ASPIRIN

PrinAs®
1 g papertabs

USE slowly in women since women

FORMULATION apparently have lower amounts of
plasma aspirin esterases. About 1%
Aspirin helps reduce the risk of of an oral aspirin dose is excreted
Each papertabs contain: blood clots in people with unhydrolyzed in urine. The
ASPIRIN........................................ cardiovascular disease or a history remainder is excreted in urine as
of clot related strokes or transient
ischemic attack (TIA). It may also
INDICATIONS help people with blood flow DRUG
problems due to blood vessel INTERACTIONS
1g disease. When arteries are already
For primary prevention of narrowed by the buildup of plaque, salicylate and its metabolites.
thromboembolic Disorders and a clot can block a blood vessel and ACE (Angiotensin Converting
stop the flow of blood to the brain or Enzyme)
cardiovascular events:
heart. Taking a regular dose of Inhibitors: Hyponatremic and
▪ Ischemic stroke aspirin diminishes the ability of hypotensive effects of ACE
▪ Transient ischemic attack (TIA) your blood to clump together the inhibitors may be diminished
▪ Acute myocardial infarction (MI) body's smallest blood cells. Acetazolamide: Increased serum
The oral dose of Aspirin is absorbed acetazolamide concentrations and
▪ Prevention of recurrent MI
toxicity due to competition at the
▪ Unstable angina pectoris renal tubule for secretion
PHARMACOKINE
For secondary prevention of Anticoagulants (Heparin, Warfarin):
TICS
cardiovascular disease in persons Increased risk of bleeding due to
with diabetes mellitus especially in drug-drug interactions and the effect
from the gastrointestinal tract for
the subgroups: on platelets
about 80 – 100%. However, the
▪ History of myocardial infarction actual bioavailability of the drug as Anticonvulsants: Salicylate can
(MI), vascular bypass procedure, displace protein-bound phenytoin
unhydrolyzed aspirin is lower since
Stroke or transient ischemic attack, and valproic acid, leading to
Aspirin is partially hydrolyzed to
and angina. decreased total concentration of
salicylate in the gastrointestinal
▪ Persons with additional risk mucosa during the absorption and phenytoin and increased serum
factors: Hypertension, smoking, on pass through the liver. Food does valproic acid levels.
Dyslipidemia, and family history of Beta – blockers: Diminished
not appear to decrease the
Cardiovascular disease. hypotensive effects of beta-blockers
bioavailability of unhydrolyzed
Revascularization procedures: For aspirin; However, absorption is due to inhibition of renal
patients who have undergone delayed and peak serum aspirin prostaglandins, leading to decreased
Revascularization procedures such concentration may be decreased. renal blood flow, and salt and fluid
as Coronary artery bypass graft retention.
Aspirin is rapidly and widely
(CABG), Percutaneous transluminal Diuretics: Diminished effectiveness
distributed into most body tissues
coronary Angioplasty (PTCA), and
and fluids. Aspirin’s volume of of Diuretics in patients with
carotid endarterectomy when there
distribution is 0.15 to 0.2 L/kg. underlying renal or cardiovascular
is pre-existing condition for which
Aspirin is poorly bound to plasma disease due to inhibition of renal
aspirin is already indicated.
proteins; the unhydrolyzed drug is prostaglandins, leading to decreased
Pregnancy – induced hypertension: renal blood flow, and salt and fluid
33% bound at a serum salicylate
For primary prevention of
concentration of 120 mcg/mL. retention.
pregnancy-induced hypertension,
Aspirin’s elimination half-life is Methotrexate: Salicylate may inhibit
preeclampsia, and intrauterine
about 15 to 20 minutes. Unlike renal clearance of methotrexate,
growth retardation particularly in
salicylate, unhydrolyzed aspirin leading to bone marrow toxicity,
pregnant women with pre – existing
chronic hypertension, auto – does not undergo capacity-limited especially in the elderly or renal
immune Disorders like systemic metabolism and does not accumulate impaired.
lupus erythematosus (SLE), positive in plasma after multiple doses. NSAIDs: Increased bleeding or may
cardiolipin antibody test, History of Aspirin is partially hydrolyzed to lead
