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Ventonix
Venetoclax
Ventonix
Venetoclax
Indications
Chronic lymphocytic leukemia
Indication detailsView
Venetoclax in combination with Rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Venetoclax monotherapy is indicated for the treatment of CLL:
Venetoclax monotherapy is indicated for the treatment of CLL:
- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
- In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.
DosageView
The starting dose is 20 mg of Venetoclax once daily for 7 days. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumor lysis syndrome.
Post-titration dose for Venetoclax in combination with Rituximab: The recommended dose of Venetoclax in combination with Rituximab is 400 mg once daily. Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg Venetoclax for 7 days. Venetoclax should be taken for 24 months from Cycle 1 Day 1 of Rituximab.
Post-titration dose for Venetoclax monotherapy: The recommended dose of Venetoclax is 400 mg once daily. Treatment should be continued until disease progression or no longer tolerated by the patient.
Post-titration dose for Venetoclax in combination with Rituximab: The recommended dose of Venetoclax in combination with Rituximab is 400 mg once daily. Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg Venetoclax for 7 days. Venetoclax should be taken for 24 months from Cycle 1 Day 1 of Rituximab.
Post-titration dose for Venetoclax monotherapy: The recommended dose of Venetoclax is 400 mg once daily. Treatment should be continued until disease progression or no longer tolerated by the patient.
Side effectsView
The most commonly occurring side effects (>20%) of any grade in patients receiving Venetoclax in the combination study with Rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common side effects were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection. The most frequently reported serious side effects (>2%) in patients receiving Venetoclax in combination with Rituximab were pneumonia, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious side effects (>2%) were pneumonia and febrile neutropenia.
ContraindicationsView
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John's wort
PrecautionsView
Tumour lysis syndrome: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with Venetoclax. Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-weeks dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venetoclax and at each dose increase. The risk of TLS is a continuum based on multiple factors, including comorbidities. Patients with high tumour burden (e.g., any lymph node with a diameter >5 cm or high ALC >25 x 109/1) are at greater risk of TLS when initiating enetoclax. Reduced renal function (CrCI <80 ml/min) further increases the risk. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics. Blood chemistries should be monitored and abnormalities managed promptly. Dosing should be interrupted if needed. More intensive measures (intravenous hydration, frequent monitoring, hospitalization) should be employed as overall risk increases. The instructions for "Prevention of tumour lysis syndrome" should be followed. Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases Venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase. Also, inhibitors of P-gp or BCRP may increase Venetoclax exposure.
Neutropenia: Grade 3 or 4 neutropenia has been reported in patients treated with Venetoclax in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.
Immunization: The safety and efficacy of immunization with live attenuated vaccines during or following Venetoclax therapy have not been studied. Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
CYP3A inducers: Co-administration of CYP3A4 inducers may lead to decreased Venetoclax exposure and consequently a risk for lack of efficacy. Concomitant use of Venetoclax with strong or moderate CYP3A4 inducers should be avoided.
Women of childbearing potential: Women of childbearing potential must use a highly effective method of contraception while taking Venetoclax.
Neutropenia: Grade 3 or 4 neutropenia has been reported in patients treated with Venetoclax in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.
Immunization: The safety and efficacy of immunization with live attenuated vaccines during or following Venetoclax therapy have not been studied. Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
CYP3A inducers: Co-administration of CYP3A4 inducers may lead to decreased Venetoclax exposure and consequently a risk for lack of efficacy. Concomitant use of Venetoclax with strong or moderate CYP3A4 inducers should be avoided.
Women of childbearing potential: Women of childbearing potential must use a highly effective method of contraception while taking Venetoclax.
InteractionsView
CYP3A inhibitors: Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased Venetoclax Cmax by 2.3-fold and AUC by 6.4-fold. Co-administration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased Venetoclax Cmax by 2.4-fold and AUC by 7.9-fold. Co-administration of Venetoclax with other strong CYP3A4 inhibitors is predicted to increase Venetoclax AUC by on average 5.8- to 7.8-fold. Concomitant use of Venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS.
At initiation and during the dose-titration phase, concomitant use of Venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided. Alternative treatments should be considered. If a moderate CYP3A inhibitor must be used, the initiation dose of Venetoclax and the doses for the titration phase should be reduced by at least 50%. Patients should be monitored more closely for signs and symptoms of TLS.
