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AquaMEPHYTON
Overview
What is AquaMEPHYTON?
Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is CHO and its molecular structure is:
AquaMEPHYTON injection is a yellow, sterile, aqueous colloidal solution of vitamin K, with a pH of 5.0 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. AquaMEPHYTON is available in 1 mg (2 mg/mL) and 10 mg (10 mg/mL) single-dose ampuls. Each milliliter of AquaMEPHYTON contains the following inactive ingredients: 70 mg polyoxyethylated fatty acid derivative, 37.5 mg dextrose, 9 mg benzyl alcohol (preservative), and water for injection. AquaMEPHYTON may contain glacial acetic acid for pH adjustment to 6.3 (5.0 – 7.0).
What does AquaMEPHYTON look like?
What are the available doses of AquaMEPHYTON?
Injection: 2 mg/mL and 10 mg/mL single-dose ampuls. ()
What should I talk to my health care provider before I take AquaMEPHYTON?
How should I use AquaMEPHYTON?
AquaMEPHYTON is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity:
Whenever possible, administer AquaMEPHYTON by the subcutaneous route
HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute
.
Monitor international normalized ratio (INR) regularly and as clinical conditions indicate. Use the lowest effective dose of AquaMEPHYTON.
The coagulant effects of AquaMEPHYTON are not immediate; improvement of INR may take 1-8 hours. Interim use of whole blood or component therapy may also be necessary if bleeding is severe.
Whenever possible, administer benzyl alcohol-free formulations in pediatric patients
.
When AquaMEPHYTON is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. AquaMEPHYTON is not a clotting agent, but overzealous therapy with AquaMEPHYTON may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate.
What interacts with AquaMEPHYTON?
Sorry No Records found
What are the warnings of AquaMEPHYTON?
Sorry No Records found
What are the precautions of AquaMEPHYTON?
Sorry No Records found
What are the side effects of AquaMEPHYTON?
Sorry No records found
What should I look out for while using AquaMEPHYTON?
Hypersensitivity to phytonadione or any other component of this medication.
Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of AquaMEPHYTON. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified
WARNINGS AND PRECAUTIONS
What might happen if I take too much AquaMEPHYTON?
Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from AquaMEPHYTON overdose.
How should I store and handle AquaMEPHYTON?
Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration (2-8°C/36-46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete.Do not use beyond the expiration date stamped on the vial.Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration (2-8°C/36-46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete.Do not use beyond the expiration date stamped on the vial.AquaMEPHYTON is a yellow, sterile, aqueous colloidal solution and is supplied in a package of 25 as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect AquaMEPHYTON from light. Store container in closed original carton until contents have been used. AquaMEPHYTON is a yellow, sterile, aqueous colloidal solution and is supplied in a package of 25 as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect AquaMEPHYTON from light. Store container in closed original carton until contents have been used. AquaMEPHYTON is a yellow, sterile, aqueous colloidal solution and is supplied in a package of 25 as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect AquaMEPHYTON from light. Store container in closed original carton until contents have been used.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
AquaMEPHYTON aqueous colloidal solution of vitamin K for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post- translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood.
In normal animals and humans, phytonadione is virtually devoid of activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors.
Non-Clinical Toxicology
Hypersensitivity to phytonadione or any other component of this medication.Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of AquaMEPHYTON. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified
WARNINGS AND PRECAUTIONS
Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine bromide.
Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of AquaMEPHYTON. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea. Administer AquaMEPHYTON subcutaneously whenever feasible. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified
The following serious adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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