Kold Time

Each prolonged-release tablet contains Cetirizine (Kold Time) diHCl 5 mg and Pseudoephedrine (Kold Time) 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.

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

Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) 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.

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

Kold Time is a decongestant (Pseudoephedrine (Kold Time)) and antihistamine (Cetirizine (Kold Time)) 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.

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

Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) Tablets may be given with or without food.

How supplied

Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) Tablets are white, round, biconvex, bilayer tablets containing 5 mg Kold Time in an immediate release layer and 120 mg Pseudoephedrine (Kold Time) hydrochloride in an extended release layer. Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) Tablets are supplied in high-density polyethylene bottles of 100 tablets fitted with polypropylene child-resistant closures (NDC 0069-1630-66).

Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) Tablets are engraved with Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) on one side.

STORAGE: Store at 20°C to 25°C (68° to 77°F)

For questions contact McNEIL-PPC, Inc at 1.800.343.7805

See also:
What is the most important information I should know about Kold Time?

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

Due to its Pseudoephedrine (Kold Time) component, Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) 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.

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

• Kold Time may be taken with or without food.
• Swallow whole. Do not crush, break, or chew before swallowing.
• If you miss a dose of Kold Time, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

See also:
What other drugs will affect Kold Time?

No interaction studies have been performed with the combination Cetirizine (Kold Time)-Pseudoephedrine (Kold Time).

Lack of Interactions: Pharmacokinetic interaction studies were conducted with Cetirizine (Kold Time) and cimetidine, ketoconazole, erythromycin, azithromycin, antipyrine and Pseudoephedrine (Kold Time); no pharmacokinetic interactions were observed.

Studies with Cetirizine (Kold Time) and cimetidine, glipizide, diazepam, and Pseudoephedrine (Kold Time) have revealed no evidence of adverse pharmacodynamic interactions.

Studies with Cetirizine (Kold Time) and azithromycin, erythromycin, ketoconazole, theophylline and Pseudoephedrine (Kold Time) have revealed no evidence of adverse clinical interactions. In particular, concomitant administration of Cetirizine (Kold Time) with macrolides or ketoconazole has never resulted in clinically relevant ECG changes.

Sedatives: No clinically significant interaction has been described with Cetirizine (Kold Time), but caution is recommended on concomitant use of sedatives.

Theophylline: In a multiple-dose study of theophylline (400 mg once a day) and Cetirizine (Kold Time), there was a small (16%) decrease in clearance of Cetirizine (Kold Time), while the disposition of theophylline was not altered by concomitant Cetirizine (Kold Time) administration.

Ritonavir: In a multiple-dose study of ritonavir (600 mg twice daily) and Cetirizine (Kold Time) (10 mg daily), the extent of exposure to Cetirizine (Kold Time) was increased by about 40% while the disposition of ritonavir was not altered by concomitant Cetirizine (Kold Time) administration.

Monoamine Oxidase Inhibitors (MAOIs): Concomitant use of sympathomimetic amines with MAOIs can result in hypertensive crisis. Because of the long duration of action of MAOIs, this interaction is still possible 15 days after stopping such a treatment.

Dihydroergotamine and Linezolid: An increase in blood pressure can also occur on concomitant administration of dihydroergotamine or linezolid.

Risk of Vasoconstriction and Increased Blood Pressure: The following combinations are not recommended as there is a risk of vasoconstriction and increased blood pressure: Bromocriptine, pergolide, lisuride, cabergoline, as well as dihydroergotamine, ergotamine, methylergometrine, and other vasoconstrictors used as oral or nasal decongestants (phenylpropanolamine, phenylephrine, ephedrine, etc).

Reduction of the Antihypertensive Effects of Drugs: Sympathomimetic amines may reduce the antihypertensive effects of β-adrenergic blockers and of drugs that interfere with sympathetic activity eg, methyldopa, guanethidine and reserpine.

Tricyclic Antidepressants (TCAs): Tricyclic antidepressants can potentiate the hypertensive effect of Pseudoephedrine (Kold Time).

Digitalis: The ectopic activity of a pacemaker can be increased when Pseudoephedrine (Kold Time) is used with digitalis; use of Kold Time is therefore not advised in digitalised patients.

Drugs Increasing or Decreasing Kold Time Absorption: Antacids and proton pump inhibitors increase the rate of Pseudoephedrine (Kold Time) absorption; kaolin decreases it.

Ventricular Arrhythmia: Concurrent use with halogenated anaesthetic agents eg, chloroform, enflurane, isoflurane, cyclopropane, halothane may provoke or worsen ventricular arrhythmia.

Tests for Allergies: Antihistamines can interfere with cutaneous tests for allergies and an appropriate wash-out period is required before conducting such tests.

Fat Meal: A high-fat meal was not found to modify the bioavailability of both active ingredients, but it resulted however in a reduced and delayed peak plasma concentration of Cetirizine (Kold Time).

Incompatibilities: There are no relevant data available.

See also:
What are the possible side effects of Kold Time?

Kold Time (Cetirizine (Kold Time), Pseudoephedrine (Kold Time)) Tablets

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

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

ZYRTEC Tablets

Controlled and uncontrolled clinical trials of Cetirizine (Kold Time) conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving Cetirizine (Kold Time) 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 (Kold Time) were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving Cetirizine (Kold Time) 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 (Kold Time) than placebo was somnolence. The incidence of somnolence associated with Cetirizine (Kold Time) was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for Cetirizine (Kold Time) were uncommon (1.0% on Cetirizine (Kold Time) 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 (Kold Time) 5 and 10 mg in controlled clinical trials in the United States and were more common with Cetirizine (Kold Time) than placebo.

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

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 (Kold Time) in U.S. trials, including an open study of six months duration. A causal relationship of these infrequent events with Cetirizine (Kold Time) 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 (Kold Time) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Kold Time) 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 (Kold Time) Hydrochloride

Pseudoephedrine (Kold Time) 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.