For patients who have completed the dose-titration phase and are on a steady daily dose of Venetoclax, the Venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. The Venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with Venetoclax as they contain inhibitors of CYP3A.
P-gp and BCRP inhibitors: Venetoclax is a substrate for P-gp and BCRP , Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased Venetoclax Cmax by 106% and AUC by 78%. Concomitant use of Venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities.
CYP3A inducers: Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased Venetoclax Cmax by 42% and AUC°° by 71%. Concomitant use of Venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided. Alternative treatments with less CYP3A induction should be considered. Preparations containing St. John's wort are contraindicated during treatment with Venetoclax, as efficacy may be reduced.
At initiation and during the dose-titration phase, concomitant use of Venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided. Alternative treatments should be considered. If a moderate CYP3A inhibitor must be used, the initiation dose of Venetoclax and the doses for the titration phase should be reduced by at least 50%. Patients should be monitored more closely for signs and symptoms of TLS.
For patients who have completed the dose-titration phase and are on a steady daily dose of Venetoclax, the Venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. The Venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with Venetoclax as they contain inhibitors of CYP3A.
P-gp and BCRP inhibitors: Venetoclax is a substrate for P-gp and BCRP , Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased Venetoclax Cmax by 106% and AUC by 78%. Concomitant use of Venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities.
CYP3A inducers: Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased Venetoclax Cmax by 42% and AUC°° by 71%. Concomitant use of Venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided. Alternative treatments with less CYP3A induction should be considered. Preparations containing St. John's wort are contraindicated during treatment with Venetoclax, as efficacy may be reduced.
Pregnancy & lactationView
Women of childbearing potential/Contraception in females: Women should avoid becoming pregnant while taking Venetoclax and for at least 30 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking Venetoclax and for 30 days after stopping treatment. It is currently unknown whether Venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Pregnancy: Based on embryo-foetal toxicity studies in animals, Venetoclax may harm the fetus when administered to pregnant women. There is no adequate and well-controlled data from the use of Venetoclax in pregnant women. Studies in animals have shown reproductive toxicity. Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Breast-feeding: It is unknown whether Venetoclax or its metabolites are excreted in human milk. A risk to the breast-feeding child cannot be excluded. Breast-feeding should be discontinued during treatment with Venetoclax.
Fertility: No human data on the effect of Venetoclax on fertility are available. Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with Venetoclax. Before starting treatment, counselling on sperm storage may be considered in some male patients.
Pregnancy: Based on embryo-foetal toxicity studies in animals, Venetoclax may harm the fetus when administered to pregnant women. There is no adequate and well-controlled data from the use of Venetoclax in pregnant women. Studies in animals have shown reproductive toxicity. Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Breast-feeding: It is unknown whether Venetoclax or its metabolites are excreted in human milk. A risk to the breast-feeding child cannot be excluded. Breast-feeding should be discontinued during treatment with Venetoclax.
Fertility: No human data on the effect of Venetoclax on fertility are available. Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with Venetoclax. Before starting treatment, counselling on sperm storage may be considered in some male patients.
Pediatric usageView
Elderly: No specific dose adjustment is required for elderly patients (aged >65 years).
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCI >30 ml/min and <90 mi/min). Patients with reduced renal function (CrCI <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCI <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
Hepatic impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase. A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment. These patients should be monitored more closely for signs of toxicity.
Pediatric population: The safety and efficacy of Venetoclax in children aged less than 18 years have not been established. No data is available.
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCI >30 ml/min and <90 mi/min). Patients with reduced renal function (CrCI <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCI <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
Hepatic impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase. A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment. These patients should be monitored more closely for signs of toxicity.
Pediatric population: The safety and efficacy of Venetoclax in children aged less than 18 years have not been established. No data is available.
Overdose effectsView
There is no specific antidote for Venetoclax. Patients who experience overdose should be closely monitored and appropriate supportive treatment provided. During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities.
StorageView
Store below 30°C. Keep Venetoclax out of the sight and reach of children. Protect from moisture and light.
