Thyrorite 25Mcg Tablet 100’S

INTRODUCTION

THYRORITE 25MCG TABLET contains Thyroxine which belongs to the group of medicines called Thyroid hormone receptors. It is used as a replacement therapy in the treatment of primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism.

It is also used as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated papillary or follicular carcinoma (a differentiated thyroid cancer where cancer develops from the follicular cells and grow slowly) of thyroid gland.

Hypothyroidism is a condition in which the thyroid gland doesn’t produce enough thyroid hormone in the blood stream. It is characterized by symptoms such as weakness, increased sensitivity to cold, constipation, dry skin, weight gain, puffy face, hoarseness and muscle weakness.

THYRORITE 25MCG TABLET is not recommended for use if you had a heart attack, acute myocarditis (inflammation/swelling of the heart muscle) or acute pancarditis (general inflammation/ swelling of the heart) recently.

Before taking this medicine, inform your doctor if you are having severe liver disease such as liver cirrhosis, kidney problems such as renal impairment, end-stage renal disease, nephrotic syndrome, renal failure, other heart problems, history of heart attack and/or history of kidney transplant.

It is not recommended for use in patients with overactive thyroid gland or untreated adrenal insufficiency (inability of adrenal glands to make enough of the hormone cortisol).

THYRORITE 25MCG TABLET should be used with caution in pregnant and breastfeeding women. It should be used with caution in children and adolescents (aged below 18 years) and elderly patients (aged above 65 years).

The most common side effects associated with the use of THYRORITE 25MCG TABLET are skin rash, itching and mild leucopenia (reduced white blood cell count). Consult your doctor if any of these symptoms worsens.

USES OF THYRORITE 25MCG TABLET
Treats primary, secondary and tertiary congenital or acquired hypothyroidism.
To manage thyrotropin-dependent well-differentiated papillary or follicular carcinoma of thyroid gland (with adjunct to surgery and radioiodine therapy)
HOW THYRORITE 25MCG TABLET WORKS

THYRORITE 25MCG TABLET works by replacing the thyroid hormone which thyroid gland fails to produce in sufficient quantity in body thus treating the symptoms of hypothyroidism.

DIRECTIONS FOR USE

Take THYRORITE 25MCG TABLET as advised by your physician. Swallow the medicine with a glass of water on an empty stomach. Administer THYRORITE 25MCG TABLET to infants and children who are unable to swallow the intact tablets by crushing it and suspending the freshly crushed tablet in a small amount of water and immediately administering the fresh suspension by dropper or spoon. Do not store the suspension.

Your doctor will decide the correct dose and duration of THYRORITE 25MCG TABLET for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF THYRORITE 25MCG TABLET
COMMON
Skin rash
Itching
Mild leucopenia (reduced white blood cell count)
UNCOMMON
Signs of agranulocytosis (deficiency of certain white blood cells) such as increased vulnerability to infection
RARE
Hair loss
Seizures (fits)

Stop taking THYRORITE 25MCG TABLET and contact your doctor if you experience any of the following side effects:     

Signs of heart problems such as chest pain, rapid/irregular heartbeat, pounding heartbeat and shortness of breath
Signs of heart attack such as crushing chest pain that radiates to the left arm and/or jaw, sweating, nausea, vomiting and shortness of breath
Signs of serious allergic reactions such as rash, raised red patches, swelling of the face, lips, tongue, or throat and difficulty swallowing or breathing
Signs of seizure (fits) such as muscle twitching, changes in emotions, confusion or loss of consciousness with uncontrollable shaking
Signs of increased pressure in the brain (in children) such as headaches, vison problems or complete loss of vision, double vision, ringing in the ears or pain in the arms
Signs of slipped capital femoral epiphysis (condition marked by weakened hip joint in children) such as stiffness/pain in the knee or groin, walking with a limp, inability to bear weight on the affected side.
Signs of osteoporosis (condition marked by decreased bone density) such as back pain, loss of height over time, stooped posture, broken bones
WARNING & PRECAUTIONS
PREGNANCY

THYRORITE 25MCG TABLET should be used with caution during pregnancy. Consult your doctor before taking THYRORITE 25MCG TABLET.

BREASTFEEDING

THYRORITE 25MCG TABLET should be used with caution in breastfeeding women as it may pass through breast milk. Consult your doctor before taking THYRORITE 25MCG TABLET.

