Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local ( ), or emergency room immediately. Symptoms may include dizziness on standing; lightheadedness; severe nausea or vomiting.
Proper storage of Hemostan tablet:
Store Hemostan tablet 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 Hemostan tablet out of the reach of children and away from pets.
Overdose of Hemostan 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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There are no known cases of intentional overdose with Hemostan Tablets and no subjects in the clinical program took more than 2 times the prescribed amount of Hemostan Tablets in a 24-hour period (>7800 mg/day). However, cases of overdose of Hemostan have been reported. Based on these reports, symptoms of overdose may include gastrointestinal (nausea, vomiting, diarrhea); hypotensive (e.g., orthostatic symptoms); thromboembolic (arterial, venous, embolic); visual impairment; mental status changes; myoclonus; or rash. No specific information is available on the treatment of overdose with Hemostan Tablets. In the event of overdose, employ the usual supportive measures (e.g., clinical monitoring and supportive therapy) as dictated by the patient's clinical status.
What should I avoid while taking Hemostan?
This medication may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.
Hemostan 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.
Thromboembolic Risk
Concomitant Use of Hormonal Contraceptives
Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because Hemostan Tablets are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when hormonal contraceptives are administered with Hemostan Tablets. This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age.
Women using hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of Hemostan Tablets, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of Hemostan Tablets with hormonal contraceptives. However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used Hemostan Tablets concomitantly with combination hormonal contraceptives. For this reason, concomitant use of Hemostan with combination hormonal contraceptives is contraindicated..
Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates
Hemostan Tablets are not recommended for women taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased.
All-Trans Retinoic Acid (Oral Tretinoin)
Exercise caution when prescribing Hemostan Tablets to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid.
Ocular Effects
Retinal venous and arterial occlusion has been reported in patients using Hemostan. Patients should be instructed to report visual and ocular symptoms promptly. In the event of such symptoms, patients should be instructed to discontinue Hemostan Tablets immediately and should be referred to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to exclude the possibility of retinal venous or arterial occlusion.
Severe Allergic Reaction
A case of severe allergic reaction to Hemostan Tablets was reported in the clinical trials, involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment. A case of anaphylactic shock has also been reported in the literature, involving a patient who received an intravenous bolus of Hemostan.
Subarachnoid Hemorrhage
Cerebral edema and cerebral infarction may be caused by use of Hemostan Tablets in women with subarachnoid hemorrhage.
Ligneous Conjunctivitis
Ligneous conjunctivitis has been reported in patients taking Hemostan. The conjunctivitis resolved following cessation of the drug.
What should I discuss with my healthcare provider before taking Hemostan?
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 Hemostan, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Hemostan 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 Hemostan in children or teenage females younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of Hemostan have not been performed in the geriatric population. Hemostan is not intended for use in women who are no longer having menstrual bleeding (postmenopausal).
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 Hemostan, 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 Hemostan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Desogestrel
Dienogest
Drospirenone
Estradiol Cypionate
Estradiol Valerate
Ethinyl Estradiol
Ethynodiol Diacetate
Etonogestrel
Levonorgestrel
Medroxyprogesterone Acetate
Mestranol
Norelgestromin
Norethindrone
Norgestimate
Norgestrel
Using Hemostan 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.
Anti-Inhibitor Coagulant Complex
Chlorpromazine
Tretinoin
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Hemostan. Make sure you tell your doctor if you have any other medical problems, especially:
Acute promyelocytic leukemia—Use with caution. Using Hemostan together with an oral tretinoin in patients with this condition may cause bleeding problems.
Blood clots, active or history of or
Deep vein thrombosis (blood clot in the leg) or
Pulmonary embolism (blood clot in the lung) or
Retinal artery or vein occlusion (blood clot in the eye), history of or
Stroke (blood clot in the brain)—Should not be used in patients with these conditions.
Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Hemostan 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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Thromboembolic Risk
Concomitant Use of Hormonal Contraceptives
Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because Hemostan Tablets are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when hormonal contraceptives are administered with Hemostan Tablets. This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age.
Women using hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of Hemostan Tablets, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of Hemostan Tablets with hormonal contraceptives. However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used Hemostan Tablets concomitantly with combination hormonal contraceptives. For this reason, concomitant use of Hemostan with combination hormonal contraceptives is contraindicated..
Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates
Hemostan Tablets are not recommended for women taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased.
All-Trans Retinoic Acid (Oral Tretinoin)
Exercise caution when prescribing Hemostan Tablets to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid.
Ocular Effects
Retinal venous and arterial occlusion has been reported in patients using Hemostan. Patients should be instructed to report visual and ocular symptoms promptly. In the event of such symptoms, patients should be instructed to discontinue Hemostan Tablets immediately and should be referred to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to exclude the possibility of retinal venous or arterial occlusion.
Severe Allergic Reaction
A case of severe allergic reaction to Hemostan Tablets was reported in the clinical trials, involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment. A case of anaphylactic shock has also been reported in the literature, involving a patient who received an intravenous bolus of Hemostan.
Subarachnoid Hemorrhage
Cerebral edema and cerebral infarction may be caused by use of Hemostan Tablets in women with subarachnoid hemorrhage.
Ligneous Conjunctivitis
Ligneous conjunctivitis has been reported in patients taking Hemostan. The conjunctivitis resolved following cessation of the drug.
What happens if I miss a dose of Hemostan?
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.
Call your doctor for instructions if you miss a dose.
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References
DailyMed. "TRANEXAMIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
