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Carmapine
Carbamazepine
Carmapine
Carbamazepine
Indications
Unipolar and bipolar depression
Indication detailsView
Carbamazepine is indicated for-
- partial and secondary generalized tonic-clonic seizures
- Primary generalized tonic-clonic seizures
- Trigeminal neuralgia
- Prophylaxis of bipolar disorder
Therapeutic classView
Primary anti-epileptic drugs
PharmacologyView
Carbamazepine depresses activity in the nucleus ventralis of the thalamus, reduces synaptic propagation of excitatory impulses or decreases summation of temporal stimulation leading to neural discharge by limiting influx of Na ions across cell membrane or other unknown mechanisms. It stimulates the release of antidiuretic hormone (ADH) and potentiates its action in promoting reabsorption of water.
DosageView
Epilepsy:
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
- Adults and children over 12 years of age- Initial: Either 200 mg b.i.d. for tablets and controlled release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d or a t.i.d. or q.i.d. regimen of the either formulations until the optimal response is obtained.
- Children 12-15 years of age- Dosage generally should not exceed 1000 mg daily, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: usually 800-1200 mg daily.
- Children 6-12 years of age- Initial: Either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. or a t.i.d.or q.i.d. regimen of the either formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance:usually 400-800 mg daily.
- Children under 6 years of age- Initial: 10-20 mg/kg/day b.i.d.or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
Side effectsView
The common side effects are dizziness, drowsiness, ataxia, dry mouth, abdominal pain, nausea, vomiting, anorexia, leucopenia, proteinuria, bradycardia, heart failure and hypotension. Erythematous skin rash, aplastic anemia may also be observed.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
ContraindicationsView
This medicine should not be used if anybody is allergic to one or any of its ingredients. It can not be used also in the following conditions:
- Problems with the electrical message pathways in the heart (atrioventricular block)
- History of decreased blood cell production by the bone marrow (bone marrow depression)
- Hereditary blood disorders called porphyrias
- Allergy to tricyclic antidepressants
- People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days
PrecautionsView
This medicine may cause dizziness and drowsiness.Special care should be taken while performing potentially hazardous activities, such as driving or operating machinery.
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
- Mixed seizures including absence seizures
- Elderly people
- History of heart disease
- History of kidney disease
- History of liver disease
- History of psychotic illness
- Raised pressure in the eye (intraocular pressure), eg.glaucoma
- History of blood disorders that were caused by any other medication
- History of previous Carbamazepine therapy that was interrupted due to side effects or allergy
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Carbamazepine treatment Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with Carbamazepine by increasing its metabolism. So an increase in dosage of Carbamazepine may be required.
Pregnancy & lactationView
Pregnancy category D. Carbamazepine and its epoxide metabolite are transferred to breast milk. Because of the potential serious side effects, decision should me made whether to discontinue nursing or discontinue the drug.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Carmapine CR
Carbamazepine
Carmapine CR
Carbamazepine
Indications
Unipolar and bipolar depression
Indication detailsView
Carbamazepine is indicated for-
- partial and secondary generalized tonic-clonic seizures
- Primary generalized tonic-clonic seizures
- Trigeminal neuralgia
- Prophylaxis of bipolar disorder
Therapeutic classView
Primary anti-epileptic drugs
PharmacologyView
Carbamazepine depresses activity in the nucleus ventralis of the thalamus, reduces synaptic propagation of excitatory impulses or decreases summation of temporal stimulation leading to neural discharge by limiting influx of Na ions across cell membrane or other unknown mechanisms. It stimulates the release of antidiuretic hormone (ADH) and potentiates its action in promoting reabsorption of water.
DosageView
Epilepsy:
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
- Adults and children over 12 years of age- Initial: Either 200 mg b.i.d. for tablets and controlled release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d or a t.i.d. or q.i.d. regimen of the either formulations until the optimal response is obtained.
- Children 12-15 years of age- Dosage generally should not exceed 1000 mg daily, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: usually 800-1200 mg daily.
- Children 6-12 years of age- Initial: Either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. or a t.i.d.or q.i.d. regimen of the either formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance:usually 400-800 mg daily.