DRIVING AND USING MACHINES

Do not drive or operate any machines as it may affect your ability to drive and use machines while taking THYRORITE 25MCG TABLET. Consult your doctor before taking THYRORITE 25MCG TABLET.

KIDNEY

THYRORITE 25MCG TABLET is used with caution in patients with kidney problems such as renal impairment, end-stage renal disease, nephrotic syndrome, renal failure or patients with kidney transplant. Consult your doctor before taking THYRORITE 25MCG TABLET.

LIVER

THYRORITE 25MCG TABLET should be used with caution in patients with severe liver disease such as severe cirrhosis and other liver problems such as hepatic impairment. Consult your doctor before taking THYRORITE 25MCG TABLET.

ALLERGY

Do not take THYRORITE 25MCG TABLET if you are allergic to thyroxine sodium or any other ingredients of this medicine.

HEART DISEASE

THYRORITE 25MCG TABLET is not recommended for use if you had a recent heart attack, acute myocarditis (inflammation/swelling of the heart muscle) or acute pancarditis (general inflammation/swelling of the heart). It should be used with caution in patients with other heart problems such as coronary artery disease, angina or have a history of heart attack, heart disease or hardening of the arteries. Consult your doctor before taking THYRORITE 25MCG TABLET.

OTHERS

THYRORITE 25MCG TABLET is not recommended for use if you:

Have signs of overactive thyroid gland such as nervousness, anxiety and irritability, mood swings and difficulty sleeping
Have untreated adrenal insufficiency (a disorder marked by insufficient production of certain hormones)
Myxoedema coma (a rare life-threatening condition of untreated hypothyroidism)

Before taking THYRORITE 25MCG TABLET, inform your doctor if you:    

Have high blood pressure
Have blood clotting disorders
Have psychotic disorders such as schizophrenia
Are a post-menopausal woman and have been on long-term thyroxine sodium therapy
Signs of malabsorption syndrome (condition marked by inability of small intestine to absorb sufficient nutrients) such as abdominal pain and distension, bloating and flatulence
Have diabetes
Are scheduled for any surgery
Have nontoxic diffuse goitre (enlarged thyroid gland) or nodular thyroid disease (condition marked by thyroid lumps)
Have hypothalamic/pituitary hormone deficiencies
Have autoimmune polyglandular syndrome (autoimmune disorder) such as adrenal insufficiency, pernicious anaemia
Are in weight control programme

Use in Paediatrics

THYRORITE 25MCG TABLET should be used with caution in children and adolescents (below 18 years of age). Consult your child’s doctor before administration of THYRORITE 25MCG TABLET to your child.

Use in Geriatrics

THYRORITE 25MCG TABLET should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking THYRORITE 25MCG TABLET.

INTERACTIONS

A. Drug-Drug Interactions

Before taking THYRORITE 25MCG TABLET, inform your doctor, if you are taking any of the following medicines:

Nutritional supplements Ex. calcium carbonate, ferrous sulfate, vitamin B3 (niacin/ nicotinic acid)
Medicines used to treat heart problems such as digitalis glycosides (Ex. digoxin), ketamine
Medicines used to lower blood pressure such as beta blockers Ex. propranolol, atenolol and metoprolol
Medicines used to prevent blood clotting such as blood thinners Ex. warfarin, heparin
Medicines used to treat abnormal heart rhythm Ex. amiodarone
Medicines used to dilate blood vessels to reduce blood pressure Ex. nitroprusside
Medicines used to increase urine output to reduce blood pressure such as diuretics Ex. furosemide
Medicines used to treat diabetes Ex. insulin, tolbutamide
Medicines used to treat digestion problems such as antacids (Ex. aluminium and magnesium hydroxides, simethicone), proton pump inhibitors (Ex. omeprazole), metoclopramide, sucralfate
Medicines used to lower high cholesterol levels Ex. colestipol, cholestyramine, lovastatin, colesevelam 
Medicines to lower levels of phosphorus in the blood Ex. polystyrene sulfonate, sevelamer, lanthanum carbonate, sevelamer
Medicines used to treat mental health problems and seizures such antidepressants (Ex. sertraline, maprotiline, amitriptyline), lithium, perphenazine, carbamazepine, diazepam, methadone, heroin, phenobarbital, amionoglutethemide or hydantoins
Medicines used to treat certain cancers such as tyrosine kinase inhibitors (Ex. imatinib, sunitinib), tamoxifen, 5-flurouracil, mitotane, mercaptopurine, octreotide, interferon alpha (IFN-a), interleukin-2
Medicines used for weight loss Ex. orlistat, other diet pills
Medicines used to treat inflammatory conditions such as corticosteroids (Ex. dexamethasone and prednisone), non-steroidal anti-inflammatory drugs (Ex. fenamic acid, phenylbutazone and salicylates)
X-ray contrast agents Ex. iodide
Medicines used to treat asthma or other breathing problems Ex. salbutamol
Medicines used to treat colds, sinus problems, hay fever or other allergies Ex. cetirizine
Medicine used to treat Parkinson’s disease and restless leg syndrome Ex. dopamine
Medicines used to treat bacterial, viral or fungal infections such as sulfamethoxazole, rifampin and resorcinol 
Medicine used to treat HIV infection Ex. ritonavir
Medicines used to treat tuberculosis such as ethionamide
Synthetic hormones Ex. estrogens, somatotropin (a growth hormone), anabolic steroids or muscle building hormones Ex. asparaginase
Other medicines used to treat thyroid problems Ex. methimazole, carbimazole, propylthiouracil (PTU)

