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Thyronor

Levothyroxine Sodium

Tablet 25 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyronor

Levothyroxine Sodium

Tablet 50 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrotab

Levothyroxine Sodium

Tablet 50 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrox

Levothyroxine Sodium

Tablet 25 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrox

Levothyroxine Sodium

Tablet 100 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrox

Levothyroxine Sodium

Tablet 50 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrozim

Levothyroxine Sodium

Tablet 100 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrozim

Levothyroxine Sodium

Tablet 50 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Thyrozim

Levothyroxine Sodium

Tablet 25 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView

As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
For the suppression of the goitrogenic effects of other drugs such as Lithium.
As a diagnostic aid in suppression tests.

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.

DosageView

Adult dose:

Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium 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.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.

Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
>12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day.

The dose should be adjusted based on clinical response and laboratory parameters.

Side effectsView

Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:

General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
Respiratory: Dyspnea.
Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
Dermatologic: Hair loss, flushing.

ContraindicationsView

Untreated subclinical or overt Thyrotoxicosis of any etiology
Acute Myocardial Infarction
Uncorrected Adrenal failure.

PrecautionsView

In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.

InteractionsView

Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.

Pregnancy & lactationView

Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.

Overdose effectsView

The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.

StorageView

Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Ti-ediplex

Vitamin B1, B2 & B6

Injection (100 mg+50 mg+100 mg)/2 ml Allopathic Specific combined vitamin preparations

Indications

Vitamin B deficiencies

Indication detailsView

It is indicated for supportive nutritional supplementation in conditions in which these vitamins are required. These include conditions causing depletion, or reduced absorption or bioavailability of vitamins such as gastrointestinal disorders, chronic alcoholism, febrile illness, prolonged or wasting diseases, hyperthyroidism or poorly controlled diabetes and conditions resulting in increased need for vitamins like pregnancy, severe burns, recovery from surgery. It is also used in beri-beri, peripheral neuritis, Wernicke’s encephalopathy, impaired digestion of starch and sugar due to thiamine deficiency, cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis, photophobia and corneal vascularization.

Therapeutic classView

Specific combined vitamin preparations, Vitamin-B preparations

PharmacologyView

Thiamine (Vitamin B1) forms thiamine pyrophosphate by combining with adenosine triphosphate; essential coenzyme in carbohydrate metabolism.

Riboflavin (vitamin B2) is required for energy utilisation from food. It is essential for normal tissue respiration. It is also necessary for the activation of pyridoxine and conversion of tryptophan to nicotinic acid.

Pyridoxine (vitamin B6) is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.

DosageView

Adults: 2 ml every day or alternate days intravenously or intramuscularly.

Side effectsView

Adverse reactions have been reported with specific vitamins, and generally at levels substantially higher than those in Vitamin B1, B2 & B6. However, allergic and idiosyncratic reactions are possible at lower levels.

ContraindicationsView

Hypersensitivity to any of its components.

PrecautionsView

It should be given cautiously to patients taking levodopa as pyridoxine reduces the effect of levodopa. Hypersensitivity may develop in patients previously given thiamine, specially after repeated injections of concentrated solution; give subsequent injections with care. Discontinue drug if untoward reactions develop. Intramuscular administration may cause transient pain; when used undiluted, administer slowly.

InteractionsView

Pyridoxine may increase the peripheral metabolism of levodopa, reducing therapeutic efficacy in patients with Parkinson’s disease.

Pregnancy & lactationView

The recommended dose should not be exceeded without medical advice.

StorageView

Store below 25°C in a dry place, away from light.

Tiagra

Tadalafil

Tablet 10 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Tadalafil is indicated in-

Erectile Dysfunction (ED)
Benign Prostatic Hyperplasia (BPH)
Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

ContraindicationsView

Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
Hypersensitivity reactions to Tadalafil

PrecautionsView

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

InteractionsView

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Pregnancy & lactationView

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

StorageView

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Tiagra

Tadalafil

Tablet 5 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Tadalafil is indicated in-

Erectile Dysfunction (ED)
Benign Prostatic Hyperplasia (BPH)
Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

ContraindicationsView

Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
Hypersensitivity reactions to Tadalafil

PrecautionsView

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

InteractionsView

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Pregnancy & lactationView

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

StorageView

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Tiapine

Quetiapine Fumarate

Tablet 25 mg Allopathic Atypical neuroleptic drugs

Indications

Unipolar and bipolar depression

Indication detailsView

Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

DosageView

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

Side effectsView

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

ContraindicationsView

Quetiapine is contra-indicated in patients who are hypersensitive to it.

