Letroz Tablet

Generic Name(s): Letrozole

Why it's used

Letroz Tablet is a prescription medicine that is used to treat is given as combined treatment in women with permanent discontinuance of periods (postmenopausal women) with hormone receptor-positive early and as permanent discontinuance of periods with hormone receptor-positive or hidden advanced breast cancer. Letroz is also given with other long-term medicines to treat postmenopausal women with advanced breast cancer who have experienced earlier standard combined tamoxifen therapy. This medicine works by decreasing the level of estrogen produced by the body. Therefore, slowing or stopping the growth of many types of breast cancer cells which need estrogen to grow.
Aromatase Inhibitors
Letroz belongs to the Aromatase Inhibitors class of medicines. Aromatase inhibitors are a class of drugs used in the treatment of breast cancer in post-menopausal women and swollen breast in men. They may also be used for the prevention of cancer in high-risk women.

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How to use

Follow directions on the product label, information guide, and provided by your doctor before using Letroz. Eat this medicine as per your doctor's instructions.
Letroz is eaten with or without food. The Letroz should be taken with a glass of water or with another liquid.

Typical Dosage

The typical adult dose of Letroz is 2.5 mg once daily. The maximum dose for adults of Letroz is 2.5 mg once daily per day. Letroz is typically used at the same time every day. By using Letroz every day at the same time, it helps to remember the correct timing of the next dose.
Letroz is to be used for longer periods of time.

Talk to Your Doctor

Tell your doctor if your condition persists or worsens or if you develop new symptoms. Talk to your doctor if difficulty in breathing, sudden chest pain, redness and swelling along a vein, blurred vision, nausea, fever, paralysis, weakness, loss of coordination, and dark-colored urine. If you have issues with the health of your liver, The dose should be reduced by 50% in patients with severe liver damage and scarring of the liver. There is no need for dose adjustment in the patients with mild to moderate abnormal functioning of the liver. Consult with your doctor before stopping the use of Letroz Tablet.
When stopping this medicine, it is possible that you may experience withdrawal symptoms such as heart disease, bone fracture, and thinning of bones.

Use in Children

The safety and effectiveness of using this medicine in children has not been established.

Storage

Store Letroz Tablet at 25°C (77°F), and protect from moisture. Keep this medicine away from children and pets.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Letroz Tablet for symptoms for which it was not prescribed. Do not give Letroz Tablet to others who may have similar symptoms as you. Self-medication can cause harm.

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How to take Letroz

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Letroz depends on the following factors:
  • the health of the patient's kidneys
  • any other medicines in use

Letroz Dosage

Dosage for early breast cancer

Adult (combined therapy of early breast cancer)
  • Recommended: 2.5 mg once daily

Dosage for extended early breast cancer

Adult (for long term combined therapy of early breast cancer)
  • Recommended: 2.5 mg once in a day

Dosage for advanced breast cancer

Adult (first and second-line therapy of advanced breast cancer)
  • Recommended: 2.5 mg once in a day

Forms

Tablet
Strength: 2.5 mg
Tablet, film coated
Strength: 2.5 mg

Special Instructions

Kidney dysfunction
There is no need for dose adjustment in patients with abnormal functioning of the kidney with creatinine clearance greater than or equal to 10 mL/min.

Missed Dose

The missed dose should be taken as soon as you remember it. However, if it is almost time for your next dose, the missed dose should be skipped, and the regular dosing schedule should be continued. A double dose should not be taken to make up for a missed dose.

Overdose

What to do if you overdose on Letroz?
In case of overdose, if the patient is alert, then vomiting should be induced by using general supportive measure. Proper monitoring of vital signs should be considered in such patients.
If you think you have overdosed on Letroz Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Letroz

Before you use Letroz, tell your doctor of your medical and health history including the following:
  • a history of bone fractures
  • allergic reaction
  • kidney disease
  • liver disease
Letroz blood levels were found to be increased in patients having mild liver damage due to scarring of the liver.
Before you use Letroz Tablet, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
The use of this medicine may change Cholesterol level. Letroz can increase the level of cholesterol.
The use of this medicine may change Follicle-stimulating hormone (FSH) Level. Letroz can increase the level of follicle-stimulating hormone (FSH).
The use of Letroz Tablet may change Letroz blood level. The Letroz blood level may increase.
The use of this medicine may change Liver enzymes. Letroz can increase the level of the liver enzyme.
The use of Letroz Tablet may change Luteinizing hormone (LH) level. The level of luteinizing hormone (LH) may get increased with the use of Letroz.

Dizziness

Letroz Tablet can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Letroz Tablet can worsen the sleepiness.

Use in Pregnancy

Pregnant/breastfeeding women should not use this medicine. Letroz is not for use by women. Letroz can cause birth defects and fetal harm when given to pregnant women.

Use while Breastfeeding

Women who are breastfeeding a baby should not use this medicine. It is not known whether Letroz may pass into human milk and can cause harm to the baby.

Use while Conceiving

Letroz may impact fertility in women. If you are trying to conceive, discuss with your doctor on the use of this medicine. The use of Letroz may reduce female fertility.

What precautions should be taken during Pregnancy and Nursing, and administering Letroz to Children or the Older Adults?

Pregnant Women

Contraindicated or Not Recommended
Warning: In pregnant women, Letroz can cause birth defects and harm to the unborn baby.

