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Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ORGANON USA INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ORGANON USA INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.
Status:
US Approved Rx
(2010)
Source:
NDA021879
(2010)
Source URL:
First marketed in 1921
Class:
POLYMER
Targets:
Quinidine is a pharmaceutical agent that acts as a class I antiarrhythmic agent (Ia) in the heart. It is a stereoisomer of quinine, originally derived from the bark of the cinchona tree. The drug causes increased action potential duration, as well as a prolonged QT interval. Like all other class I antiarrhythmic agents, quinidine primarily works by blocking the fast inward sodium current (INa). Quinidine's effect on INa is known as a 'use-dependent block'. This means at higher heart rates, the block increases, while at lower heart rates, the block decreases. The effect of blocking the fast inward sodium current causes the phase 0 depolarization of the cardiac action potential to decrease (decreased Vmax). Quinidine also blocks the slowly inactivating, tetrodotoxin-sensitive Na current, the slow inward calcium current (ICA), the rapid (IKr) and slow (IKs) components of the delayed potassium rectifier current, the inward potassium rectifier current (IKI), the ATP-sensitive potassium channel (IKATP) and Ito. Quinidine is also an inhibitor of the cytochrome P450 enzyme 2D6 and can lead to increased blood levels of lidocaine, beta blockers, opioids, and some antidepressants. Quinidine also inhibits the transport protein P-glycoprotein and so can cause some peripherally acting drugs such as loperamide to have central nervous system side effects, such as respiratory depression if the two drugs are coadministered. Quinidine can cause thrombocytopenia, granulomatous hepatitis, myasthenia gravis, and torsades de pointes, so is not used much today. Torsades can occur after the first dose. Quinidine-induced thrombocytopenia (low platelet count) is mediated by the immune system and may lead to thrombocytic purpura. A combination of dextromethorphan and quinidine has been shown to alleviate symptoms of easy laughing and crying (pseudobulbar affect) in patients with amyotrophic lateral sclerosis and multiple sclerosis. This drug is marketed as Nuedexta in the United States. Intravenous quinidine is also indicated for the treatment of Plasmodium falciparum malaria. However, quinidine is not considered the first-line therapy for P. falciparum. The recommended treatments for P. falciparum malaria, according to the Toronto Notes 2008, are a combination of either quinine and doxycycline or atovaquone and proguanil (Malarone). The drug is also effective for the treatment of atrial fibrillation in horses.
Status:
US Approved Rx
(2010)
Source:
NDA021879
(2010)
Source URL:
First marketed in 1921
Class:
POLYMER
Targets:
Quinidine is a pharmaceutical agent that acts as a class I antiarrhythmic agent (Ia) in the heart. It is a stereoisomer of quinine, originally derived from the bark of the cinchona tree. The drug causes increased action potential duration, as well as a prolonged QT interval. Like all other class I antiarrhythmic agents, quinidine primarily works by blocking the fast inward sodium current (INa). Quinidine's effect on INa is known as a 'use-dependent block'. This means at higher heart rates, the block increases, while at lower heart rates, the block decreases. The effect of blocking the fast inward sodium current causes the phase 0 depolarization of the cardiac action potential to decrease (decreased Vmax). Quinidine also blocks the slowly inactivating, tetrodotoxin-sensitive Na current, the slow inward calcium current (ICA), the rapid (IKr) and slow (IKs) components of the delayed potassium rectifier current, the inward potassium rectifier current (IKI), the ATP-sensitive potassium channel (IKATP) and Ito. Quinidine is also an inhibitor of the cytochrome P450 enzyme 2D6 and can lead to increased blood levels of lidocaine, beta blockers, opioids, and some antidepressants. Quinidine also inhibits the transport protein P-glycoprotein and so can cause some peripherally acting drugs such as loperamide to have central nervous system side effects, such as respiratory depression if the two drugs are coadministered. Quinidine can cause thrombocytopenia, granulomatous hepatitis, myasthenia gravis, and torsades de pointes, so is not used much today. Torsades can occur after the first dose. Quinidine-induced thrombocytopenia (low platelet count) is mediated by the immune system and may lead to thrombocytic purpura. A combination of dextromethorphan and quinidine has been shown to alleviate symptoms of easy laughing and crying (pseudobulbar affect) in patients with amyotrophic lateral sclerosis and multiple sclerosis. This drug is marketed as Nuedexta in the United States. Intravenous quinidine is also indicated for the treatment of Plasmodium falciparum malaria. However, quinidine is not considered the first-line therapy for P. falciparum. The recommended treatments for P. falciparum malaria, according to the Toronto Notes 2008, are a combination of either quinine and doxycycline or atovaquone and proguanil (Malarone). The drug is also effective for the treatment of atrial fibrillation in horses.
