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Castin
Carbocisteine
Castin
Carbocisteine
Indications
Mucolytic
Indication detailsView
Carbocisteine is indicated for- Acute bronchitis, Chronic bronchitis, Bronchial asthma, Upper respiratory tract inflammation (pharyngitis, laryngitis), Cystic fibrosis Bronchiectasis, Pulmonary tuberculosis, Drainage in chronic sinusitis and pneumonia, Drainage in otitis media in children.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Carbocisteine reduces goblet cell hyperplasia and therefore plays a role in the management of disorders characterised by abnormal mucous. Carbocisteine loosens thick sputum effectively by reducing its viscosity and thereby helps to expectorate that mucus more easily from the respiratory tract. The mucolytic action happens in several mechanisms. It breaks the disulphide bonds, which cross-link certain glycoprotein molecules in the mucus, the mucus produced under the influence of Carbocisteine has high sialomucin and low fucomucin content. This combined effect ultimately reduces the viscosity of the sputum and increases its volume.
DosageView
Adult: Initially, 2.25 g daily in divided doses, then 1.5 g daily in divided doses as condition improves.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
Side effectsView
Gastrointestinal discomfort, nausea, diarrhoea, gastrointestinal bleeding, palpitation, dizziness, headache, heartburn and skin rash may occur.
ContraindicationsView
Contraindicated in active peptic ulceration and in patients with hypersensitivity to the drug.
PrecautionsView
No specific precaution is recommended but Carbocisteine should be used with caution in patients with a recent history of peptic ulcer and recurrent gastrointestinal bleeding.
InteractionsView
Neither hazardous nor therapeutically useful interactions have been reported.
Pregnancy & lactationView
There is no information on the use of Carbocisteine during lactation. While there are no reports of teratogenic effects, the manufacturers do not recommend the use of Carbocisteine in the first trimester.
Overdose effectsView
Symptoms: GI disturbance.
Management: May perform gastric lavage, followed by observation.
Management: May perform gastric lavage, followed by observation.
StorageView
Store in a cool and dry place protected from light.
Castin
Carbocisteine
Castin
Carbocisteine
Indications
Mucolytic
Indication detailsView
Carbocisteine is indicated for- Acute bronchitis, Chronic bronchitis, Bronchial asthma, Upper respiratory tract inflammation (pharyngitis, laryngitis), Cystic fibrosis Bronchiectasis, Pulmonary tuberculosis, Drainage in chronic sinusitis and pneumonia, Drainage in otitis media in children.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Carbocisteine reduces goblet cell hyperplasia and therefore plays a role in the management of disorders characterised by abnormal mucous. Carbocisteine loosens thick sputum effectively by reducing its viscosity and thereby helps to expectorate that mucus more easily from the respiratory tract. The mucolytic action happens in several mechanisms. It breaks the disulphide bonds, which cross-link certain glycoprotein molecules in the mucus, the mucus produced under the influence of Carbocisteine has high sialomucin and low fucomucin content. This combined effect ultimately reduces the viscosity of the sputum and increases its volume.
DosageView
Adult: Initially, 2.25 g daily in divided doses, then 1.5 g daily in divided doses as condition improves.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
Side effectsView
Gastrointestinal discomfort, nausea, diarrhoea, gastrointestinal bleeding, palpitation, dizziness, headache, heartburn and skin rash may occur.
ContraindicationsView
Contraindicated in active peptic ulceration and in patients with hypersensitivity to the drug.
PrecautionsView
No specific precaution is recommended but Carbocisteine should be used with caution in patients with a recent history of peptic ulcer and recurrent gastrointestinal bleeding.
InteractionsView
Neither hazardous nor therapeutically useful interactions have been reported.
Pregnancy & lactationView
There is no information on the use of Carbocisteine during lactation. While there are no reports of teratogenic effects, the manufacturers do not recommend the use of Carbocisteine in the first trimester.
Overdose effectsView
Symptoms: GI disturbance.
