Aspirin Pravastatin Brand Name– Pravigard PAC
What is Aspirin Pravastatin
NOTE: This drug is discontinued in the US.
Aspirin Pravastatin combination has been approved to reduce the risk of death, non-fatal myocardial infarction, myocardial revascularization procedures and ischemic stroke in patients with cardiovascular and/or cerebrovascular disease.
Aspirin has antithrombotic and antiplatelet effects, while pravastatin is an oral HMG-CoA reductase inhibitor.
By itself, pravastatin is indicated to treat primary hypercholesterolemia, and is also used for primary or secondary prevention of myocardial infarction.
The original secondary prevention approval for pravastatin monotherapy was based on the Cholesterol and Recurrent Events (CARE) trial; 84% of patients in this trial also received aspirin.
The subsequent LIPID study also documented the secondary prevention benefit of pravastatin in patients who had a prior myocardial infarction or were hospitalized for unstable angina.
Pravigard™ PAC was FDA-approved on June 25, 2003. This FDA approval was based on combined data from five secondary prevention trials including CARE, LIPID, REGRESS, PLAC I, and PLAC II. Pravigard™ PAC includes six combinations of daily doses of buffered aspirin 81 mg or 325 mg, co-packaged with pravastatin 20 mg, 40 mg, or 80 mg tablets.
Marketing of this drug was discontinued by the manufacturer in May, 2005.
Indications
- atherosclerosis
- hypercholesterolemia
- hyperlipoproteinemia
- myocardial infarction prophylaxis
- stroke prophylaxis
Side Effects
- abdominal pain
- agranulocytosis
- alopecia
- anaphylactoid reactions
- angioedema
- aplastic anemia
- arthralgia
- azotemia
- bronchospasm
- chills
- cirrhosis
- Co-Enzyme Q-10 deficiency
- constipation
- diabetes mellitus
- diarrhea
- dizziness
- dyspepsia
- dyspnea
- elevated hepatic enzymes
- eosinophilia
- erythema nodosum
- esophageal stricture
- esophageal ulceration
- esophagitis
- fatigue
- fever
- flushing
- gastritis
- GI bleeding
- GI perforation
- headache
- hemolytic anemia
- hemorrhoids
- hepatic failure
- hepatic necrosis
- hepatitis
- hyperbilirubinemia
- hyperuricemia
- hyperventilation
- hypoglycemia
- hypoprothrombinemia
- impaired cognition
- insomnia
- interstitial nephritis
- intracranial bleeding
- laryngeal edema
- leukocytosis
- leukopenia
- lupus-like symptoms
- maculopapular rash
- malaise
- melena
- myalgia
- myasthenia
- myoglobinuria
- myopathy
- nausea
- pancreatitis
- pancytopenia
- peptic ulcer
- peripheral neuropathy
- photosensitivity
- platelet dysfunction
- prolonged bleeding time
- pruritus
- purpura
- pyrosis (heartburn)
- rash
- renal failure (unspecified)
- renal papillary necrosis
- renal tubular necrosis
- renal tubular obstruction
- Reye’s syndrome
- rhabdomyolysis
- Stevens-Johnson syndrome
- thrombocytopenia
- tinnitus
- toxic epidermal necrolysis
- urticaria
- vasculitis
- vomiting
- weakness
- wheezing
Monitoring Parameters
- creatine phosphokinase (CPK)
- LFTs
- serum cholesterol profile
Contraindications
- abrupt discontinuation
- acid/base imbalance
- acute bronchospasm
- agranulocytosis
- alcoholism
- anticoagulant therapy
- ascites
- asthma
- bone marrow suppression
- breast-feeding
- children
- cholestasis
- coagulopathy
- dehydration
- diabetes mellitus
- electrolyte imbalance
- endocrine disease
- G6PD deficiency
- geriatric
- GI bleeding
- GI disease
- gout
- head trauma
- heart failure
- hemophilia
- hepatic disease
- hepatic encephalopathy
- hepatitis
- hypertension
- hypoprothrombinemia
- hypotension
- hypovolemia
- immunosuppression
- increased intracranial pressure
- infants
- intramuscular injections
- iron-deficiency anemia
- jaundice
- labor
- metabolic acidosis
- metabolic alkalosis
- myopathy
- nasal polyps
- neutropenia
- NSAID hypersensitivity
