6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Hordazol. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system diso r der s : Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency
Ca r diac d i so r d e r s : Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g., complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris.
Gast r oin t e s t inal diso r de r s: Gastrointestinal hemorrhage, vomiting, flatulence, nausea
General diso r ders and administration site conditions: Pain, chest pain, hot flushes
Hepatobiliary diso r der s : Hepatic dysfunction/abnormal liver function tests, jaundice
Immune system diso r ders: Anaphylaxis, angioedema, and hypersensitivity
Investigations: Blood glucose increased, blood uric acid increased, increase in BUN (blood urea increased), blood pressure increase
Ner v ous system diso r der s : Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma
Renal and urinary diso r der s : Hematuria
Respirator y , thoracic and mediastinal diso r ders: Pulmonary hemorrhage, interstitial pneumonia
Skin and subcutaneous tissue diso r ders: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa), rash
V ascular diso r ders: Subacute stent thrombosis, hypertension.
See also Warning section.
Before taking Hordazol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: serious/active bleeding (such as bleeding ulcers, bleeding in the eye/brain), blood disorders (such as hemophilia, low platelet counts), heart disease (such as heart attack, chest pain, fast/irregular heartbeat), stroke, kidney disease.
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.
Hordazol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Hordazol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Hordazol safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially swelling of the hands/feet (fluid retention) or QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Medications similar to Hordazol caused an increased risk of death in patients with congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Tell your doctor if you have or have ever had congestive heart failure. Your doctor will probably tell you not to take Hordazol.
Talk to your doctor about the risks of taking Hordazol.
PRINCIPAL DISPLAY PANEL
NDC 70436-050-06 Hordazol Tablets USP 50 mg 60 Tablets Rx Only
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Carcinogenesis, Mutagenesis, Impairment Of Fertility
Dietary administration of Hordazol to male and female rats and mice for up to 104 weeks, at doses up to 500 mg/kg/day in rats and 1000 mg/kg/day in mice, revealed no evidence of carcinogenic potential. The maximum doses administered in both rat and mouse studies were, on a systemic exposure basis, less than the human exposure at the MRHD of the drug. Hordazol tested negative in bacterial gene mutation, bacterial DNA repair, mammalian cell gene mutation, and mouse in vivo bone marrow chromosomal aberration assays. It was, however, associated with a significant increase in chromosomal aberrations in the in vitro Chinese Hamster Ovary Cell assay.
In female mice, Hordazol caused a reversible contraceptive effect at a dose (300 mg/kg) that was approximately 7.4-fold greater than the Maximum Recommended Human Dose (MRHD) on a body surface area basis. These findings have not been demonstrated in other animal species.
Hordazol did not affect fertility or mating performance of male and female rats at doses as high as 1000 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound Hordazol were less than 1.5 times in males, and about 5 times in females, the exposure in humans at the MRHD.
BRAND NAME(S): Pletal
WARNING: Medications similar to Hordazol have shortened the lives of people with a certain type of heart disease (congestive heart failure). Therefore, do not use Hordazol if you have congestive heart failure.
Where can I get more information?
Your pharmacist can provide more information about Hordazol.