Ventosol
Salbutamol
Ventosol
Salbutamol
Indications
Emphysema
Indication detailsView
Salbutamol is indicated as a bronchodilator for use in-
- Asthma
- Chronic Bronchitis
- Emphysema and
- Other conditions associated with airways obstruction.
Therapeutic classView
Short-acting selective & β2-adrenoceptor stimulants
PharmacologyView
Salbutamol is a synthetic sympathomimetic agent with predominant beta-2 adrenergic activity. Salbutamol produces bronchodilatation through stimulation of beta-2-adrenergic receptors in bronchial smooth muscles, thereby causing relaxation of bronchial muscle fibers. This action is manifested by an improvement in pulmonary function as demonstrated by spirometric measurements.
DosageView
Salbutamol tablet or syrup-
Children:
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Adults:
Salbutamol Inhalation Capsule:
Children:
- 2-6 years: 2.5 ml syrup, 3-4 times daily
- 6-12 years: 5 ml syrup, 3-4 times daily
- Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
- Adults (and the elderly): 0.5 ml-1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in the hospital. 0.5-1 ml solution should be diluted to final volume of 2-4 ml with sterile normal saline solution. It will take time about 10 minutes.
- Salbutamol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebulizer and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.
- Children under 12 years of age: 0.5 ml of the solution diluted to 2.0-4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
- Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in the hospital.
- Children under 12 years: 2.5 mg up to 4 times a day. A higher dose up to 5 mg four times a day may be used if required.
Adults:
- Salbutamol I.V. infusion solution is used to prepare a solution for continuous intravenous infusion. It should not be injected undiluted. A suitable solution for infusion may be prepared by diluting 5 mL of Salbutamol I.V. infusion solution (1000 mcg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 mcg/mL.
- The only recommended diluents are Sodium Chloride Injection, or Sodium Chloride and Dextrose Injection.
- Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Infusion rates can be started at 5 mcg of salbutamol/min., and can be increased to 10 mcg/min., and 20 mcg/min. at 15 - 30 minute intervals, if necessary.
- As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
- All unused admixtures of Salbutamol infusion solution with infusion fluids should be discarded 24 hours after preparation.
Salbutamol Inhalation Capsule:
- Adults: For the relief of bronchospasm and for managing intermittent episodes of asthma, one or two inhalation capsule may be administered as a single dose. The usual recommended dosage of Salbutamol inhalation capsule for inhalation for adults for maintenance or prophylactic therapy is the contents of one 200 microgram capsule every 4 to 6 hours using a device. In some patients, the contents of two 200 microgram capsules inhaled every 4 to 6 hours may be required. Large doses or more frequent administration is not recommended. The use of salbutamol powder for inhalation can be continued as medically indicated to control recurring/intermittent episodes of bronchospasm.
- Children: One Salbutamol inhalation capsule is the recommended dose for relief of acute bronchospasm in the maintenance of episodic asthma or before exercise of children 4 years of age and older. One inhalation should be administered for three or four times a day for routine maintenance or prophylactic therapy. This dosage may be increased to inhalation of two inhalation capsule, if necessary. The bronchodilator effect of each administration of inhaled Salbutamol inhalation capsule lasts for at least four hours. Such patients should be warned not to increase the dose of inhaler, but should seek medical advice immediately.
- Adults: 400 microgram
- Child: 200 microgram, 15-30 minutes prior to any physical exertion.
Side effectsView
Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.
PrecautionsView
Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed angle glaucoma, and in those receiving antihypertensive therapy.
Pregnancy & lactationView
The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Ventoxen
Venetoclax
Ventoxen
Venetoclax
Indications
Chronic lymphocytic leukemia
Indication detailsView
Venetoclax in combination with Rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Venetoclax monotherapy is indicated for the treatment of CLL:
Venetoclax monotherapy is indicated for the treatment of CLL:
- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
- In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.
DosageView
The starting dose is 20 mg of Venetoclax once daily for 7 days. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumor lysis syndrome.
Post-titration dose for Venetoclax in combination with Rituximab: The recommended dose of Venetoclax in combination with Rituximab is 400 mg once daily. Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg Venetoclax for 7 days. Venetoclax should be taken for 24 months from Cycle 1 Day 1 of Rituximab.
Post-titration dose for Venetoclax monotherapy: The recommended dose of Venetoclax is 400 mg once daily. Treatment should be continued until disease progression or no longer tolerated by the patient.
