Active ingredients: levothyroxine sodium

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Presentation

Presentation of Puran T4

Oral use
Use Adult and Pediatric

Laboratory: Sanofi

12.5 mcg Tablets: packaging 30.

25 mcg Tablets: 28 or 30 to packaging.

37.5 mcg Tablets: packaging 30.

50 mcg Tablets: 28 or 30 to packaging.

62.5 mcg Tablets: packaging 30.

75 mcg Tablets: 28 or 30 to packaging.

88 mcg Tablets: 28 or 30 to packaging.

100 mcg Tablets: 28 or 30 to packaging.

112 mcg Tablets: 28 or 30 to packaging.

125 mcg Tablets: 28 or 30 to packaging.

150 mcg Tablets: 28 or 30 to packaging.

Tablets 175 mcg: pack of 28 or 30.

200 mcg Tablets: 28 or 30 to packaging.

300 mcg Tablets: packaging 30.

Find the best price Puran T4

Composition

Composition Puran T4

Puran 25 mcg T4: Each tablet contains 25 micrograms of levothyroxine sodium.

Puran 50 mcg T4: Each tablet contains 50 micrograms of levothyroxine sodium.

Puran 75 mcg T4: Each tablet contains 75 micrograms of levothyroxine sodium.

Puran 100 mcg T4: Each tablet contains 100 micrograms of levothyroxine sodium.

Puran 125 mcg T4: Each tablet contains 125 micrograms of levothyroxine sodium.

Puran 150 mcg T4: Each tablet contains 150 micrograms of levothyroxine sodium.

Puran T4 175 mcg: Each tablet contains 175 mcg of levothyroxine sodium.

Excipients: mannitol, corn starch, microcrystalline cellulose, magnesium stearate.

Puran 88 mcg T4: Each tablet contains 88 micrograms of levothyroxine sodium.

Puran 112 mcg T4: Each tablet contains 112 micrograms of levothyroxine sodium.

Puran 200 mcg T4: Each tablet contains 200 micrograms of levothyroxine sodium.

Excipients: corn starch, pregelatinized corn starch, microcrystalline cellulose, sodium carbonate, sodium thiosulphate, silicon dioxide, hydrogenated castor oil.

Puran 12.5 mcg T4: Each tablet contains 12.5 micrograms of levothyroxine sodium.

Puran 37.5 mcg T4: Each tablet contains 37.5 micrograms of levothyroxine sodium.

Puran 62.5 mcg T4: Each tablet contains 62.5 micrograms of levothyroxine sodium.

Puran 300 mcg T4: Each tablet contains 300 micrograms of levothyroxine sodium.

Excipients: mannitol, corn starch, microcrystalline cellulose, butylated hydroxyanisole and magnesium stearate.

1. What is this drug is indicated?

What is Puran T4

Puran T4 is intended for:

  • replacement therapy or hormone supplementation (hormone) in patients with hypothyroidism (insufficient production of hormones by the thyroid gland) from any cause (except transient hypothyroidism during the subacute thyroiditis recovery phase - inflammatory disease of the thyroid gland). In this category include: cretinism (a condition that occurs in childhood or lactating due to thyroid hormone deficiency in fetal stage), myxedema (associated with hypothyroidism is characterized by dry, rough skin, lips swollen and thickened nose) and ordinary hypothyroidism in patients of any age (children, adults and seniors) or phase (eg, pregnancy); primary hypothyroidism resulting from reduction of thyroid function; Primary decreased thyroid; partial or total removal of the thyroid gland, with or without goitre (noticeable increase of the thyroid); secondary hypothyroidism (pituitary gland) or tertiary (hypothalamus, which is a brain region that controosistema endocrine).
  • Suppression of pituitary TSH (thyroid stimulating hormone or thyrotropin) in the treatment or prevention of various types of goiters euthyroid (goiter due to increased TSH), including thyroid nodules, subacute lymphocytic thyroiditis or chronic (Hashimoto's thyroiditis / autoimmune thyroiditis) and carcinomas papillary and follicular (malignant tumors) of thyrotropin-dependent thyroid.
  • When the diagnosis suppression tests, aiding in the diagnosis of suspected hyperthyroidism (excessive hormone production by the thyroid gland) light or autonomous thyroid gland.
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2. How this medicine works?

expected action of Puran T4

Puran T4 is a drug which has in its formula a substance called levothyroxine. Levothyroxine is a hormone normally produced by the body by the thyroid gland. The Puran T4 is prescribed by the doctor to supply the deficiency of this hormone in the body.

