism

• Hypothyroidism in adults and in children in whom growth and puberty are complete, 1.7 mcg/kg/day (e.g., 100 to 125 mcg/day for a 70 kg adult) orally. Older patients may require less than 1 mcg/kg/day. Doses greater than 200 mcg/day orally are seldom required.
• For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, initial dose is 25 to 50 mcg/day, with gradual increments in dose at 6 to 8 week intervals, as needed.
• Patients with severe hypothyroidism, initial dose is 12.5 to 50 mcg orally once a day; dosage can be increased in 12.5 to 25 mcg/day increments every 2 to 4 weeks.
• Patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the oral dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range

Usual adult dose for TSH suppression

The dose of this drug used for TSH suppression should be individualized based on the specific disease and the patient being treated.

Usual adult dose for myxedema coma

IV:

• Initial loading dose: 300 to 500 mcg IV.
• Maintenance dose: 50 and 100 mcg IV, until the patient can tolerate oral therapy.

Usual geriatric dose for hypothyroidism

Initial dose: 12.5 to 25 mcg orally per day, with gradual dose increments at 4 to 6 week intervals

The dose is generally adjusted in 12.5 to 25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.

What is the dose of Berlthyrox® (levothyroxine) for a child?

Usual pediatric dose for hypothyroidism

Congenital or acquired hypothyroidism:

• Neonatal: 10 to 15 mcg/kg/day; if patient is at risk for development of cardiac failure, begin with a lower dose. In severe cases of hypothyroidism, a higher initial dose of 12 to 17 mcg/kg/day may be considered.
• Age 0 to 3 months: 10 to 15 mcg/kg orally once per day; if the infant is at risk for development of cardiac failure use a lower starting dose of approximately 25 mcg per day; if the initial serum T4 is very low (less than 5 mcg/dl) begin treatment at a higher dosage of approximately 50 mcg per day.
• Age 3 to 6 months: 8 to 10 mcg/kg/day.
• Age 6 to 12 months: 6 to 8 mcg/kg/day.
• Age 1 to 5 years: 5 to 6 mcg/kg/day.
• Age 6 to 12 years: 4 to 5 mcg/kg/day.
• Age 12 years and older: 2 to 3 mcg/kg/day.
• Patients in which growth and puberty are complete: 1.7 mcg/kg/day.

For chronic or severe hypothyroidism:

25 mcg orally once per day and increase dosage as needed in increments of 25 mcg every 2 to 4 weeks until the desired effect is achieved.

How is Berlthyrox® (levothyroxine) available?

Berlthyrox® is available in the following dosage forms and strengths:

• Tablets; Oral; Levothyroxine Sodium 100 mcg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Berlthyrox®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.