Post-titration dose for Venetoclax in combination with Rituximab: The recommended dose of Venetoclax in combination with Rituximab is 400 mg once daily. Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg Venetoclax for 7 days. Venetoclax should be taken for 24 months from Cycle 1 Day 1 of Rituximab.
Post-titration dose for Venetoclax monotherapy: The recommended dose of Venetoclax is 400 mg once daily. Treatment should be continued until disease progression or no longer tolerated by the patient.
Side effectsView
The most commonly occurring side effects (>20%) of any grade in patients receiving Venetoclax in the combination study with Rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common side effects were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection. The most frequently reported serious side effects (>2%) in patients receiving Venetoclax in combination with Rituximab were pneumonia, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious side effects (>2%) were pneumonia and febrile neutropenia.
ContraindicationsView
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John's wort
PrecautionsView
Tumour lysis syndrome: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with Venetoclax. Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-weeks dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venetoclax and at each dose increase. The risk of TLS is a continuum based on multiple factors, including comorbidities. Patients with high tumour burden (e.g., any lymph node with a diameter >5 cm or high ALC >25 x 109/1) are at greater risk of TLS when initiating enetoclax. Reduced renal function (CrCI <80 ml/min) further increases the risk. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics. Blood chemistries should be monitored and abnormalities managed promptly. Dosing should be interrupted if needed. More intensive measures (intravenous hydration, frequent monitoring, hospitalization) should be employed as overall risk increases. The instructions for "Prevention of tumour lysis syndrome" should be followed. Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases Venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase. Also, inhibitors of P-gp or BCRP may increase Venetoclax exposure.
Neutropenia: Grade 3 or 4 neutropenia has been reported in patients treated with Venetoclax in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.
Immunization: The safety and efficacy of immunization with live attenuated vaccines during or following Venetoclax therapy have not been studied. Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
CYP3A inducers: Co-administration of CYP3A4 inducers may lead to decreased Venetoclax exposure and consequently a risk for lack of efficacy. Concomitant use of Venetoclax with strong or moderate CYP3A4 inducers should be avoided.
Women of childbearing potential: Women of childbearing potential must use a highly effective method of contraception while taking Venetoclax.
Neutropenia: Grade 3 or 4 neutropenia has been reported in patients treated with Venetoclax in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.
Immunization: The safety and efficacy of immunization with live attenuated vaccines during or following Venetoclax therapy have not been studied. Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
CYP3A inducers: Co-administration of CYP3A4 inducers may lead to decreased Venetoclax exposure and consequently a risk for lack of efficacy. Concomitant use of Venetoclax with strong or moderate CYP3A4 inducers should be avoided.
Women of childbearing potential: Women of childbearing potential must use a highly effective method of contraception while taking Venetoclax.
InteractionsView
CYP3A inhibitors: Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased Venetoclax Cmax by 2.3-fold and AUC by 6.4-fold. Co-administration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased Venetoclax Cmax by 2.4-fold and AUC by 7.9-fold. Co-administration of Venetoclax with other strong CYP3A4 inhibitors is predicted to increase Venetoclax AUC by on average 5.8- to 7.8-fold. Concomitant use of Venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS.
At initiation and during the dose-titration phase, concomitant use of Venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided. Alternative treatments should be considered. If a moderate CYP3A inhibitor must be used, the initiation dose of Venetoclax and the doses for the titration phase should be reduced by at least 50%. Patients should be monitored more closely for signs and symptoms of TLS.
For patients who have completed the dose-titration phase and are on a steady daily dose of Venetoclax, the Venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. The Venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with Venetoclax as they contain inhibitors of CYP3A.
P-gp and BCRP inhibitors: Venetoclax is a substrate for P-gp and BCRP , Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased Venetoclax Cmax by 106% and AUC by 78%. Concomitant use of Venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities.
CYP3A inducers: Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased Venetoclax Cmax by 42% and AUC°° by 71%. Concomitant use of Venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided. Alternative treatments with less CYP3A induction should be considered. Preparations containing St. John's wort are contraindicated during treatment with Venetoclax, as efficacy may be reduced.
