Sozicold Uses

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What is Sozicold?

Relieving nasal and non-nasal symptoms associated with seasonal and perennial allergies such as watery or itchy eyes, runny nose, sneezing, and stuffy nose.

Sozicold is a decongestant (Pseudoephedrine (Sozicold)) and antihistamine (Cetirizine (Sozicold)) combination. It works by blocking a chemical in the body, histamine, which causes allergy symptoms. It also shrinks swollen nasal passages, which relieves nasal congestion.

Sozicold indications

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Sozicold® (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) Tablets should be administered when both the antihistaminic properties of Sozicold and the nasal decongestant properties of Pseudoephedrine (Sozicold) hydrochloride are desired.

Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) 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.

How should I use Sozicold?

Use Sozicold as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Sozicold.

Sozicold description

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Each prolonged-release tablet contains Cetirizine (Sozicold) diHCl 5 mg and Pseudoephedrine (Sozicold) HCl 120 mg.

It also contains the following excipients: Hydroxypropylmethylcellulose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, croscarmellose sodium, titanium dioxide (E171), polyethylene glycol 400.

Sozicold dosage

Sozicold Dosage

Generic name: Sozicold 5mg, Pseudoephedrine (Sozicold) Hydrochloride 120mg

Dosage form: tablet, extended release

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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

More about Sozicold (Cetirizine (Sozicold) / Pseudoephedrine (Sozicold))

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Sozicold interactions

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What other drugs will affect Sozicold?

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Sozicold and Pseudoephedrine (Sozicold) hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly.

No clinically significant drug interactions have been found with Cetirizine (Sozicold) and theophylline at a low dose, azithromycin, ketoconazole, or erythromycin. There was a small decrease in the clearance of Cetirizine (Sozicold) caused by a 400 mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.

Due to the Pseudoephedrine (Sozicold) component, Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) 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 (Sozicold) is used concomitantly with digitalis. Care should be taken in the administration of Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) Tablets concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.

Sozicold side effects

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What are the possible side effects of Sozicold?

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Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) Tablets

In two double-blind, placebo-controlled trials (n = 2094) in which 701 patients with seasonal allergic rhinitis were treated with Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) Tablets (Sozicold 5 mg and Pseudoephedrine (Sozicold) hydrochloride 120 mg) twice daily for two weeks, the percent of patients who withdrew prematurely due to adverse events was 2.0% in the Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) group, compared with 1.1% in the placebo group. All adverse events that were reported by greater than 1% of patients in the Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) group are listed in Table 1.

TABLE 1. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN SEASONAL ALLERGIC RHINITIS TRIALS OF Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) TABLETS AT RATES OF 1% OR GREATER (PERCENT INCIDENCE)

ADVERSE EXPERIENCE Sozicold PLACEBO
(n = 701) (n = 696)
Insomnia 4.0 0.6
Dry Mouth 3.6 0.4
Fatigue 2.4 0.9
Somnolence 1.9 0.1
Pharyngitis 1.7 1.1
Epistaxis 1.1 0.9
Accidental Injury 1.1 0.4
Dizziness 1.1 0.1
Sinusitis 1.0 0.6

ZYRTEC Tablets

Controlled and uncontrolled clinical trials of Cetirizine (Sozicold) conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving Cetirizine (Sozicold) at doses of 5 to 20 mg per day. The duration of treatment ranged from 1 week to 6 months, with a mean exposure of 30 days.

Most adverse reactions reported during therapy with Cetirizine (Sozicold) were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving Cetirizine (Sozicold) 5 mg or 10 mg was not significantly different from placebo (2.9% vs. 2.4%, respectively).

The most common adverse reaction in patients aged 12 years and older that occurred more frequently on Cetirizine (Sozicold) than placebo was somnolence. The incidence of somnolence associated with Cetirizine (Sozicold) was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for Cetirizine (Sozicold) were uncommon (1.0% on Cetirizine (Sozicold) vs. 0.6% on placebo). Fatigue and dry mouth also appeared to be treatment-related adverse reactions. There were no differences by age, race, gender or by body weight with regard to the incidence of adverse reactions.

Table 2 lists adverse experiences in patients aged 12 years and older that were reported for Cetirizine (Sozicold) 5 and 10 mg in controlled clinical trials in the United States and were more common with Cetirizine (Sozicold) than placebo.

TABLE 2. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN PLACEBO-CONTROLLED UNITED STATES Cetirizine (Sozicold) TRIALS (MAXIMUM DOSE OF 10 MG) AT RATES OF 2% OR GREATER (PERCENT INCIDENCE)

ADVERSE EXPERIENCE Cetirizine (Sozicold) PLACEBO
(n=2034) (n=1612)
Somnolence 13.7 6.3
Fatigue 5.9 2.6
Dry Mouth 5.0 2.3
Pharyngitis 2.0 1.9
Dizziness 2.0 1.2

In addition, headache and nausea occurred in more than 2% of the patients, but were more common in placebo patients.