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3. When should I not use this medicine?

Contraindications and risks of Puran T4

Puran T4 should not be used in case of intolerance to the components of the formula, recent myocardial infarction, untreated thyrotoxicosis (clinical syndrome untreated, resulting in high levels of thyroid hormone, adrenal insufficiency (gland located on the kidneys) decompensated hyperthyroidism and untreated.

There are no contraindications related to age groups.

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4. What should I know before using this medicine?

Precautions and warnings Puran T4

Tell your doctor if bearer of heart disease (angina, heart attack), high blood pressure, failure of the adrenal gland, lack of appetite, tuberculosis, asthma or diabetes.

Levothyroxine should be used with extreme caution in patients with cardiovascular disorders (related to heart and circulation), including angina pectoris, heart failure, myocardial infarction and high blood pressure. If necessary, smaller initial doses should be used, small increases in dose and longer intervals between dose escalations.

Thyroid hormone replacement therapy can precipitate problems of adrenal or pituitary glands if not made adequate treatment with corticosteroids.

In preterm newborns with extreme low weight, initiation of therapy with levothyroxine should be done with extreme caution due to the immaturity of the adrenal function.

thyroid hormones should not be used for weight reduction. In euthyroid patients (production of thyroid hormone levels in normal), normal dosages are not effective for weight loss; higher doses can produce severe manifestations, or even involving life-threatening, especially if administered with other specific care for reducing weight.

Effects on bone mineral density: The use of levothyroxine can be associated with risk of bone loss with subsequent development of osteoporosis and fractures. This risk was observed in some studies in women in postmenopausal using suppressive doses of TSH after differentiated thyroid carcinoma.

Special precautions

Additional care is needed when the levothyroxine is administered to patients with diabetes mellitus or diabetes insipidus (see Interactions).

The dosage should be adjusted according to the tests of thyroid function (thyroid). Monitoring of patients should be performed according to clinical symptoms, as well as with thyroid function tests. You need to monitor patients receiving concomitant administration of levothyroxine and medications that may affect the thyroid function (such as amiodarone and tyrosine kinase inhibitors) (see What should I know loved taking puran t4 - Drug Interactions).

special populations

Special care should be taken in elderly patients with goiter with normal thyroid function, who have suffered myocardial infarction or who have angina pectoris, heart failure or arrhythmia (mismatch of the heartbeat) with tachycardia (rapid heart rate).

Levothyroxine should be introduced very gradually in the elderly and in patients with longstanding hypothyroidism in order to avoid any sudden increase of the body's needs.

Changes in the ability to drive vehicles and operate machinery

There is no indication that levothyroxine may impair ability to drive or operate machinery.

Drug-food

Soybeans: in infants under diet with soy and treated with levothyroxine for congenital hypothyroidism was reported an increase in TSH level. Excessive doses of levothyroxine may be required to achieve normal levels of T4 and TSH. During and after the diet with soy, the monitoring of the T4 and TSH levels in the blood is needed, with possible dosage adjustment.

The food can interfere with the absorption of thyroxine. Thus it is recommended that the administration of T4 with puran empty stomach (1 hour before or 2 hours after breakfast or food intake), in order to increase its absorption.

Interactions of Puran T4

Enter your physician if using other medications, especially anticoagulants, oral contraceptives, cholestyramine, aspirin, antidiabetic agents or antidepressants.

