COMPOSITON
ACTIVE – P TAB
Each
tablet contains
Triprolidine
HCl 5mg
Phenylephrine
HCl 10mg
Paracetamol 500mg
INTRODUCTION
ACTIVE-P containing Paracetamol 500mg, Triprolidine HCL 5 mg and
Phenylephrine 10 mg is used to treat nasal congestion; itchy, watery eyes;
itchy throat; sneezing; headache; fever; and other symptoms associated with
allergies, hay fever , and the common cold.
PHARMACOLIGY
Pharmacodynamics
The
drug may directly stimulate adrenergic receptors but probably indirectly
stimulates both a and b adrenergic receptors by
releasing norepinephrine from its storage sites. Pseudoephedrine increases heart rate, force of contraction and
cardiac output, and excitability. It acts on a receptors in the mucosa of the respiratory tract,
producing vasoconstriction which results in shrinkage of swollen mucous
membranes, reduction of tissue, hyperemia, edema and nasal congestion, and an
increase in nasal airway potency. Pseudoephedrine causes CNS stimulation and
reportedly has an anorexigenic effect.
Triprolidine
blocks the effects of the naturally occurring chemical histamine in the body,
thereby relieving the allergic symptoms. Paracetamol relieves pain and fever by
blocking the Prostaglandin (PG) secretion to the site of pain.
Pharmacokinetics
Triprolidine
is absorbed from the GI tract and metabolized into a caboxylated derivative. It
is excreted mainly in urine.
Phenylephrine
has low oral bioavailability owing to irregular absorption and first-pass
metabolism by monoamine oxidase in the gut and liver.
Paracetamol
is readily absorbed from the GI tract with peak plasma concentration occurring
about 10-16 minutes after oral administration. It is distributed into most body
tissues, crosses the placenta and is present in breast milk. It is metabolized
primarily in liver and excreted in urine. Less than 5% is excreted as unchanged
Paracetamol.
DOSE AND ADMINISTRATION
The
maximum amount of paracetamol for adults is 1 gm (1000 mg) per dose and 4 gm
(4000 mg) per day. Taking more paracetamol could damage liver. Active-P should not be used for more
than 7 to 10 days in a row.
CONTRAINDICATIONS
Hepatic
damage, peptic ulcer and hypersensitivity.
DRUG INTERACTIONS
Active-P may increase the effects of other drugs that cause drowsiness, including
antidepressants, alcohol, other antihistamines, pain reliever, anxiety
medicines, seizure medicines, and muscle relaxants. Dangerous sedation,
dizziness, or drowsiness may occur if Active-P
is taken with any of these medications.
ACTIVE-P has drug interaction with monoamine oxide inhibitor
(MAOI). A very serious drug interaction could occur, leading to serious side
effects.
ADVERSE REACTIONS
Liver
damage, blood problems (easy or unusual bleeding or bruising) or low blood
sugar, Dry eyes, nose, and mouth drowsiness or dizziness blurred vision
difficulty urinating; or; excitation in children.
PRECAUTIONS
ACTIVE-P may cause dizziness or drowsiness so precaution should
be taken when driving, operating machinery, or performing other hazardous
activities.
Alcohol
may increase drowsiness and dizziness while taking ACTIVE-P. Alcohol may also cause damage to liver when taken with Paracetamol.
Safety
in pregnancy is not established.
ACTIVE-P may in traces metabolized through breast milk.
OVERDOSAGE
Symptoms
of an ACTIVE-P overdose include a
dry mouth, large pupils, flushing, nausea, vomiting, abdominal pain, diarrhea,
seizures, confusion, sweating, and an irregular heartbeat.