- Children under 6 years of age- Initial: 10-20 mg/kg/day b.i.d.or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
Side effectsView
The common side effects are dizziness, drowsiness, ataxia, dry mouth, abdominal pain, nausea, vomiting, anorexia, leucopenia, proteinuria, bradycardia, heart failure and hypotension. Erythematous skin rash, aplastic anemia may also be observed.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
ContraindicationsView
This medicine should not be used if anybody is allergic to one or any of its ingredients. It can not be used also in the following conditions:
- Problems with the electrical message pathways in the heart (atrioventricular block)
- History of decreased blood cell production by the bone marrow (bone marrow depression)
- Hereditary blood disorders called porphyrias
- Allergy to tricyclic antidepressants
- People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days
PrecautionsView
This medicine may cause dizziness and drowsiness.Special care should be taken while performing potentially hazardous activities, such as driving or operating machinery.
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
- Mixed seizures including absence seizures
- Elderly people
- History of heart disease
- History of kidney disease
- History of liver disease
- History of psychotic illness
- Raised pressure in the eye (intraocular pressure), eg.glaucoma
- History of blood disorders that were caused by any other medication
- History of previous Carbamazepine therapy that was interrupted due to side effects or allergy
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Carbamazepine treatment Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with Carbamazepine by increasing its metabolism. So an increase in dosage of Carbamazepine may be required.
Pregnancy & lactationView
Pregnancy category D. Carbamazepine and its epoxide metabolite are transferred to breast milk. Because of the potential serious side effects, decision should me made whether to discontinue nursing or discontinue the drug.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Carmaz
Carbamazepine
Carmaz
Carbamazepine
Indications
Unipolar and bipolar depression
Indication detailsView
Carbamazepine is indicated for-
- partial and secondary generalized tonic-clonic seizures
- Primary generalized tonic-clonic seizures
- Trigeminal neuralgia
- Prophylaxis of bipolar disorder
Therapeutic classView
Primary anti-epileptic drugs
PharmacologyView
Carbamazepine depresses activity in the nucleus ventralis of the thalamus, reduces synaptic propagation of excitatory impulses or decreases summation of temporal stimulation leading to neural discharge by limiting influx of Na ions across cell membrane or other unknown mechanisms. It stimulates the release of antidiuretic hormone (ADH) and potentiates its action in promoting reabsorption of water.
DosageView
Epilepsy:
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
- Adults and children over 12 years of age- Initial: Either 200 mg b.i.d. for tablets and controlled release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d or a t.i.d. or q.i.d. regimen of the either formulations until the optimal response is obtained.
- Children 12-15 years of age- Dosage generally should not exceed 1000 mg daily, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: usually 800-1200 mg daily.
- Children 6-12 years of age- Initial: Either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. or a t.i.d.or q.i.d. regimen of the either formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance:usually 400-800 mg daily.
- Children under 6 years of age- Initial: 10-20 mg/kg/day b.i.d.or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
Side effectsView
The common side effects are dizziness, drowsiness, ataxia, dry mouth, abdominal pain, nausea, vomiting, anorexia, leucopenia, proteinuria, bradycardia, heart failure and hypotension. Erythematous skin rash, aplastic anemia may also be observed.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
ContraindicationsView
This medicine should not be used if anybody is allergic to one or any of its ingredients. It can not be used also in the following conditions:
- Problems with the electrical message pathways in the heart (atrioventricular block)
- History of decreased blood cell production by the bone marrow (bone marrow depression)
- Hereditary blood disorders called porphyrias
- Allergy to tricyclic antidepressants
- People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days
PrecautionsView
This medicine may cause dizziness and drowsiness.Special care should be taken while performing potentially hazardous activities, such as driving or operating machinery.
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
- Mixed seizures including absence seizures
- Elderly people
- History of heart disease
- History of kidney disease
- History of liver disease
- History of psychotic illness
- Raised pressure in the eye (intraocular pressure), eg.glaucoma
- History of blood disorders that were caused by any other medication
- History of previous Carbamazepine therapy that was interrupted due to side effects or allergy
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Carbamazepine treatment Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with Carbamazepine by increasing its metabolism. So an increase in dosage of Carbamazepine may be required.