Management: May perform gastric lavage, followed by observation.
Management: May perform gastric lavage, followed by observation.
StorageView
Store in a cool and dry place protected from light.
Castin DS
Carbocisteine
Castin DS
Carbocisteine
Indications
Mucolytic
Indication detailsView
Carbocisteine is indicated for- Acute bronchitis, Chronic bronchitis, Bronchial asthma, Upper respiratory tract inflammation (pharyngitis, laryngitis), Cystic fibrosis Bronchiectasis, Pulmonary tuberculosis, Drainage in chronic sinusitis and pneumonia, Drainage in otitis media in children.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Carbocisteine reduces goblet cell hyperplasia and therefore plays a role in the management of disorders characterised by abnormal mucous. Carbocisteine loosens thick sputum effectively by reducing its viscosity and thereby helps to expectorate that mucus more easily from the respiratory tract. The mucolytic action happens in several mechanisms. It breaks the disulphide bonds, which cross-link certain glycoprotein molecules in the mucus, the mucus produced under the influence of Carbocisteine has high sialomucin and low fucomucin content. This combined effect ultimately reduces the viscosity of the sputum and increases its volume.
DosageView
Adult: Initially, 2.25 g daily in divided doses, then 1.5 g daily in divided doses as condition improves.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
Side effectsView
Gastrointestinal discomfort, nausea, diarrhoea, gastrointestinal bleeding, palpitation, dizziness, headache, heartburn and skin rash may occur.
ContraindicationsView
Contraindicated in active peptic ulceration and in patients with hypersensitivity to the drug.
PrecautionsView
No specific precaution is recommended but Carbocisteine should be used with caution in patients with a recent history of peptic ulcer and recurrent gastrointestinal bleeding.
InteractionsView
Neither hazardous nor therapeutically useful interactions have been reported.
Pregnancy & lactationView
There is no information on the use of Carbocisteine during lactation. While there are no reports of teratogenic effects, the manufacturers do not recommend the use of Carbocisteine in the first trimester.
Overdose effectsView
Symptoms: GI disturbance.
Management: May perform gastric lavage, followed by observation.
Management: May perform gastric lavage, followed by observation.
StorageView
Store in a cool and dry place protected from light.
Casyn
Aceclofenac
Casyn
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Catalan
Bromfenac Sodium
Catalan
Bromfenac Sodium
Indications
Postoperative ocular inflammation
Indication detailsView
Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction
Therapeutic classView
Ophthalmic Non-Steroid drugs
PharmacologyView
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.
DosageView
Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks
Children: Use and dose must be determined by the doctor.
Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
Children: Use and dose must be determined by the doctor.
Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
Side effectsView
The most commonly reported adverse reactions following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis. These events were reported in 2-7% of patients
ContraindicationsView
Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.
PrecautionsView
All topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Bromfenac ophthalmic solution should not be administered while wearing contact lenses.
Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Pregnancy & lactationView
Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.
StorageView
Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening.
Catavit
Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide
Catavit
Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide
Indications
Lens opacification
Indication detailsView
This eye drops is used for the treatment of lens opacification.
Therapeutic classView
Drugs for lens opacification
PharmacologyView
Anhydrous Sodium Succinate (intermediate substance) promotes the production of ATP
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
DosageView
One drop into the affected eye twice daily.
Side effectsView
Like any active ingredient, this drug may cause more or less discomfort in some patients.
ContraindicationsView
This eye drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Do not inject or swallow. In case of concomitant treatment with another ophthalmic solution, wait 15 minutes between each instillation.
InteractionsView
To avoid interaction with other drugs, it is recommended to inform your doctor of any concomitant treatment particularly with other eye drops.
Pregnancy & lactationView
It is recommended to take advice from doctor before using this medicine in pregnancy and lactation.
Overdose effectsView
Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of ingredients. The medication should be kept out of reach of children.
StorageView
Store at room temperature and protect from light. It is desirable that the content should not be used more than 4 weeks after first opening of the bottle.
