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Valdorin

Valdorin

clopidogrel + aspirin

Manufacturer:

Fredun Pharmaceuticals

Distributor:

Corbridge
Concise Prescribing Info
Contents
Per 75 mg/75 mg cap Clopidogrel 75 mg, aspirin 75 mg
Indications/Uses
Secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel & aspirin. Continuation of therapy in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) or ST segment elevation acute MI.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Hypoprothrombinaemia, haemophilia & other bleeding disorders. Active or history of peptic ulceration. Gout. Do not give to childn <16 yr unless specifically indicated (eg, for Kawasaki's disease).
Special Precautions
Not to be used in patients w/ severe renal or severe hepatic impairment. Caution in patients w/ mild to moderate renal impairment or moderate hepatic disease who may have bleeding diatheses. Not recommended in childn & adolescents <18 yr. Clopidogrel: Patients at risk of increased bleeding from trauma, surgery, or other pathological conditions (particularly GI & intraocular); patients who have lesions w/ propensity to bleed (eg, ulcers); patients w/ recent transient ischemic attack or stroke who are at high risk of recurrent ischemic events. Discontinue treatment 5 days prior to elective surgery if antiplatelet effect is not desired. Rare reports of TTP. Only use during pregnancy if clearly needed. Discontinue nursing during treatment or discontinue the drug. Aspirin: Patients w/ allergic disease; dehydration; G6PD deficiency. May precipitate bronchospasm or induce asthma attacks in susceptible patients. May interfere w/ insulin & glucagon in diabetes. Discontinue aspirin several days before scheduled surgical procedures. Not to be used in patients w/ history of coagulation abnormalities; stomach ulcer or history of stomach ulcers. Maternal use prior to birth may increase risk of intracranial haemorrhage in premature or low birth wt infants & may contribute to maternal & neonatal bleeding. Not to be taken by patients who are breastfeeding. Possible association w/ Reye's syndrome when given to childn. The elderly may be more susceptible to toxic effects of salicylates. Avoid continuous prolonged use in elderly.
Adverse Reactions
Clopidogrel: Hemorrhagic events; chest pain, accidental/inflicted injury, flu-like symptoms, pain, fatigue; edema, HTN; headache, dizziness; abdominal pain, diarrhea, dyspepsia, nausea; hypercholesterolemia; arthralgia, back pain; bruise/purpura, epistaxis; depression; URTI, dyspnea, rhinitis, bronchitis, coughing; rash/pruritus; UTI. Aspirin: Prolonged bleeding time, decreased platelet adhesiveness, hypoprothrombinaemia, thrombocytopenia, epistaxis, hematuria, purpura, ecchymoses, hemoptysis, GI bleeding, hematoma, cerebral hemorrhage; hypersensitivity reactions; tinnitus; GI irritation; skin reactions; urate kidney stones.
Drug Interactions
Clopidogrel: Increased risk of bleeding w/ warfarin. Potentiated effect of aspirin on collagen-induced platelet aggregation. Increased occult GI blood loss w/ NSAIDs. May interfere w/ the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, & many non-steroidal anti-inflammatory agents. Aspirin: Potentiated effect of heparin. Increased risk of bleeding w/ oral anticoagulants, antiplatelet agents & fibrinolytics. Increased side effects w/ other NSAIDs. Increased risk of GI bleeding & ulceration w/ corticosteroids. Reduced excretion of acetazolamide. Concurrent administration w/ carbonic anhydrase inhibitors eg, acetazolamide may result in severe acidosis & increased CNS toxicity. Increased excretion in alkaline urine w/ antacids. Possible reduced absorption w/ kaolin. Avoid aspirin until 8-12 days after mifepristone has been discontinued. May markedly enhance activity & increase toxicity of MTX. Increased toxicity of sulfonamides. Some effects of aspirin on GIT are enhanced by alcohol. Increased rate of absorption w/ metoclopramide. Reduced antihypertensive effect of ACE inhibitors. Enhanced effects of phenytoin & Na valproate. Antagonism of diuretic effect of spironolactone. Enhanced effects of insulin & oral hypoglycaemic agents. Increased plasma conc of zafirlukast. Reduced effect of probenecid & sulfinpyrazone. May interfere w/ thyroid function tests.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC30 - combinations ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
N02BA01 - acetylsalicylic acid ; Belongs to the class of salicylic acids and derivatives agents. Used to relieve pain and fever.
Presentation/Packing
Form
Valdorin 75 mg/75 mg cap
Packing/Price
100's
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