Pregnancy & lactationView
Pregnancy category D. Carbamazepine and its epoxide metabolite are transferred to breast milk. Because of the potential serious side effects, decision should me made whether to discontinue nursing or discontinue the drug.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Carmelus
Carboxymethylcellulose Sodium
Carmelus
Carboxymethylcellulose Sodium
Indication detailsView
It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
PharmacologyView
Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
DosageView
Instill 1 drop in the affected eye(s) 4 times a day or as needed.
Side effectsView
Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.
ContraindicationsView
This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.
InteractionsView
Not known.
Pregnancy & lactationView
Safe use during pregnancy and lactation has not been established.
Pediatric usageView
Pediatric use: This eye drop should not be used in infants and small children under 3 years.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
StorageView
The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.
Carmelus-G
Carboxymethylcellulose Sodium + Glycerin
Carmelus-G
Carboxymethylcellulose Sodium + Glycerin
Indications
Irritation and discomfort of the eye
Indication detailsView
This Sterile Eye Drops is indicated for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
Therapeutic classView
Drugs for Dry eyes
PharmacologyView
The combination of Carboxymethylcellulose Sodium and Glycerin relieves the symptoms of dry eye in two ways. Firstly it provides lubricating and hydrating protective shield on the ocular surface of the eye and then it works below the tear film to provide protection to the cornea.
DosageView
Instill 1 drop in the affected eyes as needed. It can be used in children.
Side effectsView
Vision may be temporarily blurred when this product is first used. Also, minor burning/ stinging/ irritation may temporarily occur.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any ingredient of this formulation.
PrecautionsView
Consult doctor if irritation, eye pain or visual changes worsen or persist beyond 72 hours.
Pregnancy & lactationView
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Carboxymethylcellulose Sodium and Glycerin should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Carboxymethylcellulose Sodium or Glycerin has not been measured in human milk. Caution should be exercised when the combination of Carboxymethylcellulose Sodium and Glycerin is administered to a nursing mother.
Use in lactation: Carboxymethylcellulose Sodium or Glycerin has not been measured in human milk. Caution should be exercised when the combination of Carboxymethylcellulose Sodium and Glycerin is administered to a nursing mother.
StorageView
Store below 30°C. Protect from light. Do not use longer than 1 month after 1st opening. Do not freeze.
Carmelus-H
Carboxymethylcellulose Sodium + Hypromellose
Carmelus-H
Carboxymethylcellulose Sodium + Hypromellose
Indications
Dry eye
Indication detailsView
This medication is used to relieve the dryness and pain associated with reduced or abnormal tear production.
Therapeutic classView
Drugs for Dry eyes
PharmacologyView
Carboxymethylcellulose Sodium & Hypromellose both of them are polymer in nature. It is a clear and colorless aqueous solution. This medication lubricates the surface of the eye in the same way as natural tears. It can therefore be used to relieve the dryness and pain associated with reduced or abnormal tear production.
DosageView
For Adults and Children: Instill 1 or 2 drops in the affected eye(s) as needed.
Side effectsView
Common side effects are blurred vision, matting or stickiness of eyelashes.
ContraindicationsView
Known sensitivity or allergy to any ingredient of the formulation.
PrecautionsView
If you experience eye pain, changes in vision, continued redness or irritation of the eye or if your symptoms continue for more than 3 days or become worse, check with your doctor.
Pregnancy & lactationView
Carboxymethylcellulose Sodium & Hypromellose have not been shown to cause birth defects or other problems during pregnancy and breastfeeding.
Pediatric usageView
This drug does not cause different side effects or problems in children than it does in adults.
StorageView
Store in a cool, dry place and protected from light, Keep out of the reach of children, Do not use more than 4 weeks after opening.
Carmina
Herbal gastric preparation
Carmina
Herbal gastric preparation
Indications
Nausea
Indication detailsView
Herbal gastric preparation is indicated in-
- Hyperacidity
- Flatulence
- Abdominal pain due to gases
- Constipation
- Stomach and liver disorders
- Nausea and Vomiting
- Loss of Appetite
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Herbal gastric preparation is a special formulation of time-tested natural ingredients that helps to control acidity, flatulence, and indigestion. This helps in toning up the mucosa of the stomach and brings about a well-tolerated balance between liver functions and gastric activities. This is a safe and effective remedy for everyday stomach discomfort for the entire family.
