Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Plasiver:
Store Plasiver at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Plasiver out of the reach of children and away from pets.
Overdose of Plasiver in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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A single 1050-mg dose equivalent to 14 tabs of Plasiver taken by a 34-year old woman did not result in any adverse event. She recovered without sequelae and without any treatment.
A single oral administration of 600 mg Plasiver in healthy volunteers resulted in the prolongation of bleeding time by a factor of 1.7 which is similar to that typically observed with therapeutic dose of 75 mg of Plasiver per day.
However, in animals, a single oral dose of 1500 or 2000 mg/kg was lethal to mice and to rats and at 3000 mg/kg to baboons and was associated with acute toxicity symptoms of prostration, difficulty in breathing and gastrointestinal hemorrhage in all species.
If quick reversal of adverse events is required, platelet transfusion may be appropriate to reverse the pharmacological effects of Plasiver.
What should I avoid while taking Plasiver?
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines.
Plasiver warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Diminished Antiplatelet Activity Due to Impaired CYP2C19 Function
Plasiver is a prodrug. Inhibition of platelet aggregation by Plasiver is achieved through an active metabolite. The metabolism of Plasiver to its active metabolite can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19.
Proton Pump Inhibitors
Avoid concomitant use of Plasiver with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of Plasiver.
General Risk of Bleeding
Thienopyridines, including Plasiver, increase the risk of bleeding. If a patient is to undergo surgery and an antiplatelet effect is not desired, discontinue Plasiver five days prior to surgery. In patients who stopped therapy more than five days prior to CABG the rates of major bleeding were similar (event rate 4.4% Plasiver + aspirin; 5.3% placebo + aspirin). In patients who remained on therapy within five days of CABG, the major bleeding rate was 9.6% for Plasiver + aspirin, and 6.3% for placebo + aspirin.
Thienopyridines inhibit platelet aggregation for the lifetime of the platelet (7–10 days), so withholding a dose will not be useful in managing a bleeding event or the risk of bleeding associated with an invasive procedure. Because the half-life of Plasiver's active metabolite is short, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
Discontinuation of Plasiver
Avoid lapses in therapy, and if Plasiver must be temporarily discontinued, restart as soon as possible. Premature discontinuation of Plasiver may increase the risk of cardiovascular events.
Patients with Recent Transient Ischemic Attack (TIA) or Stroke
In patients with recent TIA or stroke who are at high risk for recurrent ischemic events, the combination of aspirin and Plasiver has not been shown to be more effective than Plasiver alone, but the combination has been shown to increase major bleeding.
Thrombotic Thrombocytopenic Purpura (TTP)
TTP, sometimes fatal, has been reported following use of Plasiver, sometimes after a short exposure (<2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever.
Cross-Reactivity among Thienopyridines
Hypersensitivity including rash, angioedema or hematologic reaction have been reported in patients receiving Plasiver, including patients with a history of hypersensitivity or hematologic reaction to other thienopyridines.
What should I discuss with my healthcare provider before taking Plasiver?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Plasiver, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Plasiver or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Plasiver in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Plasiver in the elderly.