Breastfeeding

Contraindicated or Not Recommended
Warning: During breastfeeding, Letroz and its metabolites may pass into human milk and can cause harm to the baby.

Younger Adults Population

Contraindicated or Not Recommended
Warning: Letroz should not be used in children below 18 years.

Older Adults Population

Possibly safe
Warning: 

Letroz Side-effects

The following side-effects may commonly occur when using Letroz Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
Rarely, the use of Letroz Tablet may cause the following side-effects:
  • abnormal sensation in the body
  • abnormal urination during the day
  • blood clot in the vein just under the skin
  • blurred vision
  • breast pain
  • change in the sense of taste
  • cough
  • decreased weight
  • drowsiness
  • dry mouth
  • eye irritation
  • fever
  • formation of a blood clot in a deep vein
  • general swelling
  • hives
  • inflammation of a vein
  • insomnia
  • irritability
  • memory abnormality
  • mucosal dryness
  • pain, numbness, and tingling in the hand
  • reduced sense of touch
  • severe skin itching
  • shortness of breath
  • thirst
  • trigger finger
  • tumor pain
  • vaginal discharge
  • vaginal dryness
The following severe side-effects may also occur when using Letroz Tablet:
  • Psychiatric disorders
    Symptoms: depression
  • Metabolism and nutrition disorders
    Symptoms: decreased appetite
  • Immune system disorders
    Symptoms: serious allergic reaction
  • Blood and lymphatic system disorders
    Symptoms: decrease in the number of white blood cells
  • Infections and infestations
  • Eye disorders
    Symptoms: clouding of the eye lens blurred vision
  • Heart disorders
  • Vascular disorders
    Symptoms: blood clot in the lungs, a blood clot in artery reduced blood supply to the brain
  • Stomach and intestinal disorders
    Symptoms: constipation, diarrhea painful swelling and sores inside the mouth
  • Hepatobiliary disorders
    Symptoms: inflammation of the liver, increased liver enzymes, increased level of bilirubin yellowing of the skin or whites of the eyes
Your doctor has prescribed this Letroz because they have judged that the benefits outweigh the risks posed by side-effects. Many people using this medicine do not have serious side-effects. This is not a complete list of possible side-effects for Letroz.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Letroz by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Bone Effects

Patients using Letroz may see a decrease in lumbar spine and hip bone mineral density. The incidence of bone fractures and thinning of bones has also observed with the combined therapy of tamoxifen and Letroz. It is advised to monitor bone mineral density.

Cholesterol Level

A very high level of cholesterol in the blood has been observed with the combined use of Letroz and tamoxifen. Proper monitoring of the blood cholesterol level should be considered.

Liver Abnormality

Patients with liver damage are at an increased risk while using this medicine. Patients with scarring of the liver and severe liver damage experienced twice the exposure to Letroz. Therefore, a dose reduction is advised for such patients. The effect of liver damage on Letroz exposure in cancer patients with raised bilirubin levels has not been evaluated.

Fatigue and Dizziness

Fatigue, drowsiness, and dizziness have been seen with the use of Letroz. Take necessary precautions in such patients while driving or using machinery, until it is recognized how the patient responds to Letroz use.

Laboratory Test Abnormalities

Patients using Letroz may experience a moderate decrease in lymphocyte count and abnormally low levels of thrombocyte.

Fetal Poisoning

Letroz can induce harm to the unborn baby and should not be used in pregnant women. In post-marketing reports, the use of Letroz during pregnancy resulted in problems of unintentional abortions and existing birth defects. Pregnant women are advised of the possible risk to an unborn baby. Females of reproductive potential are encouraged to use effective contraception during treatment with Letroz and at least for 3 weeks after the final dose.

Family History Problems

Patients with rare family history problems of severe lactase deficiency, galactose intolerance or improper absorption of glucose-galactose are at an increased risk when using this medicine. Use of Letroz is not recommended in such patients.

Tamoxifen, or other Antiestrogens

Use of Letroz with tamoxifen, other anti-estrogens or estrogen-containing medicines should abstain as these substances may reduce the drug action of Letroz.

Menopausal Status

Patients whose menopausal status is not clear, follicle-stimulating hormone, luteinizing hormone, and estradiol levels should be estimated before starting therapy with Letroz. Only women who have undergone a period of menopause endocrine status should take Letroz.

Interactions with Letroz

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Letroz Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Anti-estrogen

Letroz Tablet may interact with Anti-estrogen such as tamoxifen, which is used to treat breast cancer and infertility in women. When Letroz is used with tamoxifen 20 mg, it may decrease the blood levels of Letroz. A clinical study in the second-line breast cancer cases indicates that the healing effect of Letroz therapy is not affected if Letroz is given immediately after tamoxifen.

Interactions of Letroz by Severity

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Letroz be not used?

Allergic Reaction

Letroz should not be used in patients with known allergic reaction to it or any of its components.

Pregnant Women

The use of Letroz is not recommended during pregnancy as it can cause birth defects and harm to the unborn baby.

Premenopausal Endocrine Status

Letroz should not be used in women, who are in the period before the menopause.

Breastfeeding

Letroz and its metabolites may pass into human milk, which is still unknown. Therefore, Letroz should not be given during breastfeeding.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Letroz is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Letroz Tablet .
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