Description

How Supplied

Antihistamine decongestant tablets are presented as forms that containing 2 mg chlorpheniramine maleate and 30 mg pseudoephedrine Hydrochloride, 10 Tablets per blister pack. 10 blisters with a leaflet in a box.

Category

Antihistaminic (H₁ – receptor); decongestant.

Mechanism of Action

Antihistamines used in the treatment of allergy act by competing with histamine for H₁ – receptor sites on effector cells. in varying degrees , most of the pharmacological effects Of histamine, including urticaria and pruritus. Also , the anticholinergic action of most antihistamines provide a drying effect on the nasal mucosa.and pseudoephedrine acts on alpha-adrenergic receptors in the mucosa of respiratory tract, producing vasoconstriction.the medication reduces tissue hyperemia,edema and nasal congestion, and increase nasal airway patency.

Pharmacokinetics

• Absorption: well absorbed after oral administration.
•  Elimination: Antihistamin-metabolites within 24 hours; pseudoephedrine-renal, about 55 to 75% of a dose is excreted unchanged.
• Half – life: Elimination-14 to 25 hours.

Pregnancy and breast feeding

Studies in human have not been done. FDA pregnancy category B.

This drug distributed into breast milk.

Precautions

• Avoiding use of Alcohol or other CNS depressants.
• Possible insomnia,taking the medication a few hours before bedtime.
• Possible dryness of mouth , using sugarless gum or candy , ice , or saliva substitute for relief , checking with dentist if dry mouth continues for more than 2 weeks.
• Not using concurrently with other sedatives , tranquilizers or appetite suppressants.
• caution if skin test using allergens required , possible interference with test results .
• checking with physician if symptoms do not improve within 7 days or if fever is present.
• This drug May mask ototoxic effects of large doses of salicylates.

Drug interaction

Inform your doctor if you are taking any of the following medicines :

Antacids , magnesium or aluminum containing ; Alcohol ; CNS – depression- producing medications ; Anticholinergics or other medications with anticholinergic activity; Apomorphine; Erythromycin;fluconazole; itraconazole; ketoconazole;metronidazole; Miconazole; furazolidone ; procarbazine; ototoxic medications;Selegiline; photosensitizing  medications;Halothane;Isoflurane;Methoxyflurane;Trichloroethylene;Antihypertensives or Diuretics used as antihypertensive; Beta – adrenergic blocking agents; Central Nervous system stimulation-producing medications;citrates; cocain, mucosal – local; Digitalis glycosides; levodopa; Nitrates; Rauwolfia alkaloids; other sympathomimetics.

Dosage and Administration

Usual Adult Dose :

10 ml every 6 hours , and maximum 40 ml per day.

Usual pediatric Dose :

Children 2-6 years:2.5 ml every 6 hours.

Children 6 to 12 years : 5 ml every 6 hours .

Side Effects

Those indicating need for medical attention:

Incidence rare or more frequent with high doses:

Convulsion;hallucination;irregular or slow heartbeat;shortness of breath or trouble breathing

Those indicating need for medical attention only if they continue or bothersome:

Incidence less frequent or rare:Confusion;constipation;headache;mild dizziness;mild drowsiness;nausea;vomiting;stomach pain;Difficult or painful urination; dizziness;light headedness;fast or pounding heartbeat;headache;increased sweeting;tremblimg;unusual paleness;weakness.

Incidence more frequent:nervousness;restlessness;trouble in sleeping.

Starage

Store below 30^˚c , (preferably between 15 ^ºc to 30 ^ºc),protect from light and moisture.keep out of reach of children.protect from freezing.

Data of Revision

July 2013

Manufactured by Pursina pharmaceutical Co. Tehran – Iran.