recurring toxemia in successive salicylate during absorption by To decreased renal function.
pregnancies, and hypotension esterases in the gastrointestinal Oral hypoglycemics: Moderate
developing before the 20th week of mucosa after oral administration. doses of Aspirin may increase the
gestation. After absorption, unhydrolyzed effectiveness of Oral hypoglycemic
aspirin is rapidly and almost drugs, leading to Hypoglycemia
completely hydrolyzed by esterases Uricosuric agents (Probenecid,
DOSAGE & principally in the liver but also in Sulfinpyrazone): Salicylates
ADMINISTRATIO plasma, Erythrocytes, and synovial antagonize the uricosuric action of
N fluid; hydrolysis occurs more slowly these agents.
Take each dose of Aspirin with a full in synovial fluid since the amounts
glass of of esterases in synovial fluid are
Water once daily, or as prescribed lower. Aspirin may be hydrolyzed
by a Physician. more
 of pharmacologic actions and
CONTRAINDICATI include local gastrointestinal STORE AT TEMPERATURES
ONS irritation, direct central nervous NOT EXCEEDING 30°C
system stimulation of respiration, KEEP THE PRODUCT OUT OF
Aspirin is contraindicated to patients severe acid-base and electrolyte
who have: SIGHT AND REACH OF
disturbances and are complicated by CHILDREN
▪ Hypersensitivity to aspirin hyperthermia and dehydration.
Respiratory alkalosis occurs early BATCH NO. 2428922
▪ Asthma, rhinitis, and nasal polyps. while hyperventilation is present,
Aspirin may cause severe urticaria, MFG DATE: Sept. 13, 2023
but it EXP DATE: Sept. 12, 2025
Angioedema, and bronchospasm.
Is quickly followed by metabolic
▪ Avoid use in children and teenagers acidosis. Treatment consists
with viral infections, with or without primarily of supporting vital MONDRAGON
fever, because of the risk of Reye’s functions, increasing salicylate PHARMACEUTICALS
Syndrome with concomitant use of elimination, and correcting the acid
Aspirin in certain viral illnesses. base disturbance. Gastric emptying
and/or lavage is recommended as
soon as possible after ingestion,
even if the patient has vomited
ADVERSE EFFECTS spontaneously. After lavage and/or
emesis, administration of activated
charcoal (as a slurry), is beneficial if 925 San Vicente West, Urdaneta,
Significant: Bronchospasm, asthma
less than 3 hrs have passed since Pangasinan
attacks, hypersensitivity reactions,
prolonged bleeding time; reduced ingestion. Charcoal adsorption
uric acid excretion (low dose use); should not be employed prior to
haemolytic anaemia (in patients
with G6PD deficiency), medication
CAUTION
overuse headache (long-term use),
salicylism (repeated use of large
doses). emesis and lavage.
Blood and lymphatic system Food, Drugs, and Cosmetics Act
disorders: Rarely, prohibits dispensing without
thrombocytopenia, agranulocytosis, rescription.
aplastic anaemia.
Ear and labyrinth disorders:
Reduced hearing ability, tinnitus, For suspected adverse drug
vertigo. reaction, seek medical attention
Gastrointestinal disorders: immediately and report to the FDA
Dyspepsia, nausea, vomiting, at [Link] AND
diarrhoea, mild stomach pain, Mondragon Pharmaceuticals at
heartburn. (+028) 746 - 2000 or
Hepatobiliary disorders: Hepatic productsafety@mondragonpharma.
insufficiency, hepatitis. [Link]. By reporting undesirable
Investigations: Increased effects, you can help provide more
transaminases. information on the safety of this
Nervous system disorders: medicine.
Headache.
Renal and urinary disorders: STORAGE
Impaired renal function, Na and CONDITION
fluid retention, urate kidney stones,
haematuria.
Reproductive system and breast Store at temperature not
disorders: Rarely, menorrhagia. exceeding 30°C
Respiratory, thoracic and
mediastinal disorders: Rhinitis, WARNING
dyspnoea.
Skin and subcutaneous tissue
disorders: Urticaria. If symptoms persist, consult your
A single lethal dose of aspirin in doctor. People age 60 years without
known heart or blood vessel
disease, should not start taking
OVERDOSE adaily aspirin to prevent first time
heart attack or stroke.
adults is not known with certainty
but death may be expected at 30 g. AVAILABILITY:
Aspirin (PrinAs®) 1 mg
The principal toxic effects of
papertabs, in 1 container x 10
salicylate overdosage are extension
papertabs