The following events were observed infrequently (less than 2%), in 3982 adults and children 12 years and older or in 659 pediatric (6 to 11 years) patients who received Cetirizine (Sozicold) in U.S. trials, including an open study of six months duration. A causal relationship of these infrequent events with Cetirizine (Sozicold) administration has not been established.

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, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Cetirizine (Sozicold) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Sozicold) 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 (Sozicold) Hydrochloride

Pseudoephedrine (Sozicold) 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.

Sozicold contraindications

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What is the most important information I should know about Sozicold?

Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) Tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients or to hydroxyzine.

Due to its Pseudoephedrine (Sozicold) component, Sozicold (Cetirizine (Sozicold), Pseudoephedrine (Sozicold)) 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.

Active ingredient matches for Sozicold:

Cetirizine/Pseudoephedrine

Cetirizine Hydrochloride

Caffeine/cetirizine hydrochloride/chlorpheniramine maleate/paracetamol/pseudoephedrine hydrochloride in India.


Unit description / dosage (Manufacturer)Price, USD
Sozicold Cetirizine hydrochloride 5 mg, Pseudoephedrine hydrochloride30 mg, Paracetamol 500 mg, Caffeine 20 mg, Chlorpheniramine maleate 2 mg. TAB / 200
10's$ 0.12
SOZICOLD tab 10's (Sozin Pharma)$ 0.12

List of Sozicold substitutes (brand and generic names):

SOFCOLD TABLET 1 strip / 10 tablets each (Soft Pharmaceuticals)$ 0.25
Sparcet 10mg TAB / 10x10 (Sparkles Exim Pvt Ltd)$ 1.93
Sparcet 10 mg Tablet (Sparkles Exim Pvt Ltd)$ 0.02
Speedcet 10mg TAB / 10
Starzine 10mg TAB / 100 (Captab Biotec)$ 3.01
10 mg x 100's (Captab Biotec)$ 3.01
Starzine 10 mg Tablet (Captab Biotec)$ 0.03
STARZINE tab 10 mg x 10's (Captab Biotec)$ 0.30
Stcold Cetirizine 5 mg, Pseudoephedrine 30 mg, Paracetamol 500 mg. TAB / 10 (Plus India)$ 0.36
10's (Plus India)$ 0.36
STCOLD tab 10's (Plus India)$ 0.36
Sudophin Paracetamol 500 mg, Cetirizinedihydrochloride 10 mg, Pseudoephedrine 30 mg. TAB / 10 (Pharmatech Healthcare)$ 0.31
10's (Pharmatech Healthcare)$ 0.31
Sudophin 500+30+10 Tablet (Pharmatech Healthcare)$ 0.03
SUDOPHIN tab 10's (Pharmatech Healthcare)$ 0.31
Sytra 10mg FC-TAB / 100 (Synokem Pharmaceuticals Ltd)$ 2.52
10 mg x 100's (Synokem Pharmaceuticals Ltd)$ 2.52
Sytra 10 mg Tablet (Synokem Pharmaceuticals Ltd)$ 0.03
SYTRA 10MG TABLET 1 strip / 10 tablets each (Synokem Pharmaceuticals Ltd)$ 0.21
SYTRA film-coated tab 10 mg x 10's (Synokem Pharmaceuticals Ltd)$ 0.25
Sytra 10mg Tablet (Synokem Pharmaceuticals Ltd)$ 0.02
Tab Arid Cetirizine hydrochloride 10mg, Pseudoephedrine 60 mg, Ambroxol hydrochloride 30 mg. TAB / 100 (Siesta Pharmaceuticals)$ 3.01
100's (Siesta Pharmaceuticals)$ 3.01
Tab Arid 60+30+10 Tablet (Siesta Pharmaceuticals)$ 0.03
TAB ARID tab 10's (Siesta Pharmaceuticals)$ 0.30
Taurcet-A Ambroxol hydrochloride 60 mg, Cetirizine hydrochloride 10mg. TAB / 10 (Taurus Labs)$ 0.24
10's (Taurus Labs)$ 0.24
TAURCET-A tab 10's (Taurus Labs)$ 0.24
Trezix Plus Cetirizine 10 mg, Pseudoephedrine 30 mg, Paracetamol 500 mg. TAB / 500 (Scoshia)$ 9.64
500's (Scoshia)$ 9.64
TREZIX PLUS tab 10's (Scoshia)$ 0.19
Trilert 10mg TAB / 10 (Trigenesis Lifesciences Pvt. Ltd.)$ 0.28
10 mg x 10's (Trigenesis Lifesciences Pvt. Ltd.)$ 0.28
Trilert 10 mg Tablet (Trigenesis Lifesciences Pvt. Ltd.)$ 0.03
TRILERT tab 10 mg x 10's (Trigenesis Lifesciences Pvt. Ltd.)$ 0.28
Trizin-10 10mg TAB / 10x5x10$ 14.46
Troz-10 10mg TAB / 10
Trozan-OD Cetirizine dihydrochloride 5mg, Diethylcarbamazine 120 mg SYR / 60ml (Stedman)$ 0.43

References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "PSEUDOEPHEDRINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. DailyMed. "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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