Pregnancy
Pregnancy Category
Explanation
All Trimesters
B
Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Plasiver, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Plasiver with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Aceclofenac
Acemetacin
Alipogene Tiparvovec
Alteplase, Recombinant
Amlodipine
Amtolmetin Guacil
Anagrelide
Apixaban
Ardeparin
Argatroban
Aspirin
Bivalirudin
Bromfenac
Bufexamac
Bupropion
Celecoxib
Certoparin
Choline Salicylate
Cilostazol
Cimetidine
Citalopram
Clevidipine
Clonixin
Dabigatran Etexilate
Dalteparin
Danaparoid
Desirudin
Desvenlafaxine
Dexibuprofen
Dexketoprofen
Diclofenac
Diflunisal
Diltiazem
Dipyridamole
Dipyrone
Duloxetine
Edoxaban
Enoxaparin
Eptifibatide
Escitalopram
Esomeprazole
Etodolac
Etofenamate
Etoricoxib
Etravirine
Felbamate
Felbinac
Felodipine
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Heparin
Ibuprofen
Ibuprofen Lysine
Indomethacin
Isradipine
Ketoconazole
Ketoprofen
Ketorolac
Lepirudin
Levomilnacipran
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Meloxicam
Milnacipran
Morniflumate
Nabumetone
Nadroparin
Naproxen
Nefazodone
Nepafenac
Nicardipine
Nifedipine
Niflumic Acid
Nimesulide
Nimodipine
Nisoldipine
Omeprazole
Oxaprozin
Oxyphenbutazone
Parecoxib
Parnaparin
Paroxetine
Phenindione
Phenprocoumon
Phenylbutazone
Piketoprofen
Piroxicam
Proglumetacin
Propionic Acid
Propyphenazone
Proquazone
Protein C
Rabeprazole
Reviparin
Rivaroxaban
Rofecoxib
Salicylic Acid
Salsalate
Sertraline
Sibutramine
Sodium Salicylate
Sulindac
Tenoxicam
Tiaprofenic Acid
Tinzaparin
Tolfenamic Acid
Tolmetin
Valdecoxib
Venlafaxine
Verapamil
Vilazodone
Vortioxetine
Warfarin
Using Plasiver with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Amiodarone
Atorvastatin
Fosphenytoin
Ginkgo
Lovastatin
Phenytoin
Simvastatin
Vitamin A
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Plasiver with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use Plasiver, or give you special instructions about the use of food, alcohol, or tobacco.
Grapefruit Juice
Using Plasiver with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use Plasiver, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Plasiver. Make sure you tell your doctor if you have any other medical problems, especially:
Bleeding, active (eg, peptic ulcers, head injury)—Should not be used in patients with this condition.
Stroke, recent or
Transient ischemic attack (TIA or mini-stroke), recent—May cause side effects to become worse.
Plasiver precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Bleeding and Haemotological Disorders: Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment. As with other antiplatelet agents, Plasiver should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including COX-2 inhibitors. Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of Plasiver with oral anticoagulants is not recommended since it may increase the intensity of bleedings.
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, Plasiver should be discontinued 7 days prior to surgery. Patients should inform physicians and dentists that they are taking Plasiver before any surgery is scheduled and before any new drug is taken. Plasiver prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
Patients should be told that it might take longer than usual to stop bleeding when they take Plasiver (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Bleeding and Haematological Disorders: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of Plasiver, sometimes after a short exposure. It is characterised by thrombocytopenia and microangiopathic hemolytic anemia associated with either neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Recent Ischaemic Stroke: In view of the lack of data, Plasiver cannot be recommended during the first 7 days after acute ischaemic stroke.
Cytochrome P-450 2C19 (CYP2C19): Pharmacogenetics: In patients who are poor CYP2C19 metabolisers, Plasiver at recommended doses forms less of the active metabolite of Plasiver and has a smaller effect on platelet function. Tests are available to identify a patient's CYP2C19 genotype.
Since Plasiver is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of Plasiver. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged.
Renal Impairment: Therapeutic experience with Plasiver is limited in patients with renal impairment. Therefore, Plasiver should be used with caution in these patients.
Hepatic Impairment: Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. Plasiver should therefore be used with caution in this population.
Excipients: Plasiver contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Plasiver.
Plasiver contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Fertility: Plasiver was not shown to alter fertility in animal studies.
Use in pregnancy: As no clinical data on exposure to Plasiver during pregnancy are available, it is preferable not to use Plasiver during pregnancy as a precautionary measure. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Use in lactation: It is unknown whether Plasiver is excreted in human breast milk. Animal studies have shown excretion of Plasiver in breast milk. As a precautionary measure, breastfeeding should not be continued during treatment with Plasiver.
What happens if I miss a dose of Plasiver?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Burnham Center for Chemical Geno. "SID49666423: Aqueous solubility in buffer at pH 7.4". https://pubchem.ncbi.nlm.nih.gov/bio... (accessed September 17, 2018).
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