DosageView
Syrup-
- Adults: 2 teaspoonfuls 2-3 times daily.
- Children: 1 teaspoonful 2-3 times daily or as prescribed by the physician.
- Adults: 1-2 tablet(s) 2-3 times daily
- Children: 1/2 -1 tablet 2-3 times daily or as prescribed by the physician
- Hyperacidity: 2 tablets/2 teaspoonfuls syrup before meal
- Flatulence: 2 tablets/2 teaspoonfuls syrup after meal
- Abdominal pain: 2 tablets/2 teaspoonfuls syrup with luke warm water. Repeat the dose after one hour if pain persists
- Acute indigestion: 2 tablets/2 teaspoonfuls syrup
- Chronic indigestion: 1 tablet/1-2 teaspoonful(s) syrup before and after each meal
- Loss of appetite: 1 tablet/1-2 teaspoonful(s) syrup after breakfast. 1 tablet/ 1-2 teaspoonful(s) syrup before each meal with water
- Constipation: 2 tablets/2 teaspoonfuls syrup at bed time with luke warm water
- Stomach & Liver dysfunction: 2 tablets/2 teaspoonfuls syrup immediately before meal twice daily
- Nausea and Vomiting: 1 tablet/1-2 teaspoonful(s) syrup. Tablet should be sucked slowly.
Side effectsView
No significant side effect has been observed in proper dosage.
ContraindicationsView
There is no known contraindication.
PrecautionsView
Avoid fried & spicy foods. Keep out of reach of the children.
StorageView
Store at cool and dry place, protect from light.
Carmina
Herbal gastric preparation
Carmina
Herbal gastric preparation
Indications
Nausea
Indication detailsView
Herbal gastric preparation is indicated in-
- Hyperacidity
- Flatulence
- Abdominal pain due to gases
- Constipation
- Stomach and liver disorders
- Nausea and Vomiting
- Loss of Appetite
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Herbal gastric preparation is a special formulation of time-tested natural ingredients that helps to control acidity, flatulence, and indigestion. This helps in toning up the mucosa of the stomach and brings about a well-tolerated balance between liver functions and gastric activities. This is a safe and effective remedy for everyday stomach discomfort for the entire family.
DosageView
Syrup-
- Adults: 2 teaspoonfuls 2-3 times daily.
- Children: 1 teaspoonful 2-3 times daily or as prescribed by the physician.
- Adults: 1-2 tablet(s) 2-3 times daily
- Children: 1/2 -1 tablet 2-3 times daily or as prescribed by the physician
- Hyperacidity: 2 tablets/2 teaspoonfuls syrup before meal
- Flatulence: 2 tablets/2 teaspoonfuls syrup after meal
- Abdominal pain: 2 tablets/2 teaspoonfuls syrup with luke warm water. Repeat the dose after one hour if pain persists
- Acute indigestion: 2 tablets/2 teaspoonfuls syrup
- Chronic indigestion: 1 tablet/1-2 teaspoonful(s) syrup before and after each meal
- Loss of appetite: 1 tablet/1-2 teaspoonful(s) syrup after breakfast. 1 tablet/ 1-2 teaspoonful(s) syrup before each meal with water
- Constipation: 2 tablets/2 teaspoonfuls syrup at bed time with luke warm water
- Stomach & Liver dysfunction: 2 tablets/2 teaspoonfuls syrup immediately before meal twice daily
- Nausea and Vomiting: 1 tablet/1-2 teaspoonful(s) syrup. Tablet should be sucked slowly.
Side effectsView
No significant side effect has been observed in proper dosage.
ContraindicationsView
There is no known contraindication.
PrecautionsView
Avoid fried & spicy foods. Keep out of reach of the children.
StorageView
Store at cool and dry place, protect from light.
Carmo D
Calcium Carbonate [Elemental source] + Vitamin D3
Carmo D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.