PrecautionsView

Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.

InteractionsView

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

Pregnancy & lactationView

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Pediatric usageView

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

Overdose effectsView

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

StorageView

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Tiapine

Quetiapine Fumarate

Tablet 100 mg Allopathic Atypical neuroleptic drugs

Indications

Unipolar and bipolar depression

Indication detailsView

Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

DosageView

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

Side effectsView

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

ContraindicationsView

Quetiapine is contra-indicated in patients who are hypersensitive to it.

PrecautionsView

Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.

InteractionsView

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

Pregnancy & lactationView

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Pediatric usageView

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

Overdose effectsView

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

StorageView

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Tiapine XR

Quetiapine Fumarate

Tablet (Extended Release) 200 mg Allopathic Atypical neuroleptic drugs

Indications

Unipolar and bipolar depression

Indication detailsView

Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

DosageView

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

Side effectsView

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

ContraindicationsView

Quetiapine is contra-indicated in patients who are hypersensitive to it.

PrecautionsView

Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.

InteractionsView

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

Pregnancy & lactationView

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Pediatric usageView

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

Overdose effectsView

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

StorageView

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Tiapine XR

Quetiapine Fumarate

Tablet (Extended Release) 50 mg Allopathic Atypical neuroleptic drugs

Indications

Unipolar and bipolar depression

Indication detailsView

Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

DosageView

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

Side effectsView

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

ContraindicationsView

Quetiapine is contra-indicated in patients who are hypersensitive to it.

PrecautionsView

Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.

InteractionsView

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

Pregnancy & lactationView

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Pediatric usageView

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

Overdose effectsView

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

StorageView

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Tibeta

Bisoprolol Hemifumarate

Tablet 5 mg Allopathic Anti adrenergic agent (Beta blockers)

Indications

Hypertension

Indication detailsView

Bisoprolol is indicated in-

Hypertension
Angina
Moderate to severe heart failure

Bisoprolol is not recommended for the emergency treatment of hypertensive crises.

Therapeutic classView

Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers

PharmacologyView

Bisoprolol Hemifumarate is the most selective ß1 blocker. It displays highest level of affinity for the ß1 receptor than any other beta-blocker available up to now. Selectively blocks ß1 adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by ß-blockers, in patients with non-ß1 selective ß1-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.

DosageView

Adult: In the treatment of mild to moderate hypertension, Bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.

Children: Safety and effectiveness in children have not been established.

Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.

Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction

Side effectsView

Bisoprolol, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by Bisoprolol, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.

Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.

ContraindicationsView

In patients with cardiogenic shock, overt heart failure, second or third degree A-V block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.

PrecautionsView

Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol.

InteractionsView

Other β-blocking Agents: Bisoprolol fumarate should not be combined with other β-blocking agents.

Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.

Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).

Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.

Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.

Pregnancy & lactationView

Pregnancy: Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day, which is 375 times the maximum recommended human daily dose. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day. Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5 mg/kg/day, which is 31 times the maximum recommended human daily dose, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day. There are no studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Tibeta

Bisoprolol Hemifumarate

Tablet 2.5 mg Allopathic Anti adrenergic agent (Beta blockers)

Indications

Hypertension

Indication detailsView

Bisoprolol is indicated in-

Hypertension
Angina
Moderate to severe heart failure

Bisoprolol is not recommended for the emergency treatment of hypertensive crises.

Therapeutic classView

Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers

PharmacologyView

Bisoprolol Hemifumarate is the most selective ß1 blocker. It displays highest level of affinity for the ß1 receptor than any other beta-blocker available up to now. Selectively blocks ß1 adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by ß-blockers, in patients with non-ß1 selective ß1-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.

DosageView

Adult: In the treatment of mild to moderate hypertension, Bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.

Children: Safety and effectiveness in children have not been established.

Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.

Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction

Side effectsView

Bisoprolol, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by Bisoprolol, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.

Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.

ContraindicationsView

In patients with cardiogenic shock, overt heart failure, second or third degree A-V block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.

PrecautionsView

Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol.

InteractionsView

Other β-blocking Agents: Bisoprolol fumarate should not be combined with other β-blocking agents.

Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.

Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).

Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.

Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.

