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RinafortRinafort [REPETABS Tablets]
Brand of dexbrompheniramine maleate and

pseudoephedrine sulfate


Antihistamine/Decongestant Tablets


DESCRIPTION

RINAFORT REPETABS Tablet is a smooth, uniform, round, white to off-white, biconvex, lustrous coated tablet, free from foreign matter. Each RINAFORT REPETABS Tablet contains 3 mg of dexbrompheniramine maleate (antihistamine) and 60 mg pseudoephedrine sulfate (nasal decongestant) in the outer coat for immediate action and 3 mg of dexbrompheniramine maleate and 60 mg pseudoephedrine sulfate in the inner core for a second or repeat dose. Inactive ingredients: Lactose, starch, povidone, magnesium stearate, sucrose, calcium sulfate, calcium sulfate anhydrous, talc, acacia, gum rosin, gelatin, zein, titanium dioxide, oleic acid, soap, butylparaben, white wax and carnauba wax. Preservative: Butylparaben.


RINAFORT REPETABS Tablets combine two medically recognized ingredients that provide both rapid and sustained relief from symptoms of upper respiratory mucosal congestion, such as in hay fever, nasal allergies, acute rhinitis, sinusitis, rhinosinusitis and eustachian tube congestion. The antihistaminic component of RINAFORT REPETABS Tablets provides relief of runny nose, sneezing and watery, itchy eyes. The decongestant action reduces swelling of mucous membranes, gently dries and clears nasal passages.


ACTIONS

RINAFORT REPETABS Tablets combine the antihistaminic actions of dexbrompheniramine maleate with the decongestant properties of pseudoephedrine sulfate.


PHARMACOLOGY

Dexbrompheniramine is the dextro isomer of brompheniramine maleate, an alkylamine derivative. As its parent compound, the uses and properties of dexbrompheniramine are similar to those of histamine H1-receptor antagonists; these include antimuscarinic effects and sedation.


Pseudoephedrine acts directly on both α- and to a lesser degree, β-adrenergic receptors. It is believed that a-adrenergic effects result from the inhibition of the production of cyclic adenosine-3',5'-monophosphate (AMP) by inhibition of the enzyme adenyl cyclase, whereas β-adrenergic effects result from stimulation of adenyl cyclase activity. Like ephedrine, pseudoephedrine also has an indirect effect by releasing norepinephrine from its storage sites.


Pseudoephedrine acts directly on α-adrenergic receptors in the mucosa of respiratory tract producing vasoconstriction which results in shrinkage of swollen nasal mucous membranes, reduction of tissue hyperemia, edema and nasal congestion, and in an increase in nasal airway patency. Drainage of sinus secretions is increased and obstructed eustachian ostia may be opened.


Pseudoephedrine may relax bronchial smooth muscle by stimulation of β2-adrenergic receptors; however, substantial bronchodilation has not been demonstrated consistently following oral administration of the drug.


Oral administration of usual doses of pseudoephedrine to normotensive patients usually produces negligible effect on blood pressure. Pseudoephedrine may increase the irritability of the heart muscle and may alter the rhythmic function of the ventricles, especially in large doses or after administration to patients such as those with cardiac disease who are hypersensitive to the myocardial effects of sympathomimetic drugs. Tachycardia, palpitation, and/or multifocal premature ventricular contractions may occur.


Pseudoephedrine may cause mild CNS stimulation, especially in patients who are sensitive to the effects of sympathomimetic drugs.


PHARMACOKINETICS

Dexbrompheniramine

Absorption - Dexbrompheniramine appear to be well absorbed from the gastro-intestinal tract.


Following oral administration of a single 0.13 mg/kg dose of brompheniramine maleate in healthy, fasting adults in one study, peak serum brompheniramine concentrations of 7.7-15.7 ng/ml occurred within 2-5 hours; in most of these individuals, a second lower peak, possibly secondary to enterohepatic circulation, was also observed. The antihistamine effect of brompheniramine, as determined by suppression of the wheal and flare response induced by intradermal administration of histamine, appears to be maximal within 3-9 hours after a single oral dose of the drug, but suppression of the flare response may persist for up to at least 48 hours; the antipruritic effect appears to be maximal within 9-24 hours.