DosageView
Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Side effectsView
It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
It has possible interaction with calcium, aluminium or magnesium containing antacids & other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Carnitab
Levocarnitine
Carnitab
Levocarnitine
Indications
Male infertility
Indication detailsView
Levocarnitine is indicated in-
- Chronic Fatigue Syndrome
- Heart Diseases
- Congestive Heart Failure
- Kidney Disease
- High Cholesterol
- Intermittent Claudication
- Dementia and memory impairment
- Down Syndrome
- Male infertility
- Hyperthyroidism
Therapeutic classView
Drugs for muscular energy metabolism
PharmacologyView
Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.
DosageView
Levocarnitine tablet-
- Adults: 330 mg two or three times daily. Depending on clinical response.
- Infants and children: 50 to 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.
- Adults: The recommended dosage of Levocarnitine 100 ml solution is 10 to 30 ml/day. Higher doses should be administered with caution. Dosage should be started at 10 ml/day and be increased slowly while assessing tolerance and therapeutic response.
- Infants and children: The recommended dosage of Levocarnitine 100 ml solution is 50 to 100 mg/kg/day. Dosage should be started at 50 mg/kg/day and be increased slowly to a maximum of 30 ml. /day. Levocarnitine oral solution can be given from 2-spoonful to 6-spoonful in divided dose as directed by physicians. Higher doses should be administered with caution.
Side effectsView
Generally, Levocarnitine is well tolerated. However, few side effects including transient nausea and vomiting, abdominal cramps, and diarrhoea may occur.
PrecautionsView
Gastrointestinal reactions may result from a too rapid consumption of Levocarnitine. The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N oxide (TMAO), since these metabolites are normally excreted in the urine.
Pregnancy & lactationView
There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Levocarnitine supplementation in nursing mothers has not been specifically studied. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
Overdose effectsView
There have been no reports of toxicity from levocarnitine overdosage.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Carnitab
Levocarnitine
Carnitab
Levocarnitine
Indications
Male infertility
Indication detailsView
Levocarnitine is indicated in-
- Chronic Fatigue Syndrome
- Heart Diseases
- Congestive Heart Failure
- Kidney Disease
- High Cholesterol
- Intermittent Claudication
- Dementia and memory impairment
- Down Syndrome
- Male infertility
- Hyperthyroidism
Therapeutic classView
Drugs for muscular energy metabolism
PharmacologyView
Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.
DosageView
Levocarnitine tablet-
- Adults: 330 mg two or three times daily. Depending on clinical response.
- Infants and children: 50 to 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.
- Adults: The recommended dosage of Levocarnitine 100 ml solution is 10 to 30 ml/day. Higher doses should be administered with caution. Dosage should be started at 10 ml/day and be increased slowly while assessing tolerance and therapeutic response.
- Infants and children: The recommended dosage of Levocarnitine 100 ml solution is 50 to 100 mg/kg/day. Dosage should be started at 50 mg/kg/day and be increased slowly to a maximum of 30 ml. /day. Levocarnitine oral solution can be given from 2-spoonful to 6-spoonful in divided dose as directed by physicians. Higher doses should be administered with caution.
Side effectsView
Generally, Levocarnitine is well tolerated. However, few side effects including transient nausea and vomiting, abdominal cramps, and diarrhoea may occur.
PrecautionsView
Gastrointestinal reactions may result from a too rapid consumption of Levocarnitine. The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N oxide (TMAO), since these metabolites are normally excreted in the urine.
Pregnancy & lactationView
There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Levocarnitine supplementation in nursing mothers has not been specifically studied. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
Overdose effectsView
There have been no reports of toxicity from levocarnitine overdosage.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Carniten
Levocarnitine
Carniten
Levocarnitine
Indications
Male infertility
Indication detailsView
Levocarnitine is indicated in-
- Chronic Fatigue Syndrome
- Heart Diseases
- Congestive Heart Failure
- Kidney Disease
- High Cholesterol
- Intermittent Claudication
- Dementia and memory impairment
- Down Syndrome
- Male infertility
- Hyperthyroidism
Therapeutic classView
Drugs for muscular energy metabolism
PharmacologyView
Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.