Drug-drug

Puran T4 effects on other drugs:

  • Oral anticoagulants (drugs which prevent the formation of blood clots, e.g., warfarin and dicumarol): thyroid hormones increase the effects of oral anticoagulants. anticoagulant therapy in patients still require careful monitoring when treatment with thyroid agents starts or changes as needed dosage oral anticoagulant adjustment (reduction dose).
  • insulin and oral Antidiabetics: Use of levothyroxine can lead to an increase in blood glucose in diabetic patients and may require dose adjustment of insulin or oral antidiabetic agents. This effect occurs because the thyroid hormones help regulate hepatic insulin sensitivity, which is important for inhibiting hepatic gluconeogenesis.

Effects of other drugs on Puran T4:

  • enzyme-inducing drugs (increase the action of the enzymes and its release) (eg, rifampicin, phenytoin or carbamazepine, barbiturates): increase in thyroid metabolism resulting in reduced concentrations of thyroid hormones in the blood. Thus, patients in the thyroid hormones replacement therapy should require an increase in dosage if these drugs are administered concomitantly.
  • Amiodarone inhibits the peripheral conversion of T4 to T3 levothyroxine resulting in decreased serum T3 concentrations and increased the serum TSH level.
  • Glucocorticoids, propylthiouracil and beta-sympatholytic (especially propranolol) to inhibit peripheral conversion of thyroxine (T4) to T3 and may lead to reduction in serum T3 concentrations.
  • Protease inhibitors (class of drugs that decrease viral replication): There therapeutic effect of levothyroxine reports loss when used concomitantly with lopinavir / ritonavir. Therefore, the clinical symptoms and thyroid function tests should be carefully monitored in patients taking levothyroxine and lopinavir / ritonavir concomitantly.
  • Tyrosine kinase inhibitors such as imatinib, sorafenib or sunitinib can reduce the effectiveness of levothyroxine. Therefore, clinical symptoms, as well as thyroid function must be carefully monitored in patients receiving levothyroxine and tyrosine kinase inhibitors concomitantly. It may be necessary to adjust the dose of levothyroxine.
  • Estrogens (eg, oral contraceptives): increase the binding of thyroxine, leading to errors of diagnosis and treatment.
  • Salicylates: doses greater than 2g / day may increase the free T4 levels and, when at therapeutic levels, salicylates can cause a reduction in the levels of total T4 and free T4 in the order of 20 - 30%.
  • Furosemide: High dose of furosemide (> 80 mg), intravenously associated with changes in renal function and serum albumin concentration may promote a transient increase in free T4 and reduced total T4. This effect is not observed in usual doses used in hypertensive patients or patients with heart failure.
  • Clofibrate: in animal models studies suggest that clofibrate may act as microsomal enzyme inducer and alter the metabolism of thyroid hormones with a consequent reduction of the levels of T4 and free T3.
  • Iodinated contrast media: some iodinated contrast media (iopanoic acid, ipodate sodium intravenous preparations and some iodine-containing) can interfere temporarily (approximately for 10 to 14 days, excretion of contrast time) on thyroid function. This period may be in iodine release amount (14 to 175 mg iodide) can reduce thyroid hormone secretion and cause hypothyroidism.

Drugs administered orally they can reduce the absorption of thyroxine (T4):

  • ion exchange resins (eg cholestyramine, sevelamer or calcium sulphate and polystyrene sodium salts): there is reduced absorption of ingested levothyroxine due to binding to thyroid hormones in the gastrointestinal tract.

Thus, one should separate the administration of ion exchange resins of administration of levothyroxine much as possible.

  • Drugs to the gastrointestinal tract (involving the digestive system) (eg, sucralfate, and calcium carbonate antacids): reduction occurs levothyroxine absorption in the gastrointestinal tract. Thus, one should separate the administration of drugs to the gastrointestinal tract of the administration of levothyroxine much as possible.
  • iron salts: ferrous sulfate reduces the absorption of thyroxine in the gastrointestinal tract. Thus, one should separate administration of iron salts of administration of levothyroxine much as possible.
  • Bile acid sequestrant: colesevelam binds to thyroxine and reduces its absorption in the gastrointestinal tract.