B. Drug-Food Interactions

Avoid taking consumption of grapefruit juice and food containing soybean flour, cottonseed meal, walnuts or dietary fibre while taking THYRORITE 25MCG TABLET, as these may bind and decrease the absorption of this medicine in the body.

Overdosage:

If you or anyone else accidentally takes too much of THYRORITE 25MCG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are weakness, increased appetite, weight loss, heat intolerance, fever, excessive sweating, headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, sleeplessness, tremors, muscle weakness, muscle spasm, awareness of heartbeat, fast or irregular heartbeat, increased pulse rate, high blood pressure, heart failure, angina, heart attack, cardiac arrest, breathlessness, diarrhoea, vomiting, abdominal cramps, hair loss, flushing, rashes, decreased bone mineral density, menstrual irregularities, impaired fertility, seizures (life-threatening emergency characterized by poor circulation and decreased metabolic rate), confusion, disorientation, cerebral embolism (blockage of blood supply to brain), shock, coma, exophthalmic goitre (autoimmune disease), sleeplessness or acute psychosis.

SYNOPSIS
Drug :   Thyroxine sodium
Pharmacological Category :   Thyroid hormone receptors
Therapeutic Indication :   Hypothyroidism, papillary or follicular carcinoma of the thyroid gland
Dosage Forms :   Tablet
MORE INFORMATION
Keep the medicine out of reach of children
Store THYRORITE 25MCG TABLET at room temperature
FAQs ABOUT THYRORITE 25MCG TABLET

What is THYRORITE 25MCG TABLET used for?

THYRORITE 25MCG TABLET is used as a replacement therapy in the treatment of primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also used as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated papillary/follicular carcinoma of the thyroid gland.

Who should avoid taking THYRORITE 25MCG TABLET?

THYRORITE 25MCG TABLET is not recommended for use if you had a recent heart attack, acute myocarditis (inflammation/swelling of the heart muscle) or acute pancarditis (general inflammation/swelling of the heart). It is not indicated for use in patients with overactive thyroid gland or untreated adrenal insufficiency (inability of adrenal glands to make enough of the hormone cortisol). Consult your doctor before taking THYRORITE 25MCG TABLET.

How does THYRORITE 25MCG TABLET work?

THYRORITE 25MCG TABLET works by replacing the thyroid hormone which thyroid gland fails or unable to produce in sufficient quantity in body thus treating the symptoms of hypothyroidism.

What is the method of taking THYRORITE 25MCG TABLET?

Take THYRORITE 25MCG TABLET as advised by your physician. Swallow the medicine with a glass of water on an empty stomach. Administer THYRORITE 25MCG TABLET to infants and children who are unable to swallow the intact tablets by crushing it and suspending the freshly crushed tablet in a small amount of water and immediately administering the fresh suspension by dropper or spoon. Do not store the suspension. Your doctor will decide the correct dose and duration of THYRORITE 25MCG TABLET for you depending upon your age, body weight and disease condition.