Pregnancy & lactationView

Pregnancy: Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day, which is 375 times the maximum recommended human daily dose. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day. Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5 mg/kg/day, which is 31 times the maximum recommended human daily dose, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day. There are no studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Tibilon

Tibolone

Tablet 2.5 mg Allopathic Drugs for menopausal symptoms: Hormone replacement therapy

Indications

Vaginal dryness

Indication detailsView

Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Prevention of osteoporosis in women who have gone through the menopause and are at high risk of fractures, but cannot take other medicines used to prevent osteoporosis.

Therapeutic classView

Drugs for menopausal symptoms: Hormone replacement therapy

PharmacologyView

Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.

DosageView

The dose is one Tibolone tablet per day (2.5 mg daily). The tablet should be swallowed with some water or other drink, preferably at the same time in each day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.

Starting Tibolone Tablet: Women experiencing a natural menopause should commence treatment with Tibolone tablet at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone tablet may commence immediately.

Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.

Missed dose: A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting

Side effectsView

Occasionally, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other adverse effects are headache and migraine, oedema, dizziness, pruritus, increase in body weight, nausea, abdominal pain, rash, and depression.

ContraindicationsView

Contraindicated in pregnancy and lactation, known or suspected hormone-dependent tumours, cardiovascular or cerebrovascular disorders, active deep vein thrombosis, thromboembolic disorders, vaginal bleeding of unknown etiology and severe liver disorders.

PrecautionsView

In patients with renal dysfunction, history of liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes mellitus and cholestatic jaundice.

InteractionsView

No examples of interactions between Tibolone and other medicines have been reported in clinical practice. However, the following potential interactions should be considered on a theoretical basis: Enzyme-inducing compounds such as barbiturates, carbamazepine, hydantoins, and rifampicin may enhance the metabolism of Tibolone and thus decrease its therapeutic effect. Since Tibolone may increase blood or fibrinolytic activity (lower fibrinogen levels; higher AT III, plasminogen, and fibrinolytic activity values), it may enhance the effect of anticoagulants.

Pregnancy & lactationView

Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.

Overdose effectsView

The acute toxicity of Tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose - nausea, vomiting, and withdrawal bleeding in females may develop. Symptomatic treatment can be given if necessary.

StorageView

Keep in a cool & dry place. Protect from light. Keep out of the reach of children.

Tibo

Tibolone

Tablet 2.5 mg Allopathic Drugs for menopausal symptoms: Hormone replacement therapy

Indications

Vaginal dryness

Indication detailsView

Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Prevention of osteoporosis in women who have gone through the menopause and are at high risk of fractures, but cannot take other medicines used to prevent osteoporosis.

Therapeutic classView

Drugs for menopausal symptoms: Hormone replacement therapy

PharmacologyView

Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.

DosageView

The dose is one Tibolone tablet per day (2.5 mg daily). The tablet should be swallowed with some water or other drink, preferably at the same time in each day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.

Starting Tibolone Tablet: Women experiencing a natural menopause should commence treatment with Tibolone tablet at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone tablet may commence immediately.

Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.

Missed dose: A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting

Side effectsView

Occasionally, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other adverse effects are headache and migraine, oedema, dizziness, pruritus, increase in body weight, nausea, abdominal pain, rash, and depression.

ContraindicationsView

Contraindicated in pregnancy and lactation, known or suspected hormone-dependent tumours, cardiovascular or cerebrovascular disorders, active deep vein thrombosis, thromboembolic disorders, vaginal bleeding of unknown etiology and severe liver disorders.

PrecautionsView

In patients with renal dysfunction, history of liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes mellitus and cholestatic jaundice.

InteractionsView

No examples of interactions between Tibolone and other medicines have been reported in clinical practice. However, the following potential interactions should be considered on a theoretical basis: Enzyme-inducing compounds such as barbiturates, carbamazepine, hydantoins, and rifampicin may enhance the metabolism of Tibolone and thus decrease its therapeutic effect. Since Tibolone may increase blood or fibrinolytic activity (lower fibrinogen levels; higher AT III, plasminogen, and fibrinolytic activity values), it may enhance the effect of anticoagulants.

Pregnancy & lactationView

Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.

Overdose effectsView

The acute toxicity of Tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose - nausea, vomiting, and withdrawal bleeding in females may develop. Symptomatic treatment can be given if necessary.

StorageView

Keep in a cool & dry place. Protect from light. Keep out of the reach of children.