At initiation and during the dose-titration phase, concomitant use of Venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided. Alternative treatments should be considered. If a moderate CYP3A inhibitor must be used, the initiation dose of Venetoclax and the doses for the titration phase should be reduced by at least 50%. Patients should be monitored more closely for signs and symptoms of TLS.
For patients who have completed the dose-titration phase and are on a steady daily dose of Venetoclax, the Venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. The Venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with Venetoclax as they contain inhibitors of CYP3A.
P-gp and BCRP inhibitors: Venetoclax is a substrate for P-gp and BCRP , Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased Venetoclax Cmax by 106% and AUC by 78%. Concomitant use of Venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities.
CYP3A inducers: Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased Venetoclax Cmax by 42% and AUC°° by 71%. Concomitant use of Venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided. Alternative treatments with less CYP3A induction should be considered. Preparations containing St. John's wort are contraindicated during treatment with Venetoclax, as efficacy may be reduced.
Pregnancy & lactationView
Women of childbearing potential/Contraception in females: Women should avoid becoming pregnant while taking Venetoclax and for at least 30 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking Venetoclax and for 30 days after stopping treatment. It is currently unknown whether Venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Pregnancy: Based on embryo-foetal toxicity studies in animals, Venetoclax may harm the fetus when administered to pregnant women. There is no adequate and well-controlled data from the use of Venetoclax in pregnant women. Studies in animals have shown reproductive toxicity. Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Breast-feeding: It is unknown whether Venetoclax or its metabolites are excreted in human milk. A risk to the breast-feeding child cannot be excluded. Breast-feeding should be discontinued during treatment with Venetoclax.
Fertility: No human data on the effect of Venetoclax on fertility are available. Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with Venetoclax. Before starting treatment, counselling on sperm storage may be considered in some male patients.
Pregnancy: Based on embryo-foetal toxicity studies in animals, Venetoclax may harm the fetus when administered to pregnant women. There is no adequate and well-controlled data from the use of Venetoclax in pregnant women. Studies in animals have shown reproductive toxicity. Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Breast-feeding: It is unknown whether Venetoclax or its metabolites are excreted in human milk. A risk to the breast-feeding child cannot be excluded. Breast-feeding should be discontinued during treatment with Venetoclax.
Fertility: No human data on the effect of Venetoclax on fertility are available. Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with Venetoclax. Before starting treatment, counselling on sperm storage may be considered in some male patients.
Pediatric usageView
Elderly: No specific dose adjustment is required for elderly patients (aged >65 years).
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCI >30 ml/min and <90 mi/min). Patients with reduced renal function (CrCI <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCI <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
Hepatic impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase. A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment. These patients should be monitored more closely for signs of toxicity.
Pediatric population: The safety and efficacy of Venetoclax in children aged less than 18 years have not been established. No data is available.
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCI >30 ml/min and <90 mi/min). Patients with reduced renal function (CrCI <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCI <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
Hepatic impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase. A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment. These patients should be monitored more closely for signs of toxicity.
Pediatric population: The safety and efficacy of Venetoclax in children aged less than 18 years have not been established. No data is available.
Overdose effectsView
There is no specific antidote for Venetoclax. Patients who experience overdose should be closely monitored and appropriate supportive treatment provided. During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities.
StorageView
Store below 30°C. Keep Venetoclax out of the sight and reach of children. Protect from moisture and light.
Veracal
Verapamil Hydrochloride
Veracal
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veracal
Verapamil Hydrochloride
Veracal
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veracal
Verapamil Hydrochloride
Veracal
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veracal SR
Verapamil Hydrochloride
Veracal SR
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veracal SR
Verapamil Hydrochloride
Veracal SR
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veralgin
Tiemonium Methylsulphate
Veralgin
Tiemonium Methylsulphate
Indications
Visceral muscle spasm
Indication detailsView
Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.
Therapeutic classView
Anticholinergics
PharmacologyView
Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.
DosageView
Tablet/Syrup-
Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.
- Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
- Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.
Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.
Side effectsView
Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.
ContraindicationsView
It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.
PrecautionsView
Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.
InteractionsView
Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.
Pregnancy & lactationView
The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.
Pediatric usageView
Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.
Geriatric use: Efficacy and safety were maintained with increasing age.
Geriatric use: Efficacy and safety were maintained with increasing age.