DosageView
Levocarnitine tablet-
- Adults: 330 mg two or three times daily. Depending on clinical response.
- Infants and children: 50 to 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.
- Adults: The recommended dosage of Levocarnitine 100 ml solution is 10 to 30 ml/day. Higher doses should be administered with caution. Dosage should be started at 10 ml/day and be increased slowly while assessing tolerance and therapeutic response.
- Infants and children: The recommended dosage of Levocarnitine 100 ml solution is 50 to 100 mg/kg/day. Dosage should be started at 50 mg/kg/day and be increased slowly to a maximum of 30 ml. /day. Levocarnitine oral solution can be given from 2-spoonful to 6-spoonful in divided dose as directed by physicians. Higher doses should be administered with caution.
Side effectsView
Generally, Levocarnitine is well tolerated. However, few side effects including transient nausea and vomiting, abdominal cramps, and diarrhoea may occur.
PrecautionsView
Gastrointestinal reactions may result from a too rapid consumption of Levocarnitine. The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N oxide (TMAO), since these metabolites are normally excreted in the urine.
Pregnancy & lactationView
There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Levocarnitine supplementation in nursing mothers has not been specifically studied. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
Overdose effectsView
There have been no reports of toxicity from levocarnitine overdosage.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Carnovas
Nebivolol Hydrochloride
Carnovas
Nebivolol Hydrochloride
Indications
Hypertension
Indication detailsView
Nebivolol is indicated in-
- Hypertension
- Treatment of essential hypertension
- Chronic heart failure (CHF)
- Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Nebivolol is a β adrenergic receptor blocking agent. Nebivolol inhibits both β1 and β1 adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Nebivolol does not demonstrate β1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to beta-blocking activity.
Mode of Action of Nebivolol involved include:
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
Mode of Action of Nebivolol involved include:
- decreased heart rate
- decreased myocardia contractility
- diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
- suppression of renin activity and
- vasodilation and decreased peripheral vascular resistance
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
DosageView
The dose of Nebivolol should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
Side effectsView
Headache, nausea and bradycardia.
ContraindicationsView
Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
PrecautionsView
Abrupt Cessation of Therapy: Patients with coronary artery disease treated with Nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of Nebivolol is planned, patients should be carefully observed and advised to minimize physical activity. Nebivolol should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Nebivolol be promptly reinstituted, at least temporarily.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
InteractionsView
Nebivolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Pediatric usageView
Impaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebivolol has not been studied in patients receiving dialysis.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Carnovas
Nebivolol Hydrochloride
Carnovas
Nebivolol Hydrochloride
Indications
Hypertension
Indication detailsView
Nebivolol is indicated in-
- Hypertension
- Treatment of essential hypertension
- Chronic heart failure (CHF)
- Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Nebivolol is a β adrenergic receptor blocking agent. Nebivolol inhibits both β1 and β1 adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Nebivolol does not demonstrate β1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to beta-blocking activity.
Mode of Action of Nebivolol involved include:
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
Mode of Action of Nebivolol involved include:
- decreased heart rate
- decreased myocardia contractility
- diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
- suppression of renin activity and
- vasodilation and decreased peripheral vascular resistance
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
DosageView
The dose of Nebivolol should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
Side effectsView
Headache, nausea and bradycardia.
ContraindicationsView
Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
PrecautionsView
Abrupt Cessation of Therapy: Patients with coronary artery disease treated with Nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of Nebivolol is planned, patients should be carefully observed and advised to minimize physical activity. Nebivolol should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Nebivolol be promptly reinstituted, at least temporarily.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
InteractionsView
Nebivolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Pediatric usageView
Impaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebivolol has not been studied in patients receiving dialysis.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Carnovas
Nebivolol Hydrochloride
Carnovas
Nebivolol Hydrochloride
Indications
Hypertension
Indication detailsView
Nebivolol is indicated in-
- Hypertension
- Treatment of essential hypertension
- Chronic heart failure (CHF)
- Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Nebivolol is a β adrenergic receptor blocking agent. Nebivolol inhibits both β1 and β1 adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Nebivolol does not demonstrate β1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to beta-blocking activity.