Caterol
Indacaterol Maleate
Caterol
Indacaterol Maleate
Indications
COPD
Indication detailsView
Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants
DosageView
Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.
The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.
Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.
The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.
Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.
Side effectsView
The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.
ContraindicationsView
All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.
PrecautionsView
Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.
InteractionsView
Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.
Overdose effectsView
The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.
StorageView
Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.
Caterol
Indacaterol Maleate
Caterol
Indacaterol Maleate
Indications
COPD
Indication detailsView
Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants
DosageView
Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.
The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.
Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.
The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.
Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.
Side effectsView
The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.
ContraindicationsView
All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.
PrecautionsView
Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.
InteractionsView
Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.
Overdose effectsView
The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.
StorageView
Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.
Catium
Indacaterol + Glycopyrronium
Catium
Indacaterol + Glycopyrronium
Indications
COPD
Indication detailsView
Indacaterol & Glycopyrronium combination is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Therapeutic classView
Combined bronchodilators
PharmacologyView
Indacaterol Maleate is a selective β2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8 hydroxy-1H-quinolin-2-one maleate. Indacaterol Maleate has a molecular weight of 508.56 and its empirical formula is C24H28N2O3.C4H4O4. Indacaterol Maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol Maleate is freely soluble in N methylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol. Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.
DosageView
Indacaterol 110 µg and Glycopyrronium 50 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule once daily with the ConviHaler device.
Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.
Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.
Side effectsView
Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation dizziness, insomnia, skin and subcutaneous tissue disorders & immune system disorders.
PrecautionsView
Indacaterol and Glycopyrronium combination is as a twice daily maintenance bronchodilator should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Indacaterol and Glycopyrronium combination inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
InteractionsView
Adrenergic drugs, xanthine derivatives, steroids, or diuretics, non-potassium sparing diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, QTc prolonging drugs, beta-blockers, inhibitors of cytochrome P450 3A4 and P-gp efflux transporter may interact with Indacaterol.
Pregnancy & lactationView
There is a limited amount of data from the use of Indacaterol and Glycopyrronium combination in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Indacaterol and Glycopyrronium combination should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.
Overdose effectsView
An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. High doses of Glycopyrronium may lead to anticholinergic signs and symptoms.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children. Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.
Catium ES
Indacaterol + Glycopyrronium
Catium ES
Indacaterol + Glycopyrronium
Indications
COPD
Indication detailsView
Indacaterol & Glycopyrronium combination is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Therapeutic classView
Combined bronchodilators
PharmacologyView
Indacaterol Maleate is a selective β2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8 hydroxy-1H-quinolin-2-one maleate. Indacaterol Maleate has a molecular weight of 508.56 and its empirical formula is C24H28N2O3.C4H4O4. Indacaterol Maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol Maleate is freely soluble in N methylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol. Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.
DosageView
Indacaterol 110 µg and Glycopyrronium 50 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule once daily with the ConviHaler device.
Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.
Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.
Side effectsView
Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation dizziness, insomnia, skin and subcutaneous tissue disorders & immune system disorders.
PrecautionsView
Indacaterol and Glycopyrronium combination is as a twice daily maintenance bronchodilator should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Indacaterol and Glycopyrronium combination inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
InteractionsView
Adrenergic drugs, xanthine derivatives, steroids, or diuretics, non-potassium sparing diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, QTc prolonging drugs, beta-blockers, inhibitors of cytochrome P450 3A4 and P-gp efflux transporter may interact with Indacaterol.
Pregnancy & lactationView
There is a limited amount of data from the use of Indacaterol and Glycopyrronium combination in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Indacaterol and Glycopyrronium combination should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.
Overdose effectsView
An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. High doses of Glycopyrronium may lead to anticholinergic signs and symptoms.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children. Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.
Catnil
Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide
Catnil
Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide
Indications
Lens opacification
Indication detailsView
This eye drops is used for the treatment of lens opacification.