Overdose effectsView
There is not available data regarding the overdose of Tiemonium methylsulphate tablet.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Veralgin
Tiemonium Methylsulphate
Veralgin
Tiemonium Methylsulphate
Indications
Visceral muscle spasm
Indication detailsView
Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.
Therapeutic classView
Anticholinergics
PharmacologyView
Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.
DosageView
Tablet/Syrup-
Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.
- Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
- Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.
Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.
Side effectsView
Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.
ContraindicationsView
It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.
PrecautionsView
Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.
InteractionsView
Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.
Pregnancy & lactationView
The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.
Pediatric usageView
Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.
Geriatric use: Efficacy and safety were maintained with increasing age.
Geriatric use: Efficacy and safety were maintained with increasing age.
Overdose effectsView
There is not available data regarding the overdose of Tiemonium methylsulphate tablet.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Veramil
Verapamil Hydrochloride
Veramil
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veramil SR
Verapamil Hydrochloride
Veramil SR
Verapamil Hydrochloride
Indications
Tachycardia
Indication detailsView
Verapamil Tablet:
- Essential hypertension
- Angina pectoris and prevention of re-infarction
- Supraventricular arrhythmias
- Tachycardias such as: Paroxysmal supraventricular tachycardias
- Atrial fibrillation with rapid ventricular response (except WPWS)
- Atrial flutter with rapid conduction
- Extrasystoles
- Acute hypertension
- Acute coronary insufficiency
Therapeutic classView
Calcium-channel blockers
PharmacologyView
Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
DosageView
Verapamil Tablet:
- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
- For angina the usual dose is 80 mg to 120 mg three times a day.
- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
Verapamil Injection:
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.Children:
- Newborn: 0.75-1 mg (0.3-0.4 ml)
- Infants: 0.75-2 mg (0.3-0.8 ml)
- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
- Age 6-14 years: 2.5-5 mg (1-2 ml)
Side effectsView
Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
- Digestive system: Constipation, nausea;
- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
- Respiratory system: Upper respiratory tract infections;
- Nervous system: Dizziness, headache, fatigue;
- Skin: Rash, flashing;
- Hepatic: Elevated liver enzyme.
ContraindicationsView
- Severe left ventricular dysfunction
- Hypotension or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
- Patients with known hypersensitivity to verapamil hydrochloride
PrecautionsView
Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
InteractionsView
May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
Overdose effectsView
Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Veratin
Ivermectin (Tablet)
Veratin
Ivermectin (Tablet)
Indication detailsView
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Therapeutic classView
Anthelmintic
PharmacologyView
Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
DosageView
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
Side effectsView
Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
InteractionsView
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Pregnancy & lactationView
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
StorageView
Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
Verben
Albendazole
Verben
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Verben
Albendazole
Verben
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Vercef
Cefpodoxime Proxetil
Vercef
Cefpodoxime Proxetil
Indications
Urinary tract infection
Indication detailsView
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
DosageView
Adults and Adolescents (13 years and older)
- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
- Community acquired pneumonia: 200 mg 12 hourly, 14 days
- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
- Uncomplicated gonorrhea: single dose of 200 mg
- Rectal gonococcal infections in women: single dose of 200 mg
- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
Side effectsView
Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
PrecautionsView
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
InteractionsView
Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
Pediatric usageView
Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
ReconstitutionView
Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Vercef
Cefpodoxime Proxetil
Vercef
Cefpodoxime Proxetil
Indications
Urinary tract infection
Indication detailsView
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
DosageView
Adults and Adolescents (13 years and older)
- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
- Community acquired pneumonia: 200 mg 12 hourly, 14 days
- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
- Uncomplicated gonorrhea: single dose of 200 mg
- Rectal gonococcal infections in women: single dose of 200 mg
- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
Side effectsView
Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
PrecautionsView
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
InteractionsView
Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
Pediatric usageView
Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
ReconstitutionView
Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Vercef DS
Cefpodoxime Proxetil
Vercef DS
Cefpodoxime Proxetil
Indications
Urinary tract infection
Indication detailsView
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
DosageView
Adults and Adolescents (13 years and older)
- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
- Community acquired pneumonia: 200 mg 12 hourly, 14 days
- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
- Uncomplicated gonorrhea: single dose of 200 mg
- Rectal gonococcal infections in women: single dose of 200 mg
- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
Side effectsView
Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
PrecautionsView
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
InteractionsView
Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
Pediatric usageView
Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
ReconstitutionView
Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Vercov
Ivermectin (Tablet)
Vercov
Ivermectin (Tablet)
Indication detailsView
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Therapeutic classView
Anthelmintic
PharmacologyView
Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
DosageView
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
Side effectsView
Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
InteractionsView
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Pregnancy & lactationView
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
StorageView
Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
Vergon
Prochlorperazine Maleate
Vergon
Prochlorperazine Maleate
Indications
Vomiting
Indication detailsView
Prochlorperazine Maleate is indicated-
- To control severe nausea and vomiting caused by radiation therapy, cancer chemotherapy, surgery, and other conditions.