Mode of Action of Nebivolol involved include:
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
Mode of Action of Nebivolol involved include:
- decreased heart rate
- decreased myocardia contractility
- diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
- suppression of renin activity and
- vasodilation and decreased peripheral vascular resistance
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
DosageView
The dose of Nebivolol should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
Side effectsView
Headache, nausea and bradycardia.
ContraindicationsView
Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
PrecautionsView
Abrupt Cessation of Therapy: Patients with coronary artery disease treated with Nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of Nebivolol is planned, patients should be carefully observed and advised to minimize physical activity. Nebivolol should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Nebivolol be promptly reinstituted, at least temporarily.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
InteractionsView
Nebivolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Pediatric usageView
Impaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebivolol has not been studied in patients receiving dialysis.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Carnovas HZ
Nebivolol + Hydrochlorothiazide
Carnovas HZ
Nebivolol + Hydrochlorothiazide
Indications
Essential hypertension
Indication detailsView
Essential hypertension
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
The Combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. This combination has mild vasodilating properties which reduces heart rate and blood pressure in hypertensive patients. Hydrochlorothiazide affects the renal tubular mechanisms of electrolyte reabsorption which directly increase the excretion of sodium and chloride in approximately equivalent amounts. The diuretic action of Hydrochlorothiazide reduces plasma volume, increases plasma renin activity and increases aldosterone secretion.
DosageView
Once daily, preferably at the same time every day.
Side effectsView
Nebivolol: Headache, Dizziness, Tiredness, Diarrhoea, Constipation, Nausea etc.
Hydrochlorothiazide: Vertigo, Itchiness, Rash, Increased sensitivity of skin to sunlight etc.
Hydrochlorothiazide: Vertigo, Itchiness, Rash, Increased sensitivity of skin to sunlight etc.
ContraindicationsView
Hypersensitivity to the active substances, Liver function impairment. Severe renal insufficiency (Creatinine clearance < 30 ml/min.), Bradycardia, Hypotension
PrecautionsView
Nebivolol: Beta-blockers should not be used in patients with untreated Congestive Heart Failure (CHF) & bradycardia. In patients with Chronic Obstructive Pulmonary Diseases (COPD), beta-blockers should be used with caution as airway constriction may be aggravated.
Hydrochlorothiazide: In patients with renal disease, thiazides may increase azotaemia. If progressive renal impairment becomes evident, careful reappraisal of therapy is necessary. Thiazides can cause fluid or electrolyte imbalance. Thiazides may decrease urinary calcium excretion and may cause slight elevation of serum calcium in the absence of known disorders of calcium metabolism
Hydrochlorothiazide: In patients with renal disease, thiazides may increase azotaemia. If progressive renal impairment becomes evident, careful reappraisal of therapy is necessary. Thiazides can cause fluid or electrolyte imbalance. Thiazides may decrease urinary calcium excretion and may cause slight elevation of serum calcium in the absence of known disorders of calcium metabolism
InteractionsView
Nebivolol:
- Class I & III Antiarrhythmics, Calcium channel blocker (Verapamil/Diltiazem)
- Centrally-acting antihypertensives, Anaesthetics
- Antipsychotics, Antidepressants, NSAIDs
- Drugs affecting Potassium & Calcium level
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Concomitant administration of this combination with Antipsychotics, Tricyclic Antidepressants & Barbiturates may enhance the hypotensive effect and lead to postural hypotension.
Pregnancy & lactationView
This combination is not recommended during pregnancy. It is also not recommended for mothers who are breast-feeding
Pediatric usageView
Use in children is not recommended.
Overdose effectsView
No data are available on Overdosage. Overdosage with Hydrochlorothiazide is associated with electrolyte depletion and dehydration resulting from excessive diuresis.
StorageView
Protect from light & moisture. Store below 30° C. Keep out of reach of children.
Carocet
Betacarotene + Vitamin C + Vitamin E
Carocet
Betacarotene + Vitamin C + Vitamin E
Indications
Vitamin deficiency
Indication detailsView
Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows:
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
Therapeutic classView
Anti-oxidant Multivitamin preparations
PharmacologyView
Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
DosageView
This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.