Therapeutic classView
Drugs for lens opacification
PharmacologyView
Anhydrous Sodium Succinate (intermediate substance) promotes the production of ATP
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
DosageView
One drop into the affected eye twice daily.
Side effectsView
Like any active ingredient, this drug may cause more or less discomfort in some patients.
ContraindicationsView
This eye drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Do not inject or swallow. In case of concomitant treatment with another ophthalmic solution, wait 15 minutes between each instillation.
InteractionsView
To avoid interaction with other drugs, it is recommended to inform your doctor of any concomitant treatment particularly with other eye drops.
Pregnancy & lactationView
It is recommended to take advice from doctor before using this medicine in pregnancy and lactation.
Overdose effectsView
Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of ingredients. The medication should be kept out of reach of children.
StorageView
Store at room temperature and protect from light. It is desirable that the content should not be used more than 4 weeks after first opening of the bottle.
Catopil
Captopril
Catopil
Captopril
Indications
Myocardial infarction
Indication detailsView
Hypertension: Mild to moderate hypertension as an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone.
Severe hypertension: Where standard therapy has failed. Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive.
Congestive heart failure: It is also used as an adjunct to the treatment of severe congestive heart failure.
Severe hypertension: Where standard therapy has failed. Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive.
Congestive heart failure: It is also used as an adjunct to the treatment of severe congestive heart failure.
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Captopril competitively inhibits the conversion of angiotensin I (ATI) to angiotensin II (ATII), thus resulting in reduced ATII levels and aldosterone secretion. It also increases plasma renin activity and bradykinin levels. Reduction of ATII leads to decreased Na and water retention. This promotes vasodilation and BP reduction.
DosageView
Diabetic nephropathy:
- Adult: Type 1 diabetics: 75-100 mg/day in divided doses.
- Adult: May be started 3-16 days after MI. Initially, 6.25 mg/day followed by 12.5 mg tid for 2 days, then 25 mg tid. Maintenance: 75-150 mg/day in 2 or 3 divided doses.
- Adult: Initially, 12.5 mg bid, 1st dose preferably at bedtime to avoid precipitous fall in BP, gradually increased at 2-4-wk intervals according to response. Maintenance: 25-50 mg bid. Max: 50 mg tid. Patients on diuretics: 6.25 mg bid.
- Child: Neonates and infants: 0.15 mg/kg. Max: 6 mg/kg in 2 or 3 divided doses according to response. Childn and adolescents: 0.3 mg/kg. Max: 6 mg/kg in 2 or 3 divided doses according to response.
- Elderly: Initially, 6.25 mg bid.
- Adult: Initially, 6.25-12.5 mg bid or tid. Maintenance: 25 mg bid or tid. Max: 50 mg tid.
- Child: Initially, 0.25 mg/kg/day, increased up to 2.5 or 3.5 mg/kg/day in 3 divided doses.
Side effectsView
Neutropenia, anaemia and thrombocytopenia; proteinuria, elevated blood urea and creatinine, elevated serum potassium and acidosis; hypotension, tachycardia; rashes usually pruritic, may occur; Reversible and usually self limiting taste impairment has been reported. Stomatitis resembling aphthous ulcers has also been reported.
ContraindicationsView
Angioedema related to previous ACE inhibitor treatment, hereditary or idiopathic angioneurotic oedema. Concomitant use with aliskiren in diabetic patients. Pregnancy.
PrecautionsView
Patients with bilateral renal artery stenosis, collagen vascular disease, aortic or mitral valve stenosis, volume and/or Na depletion. Renal impairment. Lactation.
InteractionsView
Concurrent treatment with NSAIDs reduces hypotensive action and increases the risk of nephrotoxicity. Additive hyperkalaemic effect with K supplements, K-sparing diuretics, and other drugs (e.g. heparin). May increase risk of leucopenia with procainamide, allopurinol, cytostatic or immunosuppressants. May increase risk of lithium toxicity. Increased risk of nitritoid reactions with gold (Na aurothiomalate).