Can [GBNKEYWORD] be used in heart patients?

THYRORITE 25MCG TABLET is not recommended for use if you had a heart attack, acute myocarditis (inflammation/ swelling of the heart muscle) or acute pancarditis (general inflammation/ swelling of the heart) recently. It should be used with caution in patients with other heart problems such as coronary artery disease and/or angina. Consult your doctor for advice before taking THYRORITE 25MCG TABLET.

What should I avoid eating while taking THYRORITE 25MCG TABLET?

Avoid taking food containing soybean flour, cottonseed meal, walnuts, grapefruit juice or dietary fibre while taking THYRORITE 25MCG TABLET as these may bind and decrease the absorption of this medicine in the body.

What if I forget to take a dose of THYRORITE 25MCG TABLET?

If you forget to take THYRORITE 25MCG TABLET dose, take it as early as possible, unless it is nearly the time for the next dose. If you skip the missed dose, then continue with your regular dosing schedule. Do not double up the dose to make up for the forgotten one. Consult your doctor if you miss 2 or more doses in a row. 

When to stop taking THYRORITE 25MCG TABLET?

Do not stop taking this medicine unless your doctor instructs you to for stopping the intake of this medicine. However, stop taking THYRORITE 25MCG TABLET and contact your doctor if you experience any of the side effects such as chest pain, rapid or irregular heartbeat, awareness of heartbeat, shortness of breath, crushing chest pain, sweating, nausea, vomiting, shortness of breath, serious allergic reactions or increased pressure in the brain (in children).

Can THYRORITE 25MCG TABLET be used in pregnant or breastfeeding women?

THYRORITE 25MCG TABLET should be used with caution in pregnant women to avoid any potential side effects that can cause foetal abnormalities. It should be used with caution in breastfeeding women as it may pass into the breast milk. Consult your doctor before taking THYRORITE 25MCG TABLET.

Can I drive or use machines while taking THYRORITE 25MCG TABLET?

Do not drive or operate any machines as it may affect your ability to drive and use machines while taking THYRORITE 25MCG TABLET until you know how this medicine affects you. Consult your doctor before taking THYRORITE 25MCG TABLET.

Can THYRORITE 25MCG TABLET be used in children?

Yes, THYRORITE 25MCG TABLET can be used with caution in children and adolescents (below 18 years of age) after consulting the doctor. This medicine on indication can be given to infants and children (who are unable to swallow intact tablets) by crushing it and suspending the freshly crushed tablet in a small amount of water. Consult your child’s doctor for advice before administration of THYRORITE 25MCG TABLET to your child.

REFERENCES

1. Laurence L. Brunton. Goodman and Gilman’s; The Pharmacological Basics of Therapeutics. Twelfth edition. 2017. Page 1142-1143.

2. Philippe Colucci, Corinne Seng Yue, Murray Ducharme, Salvatore Benvenga. A Review of the Pharmacokinetics of Levothyroxine for the Treatment of Hypothyroidism. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. March 2013. [Accessed on 11th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193522/

3. L Bartalena, F Bogazzi, E Martino. Adverse effects of thyroid hormone preparations and antithyroid drugs. NIH National Library of Medicine. National Centre for Biotechnology Information. PubMed.gov. July 1996. [Accessed on 11th October 2022] https://pubmed.ncbi.nlm.nih.gov/8862963/

4. Neolpharma, Inc. Food and Drug Administration. [Revised in December 2017] [Accessed on 11th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021342s023lbl.pdf

5. BGP Pharma ULC. Synthroid. [Revised in September 2020] [Accessed on 11th October 2022] https://www.mylan.ca/-/media/mylanca/documents/english/product-pdf/synthroid-pm-en.pdf?la=en-ca

6. Steris Healthcare Pvt Ltd. Thyrorise. [Accessed on 11th October 2022] https://www.sterisindia.com/latest-update/thyroxine-sodium-t/1454

7. Macleods Pharmaceuticals Ltd. Thyrox. [Accessed on 11th October 2022] https://www.macleodspharma.com/products/

USEFUL DIAGNOSTIC TESTS
Thyroid Function Test
Thyroid Profile Free
Thyroid Stimulating Hormone
Anti-Thyroglobulin Antibody
Net Qty
1 N
Ingredient
THYROXINE 25MCG
Hsn Code
30049099
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