Side effectsView
β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
ContraindicationsView
Carocet is contraindicated in patients with hypersensitivity to any of its components.
PrecautionsView
There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.
InteractionsView
Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.
Pregnancy & lactationView
β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.
StorageView
Should be stored in a dry place below 30˚C.
Carofol Z
Carbonyl Iron + Folic Acid + Zinc Sulfate
Carofol Z
Carbonyl Iron + Folic Acid + Zinc Sulfate
Indications
Pregnancy
Indication detailsView
It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.
Therapeutic classView
Iron, Vitamin & Mineral Combined preparation
PharmacologyView
This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.
DosageView
Adult: One Capsule daily before food or as directed by the physician.
Side effectsView
Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.
PrecautionsView
Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.
InteractionsView
Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.
Pregnancy & lactationView
Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.
Overdose effectsView
Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.
StorageView
Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.
Carol-D
Calcium Carbonate [Coral source] + Vitamin D3
Carol-D
Calcium Carbonate [Coral source] + Vitamin D3
Indications
Rickets
Indication detailsView
This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.
DosageView
One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.
Side effectsView
Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.
ContraindicationsView
Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.
PrecautionsView
In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.
InteractionsView
Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.
Pregnancy & lactationView
This can be given to pregnant and lactating mothers as per recommendation of physician.
Overdose effectsView
At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.
StorageView
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Carplatin
Carboplatin
Carplatin
Carboplatin
Indications
Stomach carcinoma
Indication detailsView
Initial Treatment of Advanced Ovarian Carcinoma: Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimenconsists of Carboplatin and cyclophosphamide. Two randomizedcontrolled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups.
There is limited statistical power to demonstrate equivalence in overal pathologic complete response rates and long-term survival ( ≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma: Carboplatin is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
There is limited statistical power to demonstrate equivalence in overal pathologic complete response rates and long-term survival ( ≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma: Carboplatin is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Carboplatin is an alkylating agent which binds covalently to DNA. It modifies the cell cycle by interfering with DNA structure and function.
DosageView
Previously untreated patients: 400 mg/m2 as single short term IV infusion over 15-60 min. Therapy should not be repeated until 4 wk after the previous course and/or until the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
Patients previously treated with myelosuppresive therapy or patients with poor performance status: Reduce initial dosage by 20-25% (300-320 mg/m2).
Patients previously treated with myelosuppresive therapy or patients with poor performance status: Reduce initial dosage by 20-25% (300-320 mg/m2).
Side effectsView
Bone marrow suppression, gastrointestinal effects, nephrotoxicity, nervous system, ototoxicity, allergic reactions, alopecia, mucositis.
ContraindicationsView
Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding. It is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum containing compounds.
PrecautionsView
Much less renal toxicity than cisplatin so no need for a vigorousm hydration schedule or forced diuresis. If AUC dosing is not used, dose should be reduced to 250 mg/m2 for creatinine clearance of 41 to 59 ml/min and to 200 mg/m2 for clearance of 16 to 40 ml/min. Corticosteroids & antihistamines are employed to alleviate symptoms.
InteractionsView
Administration of a liver vaccine may be dangerous during treatment with carboplatin. The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk
Pediatric usageView
Renal Impairment:
- CrCl (16-40 ml/min)- 200 mg/m2.
- CrCl (41-59 ml/min)- 250 mg/m2.
ReconstitutionView
150 mg injection should be reconstituted with 15 ml of sodium chloride solution (0.9%) or water for injection.
450 mg injection should be reconstituted with 45 ml of sodium chloride solution (0.9%) or water for injection.
The reconstituted solution should be diluted by 300 ml (for 150 mg) & 900 ml (for 450 mg) of 5% glucose for injection or 0.9% sodium chloride solution for infusition.
450 mg injection should be reconstituted with 45 ml of sodium chloride solution (0.9%) or water for injection.
The reconstituted solution should be diluted by 300 ml (for 150 mg) & 900 ml (for 450 mg) of 5% glucose for injection or 0.9% sodium chloride solution for infusition.
StorageView
Store at 25° C. Protect from light.