No interaction was seen when levothyroxine was administered for at least 4 hours before colesevelam.

Thus, levothyroxine should be administered at least 4 hours before colesevelam.

Use of Puran T4 in pregnancy and breastfeeding

In principle, there is no contraindication to the use of Puran T4 during pregnancy and breastfeeding. However, tell your doctor if you suspect pregnancy, during or after the use of medication. Also tell your doctor if you are breast-feeding

Levothyroxine crosses the placental barrier in limited quantities, but its use in clinical practice has shown no adverse effects on the fetus. Maintaining the levels of thyroid hormones within the normal range is vital for pregnant women to ensure their health and the fetus. Thus, treatment with Puran T4 does not need to be changed during pregnancy. Both levels of TSH (thyroid stimulating hormone or thyrotropin) as the thyroid hormone levels should be monitored periodically and, if necessary, treatment should be adjusted. During pregnancy, levothyroxine sodium is contraindicated as adjunctive treatment of hyperthyroidism treated with antithyroid drugs. The additional intake of levothyroxine can increase the dosages required of antithyroid drugs. The antithyroid drugs, unlike thyroxine, cross the placental barrier in effective dosages, which can result in hypothyroidism in the fetus. Thus, hyperthyroidism during pregnancy should be treated with a single dose Aixas antithyroid agent.

Breastfeeding can continue during treatment with levothyroxine.

The amount of levothyroxine eliminated in breast milk is minimal and is not associated with any side effects or potential for generation of tumors. adequate amounts of thyroxine are necessary to maintain normal amamentaçã.

Puran T4 can be used during pregnancy since under medical prescription.

Tell your doctor if you are making use of some other medication.

Do not use medication without the knowledge of your doctor. It can be dangerous to your health.

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5. Where, how and for how long can I keep this medicine?

Storage, manufacturing date, expiry date and physical aspect of Puran T4

Puran T4 should be kept in its original packaging, at room temperature (between 15 and 30 ° C) protected from light and moisture.

lot number and dates of manufacture and expiry: see packaging.

Do not use medicine with the expiry date. Store it in its original packaging.

puran features t4

Round tablet, white, flat, bevelled with the corresponding concentration (12.5; 25; 37.5; 50; 62.5; 75; 88; 100; 112; 125; 150; 175; 200, 300) recorded in two faces.

Before using, note the appearance of puran t4. If it is on time and you notice any changes in appearance, see the pharmacist to find out if you can use it.

All medicine should be kept out of reach of children.

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6. How should I use this medicine?

Dosage, dosage and instructions for use of Puran T4

The doses of T4 puran vary according to the degree of hypothyroidism, the age of the patient and individual tolerability. In order to adjust the dosage, it is recommended before starting the treatment effect of the dosages (T3) (T4) and TSH.

You should take the tablets with liquid, orally.

adult use

  • hypothyroidism: Puran T4 must be administered at low doses (50 mcg / day) will be increased according to the cardiovascular condition of the patient.

Initial dose: 50 mcg / day, increasing by 25 mcg every 2 or 3 weeks until the desired effect is achieved. In patients with longstanding hypothyroidism, particularly with suspected cardiovascular changes, the initial dose should be lower still (25 mcg / day).

Maintenance: recommended 75-125 mcg daily and some patients with malabsorption may require up to 200 mcg / day. Most patients do not require doses greater than 150 mcg / day. The lack of response to doses of 200 mcg / day suggests malabsorption, not obedience to the treatment or misdiagnosis.

  • Suppression of TSH (thyroid cancer) / nodes / euthyroid goiter in adults: average suppressive dose of levothyroxine (T4): 2.6 mcg / kg / day for 7 to 10 days. This dose is usually sufficient for normalization of the levels of T3 and T4 in the body and lack of response to the action of TSH. The levothyroxine sodium should be used with caution in patients with suspected thyroid gland independent, considering that the action of exogenous hormones (external source to the body) can be added to the endogenous source of hormones (originating from the body).

pediatric use

In newborns, the initial dosage should be 5 to 6 mcg / kg / day depending on the dosage of circulating hormones.