- Relieving nausea, vomiting, and attacks of dizziness or spinning sensations (vertigo) associated with Meniere's disease and other inner ear disorders.
- For the treatment of psychotic illness such as schizophrenia (hallucinations and hostility).
- Acute mania.
- For the short-term treatment of generalized non-psychotic anxiety.
Therapeutic classView
Anti vertigo drugs, Anti-emetic drugs
PharmacologyView
Prochlorperazine is a dopamine & histamine antagonist. The mechanism of antiemetic activity is due to the blockade of histamine H, & dopamine D2 neurotransmitter receptors in the chemoreceptor trigger zone and vomiting centre. It also has a weak anticholinergic effect and prevents acid reflux by increasing the tone of the lower oesophageal sphincter.
DosageView
Antiemetic-
Children (not recommended in children <10 kg or <2 years):
Antipsychotic-
Children (not recommended in children <10 kg or <2 years):
Nonpsychotic anxiety-
Children (not recommended in children <10 kg or <2 years):
- 10-14 kg: 2.5 mg every 12-24 hours as needed;maximum: 7.5 mg/day
- 15-18 kg: 2.5 mg every 8-12 hours as needed;maximum:10 mg/day
- 19-39 kg: 2.5 mg every 8 hours or 5 mg every 12 hours as needed; maximum: 15 mg/day.
Antipsychotic-
Children (not recommended in children <10 kg or <2 years):
- 2-12 years: 2.5 mg 2-3 times/day
- Increase dosage as needed to a maximum daily dose of 20 mg for 2-5 years and 25 mg for 6-12 years
Nonpsychotic anxiety-
- Adults: Usual dose: 15-20 mg/day in divided doses; do not give doses >20 mg/day or for longer than 12 weeks
- Elderly: Initial: 2.5-5 mg 1-2 times/day; increase dose at 4 to 7 day intervals by 2.5-5 mg/day; increase dosing intervals (twice daily, thrice daily, etc) as necessary to control response or side effects; maximum daily dose should probably not exceed 75 mg in elderly; gradual increases (titration) may prevent some side effects or decrease their severity.
Side effectsView
Drowsiness; jaw, neck, and back muscle spasms; fine worm-like tongue movements; rhythmic face, mouth, or jaw movements; slow or difficult speech; difficulty swallowing; restlessness and pacing; tremors; shuffling walk; skin rash; yellowing of the skin or eyes.
ContraindicationsView
Hypersensitivity to prochlorperazine or any component of the formulation, severe CNS
depression; coma; should not be used in children <2 years of age or <10 kg.
depression; coma; should not be used in children <2 years of age or <10 kg.
PrecautionsView
Caution should be taken while performing tasks that require alertness, such as driving or using machinery. The use of alcohol can cause extreme drowsiness. This medication may increase sensitivity to sunlight. Prolonged sun exposure should be avoided and sunscreen and protective clothing should be taken when anybody is exposed to the sun. This medication can reduce sweating making it more susceptible to heatstroke.
InteractionsView
Alcohol, barbiturate & other sedatives may increase the CNS depressant action. Some drugs like Antacids, antiparkinson's drug, lithium may interfere the absorption of Prochlorperazine. This drug may interfere with the plasma concentration of Propanolol and Phenobarbital.
Pregnancy & lactationView
No evidence of adverse effects of this drug has been reported during pregnancy & lactation.
Overdose effectsView
Symptoms of overdose include deep sleep, coma, extrapyramidal symptoms, abnormal involuntary muscle movements, and hypotension.
StorageView
Store below 30°C.Protect from light and moisture. Keep out of the reach of children.