Following oral administration of 2 mg of dexbrompheniramine maleate every 4 hours in healthy adults, mean peak plasma concentrations of the drug were about 22 ng/ml on the sixth and seventh days of dosing and mean trough concentrations were about 17 and 18 ng/ml on the sixth and seventh days, respectively. At steady state, 6 mg of dexbrompheniramine maleate every 12 hours as extended-release tablets (RINAFORT ) is reportedly bioequivalent to 4 mg of the drug every 2 hours as conventional tablets.


Distribution - Distribution of brompheniramine into human body tissues and fluids has not been fully characterized, but the drug appears to be widely distributed. Following oral administration of a single dose of the drug in healthy adults, the apparent volume of distribution reportedly averaged 11.7 L/kg.


Elimination - In healthy adults, the half-life of brompheniramine reportedly ranges from 11.8-34.7 hours. The metabolic and excretory fate of the drug has not been fully characterized.


Brompheniramine undergoes N-dealkylation to form monodesmethylbrompheniramine and didesmethylbrompheniramine, and is metabolized to the propionic acid derivative, which is partially conjugated with glycine, and to other unidentified metabolites. Brompheniramine and its metabolites are excreted principally in urine. About 40% of an oral dose of brompheniramine is excreted in urine and about 2% in feces within 72 hours in healthy individuals. In healthy individuals, about 5-10% of an oral dose is excreted in urine as unchanged drug, 6-10% as monodesmethylbrompheniramine, 6-10% as didesmethylbrompheniramine, small amounts as the propionic acid derivative and its glycine conjugate, and the remainder as unidentified metabolites.


In healthy adults, dexbrompheniramine reportedly has an elimination half-life of about 22 hours.


Pseudoephedrine

Absorption - After oral administration of 60 mg of pseudoephedrine hydrochloride as tablets or oral solution, nasal decongestion occurs within 30 minutes and persists for 4-6 hours. Nasal decongestion may persist for 8 hours following oral administration of 60 mg and up to 12 hours following 120 mg of the drug in extended-release preparations.


Distribution - Although specific information is lacking, pseudoephedrine is presumed to cross the placenta and to enter CSF. The drug may also be distributed into milk.


Elimination - Pseudoephedrine is incompletely metabolised in the liver by N-demethylation to an inactive metabolite. The drug and its metabolite are excreted in urine; 55-75% of a dose is excreted unchanged. The rate of urinary excretion of pseudoephedrine is accelerated when urine is acidified to a pH of about 5 by prior administration of ammonium chloride. When the urine is alkalinized to a pH of about 8 by prior administration of sodium bicarbonate, some of the drug is reabsorbed in the kidney tubule and the rate of urinary excretion is slowed.


INDICATIONS AND USAGE

RINAFORT REPETABS Tablets are indicated for the relief of symptoms of upper respiratory mucosal congestion, such as in seasonal and perennial allergies, eustachian tube congestion, acute rhinitis and rhinosinusitis. The decongestant temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and associated with sinusitis. Helps decongest sinus openings and sinus passages. Reduces swelling of nasal passages and temporarily restores freer breathing through the nose. The antihistamine alleviates runny nose, sneezing, itching of the nose or throat, and itchy and watery eyes as may occur in allergic rhinitis (such as hay fever).


DOSAGE AND ADMINISTRATION

Adults and children over 12 years : One RINAFORT REPETABS Tablet every 12 hours; one in the morning and one at bedtime. Following initial improvement, one RINAFORT REPETABS Tablet daily may successfully control symptoms.

 

In exceptional cases, one RINAFORT REPETABS Tablet every eight hours may be required to control severe conditions. Dosage should be adjusted, once control is obtained, to one to two RINAFORT REPETABS Tablets daily.


Do not exceed recommended dosage.

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