In children, the dosage should be determined on the basis of the results of hormone assays and in general is 3 mcg / kg / day.

Puran T4 tablets should be taken on an empty stomach (1 hour before or 2 hours after breakfast or food intake), in order to increase its absorption.

For children unable to ingest the tablets, they should be crushed and dissolved in a small amount of water. This suspension may be administered in spoon or dropper. The milled tablets may also be administered with small amounts of food products (cereals, juices, etc.). The prepared slurry can not be stored for later use.

No studies of the effects of T4 puran administered by routes not recommended. Therefore, for safety and to ensure the effectiveness of puran t4, the administration should be only orally, as recommended by the doctor.

elderly patients

In the elderly, the integrity of the cardiovascular system may be compromised. Therefore, this patient puran T4 therapy should be initiated at lower doses, for example: 25-50 mcg / day.

Follow the guidance of your doctor, always respecting schedules, doses and duration of treatment.

Do not stop treatment without the knowledge of your doctor.

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7. What should I do if you forget to use this medicine?

If forget a dose, administer it as soon as possible. However, if you are near the time of the next dose, wait for this time, respecting the interval determined by the dosage. They should never be administered two doses at the same time.

If in doubt, seek advice from the pharmacist or your doctor.

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8. What are the evils that this medicine can cause me?

Adverse reactions of Puran T4

In general, the adverse reactions of levothyroxine is associated with excessive dosage and correspond to the symptoms of hyperthyroidism (excessive hormone production by the thyroid gland).

May occur: tachycardia (rapid heart rate), palpitations (an awareness of heartbeats), cardiac arrhythmias (mismatch of the heartbeat), angina pain (chest pain), headache, nervousness, excitability, insomnia, tremor , muscle weakness, cramps, heat intolerance, sweating (excessive sweating), hot flashes (sudden temporary feeling of warmth), fever, weight loss, menstrual irregularities, diarrhea and vomiting. These effects usually disappear with dose reduction or temporary cessation of treatment.

There may also be allergic reactions, such as rash (rash), urticaria (rash, usually of allergic origin, which causes itching).

Attention: this product is a medicine that has new concentration in the country, although studies have indicated efficacy and safety acceptable, even if indicated and used properly, can cause unpredictable adverse events or unknown. In this casso, tell your doctor.

In case of use of large amounts of puran t4, seek medical help quickly and take the packaging or labeling of puran t4, if possible. Call 0800 722 6001 if you need further guidance.

9. What to do if someone uses a larger amount than indicated this medicine

Overdose Puran T4

Storm thyroid (thyroid crisis caused by the increased amount of thyroid hormones in the blood stream) after massive intoxication or chronic convulsions, cardiac arrhythmias, decreased cardiac function, coma, and death.

In acute overdoses, gastrointestinal absorption can be reduced by activated carbon. The treatment is often symptomatic and support: beta-blockers may be useful in controlling the symptoms of sympathomimetic hyperactivity. In cases of overdose with high quantities in plasma filtration (procedure by which plasma is separated and extracted from non-coagulated whole blood and red cells are transferred back the patient) must be considered.

The levothyroxine overdose require monitoring over a longer period, since the symptoms may be extended for up to 6 days due to the gradually peripheral conversion of thyroxine to triiodothyronine.

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Legal Phrases

SALE UNDER MEDICAL PRESCRIPTION

MS 1.1300.1023

Farm. Resp .: Silvia Regina Brollo

CRF No. SP-9815

Joined by:

Sanofi-Aventis Pharma Ltda.

Av. Mj. Sylvio M. Padilha, 5200 - São Paulo - SP

CNPJ 02,685,377 / 0001-57

Made by:

Sanofi-Aventis Pharma Ltda.

Conde Domingos Papaiz, 413 - Suzano - SP

CNPJ 02,685,377 / 0008-23

Brazilian industry

® Registered Trademark

IB230713B

This leaflet was approved by ANVISA on 18/08/2014.

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