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
Overdose effectsView
Symptoms: Severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.
Management: Perform gastric lavage, administer adsorbent and sodium sulfate with in 30 min of ingestion; NaCl 0.9% IV infusion. Treatment with angiotensin-II may also be considered. Administer atropine in case of extensive vagal reactions or bradycardia. Pacemaker is also an option. Elimination may be enhanced by haemodialysis.
Management: Perform gastric lavage, administer adsorbent and sodium sulfate with in 30 min of ingestion; NaCl 0.9% IV infusion. Treatment with angiotensin-II may also be considered. Administer atropine in case of extensive vagal reactions or bradycardia. Pacemaker is also an option. Elimination may be enhanced by haemodialysis.
StorageView
Store below 30° C
Catopil
Captopril
Catopil
Captopril
Indications
Myocardial infarction
Indication detailsView
Hypertension: Mild to moderate hypertension as an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone.
Severe hypertension: Where standard therapy has failed. Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive.
Congestive heart failure: It is also used as an adjunct to the treatment of severe congestive heart failure.
Severe hypertension: Where standard therapy has failed. Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive.
Congestive heart failure: It is also used as an adjunct to the treatment of severe congestive heart failure.
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Captopril competitively inhibits the conversion of angiotensin I (ATI) to angiotensin II (ATII), thus resulting in reduced ATII levels and aldosterone secretion. It also increases plasma renin activity and bradykinin levels. Reduction of ATII leads to decreased Na and water retention. This promotes vasodilation and BP reduction.
DosageView
Diabetic nephropathy:
- Adult: Type 1 diabetics: 75-100 mg/day in divided doses.
- Adult: May be started 3-16 days after MI. Initially, 6.25 mg/day followed by 12.5 mg tid for 2 days, then 25 mg tid. Maintenance: 75-150 mg/day in 2 or 3 divided doses.
- Adult: Initially, 12.5 mg bid, 1st dose preferably at bedtime to avoid precipitous fall in BP, gradually increased at 2-4-wk intervals according to response. Maintenance: 25-50 mg bid. Max: 50 mg tid. Patients on diuretics: 6.25 mg bid.
- Child: Neonates and infants: 0.15 mg/kg. Max: 6 mg/kg in 2 or 3 divided doses according to response. Childn and adolescents: 0.3 mg/kg. Max: 6 mg/kg in 2 or 3 divided doses according to response.
- Elderly: Initially, 6.25 mg bid.
- Adult: Initially, 6.25-12.5 mg bid or tid. Maintenance: 25 mg bid or tid. Max: 50 mg tid.
- Child: Initially, 0.25 mg/kg/day, increased up to 2.5 or 3.5 mg/kg/day in 3 divided doses.
Side effectsView
Neutropenia, anaemia and thrombocytopenia; proteinuria, elevated blood urea and creatinine, elevated serum potassium and acidosis; hypotension, tachycardia; rashes usually pruritic, may occur; Reversible and usually self limiting taste impairment has been reported. Stomatitis resembling aphthous ulcers has also been reported.
ContraindicationsView
Angioedema related to previous ACE inhibitor treatment, hereditary or idiopathic angioneurotic oedema. Concomitant use with aliskiren in diabetic patients. Pregnancy.
PrecautionsView
Patients with bilateral renal artery stenosis, collagen vascular disease, aortic or mitral valve stenosis, volume and/or Na depletion. Renal impairment. Lactation.
InteractionsView
Concurrent treatment with NSAIDs reduces hypotensive action and increases the risk of nephrotoxicity. Additive hyperkalaemic effect with K supplements, K-sparing diuretics, and other drugs (e.g. heparin). May increase risk of leucopenia with procainamide, allopurinol, cytostatic or immunosuppressants. May increase risk of lithium toxicity. Increased risk of nitritoid reactions with gold (Na aurothiomalate).
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
Overdose effectsView
Symptoms: Severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.