Status:
US Approved OTC
Source:
21 CFR 347.10(c) skin protectant calamine
Source URL:
First marketed in 1921
Source:
Saccharated Ferric Oxide N.F.
Source URL:
Class:
POLYMER
Conditions:
Ferric chloride is a compound used as a food additive, a haemostatic or treatment for hypochromic anaemia. Ferric chloride induced vascular injury is a widely used model of occlusive thrombosis that reports platelet activation and aggregation in the context of an aseptic closed vascular system. Iron i.v. ferric chloride (960 mg) has being shown to be effective in correcting anaemia in HD patients with iron deficiency.
Status:
US Approved OTC
Source:
21 CFR 347.10(c) skin protectant calamine
Source URL:
First marketed in 1921
Source:
Saccharated Ferric Oxide N.F.
Source URL:
Class:
POLYMER
Conditions:
Ferric chloride is a compound used as a food additive, a haemostatic or treatment for hypochromic anaemia. Ferric chloride induced vascular injury is a widely used model of occlusive thrombosis that reports platelet activation and aggregation in the context of an aseptic closed vascular system. Iron i.v. ferric chloride (960 mg) has being shown to be effective in correcting anaemia in HD patients with iron deficiency.
Status:
US Approved OTC
Source:
21 CFR 347.10(c) skin protectant calamine
Source URL:
First marketed in 1921
Source:
Saccharated Ferric Oxide N.F.
Source URL:
Class:
POLYMER
Conditions:
Ferric chloride is a compound used as a food additive, a haemostatic or treatment for hypochromic anaemia. Ferric chloride induced vascular injury is a widely used model of occlusive thrombosis that reports platelet activation and aggregation in the context of an aseptic closed vascular system. Iron i.v. ferric chloride (960 mg) has being shown to be effective in correcting anaemia in HD patients with iron deficiency.
Status:
US Approved OTC
Source:
21 CFR 331.11(i)(2) antacid:calcium-containing calcium (mono or dibasic salt)
Source URL:
First marketed in 1921
Source:
Precipitated Calcium Phosphate N.F.
Source URL:
Class:
POLYMER
Conditions:
Anhydrous dibasic calcium phosphate is a calcium salt of phosphoric acid. It is used as a diluent in pharmaceutical industry, in some toothpastes as a polishing agent. Calcium phosphate is generally recognized as safe by FDA. Dibasic calcium phosphate is ised as a supplement to treat conditions associated with calcium deficit, such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany)
Status:
US Approved OTC
Source:
21 CFR 347.10(c) skin protectant calamine
Source URL:
First marketed in 1921
Source:
Saccharated Ferric Oxide N.F.
Source URL:
Class:
POLYMER
Conditions:
Ferric chloride is a compound used as a food additive, a haemostatic or treatment for hypochromic anaemia. Ferric chloride induced vascular injury is a widely used model of occlusive thrombosis that reports platelet activation and aggregation in the context of an aseptic closed vascular system. Iron i.v. ferric chloride (960 mg) has being shown to be effective in correcting anaemia in HD patients with iron deficiency.
Status:
US Approved OTC
Source:
21 CFR 333.210(d) antifungal povidone-iodine
Source URL:
First marketed in 1921
Class:
POLYMER
Conditions:
Tetraglycine hydroperiodide is an iodine-containing chemical, used for water purification. Tetraglycine hydroperiodide is marketed in tablets; each tablet effectively disinfects 1 liter of clear water or 0.5 liter of tainted water by releasing approximately 8 mg free iodine. It requires approximately 30 minutes to inactivate target microorganisms and make water bacteriologically suitable for drinking. To remove iodine taste, a vitamin C pill is added to the kit.