Decancit SR tablets

Decancit SR tablets: 5 mg Cetirizine hydrochloride + 120 mg Pseudoephedrine hydrochloride 

DRUG DESCRIPTION

Decancit SR tablets (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) Extended Release Tablets for oral administration contain 5 mg of cetirizine hydrochloride for immediate release and 120 mg of pseudoephedrine hydrochloride for extended release.

Cetirizine hydrochloride, one of the two active components of Decancit SR tablets, is an orally active and selective H1-receptor antagonist.

Pseudoephedrine hydrochloride, the other active ingredient of Decancit SR tablets, is an adrenergic (vasoconstrictor) agent.

INDICATIONS

Decancit SR tablets should be administered when both the antihistaminic properties of cetirizine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired. Decancit SR tablets are indicated for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 12 years of age and older.

DOSAGE AND ADMINISTRATION

Do not break or chew tablet; swallow tablet whole.

  • Adults and Children 12 Years and over: take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours .
  • Adults 65 years and over: Ask a doctor.
  • Children under 12 years of age: Ask a doctor.
  • Consumers with liver or kidney disease: Ask a doctor. 

Decancit SR tablets may be given with or without food.

HOW SUPPLIED

Decancit SR tablets: are white, round, biconvex, tablets containing 5 mg cetirizine hydrochloride and 120 mg pseudoephedrine hydrochloride.

SIDE EFFECTS

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention. Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect. Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema. Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst. 

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder. 

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis. Reticuloendothelial: lymphadenopathy. 

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness. conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury. asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, meta.. nasal polyp. pain. pallor. periorbital edema, peripheral edema, rigors. Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevations and elevated bilirubin in association with the use of cetirizine has been reported.

In foreign marketing experience or experience in the post market period, the following additional rare, but potentially severe adverse events have been reported: anaphylaxis, cholestasis, glomerulonephritis, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, thrombocytopenia, aggressive reaction and convulsions. PSEUDOEPHEDRINE HYDROCHLORIDE: Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, nausea, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

DRUG INTERACTIONS

Cetirizine hydrochloride and pseudoephedrine hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly. 

No clinically significant drug interactions have been found with cetirizine and theophylline at a low dose, azithromycin, ketoconazole, or erythromycin.

There was a small decrease in the clearance of cetirizine caused by a 400 mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.

Due to the pseudoephedrine component, Decancit SR tablets are contraindicated in patients taking monoamine oxidase (MAO) inhibitors and for 14 days after stopping use of an MAO inhibitor.

Concomitant use with antihypertensive drugs that interfere with sympathetic activity (e.g., methyldopa, mecamylamine, and reserpine) may reduce their antihypertensive effects. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis

Care should be taken in the administration of Decancit SR tablets concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.

WARNINGS

  1. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. 
  2. Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.
  3. The elderly are more likely to have adverse reactions to sympathomimetic amines. 

PRECAUTIONS

Due to its pseudoephedrine component, Decancit SR tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. 

Patients with decreased renal function should be given a lower initial dose (one tablet per day) because they have reduced elimination of cetirizine and pseudoephedrine.

Activities Requiring Mental Alertness: In dinical trials, the occurrence of somnolence has been reported in some patients taking cetirizine or Decancit SR tablets; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery after taking Decancit SR tablets. 

Concurrent use of Decancit SR tablets with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Because cetirizine and pseudoephedrine are excreted in milk , use of Decancit SR tablets in nursing mothers is not recommended. 

Pregnancy Category C: Decancit SR tablets: Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Because cetirizine and pseudoephedrine are excreted in milk, use of Decancit SR tablets in nursing mothers is not recommended.

Pediatric Use: Decancit SR tablets contain 120 mg of pseudoephedrine hydrochloride in an extended release formulation. This dose of pseudoephedrine exceeds the recommended dose for pediatric patients under 12 years of age. Therefore, clinical trials have not been conducted in patients under 12 years of age.

OVERDOSE

Information regarding acute overdosage is limited to experience with cetirizine alone and the marketing history of pseudoephedrine hydrochloride.

Overdosage has been reported with cetirizine. In one adult patient who took 150 mg of cetirizine, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. 

In an 18-month-old pediatric patient who took an overdose of cetirizine (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications.

There is no known specific antidote to cetirizine. Cetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The acute minimal lethal oral doses in mice and rats were 237 and 562 mg/kg, respectively (approximately 95 and 460 times the maximum recommended daily dose in adults on a mg/m2 basis).

In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver. In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia.

Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

CONTRAINDICATIONS

Decancit SR tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients or hydroxyzine. Due to its pseudoephedrine component, Decancit SR tablets are contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment.

It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures.

Manifestations of patient idiosyncrasy to adrenergic agents include insomnia, dizziness, weakness, tremor, or arrhythmias.

CLINICAL PHARMACOLOGY

Mechanisms of Action’ Cetirizine, a metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of H1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and Ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity.

In clinical trials, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors. 

Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H1 receptors.

Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects. 

PACKAGE AND STORAGE

Carton box contains 1,2,3 PVC/Alu each of 10 tablets + insert leaflet. Store in a dry place at a temperature not exceeding 30°C. 

Keep All Medicine Out of the Reach of Children 

Manufactured by Multi-Apex for Pharmaceutical Industries – S.A.E. – Badr City – Egypt. 3085011101.

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