Management: Perform gastric lavage, administer adsorbent and sodium sulfate with in 30 min of ingestion; NaCl 0.9% IV infusion. Treatment with angiotensin-II may also be considered. Administer atropine in case of extensive vagal reactions or bradycardia. Pacemaker is also an option. Elimination may be enhanced by haemodialysis.
Management: Perform gastric lavage, administer adsorbent and sodium sulfate with in 30 min of ingestion; NaCl 0.9% IV infusion. Treatment with angiotensin-II may also be considered. Administer atropine in case of extensive vagal reactions or bradycardia. Pacemaker is also an option. Elimination may be enhanced by haemodialysis.
StorageView
Store below 30° C
Catrix
Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide
Catrix
Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide
Indications
Lens opacification
Indication detailsView
This eye drops is used for the treatment of lens opacification.
Therapeutic classView
Drugs for lens opacification
PharmacologyView
Anhydrous Sodium Succinate (intermediate substance) promotes the production of ATP
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
DosageView
One drop into the affected eye twice daily.
Side effectsView
Like any active ingredient, this drug may cause more or less discomfort in some patients.
ContraindicationsView
This eye drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Do not inject or swallow. In case of concomitant treatment with another ophthalmic solution, wait 15 minutes between each instillation.
InteractionsView
To avoid interaction with other drugs, it is recommended to inform your doctor of any concomitant treatment particularly with other eye drops.
Pregnancy & lactationView
It is recommended to take advice from doctor before using this medicine in pregnancy and lactation.
Overdose effectsView
Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of ingredients. The medication should be kept out of reach of children.
StorageView
Store at room temperature and protect from light. It is desirable that the content should not be used more than 4 weeks after first opening of the bottle.
Cavapro
Irbesartan
Cavapro
Irbesartan
Indications
Hypertension
Indication detailsView
Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.
DosageView
Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Side effectsView
Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.
ContraindicationsView
Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.
PrecautionsView
Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.
InteractionsView
Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Pregnancy & lactationView
Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
Pediatric usageView
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose of Irbesartan 75 mg should be considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Irbesartan.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Overdose effectsView
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.
StorageView
Store in a cool and dry place, protected from light.
Cavapro
Irbesartan
Cavapro
Irbesartan
Indications
Hypertension
Indication detailsView
Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.
DosageView
Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Side effectsView
Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.
ContraindicationsView
Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.
PrecautionsView
Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.
InteractionsView
Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Pregnancy & lactationView
Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
Pediatric usageView
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose of Irbesartan 75 mg should be considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Irbesartan.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Overdose effectsView
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.
StorageView
Store in a cool and dry place, protected from light.
Cavapro
Irbesartan
Cavapro
Irbesartan
Indications
Hypertension
Indication detailsView
Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.
DosageView
Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Side effectsView
Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.
ContraindicationsView
Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.
PrecautionsView
Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.
InteractionsView
Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Pregnancy & lactationView
Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
Pediatric usageView
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose of Irbesartan 75 mg should be considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Irbesartan.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Overdose effectsView
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.
StorageView
Store in a cool and dry place, protected from light.
Cavazide
Irbesartan + Hydrochlorothiazide
Cavazide
Irbesartan + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Irbesartan & Hydrochlorothiazide tablet are indicated for the treatment of hypertension. This tablet may be used in patients whose blood pressure is not adequately controlled on monotherapy. This tablet may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan & Hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Irbesartan: Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the RAS and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.
Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.
Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.
Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.
Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.
Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.
Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.
Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Initial therapy: Irbesartan 150 mg & Hydrochlorothiazide 12.5 mg orally once a day; may increase after 1 to 2 weeks.
Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day
Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day
Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day
Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day
Side effectsView
Irbesartan: Hyperkalemia (19%), Chest pain (2%), Tachycardia (1%), Abnormal urination (2%), Musculoskeletal pain (6%), Flu-like syndrome (3%), Edema (3%), Tachycardia (1%), Chest pain (2%), Creatinine increased (1%), Increased BUN (2%), Dizziness (10%), URI (9%), Orthostatic hypotension (5%), Fatigue (4%), Diarrhea (3%), Dyspepsia (2%)
Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache
Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache
ContraindicationsView
Irbesartan and Hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Irbesartan and Hydrochlorothiazide tablets in patients with diabetes
PrecautionsView
Child: Do not nurse
Lactation: Discontinue drug or do not nurse
Lactation: Discontinue drug or do not nurse
InteractionsView
Other antihypertensives, lithium, K-sparing diuretics, K supplements, salt substitutes containing K. CNS depressants, antidiabetics, cholestyramine & colestipol resins, corticosteroids, ACTH, digitalis glycosides, antiarrhythmics, NSAIDs, tubocurarine, antigout medications, Ca salts. Alcohol; diazoxide, atropine, beperiden, amantadine, cyclophosphamide, methotrexate.
Pregnancy & lactationView
Pregnancy Category D. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Irbesartan and Hydrochlorothiazide as soon as possible.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.
Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.
Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Renal Dose Adjustments:
- Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
- Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended
Overdose effectsView
Irbesartan: No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.
Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.
Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
StorageView
Should be stored in cool and dry place
Cavazide
Irbesartan + Hydrochlorothiazide
Cavazide
Irbesartan + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Irbesartan & Hydrochlorothiazide tablet are indicated for the treatment of hypertension. This tablet may be used in patients whose blood pressure is not adequately controlled on monotherapy. This tablet may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan & Hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Irbesartan: Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the RAS and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.
Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.
Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.
Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.
Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.
Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.
Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.
Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Initial therapy: Irbesartan 150 mg & Hydrochlorothiazide 12.5 mg orally once a day; may increase after 1 to 2 weeks.
Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day
Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day
Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day
Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day
Side effectsView
Irbesartan: Hyperkalemia (19%), Chest pain (2%), Tachycardia (1%), Abnormal urination (2%), Musculoskeletal pain (6%), Flu-like syndrome (3%), Edema (3%), Tachycardia (1%), Chest pain (2%), Creatinine increased (1%), Increased BUN (2%), Dizziness (10%), URI (9%), Orthostatic hypotension (5%), Fatigue (4%), Diarrhea (3%), Dyspepsia (2%)
Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache
Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache
ContraindicationsView
Irbesartan and Hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Irbesartan and Hydrochlorothiazide tablets in patients with diabetes
PrecautionsView
Child: Do not nurse
Lactation: Discontinue drug or do not nurse
Lactation: Discontinue drug or do not nurse
InteractionsView
Other antihypertensives, lithium, K-sparing diuretics, K supplements, salt substitutes containing K. CNS depressants, antidiabetics, cholestyramine & colestipol resins, corticosteroids, ACTH, digitalis glycosides, antiarrhythmics, NSAIDs, tubocurarine, antigout medications, Ca salts. Alcohol; diazoxide, atropine, beperiden, amantadine, cyclophosphamide, methotrexate.
Pregnancy & lactationView
Pregnancy Category D. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Irbesartan and Hydrochlorothiazide as soon as possible.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.
Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.
Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Renal Dose Adjustments:
- Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
- Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended
Overdose effectsView
Irbesartan: No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.
Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.
Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
StorageView
Should be stored in cool and dry place
Cavelon
Carvedilol
Cavelon
Carvedilol
Indications
Myocardial infarction
Indication detailsView
Carvedilol is indicated for the treatment of mild, moderate or severe heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and ACE inhibitor, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need to adjust other heart failure medications. Carvedilol may be used in patients unable to tolerate an ACE inhibitor. Carvedilol may be used in patients who are not receiving digitalis, hydralazine or nitrate therapy.
Therapeutic classView
Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.
DosageView
In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.
In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.
In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.
In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.
In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.
Side effectsView
Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.
ContraindicationsView
Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.
PrecautionsView
Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating
InteractionsView
Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.
Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.
Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.
Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.
Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.
Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.
Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.
Pregnancy & lactationView
Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.