- obstetric delivery
- organ transplant
- peptic ulcer disease
- pregnancy
- renal disease
- renal failure
- renal impairment
- respiratory acidosis
- respiratory alkalosis
- Reye’s syndrome
- rhabdomyolysis
- salicylate hypersensitivity
- seizure disorder
- sepsis
- surgery
- systemic lupus erythematosus (SLE)
- tartrazine dye hypersensitivity
- thrombocytopenia
- thrombolytic therapy
- thrombotic thrombocytopenic purpura (TTP)
- tobacco smoking
- urticaria
- viral infection
- vitamin K deficiency
Interactions
- Abciximab
- Acetaminophen
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Codeine
- Acetaminophen; Dextromethorphan
- Acetaminophen; Dextromethorphan; Doxylamine
- Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
- Acetaminophen; Dextromethorphan; Phenylephrine
- Acetaminophen; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Dichloralphenazone; Isometheptene
- Acetaminophen; Diphenhydramine
- Acetaminophen; Guaifenesin; Phenylephrine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Pentazocine
- Acetaminophen; Propoxyphene
- Acetaminophen; Pseudoephedrine
- Acetaminophen; Tramadol
- Acetazolamide
- Acetohexamide
- Acidifying Agents
- Ado-Trastuzumab emtansine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Aliskiren; Hydrochlorothiazide, HCTZ
- Alkalinizing Agents
- Alogliptin
- Alogliptin; Metformin
- Alogliptin; Pioglitazone
- Alpha-glucosidase Inhibitors
- Amiloride
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- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amoxicillin
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- Amoxicillin; Clavulanic Acid
- Amphotericin B
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- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
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- Empagliflozin; Linagliptin
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- Empagliflozin; Metformin
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- Enalapril, Enalaprilat
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- Green Tea
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- Hydrochlorothiazide, HCTZ; Methyldopa
- Hydrochlorothiazide, HCTZ; Metoprolol
- Hydrochlorothiazide, HCTZ; Moexipril
- Hydrochlorothiazide, HCTZ; Olmesartan
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrochlorothiazide, HCTZ; Quinapril
- Hydrochlorothiazide, HCTZ; Spironolactone
- Hydrochlorothiazide, HCTZ; Telmisartan
- Hydrochlorothiazide, HCTZ; Triamterene
- Hydrochlorothiazide, HCTZ; Valsartan
- Hydrocodone; Ibuprofen
- Ibritumomab Tiuxetan
- Ibrutinib
- Ibuprofen
- Ibuprofen; Oxycodone
- Ibuprofen; Pseudoephedrine
- Idelalisib
- Iloprost
- Immune Globulin IV, IVIG, IGIV
- Incretin Mimetics
- Indapamide
- Indomethacin
- Inotersen
- Insulins
- Intravenous Lipid Emulsions
- Iron Sucrose, Sucroferric Oxyhydroxide
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Ketoprofen
- Ketorolac
- Lamivudine; Tenofovir Disoproxil Fumarate
- Lansoprazole; Naproxen
- Lanthanum Carbonate
- Leflunomide
- Lesinurad
- Lesinurad; Allopurinol
- Letermovir
- Linagliptin
- Linagliptin; Metformin
- Lisinopril
- Loop diuretics
- Lovastatin; Niacin
- Low Molecular Weight Heparins
- Macimorelin
- Mannitol
- Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
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- Meglitinides
- Meloxicam
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Methazolamide
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- Methyclothiazide
- Methylsulfonylmethane, MSM
- Metoclopramide
- Metolazone
- Moexipril
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- Mycophenolate
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- Naproxen
- Naproxen; Pseudoephedrine
- Naproxen; Sumatriptan
- Nateglinide
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